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RF_DR_1_PART_2_SUDHA
W'l ■
WORLD HEALTH ORGANIZATION
DISTR.: LIMITED
ORGANISATION MONDIALE DE LA SANTE
DAP/86.3(4)
DRAFT
NATIONAL DRUG POLICY AND STRATEGY
SESSION GUIDE
PLANNING DRUG REQUIREMENTS
DISTR. : LIMITED
DISTR. : LIMITEE
WORLD HEALTH ORGANIZATION
ORGANISATION MONDIALE DE LA SANTE
DAP/86.3(4)
DRAFT
NATIONAL DRUG POLICY AND STRATEGY
SESSION GUIDE
PLANNING DRUG REQUIREMENTS
This document is part of a series of nine session guides: (1) Introduction to a National
Drug Policy, (2) Supply System Organization, (3) Selection of Drugs, (5) Procurement
Strategies, (6) Systematic Cost Reduction, (7) Financing The Drug Supply, (8) Quality
Assurance, (9) Introduction to Proper Drug Use.
This document can be used in conjunction with DAP/86.2 Trainers’ Guides.
This document is not issued to the general public, and
all rights are reserved by the World Health Organization
(WHO). The document may not be reviewed, abstracted,
quoted, reproduced or translated, in part or in whole,
without the prior written permission of WHO. No part
of this document may be stored in a retrieval system or
transmitted in any form or by any means ■ electronic,
mechanical or other without the prior written permission
of WHO.
Ce document n'est pas destine a etre distribue au grand public
et tous les droits y afferents sont reserves par I'Organisation
mondiale de la Sante (OMS). 11 ne peut etre commente, resume,
cite, reproduit ou traduit, partiellement ou en totalite, sans
une autorisation prdalable Kerite de I'OMS. Aucune partie
ne doit &tre chargee dans un systeme de recherche documentaire ou diffusee sous quelque forme ou par quelque moyen
que ce soit - dlectronique, mecanique, ou autre • sans une auto
mation prealable ecrite de I'OMS.
The views expressed in documents by named authors are
solely the responsibility of those authors.
Les opinions exprimees dans les documents par des auteurs
cites nommdment n'engagent que lesdits auteurs.
SESSION GUIDE
SESSION:
Planning Drug Requirements
DURATION:
2 hours
RATIONALE:
One of the most important decisions in the drug supply cycle is that of
determining the order quantities for Individual drugs and medical supplies.
Most often, order quantities are based on past consumption. However, when
consumption data are incomplete or unreliable, when funds are inadequate, when
drug utilization patterns seem inefficient or irrational, or when a new
program is being established, then a more methodical approach to planning drug
requirements is needed. This unit reviews different techniques which can be
used to estimate Individual drug requirements.
OBJECTIVES:
To improve your ability to:
1.
Identify at least two methods for estimating annual drug requirements:
the consumption method and the epidemiology method.
2.
Collect reliable consumption information or estimates of consumption.
3.
Organize the analysis of past consumption patterns to identify potential
ways to promote cost-effective drug utilization.
4.
Perform or supervise the steps necessary to make epidemiologically-based
estimates of drug requirements.
5.
Use the epidemiologic method of estimating drug requirements to help
rationalize drug utilization and, where funds are limited, to set
priorities for drug procurement.
PREPARATION:
Read the Session Notes.
PLAN:
1.
Discussion of what is meant by the term "planning drug requirements."
2.
Discussion of your current methods for estimating drug needs.
3.
Presentation of the consumption method.
4.
Presentation of the epidemiology method.
Managing Drug Supply, Chapter II.B.
FURTHER
READINGS:
©
Management Sciences for Health 1986. This training unit has been adapted by
the World Health Organization from material produced by Management Sciences
for Health.
DAP/86.3(4)
page 3
SESSION NOTES
Determining drug requirements is perhaps one of the most difficult responsibilities
faced by physicians, pharmacists, and supply specialists who manage pharmaceutical
procurement. On the one hand, one would like to avoid perpetuating wasteful or irrational
drug utilization by simply ordering on the basis of historical demand for individual drugs.
On the other hand, one would also like to avoid creating severe shortages of some items and
overstocks of other items by ordering entirely on the basis of some theoretically determined
need for individual drugs. Furthermore, lack of reliable information often makes it
difficult to determine accurately either historical demand or theoretical need.
Needless to say, there is no "best” way to determine drug requirements. The approach
which is taken should be selected on the basis of the drug and health care information
available, the purposes of the estimate, and the nature of the drug supply program. Methods
for estimating drug requirements fall into two main categories: consumption-based methods
and epidemiology-based methods.
Consumption methods rely on analysis of past consumption data which come from existing
inventory records or from a survey of recent drug consumption. Epidemiology methods require
information about the frequency of common health problems, information about standard
treatments, and information about the number of people who will be treated. There are a
variety of ways to use each of the methods, and it is possible to use both methods
simultaneously in order to compare the results.
A.
CONSUMPTION METHOD FOR PLANNING DRUG REQUIREMENTS
In adequately-financed and well-established drug supply programs, drug requirements are
usually based on recorded past consumption. However, in essential drug programs and other
types of public drug supply programs, a consumption-based approach to determining drug
requirements has several drawbacks. These drawbacks include the following:
1.
To the extent that there have been shortages of essential items, drug needs will be
under-estimated.
2.
To the extent that past and current prescribing and dispensing practices are
irrational or wasteful, these practices will be supported—if not encouraged—by
consumption-based ordering.
3.
Estimates of consumption based on supplies issued from the Central Medical Stores
may not reflect current drug utilization patterns at the provider level.
It may
take three months, six months, or even longer before changes in prescribing
patterns at the provider level are reflected in stock consumption at the central
level.
Despite these drawbacks, there are several advantages to a consumption-based approach to
estimating drug needs, Including the following:
1.
When accurate consumption data are available, the consumption method is the easiest
way to determine future drug needs.
2.
The consumption method does not require epidemiological data or established
standard treatments, either of which can be difficult or impossible to obtain.
3.
If consumption data are complete, if stockouts have been recorded and taken into
consideration, if prescribing practices remain relatively unchanged, and if the
program is not experiencing rapid growth, then consumption-based estimates should
result in fewer Instances of stockouts or overstocks than the epidemiology method.
The consmmption method has two important steps: data collection and data analysis.
Data Collection — In an established supply system, consumption data can usually be
obtained from the stock card records ("kardexes," etc.). Consumption data can also be
DAP/86.3(4)
page 4
obtained from customs records or import data, other government programs which provide drugs
(eg., social security or armed forces in some countries), or from sampling the consumption
at selected health facilities.
A method of estimating national consumption by sampling consumption at selected
"sentinel" health facilities could be used. A small number of representative sentinel
facilities are chosen and consumption records are reviewed for a specified period of
time—preferably at least one year in order to include seasonal variations.
The facilities
should be chosen on the basis of the morbidity pattern, the level of population coverage,
the apparent prescribing practices, the adequacy of the drug supply, and the adequacy of
information on drug consumption and patient attendance.
An obvious, but frequently overlooked, aspect of data collection is that of assuring
consistency in the data. When drugs are ambiguously described, then the data become
ambiguous.
Consumption should be recorded according to the official generic name.
Strengths, package sizes, and the counting unit must be explicitly stated to avoid confusion
among those responsible for inputing the data.
Recording of past consumption should also include information about stockouts. To the
maximum extent possible, consumption data should be adjusted to reflect the consumption
which would have occurred if there had been no stockouts.
Data Analysis — Once consumption data have been collected, they should be reviewed by a
Formulary Committee, Pharmacy and Therapeutics Committee, or other qualified committee or
individual to determine what adjustments need to be made for the next drug order.
This
utilization review is the most important part of consumption-based estimates. Utilization
review is particularly important when the projected need for drugs exceeds the available
funds and cutbacks are required.
There are at least three aspects to be considered during the utilization review;
1.
Anticipating Program Growth — If the program for which drug requirements are being
estimated is growing, then this growth needs to be reflected in the drug
estimates. Depending on the pattern of growth, next year's drug needs can be based
on a straight-line projection (which assumes constant growth) or an "S-curve"
projection (which assumes a rapid expansion phase, then a plateau).
2.
ABC Value Analysis — An ABC Value Analysis should be performed to determine where
most of the funds are being spent. An ABC Value Analysis categorizes the drugs
consumed into three classes (A, B and C) according to the value of the annual usage
(unit cost multiplied by the number of units consumed annually). This analysis
will be discussed in detail in the session on "Cost Reduction." The analysis
itself cannot establish whether or not the expenditures were reasonable, but it
should direct the attention of the Formulary Committee, Pharmacy Committee, Chief
Pharmacist, or Chief Medical Officer to those few items which account for most drug
expenditures. Review of the ABC analysis sometimes suggests items that are being
overused and points to areas of potential savings.
Figure 1 illustrates the
results of an ABC Analysis for one large Ministry of Health supply system.
3.
Therapeutic Alternatives Analysis — Drug consumption can also be reviewed by
comparing the utilization of Individual drugs within the same therapeutic
category. This type of analysis is particularly useful when the unit costs for
each item are included. Often a particular item has become popular without regard
for its cost relative to therapeutic alternatives. The therapeutic alternatives
analysis can suggest substitutions which can result in significant cost savings.
Figure 2 is an example of a therapeutic alternative analysis for one therapeutic
class.
DAP/86.3(4)
page 5
Planning Drug Renuireeents
Figure 1
ABC Value Analysis
CODE
year:
Drug Product Description
Rank
Order
.HO
VEN
Total
Z at
Cumulative X
Ess.
Cat.
Cost
Total
or 'ata! Cost
(tC)
Cost
List
TOTAL
1983
- 431 ITEMS
448
:
100.ooz
37 ITENS
39,166,166
:
69.39Z
CLASS "B' ~
a9 ITEMS
11,216,647
I
20.021
89,’IZ
CLASS '2a ■ 375 ITEMS
5.657,635
:
10.10Z
100.00X
59111 1
1 Strectcivcine Sulfate ’oucra i gp.
1
74060 :
2 Distilled eater 100“
T
V
1,640,000
581o2 1
3 Penicilline G IM Unit In;.
V
V
3,726.250
8,363.300
3,333.080
4 Crlortetracrcline 1'.
7
33061 I
5 Glucose Peri. Isctonuiie
r
V
1.639. ■’78
s8023 I
b Ir.suline Retard I f 2 40 u
<
»•
1.172.979
58051 1
’Oil ;
7 Aspirme 500 «,
T
73172 ■
8 Penicilline u-’fenicill.SFro in unit
Y
33072 1
9 Scaiuii Crlorure Per>. lsotcni:.e
T
10 Pitaepicine 150 =g.
r
59101
;
t
1
1,161.203
V
100.ooz
69.89Z
14.92Z
14.921
3.28X
23.201
6.65‘Z
29.85Z
5.95X
35.so:
2.92Z
3d.'3’Z
2.09Z
40.82Z
2.07Z
42.89Z
1.143.:’’
;
2.041
44.93Z
1,053.'7'
:
1.38Z
4o.8lX
1.31Z
48.621
z
■:
’5117 ;
11 Anti-Spaseooigues (2=Bara.3=Ava)
?i
*
785,. :■
59050 ;
12 Ethionaeide 250 ag.
T
E
763.2'.
59260 I
13 SulMgua^idme 530 ag.
•;
V
d-7-6,792
58040 !
V
626,327
r
553,318
1.40Z
:
!
50.03X
1.36Z
51.39Z
:.14Z
j2.5i'Z
1.12X
53.647.
t.ooz
54.34Z
14 Chiorenpnenicol 250 eg.
X
58280 I
15 ialfatietnox.'ovridazt.ie
*;
59090
16 Pvratinaeide 503 eg.
Y
31380 .
17 Caroat-ccMrue
N
*i
515.662
0.92’4
56.55X
58163
18 Penicilline 8 5 3 Unit hj.
'j
5;J.77
*
j 92Z
57.47Z
120’1 :
1’ Placnenacine Petard Inject. 25 eg
I
i
M
498.486
0.3’Z
53140
20 Cntatracvcline 252 eg.
489.546
■j.87Z
0.371
oO.HZ
552,40b
55 3
:
■3.lil
33082 :
21 Potassium Chicrura 250 eg.
i
£
489.1 .-0
68021 1
22 Insuline 40 U
V
V
A’1,407
:
0.84X
60.95Z
42050 ;
23 Bromure Butyl d'Hvosine 20 ig.
N
E
453.075
■
0.8P,
61.761
0. ’4X
62.49Z
74680 .
24 Anti-Infectieux Puleonaire En»ant
N
N
413.562
33111 I
25 Sodium Bicarbonate 14Z
/
►
•1
;
* a
V.6
56,10.'.
5’040 1
26 Etnaebutol 500 ag.
*6
.",53.2
:
j.oIZ
63.76k
46061 I
27 vit. 3'6 I’vrioox.Ch.:r.Inj.) 25ftg
7
>
35'.755
(. 637.
64.397.
0.621
oS.Oi:
0.51Z
65.o2X
68033 '
28 Slvt-atamioe 500 eg.
N
E
347.773
’4670 1
29 Anti-:ntectieu:< Pulecnaire ’Cuite
N
■<
343,850
23024 ,
30 Calcium 6!uccnate Inject. IiX
»
N
3«il ’ . ? “ *
0.61Z
a6.23k
54066 .
31 Hydrocortisone injectaoie 100 eg.
1
-j
324,228
;
;.58Z
66.31X
5842V ;
32 ’risul>'aeides Subaidia:. I ttn:a:. >
’•
30:,’74
;
0.54X
67.35Z
53:82 ;
33 Bentatn-.r.e Penicilline 600,000 J
"i
■<
0.52X
67.87Z
287.820
:
0.52Z
0.51Z
o8.3BZ
o8.’0Z
0.50Z
69.401
0.49Z
69.89Z
12013 :
34 Cnicrpre.acine
*
5843: ■
35 8en:atmne 8encvl Penicilline 1.2MU
,
100 sg
Y
46130 :
36 vitaaine 61 Injectable 20 eg.
I
V
279.963
;
75870 I
37 Antiacide
y
E
276,006
1
I
:
CLASS "A' -
56,
1
DAP/86.3(4)
page 6
Planning Drug Raquireients
Figure 2
SAMPLE DATA QNLt
Therapeutics Alternatives Analysis
Tear:
■
Product
1
CODE
Drua product Description
1983
Cansuaption 1984
i
VEN ;
Total
Cost per
Hueber of
:
Cate. I
Cost
Treatment
Treataent
1
Episode
Episodes
1
Route
,1AJ0R TRANfilllLiZERS
AVERAGE
■ 1,855.374.94
ERCENT OF TOTAL EXPENDITURES
IV
: n :
498.486.00
30.12
lo.550
iqotiazne (Esthers) I:.;.
*
iv
;
N
•
209.4c1.50
2.82
74,lo7
Tilarproaazine In;ect. 25 eg
IV
;
N
!
158,858.00
5.88
27,017
IV
'•
N
•
151.883.00
34.13
IV
!
n
:
41,091.60
4.70
3 <' 33
22,794.10
2 ■ 56
8,900
14.369.14
d. z
*
Tri-iuocera:ir.e ,90 ag
N
IV
4,445
2 • 3d3
•V
:
N
;
Piaotiazme (Estnersi Inj. 100 ig
IV
:
2.91
5,000
PC
N
c
14,544.
Cnlor:roaazine‘ ;OC ag
•
298,979.:
0.48
607,100
Haloperidol J-.;ect.
100 eg
te.-oseproiazine
PO
:
n
;
199.790.:
1.82
109,775
cr
;
■<
i
94,66-..
9.70
128,825
P3
.
N
:
E3.o28...
0.58
145,188
4Q
:
s
.
81.547.47
1.17
69.438
>■
65.627.Co
j.08
556,333
•'j
•j
■5 1c; " "
1.49
6,150
?c
N
S.4o4.5i.
1 . V>
4.275
PO
ag
DAP/86.3(4)
page 7
Thus, the analysis of consumption data is intended to provide insights into utilization
patterns. These insights should help to adjust drug orders to reflect anticipated program
growth and to encourage more cost-effective drug use.
If the analysis suggests ways to
improve drug utilization, then these suggestions need to be communicated to prescribers in
the form of a Ministry of Health circular, or some other educational format.
B.
EPIDEMIOLOGY METHOD FOR PLANNING DRUG REQUIREMENTS
In an adequately-financed drug supply program with reliable inventory control and
distribution systems and good prescribing practices, drugs can be ordered on the basis of
projections from recorded past consumption. However, when available funds are Inadequate
for projected needs, when available consumption information is incomplete or unreliable,
when prescribing patterns seem inefficient or irrational, when a new supply program is being
established, or when an existing program is expanding rapidly, then the epidemiology method
may be a more appropriate means of estimating drug requirements.
The epidemiology method requires the following five basic steps:
1.
Determine the population to be served.
2.
Determine the frequency of each health problem being treated.
3.
Establish standard treatments for each health problem.
4.
Calculate the quantities of drugs required by multiplying together the first three
items.
5.
Adjust for available budget.
These five steps are represented diagrammatically in Figure 3 and are described briefly
below.
1.
Population Coverage — A realistic estimate is needed of the number of patients who
will be treated. An estimate of the total population may be useful for determining
the long-term theoretical need for drugs. However, for the purposes of placing a
drug order, the estimate must reflect the number of people who will be seen in all
the health facilities supplied by the program.
It is important to know the age
distribution of the population being served.
For the purposes of estimating drug
requirements, the age breakdown can be as simple as, "under age 5" and "age 5 and
over."
2.
Health Problem Profile — Next, the frequency of each health problem (symptom,
diagnosis, or need for a health service such as prenatal care) must be determined.
The health problems must be Identified clearly enough to distinguish conditions
requiring different types of drug treatment. For example, "ear pain" is not a
precise enough category if external ear infections (otitis externa) are to be
treated with ear drops and internal ear infections (otitis media) are to be treated
with oral antibiotics.
DAP/86.3(4)
page 8
Planning Drug Requiements
Figure 3
EPIDEMIOLOGY MODEL FOR ESTIMATING DRUG REQUIREMENTS — CONCEPTUAL FRAMEWORK
Points of Medical, Pharmacy, or Management Decision or Influence
= Information and relationships which are difficult or impossible
to measure at present.
DAP/86.3(4)
page 9
Getting reliable health problem information is often the most difficult part of
estimating drug requirements. There are at least four potential sources for health
problem profile data:
a>
Existing Government Data - The Ministry of Health, Ministry of Planning, or other
government agency may collect usable information on health problems. Before using such
data, it must be looked at critically from the viewpoint of its reliability, the
specificity with which individual health problems are identified (for example,
categories such as "respiratory diseases" are too nonspecific for drug estimates), and
the age breakdowns which are available.
b"
Survey Data - If existing data are judged to be unusable, another alternative is to
conduct a survey at selected health facilities to determine what types of problems are
being seen. The survey need not be too detailed, since, for any one country, only
twenty to thirty different health problems account for over ninety percent of patients
seen by the health service. One advantage to survey is that information on the
age-distribution for each health problem can be collected exactly as it is needed for
the drug estimate.
A survey can be done by looking back at patient registers or by
collecting information on patients currently being seen.
c-
Comparable Data - Another alternative for obtaining a health problem profile is to use
data collected by a private voluntary organization operating within a certain region of
the country or data from another country whose health problems are believed to be
comparable to those of the population for which the estimate is being made.
d.
Expert Panel - A final alternative is to have a panel of doctors, nurses and other
experienced health professionals from the country construct a health problem profile
based on their experience.
Starting without any data, this may be difficult and rather
inaccurate. But it may be possible to take existing government data or comparative data
from another program and, based on judgments by an expert panel, modify this data to
more accurately reflect the health problems of the population being served.
3.
Standard Treatments — A central requirement in using the epidemiology method is that
standard treatments be written.
Standard treatments are essential for calculating drug
requirements with this method.
In addition, the process of writing and promoting
standard treatments (if they do not already exist) can play an important role in
improving drug utilization patterns. For estimation purposes, standard treatments must
be specific with regard to dosage, frequency, and duration of treatment.
For clinical
purposes, however, the standard treatments may reflect a range of treatment regimens. A
set of illustrative standard treatments for use in estimating drug requirements is being
developed by WHO, but each program must ultimately develop its own standard treatment
regimens.
4.
Calculation of Quantities Required — Once the first three steps have been completed,
the quantities of drugs required can be calculated by multiplying the number of patients
being served by the frequencies of common health problems by the quantities of
individual drugs needed to treat each health problem.
5.
Adjust for Budget - Depending on the size of the target population, the health profile,
the standard treatments, and the drug prices, the final estimate of drug requirements
may be higher than the available budget.
It is sometimes possible to use the results of
the estimate to argue for a higher budget. More often, it is necessary to adjust the
drug order to fit the budget. This can be a difficult task for which there is no
universally appropriate approach.
Factors which might be considered in making the adjustment include the relative
cost-effectiveness of individual drugs in treating specific health problems, the unit
costs of individual drugs, the frequency with which specific health problems are
encountered, the impact of specific health problems on disability and mortality, and
past consumption of individual drugs (if such information is available).
In addition,
an ABC analysis of the proposed drug order and the establisheroent of VEN categories of
the drugs may be helpful. A VEN system places the drugs into three categories: V =
Vital drugs, E = Essential drugs, and N = Non-essential drugs. This system will be
discussed in detail in the session on "Cost Reduction."
DAP/86.3(4)
page 10
This five-step estimation process can be applied at the level of the village or
community health worker, the mid-level health worker at health centers, or the level of the
hospital outpatient clinic where doctors' services are provided.
In theory, the epidemiologic method seems to provide a "truer" estimate of drug
requirements.
In practice, there are several cautions which should be considered in using
this method:
1.
Accurate estimates of population coverage and health problem frequencies are often
difficult to obtain.
Inaccurate estimates can significantly misdirect drug
purchases.
2.
The process of drafting standard treatments, if they do not already exist, can lead
to costly delays in initiating the procurement process.
3.
If the standard treatments used to estimate drug needs are not fully communicated
to health care providers, and if the standards are not generally adhered to, then
drug consumption may deviate significantly from projected drug needs. Thus, it is
possible with an epidemiologically-based estimate to create stockouts and
overstocks which might not have occurred with consumption-based orders. However,
if the standard treatments represent a significant therapeutic improvement, then
stock mismatches may represent an acceptable short-term cost of long-term
improvements in drug utilization.
Figures 4, 5, and 6 provide an illustration of the epidemiological method which will be
discussed during this session.
C.
USES FOR ESTIMATES OF DRUG REQUIREMENTS
In addition to providing estimates for use in purchasing new drug supplies for an
existing program, estimates of drug requirements derived from the consumption or the
epidemiologic method can be used in the following ways:
—to determine order quantities for new or rapidly growing programs;
—to plan health budgets at the local, district, regional, or national level;
—to identify possible ways to improve cost-effective drug utilization;
—to provide Information which might be used in negotiating for additional
foreign exchange allocations;
—to document the need for specific donor funding;
—to assess the need for specific drug products which may have been offered as
gifts.
Further, drug requirements derived from the consumption and the epidemiologic methods
can also be used to teach the health workers the discrepancies between real needs
(epidemiologic method) and actual demand (consumption method).
Figure 4
Year:
SAUFLE DA1A ONLY
Nuaber of Patient Contacts Last Year:
3,123,408
Children Under Age 5 as I of Contacts:
20.00'Z
Health Problem
:Code
I
Ha«e of
!
!
Health Problee
1 Aqe
4.11:
: 14.12 :
Acute diarrhea
Bacterial skin infections
9.11 i
■
Conjuncti-.itis
I 15.40 I
•
;
Lon bad pain
1
•
8.11 I
Headache
!
•
4.32 I
1
Heartburn, gastritis
1 10.12
•
•
Otitis aedia
1
•
5.21 1
•
Cation cold,upper resp.infect.
1
5.22 :
Acute tonsillitis
•
;
Treatment Episodes
I
Nuaber of Treatment
! Expected I
per 1000 Contacts
1
Episodes Last Y.ear
1
I
Medical
Iraratedica: I
'5
:
220.0
278.4 1
1'1,797 !
452, 148
:
75.0 :
so.? :
58.564 :
in.ize ;
15
!
95.0 1
125.4 1
74, 191
!
293,757 1
1 >=5
1
15.5 1
73.4 1
12,JOJ 1
172,4:2 1
1
5
1
37.4 :
22.6 1
23,738 1
52,942
1 '=5
:
24.0 '
14.4 1
18.740 1
34,201 1
:
5
;
2.5 1
0.0 1
1,952 '
0 1
■ '=5
1
34.0 1
19.4 1
29,111 1
45,446 1
1
<5
1
21.0 :
16.9 1
14,39? 1
39,589 1
1 .=5
:
55.4 1
42.0 1
43.259 ’
145,238 1
:
'5
1
14.0 1
13.2 1
10,932 1
1 >=5
1
46.8 1
30.0.1
34,544 1
70,277 1
1
15
1
45.6 1
40.6 1
35,607 1
141,959 1
1 '-=5
1
Episodes
tent)
f■
Medica'.
: >5
I
Adpasted Number of
Treat-nent
i (a adiust-
!
I
Change . !
:
MedicIParaaiedicai
!
:
.
>
39,922 1
1
13.4 1
15.7 1
10,620 1
<5
1
146.0 1
144.9 1
114,004 1
390,973 1
’
I
1 >=5
1
57.0 1
74.0 1
39,047 1
173,349 1
<5
1
36.0 1
36.0 :
28,111 1
84,332 1
1
■
:
;
1 7=5
1
18.5 :
15.5 1
14,446 1
36,310 1
■
1
1
1
7.6,77® 1
P la n n in g D rug R eq u irem en ts
I
I
!
IGroup ill
i
1
1985
Health Froblen Profile
Age
(Treat.
Z of Cases
Drug
No.
Treated ■/
Cede
□roue
!
Drug Product Description
Basic
Ur.it
this Test.
(BUI
90.01
71999 ORAL REHYCRAi ID.’I SALTS
SACHET
10.07.
79999 ORAL REhYCRATllf. SALTS
EACHET
5S240 SuLFAEL'ANiDINE
TAB
lu DRUE
LA
lOC.i’Z
lOO.G’i
53051
CHLORTETRhCYCLIKE IZ OPTh
TUBE
IC'j.CZ
5805! CHLOF'ETRACYCLIKE IZ CrTH
TUBE
100.OZ
53173 -SKI 6+FENI PRO 400u
AHF
7013 ASPIRINS 125 Ku Stiff
SLPF
100.0Z
53172 FEU GtpEII PRO 1HL
Ar?
7012 ASfirINE 500 HG
TAB
IDG.uZ
53133 BENZATHINE SEHI 1.2>u
ALP
>00.0’
5E183 BENZATHINE rEfi! l,2nu
A.1P
ICO. iZ
7012 ASPIRINS 501' Hu TAB
TAB
ICO.'.Z
7012 ASPIFINE 500 HG TAB
TAP
110.0Z
sl63E HAaLGI
TAB
109.GZ
T18B3 NAALCX
ETl
100.32
53111 UECHYCIN CREAK
TUBE
li,O.OZ
58il. SECNYCI.9 CREAH
TUBE
iOr.O".
70:2 ASPiR'N; 500 HG TAB
190.0Z
7013 ASPIRiNE 125 KG 5UPF
100.02
7012 ASPIRINE 500 MS TAB
Episode
Episode Episode
P la n n in g D rug R e q u ire m e n ts
Treatment Apsrcacn
Health rrchlea
Planning Drug Recuireaents
rigure 6.
Suanary of Drug Re:c:reaen:s
'fear: 1985
Drug
Total
Total Needs
Cost
Units
R1NE 500 c.g tan
1
of Total
:
Units
IBcctie of
164710 1
185 1
18,470.98 !
0.31X1
I Bo:
of ;2 suppositories
78184 !
4515 i
1C, 833.2c 1
0.18X1
cf 50 5-ol =
24125 1
483 :
55,452.91 1
0.94X1
S.322.16 1
0.16X1
of 25 15-ga tubes
1742i
5B/.1 IChLGRTt
4193E ISRiSX
of
29419 1
53172 ll-ENI S
PFC 4'
Percent
^Expenditures:
Purchase
Saze
Description
1
349 :
31,318.89 !
0.527.1
843 ;
40,474.08 I
0.67X1
274 ;
51,549.72 1
1.03X1
23389 :
2-“4 i
50,275.27 1
0.84X1
18c: cf
224105 1
5603 i
452,080.00 1
10.87X1
130416 1
3
2-,, 483.30 1
0.43X1
976,850.00 !
•5.28X1
CT 49 tatties of 1000 tabs!
P la n n in g D rug R eq u irem en ts
'Sos
LD VAJPAYEE GO TO PAKISTAN? EXCLUSIVE OPINION POLL
heWeek
C nc • Fm*-
OOD OF
KE MEDICINES
CoverStoiy/NcwsYouCiuiL’se
According to
the WHO, 35 per
cent of fake drugs
produced in the world
come from India,
which has a Rs 4,000crore spurious drug
market. About 20 per
cent of medicines in
the country are fake.
Many common
drugs, including
those used for head
aches and the com
mon cold, are fake or
substandard. Of them,
60 per cent have no
active ingredient and
16 per cent have
harmful ingredients.
A recent raid by
... the Karnataka
Lok Ayukta revealed
that authorities were
silent about 829 sub
standard drugs which
were being bought
and consumed by
the public.
FILING
YOU
d v.
' > ■ OWIY
zj
Many common medicines
available in the market are fake
By N. BHANUTEJ/Bangalore
and QUAIED NAJMI/Mumbai
hink twice before you pop
that pill. You could be
swallowing solidified
chalk
masque
radingpowder
as paracetamol.
Your fever will get worse and you will
get stomach pain as bonus. That is, if
you are lucky. Things could be much
worse. You may be taking that anti
depressant to drive away the blues. In
your bad mood, you may not have
noticed that the packing looked
different: A few' hours later, you may
be in the grip of a panic attack.
If that does not frighten you, run
your eye through these alarming
statistics. According to the World
Health Organisation, 35 percent of all
T
TRAGIC ORDEAL: Alpesh Mehta,12, (with
father and mother) almost died after
being injected with a spurious drug
38 EEE2E53 May 18.2003
fake drugs produced in the world come
from India, which has a Rs 4000-crore
spurious medicine market. Nearly 20
per cent of the medicines available in
the domestic market are fake or
substandard. Of these, 60 per cent do
not contain any active ingredient. 19
per cent contain wrong ingredients
and 16 per cent have harmful and
inappropriate ingredients. Spurious
drugs appear in commonly known
brand names. So be afraid.
"Today fake and substandard drags
harm more persons daily than the
SARS virus,’ said Ajit Singh, chairman
of the Associated Capsules Group in
Mumbai. Consumers and drug control
officials have to grapple with two
demons: fake drugs manufactured by
seedy underground units, and
substandard drugs which come from
the stable of reputed companies. Often
it is difficult to distinguish between the
two. The common factor is that both
are harmful.
May IS. 2003
37
CoverStory
The problem is more acute and
widespread than one can imagine.
Doubters can peruse these grim
findings.
♦ An Army man died in a nursing
home in Patna on May 5 after being
injected with a substandard drug.
♦ A random test of ciprofloxacin 500
The Organisation of Pharmaceutical Producers
mg tablets (batch no.154 V), an
antibiotic manufactured by British
of India has some suggestions for consumers
Pharma Laboratories of Gujarat,
THOSE BUYING MEDICINES SHOULD ALWAYS LOOK FOR:
proved that the tablets contained no
'The batch number, manufacturing date, expiry date,
ciprofloxacin.
manufacturing licence number, manufacturer’s name/address
♦ Dexamethasone 5 mg
on the pack before buying any medicine
(batch no. 145 P) tablets,
'Any sloppiness—illegible or badly printed labels, absence of one/all of
a life-saving steroid
the above details, faulty sealing and differences in colour of the packing
manufactured by the
'Broken tablets/capsules, extraneous matter in liquid preparations,
same
company,
lumps in creams/ointments
contained
dexamethasone.
TO CURB THE SPREAD OF FAKE MEDICINES:
|
♦ Destroy the empty packs/bottles of used or
w
♦
Hydrogen
left-over medicines to avoid recycling
J
peroxide (batch
.
♦
Report
to
the
company
which
manufactures/markets
the
product
!
no. 001) solution,
of your doubts about any particular medicine immediately
r
manufactured by
* The company will lodge complaints either with the
£
Medismith
of
K local police or the regulatory authorities in the
Bangalore, contained no
♦ These two agencies will investigate the
trace of hydrogen peroxide.
matter and initiate appropriate
♦ Villagers in Madhya
criminal proceedings.
Pradesh are usually given
fake drugs Conacin and
Crocinol in place of the
common brand Crocin.
Graphia/MUKESH M.
♦ Ampicillin 250 mg capsules, another
commonly used antibiotic for
of events. These are just
northern region,
respiratory infections, made by
random samples. What ifwe
with Bhagirath
Economic Pharma of Mumbai (batch
had gone looking for fake medicines?"
Palace
in Delhi
no 5604), contained a powder that had
reportedly being the hub of fake
no ampicillin in it.
hey would have found it all over
medicine trade in south Asia. Indore
♦ Paracetamol syrup, usually
the place. To use a cliche, the web
in Madhya Pradesh is another
prescribed to control fever in children,
of fake medicines spreads from
breeding ground of fake drugs. Neai/)t
manufactured by Sinclair Pharma
Kashmir to Kanyakumari, though,
150 small-scale drug manufacturing'
(batch no. SP 001), contained no
according to available information, it
units operate from garages and hovels
paracetamol at all.
becomes flimsy down south. The
here. From Indore, fake medicines
The list goes on and on. The rot
steely filaments of the web are in the
have found their way to Russia and
runs deep.
Uzbekistan. Medicines are being
This was made amply clear in a
churned out in slums outside
recent raid by the Lok Ayukta on the
Lucknow and Ahmedabad. They have
Drugs Control Department of
a thriving market in South Africa,
Karnataka. There were a lot of fake
creating huge problems for the health
drugs in the market and the
officials there, not to speak of
authorities couldn’t care less. The Lok
neighbouring countries like Myanmar
Ayukta discovered that in the last three
and Bangladesh.
years, the department had found that
The most established and fast
829 commonly known medicines were
moving
brands are the targets of the
of poor quality. Still, the department
drug mafia. Hoechst Marion Roussel
took no action and allowed people to
Ltd found to its utter shock that 15 per
buy and consume the drugs. “This is
CROCIN Paracetamol tablets
cent of all its products available in the
just the tip of an iceberg," said an
Batch no. 0100 and S9238
market
were
fake.
Knoll
official who was anguished at the turn
Manufacturer: Smithkline Beecham
Pharamaceuticals suffered losses
SPOT THE
FAKE ONES
\
worth Rs 75 lakh on three
popular brands: Brufen,
Entamizole forte and
Eptoin.
Smithkline
discovered that its popular
brand lodex had been
duplicated everywhere.
Spurious drugs were
being sold in Uttar
Pradesh, Bihar, parts of
. ■ Karnataka and Tamil
Nadu.
Unofficial
figures
gathered by consumer
bodies estimate that more
than 40 per cent of the
medicines which hit the
rural market are fake or
•mbstandard. The illiterate
•Willager is easy prey to the
fake drug mafia which
colludes with local doctors and
chemists. Many over-the-counter
products sold in interior Madhya
Pradesh are fake. A villager cannot be
expected to distinguish Glysun-D and
Glycon-D from Glucon-D. Vips and
Vims are balms which officiate for the
popular Vicks. In Hyderabad, drug
control officials had a hard time
distinguishing between Crocin and its
fake cousin. The packings were almost
the same.
Fake drugs have spread terror in
Kashmir, too. In 1999, the drug
controller’s department in the Valley
blacklisted Jackson Pharmaceuticals
VICTIM: Rakesh Kumar Das
was injected with a fake drug
spurious drug manufacturer
puts up a nameplate
announcing his business and
in most cases, these are
garage-type operations," said
S. Ramesh of the research
wing ofAssociated Capsules
Group at Andheri. “ It is
difficult to catch them as
they know all the loopholes
of the law,” said a doctor.
Drug control officials and
doctors have much to say
about the hot spots and
about
fake
drug
manufacturers breeding like
mosquitoes, but when one
PARAS NATH
gets down to specifics, they
shrug their shoulders.
Ltd after its products were found to be
substandard. The company is,
hose who consume the spurious
however, back in business. The Uttar
drugs cannot dismiss the problem
Pradesh Police raided a dingy house in
with a casual expression of resignation.
Lucknow two years ago and seized 300
Sometimes they pay with their lives,
bottles and 1,000 fake labels of
as in the case of Rakesh Kumar Das,
Betadine. The fake drug market
an Army man, who died in a nursing
thrives in towns like Meerut.
home in Patna after he was
Despite its spread, the pharma
administered three injections of Lasix
companies and authorities do not have
on May 5. His father alleged that his
any concrete data on the producers of
son was injected with a substandard
these medicines. Most of the small
drug. Interestingly, the owner of the
units operate from hovels and garages.
nursing home, Dr Ramendra Narayan
Some of them had been associated
Singh, does not dismiss the allegation.
with big companies. The general
“Anything can happen in this country,"
impression is of a shadowy crowd. “No
T
38 6£S2Z33 Mat 18,2003
° Into the lion’s den
By NISTULA HEBBAR
n a cramped room in Shakarpur in Delhi, Sanjay
Khanna is busy overseeing the production of a batch
of fake tablets. His speciality is over-the-counter drugs
like paracetomol and disprin. The entire manufacturing
unit cost him around Rs 1,00,000, but the profits have
I
more than made up the cost.
What makes fake tablets so profitable? According to
Dr C.M. Gulhati, editor ofthe Monthly Index ofMedical
Specialities, it is the economics of the situation. A strip
of IO Nimuselide tablets has a sale price of Rs 25.75. The
cost ofthe drug in bulk is Rs 250 per kg—one tablet would
be equal to 100 mg. So the cost of 10 tablets would be 25
paise. The cost of printing and packaging a tablet would
T
be about Rs 1.40. Thus the entire tablet is ready for sale
at Rs 1.65. Big brands factor in research and development
costs, the costs of clinical trials and other overheads. But
in fake manufacturing the cost is much less as they skip
R&D; they simply lift the formula.
Gulhati is careful in distinguishing between fake and
substandard drugs. "Fake drugs may contain the right
formula and may just fake the brand, but substandard
drugs are from licensed manufacturers where the
standardisation procedure has not been followed," he says.
Three years ago, in Shakarpur, the Economic Offences
Wing of the Delhi Police had raided a shop, seizing Rs
2,00,000 worth of Nimulid and Glizid tablets. But
Khanna is not worried about the law getting to him. “They
(the police) will have to pick up the samples first," he says.
“We will come to know long before that."
What worried him more was last month’s truckers
strike that disrupted his supply line between Delhi and
Meerut.
May 18,2003 Ha'.'Wl 39
CoverStory
Caught in the trap
By QUAIED NAJM1
hen
disaster
struck
Lakhpatraj Mehta, 36, it was
total and unforgiving. The victims
were his two sons, Alpesh, 12, and
Aman, 8. While Alpesh nearly lost
his life to spurious drags, Aman died
because of alleged medical
negligence.
It all began on March 28, 2002,
when the three met with a road
accident in Pune. Alpesh was
admitted to the KEM Hospital while
Aman was rushed to the Jehangir
Hospital. Mehta claims that 59
doses of Imipanium, a very
expensive injection (an ampoule
costs Rs 1,850) imported from
Holland were administered to
Alpesh. All the ampoules were
purchased from a private pharmacy
store, KM medical store, located in
the hospital compound. Though
Mehta had noticed that details like
the date of manufacture and expiry
date were missing, in the heat ofthe
moment he did not report it.
After the injections were
W
he said.
Dealing with ill-effects of fake
drugs is daily routine for Ahmedabadbased sexologist Dr Paras Shah. “Skin
fibrosis due to fake sprays promising
penis enlargement is quite common,”
he said. Gujarat, according to him, is
flooded with fake medicines promising
wonder cures for sexual problems.
Brij Narayan, a 58- year-old
farmer of Bhopal, was laid low by
viral fever. But the drags which the
doctors administered gave him
no relief. His condition
worsened. Finally his sons
took him to another hospital,
where he got well. It later
turned out that he had been
given substandard drugs
in the first instance.
In Hamidia hospital
QWi
of the Bhopal Medical
College, surgeons face
what they call an
40 EHSS53 Mat is, 2003
RECOVERING: Alpesh in hospital
administered, Alpesh’s condition
began to deteriorate. His body
blackened and he began to bleed. He
also developed severe bouts of fits.
When there were no signs of
improvement even after 55 days,
Mehta talked to the doctors. But they
insisted that the treatment was proper
“anaesthesia problem”. Said one: “We
are supplied with ketamine
hydrochloride injection to be used as
anaesthetic agent. Normally 10 mg is
enough to make a patient unconscious^
But we have to use three to five times
more.” The particular drug is
manufactured at Sanwer Road,
Indore.
“Spurious drugs are a major
threat to people’s health and
well-being,” said Ajit Singh.
“Those who make them are
terrorists." According to C.H.
Unnikrishnan,
senior
assistant
editor
of
Pharmabiz, some drugs were
made of chalk dust, fine
sand or limestone
POLYBION SYRUP
B-complex syrup;
Batch no. LR 697.
Manufacturer: E Merck
and that they would give him a total
of 120 doses.
Fearing for the boy’s life, his
family rushed him to another
hospital where his treatment
schedule was changed. Now he is
back on the road to recovery with
only a few visits to the hospital.
It was later learnt that the
medicine was a counterfeit made in
India and passed off as the imported
one. It was sold in regular stores at
approved rates. Mehta said that he
had contacted the Dutch company
that manufactures Imipanium and
was told that the ideal dosage for a
boy of 12 would be 14 to 15 shots,
which added fraud to the list of
grievances.
Mehta complained to the FDA
in Pune and Mumbai, which has
lodged criminal complaints against
the pharmacy and its proprietor Jain
at Samarth Police Station, Pune.
Now, Mehta wants the authorities to
institute a CBI enquiry into the drag
racket in Pune hospitals. He is
determined in his fight despite
receiving threats from the drugs
mafia. “I am not going to rest until
the racket is busted and the culprits
are booked,” he said.
powder. “Others are positively
harmful,” he said.
Sometimes
it can
cause
complications. “A patient who was
suffering from a chest disease wad
being given a syrup,” said Dr
Wancho of Srinagar. “Fie complained
that it was not helping him. We later
found out that it was a substandard
drug and it created other problems for
him.” Sometimes, it can prove fatal:
five tribals of Ranchi died five years
ago after consuming spurious
medicines. Some substandard drugs
may contain a small amount of the
active ingredients that would build up
resistance to a particular drag.
Though physicians express
anguish at the prevalence of fake
drugs, the fact remains that the racket
operates with their connivance,
especially in rural areas. A leading
doctor in Indore is known to have
taken a car as a gift from a dubious
COUNTERFEITS ►►►
■ Paracetamol tablets
INGREDIENTS ►►►
EFFECT
■ Regular intake
■ Chalk powder
could cause gastric
disturbance
■ Contraceptive pills
■ Wheat flour
■ Fails to provide
■ Antibiotic capsules
■ Rice flour, soda
■ Fails to improve
bicarbonate
the patient's
and turmeric powder
condition
the desired result
(turmeric powder is
used to make fake
■ Paracetamol syrup
tetracyclin)
Industrial solvent
■ Could affect optic
nerve, liver and brain
Chloramphenicol counterfeits are usually made of soda bicarbonate. When administered
to a patient with typhoid, it fails to bring down the fever, often proving fataL
Graphics/.MUKESH M.
pharma, company. He prescribes its
medicines regularly. Dozens of shady
pharmaceutical firms in Madhya
j’Z-, . Pradesh have cut deals with doctors to
4W,‘
market their medicines. Some smalltime doctors in Gwalior, Sagar,
f$?.. Ujjain and Dewas have
_
/vXi gone one step further and pS.
have become partners in
these units.”Small-time ;
y • ’ doctors perpetuate the
•
-' W spurious drug racket," said , ‘ ; 8.
\Agnihotri of the Indian
... .^0iarmaceutical Alliance.
'
Veterans of the
pharmaceutical iriduJ\
‘
shy admit that it had
unwittingly played a
part in creating this Frankenstein’s
monster. Some companies neglected
“production” handing it over to smallscale units. Over a period, many of the
small-scale operators found it more
profitable to switch over to
■—.
producing counterfeit drugs
on their own.
Said Dr C.M. Gulati,
I
editor of The
Monthly Index of
GENTAMYCIN
EYE DROPS
Batch no. 597
Manufacturer:
R.S. Pharma
ceuticals
I’lK'Week
„
-------- CBassafieds
fotoaafis t© adverse Ln tits Coiunrs.
PfesseccntactQ
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caa-ssrstsaswrsi.swrsss
PUNE
CHENNAI
CALCUTTA
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HYDERABAD
.
THIRUVANANTHAPURAM:Q4FT -23231'38
KOCHI
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KOLLAM
TRICHUR
C437-2443645
PALAKKAD
KANNURmalappuram'
Or Write to:
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K.K. Road
Kottayam-686001.
Kerala
Phene: 04S1-563646
Fax: 565339, 562479
Medical Specialties: “India has
inexpensive tableting machinery,
which need only a small room. Bulk
chemicals are available cheap.
Anybody can become a drug
manufacturer.”
The drug control officers of the
states, which are meant to haul up fake
drug manufacturers, are universally
reviled. “Our drug regulatory
authorities have no teeth, few
inspectors and even fewer experts,”
said Prof. Ranjit Roy Chowdhury of
the National Institute of Immunology.
To be fair, policing by the Drug Control
Authority is efficient in Hyderabad,
which is a bulk drug capital, but in
Karnataka, after the Lok Ayukta raids,
The only solution for
Damp Walls
n iiniift
WALL PANELLING
a
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FAX (02764) 220385 ema.l plMcffs^co in
5
May IS. 2003
y 41
CoverStory
the officials of the authority are seen
as being totally corrupt. The same is
the case with Madhya Pradesh, Uttar
Pradesh and Bihar.
Drug control officials, however,
complain that it is not they who lack
teeth, but the law. The major problem
is that manufacturing fake drugs is not
a cognizable offence. It comes under
the Drugs and Cosmetics Act, 1940 or
the Copyright Act. An accused can only
be punished for two or three years and
is often let off with a fine of Rs 5,000.
Also, identification of fake or
substandard medicines is not an easy
task and there are many loopholes
through which the perpetrators can
escape. Drug control officials can rattle
their sabres but have to put them back
in scabbards.
The Mashelkar committee, set up
in 2002, is learnt to have
recommended amendment of the act
and the setting up of a national drug
control organisation.
All this will take time and as of
for instance, came up with I
printing the brand nam
capsules in a circular fashior
not easy to duplicate
Laboratories, whose anti-tu
drug was widely duplicate
getting fewer complaint
adopted this method. Omez
antacid made by Dr
Laboratories, now has a hole
the fake drug manufacturer
surged ahead by putting tec
good use in packing.
For the bewildered consi
is no choice but to be well-i ni
vigilant. He has to exa
medicine carefully before ta.
has to identify tell-tale sigrt
§ His life may depend on it. I
WARNING NOTE: Dr C.M. Gulati
Dark mood
Australia grapples with fake
medicine problem
By SACHIDANANDA MURTHY/Canberra
ALLEGRON-25 was a common
anti-depressant tablet sold in
pharmacies in Australia over the
counter. People used it to chase
away the blues. Recently, users
complained that instead of
fighting depression, the tablet
intensified the dark moods. They
were better off than the users of
Travacam, a tablet widely used to
fight travel sickness. Australians brave the nine-hour ferry7
journey from Melbourne to Tasmania by popping
TYavacam, which was also a favourite in long-distance
air travel. But in the last three months, the Therapeutic
Drug Administration (TGA), which governs drug
standards, found that 19 persons who took the tablet had
been hospitalised and 68 others experienced “life
threatening adverse reactions”.
These two were among a thousand drugs which were
recalled from pharmacies across the country in April and
May. The panic persists as the TGA investigators are
44 EUEZ53 Mat is. 2003
with NISTULA H
DEEPAKTI]
now, the authorities cannot do much.
Sensing this, the companies
themselves have come up with some
defence strategies; it’s their money
after all. Associated Capsules Group,
TARIQ BH
LAL1TA IYEE
AJAY UPR
KANHAIAH B
and ANOSH MALEKA
finding more and more drugs to be spt
substandard. Trish Worth, the parlic
undersecretary for health, called it “shonky man
of medicines" and promised stern action a;
makers.
Pan Pharmace' - acais, whose 200 drugs we
and production impended, had tinkered with
in a big way. The TGA said that “one of ■ ’
ingredients varied in content from zero to 700
the listed dosage”. Patients either got no reli
given, a seven times higher dosage, which ma
them'.want to jump off planes and trains.
The TGA went on recalling drugs as it disco
big companies had given a contract to Pan Phar
to manufacture their drags. Curacel was fined I
manufacturing counterfeit medicines and a dii
company was fined $12,000 for switching lab ■
The TGA also found that beef cartilage used
drugs was substituted by shark cartilage.
The Australian Self Medication Indus
repair the damage done to the 1,424 ccmpar
to manufacture overithe-counter drugs Bu
worms led to other jeans oi worms. If yaii
chicken nugget revealed hard plastic, sard
imported from Thailand, contained substanil
“cause headache, itching and upset stomaci
Prime Minister John Howard insisted t’j
had come up only because of the stringent d
laws, and said the battle against unscrupu
food manufacturers would be wage
vigorously.
ENCOURAGEMENT
OF NEW CLINICAL
° DRUG DEVELOPMENT:
THE ROLE OF DATA
EXCLUSIVITY
International Federation
of Pharmaceutical
Manufacturers Associations
Federation Internationale
de 1'lndustrie du Medicament
Federacion International
de la Industria del Medicamento
FIIM
IFPMA
Dear Reader:
Pharmaceutical and vaccine research and development increas
ingly promise new therapies and preventions for infectious dis
eases, including H1V/AIDS, as well noncommunicable diseases,
such as cancers, arthritis, heart disease, mental disorders and dia
betes. Over 100 HIV/AIDS medicines are in development, includ
ing more than 10 vaccines. There are also more than 700 medi
cines in development for diseases important to a globally aging
society - diabetes, arthritis, etc
For the pharmaceutical industry to invest the billions of dollars,
Euros, yen, etc. in these highly risky health care solutions, intellec
tual property protection is essential However, patent and trade
mark protections are not the entire story. This paper corrects
for the relative lack of attention given to another important compo
nent essential, for continued therapeutic progress - the protection
of critical information generated by painstaking analysis in the
drug and vaccine development process International treaties,
including TRIPS, recognize this area of intellectual property rules;
and this paper expands the discussion of data exclusivity rules and
implementation.
We thank consultant Dr. Jacques Gorlin for undertaking work in
this area.
Dr. Harvey E Bale, Jr.
Director-General, IFPMA
International Federation
of Pharmaceutical
Manufacturers Associations
Federation Internationale
de 1'Industrie du Medicament
Fcdcracidn Intcrnacional
IFPMA de la Industria del Medicamento
© 2000 by IFPMA, International Federation of Pharmaceutical Manufacturers Associations
30, rue de Saint-Jean, P.O. Box 758, 1211 Geneva 13, Switzerland
Encouragement
of New Clinical Drug
Development:
The Role
of Data Exclusivity
TABLE OF CONTENTS
I
II
III
IV
V
Introduction
...............................
. . .
Background
Commercial and Economic Rationale for Test Data Confidentiality .
Current Slate of Data Protection
..............
Conclusion
1
2
6
8
11
Annexes
I
II
III
Glossary of relevant terms
.................................
Text of Article 39 3 of the Agreement on Trade-Related
Aspects of Intellectual Property Rights (TRIPS Agreement)
12
13
14
I.
Introduction
The discovery of a new pharmaceutical compound or vaccine is not suf
ficient to bring a safe and effective product to the market for use by
patients Rather, the public reaps the benefits of an innovative drug or
vaccine only after relevant data, generated in extensive prechnical and
clinical trials, demonstrate the drug’s safety, quality and efficacy to the sat
isfaction of regulatory authorities.
The generation of such proprietary data involves a considerable amount
of lime and expense, the entire drug development process from discovery
to marketing lakes an average of 10 years and costs, on average, $500 mil
lion in industrialized countries.
The protection of test data is a legally required and economically neces
sary component of the intellectual property package that serves to provide
incentives for the development of innovative pharmaceutical products.
The Agreement on Trade-Related Intellectual Properly Rights (the “TRIPs
Agreement’) specifically recognizes the “protection of undisclosed infor
mation" as being a category of intellectual property subject to protection
Article 39 3 of lhe TRIPs Agreement provides that'
“Members, when requiring, as a condition of approving the marketing
of pharmaceutical or of agricultural chemical entities, the submission of
undisclosed test or other data, lhe origination of which involves a con
siderable effort, shall protect such data against unfair commercial use.
In addition. Members shall protect such data against disclosure, except
where necessary to protect the public, or unless steps are taken to
ensure that the data are protected against unfair commercial use.”
The intellectual property right reference in Article 39.3 is commonly
referred to as “data exclusivity" m the U. S and “data protection' or "regu
latory data protection’’ in the European Union Throughout this article,
these terms are used interchangeably.1 Data exclusivity is an independent
intellectual property right and should not be confused with the protection
provided by other rights, especially patents. Il provides the holder with
specific rights, namely that lhe data generated by lhe holder may not be
referred to or used by another person or company for a specific period of
lime It does not prevent another company from generating the data. Thus,
the right is quite limned in the first instance. However, it has been consid
ered to be of critical importance by countries to provide lhe necessary
incentives for companies to generate the necessary data that accompanies
registrational packages for medicinal products.
1 See glossary of relevant icons in Annex I.
II.
Background
1)
Definition of the issue
In order to demonstrate a drug's efficacy and safety for us intended
therapeutic use. it is necessary for the originator of the drug to conduct
extensive testing on animals and humans tn pre-clinical and clinical trials
as well as toxicology, manufacturing feasibility and other scientific studies.
The results of these tests and studies, which are proprietary, are contained
in a registration dossier that is submitted to governmental authorities to
obtain marketing approval for the drug
The generation of this confidential registration data involves a very sub
stantial amount of time and expense for the originator; the entire drug
development process from discover)’ to marketing may lake as long as fif
teen years and cost, on average, S500 million in industrialized countries.
The registrational data are provided to the authorities in confidence and
are not meant to be referred to by third parties. If these data were immedi
ately available to third parties, there would be no incentive for a company
to generate these data in the first instance, unless the investment in terms
of both time and costs were protected by another means In many
instances, a patent will cover the pharmaceutical product al issue. Howev
er, more and more compounds which are not patent protected (for what
ever reason) are being developed and thus data exclusivity in some
instances is the only available intellectual property protection right It is
important that governments protect the confidentiality of these data
against ns unauthorized use or disclosure in order to protect the propri
etary interests of scientists and others and to maintain the economic incen
tives for further pharmaceutical research and development.
However, because of a concern for avoiding repetitive tests and trials on
animals and human, governments have sought to limit the originators pro
prietary data rights. Therefore, the U. S. and the EU have acknowledged
the right of data protection for a certain fixed period of time. After the
period has expired, reference to the data is permitted by generic compa
nies. This compromise is viewed as protecting the investment of the origi
nator, while at the same time preventing unnecessary repetitive tests and
trials. Arguably, if a country had no data protection law al all, then the data
submitted as part of a registrational package should never be permitted to
be referred to by a generic company.
The period of data exclusivity is not fixed by the TRIPs Agreement. Ear
lier drafts of the TRIPs Agreement provided a minimum five year period of
protection However, this specific minimum time frame was removed from
the final version. The time period must be sufficient to protect the origina
tor's investment.
Given the substantial amount of time and resources that is dedicated to
obtaining marketing approval and the fact that the data generated in such
testing are proprietary and only disclosed by the originator when required
by governmental authorities to obtain marketing approvals, governments
should be required to protect the data against “unfair commercial use “
That is, governments should be required not to disclose nor rely on these
data for the marketing approval of generic copies of the pharmaceutical
product without the prior approval of the originator for a fixed period of
time. Furthermore, governments should be required to protect the data
that they receive in a manner that will enable the originators to enforce
their rights in every country in the world
2)
Patents versus Data Exclusivity
As opposed to a patent right, which gives the right holder the right to
exclude others from making, using, selling, offering for sale, or importing
the patented product, the protection that governments must accord pro
prietary Lest data does not, per se, exclude the copier from running its own
tests and submitting the results to the regulatory authorities. Assuming the
absence of any intervening patents, a generic alternative may still receive
marketing approval, provided that the generic manufacturer conducts its
own pre-clinical and clinical trials and independently seeks marketing
authorization by the regulatory bodies.
While data exclusivity and patents are the two most critical and, hence,
relevant intellectual property rights for the pharmaceutical industry, they
are distinct forms of protection; protection of one right is neither depen
dent on the other nor linked to the other tn any intrinsic way and any link
age between the two contravenes TRIPs. The distinctive character of each
intellectual property right is reflected in the structure of the TRIPS Agree
ment, which assigned each right to a separate, parallel section in Part 11 of
the Agreement, Standards concerning the availability, scope and use of
intellectual properly rights
3)
"Considerable Effort": The logic for requiring data exclusivity
TRIPS Article 39.3 on the protection of undisclosed information con
tains the logic for requiring protection by governments of registration
data. This article recognizes the “considerable efforts" involved in original-
3
ing the data, links the protection provided to the data to that "consider
able effort" and declares, in essence, that any failure by the government to
provide the required protection is “unfair commercial use” of the data.
This article relates the protection of the data to the value of the data per se
and not to the value of the product or the product in support of which the
data were provided to the governments.
While WTO members are obligated to provide protection to propri
etary data at a level that is commensurate with their obligations under
Article 39 3 of the TRIPS Agreement, many countries—both developed
and developing—fail to do so. Some countries do not provide any protec
tion at all for proprietary registration data; other countries provide some
protection, but not at the level required by TRIPS Article 39.3; while still
others have the statutory basis for the protection but do not enforce the
data exclusivity.
4)
Protection in the United States, the EU and Switzerland
Most developed countries protect data that are submitted to the regula
tory authorities In practice, abbreviated applications for regulatory
approval by subsequent applicants cannot be filed in the United States for
five years after the originators approval. In the EU, Directive 65/65 pro
vides a penod of data protection of either 6 or 10 years depending on the
Member State at issue. The larger Member States provide 10 years, while
the smaller provide only 6 years. However, for products which are
approved through the centralized procedure, Regulation 2309/93 provides
a 10 year period of data protection (see Article 13 4) During this period of
time, no applications that seek to rely on the originator's data may be
approved by the regulatory authorities.
While “paper dossiers" (which rely on published scientific literature to
demonstrate the efficacy, quality and safety of the competitive drug) are
permitted under Directive 65/65, they may only be filed for a drug with an
“established medicinal use," which the European Court of Justice has indi
cated would normally be met only after at least one decade This loophole
has now been closed by Commission Directive 1999/83 (which amends
Directive 75/318) and provides that a minimum period of not less “than
one decade from the first systematic and documented use of that substance
as a medicinal product in the EU” is required for a finding of “well estab
lished medicinal use."
In most larger European countries, new chemical entities approved by
the national regulatory authorities (the alternative approval process to the
use of the centralized procedure) receive ten years of data exclusivity. As a
result of a recently-enacted revision to the Intercantonal Convention on
the Control of Medicines, Switzerland now provides ten years of market
exclusivity for New Chemical Entities (NCE).
a) In Brief: the Obligation to Provide Data Exclusivity
There appears to be a United States-EU-Swiss consensus that protection
of registration data against “unfair commercial use," as reflected in TRIPS
Article 39.3, requires governments to prevent reliance, by regulatory
authorities or third parties, on the data for the marketing of subsequent
versions of the drug during the period of exclusivity without the origina
tor’s consent. Where the two regions differ is over the length of the period
of data exclusivity. While the United Slates has a five year period, the EU
has a six or ten year period, and Switzerland has a ten year period.2 [A key
difference is also that the US gives (shorter) protection to new indications
but the EU does not] The five year period in the United States is not suffi
cient for recouping the huge investment of money and lime for developing
new pharmaceutical products.
b) Data Exclusivity as a Governmental Function
Protection of registration data, through the data exclusivity that results
from non-rehance on the data, is a governmental function.3 The authori
ties may not consider an application for a marketing authorization during
the period of data protection. An application relying upon a third party’s
data may only be submitted after the period of data protection has expired.
In the EU, where the periods of data protection differ, the European Com
mission has made it clear in its “Commission communication on the Com
munity marketing authorization procedures for medicinal products, 1998
2 For a country without any tradition of protecting test data, the five to ten year periods of data exclusivity may
not be enough and may be undercounling the actual length of time that the data should be protected. The peri
ods of time cued for the United States, the EU and Switzerland assume that the data will not be disclosed or
relied upon by the regulator)’ body before the originator of the data receives the marketing approval for the new
product It is critical that any enumeration of the penods of data exclusivity that are required by Article 39 3
include the time after the data is provided but before the marketing approval is granted As a general rule, this
will add three to four years to the five to ten year period cited as the practice in the United States and the EU.
' With the proliferation of freedom of information acts, which provide lor the public release of govcmmentally-hekl information, it is critical that regulator)’ bodies not disclose proprietary data submitted by originators
At the time of a drug’s marketing approval in the US, the Food and Drug Administration compiles a Summary
Basis for Approval, which contains conclusionary data and non-proprietary information and is publicly avail
able under the US Freedom of Information Act Similarly disclosed information is available m Europe. Dis
closure of proprietary information in such documents would call into question the protection required under
TRIPS Article 39.3.
C 229/4, at C229/13’ that "if the [data] protection period in the concerned
Member State is longer than in the reference Member State, mutual recog
nition in the concerned Member State is not possible before the expiry of
the 10-year period " (page C 229/13).
Thus, while governments are only required to provide the legal envi
ronment in which the patent holder may enforce his right against an
infringer, it is another matter with respect to the protection of registration
data. It is the government, through us regulatory agencies, and not the
originator of the data, that has the responsibility for preventing copiers
taking advantage of proprietary data during the period of data exclusivity.
Governments of most developing countries do not protect registration
data and freely rely on the data that the pioneer drug companies provide in
order to facilitate the expeditious marketing of generic copies of the pio
neer drugs. However, this approach may remove the incentive of an inno
vator to launch in a particular market.
111.
Commercial
and Economic Rationale
for Test Data Confidentiality
As briefly noted above, the generation of the data necessary for the
original marketing approval requires a very substantial investment of time,
expertise, resources and money. The originators of the drug must be given
an opportunity - and the incentive - to recoup the enormous costs
involved m generating such data before a competitor is permitted to rely
on those data for the approval of the generic alternative.
For example, research-based pharmaceutical companies in the United
States invested $21.8 billion in R&D in 1998, a 10% increase over 1997.
With forty percent of these R&D expenditures going to pre-climcal func
tions and thirty percent going towards completing the Phase I, II, and III
clinical trials required by the FDA, seventy percent of all R&D expendi
tures in the United States go to gain regulatory approval.
A new drug costs, on average, $500 million and requires as long as 15
years to develop, if preclinical and clinical trial phases are taken into
account. Only three out of ten drugs introduced m the United States from
1980 - 1984 had returns higher than their average after-tax R&D costs.
Comprehensive drug testing in the clinical trial stage alone can cost $150
million or more for a single medication, and only 10% - 20% of drugs ever
clear the full set of pre-chnical and clinical trials. In stark contrast, a man
6
ufacturer of a generic alternative, if it is not required to generate its own
test data to gain marketing approval, needs only to invest $1 million to
launch a competitor drug, as long as it can demonstrate bioequivalency.4
When the later applicant receives the benefit of the data generated by
the originator without any investment on its part, the originator is placed
at a significant commercial disadvantage. Such a situation undermines the
investment potential existing even in countries with strong and effective
patent protection, since the results of the originator’s tests are immediately
available to competitors at no cost In addition, the burden is placed
entirely on the originator to pursue any patent rights; under the data pro
tection scenario, a product is only considered for marketing approval once
the period of data protection has passed. Given the imbalance between the
cost to the originator of gaining marketing approval for its drug and the
copier's cost of coming on to the market, the research-based industry
would have a reduced incentive, without such protection, to engage in the
important R&D activities that will ultimately benefit patients through the
availability of new and innovative drug therapies
The incentive for developing new drug therapies that is provided by a
period of data exclusivity is especially critical when the new drug therapy
is not patentable. For example, had generic copies of TAXOL®, (paclitax
el), Bristol-Myers Squibb’s anti-cancer drug, which did not have any
patents on its active ingredient, been able to be approved immediately,
BMS would not have had any incentive to incur the extensive costs (esti
mated at well in excess of $500 million) to develop, test and bring TAXOL
to market.
The fact that both patent protection and data exclusivity provide incen
tives reflects the dual nature of the drug development process.
• Without the period of market exclusivity provided by a patent, the
research-based industry would not have any incentive to undertake the
research leading up to the discovery of the innovative drug therapy
• Without data exclusivity, the originators of the innovative drug would
be placed at an unfair commercial disadvantage when compared to their
generic competitors, who do not face similar costs of meeting the mandat
ed requirements set by regulatory bodies for drug approval.
4 Bioequivalcncy between a generic and a pioneer drug is demonstrated by the bioavailability of the two prod
ucts. Bioavailabtlity is the extent and rate at which the body absorbs the drug. Scientists measure the time it
takes the generic drug to reach the bloodstream The generic drug must deliver the same amount of the active
ingredient in the same time period as the pioneer drug in order to be biocquivalent.
The distinctiveness of the two incentives is recognized in the United
States and the European Union, where patent protection and data exclu
sivity provide, side-by-side, incentives to discover new drug therapies and
to undertake the extensive testing required to bring them to market.
Current
IV.
State of Data Protection
Many developed and developing countries currently fail to provide data
exclusivity along the lines mandated by Article 39.3 of the TRIPS Agree
ment. The forms of the noncompliance range from the total absence of
protection to provisions and practices that limit the effective scope of the
protection. The following are examples of these practices:
1)
Absence of data protection
Countries such as South Afnca, Brazil and Israel currently do not have
any laws on their books that provide protection for proprietary registration
data Notwithstanding that Articles 78 and 79 of Decision No. 344 of the
Andean Pact provide for the protection of registration data, the individual
member countries, such as Bolivia, Colombia, and Ecuador, do not pro
vide such protection in their legislation
2)
Linkage of the period of data exclusivity to the life
of rhe underlying parent
Spain links data exclusivity to the life of the underlying patent for the
product for which marketing approval is being sought. Linkage of the peri
od of data exclusivity to the life of the underlying patent violates TRIPS
obligations, since nowhere in Article 39.3 is there any linkage of the pro
tection for trade secrets to any of the other protections found in Part II of
the TRIPS Agreement. Indeed, trade secret protection is entirely indepen
dent of other protection and it is not permitted to link the two.
3)
Springboarding
Canadian regulatory authorities accept applications for marketing
approval of generic copies that rely on the originator’s data before the peri
od of data exclusivity expires. Even though the product appears on the
market after the period of data exclusivity expires, the review of the
dossier occurs during the period of data exclusivity. This practice is a vio
lation of the TRIPS obligation not to rely on the originator’s data during
the period of data exclusivity.
4)
Vogue and questionable definitions of data exclusivity
Singapore curtails the five-year period of data exclusivity by starting
protection from the date of filing of the originator's pharmaceutical prod
uct, rather than from the date of its marketing authorization, which is the
standard practice in the United States and the EU. Beginning the count
from the date of filing is illogical, since the originator does not reap any
commercial benefit from the data exclusivity when its product is awaiting
marketing approval and, thus, is not on the market. The effective period of
data exclusivity provided in Singapore is thus curtailed by nine to fifteen
months
In addition to its "springboarding” policies, Canada interprets the defi
nition of “reliance’ in a strictly literal manner. On November 3, 1998, Jus
tice Evans in Bayer Inc v. Attorney Ceneral of Canada and Minister of Health,
supported the Government of Canada’s contention that if the authorities in
the Ministry of Health do not physically open the dossier, then reliance has
not occurred. Judge Evans further compounded the problem when he stat
ed that “a period of five years is a long time to grant a de facto monopoly
for a drug that is not protected by a patent,’' thereby confusing the two
separate intellectual properly rights and erroneously equating patent pro
tection with the period of data exclusivity.
5)
Nullification of existing law
Korea had a data exclusivity law on its books but, in May 1997, deleted
part of the law that had specified that data on “efficacy” and “domestic use”
were required for generic drug applications submitted within the six-year
re-examination period Local clinical trial data or proof of bioequivalency
is now no longer needed for a copier drug to enter the Korean market,
thereby negating the value of the six-year re-examination period
6)
Permitting on the market "similar” copies of originator drugs that
were either approved for marketing abroad or in the country
The Government of Argentina, which previously did not have any
statutory protection for registration data, look a step backwards when it
passed a data exclusivity law in December 1996, legitimizing the reliance
on the originators registration data submitted to the Argentine public
health authorities for use by producers of similar products. Argentina pro
vides for an expedited marketing authorization of a “similar” drug when
the originator drug has already been marketed in Argentina or in a number
of other (developed) countries. Argentina reportedly will permit the mar-
keling of the generic copy if a certificate of free sale can be provided from
abroad for the originator drug
Argentina claims that such use of certificates of free sale to approve the
marketing of a generic copy of the originator's drug does not constitute
reliance on the originators data. A recently enacted law in Israel permits
the importation and marketing of any drug that is “similar" to a drug that
is already registered in Israel.
7)
Unauthorized disclosure of proprietary data embodied
in the registration dossier
While TRIPS Article 39.3 pennits the disclosure of the data, it only
does so if the disclosure is accompanied by steps to ensure that the data
are protected against “unfair commercial use.” The countries of Eastern
and Central Europe, in preparation to join the European Union, are
attempting to converge their marketing regulatory requirements with
those of the European Union With the exception of the Czech Republic,
these countnes are demanding full access to the registration dossiers of the
originator drugs, without providing any guarantee that the data will be
protected from disclosure. Slovenia reportedly does not take any safe
guards to protect registration dossiers against disclosure to generic
copiers.5
Requirement to disclose test data without taking measures
to protect confidentiality
Although Japan precludes the issuance of any second approval without
full clinical and non-clinical data for six years after the originator's
approval, n is not for the purpose of protecting the data but to confirm,
during the re-examination period, the efficacy and safety of the approved
new drug.
In addition, the Japanese Ministry of Health and Welfare ( “MHW”)
intends to publish a “Summary Basis of Approval" after the approval of
each new pharmaceutical product. As the “Summary Basis of Approval"
includes all necessary information for examination of such new products
by MHW, with a total length of 500 pages or more, the scope of this publi
cation will be significantly greater than the FDAis SBA and the European
“Summary of the Product Characteristics”, which are about 40-50 pages in
8)
' As pan of the acquis cominumtaiic. Slovenia has decided io link the penod o( data exclusivity to the life of the
underlying patent for the product for which marketing approval is being sought This violates the TRIPS
Agreement. The new data protection law provides a period of six years of data protection from either the initial
approval in the EU or Slovenia
10
length. Given that a data protection law is not available in Japan, this
wide-ranging publication gives rise to doubts about this policy being in
compliance with TRIPS.
Furthermore, a "Freedom of information Act" is to be implemented in
Japan from 1 April 2001. Since the Japanese Freedom of Information Act
will require the widest range of publication in the world, the Act will give
rise to serious doubts about its being TRIPS-compliant, unless it is proper
ly applied
V.
Conclusion
Data exclusivity is an independent intellectual property right and
should not be confused with the protection provided by other rights, espe
cially patents. Countries with the leading research-based pharmaceutical
industries recognize the strong incentive provided by data exclusivity and
have taken steps to ensure that the proprietary registration data that com
panies are required to submit to gain marketing approval are protected
against unfair commercial use and disclosure.
The protection of data embodied tn the “non-rehance/non-disclosure”
concept is time-related - data exclusivity should be provided for at least
ten years from the originator’s marketing approval. This lime frame is evi
dent from the negotiating history of the TRIPS Agreement and the current
practice of countries with leading research-based pharmaceutical indus
tries, such as the European Union and Switzerland.
The obligation to protect registration data against “unfair commercial
use" is incumbent upon governments, not the originators of the data
Since January 1, 2000, all WTO member countries - with the exception of
only the least developed countries - have been required not only to have
TRIPS-compliant protection for proprietary registration data but also to
enforce effectively this protection
As described above, many countries currently either fail to provide
such protection or the protection that they provide falls below the levels
required by TRIPS. Only with a clear understanding of the data exclusivity
issue and a concerted effort by governments, will industries, such as the
pharmaceutical industry, that are required to provide registration data to
governments have the assurances that their extensive efforts to research,
develop and bring new, innovative products to market will not be subject
to unfair commercial use.
Annex I
Glossary of Relevant Terms
The concept of “data exclusivity" is sometimes confused with the con
cepts of “data privacy" and “trade secrets or business confidential informa
tion " The following brief definitions may help to alleviate that confusion :
1. Exclusivity of Registration Data - period of non-reliance and non-dis
closure that a government must provide to pharmaceutical registration
data Pharmaceutical registration data are the proprietary data generated
by scientific research conducted to demonstrate the efficacy and safely of
new medicines and submitted to regulatory authorities for marketing
approval.
2. Data Privacy - individually-identifiable information, e. g., medical
background and personal health data, that may not be disclosed or trans
ferred inappropriately without the explicit or implicit authorization of the
individual. Unlike registration data, which applies only to those industries
such as the pharmaceutical and agro-chemical industries, data privacy
applies to all industnes.
3 Trade Secrets or Business Confidential Information - information deriv
ing us value from not being known to the public, competitors or other
parlies who may gain benefits from its disclosure or use. To receive protec
tion as a “trade secret," business confidential information must be secret.
have commercial value because it is secret and have been subject to rea
sonable steps taken under the circumstances to keep it secret
Annex II
SECTION 7: PROTECTION OF UNDISCLOSED INFORMATION (TRIPS)
Article 39
1. In the course of ensuring effective protection against unfair competition
as provided in Article 1 Obis of the Paris Convention (1967), Members
shall protect undisclosed information in accordance with paragraph 2
below and data submitted to governments or governmental agencies in
accordance with paragraph 3 below
2 Natural and legal persons shall have the possibility of preventing infor
mation lawfully within their control from being disclosed to, acquired
by, or used by others without their consent in a manner contrary to
honest commercial practices
*
so long as such information:
- is secret in the sense that it is not, as a body or in the precise config
uration of its components, generally known among or readily acces
sible to persons within the circles that normally deal with the kind
of information in question;
- has commercial value because it is secret; and
- has been subject to reasonable steps under the circumstances, by the
person lawfully in control of the information, to keep it secret
3 Members, when requiring, as a condition of approving the marketing of
a pharmaceutical or of agricultural or chemical products which utilize
new chemical entities, the submission of undisclosed test or other data,
the origination of which involves a considerable effort, shall protect
such data against unfair commercial use. In addition. Members shall
protect such data against disclosure, except when necessary' to protect
the public, or unless steps are taken to ensure that the data are protect
ed against unfair commercial use.
* For (he purpose of (his provision, a manner contrary to honest commercial practices" shall mean at least
practices such as breach of contract, breach of confidence and inducement to breach, and includes the acqui
sition of undisclosed information by third panics who knew, or were grossly negligent m failing to know, that
such practices were involved in the acquisition.
13
Annex 111
Nature of Obligations under TRIPS Article 39.3
The TRIPS Agreement, which was negotiated as part of the Uruguay
Round of trade negotiations in the GATT, the predecessor organization to
the World Trade Organization (WTO), was the first international intellec
tual properly agreement to include obligations for the protection of trade
secrets, especially the proprietary data submitted by innovators to govern
ments?
Observers have come to realize the growing commercial significance of
the incentives provided by a period of data exclusivity for products that
were not under patent protection, either because the new chemical entities
did not meet the novelty test for a patent from the outset and were, there
fore, not patentable or because the chemical entities involved new uses of
products whose patents may have expired. Another contributing factor to
the emergence of data exclusivity is the expiration of the transition period
for TRIPS implementation by the developing countries and the countries
of Central and Eastern Europe that are tn the process of transformation
from centrally-planned into market, free-enterprise" economies On Janu
ary 1, 2000, these countries were obligated to have implemented Article
39.3 together with the rest of the TRIPS Agreement, and any failure to do
so exposes them to WTO dispute settlement. Even those countries that
will be permuted by the TRIPS Agreement to delay until January 1, 2005
the application of the TRIPS patent obligations to pharmaceutical products--e g., India, Argentina, and Egypt—were required, as of January 1,
2000, to have their proprietary data protection at the level mandated by
the TRIPS Agreement.
Article 39.3 requires a WTO member state to protect registration test
data submitted to regulatory authorities against “unfair commercial use
and disclosure," except when necessary to protect the public, or unless it
can ensure that the data are protected against unfair commercial use. Arti
cle 39.3 contains two obligations: protection against disclosure and pro
tection against unfair commercial use The Office of the General Counsel
of USTR defines these two obligations in the following manner:
* Although the NAFTA Agreement was concluded in 1992. pnor to lhe completion of the TRIPS Agreement.
TRIPS Article 39 3 appeared m its final form in the Dunkel text of the TRIPS Agreement, which appeared in
December, 1991 Similarly, while lhe OECD Council Recommendation concerning the Exchange of Confi
dential Data on Chemicals was adopted pnor to the Dunkel Text - on July 26. 1983 - it was only a recom
mendation io the OECD member states and not a binding international instrument
... With regard to the first requirement, test data must be protected
against disclosure to the public (or even within the government) unless
such disclosure is necessary for public safely or unless steps are taken
to ensure that the data are protected against unfair commercial use.
With regard to the second requirement. TRIPS Agreement negotiators
understood it [the term “unfair commercial use" | to mean that the
data will not be used to support, clear or otherwise review other appli
cations for marketing approval for a set amount of time unless autho
rized by the original submitter of the data Any other definition of this
term would be inconsistent with logic and the negotiating history of
the provision 7
A similar understanding of the obligation to protect "against unfair
commercial use’ was contained in a paper presented by New Zealand at
the APEC Seminar in 1995:
Defining ‘unfair commercial use' can only properly be done by refer
ence to the context of the complete provision, i. e the purpose behind
the provision In the light of this we interpreted Article 39 3 as meaning
that there is a restriction on the use which regulatory authorities can
make of original data they hold in order to approve subsequent appli
cations for approval of generic medicines, animal remedies or pesti
cides. In other words, where undisclosed information is provided to a
regulatory authority by an applicant so that the authority can approve
the applicant’s product, if this information is then used by the authori
ty to approve the product of a second applicant that is, tn New
Zealand’s view, ‘unfair commercial use. ’ In effect, the regulatory'
authority is giving commercial advantage to the second applicant in
that the applicant does not have to generate the data which was
required of the first applicant. This can be a significant economic sav
ing-8
The negotiating history of TRIPS Article 39.3 supports "non-reliance on
the originator’s data for a particular period of time’’ as the definition of the
obligation to protect the data against “unfair commercial use.’’ Early drafts
of the agreement had specified a period of lime during which governments
should not rely on such data for the approval of competing products with
out the consent of the originator of the data. For example, the draft of
November 23, 1990 contained the obligation that, "... the data may not be
7 “The Protection of Undisclosed Test Data in Accordance with TRIPS Article 39.3." unattributed paper which
was drafted by the Office of the General Counsel of USTR for submission in bilateral discussions with Aus
tralia. May 1995
15
relied upon for the approval of competing products for a reasonable time,
generally no less than five years...”
The obligations in Article 39.3 apply to “new chemical entities.” “New
chemical entity” is a regulatory' concept and should not be confused with
the “novelty" requirement of a patent. Drug regulatory agencies, such as
the U S. FDA and the national agencies in Europe, define a “new chemical
entity" as a new compound with no prior approval as a drug, that has
undergone full development and testing, and is proven to be safe and
effective “New chemical entity” status does not relate to the time when the
active ingredient was first discovered or symthesized.
1995, Pre^matonl^NewS
16
17-19 May
International Federation of Pharmaceutical Manufacturers Associations/
30, rue de Saint-Jean, PO. Box 758, 1211 Geneva 13, Switzer.l
Tel: +41 (22) 338 32 00 - Fax: +41 (22) 338 32 99
E-mail: admin@ifpma.org - IFPMA Web site: http://www.ifpi
•wain Identity
rrom:
"Dr. Laing" <.iaingr@wiio.int>
To:
"INDIA DRUG" <india-drug@usa.healthnet.org>
Sent:
Thursday, July 17, 2003 7 13 PM
<BE082039503 71C489D4FE2BB2FA3C08D031 BEFE6@ whqkakiC>2. who. igl>
Subject: [india-drug] Response to Essential Medicines materials for School Health
Sender ownci-india-diw@usa.heaIihact.oiR
Precedence: bulk
Reply-Tc: indie-drug@usa.healthnet. erg
Response Io Essential Medicines materials for School Health
Dear Dr Sathyanaravanan.
Thank you for your very interesting reply. Many years ago when I was
doing work on Plantation health services in South India, I visited some
schools in T amil Nadu and was very impressed with their school feeding
program.
But your response also highlights (he problem that I am facing. I am
not primarily hying to get materials about school health programs. I
am trying to get materials on what children arc taught about medicines.
The paper that 1 quoted by Geisler shows that children already know
quite a lot and need to know more. Pat Bush at the USP described what
children needed to know.
BUT apart from a message from New Zealand I ha ve not heard of materials
that could be used in a school health program.
Imagine if I had asked for materials about drags of abuse. I would have
been flooded with mult-rials
So if you or your colleagues have such curricula or materials I would
be very interested to sec it.
Th-mk you,
Richard I aing
Richard Laing (Medical Officer)
Policy, Access and Rational Use,
Essential Drugs and Medicines Policy,
7/18/03
Page 2 of 2
World Health Organmation
CH-121 i Geneva 27, Switzerland
Tel 41 22 791 4533
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i.
ST. JOHN’S NATIONAL ACADEMY OE MEDICAL SCIENCES
INSTITUTE OF POPULATION HEALTH AND CLINICAL RESEARCH
CLINICAL TRIALS DIVISION
Head
Dr. Prem Pais MD
Prof & Head of Medicine & Vice Dean
Coordinator
Dr. Denis Xavier MD
Asst. Professor, Pharmacology
Advisors
Dr. K. Srinivasan MD
Prof & Head, Psychiatry
Dr. George D’Souza MD
Professor & Head, Chest Medicine
CONTENTS
1)
Areas of our work and some examples
2)
Collaborating agencies
3)
What we have developed
Personnel and infrastructure
a]
b]
-
Capacity
Regulatory
Clinical trials development
Trials management
Data management
Clinical research supplies management
Blood and other samples
4)
Our vision for the future
5)
A snap-shot of our major projects
MAILING ADDRESS:
Dr. Prem Pais/ Dr. Denis Xavier
Room no. 210, first Floor, St. John’s Medical College
Koramangala PO, Bangalore 560 034, INDIA
Telefax: +91-80-5523416, 5526382, 2065033
Email: clepidsjmc@vsnl.com
11 AREAS OF OUR WORK AND SOME EXAMPLES
1| CLINICAL EPIDEMIOLOGY IN CARDIOVASCULAR DISEASE
INTERHEART, ICMR Case Control Study, CREATE Registry, OASIS Registry
2)
CLINICAL TRIALS
As Coordinating center - CREATE, POISE, VITATOPS, OASIS-5
As Investigating center - HERO 2, DREAM, NN - IGT
and several Phase 4 studies
3| GUIDELINES DEVELOPMENT
Diabetes guidelines for developing countries -CDC Supported study
WHO -Hypertension management at the primary care level
4]
HEALTH POLICY
WHO PREMISE
5]
TRAINING
Research Methodology Course
Investigators / Clinical Research Coordinators - GCP and Clinical Trial
Logistics
2| COLLABORATING AGENCIES
1.
World Health Organization
2.
NIHZ CDC [Atlanta, USA]
3.
Indian Council of Medical Research
4.
Academic: McMaster University - Canada, Edinburgh - UK,
Green Lane Hospital - New Zealand, Royal Perth Hospital Australia
5.
Several Pharmaceutical Companies - Astra Zeneca, Aventis Pharma,
Abbott, Novo Nordisk, Pfizer, Sanofi Synthelabo-Recherche, Ranbaxy,
Torrent etc.
3| WHAT WE HAVE DEVELOPED
A| PERSONNEL AND INFRASTRUCTURE...
>
1910 sqft of office and storage space
>
6 faculty and 14 research staff
>
From 3 departments
>
Ability to coordinate large clinical trials
and provide total solutions
B] CAPACITY...
1]
REGULATORY
□
Liaison to obtain Regulatory [DCGI’s] approvals for clinical trials
□
Import license for drugs and equipment
E3
Liaison with customs personnel
□
Ethics approvals - local / national
2| CLINICAL TRIALS DEVELOPMENT
O
Protocol
O
Case Report Forms
O
Manuals
O
Other Study Materials
O
Statistical Issues
3]
TRIALS MANAGEMENT
■
Investigator/ Site / Area Identification
□
Documentations
£1
Investigators Meetings/ Training
□
Study Initiation
O
Monitoring & Audit
□
Study Close Out
4J DATA MANAGEMENT
□
Data Base Creation
□
CRT Storage [Current / Archiving]
□
Data Entry & Quality Checks
5] CLINICAL RESEARCH SUPPLIES MANAGEMENT
□
For Drugs & Other Materials
□
Storage
□
Packaging and Distribution Logistics
□
Maintaining Stocks at Centers
□
Drugs Accountability
□
Drugs Destruction
6]
BLOOD AND OTHER SAMPLES
B
Temperature Controlled Storage
□
Sample Analysis
□
Appropriate Destruction
41 OUR VISION FOR THE FUTURE
□
To develop and conduct Clinical Trials and Epidemiological Research with
special relevance to India and other developing countries
3
To achieve world class standards at ‘realistic’ costs
□
To transform knowledge to better health through policy change
AND HOW ?
□
By further developing infrastructure and expertise for total solutions in clinical
trials and epidemiological research
GJ
By appropriately disseminating knowledge and advocacy
51 A SNAP SHOT OF OUR MAJOR PROJECTS
TITLE
DESCRIPTION
SPONSOR
STATUS
EPIDEMIOLOGY AND PRACTICE PATTERNS
INTERHEART
ICMRTask
force study
WHO, Astra
Zeneca,
A global case control study
World Heart
to identify the risk factors for
Federation;
Acute Myocardial Infarction
Coordinated
in different ethnic
by McMaster
populations
University,
Canada.
Risk factors in acute
myocardial infarction study.
A national multi-centre case ICMR
control study based in Indian
urban hospitals.
- Recruitment completed
- 282 cases & 563
controls
- Country coordinator
- Completed
- 1000 cases and
2000 controls
CREATE
Registry
Prospective observational
study of Practice Patterns in
Acute Ml and Unstable
Angina in India.
Aventis
Pharma
- Country coordinator
- 79 centers in
India
- 13,000 subjects
recruited
- Target: 20,000
WHOPREMISE
Study
Prevention of REcurrences
of Myocardial Infarction and
StrokE (PREMISE).
Through Community -Based
and Health Service
Interventions
WHO
- Phase one completed
- Plans on for phase two
CLINICAL TRIALS
TITLE
DESCRIPTION
SPONSOR
STATUS
The CREATE
Study
A large, simple trial with low
molecular weight GIK in
patients with acute
myocardial infarction
McMaster
University,
Canada
- Country coordinator
- 67 centers in India
- 4,100 subjects
recruited [May 2003]
- Target 8000
Diabetes REduction
Assessment with ramipril
and rosiglitazone Medication
Canadian
Institutes of
Health
Research,
Aventis, King,
Glaxo
SmithKline.
- Recruitment completed
- Follow up ongoing
The DREAM
Trial
POISE Study
VITATOPS
Study
OASIS-5
A large, simple trial of
metoprolol versus placebo in
McMaster
patients undergoing
University,
noncardiac surgery at
Canada
moderate and high risk of a
perioperative cardiac event
[VITAmins TO Prevent
Stroke], the efficacy and
Royal Perth
safety of multi-vitamin
Hospital,
therapy in secondary stroke Australia
prevention
A phase 3 international
multicenter study in unstable SanofiSynthelaboangina / NSTEMI with
Fondaparinux,
Recherche
- Country coordinator
- Trial to be initiated
shortly
- 1500 patients from 30
centres
- Country coordinator
- 500 patients from 20
centres
- Country coordinator
- 1000 patients
- 20 hospitals
GUIDELINE DEVELOPMENT
DIABETES
GUIDELINES
PROJECT
A study for the development
of low - cost algorithm for
management of diabetes in
developing countries
WHO-HTN
Project
A global program on
detection, control and follow
up of hypertension a the
primary care level in middle
and low income countries
World Bank
and CDC,
USA.
WHO
Completed
- Program development
completed
- Will be implemented by
the WHO in about 30
developing countries
GOVer St 0 ry/.\ ewsYou Cant! sc
y?—±.
a According to
/
the WHO, 35 per
cent of fake drugs
produced in the world
come from India,
which has a Rs 4,000crore spurious drug
market. About 20 per
cent of medicines in
the country are fake.
*
Many common
drugs, including
those used for head
aches and the com
mon cold, are fake or
substandard. Of them,
60 per cent have no
active ingredient and
16 per cent have
harmful ingredients.
Many common medicines
available in the market are fake
By N. BHANUTEJ/Bangalore
and QUAIED NAJMI/Mumbai
A recent raid by
•
the Karnataka
Lok Ayukta revealed
that authorities were
silent about 829 sub
standard drugs which
were being bought
and consumed by
the public.
hink twice before you pop
that pill. You could be
swallowing solidified
chalk powder masque
rading as paracetamol.
Your fever will get worse and you will
get stomach pain as bonus. That is, if
you are lucky. Things could be much
worse. You may be taking that anti
depressant to drive away the blues. In
your bad mood, you may not have
noticed that the packing looked
different. A few hours later, you may
be in the grip of a panic attack.
If that does not frighten you, run
your eye through these alarming
statistics. According to the World
Health Organisation, 35 per cent of all
T
TRAGIC ORDEAL Alpash Mehta,12, (with
father and mother) almost tiled after
being injected with a spurious drug
36 £5352253 May 18,2003
fake drugs produced in the world come
from India, which has a Rs 4000-crore
spurious medicine market. Nearly 20
per cent of the medicines available in
the domestic market are fake or
substandard. Of these, 60 per cent do
not contain any active ingredient, 19
per cent contain wrong ingredients
and 16 per cent have harmful and
inappropriate ingredients. Spurious
drugs appear in commonly known
brand names. So be afraid.
"Today fake and substandard drugs
harm more persons daily than the
SA RS virus," said Ajit Singh, chairman
of the Associated Capsules Group in
Mumbai. Consumers and drug control
officials have to grapple with two
demons: fake drugs manufactured by
seedy underground units, and
substandard drugs which come from
the stab! ■ reputed companies. Often
it is difficult to distinguish between the
two. The common factor is that both
are harmful.
Mav 18,2003 EEE213 37
CoverStory
The problem is more acute and
widespread than one can imagine.
Doubters can peruse these grim
findings.
♦ An Army man died in a nursing
home in Patna on May 5 after being
injected with a substandard drug.
♦ A random test of ciprofloxacin 500
mg tablets (batch no.154 V), an
antibiotic manufactured by British
Pharma Laboratories of Gujarat,
proved that the tablets contained no
ciprofloxacin.
♦ Dexamethasone 5 mg
(batch no. 145 P) tablets,
a life-saving steroid
manufactured by the
same
company,
contained
dexamethasone.
SPOT THE
FAKE ONES
The Organisation of Pharmaceutical Producers
of India has some suggestions for consumers
THOSE BUYING MEDICINES SHOULD ALWAYS LOOK FOR:
'The batch number, manufacturing date, expiry date,
manufacturing licence number, manufacturer’s name/address
on the pack before buying any medicine
'Any sloppiness—illegible or badly printed labels, absence of one/all of
the above details, faulty sealing and differences in colour of the packing
'Broken tablets/capsules, extraneous matter in liquid preparations,
lumps in creams/ointments
TO CURB THE SPREAD OF FAKE MEDICINES:
♦ Destroy the empty packs/bottles of used or
left-over medicines to avoid recycling
Report to the company which manufactures/markets the product
of your doubts about any particular medicine immediately
manufactured
Medismith
of
Bangalore, contained no
trace of hydrogen peroxide.
♦ Villagers in Madhya
Pradesh are usually given
fake drugs Conacin and
Crocinol in place of the
common brand Crocin.
♦ Ampicillin 250 mg capsules, another
commonly used antibiotic for
respiratory infections, made by
Economic Pharma of Mumbai (batch
no 5604), contained a powder that had
no ampicillin in it.
♦ Paracetamol syrup, usually
prescribed to control fever in children,
manufactured by Sinclair Pharma
(batch no. SP 001), contained no
paracetamol at all.
The list goes on and on. The rot
runs deep.
This was made amply clear in a
recent raid by the Lok Ayukta on the
Drugs Control Department of
Karnataka. There were a lot of fake
drugs in the market and the
authorities couldn’t care less. The Lok
Ayukta discovered that in the last three
years, the department had found that
829 commonly known medicines were
of poor quality. Still, the department
took no action and allowed people to
buy and consume the drugs. “This is
just the tip of an iceberg,” said an
official who was anguished at the tum
38 EEIEE33 May 18, 2003
0 The company will lodge complaints either with the
local police or the regulatory authorities in the state.
These two agencies will investigate the
matter and initiate appropriate
criminal proceedings.
Graphics/MUKESH M.
of events. “These are just
random samples. What ifwe
had gone looki ng for fake medicines?”
hey would have found it all over
the place. To use a cliche, the web
of fake medicines spreads from
Kashmir to Kanyakumari, though,
according to available information, it
becomes flimsy down south. The
steely filaments of the web are in the
T
CROCIN Paracetamol tablets
Batch no. 0100 and S9238
Manufacturer: Smithkline Beecham
northern region,
with Bhagirath
Palace in Delhi
reportedly being the hub of fake
medicine trade in south Asia. Indore
in Madhya Pradesh is another
breeding ground of fake drugs. Nearly
150 small-scale drug manufacturing
units operate from garages and hovew^
here. From Indore, fake medicines
have found their way to Russia and
Uzbekistan. Medicines are being
churned out in slums outside
Lucknow and Ahmedabad. They have
a thriving market in South Africa,
creating huge problems for the health
officials there, not to speak of
neighbouring countries like Myanmar
and Bangladesh.
The most established and fast
moving brands are the targets of the
drug mafia. Hoechst Marion Roussel
Ltd found to its utter shock that 15 per
cent of all its products available in the
market
were
fake.
Knoll
Pharamaceuticals suffered losses
worth Rs 75 lakh on three
popular brands: Brufen,
Entamizole forte and
Eptoin.
Smithkline
discovered that its popular
brand lodex had been
duplicated everywhere.
Spurious drugs were
being sold in Uttar
Pradesh, Bihar, parts of
Karnataka and Tamil
’
Nadu.
Unofficial
figures
gathered by consumer
bodies estimate that more
than 40 per cent of the
medicines which hit the
rural market are fake or
substandard. The illiterate
^fllager is easy prey to the
JP<e drug mafia which
colludes with local doctors and
chemists. Many over-the-counter
products sold in interior Madhya
Pradesh are fake. A villager cannot be
expected to distinguish Glysun-D and
Glycon-D from Glucon-D. Vips and
Vims are balms which officiate for the
popular Vicks. In Flyderabad, drug
control officials had a hard time
distinguishing between Crocin and its
fake cousin. The packings were almost
the same.
Fake drugs have spread terror in
Kashmir, too. In 1999, the drug
controllers department in the Valley
blacklisted Jackson Pharmaceuticals
VICTIM: Rakesh Kumar Das
was injected with a fake drug
Ltd after its products were found to be
substandard. The company is,
however, back in business. The Uttar
Pradesh Police raided a dingy house in
Lucknow two years ago and seized 300
bottles and 1,000 fake labels of
Betadine. The fake drug market
thrives in towns like Meerut.
Despite its spread, the pharma
companies and authorities do not have
any concrete data on the producers of
these medicines. Most of the small
units operate from hovels and garages.
Some of them had been associated
with big companies. The general
impression is of a shadowy crowd. “No
• Into th® Ohm’s den
By NISTULA HEBBAR
n a cramped room in Shakarpur in Delhi. Sanjay'
Khanna is busy overseeing the production of a batch
of fake tablets. His speciality is over-the-counter drugs
like paracetamol and disprin. The entire manufacturing
unit cost him around Rs 1,00,000, but the profits have
more than made up the cost.
What makes fake tablets so profitable? According to
Dr C.M. Gulhati, editor ofthe Monthly Index of Medical
Specialities, it is the economics ofthe situation. A strip
of 10 Nimuselide tablets has a sale price of Rs 25.75. The
cost ofthe drug in bulk is Rs 250 per kg—one tablet would
be equal to 100 mg. So the cost of 10 tablets would be 25
paise. The cost of printing and packaging a tablet would
I
spurious drug manufacturer
puts up a nameplate
announcing his business and
in most cases, these are
garage-type operations," said
S. Ramesh of the research
wing of Associated Capsules
Group at Andheri. “ It is
difficult to catch them as
they know all the loopholes
of the law,” said a doctor.
Drug control officials and
doctors have much to say
about the hot spots and
about
fake
drug
manufacturers breeding like
mosquitoes, but when one
gets down to specifics, they
shrug their shoulders.
hose who consume the spurious
drugs cannot dismiss the problem
with a casual expression of resignation.
Sometimes they pay with their lives,
as in the case of Rakesh Kumar Das,
an Army man, who died in a nursing
home in Patna after he was
administered three injections of Lasix
on May 5. His father alleged that his
son was injected with a substandard
drug. Interestingly, the owner of the
nursing home, Dr Ramendra Narayan
Singh, does not dismiss the allegation.
"Anything can happen in this country,"
be about Rs 1.40. Thus the entire tablet is ready for sale
at Rs 1.65. Big brands factor in research and development
costs, the costs of clinical trials and other overheads. But
in fake manufacturing the cost is much less as they skip
R&D; they simply lift the formula.
Gulhati is careful in distinguishing between fake and
substandard drugs. "Fake drugs may' contain the right
formula and may just fake the brand, but substandard
drugs are from licensed manufacturers where the
standardisation procedure has not been followed," he says.
Three years ago, in Shakarpur, the Economic Offences
Wing of the Delhi Police had raided a shop, seizing Rs
2,00,000 worth of Nimulid and Glizid tablets. But
Khanna is not worried about the law getting to him. “They
(the police) will have to pick up the samples first," he says.
“We will come to know long before that."
What worried him more was last month's truckers
strike that disrupted his supply line between Delhi and
Meerut.
Mil IS. 2003 BTu'SS 39
CoverStory
and that they would give him a total
of 120 doses.
Fearing for the boy’s life, his
family rushed him to another
hospital where his treatment
schedule was changed. Now he is
back on the road to recovery with
only a few visits to the hospital.
It was later learnt that the
medicine was a counterfeit made in
India and passed off as the imported
one. It was sold in regular stores at
approved rates. Mehta said that he
had contacted the Dutch company
that manufactures Imipanium and
was told that the ideal dosage for a
boy of 12 would be 14 to 15 shots,
which added fraud to the list of
grievances.
Mehta complained to the FD/^
Caught in the trap
By QUAIED NAJMI
hen
disaster
struck
Lakhpatraj Mehta, 36, it was
total and unforgiving. The victims
were his two sons, Alpesh, 12, and
Aman, 8. While Alpesh nearly lost
his life to spurious drugs, Aman died
because of alleged medical
negligence.
It all began on March 28, 2002,
when the three met with a road
accident in Pune. Alpesh was
admitted to the KEM Hospital while
Aman was rushed to the Jehangir
Hospital. Mehta claims that 59
doses of Imipanium, a very
expensive injection (an ampoule
costs Rs 1,850) imported from
Holland were administered to
Alpesh. All the ampoules were
purchased from a private pharmacy
store, KM medical store, located in
the hospital compound. Though
Mehta had noticed that details like
the date of manufacture and expiry
date were missing, in the heat ofthe
moment he did not report it.
After the injections were
W
he said.
Dealing with ill-effects of fake
drugs is daily routine for Ahmedabadbased sexologist Dr Paras Shah. “Skin
fibrosis due to fake sprays promising
penis enlargement is quite common,”
he said. Gujarat, according to him, is
flooded with fake medicines promising
wonder cures for sexual problems.
Brij Narayan, a 58- year-old
farmer of Bhopal, was laid low by
viral fever. But the drugs which the
doctors administered gave him
no relief. His condition
worsened. Finally his sons
took him to another hospital,
where he got well. It later
turned out that he had been
given substandard drugs
in the first instance.
In Hamidia hospital
of the Bhopal Medical
College, surgeons face
what they call an
40 SEEEB33 Mat is, 2003
RECOVERING: Alpesh in hospital
administered, Alpesh’s condition
began to deteriorate. His body
blackened and he began to bleed. He
also developed severe bouts of fits.
When there were no signs of
improvement even after 55 days,
Mehta talked to the doctors. But they
insisted that the treatment was proper
“anaesthesia problem”. Said one: “We
are supplied with ketamine
hydrochloride injection to be used as
anaesthetic agent. Normally 10 mg is
enough to make a patient unconscious.
But we have to use three to five times
more.” The particular drug is
manufactured at Sanwer Road,
Indore.
“Spurious drugs are a major
threat to people’s health and
well-being,” said Ajit Singh.
“Those who make them are
terrorists.” According to C.H.
Unnikrishnan,
senior
assistant
editor
of
Pharmabiz, some drugs were
made of chalk dust, fine
sand or limestone
POLYBION SYRUP
B-complex syrup;
Batch no. LR 697.
Manufacturer: E Merck
in Pune and Mumbai, which has
lodged criminal complaints against
the pharmacy and its proprietor Jain
at Samarth Police Station, Pune.
Now, Mehta wants the authorities to
institute a CBI enquiry into the drug
racket in Pune hospitals. He is
determined in his fight despite
receiving threats from the drugs
mafia. “I am not going to rest until
the racket is busted and the culprits
are booked,” he said.
powder. “Others are positively
harmful,” he said.
Sometimes
it can
cause
complications. “A patient who was
suffering from a chest disease was
being given a syrup,” said Dr Amit
Wancho of Srinagar. “He complaint^
that it was not helping him. We later
found out that it was a substandard
drug and it created other problems for
him.” Sometimes, it can prove fatal:
five tribals of Ranchi died five years
ago after consuming spurious
medicines. Some substandard drugs
may contain a small amount of the
active ingredients that would build up
resistance to a particular drug.
Though physicians express
anguish at the prevalence of fake
drugs, the fact remains that the racket
operates with their connivance,
especially in rural areas. A leading
doctor in Indore is known to have
taken a car as a gift from a dubious
Wat ch
^COUNTERFEITS ►►►
■ Paracetamol tablets
o u t
INGREDIENTS
EFFECT
■ Chalk powder
■ Regular intake
could cause gastric
disturbance
■ Contraceptive pills
■ Wheat flour
■ Fails to provide
■ Antibiotic capsules
■ Rice flour, soda
■ Fails to improve
bicarbonate
the patient’s
and turmeric powder
condition
the desired result
(turmeric powder is
used to make fake
tetracyclin)
■ Industrial solvent
■ Paracetamol syrup
■ Gould affect optic
nerve, liver and brain
Chloramphenicol counterfeits are usually made of soda bicarbonate. When administered
to a patient with typhoid, it fails to bring down the fever, often proving fatal
Graphics/MUKESH M.
pharma company. He prescribes its
medicines regularly. Dozens of shady
pharmaceutical firms in Madhya
Pradesh have cut deals with doctors to
market their medicines. Some small
time doctors in Gwalior, Sagar,
Ujjain and Dewas have
gone one step iurther and
have become partners in
these units.”Small-time
doctors perpetuate the
spurious drug racket,” said
V.K. Agnihotri ofthe Indian
Pharmaceutical Alliance.
| Veterans of the
pharmaceutical indu
stry admit that it had
unwittingly played a
ThcWeek
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part in creating this Frankenstein’s
monster. Some companies neglected
“production” handing it over to smallscale units. Over a period, many of the
small-scale operators found it more
profitable to switch over to
producing counterfeit drugs
on their own.
Said Dr C.M. Gulati,
editor of The
Monthly Index of
GENTAMYCIN
EYE DROPS
Batch no. 597
Manufacturer:
R.S. Pharma
ceuticals
fl
Medical Specialties: “India has
inexpensive tableting machinery,
which need only a small room. Bulk
chemicals are available cheap.
Anybody can become a drug
manufacturer.”
The drug control officers of the
states, which are meant to haul up fake
drug manufacturers, are universally
reviled. “Our drug regulatory
authorities have no teeth, few
inspectors and even fewer experts."
said Prof. Ranjit Roy Chowdhury of
the National Institute of Immunology.
To be fair, policing by the Drug Control
Authority is efficient in Hyderabad,
which is a bulk drug capital, but in
Karnataka, after the Lok Ayukta raids,
The only solution for
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Phone:0481-563646
Fax: 565399, 562479
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KALDt (N GUJARAT
May in. 2003 EEA53
i:
CoverStory
the officials of the authority are seen
as being totally corrupt. The same is
the case with Madhya Pradesh, Uttar
Pradesh and Bihar.
Drug control officials, however,
complain that it is not they who lack
teeth, but the law. The major problem
is that manufacturing fake drugs is not
a cognizable offence. It comes under
the Drugs and Cosmetics Act, 1940 or
the Copyright Act. An accused can only
be punished for two or three years and
is often let off with a fine of Rs 5,000.
Also, identification of fake or
substandard medicines is not an easy'
task and there are many loopholes
through which the perpetrators can
escape. Drug control officials can rattle
their sabres but have to put them back
in scabbards.
The Mashelkar committee, set up
in 2002, is learnt to have
recommended amendment of the act
and the setting up of a national drug
control organisation.
All this will take time and as of
for instance, came up with the idea of
printing the brand name on the
capsules in a circular fashion. This was
not easy to duplicate. Lupin
Laboratories, whose anti-tuberculosis
drug was widely duplicated, started
getting fewer complaints after it
adopted this method. Omez, a popular
antacid made by Dr Reddy’s
Laboratories, now has a hologram. But
the fake drug manufacturers have also
surged ahead by putting technology to
good use in packing.
For the bewildered consumer, there
is no choice but to be well-informed and
vigilant. He has to examine the
medicine carefully before taking it. He
has to identify tell-tale signs of deceit.
His life may depend on it.
WARNING NOTE: Dr C.M. Gulati
now, the authorities cannot do much.
Sensing this, the companies
themselves have come up with some
defence strategies; it’s their money
after all. Associated Capsules Group,
Dark mood
Australia grapples with fake
medicine problem
By SACHIDANANDA MURTHY/Canbarra
ALLEGRON-25 was a common
anti-depressant tablet sold in
pharmacies in Australia over the
counter. People used it to chase
away the blues. Recently, users
complained that instead of
fighting depression, the tablet
intensified the dark moods. They'
w'ere better off than the users of
Travacam, a tablet widely used to
fight travel sickness. Australians brave the nine-hour ferry'
journey from Melbourne to Tasmania by popping
Travacam, which was also a favourite in long-distance
air travel. But in the last three months, the Therapeutic
Drug Administration (TGA), which governs drug
standards, found that 19 persons who took the tablet had
been hospitalised and 68 others experienced “life
threatening adverse reactions’’.
These two were among a thousand drugs which were
recalled from pharmacies across the country in April and
May. The panic persists as the TGA investigators are
44 EE3333 May 18. 2003
with NISTUIA HEBBAR/DelhL
DEEPAK TIWARI/Bho^
TARIQ BHAT/Srinagar,
LALITA lYER/Hyderabad,
AJAY UPRETY/Lucknow,
KANHAIAH BHELARI/Patna
and ANOSH MALEKAR/Ahmedabad
finding more and more drugs to be spurious or
substandard. Trish Worth, the parliamentary
undersecretary for health, called it “shonky' manufacturing
of medicines” and promised stern action against the
makers.
Pan Pharmaceuticals, whose 200 drugs w’ere recalled
and production suspended, had tinkered with Travacam
in a big way. The TGA said that “one of the active
ingredients varied in content from zero to 700 per cent of
the listed dosage”. Patients either got no relief or were
given a seven times higher dosage, which made some of
them w'ant to jump off planes and trains.
The TGA w'ent on recalling drugs as it discovered many
big companies had given a contract to Pan Pharmaceuticals
to manufacture their drugs. Curacel was fined $84,000 for
manufacturing counterfeit medicines and a director ofthe
company was fined $12,000 for switching labels of drugs.
The TGA also found that beef cartilage used for vitamin
drugs was substituted by shark cartilage.
The Australian Self Medication Industry' tried to
repair the damage done to the 1,424 companies licensed
to manufacture over-the-counter drugs. But the can of
worms led to other cans of worms. If cans of frozen
chicken nugget revealed hard plastic, salted mackerel,
imported from Thailand, contained substances which can
“cause headache, itching and upset stomachs.”
Prime Minister John Howard insisted that these cases
had come up only because of the stringent quality testing
law’s, and said the battle against unscrupulous drug and
food manufacturers w’ould be waged even more
vigorously.
Page 1M2/03
Main identity
From;
To:
Sent:
kitsch"
Subject:
"Dr Dabade" <drdabade@sanchamet.in>
<drugacticnindia@healthyskepticism.org^
Wednesday, December 10. 2003 11:46 PM
ATT00070.txt
[drugactionindia] Deccan Heraid
Tuesday, December 09, 2003
Deccan Herald » Edit Pase » Full Story
IN PERSPECTIVE
Drug price control: no relief for poor
By GOP AT, DABADE
j
The number of drugs under price control has come down drastically over the years,:
affecting public health
Tn the last few months the media has been so much seized with the issue of substand
"spurious medicines", including the sensational news about death penalty for spurioi
manufacturers that major issues concerning medicines seem to have been totally sidi
the issue of medicine pricing is much more scandalous and invites equal or even mu
attention.
Medicine pricing and its policies have only at times attracted global media attention
known example is that, when an Indian drug company, Cipla brought down the price
needed medicines for AIDS/HTV. The price came down from SI000 per person per j
350 per person per year.
Even at the_se_priLces_it has been guessed that Cipla would have made a profit..o£2.0.0
an Indian drug company exploded the global myth (often perpetuated by giant multi
companies, most of them being American and Europe-based) that good and quality i
canno£bc manufactured at low' prices. The need for these medicines is immcnsc~aEd
Sub-Saharan Africa where the disease is rampant.
Though India has contributed its might to the global challenges of medicine pricing,
India the picture is not one of contentment especially for the common man and the p
with decreasing government spending on health, increasing deregulation of drug, prii
expenditure on health has increased tremendously.
Foothold of equity
The National Pharmaceutical Pricing Authority (NPPA) sei up in 1997 was eslabiisr
Government of India to monitor the compliance of the DPCO (Drag Price Control C
observed that through these bodies in general rhe number of drugs under price eonrr.
has come down drastically.
The concept of Essential Drugs was realised by the World Health Organisation durh
and was strongly based on the foothold of equity which is central to public health ar
the people who need the drugs the most are not denied access to them. This concept
applied and many developing countries have drawn up their Essential Drugs lists. Et
are those that satisfy the health care needs of the majority of the population; they sh<
at all times in adequate amounts and, in appropriate dosage forms, with assured qua!
12,T 2/03
Page 2 of 2
information, and at a cost that the community and individual can afford.
This concept of Essential Drugs of WHO is extremely relevant in the Indian context
of people within this country are the below poverty line and many more around it. N
emerged as the second commonest cause of rural indebtedness. And also it is estima
part of the family's expenses on drugs and diagnostics goes to non-essential or hazar
This is estimated from 60% (the most conservative) to over 90%. Given these situat;
extremely important that the government implement the Essential Drug Policy on th
WHO. The pricing of drugs should not be left to market forces.
Half-hearted gesture
Let us look at the DPCO of 1995, in which the Government of India came out with;
price control in response to the various emerging public health problems. Unfortuna
docs not dwell on these major health issues, but on the other hand the list includes d
useless and even some hazardous ones. For example the DPCO docs not mention an
regulation drugs for iron deficiency anaemia, HIV/AIDS, filariasis, coronary artery i
rheumatic valve heart disease. Il also does not mention price regulation for oral rehy
cancer drugs and many vaccines (for rabies etc). It also looks half-heartedly al TB b
one drug (which is Rifampicin)!
The list on the other hand contains many drugs which are totally unessential like Vit
B2, Naproxen (an outdated, pain killer) and Sulphadimidine (an outdated anti-infecti
forth as the list is quite exhaustive. To add to the misery the list includes even few d
Analgin (a pain killer) that are even hazardous.
Successive DPCOs from 1979 onwards have only reduced the number of drugs unde
restriction. During 1987 the number of price controlled drugs were 142 and was red;
1995 and in 2003 it is expected to slump to a mere couple of dozens, the reason bciti
immense pressure from drug manufacturers. These companies have a good excuse, <
Government of India has to change its patent laws by 2005. And the multinational d.
are after the government to change its Patent Act, so that they can make more profit:
Copyright, 1999 The Printers (Mysore) Private Ltd., 75, M.G. Road, Post Box No 5331,
Bangalore - 560001
Tel: +91 (80) 5880000 Fax No. +91 (80) 5880523
12’12/03
HAi
BUKO
Pharma-Kampagne
Health Action International
Direct-to-Consumer Prescription Drug Advertising
The European Commission’s Proposals for Legislative Change
Health Action International (HAI-Europe), December 2001
The European Union currently forbids advertising
of prescription drugs to the public, as do all other
countries except the United States and New
Zealand. This restriction on advertising is part of
the protection offered to the public by prescriptionAly status.
Last July, the Commission announced a proposal to
change the law to allow advertising of prescription
drugs to treat AIDS, diabetes and asthma. The key
change involves the advertising regulations
contained in Articles 86 to 88 of Directive 2001/83/
EC on the Community Code Relating to Medicinal
Products for Human Use.
The proposed changes affect only a subset of
prescription drugs. However, these are drugs for
serious diseases. They would also represent an
important ‘foot in the door’ for direct-to-consumer
(DTC) advertising and drug promotion in Europe.
What will these changes mean for public health, for
sustainability of national health care services, and
for consumer and patient information rights?
This paper discusses the proposed changes, reviews
the main evidence on effects of DTC advertising in
the US and New Zealand, and concludes with
recommendations.
Why maintain the current ban on direct-to-consumer (DTC) advertising of
prescription drugs?
•
DTC advertising drives up prescription drugs costs, threatening the
sustainability of national health care services and universal access to health care as a
fundamental human right.
•
DTC advertising fails to inform. It does not provide the impartial, objective
information consumers and patients need for informed health care decisions.
o
DTC advertising compromises public safety. It can lead to rapid widespread
exposure to dangerous drugs before risks are fully recognized, as occurred with
troglitazone (Rezulin) for diabetes and cisapride (Propulsid) for nighttime heartburn in the
US. Additionally, most new drugs are costlier than existing treatments, but few provide any
therapeutic advantage.
•
DTC advertising promotes the medicalisation of normal life. The most heavily
advertised drugs are for long-term use by large target audiences, often for mild conditions
and ‘lifestyle’ problems that may not need drug therapy.
The current legislation reflects both
rationales. Article 88 (I) prohibits
advertising of prescription-only
medicines to the public. Article 88 (2)
prohibits all advertisements mentioning
a specified list of serious diseases.
What changes is the
Commission proposing?
The Commission’s proposal would
allow manufacturers to advertise
treatments for AIDS, diabetes and
asthma and other chronic respiratory
diseases.
Unnecessary Medicalisation
Why shouldn't normal New Yorkers feel anxious two months after the
attack on the World Trade Centre, when this ad for paroxetine (Paxil) ran
in the New York Times Magazine?
“Talk to your doctor about non-habit forming Paxil today," says the ad.
The fine print on the back tells another story: discontinuation reactions
include depression, somnolence, agitation, tremor, nausea, diarrhea, etc.
Withdrawal reactions such as these signal a potential risk of drug
dependence.
Manufacturers must set up national selfregulatory procedures and submit ads to
the European Medicines Evaluation
Agency for pre-screening. The Agency,
in turn, must examine materials and
register any objections within 30 days or
the ad can run as submitted. The Agency
is also required to maintain a database
of ads and write yearly reports, with a
detailed review after five years.
Additionally, the Commission is
proposing deletion of the section of Article 88 (2)
that prohibits advertisements to the public
mentioning specified serious diseases: tuberculosis,
sexually transmitted diseases, other serious
infectious diseases, cancer and other chronic
diseases, chronic insomnia, diabetes and other
metabolic illnesses. The clause on serious diseases
refers to all advertisements, not just prescriptiononly products. This deletion appears to pave the
way for across-the-board advertising of treatments
for serious illness.
Why is prescription drug advertising
currently forbidden?
Compared with medicines that can be bought overthe-counter (OTC), prescription-only products are
generally used to treat more serious diseases, have
greater toxicity, and a less well-understood profile
of risks and benefits. Prescription-only medicines
cannot be bought and sold freely. The aim of laws
restricting companies’ marketing and advertising
rights is health protection.
As prescription drugs often treat serious diseases,
restrictions on advertising also take account of the
extra vulnerability of people who are seriously ill.
Someone in pain, who has been diagnosed with a
debilitating illness, or who is caring for an ill family
member is vulnerable in a way that is different from
someone who is going shopping for a new car or a
loaf of bread.
Are there restrictions on how companies
can advertise these products?
The proposal includes no explicit restrictions on
media or content, other than conformity to general
principles of pharmaceutical advertising listed in
Article 87. Article 88 (2), clauses (a) to (f), sets out
conditions for how this information would be
disseminated. These conditions do not explicitly
exclude any media -such as television -nor do they
limit target audiences.
2
The proposal for Article 88 (2) broadly authorizes
lull product advertisements: ‘'...This provision
applies to product information appended to the
maiketing authorization as well as to additional
related information. ”
The US experience - drug costs
out of control
Spending on DTC advertising has grown
exponentially in the US within the last decade,
from $55 million in 1991 to $2.5 billion in 2000. If
DTCA did not stimulate sales, companies would
not be spending more and more each year on this
marketing strategy.
A separate clause, already in place, allows Member
States to ban the advertising of publicly funded
drugs should they choose to do so.
Top 50 DTC advertised drugs responsible
for large cost increases
In 2000 over 95% of DTC advertising
spending was on 50 drugs;
These 50 drugs had combined retail sales of
$41.3 billion;
This was nearly one third of total US retail
prescription drug spending in 2000;
These 50 drugs were responsible for $9.94
billion of the $20.8 billion increase in US
retail prescription drug spending from 1999
to 2000, or 47.8% of this increase.
(Findlay, 2001)
What rationale is presented for these
changes?
The Commission states that these changes are
being introduced “in order to respond to the
expectations expressed by the patients’ groups”.
The current law does not limit the public’s access
to drug information; it prohibits advertising. Many
organizations currently provide drug information to
the public. Access to information is often
“adequate, but this results from policy decisions
not to prioritize patient information, rather than
legal barriers.
The Commission has not said which patient groups
have requested changes to advertising regulations
nor which groups may request advertising
campaigns should the change be implemented. The
Commission makes no reference to any measures
taken to eliminate conflicts of interest. Increasing
numbers of patient groups are substantially funded
by drug companies, which have a vested interest in
DTC advertising.
Source: Figure 1, Findlay, NIHCM, 2001
The bottom line: why does the industry
want legislative change?
A US market research firm. PERQ/CHI analyzed
the returns on investments for print and television
DTC ads in 1999, based on spending and sales data
supplied by 25 major manufacturers. On each dollar
invested in DTC advertising, the average return was
$ 1.69 for TV ads alone; $2.51 for magazine
advertising, and $2.11 for campaigns involving a
mix of print and TV ads. (PERQ/CHI, 1999) These
are impressive returns - but they also mean
impossible costs for public and private drug plans.
"... In July, DG Enterprise proposed to lift the
ban for asthma, diabetes and HIV [and]
companies will be allowed to impart
information promoting “awareness of the
availability” of products. Nobody believes it
will end there. ”
- Sarah Boseley, Just Say No to Drug Ads.
The Guardian. UK. Dec 10, 2001
3
“Aggressive direct-to-patient marketing by pharmaceutical companies, high prices for new drugs ate
making prescription drugs one of the major costs of health care. This issue is not being given the
attention it deserves. It’s time to put science ahead of marketing. ”
- Premier U.jjal Dosan.jh, May 24, 2000. British Columbia Government News Release. Victoria,
B.C., Canada.’’[Canadians are heavily exposed to cross-border DTCA from the US.]
Can the public find out what drugs are
available from DTC advertising?
DTC advertising does not provide an overview of
available treatments. Very few drugs are advertised
to the public. In the US, over 40% of spending each.
year goes towards just 10 products. These are
mainly new, expensive drugs for chronic or
intermittent long-term use by large numbers of
people. They exclude off-patent drugs even if these
are superior first-line treatments, such as diuretics
for uncomplicated high blood pressure. The
decision to advertise a drug is a marketing decision,
not a public health decision. Sales revenues for the
top 10 drugs exceeded US $16 billion last year.
Products with Top DTC Advertising Budgets in 2000
Drug
Condition
DTC Spending
Millions US$
Sales
Millions USS
Vioxx (rofecoxib)
Arthritis
$ 160.8
$ 1,518.0
Prilosec (omepraxole)
Ulcer/Reflux
$ 107.5
$ 4,102.2
Claritin (loratadine)
Allergy
$ 99.7
$ 2,035.4
Paxil (paroxetine)
Anxiety/Depression
$ 91.8
$ 1,808.0
Zocor (simvastatin)
High cholesterol
$ 91.2
$ 2,207.0
Viagra (sildenafil)
Impotence
$ 89.5
$
Celebrex (celecoxib)
Arthritis
$ 78.3
$ 2,015.5
Flonase (fluticasone)
Allergy
$ 73.5
$
Allegra (fexofenadine)
Allergy
$ 67.0
$ 1,120.4
Meridia (sibutramine)
Obesity
$ 65.0
$
$ 924.3
$ 16,347.8
Total
809.4
618.7
113.2
Source: Findlay, 2001
/ recently sat in on a focus group sponsor ed by a drug advertiser... The group remarks were rnostlv - how
can you make statements like this since they wanted to show amazing benefits while downplaying any
possible side effects. In the end it was a pure advertising show and all we disliked was overlooked. The ads
run now and probably increased sales al the expense of doctors being pressured by regular patients [or a
drug they really do not need. Needless to say I support more stringent rules in this area. ”
- John Madura, letter to British Medical Journal, Oct 19, 2001 www.bmi.eom/cgi/cletters/323/7318/889#ELi
4
DTC advertising:
an accurate information source?
Steven Woloshin and colleagues (2001) examined
the content of DTC ads in 10 consumer magazines
published in 1998 and 1999. Nearly 9 out of 10 ads
“described the benefit of a medication in vague.
qualitative terms” and did not provide any evidence
to support claims; one-quarter used terms such as
'proven relief, proven effective or clinically
proven’; nearly one-fifth cited widespread use as a
claim of benefit; and one eighth used personal
testimonials.
DTC ads are commonly found to violate US law
because they contain inaccurate and misleading
information. The US Food and Drug
Administration (FDA) directly regulates drug
promotion. From 1997 to mid 2001, the FDA sent
out 94 notices to companies about DTC
advertisements that violated federal regulations, 48
on broadcast and 46 on print advertising. (Ostrove,
2001) In 1998, more than half of products
advertised on TV violated regulatory standards.
(Koerner, 1999) The most common reasons were
exaggeration of benefits and minimization of risks.
Researchers in California looked at the educational
content of US magazine ads published over a 10
year period, 1989-1998, based on whether the ad
mentioned key pieces of information consumers
need to know. (Bell et al, 2000) They found the
educational value to be minimal:
• 91% did not say the likelihood of treatment
success;
• 76% made no mention of other helpful activities,
like exercise or diet;
• 73% did not mention any causes or risk factors
for the treated condition;
• 71 % made no mention of any other possible
treatments;
• 64% failed to explain how the drug works.
New Zealand depends on industry seif-regulation,
but in a recent spot check (Pratt, 2000), the
Ministry of Health found that five of six voluntarily
^ibmitted TV ads and a fourth of print ads violated
■We Medicines Act. This was in spite of voluntary
pre-screening by the Therapeutic Advertising
Advisory Service. In nearly all cases risk
information was absent, incomplete or illegible.
w
“The 60-second full-product’ TV advertisement is misleading because the totality of the images,
the music and the audio statements that you present overstate the efficacy of Celebrex... [they]
collectively suggest that Celebrex is more effective than has been demonstrated by substantial
evidence. ”
9
- US FDA letter to Searle, Nov 2000
“The graphics of the advertisement show a frustrated woman trying to pull her shopping cart out
of its interlocked lineup in front of a store. The concurrent audio states “Think it’s PMS? It could
be PMDD. ” The imagery and audio presentation of the advertisement never completely define or
accurately illustrate premenstrual dysphoric disorder (PMDD) and there is no clear distinction
between premenstrual syndrome (PMS) and PMDD communicated. Consequently, the overall
message broadens the indication and trivializes the seriousness of PMDD... ”
- US FDA letter to Lilly, Nov 2000
5
“In patients with type 2 diabetes rosiglitazone
improves some surrogate markers and worsens
others. Long-term trials are required to know
whether this class of drugs reduces morbidity and
mortality outcomes. ” (Therapeutics Initiative,
US ads for diabetes, asthma and
AIDS, a model for Europe?
Diabetes: blurring the distinction between
life-threatening and life-saving
Rezulin (troglitazone) is a diabetes drug, banned in
the UK in 1997 because of severe liver toxicity.
Rezulin was advertised to the US public for over
two years after the UK ban. It was eventually
removed from the market in 2000. By that time it
had been named as the suspected cause of nearly
400 deaths. 63 from liver failure. (Willman, 2000)
US DTC ads for Rezulin stressed its widespread
use: “more than 1,000.000 people have begun
using Rezulin to help manage diabetes.’' (Woloshin,
2001) These ads made no mention of the UK
market withdrawal.
2000)
AIDS: Unrealistic Expectations of
Treatment Success Linked to Risk-taking
Behaviours
“Direct-to-consumer advertising may be
influencing trends of increasing sexual risk
behavior and subsequent STDs including new HIV
infections among MSM in San Francisco.
Strategies to reduce the possible harmful effects of
HIV drug advertising are needed. ”
-Jim Klausner, San Francisco Department of Public
Health
Two new dings in the same class, Avandia
(rosiglitazone) and Actos (pioglitazone) are
currently on the US market, and are being
advertised to the US public. Health authorities have
issued warnings that both drugs can cause fluid
retention leading to heart failure.
The San Francisco Department of Health warned in
early 2001 that it was considering banning DTCA
for AIDS drugs within the city limits. A survey of
262 male patients in San Francisco’s STD clinics
had shown that young men were less likely to
practice safe sex because the unrealistic images in
DTC ads for AIDS drugs made it seem like AIDS
could be effectively controlled. Some adverts
showed vigorous men climbing mountains. This is
nothing like the reality of life on triple therapy.
(Klausner and Kim, 2001)
Any prescription drug may be advertised to the
public in the US, even if it is similar to a drug
withdrawn for safety reasons or has been associated
with serious risks.
These new diabetes drugs have not been shown to
save lives. They simply have not been tested for
long enough in large enough groups of patients.
They were approved for marketing on the basis of
their ability to control blood glucose. This effect
may or may not translate into long-term health
benefits as compared to other drug and non-drug
approaches. To quote an independent assessment:
Gay men with higher DTC advertising exposure
were more likely to have engaged in unprotected
sex with an HIV positive or unknown partner
within the last month (27% vs. 16%) and were
more likely to believe that triple therapy (HAART)
had made HIV infection a less serious disease (25%
vs. 17%).
“... You present the statement “Avandia is not indicated for use with insulin ” in the audio portion of your
‘Real Stories’ broadcast advertisement simultaneously with the super “Avandia- Help use the natural
insulin in you. " This presentation minimizes the communication of the risk of the Bolded Warning by
presenting consumers with conflicting messages about the use of Avandia and insulin...In addition your
broadcast advertisement is misleading because you fail to present the precaution concerning weight
gain caused by Avandia...Moreover, your print advertisement is misleading because the risk information
is presented under the header “Strengthen your body’s own ability to help control blood sugar. ” This
presentation...minimizes the risks associated with Avandia treatment ”
US FDA letter to GSK, June 2001
6
The most important public health message for
AIDS is prevention. Unrealistic advertising
campaigns for AIDS drugs have interfered with that
message in the US. Are there any guarantees that
the same companies will behave more responsibly
in Europe?
Singulair is one of two new oral asthma drugs in a
class called leukotriene antagonists. Both are
among the top 50 drugs advertised to the US public
in 2000. Independent assessments have judged their
place in the treatment of asthma to be limited. A
1999 drug bulletin states: “Average clinical effects
are small and would unlikely be detectable by
individual patients... [These drugs] cause average
clinical benefits that are less than low-dose inhaled
glucocorticoids.” (Therapeutics Initiative, 1999)
Mistaken Impressions: ad for an asthma
drug, Singulair (montelukast)
The US Kaiser Family Foundation published a study
on consumer responses to three television DTC ads
in November 2001. One of the ads was for an asthma
drug. Singulair (montelukast).
The Kaiser Foundation study randomly assigned
participants to view different ads, then compared
knowledge between viewers and non-viewers. They
found that more viewers of the Singulair ad knew
that there were pills people could take to prevent or
limit asthma attacks (71% vs. 36%). However,
more Singulair ad viewers came away misinformed
about what these pills do: 25% thought they could
take a pill rather than use an inhaler during an
asthma attack versus 13% of non-viewers. This is
dangerous misinformation, as it could delay
effective treatment during a potentially life
threatening situation.
CR1XIVAN may help you live
a longer, healthier life.
The ad says that Singulair doesn’t
work during an acute attack.
However, this voice-over is
accompanied by different text on
screen and viewers may be
distracted. The main emotive
message is one of effective relief.
Nowhere does the ad even hint that
effectiveness is mild or inferior to
inhaled steroids, which are also
used for prevention. The US FDA
allowed Merck to run this ad. The
EMEA might similarly allow it.
The information it contains is not
false. However, the lack of
information on relative efficacy is
misleading.
Climbing mountains, flexing
muscles and throwing a javelin:
unrealistic images of the reality of
antiretroviral therapy.
In New Zealand, Merck’s ad campaign for
Singulair included a promotional offer of one
month’s free medication.(MacKinven, 1999)
Nearly 20% of New Zealand's GPs prescribed the
drug during its first two weeks on the market. The
free promotional offer was criticized as creating an
unnecessary strain on patients, since Singulair is
expensive and is intended for long-term use.
7
Advertising only non-subsidized drugs:
is this the answer?
Under existing legislation. Member States can
choose to impose a ban on advertising of publicly
subsidized drugs. If the Commission’s proposal is
accepted, this clause could be used to avoid paying
for the prescriptions stimulated by DTC
advertising.
claims that patients will see the ads, recognize their
symptoms and get earlier treatment and therefore
avoid more serious disease. However, there is no
research evidence to back this claim. Some market
research studies show that ad campaigns increase
the number of doctor visits for advertised
conditions, but they don’t distinguish between
people who needed medical care and people who
did not have a medical problem and were therefore
unlikely to benefit. Ad campaigns cast a wide net in
order to maximize sales, often suggesting that
common symptoms are signs of serious problems,
as in the case of this ad for an Alzheimer’s drug.
This approach is unlikely to attract only those in
need of care.
Unsubsidized drugs are products that drug benefit
plans have decided not to fund, usually following
an evaluation of cost-effectiveness. These drugs
tend to be more expensive than equivalent
alternatives, relatively ineffective, have a poor risk/
benefit profile, or are for ’lifestyle problems’ for
which drug treatment may not be appropriate.
The effect of DTC advertising on compliance has
not been adequately tested. In two surveys by
Prevention Magazine, between 5% and 8% of
respondents said that seeing ads made them more
likely to take their medicines. (Prevention, 1998,
1999) Most users of advertised medicines said the
ads did not remind them to take the drug. This
To allow advertising only of these products creates
a perverse incentive for manufacturers. It also adds
to the misleading impact of advertising because the
public only sees emotive messages lauding the
benefits of products that by definition are either
overpriced, inferior or unnecessary.
Although the government is not paying for these
drugs directly it faces associated costs:
• extra doctor visits
• extra diagnostic tests
• extra health care and hospitalizations from
adverse events, especially in the case of
additional discretionary drug use.
Is it just forgetfulness...
Do DTC ads lead to better health or health
care services?
Pharmaceutical industry representatives claim that
advertising improves communication between
doctors and patients, that it will help untreated
patients receive needed care at an earlier date, and
that it improves compliance. (Holmer, 1999)
There is no evidence that DTC advertising
improves doctor/patient relationships, and surveys
of US doctors indicate that opinions are largely
negative. (Lipsky, 1997; Time Magazine, 1998)
A
ricept
(donepezil HCI)
Today s Trhatmiwt
For Alzhki.wkrs Disuash
To lc-;tm more, tiill toll-tree
There is no evidence that exposure to DTC
advertising can lead to better health, fewer
hospitalizations or lower mortality. The industry
8
survey is frequently cited as evidence of improved
compliance although it did not measure behaviour
change and failed to mention what types of drugs
the tespondents were using. If they were
symptomatic treatments such as allergy drugs or
painkillers, improved compliance is of no health
benefit and in some cases can cause serious harm.
(Herxheimer, 1998)
2. Maintain universal coverage of
essential medicines
“Access to health care is a right enshrined in the
European Union’s Charter of Fundamental Rights
and an essential element of human dignity. It must
therefore be guaranteed for all. ”
-European Commission, December 2001
Prescription drug advertising threatens universal
health care coverage by pushing drug spending out
of control. Annual increases in pharmaceutical
costs similar to the US $10 billion (15%) increase
last year from sales of DTC advertised drugs would
make public and non-profit drug plans
unsustainable. Most of these drugs provide little to
no advantage compared to existing alternatives.
Most are more expensive.
Patients with chronic diseases such as AIDS or
diabetes are often well informed about their
illnesses. For such patients, the key role of ads is to
stimulate a switch to newer, more expensive drugs.
The US experience shows that this can cause harm:
troglitazone was an unnecessarily harmful new
drug for diabetes; the leukotriene antagonists for
asthma have a limited role in asthma therapy
because of unimpressive efficacy; and ads for new
AIDS drugs appear to have convinced some
vounger gay men not to worry about disease
Invention.
The proposal to advertise only non-subsidized
drugs would stimulate widespread use and sales of
the least cost-effective products. European
consumers would then suffer twice: first by paying
out-of-pocket for dings they mistakenly believe are
better; secondly, because they will pay through
their taxes for increased doctor visits, diagnostic
tests and medical care for those suffering
unnecessary adverse effects.
Recommendations
1. Above all, do no harm
Given the lack of evidence of benefit and
considerable evidence of harm from the US
experience, prescription drug advertising should
not be introduced in Europe for drugs for diabetes,
asthma and AIDS. These are serious illnesses for
which glossy advertising campaigns are
inappropriate and potentially dangerous.
3. Make shared informed health care
choices a reality
Patients and the public need independent,
comparative information on the pros and cons of all
drug and non-drug treatments and the option not to
treat. This type of information does not require a
change to advertising legislation. It cannot be
produced by pharmaceutical companies, which
have a vested interest in selling a specific product.
However, if informed choice in health care
decisions is to become a reality, independent
information needs to become an integrated part of
national health care systems.
Unless there is clear evidence of lack of harm and
of health benefits, the prohibition against direct-toSnsumer advertising of prescription drugs should
be maintained. The European Union is committed
to the precautionary principle. This principle is as
relevant to advertising policies with health
consequences as to direct chemical exposures.
The key issue from a public health perspective is
not how to reduce the protection offered by
prescription-only status, but how to ensure that the
public, throughout Europe, has access to
comprehensive, unbiased and reliable medicines
information.U
9
References:
Mintzes B. Blurring the Boundaries: new trends in drug
promotion. Amsterdam: Health Action International, 1998
Bell RA. Wilkes MS, Kravitz RL. The Educational Value of
Consumer-Targeted Prescription Drug Print Advertising.
Journal of Family Practice 2000: 49(12): 1092-1098
Ostrove N. Division of Drug Marketing, Advertising and
Communication. US FDA. Prescription Drug Issues. FDCH
Congressional Testimony. Committee on Commerce, Science
and Transportation. Washington DC. July 24. 2001
European Commission. Healthcare : Commission proposes
three common EU objectives for healthcare and care for the
elderly - access for all. high quality, financial sustainability.
Press Release. DN: IP/01/1747. Brussels. Decembers. 2001
PERQ/CH1.1999. Magazines: a Healthy Diagnosis.
lwww.magazine.org; accessed Dec 2001]; Calculations based
on extra use in exposed consumers vs. unexposed x cost per
script x average refill rate/category
Findlay S. Prescription Drugs and Mass Media Advertising.
2000. National Institute of Health Care Management.
Washington DC: Nov 20, 2001 [www.nihcm.org]
Pratt P. Assessment of Regulatory Compliance for Medicines
Advertised Direct to Consumer. Medsafe. New Zealand
Ministry of Health. Wellington, 2000
Herxheimer A. Many NSAID users who bleed don’t know
when to stop. British Medical Journal 1998; 316:492
Holmer AF. Direct-to-consumer prescription drug advertising
builds bridges between patients and physicians. JAMA
1999;281(4):380-2
Prevention Magazine. National Survey of Consumer
Reactions to Direct-to-Consumer Advertising. Rodale Press,
1998: Year two: A National Survey of Consumer Reactions
to Direct-to-Consumer Advertising. Rodale Press. 1999
Kaiser Family Foundation. Understanding the effects of
Direct-to-Consumer Prescription Drug Advertising.
November 2001: [www.kff.org]
Therapeutics Initiative. Leukotrine Antagonists. Therapeutics
Letter 29: University of British Columbia; April/ May 1999
[http://www.ti.ubc.ca/pages/letter29.html
Klausner J, Kim A. Are HIV drug advertisements
contributing to increases in risk behavior among men in San
Francisco? San Francisco Dept of Public Health. March 14.
2001 [www.surviveaids.org/klausnerabs.html]
Therapeutics Initiative. New Drugs VI. Rosiglitazone.
Therapeutics Letter 36; University of British Columbia;
July/Aug 2000. [www.ti.ubc.ca/pages/
letter36.htm#Rosiglitazone]
Koerner C. US FDA. Division of Drug Marketing,
Advertising and Communications. The Regulation of Directto-Consumer Promotion of Prescription Drugs. Presentation
at Health Canada Multi-Stakeholders’ Consultation on
Direct-to-Consumer Advertising. Aylmer. Quebec. April 14,
1999
Time Magazine. Consumer and Physician Attitudes Towards
Direct-to-Consumer Advertising. Time Inc., August 1998
Willman D. FDA: How a New Policy Led to Seven Deadly
Drugs. Los Angeles Times. December 20, 2000
[www.latimes.com/news/nation/reports/fda/
lat fda001220.html
Lipsky MS. Taylor CA. The opinions and experiences of
family physicians regarding direct-to-consumer advertising.
J Fam Pract 1997 45(6):495-9.
Woloshin S, Schwartz LM, Trammel J. Welch HG. Direct-toconsumer advertisements for prescription drugs: what are
Americans being sold? Lancet 2001: 358: 1141-1146
MacKinven M. Pill purveyors go direct. New Zealand
Doctor. 17 March 1999, pl I
Written by Barbara Mintzes for Health Action International (HAI-Europe). With thanks for comments and
suggestions from: Charles Medawar, Social Audit UK, Joel Lexchin, Medical Reform Group of Ontario,
Peter Mansfield, Healthy Skepticism, Markus Fritz, Swiss Drug Information Centre, and Margaret Ewen,
HAI-Europe.
10
e
BUKO
Pharma-Kampagne
HAI
Health Action International
BUKO Pharma-Kampagne Federal Coordination Internationalism is a
network of around 200 German solidarity groups. In 1981 BUKO started a
campain against global malpractices in drug marketing by multinational
pharmaceutical companies. The focus of the Pharma-Kampagne is to stop
unethical drug marketing practices and to foster rational use of drugs all
over the world. The Pharma-Kampagne works with medical students,
doctors, pharmacists and medical scientists, through campaigns,
publications, press work, public debate and dialogue. BUKO PharmaKampagne is one of the co-founders of Health Action International (HAI).
BUKO Pharma-Kampagne, August-Bebel-Str. 62, D-33602 Bielefeld,
Germany
Tel.+49(0)521-60550, Fax -63789, e-mail: info@bukopharma.de
Web site: www.bukopharma.de
Health Action International (HAI) is an informal network of some 150
consumer, health, development action and other public interest groups
involved in health and pharmaceutical issues in more than 70 countries.
HAI believes that all drugs marketed should meet real medical needs,
have therapeutic advantages, be acceptably safe and offer value for
money.
For more information, contact: HAI Europe, Jacob van Lennepkade 334-T,
1053 NJ, Amsterdam, The Netherlands.
Tel: (+31-20) 683 3684, Fax: (+31-20) 685 5002,
E-mail: info@haiweb.org
Website: http://www.haiweb.org.
This publication is a reprint of the original publication of Health Action
International (HAI), first published December 2001. We thank HAI for the
permission to reprint the publication and for the financial support bv the
Nordrhein-Westfalische Stiftung Umwelt und Entwicklung (Bonn)
BUKO Pharma-Kampagne, Bielefeld, July 2002
Li
Nordrhein-Westfalische
Stiftung fur Umwelt und Entwicklung
E COVER
STORY
DRUG TRIALS AND ETHICS
A Frontline investigation comes up with new revelations on funding, business connections and conflicts
of interest in the Johns Hopkins-linked drug trials at Kerala's Regional Cancer Centre.
R. KRISHNAKUMAR
in Thiruvananthapuram.
NON-MEDICAL scientist with a
potential anti-cancer “drug” discov
ery, and links with a “start-up” company.
A university holding a patent for the
experimental drug. A businessman willing
to invest a couple of million dollars in rhe
company for further development of
twirug through trials in human beings.
An international contract research organ
isation that scouts worldwide for oppor
tunities to do clinical research using rhe
drug. An institution in a Third World
country willing to conduct trials on its
patients for them. These are among the
ingredients of what has now come to be
A
known as the “Johns Hopkins-R.CC drug
trial controversy” in Kerala.
It was on July 30 that the Baltimore
based Johns Hopkins University (JHU)
revealed to the media in the United States
that the clinical trial of the “experimental
anti-cancer drug” developed by one of its
faculty members, conducted at the
Regional Cancer Centre (RCC) in
Thiruvananthapuram, did not have its
authorisation. The JHU went on to say
that the trial did not have the approval of
any of its Institutional Review Boards
(IRBs) that ought to have considered
whether it would be safe to conduct
human trials of the drug.
In an interview to a U.S. newspaper
on July 31, the faculty member, Dr. Ru
Chih C. Huang, a Biolog}’ Professor at the
JHU since 1965, said that she was
unaware that the university had a require
ment to seek internal approval of experi
ments conducted abroad. She added that
she had gone ahead with the clinical trial
because it already had the approval of a
“similar panel” in the RCC.
“I will never do this again this way.
But certainly I did not hurt the people in
that country in any way, and I think this
will prove to be an effective anti-cancer
drug,” Huang, who did not respond to an
e-mail message sent by Frontline, is quot
ed as saying in The Baltimore Sun.
But perhaps the most significant state
ments reported in the newspaper as hav
ing been made by Huang are that her
The Regional Cancer Centre in Thiruvananthapuram, situated In the Medical College Hospital campus.
FRONTLINE. AUGUST 31,2001
“study was funded by $2 million from
'Biocure Medical of Minnesota’” and that
^Hopkins holds a patent on the drug and
Buhl profit if the company can bring it
to market as a cancer treatment”.
On a request for confirmation, one of
the correspondents of The Baltimore Sun
wrote to Frontline that the information
about the source of funding (Biocure
Medical of Minnesota) and the patent
(held by the JHU) was obtained by him
from Ru Chih Huang in the course of a
telephonic interview. The correspondent
said that Huang had described the com
pany as a “start-up” and that she had
expressed the hope that “Hopkins could
make a profit if the drug is brought to the
market in four or five years”.
Responding to a request for clarifica
tion, a spokesperson for the JHU and its
Executive Director, Communications and
Public Affairs, Dennis O’Shea, wrote to
Frontline-. “Yes, Hopkins does hold a
patent on the M4N drug that was used in
FRONTLINE. AUGUST 31. 2001
the study. This patent was assigned to the
university by the researcher in routine
compliance with the university’s technol
ogy transfer polity. Such patent assign
ments are standard operating procedure
with any discover}' or invention made at
Johns Hopkins. The assignment of the
patent to the university had nothing to do
with the clinical trial in India and it did
not in any way alter the researcher's oblig-
Dr. Ru Chih C. Huang, Biology Professor
at the Krieger School of Arts and
Sciences, Johns Hopkins University.
ation under university rules to submit the
proposed trial to an institutional review
board."
O’Shea also said that while the patent
application had been filed on October 15,
1999. before the trials, rhe patent had not
been granted until April 10, 2001, well
after the trial was completed. Replying to
a question on the source of funding for the
study, he said that “the source of the fund
ing of the trial remains a focus of the inves
tigation” ordered by the university in the
wake of the controversy in India. O’Shea
added that the J HU investigation "is being
conducted as expeditiously as possible,
given the complexity of the facts involved”
and that there was no deadline for its con
clusion.
However, a report published last year
in the JHU newspaper, The Gazette
Online, gives a clear indication of the
fundi-, g that Huang’s study would have
received. On July 3, 2000. the online
newspaper (Volume 29. Number -10)
expectation was that the drug
could be manufactured “fair
ly inexpensively” since it was
a modification of a natural
product. She says: “That still
has to be confirmed, as does
the product’s potential as a
cancer treatment, but we are
hopeful that if this works out,
we might be able to price any
resulting drugs in a way that
makes them available to all the
people of the world and still
makes returns for the univer
sity and the investor.”
The July 2000 report in
the JHU’s online newspaper
also said that the university,
which holds the patent rights,
will grant an exclusive licence
to the new company to
those inventions and that
“there will be contracts
between the university and
Commission regarding the therapy.
HE first-ever human tri
the company for Hopkins to
als of two chemicals, tetra-O-methyl months after the trials at the RCC were continue work on new drug analogs and
nor-dihydro-guaiaretic acid (M4N) and completed. It quotes the university’s clinical development”.
tctraglycinyl nor-dihydro-guaiaretic acid Director of the Office of Technology
Siegler also said that “most of the
(G4N) - originally isolated from the cre Transfer, Nina Siegler, as saying that “one money will go into clinical trials, not into
osote bush Larrea tridentata at the J HU of the first objectives of rhe new company corporate overhead” and will be “dedicat
laboratory by Huang and her co-workers will be to design and conduct FDA (Food ed to seeing if the compound can work in
- were conducted between November 12, and Drug Administration)-approved clin a variety of human cancers”, although it
1999 and April 8, 2000 on oral cancer ical trials of these substances.” This puts a would not be “fair” to call it a “virtual com
patients awaiting surgical treatment at the question mark on the approval status of pany”. She also announced tentative plans
RCC (Frontline, August 17). From avail the RCC trials, which had already been of the J HU to hire a contract research
able indications, including statements completed.
organisation to help implement clinical tri
made by a few patients and Dr. V.N.
George Lee, a U.S.-based representa als that received the approval of rhe FDA.
Bhattathiri of the RCC who first brought tive of Ang Tiong Lee, is also reported in
An earlier report in The Gazette Online
the issue to public attention, the majority The Gazette Online as saying that although said that in the latter halfof 1998 theJHU
of the 25 patients on whom the trial was the new company is a business venture, it had signed an agreement with one of the
conducted had not realised that the injec intends to keep the price of the drug “as largest pharmaceutical contract research
tions they received were not part of their low as possible”. According to Siegler, the organisations with offices in about
treatment but belonged to an
countries, including Ind^
experiment to understand
< The move was aimed at findrhe effectiveness of the
| ing clinical research opportuchemicals in treating some
o nities for the university’s
forms of human cancer.
m corporate-sponsored clinical
Although the RCC claimed
drug research. There arc indi
that there was no harm done
cations that the organisation’s
to the patients and that the
Indian arm was involved in the
injections had substantially
drug trials at the RCC.
reduced the extent of the
Fl owe ver, it is yet to be
tumours, there was no evi
known
whether 'Biocure
dence of continuous moni
Medical, Minnesota', the com
toring of the patients, most
pany Huang referred to in her
of whom were sent home
interview with The Baltimore
after
the
drug-injected
Sun, is the same as the one pro
tumours were surgically
posed through the letter of
removed.
Regional Cancer Centre
Dr. V.N. L ’: Uathiri, Associate
intent and whether the $2 mil
The Gazette Online Director Dr. M. Krishnan Nair,
Professor ■ Radiotherapy at
lion funding that she said her
report indicates that the let who is also Professor and
the RCC. whose complaints
study had did indeed come
regarding the drug trials
ter of intent was signed in Head of the Department
from AngTiong Loi. The 1111
set off the controversy.
April 2000, about two of Radiotherapy.
newspaper report also ns •.
reported that a Singapore
based businessman planned
co make “a multi-million-dollar investment in a ground
breaking
new
start-up
company that will further
develop basic cancer treat
ment research conducted at
Johns Hopkins”.
The report said that real
estate businessman
Ang
Tiong Loi had signed a letter
of intent on June 27,2000 “to
invest in a new company ded
icated to developing a group
of naturally occurring com
pounds isolated from creosote
bushes that have shown some
early signs of promise as can
cer treatments” in the experi
ments conducted by Huang
M. Gopalan from Tirupur in Tamil Nadu, one of the patients
and some other members of on whom the ‘anti-cancer drug’ was tested by RCC doctors
her laboratory.
and who filed a complaint before the State Human Rights
T
cions Ted Poehler, Vice
Minnesota’ go?
These are a few of the
Provost for Research at the
gaps in the Hopkins-RCC
university, as saying that rhe
w jigsaw puzzle, which remain
arrangements for rhe “new
to be filled by the JHU
start-up” had come with
inquiry. It is unusual that the
“unusual speed” and that
study by Huang did not
there were “a number of par
attract attention within the
ties, including Ang” who were
JHU because she was a
very impressed with the work
Biology Professor at the uni
Huang and her team had done
versity’s Krieger School of
until then, and “how far they
Arts and Sciences, where
have been able to take it”.
hardly any drug research is
Significandy, The Gazette
done. Moreover, she is a
Online had also reported that
non-medical scientist who
businessman
Ang
knew Dr. Parvesh Parikh of the Tata Memorial Hospital,
Mumbai (right), who constitutes the one-man inquiry
tested the experimental anti
Huang “both through family
commission appointed by the State government, at
cancer chemicals earlier only
connections and through her
a hearing in Thiruvananthapuram.
in mice and, ever since the
reputation in Asia” and that
he had decided to support the business was in possession of documents that controversy erupted, has been asked by
because he believed in the programme and proved that funds hfid been sanctioned the JHU not to take part in any other
uang. However, rhe stand of the JHU with the authorisation ofJHU authorities human trials. The JHU also asked
, after rhe RCC trials set off a con and that the documents had been signed Huang to cease all activities regarding
her current work and stick to basic
troversy, is that “the source of the fund by the “treasurer” of the university.
After the signing of the letter of intent research in her laboratory.
ing for the trial remains a focus of its
The gaps in the jigsaw assumed a seri
on June 27, 2000, a few months after the
investigation”.
According to RCC Director Dr. M. first trials for M4N and G4N (the latter nor ous dimension on August 10 when coun
Krishnan Nair, Huang first approached mentioned in the JHU statements) chem sel for one of rhe patients, who had earlier
his institution with the proposal co con icals were conducted, did Dr. Huang go approached the Kerala State Human
duct clinical trials of the new chemicals ahead with the project on her own, with Rights Commission, produced “RCC
in June 1998, much before the applica out the knowledge of her university, as the documents” before the Dr. Parvesh Parikh
JHU statements indicate? Did she obtain inquiry' commission. Counsel demand
tion for the patent was filed.
In a press statement issued on August funding from sources other than Ang ed that the death of two patients within
3, following rhe JHU's denial that it had Tiong Loi? If the RCC was to receive only less than 50 days of their participation
authorised rhe clinical trials conducted at Rs.25 lakhs a year for coordinating the tri in the trial in early 2000 was caused by
rhe RCC, the cancer centre’s Finance als in its clinic and in three other hospitals the injections that they received. The rel
Manager (Projects) K.R. Bhaskaran Nair in India, who Rinded the study at the JHU atives of a 60-year-old woman patient
said: “A section of the media has reported laboratories until then? Where did the rest who was suffering from “terminal malig
that the M4N clinical trials at the RCC of the $2 million from ‘Biocure Medical, nancy” told mediapersons, after they
deposed before the commiswere not funded by the Johns
| sion, that rhe doctors had
Hopkins University. The
2 asked their willingness to
RCC denies this baseless news
a include the patient in a new
report. There is very clear doc^ftneary evidence that RCC
5 project of the contract
research organisation (with
had received funds from
which the JHU had signed
Johns Hopkins University for
an agreement in 1998) that
the clinical trials conducted
would provide her free of
under the leadership of Dr.
cost five doses of the experi
Ru Chih Huang (Ordering
mental
drug,
worth
bank: First Union National
Rs. 10,000. They said that
Bank, New York; Ordering
the woman's condition had
customer: Johns Hopkins
worsened before the fifth
University, Baltimore). This
injection. Dr. Parikh said the
statement is being issued to
commission would inquire
remove the wrong impression
into the deaths and go
that people may have because
through the entire sequence
of the news report.”
of events relating to the tri
Dr. Parvesh Parikh of the
als. The commission is
Tata Memorial Hospital,
expected to submit its report
Mumbai, who constitutes the
in three weeks. Meanwhile,
one-man
commission
the inquiry ordered by the
appointed by the State gov
At
the
Johns
Hopkins
University,
administering
photo
dynamic
Central government is also
ernment to inquire into the
progressing. 3
controversy, also said that he therapy to a cancer patient, a February 1998 picture.
«
FRONTLINE. AUGUST 31. 2001
■ COVER STORY
The changing creed
In the global context of unethical practices in research involving
human participants, the demand for strict monitoring and laws
governing such work becomes more relevant everywhere.
R. KRISHNAKUMAR
HE most significant outcome of the
Johns Hopkins-Regional Cancer
Centre drug trial controversy could be an
increase in public awareness in India about
clinical trials and the effect of unseen, marBet-driven forces that threaten the safety
of the patients involved and taunt the
objectivity of investigators and the scien
tific integrity of drug trials.
Unlike in India, awareness about the
extent to which academic research has
become interlinked with the pharmaceu
tical and biotechnology industries and
other commercial interests and the bene
fits and risks involved in such alliances is
well-established in developed countries
like the United States.
Daniel J. Kevles, Professor of History
at Yale University (whose research inter
ests include the interplay of science and
society, history of modern biology and sci
entific fraud and misconduct) explained in
an e-mail message to Frontline'. “Since the
1970s in the U.S., the growth of biomed
ical research in academia has outpaced the
growth of federal funding for its activities.
University administrators have increasing^felt the need to turn to private, includ
ing industrial biotechnology, sources for
support. For this reason, among others,
they have fostered close relationships
between biomedical firms and the labora
tories on their campuses.”
The most striking example for wellknown academic-research institutions in
the U.S. having such links with industry is
perhaps the Johns Hopkins University
(JHU) itself. Spurred by the fear of being
left behind in the race for research funds and
top-notch faculty and students, the institu
tion, once dedicated to pure research, is now
in the forefront ofuniversities trying to forge
partnerships with business.
After the cancellation of federal funds
following the death ofa "healthy volunteer”
participatingin an asthma study at the J HU
on June 2, the university has remained in
media focus with regard to the growing
T
FRONTLINE. AUGUST 31, 2001
involvement of clinical investigators and
research institutions with business.
According to a report in The Baltimore Sun,
the university had filed more parent appli
cations in 1999 than all but two other major
research centres in the U.S. Moreover, in
recent years the JHU had helped launch 18
companies, and the volume of corporatesponsored research at its medical school had
nearly quadrupled in the last 10 years, the
report said.
The point in The Baltimore Sun article
is in its title - “The changing creed of
Hopkins Science”. It spoke of how the uni
versity’s culture was being transformed as
it embraced business opportunities,
allowed its scientists to be consultants and
paid scientific advisers to corporations and
to own patents for discoveries developed in
its laboratories using corporate funds.
Significantly, it focusses on the risks that
this new creed brings in its wake, “for the
integrity of research, for the safety of
patients participating in experiments and
for the university's most valuable asset - its
reputation”.
The report quotes JHU officials as say
ing that the university’s defence against bias
in corporate-sponsored research is “disclo
sure” - die rule that volunteers in drug stud
ies be told when the JHU has a financial
interest. There is no bar on scientists con
ducting research when, for example, they
have more than a certain amount invested
in the company sponsoring the work, a sit
uation chat could bring forth many an eth-
The creosote bush Larrea tridentata,
from which the NDGA derivatives were
originally isolated.
ical dilemma. “Instead, Hopkins officials
say they ‘manage’ financial conflicts ofinter
est by taking steps to discourage abuses requiring scientists to place stock in escrow
and to disclose to patients and publications
their financial ties in drug trials,” The
Baltimore Sun report said. However, such a
disclosure was conspicuous by its absence in
the trial conducted on patients ar the RCC
by the JHU Biology Professor, Dr. Ru Chih
C. Huang.
The JHU provides but one example of
the conflicts of interest that face academic
institutions in the developed world. Almost
all the major universities today face the prob
lem of having to rise above such conflicts of
interest and yet are unable to resist the need
to relax rules and to lend its name for almost
purely commercial ventures. Recently, when
the main academic “rival” of the JHU,
Harvard University, thought aloud about
relaxing its strict conflict-of-interest rules,
there was a hue and cry in the U.S. 11 prompt
ed The New England Journal of Medicine,
widely regarded as one of medicine’s most
distinguished and influential journals, to
write one of its best-known editorials - “Is
Academic Medicine for Sale?” - urging
Harvard to encourage other universities to
adopt stronger conflict-of-interest guide
lines instead of trying to soften its own rules.
.All over the world onecan find instances
of commercial ties and financial require
ments leading to unethical practices in
research involving human participants,
mainly to satisfy the market’s need for
speedy, cost-effective development of drugs
and medical devices. This has also increased
the demand for strict monitoring and laws
regarding human research, especially in
developed nations like the U.S.
On April 18, a U.S. presidential com
mission, the National Bioethics Advisory
Commission, constituted to suggest ways to
improve ethical conduct of international
clinical trials, recommended a series ofsteps
“to reduce the potential for exploitation of
research participants in developing coun
tries, ensuring that studies are responsive to
the health needs of rhe country, and ensur
ing that post-trial access to successful
research products are improved”.
According to a press statement issued
by the commission soon after its report was
presented to President George Bush, its
chairman (and president of Princeton
University) Harold T. Shapiro said that the
potential for exploitation or participants
from developing countries by researchers
and sponsors from prosperous countries “is
cause for a concerted effort to ensure that
protections are in place for all persons par
ticipating in international research”.
Significant in the context of the JHURCC drug trial controversy is the recom
mendation of the commission that efforts
to enhance research collaboration must
account for the capacity of the ethics review
committee in developing countries to
review research, and the need for U.S.
researchers and sponsors to ensure that their
research projects are conducted “according
to ethical standards applied in the U.S”.
The research collaborations are also to
comply with some basic requirements for
the protection of human research partici
pants, such as prior review by ethics review
committees, minimisation of risk and hav
ing a reasonable risk-benefit ratio, voluntary
informed consent by each participant and
an equitable distribution of the burdens and
benefits of the research.
Prof. Kcvles agreed that this was indeed
a new area of conflict of interest - of com
parative requirements of ethical research
conducted in develop
and developing
countries.
.man rr''tls tend to be more
stricdy regulatcu, d thus more cosdy, in
the U.S. than in developing countries. It is
therefore tempting to conduct trials in the
Third World,” he said.
| <HE Hopkins-RCC drug trial conJL troversy is a wake-up call for India,”
said Dr. K. Mohandas, Director of the Sree
Chitra Tirunal Institute for Medical
Sciences and Technology. “India is an amal
gam. Wc have the best of institutions and
the worst. We have no uniformity of stan
dards in our institutions and die regulatory
mechanisms are not often very effective. But
because of that we cannot keep away from
doing clinical trials, because then we shall
not be able to develop our own research and
shall be completely sidelined by the rest of
the world,” he said.
Dr. C.R. Soman, chairman of the
activist organisation Health Action by
People, said that if die ‘Ethical Guidelines
for Biomedical Research on Human
Subjects’ formulated by the Indian Council
of Medical Research’s (ICMR) Central
Ethics Committee on Human Research
(CECHR) was accepted and adopted at
least by the medical colleges in the country,
India could be said to be truly ready for clin
ical trials. The ediics committee is headed
by Justice M. N. Venkatachaliah, former
Chief Justice of India.
Dr. Soman said that along with the con
cerns raised about clinical research involv
ing scientists from reputed academic
institutions which have commercial ties,
multinational pharmaceutical companies
10
“What wc need to consider
are flooding the Indian mar
is the reason why, despite
ket with a spate of“new mol
the widespread conduct of
ecules”. “a whole range of
clinical trials all over the
chemicals”. “But the major
developed world, there is
ity in the medical profession
not much room left for
is supremely ignorant of this,
complaints there,” he said.
and drug manufacturers get
“The answer lies in building
away with everything. The
up and strengthening insti
majority of the doctors are
tutional checks and bal
unaware ofeven the different
ances.
Unlike
the
phases of drug development,
happenings at the RCC,
or the principles behind the
there are any number of
requirement for informed
examples of faults and ethi
consent,” he said.
Dr. K. Mohandas, Director
cal pitfalls in clinical trials
Dr. Soman said the sit of the Sree Chitra Tirunal
being detected effectively by
uation was compounded by Institute for Medical
institutional review boards
the emergence of contract Sciences and Technology.
or other monitoring agen
research organisations, “sort
cies sufficiently early and of
of event managers”, who
even drugs or trials bein^
took up contracts to organ
withdrawn without aflcc®
ise • Knical trials and provide
ing the faith that a patient
relates services from the
has in his physicians,” Dr.
pre-clinicai stage to the mar
Vijayaraghavan
said.
keting of the drug for the
He
added:
pharmaceutical companies.
“Monitoring has to be
He said: “All they require of
strengthened at the institu
the general Indian physician
tional level based on the
is to dot the ‘i’s and cross the
well-laid-out
principles
‘t’s, and the majority ofdoc
enunciated in the Helsinki
tors mechanically do it with
Declaration, the guidelines
no intellectual input from Dr. C.R. Soman,
chairman of the
issued jointly by the
their part.”
activist organisation
Council for International
However, Dr. Soman
Health Action by People.
Organisation of Medical
said, this did not mean that
all companies were engaged in such oper Sciences and the World Health
ations. He said that out of self-interest Organisation, the ICMR guidelines and so
many of them might be meticulous in fol on. Each institution has to establish clear
lowing ethical norms while conducting principles to evaluate research on human
clinical trials or introducing drugs into the subjects and specific measures to protect
market. “But there are a lot of imposters.” human subjects from possible harm.”
Dr. Mohandas said: “We really don’t
Already, according to Dr. Mohandas,
know what exactly is happening in the there are moves in the right direction. Tj»
country. We don’t know whether testing ICMR is planning to set up training cJB
of drugs or clinical Phase 1 and II research tres in several parts of the country7 to pro
(to gather data on the safety and efficacy vide support to institutions and
of a drug respectively) is taking place on a professionals on the ethical issues involved
large scale even in institutions or clinics not in human research. International work
equipped to conduct such experiments. In shops are also being organised at the Sree
the absence of a mechanism for monitor Chitra Tirunal Institute and three univer
ing and supervising clinical trials, we do sities - in South Africa, Mexico and in the
not know the magnitude of rhe problem. U.S. at Harvard - on ethical guidelines in
There was this instance when a banned health research with special reference to
drug, which was used for the treatment of international research. The seminar held
malaria, was tried out as a method of ster in Sree Chitra had participants from 15
ilisation in women, and there was a major countries, the majority of them from the
public campaign by some doctors and Third World. Dr. Vijayaraghavan said:
activists. It definitely is there, but how big “As long as institutions learn to insist and
is rhe problem, we don’t know.”
ensure meticulously that ethical safety
However,
cardiologist
Dr.
G. guidelines are followed, developing coun
Vijayaraghavan, formerly of Kuwait tries like India need nor be afraid of inter
University, cautioned that it should not be national collaborations in human
argued that clinical trials conducted on research, pharmaceutical companies or
human beings should bestopped forthwith. contract research organisations. El
/
I COVER STORY
Claims and contradictions
There are several unsettled questions that remain at the Johns Hopkins end and the Indian end with
regard to the procedural and other aspects involved in the drug trials.
R. RAMACHANDRAN
in New Delhi
HERE are further twists to the con
troversial anti-cancer drug trials at the
Regional Cancer Centre, Thiruvananthapuram, and the business links associated
with the Johns Jopkins University's
J|HU) joint study with the RCC.
B The purpose of the study was to prove
in cancer cells the activity that was dis
covered by the JHU Biology Professor,
Dr. Ru Chih C. Huang, and her associ
ates in viruses. The objective was to prove
in human trials the inhibition of growth
in tumour cells that the JHU team had
observed in studies conducted in animals.
Dennis O’Shea, JHU spokesperson,
claimed that rhe university had never
“directly" funded the study. However, his
claim was contested by the RCC project
leader, Dr. Manoj Pandey. According to
Pandey, the RCC had received two
cheques, signed byJHU treasurer William
E. Snow Jr, worth S19,400 and was await
ing the third. Dr. M. Krishnan Nair, RCC
Director, is also reported to have stared in
March that the project is funded by the
JHU. He said that the RCC was to receive
Rs.25 lakhs and the amount could later be
creased to Rs. 1.25 crores. Interestingly,
Indey claimed that the JHU received
permission from the U.S. government to
import the tissue of Indian cancer patients
for study.
O'Shea told the journal Science: “I am
not saying we know where these funds
came from. Just because Johns Hopkins
cuts a cheque it docs not necessarily mean
that ir approved rhe project being funded.
Making sense of the financial transactions
is a task for rhe new investigative panel.”
O'Shea's remark that the study was
not directly funded by the JHU assumes
significance in the light of Huang's com
ments to Science. She told Science that the
funding for the project came entirely from
private sources, including the JHU and a
Minnesota-based company, Biocure
Medical LLC. The company was set up
with the objective of designing and con
ducting clinical trials of compounds
T
derived from nor-dihydro-guaiaretic acid
(NDGA).
According to Huang, the supporters
of the project have committed about $2.5
million to conduct pilot trials in four
places in Asia. Dr. Krishnan Nair had stat
ed that Phase II trials were also to be car
ried out at, besides RCC, the KJ.
Hospital, Kanpur, and the Banaras Hindu
University, Varanasi, under the RCC's
supervision.
The catch was that let alone the Food
and Drug Administration of rhe U.S.,
even the JHU's Institutional Review
Board (IRB) had not approved the trial
although Huang had submitted the pro
tocol for the clinical trials to the IRB early
this year. More pertinently, according to
a press release issued by the Press
Information Bureau (PIB) on behalfofthe
Union Health Ministry in the wake of the
controversy, the approval by the Drug
Controller General of India (DCGI)
seems to have been granted only in
February this year, months after the exper
iments were conducted.
The PIB press release said that the
RCC was granted permission on February
2,2001, to import M4N (tetra-O-methyl
nor-dihydro-guaiaretic acid) from the
JHU to undertake a study to evaluate its
efficacy in advanced oral and cervical
malignancies on the basis of pre-clinical
and other relevant data submitted by the
RCC Director.
“It is not a retrospective sanction. The
proposal came to us only then. We do not
know if the trials had been going on ear
lier,” said S. Ramteke, Deputy DCGI. On
the other hand, Dr. Krishnan Nair had
claimed that the initial application for rhe
trial had been submitted to the DCGI on
September 12, 1998, and rhe Ethics
Committee of the RCC had granted its
permission for the conduct of the study
on November 10, 1999. Meanwhile,
according to Dr. Krishnan Nair, discus
sions were held with the DCGI and, based
on his verbal consent, the study was com
menced.
The DCGI refused to comment on
Dr. Krishnan Nair's claim and said that a
central committee had been constituted to
investigate the issue. When asked about
•
FRONTLINE, AUGUST 31, 2001
A demonstration near the Regional Cancer Centre, organised by the
'RCC Protection Forum'.
the granting of sanction after two years of
trials, DCGI ■ Ashwini Kumar said:
“Clinical trials of new molecules, experi
mental drugs and so on are new to our
country. The systems are still evolving. We
shall know whether the trials had been
going on since 1999 only after the inves
tigating team submits its report.”
Meanwhile, the three-member team
constituted by the Union Health Minister
to inquire into the controversy was in
Thiruvananthapuram waiting for Dr.
Pandey to return from the U.S. The com
mittee was expected to submit its report
by August 16.
The normal procedure for obtaining
approval for clinical trials (Phase I, II and
III) is to submit the toxicological data col
lected from animal experiments to the
DCGI. The toxicological data are sent by
the DCGI to the Indian Council of
Medical Research's (ICMR) Toxicology
Committee forevaluation and, if found to
be safe, the DCGI gives sanction for Phase
I trials.
However, Ranjit Roy Choudhury,
chairman of the ICMR Toxicology
Committee, said the committee had not
received any proposal from the RCC for
trials or any data regarding the proposed
trials. He added that oflate the DCGl did
not refer all cases to the committee.
Choudhury said that with many new
drugs coming into the market, imported
and otherwise, the DCGI had begun to
refer the data to its expert committee or a
chosen set of experts rather than to the
ICMR committee.
Regulations with regard to Good
Clinical
Practices
(GCP),
Good
Laboratory Practices (GLP) and Standard
Operating Procedures (SOP) are still in
the draft stage. However, N.K. Ganguly,
Director General of the ICMR, said that
the basic regulations governing clinical tri
als were put in place by the Drugs and
Cosmetics Act, 1940 and several clinical
trials on new drugs and molecules had
been carried out in India in conformity
with the Act. Moreover, the ICMR had
brought out a base document on Ethical
Guidelines for Biomedical Research on
Human Subjects in September 2000.
The ICMR document makes clear the
legal provision forclinical trials: “The pro
posed trial should be carried out only after
the approval of tire DCGI as is necessary
under Schedule Y of the Drugs and
Cosmetics Act. The investigator should
also get the approval of the Ethics
Committee of the institution before sub
mitting the proposal to the DCGI. All the
guiding principles should be followed irre
12
spective of whether the drug has been
developed in this country or abroad or
whether clinical trials have been carried
out outside India or not.”
The DCGI is being evasive when he
tries to make a distinction between an
experimental drug for a research project
and a new drug and says that the regula
tions for experimental studies do not exist.
The Drugs and Cosmetics Act is clear on
the definition of a new drug as part of the
Rules framed under the Act and it includes
any new chemical entity (NCE). Schedule
Y of the Act states: “For new drug sub
stances discovered in other countries,
Phase I trials [the kind being carried out
at the RCC] are not usually allowed to be
initiated in India unless Phase I data from
other countries are available. However,
such trials may be permitted in the absence
of Phase I data from other countries if the
drug is of special relevance to the health
problems of India.” Since even Phase I
data from the U.S. were not available, on
what basis did the DCGI give its approval
in February 2001?
According to informed sources in rhe
ICMR, the RCC had applied for a finan
cial grant for the study from the ICMR
during 1998-99. The ICMR raised some
objections about the proposal and reject
ed the application. The exact grounds on
which the proposal was rejected are not
known, according to them. Four and a half
years ago, the ICMR had rejected an appli
cation for financial grant to conduct a
study on foetal tissue transplantation in
patients of retinitis pigmentosa under an
India-U.S. collaborative research pro
gramme at the L.V. Prasad Eye Institute,
Hyderabad. The application was rejected
on the grounds that undertaking such
clinical trials on Indian subjects for an
experimental procedure, which were not
done on U.S. subjects, was not ethical and
hence not acceptable.
In a statement issued then, the ICMR
said: “The ICMR stands by the decision
unless documentary evidence is provided
by the principal investigator that the con
duct ofsuch experiments in human beings
will be done (or has already been done) on
subjects of both countries collaborating in
rhe project, the proposal cannot be con
sidered ethical." Hence, the ICMR may
have turned down the RCC's request for
financial support because in rhe RCCJHU drug trial case too no parallel stud
ies on U.S. subjects were proposed to be
done. ■
The misuse of science:
Column by Praful Bldwal - Page 96
Dr. M.S. Valiathan, now Honorary
Adviser to and formerly ViceChancellor of rhe Manipal Academy of
Higher Education (MAHE), was for
20 years Professor of Cardiac Surgery
and simultaneously Director of the
Sree Chitra Tirunal Institute for
Medical Sciences and Technology,
Thiruvananthapuram, the premier
institution under the Department of
Science and Technology, Government
of India. It was under his directorship
that one of the earliest institutional
ethics committees in the country, with
a retired High Court Judge as its chair
man, was established at the Sree Chitra
Tirunal Institute. The institute need
ed to ensure strict ethical compliance
in order to be commercially successful
when it became the first such institt^H
in India to engage in the development
of biomaterials and medical devices
including the Chitra heart valve. In an
e-mail interview he gave R.
Krishnakumar, Dr. Valiathan spoke
about the various aspects of clinical tri
als in the context of the RCC-Hopkins
drug trial controversy. Excerpts:
► Is India really ready for clinical tri
als!
Whether India is ready for clinical
trials is a vague question. Many insti
tutions are ready and have, in fact, been
conducting clinical trials quite well
and as per international norms. For
example, domiciliary treatment of
tuberculosis at TRC (Tuberculosis
Research Centre), Chennai. Readiness
must be assessed for institutions, not
countries.
► Do you think that India is incrwB
ingly becoming a favoured destination
for human trials! What are the reasons
for this!
Yes, the developing world includ
ing India is becoming a favoured des
tination for clinical trials. You may
recall the recent U.S. House legislation
which puts restraints on U.S. drug
firms conducting clinical trials in the
developing countries. The reasons for
the popularity of rhe developing world
are the following:
(a) Large population (b) Low cost
(c) Legislative vacuum or infirmities
(d) Ignorance about the legal and eth
ical issues of human trials among the
public and even health care profes
sionals and (e) Craze among the devel
oping countries to link up with
FRONTLINE, AUGUST >1. 2001
‘Clinical trials should promote health care’
Interview with Dr. M.S. Valiathan.
Western institutions unthinkingly and
at any cost.
► What do you think is a more serious
problem today in India - unethicalprac
tices involving the kind offirst-time trials
ofchemicals in human beings (as it hap
pened at the RCC) or trials ofnew or metoo drugs by pharmaceutical companies! Is
the latter a pardonable offence?
A serious problem arises when med
ical investigators and companies go
about clinical trials without paying the
slightest attention to the Ethical
Guidelines for Biomedical Research on
JHuman Subjects issued by the Indian
^>uncil for Medical Research (ICMR).
The ICMR document emerged through
the effort of the Justice Venkatachaiiah
Committee which held extensive con
sultations at the national level. I cannot
understand why this document is
ignored by investigators and companies.
Between the rules of the Drugs
Controller General (India) and the
ICMR guidelines, the issues of the trial
of new chemical entities and that of metoo drugs are fully covered.
► Cannot Indian institutions, researchers
and doctors say no to unethical trials and
still “survive"? What do you think are the
incentives that make institutions agree to
unethical practices?
Indian institutionscan certainly sur
vive the refusal to take part in unethical
trials. The reasons for institutions
adopting unethical conduct are no diftnt from those which tempt individs to become corrupt.
► Is there a general lack of awareness
among Indian medical professionals about
ethical requirements? How effective are
Indian guidelines and laws?
Yes, there is a serious lack of aware
ness of ethical guidelines among health
care professionals - not doctors alone,
administrators, politicians, media, etc.
Apart from the ICMR guidelines, the
DBT (Department of Biotechnology)
has set up a separate set of admirable
guidelines on human genome research
which is in its infancy in India.
Therefore, one cannot claim that we
have no guidelines. Of course, guide
lines are not laws, but legislation on the
basis of guidelines will emerge soon.
However, it is a fact that in practice the
•
FRONTLINE, AUGUST 31, 2001
the middle path by sticking to the
national guidelines and keeping oneself
posted on what is happening in bio
medical research at the international
level. The human trial should be
planned on the basis of an MoU
(Memorandum of Understanding)
between the firm which developed the
product and the medical institution,
which would obviously take the
approval of its own ethics committee
and other approvals as necessary. There
is no place for third parties or middle
men in this exercise.
► What should the country be cautious
about and what needs to be done at the
practical level tvhen trials involve
researchers and resources from developed
guidelines are not often observed. This countries and multinational companies?
is no more than another illustration of Are Indian companies and research insti
our scant regard for laws and guidelines tutions comparatively better in the matter
ofsticking to ethical rules?
in India.
► Is getting "informed consent" a diffi
As I mentioned earlier, clinical trials
cult task in the case ofa majority ofpatients are necessary insofar as they promote the
here? What has been your experience? In interests of health care. The problem is
that case shouldsuch people be made “par a mismatch between the interests of the
ticipants" in drug trials at all? Is getting group which developed the product and
those evaluating it in human subjects.
“volunteers"a difficult task here?
It is not difficult to get informed Firms in India and abroad who spend
consent - on the basis of my Kerala expe millions on developing products would
rience. It is true that when patients are want to maximise profits; ethics in busi
illiterate and uneducated (not the same ness is a controversial subject. On the
thing) and look upon doctors as gods, other hand, the evaluating institutions
informed consent would become diffi need money and must also protect the
cult. Getting volunteers by giving finan interests of patients and subjects.
investigators
who
are
cial incentives is, of course, unethical. Medical
Ultimately, the inclusion criteria for approached to take up
clinical trials therefore face serious
subjects, including their ability to give
informed consent, should be deter ethical dilemmas. This is true as much
mined by the principal investigator and in the affluent countries as it is in India.
his colleagues. Incidentally, the rights of in the last few years, this issue has
the subjects in a trial are spelt out in the become pressing because medical inves
tigators have themselves promoted
ICMR guidelines.
► There is a new breed of contract firms. It is now mandator}’ for authors
research organisations which act as a sort of papers for top journals to indicate any
of “event managers" for the drug compa direct or indirect links they may have
nies, organising clinical trials. Do you with the firms/industry where the prodthink they are good or badfor the Indian ucr/process being reported on were
developed. In fact, the affiliation is pub
scene?
Clinical trials are essential for mak lished with the paper.
ing progress on many fronts - drugs,
Lastly, it is no use blaming institu
devices, vaccines, diagnostic kits, etc. If tions and firms in affluent countries for
the trials are restricted too rigidly, there exploiting us. We are grown up and
would be little scope for innovation; if should look after our own interests.I fwe
unrestricted, there would be chaos and are upright and do a thorough job no on.
human exploitation. One has to adopt stops u in this and all would be well. J
*
DRUG POLICY
OF
THE NATIONAL CAPITAL
TERRITORY
OF
DELHI
The Govt, of National Capital Territory of Delhi
APRIL 1994
Drag Policy of the State of Delhi
A comprehensive statement of the drug policy of the state of Delhi is
necessary at this stage in order to provide a strong framework within which
the different components would be implemented in the coming years. Such a
policy statement would also clearly enunciate the social and economic goals,
based on equity and care for the underprivileged, which are sought to be
attained through this drugs policy.
The main elements of the policy are the following:
1)
All the essential drugs needed for health care should be available at all
times at all the health facilities of the state. These drugs should be safe,
effective and of good quality.
2)
The facilities and manpower needed for providing a good and continuing
quality control and assurance system for the drugs being used will be
strengthened.
3)
The system for procurement, storage and. distribution of drugs will be
modified to ensure that drugs of good quality, obtained at competitive
prices, are always available at the health units.
4)
5)
Rational use of drugs will be promoted. Rational use is the use of the most
appropriate drug prescribed at the correct dose for the correct length of
time. Medicines will be prescribed and ensuring as far as is possible that
appropriate drugs only are prescribed will.
Doctors at all public health facilities will be encouraged to prescribe drugs
by their generic names. Procurement of drugs will also be by generic
names.
6)
There will be a strengthening of the health education programmes of the
government specially relating to drugs. This would promote rational use
of drugs and enhance compliance. There would also be an acceleration of
the continuing education programmes for doctors and paraprofessional
personnel in the field of drugs. This would include establishment of a
Drug Information Centre and development of links with non-governmental
organization.
7)
Research on all aspects of use of drugs will be an integral part of the drug
policy in the state so that these results would be continuously utilized to
modify the different components of the programme for the benefit of the
people. It is important, for example, to collect information as to what is
happening at this time. A survey will be carried out by the best available
professional consultancies available to understand the strengths and
weaknesses of the present system. As each new mechanism will be
introduced studies will be initiated to document the impact of such
interventions.
It is important to emphasize that all these seven components of the drug
policy for the state need to be implemented if the results are to be effective and
make an impact:
1)
Availability of safe and effective Drugs
2)
A Good Quality Control and Assurance System
-3)
Improved procurement, storage and distribution System
4)
Rational Prescribing of Medicines
5)
Prescribing by Generic Names
6)
Strengthening of Health Education Programmes
7)
Research on AU Aspects of Drug use
It is the objective of the policy that a limited list of carefully selected drugs
will always be available at all health centres and hospitals of the state. These
medicines would be procured at reasonable prices thus enabling the drug
budget to be used for a much large number of persons then is now available.
These drugs would be of good quality and there would be a good are being
taken, are of good quality, safe and effective. The prescribing of the drugs
would be based on rational pharmacological and therapeutic knowledge and
the patients would also be aware of the medicines they are getting and thereby
actually take the medicines in the way they should be taken. Information about
these essential medicines would also be available to the doctors and
paraprofessional staff. Wherever justified additional complementary medicines
not on the essential list of drug would be provided through a mechanism
established for this purpose. Each hospital, if it so desires could order drugs
not on the common list of essential drugs but not more than 10% of the budget
spent on drugs.
Steps Being Taken by the Government of Delhi to
Implement the New Policy
A series of steps are being taken to implement the drug policy of the state
as described above. These are detailed below:
1)
Selection of a list of essential drugs
The cornerstone of the drug policy is the selection of a limited number of
medicines to be used throughout the state. A list of drugs to be used at the
primary health care level and different levels of the health care system is being
prepared. Different lists have been prepared for the Outpatients and Inpatients
at hospitals. This list will be prepared every year by a Special Committee
consisting of eminent experts from the different hospitals in the state and other
leading specialists.
2)
Pooled procurement of drug for all hospitals in Delhi State-Establishment
of a Central Drug Procurement, Storage and Distribution Centre.
Only those drugs on the list of drugs prepared will be procured by a
centralized procurement unit which will invite tenders and order the medicines
for all hospitals and medical facilities in the state of Delhi. The present practice
of every hospital ordering its own drugs will be phased out. All ordering will
be carried out by the Central Procurement, storage and Distribution Centre to
be established. In the first phase a rate contract will be prepared for the different
drugs to be ordered. This will be done by floating tenders and selecting suppliers
based on strict criteria such as whether these are actual manufacturers of the
medicines, past performance, quality of drugs and prices. This rate contract
will be supplied to all hospitals who could then order only from this rate
contract. In the next phase the drugs for all hospitals will be ordered centrally
but the medicines will be delivered to the hospitals directly. Finally in the third
phase when a computerized procurement, storage and distribution centre has
been established all drugs will be ordered by the Centre, stored there and
distributed to the different hospitals in the state. The geographical entity of the
state of Delhi is such that this is possible and feasible. Modem techniques of
drug storage and inventory control will be introduced so that the central unit
is aware at any time of the different drugs available at the different hospitals
and health care facilities. This would ensure that drugs would not pass their
expiry dates and that any imbalances such as shortage of a particular drug at
one hospital and unused stocks at another would be identified and corrective
measures taken well in time. Checks and counterchecks, such as computerized
inventory systems, modern accounting procedures, and surprise checks will be
initiated to ensure that losses due to illegitimate activity is kept down to the
bare minimum. Training of pharmacists in stores management and
improvements in monitoring systems will from an integral part of the system.
3.
Preparation of a formulary
To ensure proper and rational use of drugs which in turn would decrease
the unnecessary expenditure spent today on medicines a Delhi State Formulary
will be prepared. This would provide uptodate information about drugs which
are included in the Essential List of Drugs for the state. This formulary would
be made available free of cost to all doctors, pharmacists and paraprofessionals
in the health field working at state health units. It has been the experience that
preparation and use of formularies in different countries have reduced the
expenditure on drugs by about fifteen to twenty percent. This formulary would
be prepared by a Formulary Committee set up by the State of Delhi and will
be updated every year in accordance with the updating of the list of essential
drugs This formulary will consist of information which will help the doctor in
prescribing drugs - such as therapeutic indications, contraindications,
interactions and side effects associated with each drug.
In addition to the Delhi State Formulary a small pocket book containing
names and doses of drugs in the essential list will be printed and provided to
all doctors, pharmacists and nurses. This will help them to prescribe and provide
drugs only from this list.
4.
Quality assurance
The State Drug Control Authority will be considerably augmented and
strengthened so that drugs reaching the patient are safe, effective and meet
approved specifications and standards. The quality control and assurance system
will include managerial, technical and legal aspects. Some of the activities will
be (a) strenghening of the Drug Inspectorate Unit (b) strengthening the Quality
Control Laboratory and (c) establishing an efficient system for withdrawal
from circulation of products which have been found to be below the standard
required.
5.
J
Training in Rational use of Drugs
To make certain that the drugs on the test are prescribed will a series of
workshops on rational use of drugs would be held throughout the state for all
categories of persons involved in prescribing drugs. This will be carried out in
collaboration with the staff of medical, nursing and pharmacy institutions in
Delhi and organizations such as the medical and pharmacy associations. The
government will help in any way it can to implement and strengthen ongoing
programmes aimed to introduce the concept of essential drugs in the medical
and nursing curriculi so that emerging graduates of the future possess more
sensitivity towards rational prescribing than is present at the moment. Much
of this training will be imparted while working at the hospitals and health
centres in Delhi State.
r
6.
Drug Information
The aim of the policy is to see that practical unbiased information on
rational use of drugs and on handling of drugs is provided to all health workers
at all levels. Appropriate information will be provided to traditional medical
practitioners, retailers, patients and the general public. All available techniques
available for such communication using the print, electronic and even, where
appropriate, the traditional folk media would be used. Training programmes,
workshops, lectures and discussions for different groups of persons would be
held. For specialized information on different aspects of drugs it is proposed,
in collaboration with the National Informatics Centre and the Delhi Medical
Association, to set up a computerized Drug Information Centre. In due course
a Delhi State Drug Information Letter will be published. This will contain
objective, up-to-date, information about drugs and will be widely circulated.
7.
Preparation of Standard Treatment Schedules
In an effort to rationalize prescribing, reduce cost and prevent loss of
medicines it is proposed to prepare Standard Treatment Schedules for those
drugs being used at the primary health centres and at the Outpatients
Departments of hospitals. It would be one more step like the preparation of a
list of essential drugs, establishing combined pool procurement, development
of a formulary and centralized monitoring of medicines, which would help in
using a limited budget for drugs for the maximum number of persons without
reducing, in any way, the standard of health care delivered.
8.
Drug Advertising and Promotion
Ethical criteria for drug promotion and advertising will be established for
the State of Delhi along the lines of such ethical criteria developed by the
World health Organisation. Drug promotional activities not in accordance with
the law or with such criteria will not be permitted in the state. This will help
to protect the public from being exploited.
9.
Research
The type of research will be carried out will be, initially surveys which
will enable a picture to be drawn as to what is happening today e.g. how much
the expenditure is on the four major groups of high-use drugs like antibiotics,
how many people actually are provided medicines, how many people are
asked to purchase medicines outside, what kind of medicines and other similar
issues. Later, as interventions are introduced the effect of these interventions
will be documented. Other studies on drug utilization and on behavioural
aspects of patients and the public relating to use of drugs will also be carried
out as also studies on drug economics. This type of research - health systems
research - will enable the results to be used to modify programmes thereby
utilizing such research for the benefit of the people.
10.
Monitoring and evaluation
Monitoring and evaluation of the policy and its implementation will be
carried out by establishing a monitoring and evaluation mechanism at the
Ministry of Health. This unit will study performance in relation to projected
activities. Three standing committees would be established; for Selection of
Drugs, for Drug Procurement and Stores Management, and for preparing the
formulary.
_
CRITERIA FOR SELECTION OF
MANUFACTURES FOR SUPPLY OF
MEDICINES TO THE GOVT. OF NCT OF DELHI
ex Ci
1.
The manufacturer should have a valid license under the Drugs and
Cosmetics Act for Medicines that he intends to tender for supplies.
2.
The manufacturer should have a turnover of not less than Rs. 8 crores.
3.
The firm should be found satisfactory after inspection by especially
approved inspectors.
4.
The inspectors selected to assess and audit the manufactures’
compliance with Good Manufacturing Practices should be persons with
a high degree of competence and credibility from outside the
Government.
5.
In the interim period, suppliers already on the list would be allowed to
continue supplies but if found unsatisfactory during GMP Inspection,
their names were to be removed from tire list.
6.
Random samples picked up by inspectors should conform to approved
standards when tested by one of the specially selected testing
laboratories.
1
GOVERNMENT OF NATIONAL CAPITAL TERRITORY OF DELHI
GMP Inspection Form
Pari I
(To be filled by the inspecting GMP experts)
Names of the inspecting (IMP experts :
a)
b)
Dates of inspection :
Part H: Information to be furnished by the unit to be inspected
Any documents attached must be appropriately cross-indexed or identified by the firm. All
pages of this part including any attached documents should be signed by firm's representative
and handed over to the inspecting GMP experts.
1
Name of the firm
2
Address oft he firm's office
(for correspondence purposes)
Address of the firm's unit or
factory to be inspected
4
(a) Name of the contact person
(b)
(c)
(d)
(e)
Telephone No. (Off.)
Telephone No. (Res.)
Fax No.
e-mail
2 •-
5.
(a) Does the firm have any other
additional unit manufacturing
items mentioned in the R/C or
their application
Yes/No
(b) If yes, give address(es) of such
other unit(s)
6.
Year of establishment
7.
Annual turn over of the Company
8.
(a) Licencing authority (LA) under
the Drugs & Cosmetics Act
(b) Licence No(s)
(c) Valid upto
9.
Plan of premises at the time of
granting licence by LA
(Attach line sketches/blue prints
and mark clearly the areas allocated
for various functions)
10.
(a) Any changes made since the
last approval by LA
(b) If yes, give details
(Attach additional sheets, if
necessary)
11.
(a) Total land available for the unit
to be inspected.
(b) Total area utilized for admini
stration, utilities/faciiities,
production and quality control
Yes/No
-• 3 :-
(e) Manufacturing areas allocated
to various sections
i)
Tablets
ii)
Capsules
iii)
Oral Liquids
iv)
Oral Powders
v)
Injectable preparations
vi)
Ophthalmic preparations
vii)
Any other dosage form
(If yes, name the category)
viii)
Bulk Drugs
(If yes, name the products)
d) Is factory centrally air-conditioned:
:
Yes/No
e) If no, indicate areas airconditioned. Also show clearly
in plans attached against items 9
and 10.
12.
Products with formulae permitted
to be manufactured (list to be
attached by the firm)
13
Organisational chart of the firm
(Attach separate sheet, if necessary)
14
(a) Total number of employees
(b) Total number of technical
personnel
Male
Female:
Male
Female:
4 :-
15
Name, qualifications and experience
of the head of the Production Deptt.
16.
Name, qualifications and experience
of the head of the Quality Assurance
Department
17
Name, qualifications and experience
of the head of the R.&D Deptt,
18
Department-or section-wise list of
technical personnel engaged in
manufacturing/maintenance/quality
control functions (Attach list indica
ting the qualifications, experience and
department/section in which working.
Also indicate the names of the person
nel approved, if any, by the LA)
19.
Does a Quality Policy exist in the
Company 9 If so, attach copy
20.
List of Standard Operating Procedures
(SOPs) followed in the company. (Use
separate sheets, if necessary)
21.
List of documents maintained by the
Co. in support of GMP compliance.
(Use separate sheets, if necessaiy)
:
(Signature of the person
submitting the information
on behalf of the company)
Name
Designation
Date
GOVERNMENT OF NATIONAL CAPITAL TERRITORY OF DELHI
GMP Inspection Form
Part 111
Observations of the GMP Experts
(Record your observations in brief against each parameter
attach separate sheet and cross-link it suitably.
If space is inadequate, please
Observations
I
Location and environment:
I I
Any source of pollution in the
neighbourhood 9
Yes/No
1.2
Any open drain, or public
lavatory nearby ?
Yes/No.
1.3
Are any products other than
drugs manufactured in the same
or adjacent building and are
these safe 9
Yes/No
Factory premises:
2.1
Layout and construction
2.1.1
Are materials of const
ruction satisfactory 9
Yes/No
Observations
Are buildings and facilities/
utilities properly located and
Yes/No
constructed for smooth
operations and maintenance9
2.1 3
Do adequate measures exist
to check entry of rodents.
insects and birds 9
2.1.4
Aie lighting and ventilation
adequate 9
Yes/No
Yes/No
Adequacy of space.
Are sufficiently large and suitably
equipped areas available for
2.2 1
Receiving and despatching
ofgoods
2.2. II Isa separate dispensing area
provided ?
Yes/No
Yes/No
2.2.2
Storage of raw materials (RMs)
Yes/No
2.2.3
Storage of packaging
materials (PMs)
Yes/No
Observations
2.3
224
Storage of intermediates or
scmi-linished ptoducls
Yes/No
22 5
Storage of finished products
(FPs) before transfer to main
warehouse and distribution
Yes/No
2.2 6
Manufacturing operations for
which the firm is licenced ?
Yes/No
Cleanliness and maintenance
2.3 1 Are floors, walls and ceilings
properly constructed and easy
to clean, maintain and disinfect ?
Yes/No
2.3 2
Arc sewaue. trash and other
effluents disposed off
properly 9
Yes/No
2.3.3
Are areas where penicillin.
Cepha or penicilin- or
Cepha-based products are
manufactured completely
separated from areas used
for manufacture of other
products
Yes/No
%
4
Observations
2.4
Facilities and utilities'
2.4.1
Are air handling units adequate
and properly located and
functional?
Yes/No
2.4.2
Is air conditioning system
adequate and functional ?
Yes/No
2.4.3
Are steam generation facili
ties adequate anil functional ?
2.4.4
%
Yes/No
Is vacuum system
adequate and functional ?
Yes/No
2.4.5. Is compressed air system adequate
and properly functioning ?
Yes/No
2.4.6
is water supply system
alright ?
Yes/No
2.4.7
Is distilled water quality and
supply system alright ?
Yes/No
Observations
Is demineralised water supply
system alright 9
2.4.8
2.4
9
is standby electrical generation
provided 9
2 4 10 Arc SOPs in existence foi
regulation of the above actitvities 9
Yes/No
Yes/No
Yes/No
.1
Personnel:
> I
Are the technical personnel
responsible for manufacturing and
quality assurance functions adequate
in numbers ?
Yes/No
Does the stall'in the above operations
have adequate qualifications and
experience 9
Yes/No
4.
Training:
-I I
Is personnel engaged in manufaluiing, quality assurance, ware
housing, cleanliness and main
tenance operations periodically
trained in accordance with needs ?
Yes/No
4.2
f yes, are any SOPs for training in
existence ?
Yes/No
6 -
Observations
4.3
Was documentation in support of
Yes/No
such liaininv. available I'm
inspection ? If yes, record your
observations.
Hygiene and lienllli:
5.1
Are medical check ups conducted
(a) on entry of personnel
Yes/No
(b)periodically thereafter
Yes/No
Are facilities for changing street
clothes, footwear, washing and
toilets adequate and satisfactorily
maintained
Yes/No
5.3
Are protective steps against likely
damage to health due to occupational
hazards satisfactory ?
Yes/No
6.
Technical equipment:
(>. I
Is equipment for each section
adequate ? Please record observations
for each section.
Yes/No
Yes/No
Yes/No
7
Observations
Are equipments installed in a
manner that corrosion is avoided ?
Yes/No
6.3
Are the equipments maintained in
a mannei that contamination with
lubricants, dirt, etc is avoided ?
Yes/No
64
Are records of setting up, maintenance and calibration of equipment
kept and available for inspection ?
If yes, comment on their adequacy
Yes/No
65
Are weighing balances appropriate
to the quantities to be weighed ?
Yes/No
6.6
Are cleaning SOl’s in existence and
followed ? Check logs
Yes/No
6.7
At e sequential records of manufactured
batches on an equipment available ?
Yes/No
6.8
Are procedures for line clearance for
product change over adequate '>
Yes/No
8
Observations
('
Is equipment status in terms of
'Cl.LAN'. 'IN USE', TO Bl/. CLEANED'
properly indicated and relevant details
of the product, its batch No. etc noted
on the equipment during manul'actuiing
operations ?
7
Production or manufacturing:
7.1
Is master formula (MF) available
for each product ?
Yes/No
72
Does the MF for each
product contain the required details ?
Yes/No
73
Is production carried out in accord
ance with the instructions
Yes/No
Yes/No
74
Are batch production records
(BPRs) maintained in accordance
with the MF ?
Yes/No
75
Is each step of manufacture duly
signed/initialled by the operator and the
supervisor in token of compliance with
proper'DOER-CHECKER' drill for
manufacturing controls 9
Yes/No
%
Observations
7 (i
Are alterations Io processes
recorded and authenticated by
competent authorised persons 9
Yes/No
7.7
Do all containers of active RMs,
excipients and intermediates bear
appropriate labels at all stages of
manufacture 9
If no, give details
Yes/No
78
Are only materials, containers and
appliances necessary for the job
in hand stored in the vicinity of the
manufacturing areas and are these
properly labelled with name of the
product, batch No., dates, etc 9
Yes/No
7.9
Are containers checked for cleanliness and suitability for packaging
before use 9
Yes/No
7 It)
Are containers of intermediates and
FPs intended for use in the plant or
for transport outside closed in such
a manner that unauthorised inter
ference is not possible (eg. by seal
ing, etc.)
Yes/No
l() -
Observations
7.1 I
Are empty containers freed of old
labels and checked immediately prioi
to use
Yes/No
7 12
Do all apparatus/equipment bear
appropriate labels to identify the
product lot which the equipment
is used, its batch No , date etc
Yes/No
7.13
Are KMs, I’Ms and solvents used
after approval by the QC Department?
If no, give details
Yes/No
7 Id
Are labels on containers of RMs to
be used in manufacture checked
with regard to identity, quantity
and QA approval?
If no, give details
Yes/No
7.15
Are all volume and weight
measurements checked by a
second person before use 9
If no. give details
Yes/No
7 16
Is stage of manufacture clearly
indicated on containers ?
Yes/No
Observations
1 \1
Are working instructions available
at place of work ?
If no, give details
Yes/No
Do the manufacturing records
contain all relevant particulars
like :
Yes/No
a)
Balch No,
b)
Date of manufacture
c)
Names of persons directly
responsible for operation
and supervision
d)
Details regarding apparatus
used (eg. eqpt No., etc )
e)
Balch size
f)
Yield by weight/volume
g)
Percentage of theoretical
yield
h)
Reasons for abnormal
variations, if any
i)
List of RMs, I’Ms used with
their weights/voluines/quantities
and analytical reports under
which approved by QA.
j)
Description of work
carried out
Observations
7.19
k)
Details regarding in-piocess
QC checks
I)
Details regarding Quality
Assurance approval efl'P
m)
Certificate by QA or other
authorised person to the effect
that everything concerning the
batch is in accordance with
GMP requirements.
Is batch integrity maintained during
a)
manufacture
Yes/No
b)
packaging
Yes/No
c)
stocking
Yes/No
7
20
Is there a system of identification
and segregation of rejected batches ?
Give details
Yes/No
7
21
Is reworking of rejected lots properly
documented
Ifyes. comment on the same
Yes/No
7 22
Is tamper-evident sealing of tlie
finished product done ?
Yes/No
13 -
Observations
7.23
Is inert gas used in any operations
including packing 9
If yes, identity the gas and the products
for which used ?
Yes/No
7.24
Is filtration of water, solvents, air.
gas, etc during the final stages of
manufacture satisfactory ?
Yes/No
7.25
Are plant working instructions
available at each place of work ?
Yes/No
7 .26
Are written SOPs and specifications
for packaging and labelling in existence ?
Yes/No
7.27
Are SOPs for reworking of non
conforming batches in existence ?
If yes, check records
Yes/No
7.28
Are appropriate in-process checks
carried out by ()(' personnel and records
maintained
Yes/No
8
Warehousing:
8.1
Are areas for storage of RMs, PMs
and FPs adequate and properly
segregated
Yes/No
A
- 14 ■-
Observations
8.4
Aie all areas clean and ordcily 9
Yes/No
Are the stores protected from
entry of rodents, birds, insects, etc. ?
Yes/No
Are incoming materials properly
quarantined into "QUARANTINED"
"UNDER. TEST", "APPROVED” and
"REJECTED" categories with distinct
labels for ease of identification ?
Check SOP and compliance
Yes/No
Are areas requiring controlled
temperature and humidity adequate ?
Yes/No
8.6
Are FPs requiring controlled
temperature and humidity stored
properly ?
Yes/No
87
Are flammable, corrosive and toxic
materials stored separately with
proper safety measures 9
Yes/No
8
5
-15 -
Observations
9
Standard Operating Procedures:
9.1
Are SOPs Cor various activities in
existence ?
Check with the list
supplied by the firm in Part 11
Yes/No
9.2
Aie the SOI’s adequate and clearly
written
Yes/No
9.3
Are the SOPs followed ? Please
check documentation in support
Yes/No
94
Are the SOPs reviewed periodically ?
If yes, what is the frequency
Yes/No
10
Documentation:
10.1
Is a duly-approved Quality Policy
in existence ? If so, examine it and
comment on its adequacy
Yes/No
10 2
Are batch records capable of giving
complete history of the batch right
from the RM stage to the distribution
of the FI’ 9
Yes/No
10
Observations
10.3
Are control documents and control
samples readily available 9
Yes/No
10 4
Aie control samples and records
maintained in accordance with the
requirements of the D&C Act and
the Rules?
Yes/No
10.5
Are analytical reports and in-process
controls adequately supported by the
raw data ?
Yes/No
10 (■>
Is the data/information recorded
concurrently with the operations 9
Yes/No
I I.
Safety
III
Isa safety manual available 9
Yes/No
I 1.2
Are safety equipments like helmets,
shoes, goggles, gloves, showers,
aprons, masks, breathing aparatus.
etc available in the factory ?
Yes/No
-• 17 :-
Observations
I 1.3
Is adequate first-aid equipment
available al convenient places in
the factory ?
Yes/No
1 1.4
Is periodic first-aid training given to
stall'9
Yes/No
II 5
Are electrical connections, wiling
etc checked regularly ?
Yes/No
116
Is flame-proof equipment used
where flammable solvents or materials
are stored or handled dining
manufacture 9
Yes/No
11,7
Is adequate fire lighting equipment
like fire extinguishers, ladders, fire
buckets filled with water/sand.
etc. available 9
Yes/No
Is the building safe and provided
with emergency exists, escape
routes, ladders, etc 9
Yes/No
Does the firm maintain accident
history/record 9
If ves. comment on its adequacy
Yes/No
1I 9
- 18
Observations
12.
Utilities:
12.1
Are arrangements for the following
adequate ?
12.1.1
Raw waler
Yes/No
12 1.2 Demineralised water
Yes/No
12.1.3
Vacuum
Yes/No
12 1.4 Compressed air
Yes/No
12 1.5 Steam
Yes/No
12.2
Are measuring devices for
volume
Yes/No
temperature
Yes/No
pressure
Yes/No
vaccum
Yes/No
properly calibrated in accordance
with the written down procedures ?
If yes, record observations
against each
%
19
Observations
13
Pollution control:
13 1
Are arrangements for the following
adequate
Yes/No
13.1 .1 Disposal of solid/semi-solid
waste
Yes/No
13 1.2 Disposal of sewerage
Yes/No
13 1.3 Disposal of liquid laboratory waste
Yes/No
13.1 4 Management of gaseous pollutants
Yes/No
Is effluent treatment plant in
existence 9
If yes, comment on it
Yes/No
13.2
13.3
Are fume hoods of adequate design
in existence and used wherever
necessary
14
Packaging:
14 I
Are written procedures and specifi
cations available for:
14 2
Yes/No
a)
Packaging components
Yes/No
b)
Packaging operations
Yes/No
c)
Labels and label control
Yes/No
is batch separation maintained
during packaging operations 9
Yes/No
- 20
Observations
Complaints and recalls:
10.
Is a record of complaints/recalls
maintained ?
If yes. comment on the same
Yes/No
Arc adequate measures taken in
such cases and recorded ?
If yes, comment
Yes/No
Summary and recommendations'
Signatures of Hie GMP Experts
Name
Name
Address
Address
GOVERNMENT OF NATIONAL CAPITAL TERRITORY OF DELHI
GMP inspection
SAMPLE RECEIPT FORM
Institution/Company (under inspection)
Address
Dale of inspection
Name of representative of the inspected establishment
Name(s) of Inspector
Name of the Drug sampled
Dosage form
BalchNo
Date of manufacture
Date of expiry
Place samples (warehouse, production line, packaging section, etc.)
No of samples taken (tins, strips, packets, etc.)
(Signatures and name(s) of inspectors)
Signature and name of
representative of the
inspected establishment
| Developing Essential
"o Drugs Policies
•
A Guide for NG Os
Developing Essential
Drugs Policies
°
A Guide for NGOs
Developing Essential Drugs Policies A Guide for NGOs
Members of the International NGO Working Group (1995-7)
• Carolyn Green. ECHO International Health Services Ltd.. United Kingdom
• Ellen't Hoen and Catherine Hodgkin, Health Action International (HAl)-Europe
• Eva Ombaka, the Pharmaceutical Programme CISS International (World
Council of Churches), Kenya
• Philippa Saunders, Essential Drugs Project, United Kingdom
• Erik Schouten, Mcdecins Sans Frontieres/HeakhNet International, The
Netherlands
HAI-Europe would like to thank the following people for providing comments
on various drafts ofthis publication:
• Christel Albert - Misereor e.V., Germany
• K. Balasubramaniam - CI/ARDA/HAI-Asia, Malaysia
• Wilbert Bannenberg - Consultants for Health and Development, The Netherlands
• Pascale Brtidon-Jacobowicz -WHO-DAP, Switzerland
• Carinne Bruneton - PIMED, France
• Sr. Joan Drcane - MEDS, Kenya
• Andrew Herxbeimer - Cochrane Collaboration/ISDB, United Kingdom
• Hans Heuvelmans - Mcdecins Sans Frontieres, The Netherlands
• Lis Jorgensen - IBIS Health Group, Denmark
• Richard Laing - Center for International Health/Boston University, United States
• Leo Locher - Medico International, Germany
• Roberto Lopez Linares - AIS, Peru
• Kurt Markwalder - Swiss Red Cross, Switzerland
• Albert Petersen - DI FAM, Germany
• Eric Ram - World Vision International, Switzerland
• Diana Smith - CMC/World Council of Churches, Switzerland
• Mark Weber - Swiss Red Cross, Switzerland
• Karin Wiedenmayer - Swiss Tropical Institute, Switzerland
This document has been produced with support from the European Commission,
DG-VIII.
Design & illustrations: Marit van Mict
Developing Essential Drugs Policies: /I Guidefor NGOs
1
5
Introduction
An essential drugs framework
5
Strengthening NGO effectiveness
6
2
Developing Essential Drugs Policies for NGOs
Assessing needs
10
Drug selection
10
Procurement
11
Assessing quality
11
Management, storage and distribution of drugs
12
Financing a sustainable drug supply
15
Controlling drug donations
13
Drugs for'use in emergencies
15
Rational use of drugs
15
Appropriate labelling
15
Evaluating funding requests from NGOs
16
w
9
3
Where to Obtain Additional Information
17
4
Key Resources
24
3
Developing Essential Drugs Policies A Guide for NGOs
Background
This introduction to non-governmental organisation (NGO) drug
policies is the result of the work of an NGO Working Group that saw
the need to clarify a number of issues surrounding essential drugs in
NGO work. The specific goals of the group were to:
• ensure that internationally agreed standards are translated into
appropriate terms for NGOs;
• highlight the components of drug policy that will ensure a
sustainable supply of safe and effective drugs and their proper use;
• encourage regular policy review;
• discuss some of the problems and dilemmas which NGOs face in
this area;
• provide information about organisations, networks, training
opportunities and documentation to support development and
implementation.
A first draft of this paper was widely circulated and used during 1996
and 1997. This revised version includes many suggestions from
NGOs and individuals who reviewed or used the earlier draft.
4
Introduction
This booklet is tin introduction to essential drug policiesfor NGOs -working on health service
delivery in developing regions. It is intended for NGO staff -working in policy and
management positions at regional- or country-levels who could develop and implement an
essential drugs policy for their organisation. This booklet is not a comprehensive guide to
policy development, nor docs it seek to provide the information necessary to develop and
manage pharmaceutical projects or programmes.
Section one sets out the basic principles of the essential drugs concept. Section two
outlines the key considerations that NGOs should address in developing their own
essential drugs policies. It also includes questions that donors should consider in
supporting NGO work in pharmaceutical supply. Sections three and four contain a list of
contact organisations and references that will enable NGOs to get additional information
and technical support.
An essential drugs framework
In 1977, the World Health Organization (WHO) published the first WHO Model List of
Essential Drugs This original list identified some 220 essential drugs that a country' could
use to meet the majority of its people’s health problems calling for drug solutions. Since
that time, the list has been updated on a regular basis and, when necessary', expanded. It
serves as a model for countries in developing their own national lists. At the same time, an
essential drugs list is just a starting point. Il needs to be developed together with other
policies to ensure that essential drugs are effectively managed and used.
1 Full details and a short description of all publications mentioned in the text arc
given in section 4 ‘Key Resources’.
5
Developing Essential Drugs Policies A Guide for NGOs
For the past 20 years, WTIO has advised countries to base their drug policies on the
essential drugs concept. This concept stresses the selection of drugs to meet real public
health needs. WHO emphasises that all drugs chosen should be safe, effective, affordable
and of acceptable quality. The essential drugs concept implies efficient management of the
drug supply and rational use. To date, 51 countries have developed and adopted national
drug policies based upon the WTIO model and three dozen more countries are in the
process of doing so. In addition, more than 140 countries now use an essential drugs list.
"Essential drugs are those that satisfy the health care needs
^5
of the population; they should therefore be available at all times in adequate amounts
and in the appropriate dosage forms."
• The Use of Essential Drugs, WHO (1990) •
Strengthening NGO effectiveness
Essential drugs policies are based on the WTIO essential drugs list and concept. These
policies provide the framework for an adequate supply of safe and effective drugs of good
quality, at a reasonable price and help to ensure that they are properly prescribed and used.
Policies based on the WTIO essential drugs concept can help to ensure that scarce
resources are well spent and that the best possible use is made of money, medicines and
human resources. Essential drugs policies provide a framework which helps to ensure wide
access to effective and safe drugs of good quality at low cost.
The essential drugs concept is not only useful at the national level. Its combination of
«
ideas on correct treatment and good management can also be used by local programmes^'
by hospitals and by NGOs as a framework for developing specific policies for organisations
or programmes.
Essential drugs policies based on the WTIO concept can also enable NGOs to use their
limited resources to manage drugs effectively and meet priority needs. An essential drugs
policy can help NGOs provide improved information, education and training, as well as
more efficient supply, storage and distribution of drugs. WTiile many NGOs have
advocated the adoption of the WHO essential drugs concept by governments, only a few
have integrated it systematically into their own practice.
6
The costs of inefficient drug management are high, while the benefits in terms of better
and more cost-effective treatment can be considerable. The potential gains extend beyond
the scope of individual NGOs. If more NGOs were to implement the essential drugs
.concept it would be easier to organise joint services. In Kenya, Nigeria and India, for
Jfiimple, specialised units already undertake joint procurement, training and support for
NGOs. Such groups can also link together internationally to gather information and
influence policies affecting the welfare of the people they serve.
7
The Advantages of Having an Essential Drugs Policy
One NGO's Experience
Developing Essential Drugs Policies A Guide for NGOs
ECHO International I lealth Services is an NGO, non-profit, medical supply agency
which supplies USS4 million worth of pharmaceutical supplies each year for use by
other NGOs and national governments around the world. Its staff members have
found that developing a clearly stated drugs policy has several advantages:
Uses limited resources "well
It helps to protect the end users from financial exploitation and misuse of scarce
resources.
Promotes rational drug use messages
Such a policy facilitates discussions with clients and donors on the rational use of
drugs in various health care settings, often allowing either much better value for the
money available or a reduction in budget requirements.
Assists the development ofstandards
It helps to encourage the use of standard treatment protocols and rational prescribing
policies.
Eliminates confusion
The policy can be clearly stated to clients and donors so that there is no confusion
about how ECHO is prepared to help.
Provides clear guidelinesfor decision making
It justifies die rejection of inappropriate requests or donations even when clients or
donors arc not willing to engage in a discussion of the reasons behind the policy.
Suggests appropriatefinding activities
Using this type of policy' as a framework helps ECHO to advise donors who have
collected funds but are not sure what kind of drugs to send!
Contributes to sound financial decisions
It provides a solid basis for financial decisions about which products to offer, which
should take priority and which are most likely to be in demand or available at lower cost.
• Compiled by Carolyn Green, Senior Pharmaceutical Adviser,
ECHO International Health Services, United Kingdom •
8
Developing Essential
Drugs Policies for NGOs
Policies bused on the essential drugs concept should match the cirannstances and needs of
different organisations. They must be clear and practical and should be useful in planning,
implementing and evaluating health projects. They should take into account the fact that
drug supply is a complex process and each stage ofthe process needs to be critically examined
and well managed. The scope and detail of the policy guidelines will depend on the nature of
the NGO involved and the answers given to the following questions:
In what way is the NGO involved in supplying drugs or providing funding for
drags?
VVhat type of training and advocacy work does die NGO cany out regarding drags
and drug policy?
Does the organisation already have a drag policy? Does it need review?
This section identifies and describes key considerations that should be the basis of
discussions to develop overall drug policies and essential drags policy guidelines that are
appropriate to an NGO’s mandate. The process of developing an essential drugs policy
|j£:i be different for each NGO. It will depend on the scope and scale of the organisation’s
operations. For example, an NGO involved in operational work at the country level will
need to have detailed systems in place to deal with each component of a drug policy.
Ensuring that policies are in line with, and supportive of, national essential drug policies is
important. Partnership, collaboration and cooperation arc essential for successful policy
implementation.
For NGOs providing drugs or funding for drugs to partner organisations in other
countries, the policy may be based largely on the need to assess requests for funds and
evaluate the implementation of projects. A series of questions arc provided at the end of
the section that are designed to help NGO and other types of donors assess funding
requests using an essential drugs framework.
9
Developing Essential Drugs Policies A Guide for NGOs
Assessing needs
Drug policies should reflect overall health priorities and objectives. If drugs are provided
without knowledge of the national/regional policy it is possible that the aid provided will
undennine national policy or national regulations. In addition, an assessment of the
specific local health needs will determine which drugs are selected. If drugs are purchased
or provided without adequate knowledge of local health needs there is every chance that
money will be wasted on inappropriate drugs and incorrect dosages or quantities. The
WHO Action Programme on Essential Drugs (DAP) has details of all national drug
policies and publishes a regularly updated list of therapeutic guidelines and national
t
essential drugs lists. In addition information about simple methods of estimating drug
'
requirements can be obtained from the WHO-DAP. (See section 3 for details.)
Drug selection
As well as saving on costs, working with a limited list of essential drugs makes it easier both
to quantify needs and to procure and manage drugs more efficiently. Staff members arc
better able to understand the drugs they are prescribing because there are fewer of them.
The limited number also makes it easier for them to communicate this understanding to
each other and to patients. An essential drugs list provides a firm foundation on which to
introduce standard treatment guidelines, and for training and evaluation of performance.
National essential drugs lists, where they exist, should guide the choice of drugs. Where
no national list exists, the most recent version of \\'l Ill's !/«</<■/ I.isr of Dscntiiil Drugs can
be used (see section 4). Different levels of the health care system have different
requirements. Provincial or district-level facilities will require a fuller list whereas 20 or 30
drugs might be selected for use at the primary health care level. Where drug supply is
10
extremely limited, the
IO Emergency List can be adapted for use at the primary' level.
Details of this list can be found in WHO’s /Vra’ Emergency Health Kir (see section 4). These
two documents are invaluable resources.
Procurement
Choose Generics In general, drugs on the essential drugs list should be generic products;
any' exceptions to this rule should be justified. Generic drugs are no longer patented. Their
£ks and benefits are well understood because they have been tried and tested over many
^ars. Because they' are not sold under patent they are also usually cheaper than brand
name drugs.
I he use of generic names should be encouraged at all stages of procurement, distribution,
prescribing and use. I sing generic names avoids the possibility’ of confusion leading to
duplication ol active ingredients when several drugs are used at the same time. They also
simplify naming, enabling stall and patients to better recognise and understand the drugs
they use.
Bulk Packaging Bulk packages are much cheaper than small packs but they cannot be used
in all circumstances.
Location of Manufacture This can be a difficult problem for those involved in choices about
dnig purchasing. If a local industry is producing good quality drugs at competitive prices
then that may be a strong reason to purchase drugs locally. However, problems can arise if
either the prices are not competitive or if the quality’ of the locally produced products is in
doubt. Drugs which do not meet the required quality standards should not be bought
simply to support local manufacturing. Fortunately', a growing number of national and
• crnational NGO low-cost suppliers are an excellent source of reasonably priced drugs of
acceptable quality’.
Assessing quality
The quality ol drug manufacturing is difficult to assess anti requires the work of
professionals Some manufacturers, local or foreign, produce drugs uith little regard for
quaint or real costs. Poor control in the manufacturing process can easilv produce drugs
that do not meet acceptable standards. If the quality of drugs available on the open market
is not reliable and if insufficient attention is paid to quality assurance then substandard
di ugs may be bought u Inch could be dangerous and/or useless.
11
Developing Essential Drugs Policies A Guide for NGOs
Factory inspections and laboratory testing are part of systems to assure quality. Laboratory
testing has a useful role in quality assurance, but it is expensive, time consuming and often
the necessary facilities are not available. It is important therefore to incorporate other
aspects of quality assurance.
Get to know your suppliers and exchange information with other NGOs. Every effort
should be made to buy drugs from an established, experienced, low-cost supplier. This
may be a central medical store, a recognised NGO supplier or a reliable commercial
company. The WHO operates a certification scheme which can be used to obtain
information about manufacturers and whether or not a drug is used in the country' of
manufacture.
jjN
In general, it is risky to buy drugs on the open market especially from unknown suppliers.
It is useful to check where each drug was manufactured and ask to see a sample before
making a purchase. The quality of the labelling may’ help you to know whether the drugs
are fake or not - look out for slight spelling mistakes, odd looking addresses and extra
labels pasted over old ones. If you have any suspicions do not buy the goods.
Always inspect newly purchased drugs and carry out some basic tests to help identify'
substandard products. Re-check the labels and ensure that the following are clearly legible:
generic name, manufacture and expiry' dates, batch numbers, storage requirements,
manufacturer’s name and address. Check the contents for appearance, looking out for
breakages, discoloration, excessively powdery tablets or capsules, injection solutions that
are cloudy when they should be clear and so on. Staff should also identify' inadequate or
damaged packaging. Do die contents of the package look fit for use? Labels should be
checked to see if the generic name, the expiry date, and the name and address of the
supplier are legible. Is adequate information supplied?
Management, storage and distribution of drugs
n
Inadequate attention to the management of drugs can result in heavy financial losses.
Inventory mistakes leading to understocking or overstocking can be very' expensive. The
distribution network often develops in a somewhat haphazard way. With better planning
of storage points and transport, and with improved inventory' control and record keeping,
waste in terms of drugs and other supplies, transport and staff time can be kept to a
minimum. Donor NGOs can help to ensure that money on pharmaceuticals is well spent
by making sure that sufficient funds are allocated to management training activities.
12
Financing a sustainable drug supply
The cost of drugs and supplies can absorb between 20-40 percent of health budgets and
this is a recurrent cost which may require access to foreign exchange. Deciding how to
meet these costs is a high priority.
The first step should be to ensure that waste is reduced and that the best possible use is
made of the money available. Good assessment, procurement and distribution systems will
jgll reduce waste, as will education and training for prescribers and consumers and the use
Bf treatment guidelines.
If it is necessary to charge fees to recover drug costs and maintain a regular supply of
drugs, steps should be taken to ensure that access to care is not seriously inhibited. Often
those who are least able to pay are exempted from charges. Many NGO health
programmes have experience in administering revolving drug funds. Various options for
user charges and other mechanisms for co-payment can be considered. Pre-payment
insurance schemes can provide an alternative.
Controlling drug donations
It has become increasingly apparent during the past 10 years that donations of medicines
can create more problems than they solve. WTile some donations are generous and
appropriate, many arc sent without knowledge of the needs of the recipients or an
understanding of the conditions in which they will be used. In many cases, donated drugs
are unusable and therefore have to be destroyed. Getting rid of unwanted drugs involves
pharmacists or other personnel in dangerous, time-consuming incineration procedures as
Mell as in unnecessary costs.
Donations arc given in several ways. Some consist of unused drug samples and returned
prescription medicines which are collected by pharmacies in many European countries for
redistribution abroad as gifts. In addition, some national governments offer tax incentives
to companies donating medicines. Often these medicines are approaching their expiry date
when they arc sent as donations.
13
The Consequences of Inappropriate Drug Donations:
Two Country Examples
Developing Essential Drugs Policies A Guide for NGOs
Eritrea 1989 During the war for independence, despite the careful wording of
appeals, many inappropriate donations were received. Examples included seven truck
loads of expired aspirin tablets that took six months to burn and 30,000 half-litre
bottles of expired amino-acid infusion that could not be disposed of anywhere near a
settlement because of the terrible smell.
Former Yugoslavia 1994-1995 Of all the donations received by the WHO field &
office in Zagreb in 1994, 15 percent were completely unusable and 30 percent were•**
not needed. By the end of 1995, 340 tons of expired drugs were stored in Mostar.
Most of these were donated by different European nations.
• Guidelines for Drug Donations (WHO-DAP 96.2) •
Unfortunately, inappropriate drug donations are common. NGOs such as the World
Council of Churches and the International Committee of the Red Cross have led an
international effort to improve the standard of donated drugs. Recently WHO published
the Guidelines for Drug Donations that have been endorsed by many of the major
humanitarian organisations active in emergency relief. These guidelines are built around
four core principles:
• All donations should be based on an expressed need and unsolicited donations should
be discouraged;
• A donation should be given with full respect for the wishes and authority of the
recipient;
• There should be no double standards in quality. If the item is unacceptable in the
donor country, it is also unacceptable as a donation;
• There should be effective communication between the donor and the recipient.
These guidelines have been developed to be useful for both donors and recipients. NGOs
can promote their use and can incorporate the principles into their own drug policies. The
Guidelines can be obtained from WTIO-DAP (see section 4).
14
Drugs for use in emergencies
In an emergency, clear policy guidelines arc even more crucial. Supplying drugs in an
emergency requires care and detailed planning. It is very important that the drugs supplied
are the ones which are most needed. Inappropriate donations can cause confusion and
hamper the efficiency of an emergency operation. The use of special pre-packaged
emergency health kits may often be the most appropriate option for the period of the
emergency. Details of emergency kits are given in The New Emergency Health Kit (see
section 4).
Rational use of drugs
Making sure that die correct drugs arc prescribed, dispensed ami are used appropriately is
of great importance. Efforts put into making sure that essential drugs are available can be
wasted if the drugs are not properl}’ used. The essential drugs list, formularies and
therapeutic guidelines are important tools but they will have little impact unless they are
developed with the involvement of those who will use them and arc accompanied by
training, supervision and evaluation. Recent studies have shown that the quality' of
dispensing is often very poor. In many countries, prescribing and dispensing time can be
measured in seconds and often no time is taken to explain the drug and use with patients.
Monitoring how drugs are used can be easily assessed using methods described in the
WHO manual How to investigate drug use in health facilities (see section 4).
Appropriate labelling
All drugs should be clearly labelled in easily read print using the generic name. Labels
should be accompanied by clear and correct information for the prescriber, the
storekeeper/dispenser and the patient. The label should always include the expiry date.
Jabel information should be written in the local language or in another language
understood in the region. Sometimes getting translations of labels takes additional time,
but it will help ensure health workers know how to use the drags correctly.
Drugs procured for Georgia and Azerbadjan by Medecins Sans Frontieres were
relabelled in Russian by the International Dispensary Association (IDA) which supplied
the drugs. This involved a delay of about one month but it helped to ensure that
health workers knew how to use the drugs correctly.
• Information collected by Erik Schouten,
Medecins Sans Frontieres/Health Net International •
15
Developing Essential Drugs Policies A Guide for NGOs
Evaluating Funding Requests from NGOs
Some NGOs involved in drug supply provide funding to other NGOs. The questions
below are designed to help donor NGOs apply an essential drugs framework in evaluating
funding requests. These questions would be applicable and useful for any donor that funds
drug supply programmes or projects.
1. What is being requested and for whom?
2.
Has there been an assessment of needs?
3.
Do the requests match national or local essential drugs lists?
4.
Are generic drugs used wherever possible and are generic names used?
5.
How does the donor or the recipient assure the quality of the drugs?
6.
What level of expertise does the project's staff have?
7.
Would additional training or technical support contribute to better management
of drugs?
8.
Are there adequate facilities for storage and distribution of drugs?
9.
What will happen after this supply of drugs has been used?
10.
How will the recipients dispose of/destroy any unwanted or unusable drugs?
11.
How will the way the drugs are used be monitored?
12.
Are there ways in which the project can be helped to become sustainable?
13.
Is there a danger that the project might undermine the sustainability of other
existing projects?
16
Where to Obtain
Additional Information
comprehensive list of the many organisations working in this field cannot be given, but
^Kje following organisations (which are listed in alphabetical order) are a good starting point
for anyone working on essential drugs policies. Any of these contacts will provide support,
suggestions and information for NGOs involved in drug policy or the provision of essential
drugs.
Extra copies of this publication can be obtained from HAI-Europe.
CMC Churches' Action for Health/ World Council of Churches
The CMC works with church-related health institutions and NGOs involved in drug
supply and the promotion of rational use of drugs. CMC has worked towards the
rationalisation of drug donations and has developed guidelines for drug donations and
equipment donations.
—
CMC Churches' Action for Health/World Council of Churches
P.O. Box 2100
CH-1211 Geneva 2
SWITZERLAND
tel: (+41-22) 791 6061/791 6111
fax: (+41-22) 791 0361
and
The Pharmaceutical Programme
CISS International (Community Initiatives Support Services)
P.O. Box 73860
Nairobi
KENYA
tel: (+254-2) 729 095
fax: (+254-2) 711 918
17
Developing Essential Drugs Policies A Guide for NGOs
ECHO International Health Services
I'.CI l() is a non-profit, non-commercial, self-financing medical supply agency committed
to providing quality-assured, affordable medical supplies, essential drugs and new or
reconditioned medical equipment for health care programmes in developing countries and
for disaster relief.
ECHO International Health Services
Ullswater Crescent
Coulsdon
Surrey CR5 2HR
UNITED KINGDOM
tel: (+44-181) 660 2220
fax: (+44-181) 668 0751
e-mail: CS@ECHOHEALTH.ORG.UK
| '■
Essential Drugs Project
This organisation was set up by several UK NGOs to promote equitable access to essential
drugs and the rational use of all drugs. It provides support and advice to health agencies
and NGOs in the UK and collaborates with individuals, groups and networks
internationally on a wide range of issues.
Essential Drugs Project
77 Lee Road
Blackheath, London SE3 9EN
UNITED KINGDOM
tel/fax: (+44-181) 318 1419
e-mail: EDP@GN.APC.ORG
18
Health Action International (HAI)
11.•XI is a global network of health, development, consumer and other public interest
groups in more than 70 countries working for a more rational use of medicinal drugs. I I XI
represents the interests of consumers in drug policy and believes that all drugs marketed
should be acceptably safe, effective, affordable and meet real medical needs.
II/XI has three regional coordinating offices:
HAI-Europe
Jacob van Lennepkade 334-T
1053 NJ Amsterdam
THE NETHERLANDS
tel: (+31-20) 683 3684
fax: (+31-20) 685 5002
e-mail: HAI@HAI.ANTENNA.NL
HAI Clearinghouse/Action for
Rational Drug Use in Asia (ARDA)
c/o Consumers International
P.O. Box 1045
10830 Penang
MALAYSIA
tel: (+60-4) 229 1396
fax: (+60-4) 228 6506
e-mail: CIROAP@PC.JARING.MY
HAI/AIS Latin America
Oficina de Coordinacion AIS LAC
Aptdo. 41-128
Lima
PERU
tel/fax: (+51-1) 346 1502
e-mail: AIS@AMAUTA.RCP.NET.PE
19
Developing Essential Drugs Policies A Guide for NGOs
International Dispensary Association (IDA)
IDA was set up to support health care initiatives in developing countries on a non
commercial basis by supplying high-quality medicines and medical supplies at the lowest
possible price.
International Dispensary Association
Postbus 37098
1030 AB Amsterdam
THE NETHERLANDS
tel: (+31-20)403 3051
fax: (+31-20) 403 1854
e-mail: IDA_SALE@EURONET.NL
.
International Network for the Rational Use of Drtigs (INRUD)
INRUD works through research and training to promote rational drug use. It can provide
particular help for those wishing to develop research or training programmes. INRUD
does not supply drugs.
International Network for the Rational Use of Drugs
1655 North Fort Myer Drive, Suite 920
Arlington, VA 22209
UNITED STATES
tel: (+1-703) 524 6575
fax: (+1-703) 524 7898
e-mail: INRUD@MSH-DC.ORG
20
International Society of Drag Bulletins (ISDB)
ISDB encourages the development of high-quality, independent
information about drugs and therapeutics and supports the work of
independent drug bulletins all over the world. The organisation
provides training, information exchange and support for organisations
involved in information provision on drugs.
W
ISDB
P.O. Box 459
75527 Paris Cedex 11
FRANCE
tel: (+33-1)4700 3320
fax: (+33-1) 4700 2864
e-mail: ISDB@COMPUSERVE.COM
Management Sciences for Health (MSI!)
This non-profit organisation supports the development and
application of management principles in primary health care and
other medical fields. It works with government ministries,
international agencies, private organisations and local agencies in
more than 50 countries to find solutions to public health problems.
MSH has created a ‘Drug Management Program’ which works with
managers and policy makers in developing countries to develop new
systems and maximise therapeutic benefits while minimising costs. It
provides technical assistance and training in die areas of procurement,
logistics, rational use, finance and management information systems.
Management Sciences for Health
Drug Management Program
1655 North Fort Myer Drive, Suite 920
Arlington, VA 22209
UNITED STATES
tel: (+1-703) 524 6575
fax: (+1-703) 524 7898
e-mail: RPM@MSH-DC.ORG
21
Medceitis Suns Ijonticres (MSI')
MSI- focuses on relief in emergency areas. In addition, they produce several valuable
publications.
Developing Essential Drugs Policies A Guide for NGOs
Medecins Sans Frontieres
Max Euweplein 40
1017 MB Amsterdam
THE NETHERLANDS
tel: (+31-20) 520 8700
fax: (+33-20) 620 5170
L'nitcd Nations Children's Fund (UNICEF)
I XTCIThasI >een active in providing support to governments regarding the acquisition.
storage, distribution and rational use of essential drugs. The agency’s supply dis ision
organises the purchasing of such drugs at low prices.
UNICEF Supply Division
UNICEF Plads-Freeport
DK-2100 Copenhagen
DENMARK
tel- (+45-3) 527 3527
fax- (+45-3) 526 9421
e-mail. SUPPLY@UNICEF.DK
IVorld Health Organization (WHO)
Action Programme on Essential Drugs (DAP)
The Action Programme on Essential Drugs has played a major role in developing and
promoting the essential drugs concept. It works to promote the development of national
drug policies and to pros ide leadership and advocacy’ on dntg issues. The programme’s ^p
staff produces a wide range of materials.
World Health Organization
Action Programme on Essential Drugs
20 Avenue Appia
CH-1211 Geneva 27
SWITZERLAND
tel: (+41-22) 791 2111
fax: (+41-22) 788 0196
e-mail: DAPMAIL@WHO.CH
22
IKHO Division of Drug Mmiagcmcnt mid Policies (DMP)
This division is responsible for programmes in the areas of drug quality and information
on safety and efficacy.
World Health Organization
Division of Drug Management and Policies
20 Avenue Appia
CH-1211 Geneva 27
SWITZERLAND
tel: (+41-22) 791 2111
fax: (+41-22) 791 0746
23
Developing Essential Drugs Policies A Guide for NGOs
Key Resources
The following publications all provide information on various aspects of rational drug use
and essential drugs. Copies of the material should be requested directly from the publishers
listed. Unless noted, these publications are available only in English. /i price indication is
given when possible.
General
Managing Drug Supply
Management Sciences for Health (1997)
Available from Kumarian Press, Inc. 14 Oakwood Avenue, West Hartford,
CT 06119-2127, USA
This newly revised edition provides a complete overview as well as step-by-step
approaches on how to manage pharmaceutical systems effectively.
National Drug Policy
Report ofthe HT7O Expert Committee on National Drug Policies
Ref. no. WHO/DAP/95.9
WHO (1995); English/French; Available from WHO-DAP; Free of charge
The guidelines cover the major components of drug policy and are intended to provide Q
general principles and strategies that should be adapted to country needs.
Selection and Use
Estimating Drug Requirements. A Practical Manual
Ref. no. WTIO/DAP/88.2: VVTIO (1988); English/ French/Spanish
Available from WHO-DAP; Free of charge
The manual consists of eight training modules which explain the various steps necessary' to
estimate drug requirements.
24
The Use ofEssential Drugs. Model List of Essential Drugs
(Ninth List, Seventh Report of the WHO Expert Committee)
Technical Report Series No. 867; WHO (1997); English/ French (Russian and
Spanish versions to be published shortly); Available from WHO-DAP; Price:
fr. 15-/USS13.50, in developing countries Sw. fr. 10.50
The Model List is intended to guide the selection of dings in
situations where the need is great and the resources are small.
The list includes information on route of administration, dosage
forms, and strengths for some 300 essential drugs.
British National Formulary
jointly published by the British Medical Associauon and the Royal Pharmaceutical Society of Great Britain:
Available from the Pharmaceutical Press, P.O. Box 151, Wallingford, O.xon. 0X10 8QU, UK or from
booksellers. Low cost edition for developing countries available from TALC (Teaching Aids at Low Cost)
P.O. Box 49, St Albans, Herts, AL1 5TX, UK; Price: UK&5-/USS8.35 plus postage and packing.
This standard UK prescribing manual gives treatment guidelines and UK prescribing costs
of generics and branded medicines. It is published twice a year.
Clinical Guidelines Diagnostic and Treatment Manual
^Piiecins Sans Fronticrcs; English/ French/Spanish/Russian/Arabic/Portuguese
Available from MSF-Thc Netherlands (sec section 3); Price NLG 25-/USS 12.50
Guidelines to Rational Drug Use
von Massow, Ndele, Korte
Macmillan (1997); Available from TALC, P.O. Box 49, St Albans, Hens, AL1 5TX, UK or from
booksellers; ISBN 0-333-69922-X; Price UKS6.95/USS11.61
Standard treatment guidelines and cost comparisons for essential drugs for developing
cquntry use.
25
Problem Drugs
A. Chetley; HAI/ZED Books (1995); Available from Health Action International (see section 3);
English/Spanish (French and Russian versions to be published shortly); Price: NLG 40-/USS20; reduced
rates for groups in developing countries
Covers 10 categories of medicines which are commonly used inappropriately. It contains
detailed information on the “problem drugs’’ currently being marketed together with
Developing Essential Drugs Policies A Guide for NGOs
recommendations for action.
How to investigate drug use in health facilities; selected drug use indicators
r
<Jnler no. 1930049; WHO (1993); F.nglish/French/Spanish
Variable from WHO-DAP(see section 3)
I he manual describes a simple standard methodology for gathering essential data on drug
use patterns and prescribing behaviour in health facilities.
How to investigate drug use in communities
Ref no. WHO/D \P/92.3. I lardon. Bnidonjakolxmicz. Reelcr
WHO (199J); English/French: bailable from WHO-I) \ P (see section 3)
This guide provides simple research methods to identify problems in the provision and use
of drugs at the communin’ level.
Supply and Marketing
MSH International Drug Price Indicator Guide
Produced annually by Management Sciences For Health (see section 3)
Single copies available free of charge
A regularly updated list which provides an indication of die current generic prices from
non-profit suppliers on the international market.
26
The New Emergency Health Kit
Order no. 1930018; Wl II) (1990); I nglish/Spanish/French; Available from WI IO-DAP (sec section 3);
Price Sw.fr.8-ZL'SS2.86. in developing countries S« .fr. 5.60
This booklet provides information on the development of the kit, now adopted by many
organisations as a reliable, inexpensive, appropriate and quickly available source on the
essential drugs anti equipment urgently needed tn a disaster situation. It provides a
description of the kit's contents, treatment guidelines and some useful checklists for
suppliers anti users.
Guidelines for Drag Donations
Interagency ( iuitleliiics. Ref no. \VI IO/D \PZ‘>6.2; \\ I II) (I*>96); I nghshZ I-’remhZRussianZSp.mish.
\vailable from \VI IO-D \ P (sec section 3)
Free of charge
WHO has developed these Guidelines in collaboration with the major relict organisations.
They can help both donors and recipients to maximise the potential benefits of drug
donations.
Guidelines on Equipment Donations
CMC Churches’ Action for HcalthAVorld Council of Churches.
zXvailable from CMC (sec section 3); EnghshZFrenchZSpanishZPortuguese
Developed to help donors and recipients maximise the potential benefits of donations of
medical equipment.
Ethical Criteria for Medicinal Drug Promotion
WHO (1988), Arabic/Chinese/English/French/Russian/Spanish; Available from WHO-D.XP (see section
3); Price: Sw.fr.. 8-/USS2.86. in developing countries Svv.fr. 5.60
The criteria give manufacturers, prescribers and NGOs a framework to ensure that
promotional practices are in keeping with acceptable ethical standards.
27
E-Drug electronic conference
Today approximately 700 health professionals have subscribed to this electronic network
that focuses on essential drugs and related topics. No costs are involved and interested
individuals can sign up by sending an e-mail message to:
MAJORDOMO@USA.HEALTHNET.ORG
Developing Essential Drugs Policies A Guide for NGOs
with the following text in the body of the message:
subscribe e-drug <your e-mail address>
The subject heading should be left blank.
Newsletters
Contact
This bi-monthly publication highlights various activities on rational drug use and often
contains full reprints of new guidelines and other material. Subscription information
available from: CMC/Churches’ .Action for HealthAVorld Council of Churches (sec
section 3).
English/French/Spanish/Portuguese
The Essential Drugs Monitor
Published by WHO-DAP, this newsletter provides information on essential drug activities
by governments and NGOs. Copies available from WHO-DAP (sec section 3).
English/French/Spanish/Russian
HAI News
®
This publication reports on issues related to rational drug use and includes summaries of
work carried out by members of the international HAI network.
Subscription information available from HAI-Asia/ARDA (see section 3).
HAJ-Lights
This quarterly newsletter focuses on news affecting HAI groups and interested health and
development NGOs working on rational drug use in Europe.
Subscription information available from HAI-Europe (see section 3).
28
Essential drugs policies based on the WHO
concept enable NGOs to use their limited
resources to manage drugs
effectively and meet priority needs.
An essential drugs policy can help NGOs
provide improved information, education
and training, as well as more efficient
supply, storage and distribution of drugs.
While many NGOs have advocated the
adoption of the WHO essential drugs
concept by governments, only a few have
integrated it into their own practice.
This booklet aims to help change that. It
offers practical advice for NGOs interested
in developing and implementing essential
drugs policies for their organisation.
HAi
Hoalth Action International
W-i_.
From:
To:
Sent:
Subject:
Aviva” <aviva@netnam.vn>
<"oha-exchange@kabi"@healthnet.org:
Tuesday, February 24, 2004 3:33 PM
PHA-Exchange> WHO launches intellectual property commission
WHO launches intellectual property' commission
The World Health Organisation ( WHO) has announced details of
a new commission that aims to analyse how intellectual
property rights affect the creation of new drugs against
'diseases of poverty' in the developing world.
The Commission on Intellectual Property' Rights. Innovation
Public Lisultb ^ClPIPly will bs isd by Jbutb IDrsifbss,
former President of Switzerland, The vice-chair will be R. A.
Mashelkar, di rector-general of India's Council of Scientific
and rhuustnai Researcn.
Leading economists, lawyers, medics, industry'
representatives and scientists from across the globe make up
the remainder of the 10-person committee (for full list,
chck here).
The pharmaceutical industry has welcomed the announcement. A
statement from the International Federation of
Pharmaceutical Manufacturers Associations, which represents
more thait60 national indusiry organisations, says that the
Commission is "soundly positioned to delve into issues of
intellectual property, its interfaces and linkages with
pharmaceutical innovation and public health".
The Commission, which has been set up at the request of last
year's World Health Assembly, will review existing research,
development and innovation efforts directed at diseases that
affect the poor. It will then consider how effectively
intellectual property regimes and other incentive anu
funding mechanisms are stimulating research into new
Governments, UN bodies, other international agencies and
private sector and civil-society organisations will be
consulted in drawing up the report, which will be presented
to the WHO Executive Board in January 2005.
r .'nV to terms of reference of the Commission
hup://www.who.int/'gb/EB Wri/‘vPDF/EB 113/eeb'l 13idl.pdf
PHA-Exchange is hosted on Kabissa - Space for change in Africa
2/25/04
M- 1i’/iain identity
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vsnl.com>
Re: I nanK you once aoam with a oicture
1 hat s wnnt people sometimes say about the bavarian sky'..
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Page 1 of 1
community health cell
From:
To:
Sent:
Subject:
"sahajbrc" <sahajbrc@icenet.co.in>
<pha-ncc@yahoogroups.com>: "ctddsf" <ctddsf@vsnl.com>
Friday, March 11, 2005 7:33 PM
Re: [pha-ncc] URGENT: JSA Presentation on issues relating to health rights at the national level
Amit,
You can add that price control of some form or the other is the norm in
most countries -with examples etc.(sec below from Gulhati's article.) Also
you may need to address the argument that we will have universal health
insurance and therefore diluting price controls does not matter.
Chinu
United States: Nearly every one is insured against illness. Cost of drugs
are reimbursed by insurance companies who keep an eagle's eye on both,
prescriptions and prices. If a doctor is found to be unnecessarily
prescribing high cost drugs when cheaper alternatives are available, he can
loose insurance business. This in effect means he will have to give up
profession. Similarly, manufacturers cannot charge more than what they are
charging in other countries.
i> United Kingdom: The entire medical costs are met by the Government through
National Health Sendee. Manufacturers have to negotiate prices with the
government, in fact the price control is more rigorousjnjEngland than India
because there is only one buyer. The NHS pays substantially discounted
„ prices on ail medicinesTTor example Buscopan is sold to NHS at a discount
of 42% over the MRP. In any case, individual patients are not concerned.
Belgium (as an illustration of European Community countries): Every
resident, including foreigners, get total reimbursement of all medical costs
from three government-controlled "mutuelle" vvhu^onipelewvitfi-eavh.other but
‘ ibeir annual subscriptions are decided by the state and are most reasonable.
The effectiveness of the above measures can be gauged from the fact that US
Government is currently prosecuting Glaxo Smith Kline for billion of dollars
for overcharging on ranitidine and thus~" cheating USa.
On the other hand in India, the^entire system is based on MRP. What about
the transfer prices from a related manufacturer or on loan license? There
are cases where there is huge difference between the transfer price (price
charged by actual manufacturers/loan licensees to the marketers/manufacturer
and the MRP
Gist of the Makapur Committee Report on Medicines Purchase and supply
for the Government Health Care Institutions in Karnataka
Terms of Reference:
To study the existing set-up, functions and working of the Government Medical Stores and
makes specific recommendations with reference to the following:
(1) Qualification of drug requirements (including the basis on which the quantities required
are to be assessed).
(2) Procurement and inventory management (including records to be kept computerisation of
inventory control, scheduling of purchases and minimum and maximum stock limits to be
maintained in respect of each drug).
(3) Distribution of drugs to the Districts (including whether the delivery system or collection
system to be followed and in case of the former, whether such delivery is to be done by
the Government Medical Stores or the R.C. holders).
(4) Establishment of Sub-stores at the District/ Division level (including whether the sub
stores should only act as a storage and distribution centre ad the present system of
centralised procurement should continue or whether the sub-stores should directly
procure the drugs from the R.C. holders as per the local requirements and settle the bills
on the basis of funds released by the Directorate).
(5) Storage requirements with reference to legal/licensing conditions and the estimated cost.
(6) Staffing pattern and training requirements (financial implications should be assessed in
case additional staff is proposed).
(7) Stock and issue Registers to be maintained in the hospitals/centres/institutions and how
lire public is to be kept informed about the drugs available in stock.
(8) Whether the present financial limits for supply of drugs to the various institutions needs
to be enhanced and if so to suggest the enhanced financial limits together with the
additional requirement of funds.
(9) Any other matter incidental to or arising from any of the above terms.
Process adopted: Apart from Internal discussions Discussion with users; select District Level
administrative Health Officers and Personnel from GMS. Visit to Tamil Nadu : discussion with
officers of the Tamil Nadu Medical Corporation, visit to district sub -stores and select hospitals
Highlights of the report:
The Report has three main parts: Part 1 reviews and identifies the deficiencies in the existing system
of the Medicnes procurement and supply Part 2 reviews the existing system in the Sate of Tamil
Nadu Part 3 consists of the recommendations of the committee.
Annual identification of the List of Drugs and Its formulation by an expert committee, which
includes the Drugs controller and other specialists. The WHO List of essential drugs, and the
GO1 List to be utilised.
2. Superfluous staff in Group C and Group D; Computerisation of supply orders, receipt of
drugs, issue of drugs, collection of vouchers and payment to suppliers; District level
warehouses for storage and supply of drugs.
3. Deficiency in the Quality control mechanism of drugs
4. The following specific deficiency has been noted:
1.
5.
a) Delay in finalisation of list of drugs, tender process and of Rale contract.
b) Non-receipl of drugs requirements from all indenting institutions and thereby drugs
requirements not quantified in the lender process.
c) The busy Director not able to give required attention.
d) Moderate delay in finalisation of Rate contract
e) Delayed purchases due to non-receipt of requirements / indents.
f) Manual inventory system
g) Inadequate storage facilities
h) Year end purchases by ZP
i) No uniformity in ZP purchases
j) All required drugs not in Rate contract
k) Delay in release of budget to the District Surgeons and other Health Care Institutions.
Recommendations:
a) Restructuring the organisation (Upgradation of the post of the Joint Director to
Additional Director and providing additional staff - computer operators; Independent
quality control wing)
b) Recommendations regarding the job responsibilities of the staff of the GMS
c) Procure and management of Drugs - formation of the therapeutic committee, Tender
evaluation committee and empowered committee; functions and responsibilities
defined
d) Estimated requirements to be specified in the tender document with a permitted
variation of 25%; commensurate with the manufacturing capacity orders to be placed;
Generic name drugs to be identified and listed to enable the purchases if any to be
made even outside the Rate contract. Committee recommends a list of the drugs
following the pattern in Tamil Nadu.
e) Procurement of Drugs: Calendar of events recommended Listing of drugs (August) to
Issue of GO by March
I) Tender Process deatiled
g) Procurement and distribution mechanisms: Establishment of District Warehouses
(rental or other wise); equipped
h) Distribution of Drugs: Introducing the Pass Book System in duplicate - one with the
Health Institution and one with the Warehouse;
i) Inspection of the District warehouse
j) Licensing of the Institutions who store and distribute drugs
k) Recommendations regarding Inventory management
1) Finances: recommendations for Change of the proportion of Medicine finances
handled - 90% GMS 10% Individual institutions or 10% Individual Institutions 50%
by DHO for ZP only by Rate Contract and stored at District Warehouse - ZPs and
>100 Beded Institution; 100 beded Inslituions - 60% taken back to GMS; Instituions
outside the ZP 90% by GMS; PHUs to be made indenting instituions; Increase in Drug
budget by 20% The additonal allotment is reserve and is justified and recommended
by higher authorities.
m) Expected expenditure is Recurring Rs. 2,20,39,000 and Investment costs Rs: 43,60,000
n) Quality control: establishment at GMS and 1.5% invoice value from the suppliers
o) Training programme
IMail - Print
I '
from
FMRAI <fmrai@vsnl.net>
date
Thu, 22 Ju! 2004 17:58:17 +0530
to.
subject,
Page 1 of2
Janswathya Abhiyan <pha-ncc@yshoogroups.com>
[pha-ncc]
□ear A!'
Giving below a scotch aboout our position on the drug policy which may be presented before the Ministry. This is a pruned
thinking which may be remodelled based on the suggestions of JSA meeting and then it may be made specific on each
points. This is being proposed for discussion in the JSA meeting at Bhopal.
Pharmaceutical Policy:
Last couple of years Govt, has taken executive decisions in rapid successions for which the first Drug Policy,
1978 has been thoroughly changed. The political good v/ill under which Drug Policy, 1978 was developed is wiped away
making the basic tenant of the policy redundant. Present status of the policy reflects virtually scant Govt, control and add
this unwillingness of the past NDA Govt to implement whatever left in the policy has created an anarchy in the
:aceutical field. It is , therefore needed to prepare and adopt anew policy in the new global regime keeping interest
the foreground.
xcepting industrial part of the policy, all other area should come under the purview of the Health Ministry.
ction of drugs of National Essential Drug List (EDL), quality assurance, Drug Laws etc., should be the exclusive
onsibility of the Health Ministry. Issues like drugs prices may be the
esponSibility of the Ministry of Chemicals and Fertilisers and the Ministry of Health.
Govt, used to monitor production of 93 bulk drugs. In order to ensure availability, the Govt, should monitor al!
drugs which come under national EDL. Govt shall publish production status of all these drugs at least once :r. a year
Govt, should also establish a cell to estimate need of all the drugs under EDL and should explore shortfall in indigenous
production to determine import requirements or expansion of indigenous production. Public sector pharmaceutical units
should be given priority for production and a policy to revive this sector should be developed.
A national authority should be constituted for developing policy and monitoring should be prepared which should be
provided with statutoiy power.
National Essential Drug List:
The EDL shops should be prepared by an expert committee every after three years. Experts from different fields
of medical profession, consumers, etc.
The list should be popularised with a guideline of use Standard Treatment Guideline) among the users. Its use
should be mandatory among Govt., Public Sector Units and for use in reimbursement or for insurance coverage. Drugs
under the list should be priced low. Industry should be given incentive for production of these drugs. Prescription of
these drugs should be made in generic names.
Quality Control!:
Drugs & Cosmetics Act should be amended to ensure quality control. Stringent punishment should be enacted
for violation of quality norms. Drug testing laboratories should be established by the Govt, in each states. Consumers of
Consumer organisations should be allowed to directly test any drug with doubtful quality with minimum charges in these
laboratories. Separate vigilance cell should be created under
Drug Control machinery to watch quality of medicines.
Irrational and Hazardous Drags:
All irrational and hazardous drugs should be withdrawn. Registration system needs to be revamped. All drugs
should be re-registered within a regular interval for establishing their therapeutic validity.
Research aiad DevelopmeEt:
Govt, should involve the research establishments of its own with adequate fund and encourage them for developing cost
effective precess technology. Any private company which develops new molecules should be encouraged for marketing
-their drug
in the domestic market at cheaper price. Only with this condition, they may be given grants from the Govt.
. he Govt, should abolish Loan/1 hird Party License system.
Ail drugs under EDL shall be price controlled. Control of price of other drugs should also be covered and mark
up shall be kept low based on the annual turnover.
Providing of cost data by the manufacturers should be mandatory. Any violation of price fixed shall be entitled to
r..Tp://63.95.239.85:3383/Xaead9c9b99cfc9cb9c97f56882/print.39299.cgi?mbx=Main&msgsort=15&ms...
23/07/fX
Page2of2
[Mail-Print
sever punishment.
Prices of imported drugs should also be controlled based under the import price documents. Imported medicines
may draw more duties than indigenously produced drugs.
Wholesale and retail margins should be determined by the Govt, which should be strictly followed. Like over
pricing, under pricing should also be disallowed, incentive, trade bonus should only be allowed in such a manner that
would finally reduce prices to the consumers.
Prices of medicines should be net of taxes and shall be uniform all over the country.
Setup like NPPA should be strengthened with sufficient staff and statutory pov/er.
Pharmacy Act:
Pharmacy Act should be amended so that each shop employ full time qualified pharmacist. More pharmacy collages
should be established to produce adequate number of qualified pharmacists. Preference should be given to qualified
pharmacists for granting license to open retail chemist shops.
Phsrmacenittcal Authority:
A national Pharmaceuticals Athority should be constituted for monitoring production, selection of drugs, pricing,
monitoring research, withdrawal of drugs. This committee should include experts from medical practitioners, industry,
consumers, academics.
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?.up://63.99.209.85:8383/Xaead9c9b99cfc9cb9c97f56882/print.39299.cgi?mbx=Main&msgsort=15&ins...
23/07/04
JUST PUBLISHED!
World Health Organization
Regional Office for Europe
The EuroFterm TooOfe©^
A CD-ROM for professional
management
To implement a new professional service a lot of
choices have to be made. This interactive education
tool provides a step by step approach to developing
national implementation plans for professional
programmes. Generalized from the EuroPharm
pharmacy-based service programmes, the CD-ROM is
designed to stimulate and support practicing
pharmacists, health professionals, universities and
pharmacy schools as they disseminate and implement
best practices in any type of public health services.
The CD-ROM toolbox collates ail the EuroPharm Forum
model programmes and includes four central elements,
i.e. a fictive case study, a real case study, the Forum
guidelines and instruments, and country materials.
The fictive case study is a combination of theory and
practice. Subjects like defining goals, implementation
barriers, risk analysis, activity plan, communication
plan, individual motivation plan and feedback are
presented and, together with the EuroPharm models,
used to create a guide to managing and implementing a
best practice programme at national level. The patient
education campaign Ask about your medicines is used
as an example to explain the programme and guides
the user through the process of adapting the campaign
model to the specifics of his country and takes him
through all the stages of developing and implementing
such a project.
By Willem de Boer, Kirsti Bult, Eeva Terasalmi,
Marja Airaksinen, Th. F.J. Tromp, Maaike Smit,
and Ida Gustafsen
2005, CD-ROM, English
CHF 100.00/US$ 90.00/EUR0 65.00
In developing countries: CHF 70.00/US$ 63.00
Order no.: 13400058
EumPharm Forum is a joint network of national
pharmaceutical associations and the World Health
Organization Regional Office for Europe
The real case study for inspiration and motivation is
from Finland. It describes the development and use of
the Ask about your medicines campaign as a tool for
professional change, focused on longterm goals, as
well as objectives and consistent leadership to
overcome the barriers that most likely will appear in the
process.
The EuroPharm Forum material includes specific
practice-oriented programmes within tobacco control,
diabetes care, asthma care, hypertension management
and patient education, and more general instruments
like the communication plan and the feedback system.
The country material includes theories and models
used in the EuroPharm Forum member countries and
shows for example how the Forum instruments have
been used in the specific countries.
Publications
WHO, WHO Press, 1211 Geneva 27. Switzerland
Tel +41 22 791 24 76 - Fax +41 22 791 48 57 - Email: publications@who.int
Web site: http://www.who.int/bookorders
Contents
Introduction
Reasons for developing the product and how
to use it.
4.
Part A
1. How to develop the implementation of the
patient education campaign QaM
- A case study on project management
- Theory: Enabling stage
- Theory: Promoting stage
- Theory: Willing stage
- Theory: Doing stage
Part B
Theory and models used by EuroPharm
Forum but not explained in part A (edited
by the project group)
- EFS (feedback system)
- WebBoard conferences
- Cycle of project development and management
2.
-
Annex
EuroPharm QaM 1993
EuroPharm QaM update 2004
Additional theoretical materials
- Communication plan EuroPharm Forum
- Theory about indicators
- Material Holland and Nimmo
- Text about leadership and team
building
- Presentation
Part C
Theory and models used within the
EuroPharm Forum projects
- About the Forum
- Asthma services
- Smoking cessation
- Diabetes care
- Hypertension management
3. Additional examples of QaM practices (best
- Pharmacists and HIV/AIDS
practices)
- Twinning
- Case Finland
- Declarationsand resolutions
- Questionnaire about legislation from
Finland
Part D
Theory and models used in member
countries (unedited material)
ORDER FORM
|
| Please send me____ copies of The EuroPharm Toolbox
CD-ROM at the price of CHF 100.00/US $90.00/EURO 65.00;
In developing countries CHF 70.00/US$ 63.00/EURO 45.50
(order no. 13400058)
Payment enclosed
Please charge to my credit card
Visa
Cl American Express
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Eurocard/Access/Mastercard
Card no.
Name
Expiry date
Address
Date of order
Signature
Tel./Fax/E-mail
Order online: http://www.who.int/bookorders
WHP.EUR.058
WHO, WHO Press, 1211 Geneva 27, Switzerland
Tel +41 22 791 24 76 - Fax +41 22 791 48 57 - Email: publications@who.int
Web site: http://www.who.int/bookorders
Indian Express, 26th December, 1994
Marginal rise in
drug price likely
EXPRESS NEWS SERVICE
BANGALORE
HE government and the
drug manufacturers antici
pate a marginal increase in
the prices of drugs and phar
maceuticals soon, following the
implementation of the modified
drug policy of the Centre. The
increase in drug prices is also
attributed to the entry of multi
national companies in a big way.
T
abnormal increase in drug prices,
either due to the new policy or
due to GATT proposals, he said
the government had the powers to
impose price control measures on
the drug industry if the latter
resorted to unreasonable increase
in prices.
POLICY NOT HELPFUL: Kar
nataka State Drugs and Cosmetic.
Manufacturers Association Presi
dent Jayaprakash Mady com
plained that the new policy had
fallen short of expectations of the.
The indication to this effect was pharmaceutical industry.
According to him the industry.
given at a seminar on “Consumers
and the New Drug Policy” orga-, will face a crisis due to restrictive
nised by the Consumers Rights, measures regarding pricing of
Education and Awareness Trust ,. drugs. “The indigenous drug in
(CREAT) here on Sunday. Assis dustry will have to give up re
tant Drug Controller B G Prabha search and development activities
kumar said the prices of drugs’ as they will be starved of funds
which by and large had remained besides facing a stiff competition
stagnant since the last few years from multi-national companies,”
may increase marginally. Howev Mr Mady said.
According to him the net pro
er, he ruled out the possibility of
abnormal increase in the prices of fitability of drug industry was
drugs as feared in some quarters. below four per cent and the prices
Under the modified drug policy of drugs in India are cheapest in
adequate care has been taken to the world. “To invent a new drug
check the drug prices he said, Rs 250 crore is needed over a
adding that the National Phar- period of 10 years and this will not
amaceuticals Pricing Authority to be possible in the new world trade
be constituted shortly, will be order” he added.
Mr.Mady urged the govern
entrusted with the task of fixation
of drug prices. ■
ment to review the revised policy
to make it more realistic and
NATIONAL DRUG AUTHOR flexible.
CONSUMERS NEGLECTED:
ITY: Mr Prabhakumar disclosed
that the modified drug policy also Dr' Shiradiprasad Tekur of the
envisages creation of a National Community Health Cell said the
Drugs Authority (NDA) the bill drug policy and the drug industry
on which is pending before Parlia have failed to take the needs of’
ment. The proposed authority consumers into consideration. He
which will have the task of im alleged that the drug industry, is
plementing and supervising the ionly-profit oriented and has failed
policy effectively will also include to manufacture drugs badly re?
quired for people suffering from
consumer representatives.
However, he was sceptical ab tuberculosis, anaemia ‘and malar
out early functioning of the au ia, which are rampant in rural
thority as personnel, including apeas. He criticised the new policy
400 drug inspectors, needed to be for being silent on irrational and
recruited. Allaying fears about an hazardous drugs.;.
Social Audit Limited
9
medico friend circle
[organization & bulletin office]
320, V Main, 1st Block
Koramangala, Bangalore-500034
Poland Street London W1V 3DG
Tel: 01-734 0561
PRESS STATEMENT
DRUG DIPLOMACY
Decoding the conduct of a multinational
pharmaceutical company and the failure
of a Western remedy for the third world
A new report from Social Audit
"Senior scientists in the US multinational pharmaceutical
company, G.D. Searle, have consistently misinterpreted or
misunderstood vital evidence about the hazards of the drug
Lomotil for young children."
"Searle has promoted its drug Lomotil for the treatment of
infants in the third world — though forbidden by law to
do so in the US, since 1973. An overwhelming consensus of
informed, independent medical opinion holds that Lomotil
should not be used to treat children — and that it is
potentially dangerous to do so."
"Searle has defended its promotion of Lomotil for infants
with evidence from clinical trials — most of which is
irrelevant, and much of which is shockingly bad."
These and other charges are made in a new book,
Drug Diplomacy, published today by the British
action-research group, SOCIAL AUDIT. The book is
co-authored by Charles Medawar, Director of SOC
IAL AUDIT — and by Barbara Freese, now a senior
year undergraduate student at the University of
Minnesota.
Drug Diplomacy examines the allegation that West
ern and other drugs "are undermining public health
in the developing countries". It does this mainly
by looking meticulously at the evidence for and
against Searle's product Lomotil. Drug Diplomacy
also gives a detailed account of recently-ended
negotiations between SOCIAL AUDIT and Searle —
after which the Company agreed to radically revise
its marketing policies for Lomotil, throughout the
world.
A Non-Profit Making Company
Registered No. 1042193 England Registered Office: 18 Victoria Park Square, London E2
Chairman: Christopher Zealley Directors. Andrew Phillips Charles Medawar William Osborn USA Oliver Thorold
Anthony Sampson Secretary: Maurice Frankel
Associated with Public Interest Research Centre Ltd
2
SOCIAL AUDIT'S negotiations with Searle ended
when the US Company's top scientists and public
relations staff came to London, to tell SOCIAL
AUDIT that Searle would no longer recommend the
use of Lomoti1 for children aged under two
and to say that the Company would revise its
prescribing instructions for physicians, world
wide, to bring them into line with current US
recommendations.
But SOCIAL AUDIT is far from satisfied with this.
According to Medawar: "to see this as a happy
ending is to miss the point almost completely.
The point here is not that reason won the day.
It is that normally, companies like Searle seem
ever ready to abandon reason, and even to pursue
ignorance in the search for corporate bliss."
Medawar went on to explain why SOCIAL AUDIT rem
ains "profoundly unhappy" about the present sit
uation :
"One. This Company's senior scientists
continue to stand by evidence from
clinical trials — most of which is
irrelevant and much of which is shock
ingly bad. Anyone who can add, subtract
and divide would be appalled that Searle
could ever have relied on such data —
and will be extremely disturbed to know
that the Company apparently still does."
(See pp. 31 - 44 and p. 32).
"Two. This case-history clearly suggests
that comparable, conspicuously poor evid
ence is widely accepted at face value. It
is alarming that government drug regulatory
authorities should have licensed the use of
Lomotil for infants, when the evidence in
its favour is so dubious — and when the
evidence against is so strong. Even the
World Health Organisation — which hardly
ever criticises named products — has
stated that Lomotil, and other antidiarrhoeal
drugs like it, are of 'no value' and 'are
dangerous in children." (See pp. 11 - 13).
3
"Three. Lomotil has this disastrous effect
in developing countries in spite of the
fact that it is a pharmacologically reput
able drug. In theory, at least, Lomoti1
represents an improvement on the thousands,
rather than hundreds, of other Western drugs,
whose effect in developing countries is
mainly to turn things from very bad to very
much worse." (See pp. 50 - 56).
SOCIAL AUDIT is looking to the World Health Organ
isation to control abuse by multinational pharma
ceutical companies in the third world — though
with obvious misgivings. SOCIAL AUDIT in fact
suggests that the WHO "may not be equal to this
elementary reform of world health". The report
Drug Diplomacy strongly suggests that the WHO's
very existence would be jeopardised by business
and national interests, if it tried to do so. (See
pp. 57 - 63) .
NOTES FOR EDITORS AND REVIEWERS
The SOCIAL AUDIT report was largely researched by a
young American student, Barbara Freese (21), who
worked with SOCIAL AUDIT during a "junior year abroad"
in 1981. Drug Diplomacy was largely written by Charles
Medawar, who supervised Freese's work — which was
undertaken in part-fulfilment of a 4-credit course on
"International Relations". Freese had been directed
to SOCIAL AUDIT by Ralph Nader — for whom Medawar
worked in 1971, and who remains a keen and active
supporter of SOCIAL AUDIT'S work.
SOCIAL AUDIT is an independent, non profit organisat
ion, concerned with improving government and corporate
responsiveness to the public generally. Its concern
applies to all corporations and to any government,
whatever its politics. SOCIAL AUDIT acts as the
publishing arm of PUBLIC INTEREST RESEARCH CENTRE
LTD — a registered charity, whose work has been
supported by the Joseph Rowntree Social Service and
Charitable trusts, the Social Science Research Council
the Ford Foundation and other sponsors. This project
was supported notably by the British welfare group
WAR ON WANT and by the INTERNATIONAL ORGANISATION
OF CONSUMERS UNIONS.
4
Drug Diplomacy is available from SOCIAL AUDIT at
9 Poland Street, London W1V 3DG. Price: £3.95
plus 35p p&p in the UK. (Elsewhere, add 55p for
surface mail to all countries. For air mail post
add 90p in Europe and £1.80 for other countries)
Further information from:
In the UK:
CHARLES MEDAWAR on
VIRGINIA BEARDSHAW
01 734 0561
01 734 0314
In the US:
BARBARA FREESE
612 934 4813
on
(S.1/2/82)
< ■■■:■ ■/' o- ><;5
•l£l {
(- - pj
BO
_____ —- - ,
v-fii-
PHARMACEUTICALS (MONOCOMPONENT PRODUCTS)
Product name
Sulfaguanidine
C A.S number
57-67-0
121
and common names, and synonyms
BENZENESULFONAMIDE. 4-AMINO-N-(DIAMINOMETHYLENE)N-AMIDINOSULPHANILAMIDE MONOHYDRATE
N1 -(DIAMINOMETHYLENE)SULFANILAMIDE
SULFAMIDINUM
SULGINUM
■
lronoiac>.
ric>ed iofi
^‘Sang'J
i’^J^i.latlve or regulative action
over 25 1
idencg ‘ .Ql/counlry
led’io'-r
of this
DOM
d Iron, ’
te also''
i Drug '
4
'^/IRN
Effective
Date
Description of action taken
grounds lor decision
June 1971
Prohibited for import, manufacture, distribution, storage, sale or medical prescription. It has
been found to be ineffectual in the treatment of acute bacterial dysentery and in therapeutic use
with colon surgery in reducing hospitalization Furthermore, it has been shown that most strains
of Shigella have developed a resistance against this drug in vivo.
1972
The Ministry of Health has prohibited the importation and production of all drugs containing
sulfaguanidine.
THA
Jan. 1975
TUR
4 Mar. 1985
May only be used in the treatment of diarrhoea.
Banned for production and sale having regard to severe adverse reactions.
Withdrawn from the market by the manufacturer
DNK
Not approved for use and or sale Compound currently under study.
VEN
WHO comment: Sulfaguanidine, a sulfonamide anti-mfective agent, was introduced in 1941 for
the treatment of bacterial infections The importance of sulfonamides has subsequently de
creased as a result of increasing bacterial resistance and their replacement by antibiotics which
are generally more active and less toxic Although sulfaguanidine. which is poorly absorbed
from the gastrointestinal tract, is no longer recommended in some countries, it continues to be
used m others for the treatment of local intestinal infections, including bacterial dysentery, and
for pre-operative bowel preparation.
■ise
1 of
a)
os
in
Product namo
Sulfamethizole
C.A S number
144-82-1
Scientific and common names, and synonyms
BENZENESULFONAMlOE J-AMiNO-N-(5-METHYL-1.3 4-THIAOIAZOL-2-YL)NH5-METHYL-1 3.4.THlAOlAZOL-2-VLhSULPHANILAMlOE
N1 -(5-METHYL-1 3.4- rHIAOlAZCL-2-YL)SULFANILAMINE
illative or regulative action .
’
Country
Effective
Date
SWE
i Feb. 1984
Description of action taken
grounds for decision
Withdrawn following discussions between the manufacturer and the National Board of Health
and Welfare. A combination of adverse reactions and low sales led to this decision.
WHO comment: Sulfamethizole. a sulfonamide anti-infective agent, was introduced in 1953 for
the treatment of bacterial infections. The.importance of sulfonamides has subsequently de
creased as a result of increasing bacterial resistance and their replacement by antibiotics which
are generally more active and less toxic. However sulfamethizole. which is rapidly eliminated,
retains a place in the treatment of urinary infections in some countries whereas in others its use
has been discontinued
Legislative or regulative action
490
PHARMACEUTICALS (MONOCOMPONENT PRODUCTS)
Somatropin (pituitary-derived)
12629-01-5
TRADE AND BRAND NAMES :
Anluilrin growth
Anluitrm-t
Asellacnn
Cb 3ii
Corpormon
Crescormon
Grorm
Hgh
Human growth hormon
Leutrophin
Nanormin
Nanormon
Phynatol
Phyol
Phyoneon
Protopin
Protropin
Rx 099916
Somacton
Somalonorm
Somatormone
Somatrolm
Somatropin
Sth
22krl
For regulatory information, see page 118
Spironolactone
52-01-7
TRADE AND BRAND NAMES :
Acelat
Airolactone
Aldace
Aldacuoe 25
Aldacione
Aidacione-a
Aldazida
Aldonorm
Aldoour
Aldosoirone
Aldozone
Alexan
Aimalol
Alpamed
Aiiex
Aiiexide
Aporasnon
Aauareduct
Cardilan
Crk 635
Cl-spiro
Deveroi
Diaionsec
DiQi-aidopur
Dilakton
Dira
Duraspiron
Euteberol
Hokulaton
Hokuraton
HydfOSpiron
Idrolation
Lacalmin
Lacdene
Lasilacton
Lasitone
Loractone
Ml 2i8d
Nelurolan
Noidouble
Os>ren
Osyrol
Osyrol-lasix
Penanun
Pirolcaton
Platenil
Practon 50
Raudazida
Risicordm
Rolacione
Sagisai
Sali-spirocian
Saluretin
Sas 1060
Sc 9420
Servilactone
Sincomen
Spiresis
Spirelic
Spiridazide
Spindon
Spinx
Spiro comp
Spiro-f
Spiro-lablinen
Spirocian
Spirodigiial
Spirolang
Spiron
Spironomocompren
Spironone
Spironoihiazide
Spiropal
Spiroprop
Spirostada
Spirotone
Spiro50-d
Suprapuren
Suracton
Synurelicum
Tensollex
Uractone
Urusonin
Verospiron
Xenalone
For regulatory information, see page 119
Sulfaguanidine
57-67-0
TRADE AND BRAND NAMES :
Aseptil-guanidma
Alerian
Cohseptaie
Devaguanil
Diacta
Oirkan
Emenn
Enie-rivo simplex
Gamdan
Granidan
Guamide
Guanicil
Guanidan
Guanowepl
Guasept
Inorgan
Intestovet
Ordenol
Orgaguanidon
Percural
Resulfon
Ruocil
For regulatory Information, see page 121
Manufacturer data
S-guanidan
Sgd
Shigalox
Suganyl
Sullacarbon
Sulfaglobenicol
Sulfentidine
Sulfogua
Sulgm
Tetrawest
Trisulvet
PHARMACEUTICALS (MONOCOMPONENT PRODUCTS)
110
Product nam®
Phthalylsulfathiazole
C.A.S number
85-73-4
Fourth Issugj
'’J-4
VScientific and common names, and synonyms
BENZOIC ACID. 2-(((4-(2-THIAZOLYLAMINO)SULFONYLPHENYL)AMINO)-CARBONYL)4‘.(2-THIAZOLYLSULPAMOYL)PHTHALANILIC ACID
6'-(THIAZOLYLAMINOSULFAMOYL)PHTHALANIC acid
■4.-?9
-j
Legislative or regulative action :
-------------------------------------------------------------------------------------------------------------------- ---------- —---------------- >
Country
Effective
Date
BGD
1982
Description of action taken
grounds for decision
Under the provisions of the Drugs (Control) Ordinance, this product has been banned. It has'
been found to be of little or no therapeutic value, its side effects can be harmful, and it is subject ■
to misuse. (Reference: (BGDCO) The Drugs (Control) Ordinance ., 1982)
WHO comment: Phthalylsulfathiazole. a sulfonamide anti-infective agent, was introduced in
1946 for the treatment of bacterial infections. The importance of sulfonamides has subse- ?
quently decreased as a result of increasing bacterial resistance and their replacement by;;
antibiotics which are generally more active and less toxic. Although phthalylsulfathiazole. which
is poorly absorbed from the gastrointestinal tract, is no longer recommended in some coun-’*
tries, it continues to be used in others for the treatment of local intestinal infections, including
bacterial dysentery, and for pre-operative bowel preparation^-.
Product name
Pipamazine
1
84-04-8
Scientific and common names, and synonyms
10-(3-|4-CARBAMOYLPIPERIDINE)PROPYL)-2-CHLOROPHENOTHIAZINE
3
Legislative or regulative action :
Country
Effective
Date
Description of action taken
grounds for decision
USA
July 1969
Withdrawn from the market and prohibited for export by the Food and Drug Administration due
to the lack of proof of efficacy and safety for use as an antinauseant and antiemetic for pregnant
women.
WHO comment: Pipamazine. which is pharmacologically similar to chlorpromazine, was intro-, 1
duced in 1959 lor the treatment of nausea and vomiting Although it was withdrawn in 1969 by '
the United States FDA on grounds of lack of proof of efficacy and safety, it remains available in *
some countries.
■ *
---- —- -------- I
Product name
Piperazine
i
C.A.S number
110-85-0
<-
Legislative or regulative action :
_______________________________________
.3
'-£
Country
Effective
Date
ITA
1977
Products with anthelminthic indications have been withdrawn due to an unfavourable
risk/benefit balance. Since 1975, warnings have been added to the labels concerning the ta
possibility of neurotoxic effects with high dosages. In 1979, the label was revised to advise use .9
on an empty stomach and for short periods of time with long intervals, in order to avoid
interaction with nitrites.
SWE
1983
In the light of the carcinogenic and mutagenic potential of piperazine demonstrated in recently
studies, discussions between the manufacturers and the Department of Drugs have led to thsz'g
withdrawal of registration for this drug.
DNK
2 July 1984
Following recent evidence leading to the possibility that carcinogenic nitroso-derivatives may\®
be generated in vivo, preparations containing piperazine have been placed under prescription .?£
control. (Reference: (UGLAAD) Ugeskrift for Laeger, 1949 , June 1984)
' 'Kat
...[Continued] Jg
I’
I
Description of action taken
grounds for decision
Legislative or regulative action
T'
I
PHARMACEUTICALS (MONOCOMPONENT PRODUCTS)
rth issue.
485
thalylsulfathiazole
73-4
PEANO BRAND NAMES:
Enterocalme
Enterosteril
Entexidina
Esteraphdm mag
Eugentieed
Fitazil
Ftaiil-esteve
Ftalil-septol
Ftalil-tiazol
Ftalysept
ilentazol
Ingalipt
Inrestibla strepto
Intestiazol
lodentero-neomicma
Logical
Massotalil
Neo-sullazon
Novosullina
Phtalazol
Phtazol
.anti-d<afr
me
Enleramida
igfltefo-hermes
fcitero-red
xEnlero-sullina
'£nlG'O-ioxan
Porcijec
Septif tahl
Sulfacetil
Sulfathahdine
Sulftalyl
Syptan
Syralbina
Taleudron
Talidine
Talisulfazol
Taloudron
Tamil
Thalazole
Thalinil
Thalistanin
Thalistatyl
Thiazole
Trisulvet
Ultraliazol
Vetoryl
^‘fOr regulatory information, see page 110
^Pipamazine
$^-84-04-8
£&<-THADE AND BRAND NAMES :
Normetine
Nausidol
JUornidme
For regulatory information, see page 110
^Piperazine
,110-85-0
TRADE ANO BRAND NAMES :
f Adelmintex
. Ad'oalis
- Adipalit
• Adiprazine
Adiver
^ncans thenium
B^ncazine
r Anlelmma
. Anteoar
, Aniepar (b-»v)
; Anterobius
Anihalazine
Anthelmma
Anttcucs
•’Aniiten
-'Antivermme
Anioban
■Arduvermin
lApezme
JAsca-rrol no 3
r Ascahx
.Ascannex
,Ascarivei
,A$epar
;Askaripat
Averamexan
.B-Piperazine
Bcl-zme
Bioxurin
x.
Bnrel
Brvrel
Candizme
Ciperazm
C-bazme
Coooane
Dak
Demovermil
Diaiesunco
Dicevermin
Dietelmm
Dtgesan
Dilaurazme
Disoermin
Diurazma
Divermex
Dowzene
Dyrex
Ecosan
Endorid
Entacyl
Eniazin
Eauizole-a
Eraverm
Escovermin
Esteropipate
Etaphyilme (acelyihnate)
Exeimin
Exooin
Genhazma
Glycopiparsol
Heksaoar
Helmacid
Helmezin
Helmicide
Helmifren
Helmipar
Heimirazme (adipate)
Helmirazme (citrate)
Helmitin
Helmizm
Herb royal round worm treatment
Hexanthelm
Ismiverm
Janes liquid permifu
Jarabe neox
Jetsan supp (adipate)
Juslalmin
Kennel-maid
Kihomato
Kontipar
Lamboxil
Lorn
Lombricida tropico
Lombrifher
Lombrikal
Lombrimade
Lumbncal
...[Continued]
Manufacturer data
5W?
fourth Issue
PHARMACEUTICALS (MONOCOMPONENT PRODUCTS)
Product name
Neomycin sulfate
C A S number
1405-10-3
Legislative or regulative action :
Description of action taken
grounds for decision
Country
Effective
Date
BGD
1982
Under the provisions of the Drugs (Control) Ordinance, this product has been banned since it
has been shown to cause malabsorption in children and to be of little or no therapeutic value.
(Re'erence: (BGDCO) The Drugs (Control) Ordinance ., 1982)
PHL
July 1982
All anti-diarrhoeal preparations for oral administration containing this product have been
banned. Most cases of diarrhoea have been found to be resistant to the drug and its constant
use promotes pseudomembranous colitis in infants and children. Neomycin can cause other
serious adverse effects including renal damage, neuro-muscular blockage and ototoxicity, pos
sibly leading to deafness in some patients. (Reference: (PHADO) Administrative Order No. 24,
July 1982)
WHO comment: Neomycin sulfate, a broad-spectrum antibiotic, was first isolated in 1949 and
has subsequently been included in topical, oral and parenteral preparations. Its value in the
treatment of diarrhoea is widely questioned although it is still contained in a number of widely
available antidiarrhoeal preparations. In some countries the officially approved indications for
oral preparations are restricted to the preparation of the bowel prior to surgery and the manage
ment of hepatic coma. Topical preparations of neomycin sulfate are included in the WHO
Model List of Essential Drugs. (Reference. (WHTACl) Model List of Essential Drugs. 2nd
Report of the WHO Expert Committee 722 . . 1985)
Product name
Nialamide
C.A S number
51-12-7
Scientific and common names, and synonyms
ISONICOTINIC ACID 2-((-BENZYLCAR8AMOYL)ETHYL)HYORAZIDE
Legislative or regulative action ;
Description of action taken
grounds for decision
Country
Effective
Date
JPN
Nov. 1974
The Ministry of Health and Welfare withdrew all products containing isocarboxazid and
nialamide on the grounds that they lack substantial evidence of efficacy and safety
IND
1983
Prohibited for manufacture and sale for reasons of health risks associated with use and or
questionable therapeutic value. (Reference: (GAZIE) The Gazette of India: Extraordinary (Part
ll-Section 3.1), . 1983)
Oub
Prohibited from use by the national formulary commission (1982) on grounds of reported
toxicity and in view of the availability of other less toxic drugs.
DNK
Withdrawn from the market by the manufacturer.
SAU
Products now controlled by the authorities.
THA
Products have been banned.
VEN
Banned for use and.or sale.
WHO comment: Nialamide, a monoamine oxidase inhibitor (MAOI), was introduced in 1959 for
the treatment of depressive illness. Subsequently concern regarding potentially serious inter
actions between MAOIs and foods containing tyramine inspired much restrictive regulatory
action However, MAOIs still retain a place in the treatment of serious depressive illness al
though there is no international consensus on which compounds should be preferred. Thus
nialamide remains available in several countries.
Legislative or regulative action
474
PHARMACEUTICALS IMONOCOMPONENT PRODUCTS)
Neomycin sulfate
1405-10-3
TRADE AND BRAND NAMES :
Abilene
Akentect
Amcorl
Amphocort
AniibHulle
Apokahn
Aurex
Auriod
BaneoDol
Barnere-mycm
Bastu-angin
Bedermm 100
Benestermycm
Bio-viiastrepl
Biodry
Biolradin
Biolur
Biosol
Biosol-m
Bivacyn
Biastoesbmulina
Bykanula
Bykomycin
Canaural
Canoral
Cebemyxine
Cefrocyn
Cg 3224 _
Cicatrex
Cieniaerm
Clorpine
Conderm
Coniuclilone
Comemin
Cortinen
Damapo
Davimycm
Degramycm
Dermadex
Dercmcema
De'mo sonerge
Dermolace
Dermosan
Dermovate-nn
Derobion
Dexaamisolone-n
Dexabiolan
Dexacidin
Dexamist
Dexavetaderm
Dia-jecl
Diaban
Diacin
Diarest
Dicortinelf
Dienterol
Dimictna
Doreplaston/doser'l
Dorithicm
Dulcicorlme
Duphacerale
Dv 201
Emcortina
Emorex k berna
Enbacm
Endomixtn
Enteral
Enteromac
Enteropast
Enterosmtex
Eustoporin
Extracort
Febrizene
Fissan
Fl 6321 n
Fluonid
Fml-neo-lrquihlm
Foille
Forbesotic
Formula 888
Forte
Forticillin
Fradyl
Frakidex
Frakitacine
Gastromycin
Gregoderm
Gusbbon
H plus n
Hagrosept
Halicomb
Halog
Hehomycort
Hydro-neo oculos
Hydrocorttderm
l-caps
Idepa
Ido-op
Intradermo cal
lodenteroOneomicma
Itro
Jenomycin
Kanagotas
Kortikiod mepha
Lanbiolic
Larmicm
Latodurin
limtul
Mammanopon
Mastrmal
Medisec neo
Medisec-cloxa
Medri-biotic
Moimyd
Menaderm antiacne
Myacyne
Mycerin
Mycidox
Mycilradm
Myciguent
Mycimist
MycipO
Mytrex
Naso-neomicin
Nasomixin
Nasydrin
Nelluan
Neimicma roger
Neo decaderm
Neo-analsona
Neo-cantil
Neo-delta-cortef
Neo-hydro
Neo-m
Neo-mantle
Neo-mastitar
Neo-myx
Neo-otosol-hc
Neo-remusin
Neoaristovet
Neobacimyx-h
Neobicin
Neobiotic
Neobrettin
Neobristan
Neocidin
Neocillin
Neoclox
Manufacturer data
Neocones
Neodecasono
Neofluid
Neomtestin
Neolate
Neomac
Neomin
Neomix
Neomycane
Neopenol
Neopt
Neostrep
Neosule
Neosulf
Nifuramicm
Nisocla
Nisoclyn
Nisodyn
Nivemycm
Nodryl
Nokamycm
Noperil
Normoc
Npa
O-biol
Ophthlmycm
Optipnme opthcoat
Optison
Optisone
Oribiotic
Oterna
Olicair
Oto vitna
Oto-Hunal
Oto-sinerbe
Otocortison
Otomycin
Panotile
Paraien
Parkeole
Parkesteron
Pervet
Phytacorcm
Pivaione
Polemycm
Poly-pred
Polybactrin-g
Polydexa
Polygynax
Polyspecrm
Porctjec
Prednicidm
Prevotec
Propaderm-n
Pulveodil
Pyocidm he
Quadrex
Renokab
Rino
Rino vitna
Rinofilax
Rmoict
Rovicine
S-thalmic
Sanibiovit
Sanimix
Samstress
Secantol
Septa
Septomixine forte
Silderm
Siquent neomycin
Solan
Spersapolymyxin dispersa
-----------'.............................................
Fourth issue
PHARMACEUTICALS (MONOCOMPONENT PRODUCTS)
Product name
Difurazone ...[Continued]
Legislative or regulative action :
Country
Effective
Date
Description of action taken
grounds for decision
WHO comment: Difurazone. a nitrofuran derivative, was formerly used as an antiinfective
agent. It has. however, been superseded by safer compounds and WHO has no information to
suggest that it remains commercially available.
Product name
Dihydrostreptomycin
C.A S number
128-46-1
Scientific and common names, and synonyms
DHSM
DST
Legislative or regulative action :
Description of action taken
grounds for decision
Country
Effective
Date
USA
Sep. 1970
Withdrawn from the market (injectable form) and prohibited for export by the Fooo and Drug
Administration on the grounds of an unfavourable benefit/risk ratio. This antibiotic is considered
unsafe due to its ototoxic hazards.
PHL
1972
Dihydrostreptomycin and its salts, singly or in combination, were withdrawn from sale for
human use The drug can cause severe vestibular damage.
ESP
1 Oct. 1983
The Ministry of Health and Consumer Protection has withdrawn approval for dihycrostreptomycin except in oral preparations (Reference: (ESPMC) Programa Selective de Revision de
Medicamentos PHASE 1.. Sep. 1983)
Prohibited for use and/or sale since scientific studies have shown that it can cause deafness.
DOM
Withdrawn from the market owing to an unfavourable risk-benefit ratio and the lack of substan
tial evidence of efficacy.
ITA
Prohibited for use in its injectable form It has been found to cause permanent deafness
PER
WHO comment: Dihydrostreptomycin, a derivative of the aminoglycoside antibiotic strep
tomycin with similar antibacterial activity, was first synthesized in 1947 and subsequently used
m the treatment of tuberculosis and gram-negative infections. Preparations for systemic use
have been widely withdrawn as a result of concern regarding their severe ototoxicity
Dihydrostreptomycin is poorly absorbed from the gastrointestinal tract. It remains available in
oral preparations in some countries.
Product name
Dihydroxymethylfuratrizine
C.A S number
794-93-4
Scientific and common names, and synonyms
((6-2(5-NITRO-2-FURYL)VINYL)-AS-TRIAZIN-3-YL)lMIDO)DI-METHANOL
BIS(HYDROXYMETHYL)FURATRIZINE
Legislative or regulative action ;
Country
Effective
Date
The withdrawal of nitrofuran compounds is under consideration since they have been super
seded by safer and more effective preparations.
SAU
JPN
VEN
Description of action taken
grounds for decision
July 1977
Withdrawn from all marketed preparations in 1977 on the grounds that it has been superseded
by safer and more effective preparations.
Not approved for use and/or sale
...[Continued]
Legislative or regulative action
456_________________________ PHARMACEUTICALS IMONOCOMPONENT PRODUCTS)
Diethylstilbestrol ...[Continued]
TRADE AND BRAND NAMES :
Raoestrol rt83
Remrumestroi 2
Rumestrol 1
Rumestrol 2
Rymestrol rt83
Sedestran rt83
Serral
Sexocretin
Stool
Sintestrol rt33
Stearettes
Stibilium rt83
Stil
Slil-rol
Stilbestrol
Stilbetin
Stilbetine
Stilbette
Stilbilium
Stilboefral
Stilboestroform
Stilboestrol
Stilbofolhn rt83
Stilbol
Snlbosol
Stilcap
Stilkap
Stilnestrin
Stilphostrol
Stimplants
Synestrin
Synoestrin
Synthoestrin
Synlhofolin
Syntololm
Tampovagan stilboestrol rt83
Tend-a-water
Tribiotic
Tylosterone
Ut forte
Vagestrol
Vet nutri
For regulatory information, see page 49
Difurazone
804-36-4
TRADE AND BRAND NAMES :
Panzon
Payzone
For regulatory information, see page 50
Di hydrostreptomycin
128-46-1
TRADE AND BRAND NAMES :
Abiocine
Abocillin
Biostrep
Complexobiotico
Dhsm
Diapenin oaisamico
Diaoenm 3
Diarrestival
Didromycin
Didrotnenate
Dihydrocidan sulfato
Dihydrostreptofar
Dihydrostreptom
Dndro-pantostrept
Distreptopab
Dreiciclina balsamica
Dst
Entera-suept
Estreptoluy
Helle-strep-forte
Hp 48
Mastigun
Mixtencillin
Retromyooen
Rocopenstrep
Sanstrepto
Solvo-strept
Streptoduocin
Veticar
Veycil-as
Vibrtomycin
For regulatory information, see page 51
Dihydroxymethylfuratrizine
794-93-4
TRADE AND BRAND NAMES :
Furaione
Panfuran s
For regulatory information, see page 51
Dimazole
95-27-2
TRADE AND BRAND NAMES :
Asterol
Atelor
Atelora
Aterola
Kesten
Mycotol
For regulatory information, see page 52
Manufacturer data
PHARMACEUTICALS (MONOCOMPONENT PRODUCTS)
Fourth issue
77
.---------------
Product name
Lobelia
Legislative or regulative action
Country
———
BGD
.
Effective
Date
1982
Description of action taken
grounds for decision
Under the provisions of the Drugs (Control) Ordinance, this drug has been prohibited for use.
All prescription chemicals and galenical preparations not included in the latest edition of the
British Pharmacopeia or British Pharmaceutical Codex have been prohibited for use.
(Reference: (BGDCO) The Drugs (Control) Ordinance ,, 1982)
Withdrawn from the market owing to an unfavourable risk-benefit ratio and the lack of substan
tial evidence of efficacy.
ITA
WHO comment: Lobelia comprises the dried aerial parts of lobelia species, the activity of
which is due chiefly to the alkaloid lobeline. Although preparations containing lobelia were
formerly available for use in the symptomatic treatent of asthma, they are now largely obsoles
cent as a result of their irritant properties and the availability of more effective preparations.
e
Product name
Loperamide
CAS number
53179-11-6
Scientific and common names. and synonyms
PiPERlDiNEBUTANAMIDE. 4-(4-CHLOROPHENYL)-4-HYDROXY-N.N-DIMETHYL-aloha. alpha-DlPHENYL
4.(P-CHLOROPHENYL)-4-HYDROXY-N.N-DIMETHYL-alpha.alpha-DlPHENYL- 1 - PiPERlDlNEBUTYRAMlDE
Legislative or regulative action
Country
Effective
Date
PHL
Nov. 1982
Description of action taken
grounds for decision
Restricted for use as an antidiarrhoeal drug. Contraindicated in children below two years of age
due Io the risk of central nervous system damage.
WHO comment: Loperamide, an inhibitor of intestinal peristalsis, was introduced in 1975 for
the treatment of acute and chronic diarrhoea. In many countries its use is discouraged in young
children. A WHO Steering Committee has recommended that loperamide should not be used m
children below five years of age with acute diarrhoea.
Product name
Lynestrenol
C.A.S number
52-76-6
^Rntific and common names, and synonyms
19 NORPREGN-4-EN-20-YN-17-OL. (I7aipha)19-NOR-i 7-alpha-PREGN-4-EN-20-YN-17-OL
Legislative or regulative action
Country
Effective
Date
AUS
1980
SAU
Description of action taken
grounds for decision
High dosage (2 5mg) lynestrenol products were withdrawn following demonstration of a doserelated incidence of mammary tumours in the beagle bitch. It is acknowledged, however, that
this species may not offer a reliable model for predicting possible carcinogenicity of progestogens in humans. (Reference. (AUDEC) Report of the Australian Drug Evaluation Commit
tee No.90,,)
Products under control by the authorities.
...[Continued]
Legislative or regulative action
466
PHARMACEUTICALS (MONOCOMPONENT PRODUCTS)
Lead oxide and lead salts
TRADE AND BRAND NAMES :
Hiroval
Wndomethasone
For regulatory information, see page 75
Levamfetamine
156-34-3
TRADE AND BRAND NAMES :
Amphednne-m
Cydril
For regulatory information, see page 75
Loperamide
53179-11-6
TRADE AND BRAND NAMES .
Ami-29
Arret
Blox
Brek
Colifelin
Dissenten
Dissenter
Duplibiot
Elcoman
Firtasec
Imodium
imosec
Looemid
^pernin
L°peran
Lopenn
Lopetmid
Loperyl
Motilix
Orulop
PI 185
Pricilone
R-18553
Repulane
Setdiar
Suorasec
Tagumol
Telboc
Totrtasec
For regulatory information, see page 77
Lynestrenol
52-76-6
TRADE AND BRAND NAMES :
Anacylin
Anacylin 101
Anacylin 28
Ancylin
Athilyn
Endomelril
Exlutena
Exlulion
Exluton
Exluton (a)
Exlutona
Fisioquens
Fysioquens
Lindiol 2.5
Lyn-ratiopharm
Lyndeol
Lyndiol
Lyndiol e
Lyndioiett
Lynoenslrenol
“,nelle
M|n'Ptegnon
Minilyn
Ministat
Neo-lmdiol
Neo-lynobol
Nonovulet
Noracyclin
Noracyclin 22
Normophasic
Org 485-50
Orgaluton
Orgameti1
Orgametril
Orgametroi
Ovamezzo
Ovoresta
Ovoresta m
_
°vosta
Ovostat
Ovostat-micro
Ovostat-28
Physistat
Pregnon
Pregnon-28
Restovar
Yermonil
For regulatory information, see page 77
Meclozine
569-65-3
TRADE AND BRAND NAMES:
Ancolan
Ancoloxme
Antiverl
Bonamina
Bonamine
Bonexyl
Manufacturer data
PHARMACEUTICALS (COMBINATION PRODUCTS!139
Product name
Acetylsalicylic acid/phenacetin/caffeine (APC)
^entitle and common names and synonyms
APC
CAFFEINE PHENACETIN ACETYLSALICYLIC ACID
PHENACETIN/ACETYLSALICYLIC ACiD-CAFFEINE
Legislative or regulative action
Country
----- -—
THA
Effective
Date
1983
Product name
Description of action taken
grounds for decision
Banned for manufacture for immediate effect but existing stocks may be sold for a further
period of one year Preparations must be reformulated to contain only acetylsalicylic acid
Antirheumatic combinations with glucocorticosteroids
Legislative or regulative action
Description of action taken
grounds for decision
Country
Effective
Date
AUT
Jan. 1986
Enteral preparations have been withdrawn and parenteral preparations may only be used for
very limited indications and under strict medical supervision.
DEU
1 Jan. 1986
Fixed combinations have been withdrawn since concurrent administration of such orugs poten
tiates adverse effects without increasing benefit.
Product name
Atropine
C A.S number
51-55-8
Scientific and common names, and synonyms
aloha H 5alpha H-TRQPAN-3alpha-OL( ♦ -)-TROPATE (ESTER)
BENZENEACETIC ACID. aipha-(HYDROXYMETHYL)-8-METHYL-3-AZABlCYCLO(3.2 1) OCT-3-YL ESTER ENDO ( * '-)
Legislative or regulative action
Country
Effective
Date
PHL
Sep. 1976
Description of action taken
grounds (or decision
Combinations of atropine sulfate with difenoxylate, furazolidone and dimethylpolysiloxane have
been disapproved due to possible adverse reactions such as dysuria (from atropine and
furazolidone), tachycardia, palpitation and blurring of vision.
WHO comment: Atropine, an alkaloid with anticholinergic activity extracted from Atrooa bel
ladonna, has been widely used in medicines for centuries. The action taken in the Philippines
relates specifically to the use of atropine in combination products. Elsewhere, preparations
containing atropine remain available and the substance is included in the WHO Mode, List of
Essential Drugs. (Reference: (WHODI) WHO Drug Information 2.1. 1988)
Product name
Barbiturates in combination
Scientific and common names, and synonyms
ANALGESICS; BARBITURATES
ANTACIDS/BARBlTURATES
J.
ANTIASTHMATICS BARBITURATES
...[Continued]
Legislative or regulative action
PHARMACEUTICALS (MONOCOMPONENT PRODUCTS)
Fourth issue
Product name
Hexobarbital
C.A.S number
56-29-1
69
Scientific and common names, and synonyms
2.4,6(1 H.3H 5H)-PYRIM|DINETRIONE. 5-( 1 -CYCLOHEXEN-1 -YL) 1,5-OIMETHYL
5-<CYCLOHEX-1-ENYL)-1.5-DIMETHYLBARBITURIC ACID
5-( 1 -CYCLOHEXEN-1 -YLH ,5-DIMETrlYLBARBITURIC ACID)
Legislative or regulative action :
Country
Effective
Date
Description of action taken
grounds for decision
gyyg
Oct. 1984
Withdrawn following discussions between the manufacturer and the National Board of Health
and Welfare. Fatal intoxications and abuse are associated with use of preparations containing
hexobarbital.
WHO comment: Hexobarbital is a short-acting barbiturate. See WHO comment for barbitu
rates.
Product name
Hyoscine methonitrate
C.A.S number
6106-46-3
Scientific and common names, and synonyms
METHYLSCOPOLAMINE NITRATE
Legislative or regulative action
Country
Effective
Date
SWE
June 1981
Description of action taken
grounds for decision
Hyoscine methonitrate, an antimuscarinic agent, has been withdrawn from appetite suppres
sant preparations.
WHO comment: Hyoscine methonitrate, a quaternary ammonium anticholinergic agent, was
introduced in 1947 for use as a gastrointestinal antispasmodic. The action taken in Sweden
relates to the use of this compound in preparations for suppressing the appetite. Preparations
may remain available elsewhere.
Product name
Indalpine
C.A.S number
63758-79-2
Scientific and common names, and synonyms
’ 2-(3-(4-PIPERIDYL)ETHYL)INDOLE
Legislative or regulative action .
Country
Effective
Date
FRA
13 July 1985
Description of action taken
grounds for decision
Following reports of agranulocytosis and severe neutropenia associated with the use of indal
pine. the maior manufacturer in consultation with the French health authorities decided to
suspend the marketing of this drug. (Reference: (FMOPL) Le Moniteur des Pharmacies et des
Laboratoires 1666 , .June 1985)
WHO comment: Indalpine. an antidepressant with serotoninergic action, was introduced in
1983 and marketed exclusively in France. In 1984 its use was associated with cases of
leucopenia and agranulocytosis which led to the voluntary suspension of clinical trials in the
USA. In 1985 the ma,or manufacturer voluntarily withdrew the drug from the market.
Legislative or regulative action
464
PHARMACEUTICALS (MONOCOMPONENT PRODUCTS)
Hyoscine methonitrate
6106-46-3
TRADE AND BRAND NAMES :
Mescomme ln86
Mescomt
Skopolate tn86
Skopyl tn86
Skopyle
Viscope tn86
For regulatory information, see page 69
Indalpine
63758-79-2
TRADE AND BRAND NAMES :
Lm 5008
Upstene
For regulatory information, see page 69
Indoprofen
31842-01-0
TRADE AND BRAND NAMES
Bor-md.
Endyne
Fenmi
Fiogosan
Fiosm
Flosine
Flosint
Flosyn
Isindone
K 4277
Miantor
Praxis
Reumotene
For regulatory information, see page 70
Iodinated casein strophanthin (neo-barine)
TRADE AND BRAND NAMES
Coratose
For regulatory information, see page 70
Iproniazid
54-92-2
TRADE AND BRAND NAMES .
Euphozid
Ipropran
isotarr.ine
Lamazid
Marsilid
Nydrazid
P-1-n forte
Pms isoniazid
Rifamate
Rimactane
For regulatory information, see page 70
Isaxonine phosphate
4214-72-6
TRADE AND BRAND NAMES :
Nerfactor
Verfactor
For regulatory information, see page 71
Manufacturer data
Rimilon
Ro 7-1554
Teeoaconin
Tnmad
Umad
F<rj£LDJ-SSUe_________________ p^APMACc'JPCALS /MO.NOCOMPOMENT saCOUCTSi___________________________ 65
Product name
Griseofulvin ...[Continued]
Lf^»laUVe or regulative action
~- --
-^nUY
—■--------
Effective
Date
Description of action taken
grounds for decision
Having regard to recently evaluated reocrts of carcinogenicity, fetctoxity ana teratogenicity n
rocents administered very hign doses of griseofulvin. tne Committee on the Review of Medi
cines nas recommenced that all products containing griseofulvin snould ice restricted in their
use to the treatment ol oermatoohyte infections of tne skin, scalp, hair ano nans wnen topical
therapy has failed or is considered macpropriate. It also recommends that such products
should not te used curing pregnancy or fcr prophylactic treatment
G5R
WHO comment: Griseofulvin. isolated from a ceniciilin producing moulc. has been widely
used as a systemically administered antifungal agent in man for over 20 years It is effective in
d^rmatoohyte infections lincluding tinea barbae and tinea capitis) but it is inactive against
yeasts and bacteria Evidence that very nigh doses of griseofulvin are carcinogenic, teratogenic
anc fetotoxic in laboratory animais has led to an acceptance that it should not ce used to treat
trivial infections that respond to topical therapy. Ora, formulations of griseofulvin are mciuceo in
the WHO Model List of Essential Drugs (Reference. (WHTACf) Model List of Essential Drugs.
2nd Report of the WHO Expert Committee 722 .. 1985)
•
Product name
Guanofuracin
C.A.S number
300-25-4
Scientific and common names, and synonyms
5-NITROFURFURYLIDENAMINOGUANIDINE
Legislative or regulative action
Country
Effective
Date
Description of action taken
grounds for decision
JPN
July 1977
Withdrawn from all marketed preparations on the grounds that it has been superseded by safer
and more effective preparations.
Not approved for use and or sale.
VEN
WHO comment: Guanofuracin. a nitrofuran derivative, was formerly used as an antnnfective
agent It has. however, been superseded by safer compounds and WHO has no information
that it remains commercially available.
Product name
Halogenated hydroxyquinoiine derivatives
C.A.S number
148-24-3
•
Scientific and common names, and synonyms
OXINE
OXYQUINOLINE
8-QUINOLINOL
Legislative or regulative action :
Country
Effective
Date
DNK
1978
All halogenated hydroxyoumoline derivatives intended for oral administration have been with
drawn from use. (Reference: (UGLAAD) Ugeskrift for Laeger 140.1181.) 978)
CYP
1980
The Drug Council withdrew all products containing halogenated hydroxyquinoiine derivatives
intended for internal use due to the possible risk of occurrence of sub-acute myelo-optic
neuropathy (SMON) in treated patients.
PHL
Aug. 1980
Withdrawn from the domestic market due to reports of neurological disorders (SMON) with
their use in Japan.
...[Continued]
Description of action taken
grounds for decision
Legislative or regulative action
462
PHARMACEUTICALS (MONQCOMPQNENT PRODUCTS)
fourth
Glutethimide
77-21-4
Sa
TRADE AND BRAND NAMES :
Alfrmid
C "5“
Donden
Donden-sed
Donoene
Dondme
Dorimid
Elrodorm
Glimid
Giudorm
Noxyron
Rigenox
Sarodormin
ft-’-?
Somvit
Tardyl
For regulatory information, see page 64
.7^
Griseofulvin
126-07-8
TRADE AND BRAND NAMES:
B-gl
Deimofulvina
Futcine
Fuicine-s
Fulcine-125
Fulvicin
Fulvicin U'f
Fulvicma
Fungivin
Geluivine
Greosm
Gricin
Grisovin-fp
Grisovina
Grisowen
Grysio
Lamoryl ' • ’ .
Lamoryi-novum ’ ■
Likuoen
Neo-iilcin
Norofluvin
Polygns
Sulvtna
Grifulin
Grifulvin
Grifulvin v
Gns-peg
Gnsaclin
Gnsalun
Gnselulin
Gnselulvin
Gnseo
Gnseomed
Griseostatm
Gnsovin
For regulatory information, see page 64
3
Halogenated hydroxyquinoline derivatives
148-24-3
I
TRADE AND BRAND NAMES .
Aci-jel
Co-cao
Fennosan h 30 ln86
Herial
Hyafoxydenoxopyndine
Oxm tn86
Oxine tn86
Oxyqumolme-rhp
Pedivol
Phenopyridine tn86
Preconsol
Qumoped
Qumophenol In86
Semori
Serohinol
Superol
Tumex
For regulatory information, see page 65
i
Halogenated salicylanilides
-JO
TRADE AND BRAND NAMES :
Aiamin
Annul
Bada
Hilomid
'A_:.
Salimdol
Temasept
For regulatory information, see page 66
Heptabarb
509-86-4
1
TRADE AND BRAND NAMES :
Heptadorm
Medapan
<3
Medomin
Medomma
Medomine
For regulatory information, see page 67
•O
Manufacturer data
1
190
AGRICULTURAL CHEMICALS
Product name
Fourth Issug
Chlorobenzilate ...[Continued]
Legislative or regulative action :
Country
Effective
Date
Description of action taken '
grounds for decision
Prohibited for import except in cases of emergency as determined by the authorities.
PHL
Importation and sale for local use is banned This decision was taken to safeguard water
sources. (Reference: (MINHS) Ministry of Health ,, 1983)
SGP
Apr 1984
SWE
31 Dec. 1979
Has been withdrawn after mutual discussions between National Products Control Board and the ’?
importers because of its carcinogenic effect on experimental animals. (Reference: (PKB) pro. &
duktkontrollnaemndens Beslut fraan Den.,. 31 Dec. 1979)
-)t
USA
Feb. 1979
Cancellation and denial of registration of chlorobenzilate products for uses other than citrus ?
uses in Florida, Texas, California, and Arizona Notwithstanding the above, registration of .x
chlorobenzilate products for citrus use in these four states will also be cancelled or denied »
unless registrants or applicants for new registrations modify the label to include the following: $
"Restricted use pesticide For retail sale and use only by certified applicators. Special precautions are to be taken when handling the product and special clothing to be worn." Several 'i
scientific studies provided a reliable basis for concluding that chlorobenzilate induces on- J
cogenic effects (i.e. produces tumors) in certain mammalian species and that tnese laboratory
studies and information on human exposure provided substantial evidence that chlorobenzilate 1
poses a risk of cancer and adverse testicular effects (Reference: (FEREAC) Federal Register %
44,9548.1979)
■>
5
I
Bibliographical references
FAO PLANT PRODUCTION & PROTECTION PAPER 26 . . i960
FAO PLANT PRODUCTION & PROTECTION PAPER 26 SUP
. 1980
IARC MONOGRAPH 30 . 73 . 1983
IARC MONOGRAPH . 5 . 75. 1974
Product name
Chloroform
C.A.S number
67-66-3
■-
I
I
Scientific and common names, and synonyms
METHANE. TRICHLORO
TRICHLOROFORM
TRICHLOROMETHANE
■
Legislative or regulative action :
Description ol action taken
grounds for decision
Country
Effective
Date
DEU
1 Apr. 1985
Prohibited for use as a plant protectant. (Reference (BGBL) Bundesgesetzblatt IS.363 ., 1986)
PAN
Sep. 1987
Import and use prohibited for agriculture. (Reference: (PANPA) Listado de Productos Agro-.:
quimicos Prohibidos ,. 1987)
■
Bibliographical references
IARC MONOGRAPH . SUPPL 4 . 64 , 1982
IARC MONOGRAPH . SUPPL 4 . 87 . 1982
IARC MONOGRAPH . 1 . 61 . 1972
IARC MONOGRAPH . 20 . 401. 1979
IARC MONOGRAPH . 4 . 239. 1974
WHO FOOD ADD . 14 , 24 . 1980
Legislative or regulative action
Ji
J
product name
Chlorofluorocarbons
or regulative action :
Effective
Date
fcAN-
Description of action taken
grounds for decision
1 May 1980
The import, manufacture, processing, sale or use of totally halogenated CFCs for use as a
propellant in aerosol hair sprays, deodorants and antiperspirants is prohibited for the purpose
of subsection 8(2) of the Environmental Contaminants Act. (Chloroflurocarbon regulations
(SOR 80-254)). (Amendment: SOR'81-365 May 7, 1981). Reasons for the control action: Dan
ger of CFCs as a potential depleter of the stratospheric ozone layer. (Reference: (CAGAAK)
Canada Gazette Part II 117,1289.3 . Apr. 1980)
May 1981
Under the Environmental Contaminants Act, the import, manufacture, processing, sale or use of
dhlcrofluorocarbons for use as a propellant constituent in aerosol hair sprays, deodorants and
antiperspirants is prohibited because of the danger of depletion of the stratospheric ozone
layer. (Reference: (CANGZ) Canada Gazette 115, 1410,1981)
Aug. 1981
In accordance with a Royal Decree of 5 August 1977, it is prohibited to manufacture or import
aerosol cans and the like where chlorofluorocarbons are employed as a propellant. The prohibi
tion applies to manufacture both for domestic and export purposes. Certain medicinal products
are exempted from this prohibition. These restrictions are based on a 1976 finding by the
National Academy of Sciences that chlorofluorocarbons represent a danger to the ozone layer
Chlorofluorocarbons may be exported with no requirement of foreign notification of domestic
restrictions on their use.
PHL
1983
Gases being phased out of use due to the threat to the ozone layer.
SWE
1980
Spraying devices containing aerosol propellants in the form of completely halogenated
chlorofluocarbons may not be manufactured or imported. (Reference: (SOSFS) Socialstyrelsens Foerfattningssamhng 1980.92 , 1 . 1980)
Use in aerosols has been restricted to specific types of drug and cosmetic preparations to
protect the stratospheric ozone. (Reference: (MINPT) Ministry of Public Health 26 .. 1981)
THA
Product name
Chloroform
C.A.S number
67-66-3
'Legislative or regulative action :
Effective
Date
Description of action taken
grounds for decision
i Feb. 85
Chlorolorm is not allowed in cosmetic and drug products since 1 Feb. 1985. From that date.
import, export and sale ol products containing chloroform became illegal. The decision was
based on reports from literature of the carcinogenic effects of chloroform on animals and
possible hepatotoxic and nephrotoxic effects after prolonged use by humans. (Reference:
(AARNO) Administrative Action Reference Number MH.1856/S.3T(112),15 Sep. 1983)
a
Product name
Chromium
C.A.S number
7440-47-3
or regulative action :
Effective
Dele
ESP
Sep. 1967
Descnption of action taken
grounds for decision
Use of the following is prohibited in toys and accessories for children: lead, zinc and potassium
alloys which contain more than 10% of these metals, even when coated with inert metais.
arsenic and its compounds in whatever quantity, as well as the use of dyes containing an
timony. arsenic, copper, mercury, uranium, over 1 per cent of lead, chromium oxide and
soluble salts or barium carbonates, cadmium, chromium and zinc. (Reference: (ESPBC) Ei
Codigo Alimentario Espanol. Ch.IX ,, Sep. 1967)
Legislative or regulative-action
34
PHARMACEUTICALS (MONOCOMPONENT PRODUCTS)
Product name
Chlornaphazine
C.A.S number
494-03-1
Fourth issue
Scientific and common names, and synonyms
beia-NAPHTHYLBISibeta-CHLOROETHYLiAMiNE
N N-BIS(2-CHLOROETHYL'i- 2-NAPHTHYLAMINE
NAPHTHYLAMINE MUSTARD
Legislative or regulative action
Country
Effective
Date
‘ DNK
1964
Description of action taken
grounds for decision
The National Health Service withdrew chlornaphazine, a drug used against lymphogranulomatosis, polycythaemia and chronic leukaemia, as it appeared to be carcinogenic espe
cially in the bladder.
Not approved for use and'or sale.
VEN
WHO comment: The World Health Organization has no information further to the above re
garding preparations containing chlornaphazine or to indicate that they are still commercially
manufactured.
Product name
Chloroform
CAS number
67-66-3
Scientific and common names, and synonyms
METHANE. TRICHLORO
trichloroform
trichloromethane
Legislative or regulative action
Description of action taken
grounds for decision
Country
Effective
Date
GRC
1976
Not accepted in pharmaceuticals or cosmetics
TUR
1976
Removed from all cough syrups after a decision by the Ministry ol Health based on a review of
published information regarding carcinogenicity in rats. Export of this product is prohibited.
JPN
May 1976
Banned by the Pharmaceutical Affairs Bureau in Drugs and Cosmetics for reasons of car
cinogenicity.
USA
July 1976
Withdrawn from the market and prohibited for export in drugs and cosmetics by the Food and
Drug Administration on the basis of findings of liver cancer in experimenral mice and rats by the
National Cancer Institute. (Reference: (FEREAC) Federal Register 41 . 26842 . July 1976)
PAN
30 Nov. 1976
The Ministry of Health has banned the sale of pharmaceuticals containing chloroform.
(Reference: (PANMR) Ministry of Health Resolution 1843 .. Aug. 1976)
SAU
1977
Sale or supply of any medicinal product containing chloroform has been prohibited by the Drug
Committee.
BRA
25 May 1977
Products containing chloroform are prohibited. (Reference: (BRAPT) Portaria do Servico
Publico Federal No.15 .. May 1977)
Withdrawn from the market owing to suspected carcinogenicity.
ITA
1978
CAN
Jan. 1978
National legislation has provided that no manufacturer or importer shall sell a drug for human
use that contains chloroform as an ingredient The Health Protection Branch has reviewed
evidence from the National Cancer Institute in the US which suggests that chloroform may be
carcinogenic in rats and mice when administered in high doses over prolonged periods. Export
of this product is allowed with no requirement of foreign notification regarding domestic restric
tions on its use. (Reference: (CANGZ) Canada Gazette ,, Nov. 1977)
NOR
Apr. 1978
Prohibited for use in pure form or as an additive to pharmaceutical preparations.
...[Continued]
Legislative or regulative action
issue
35
PHARMACEUTICALS (MONOCOMPONENT PRODUCTS)
Product name
Chloroform ...[Continued]
Legislative or regulative action
Country
Effective
Date
Description of action taken
grounds for decision
PHL
Apr. 19'8
Prohibited for use as an ingredient in human drugs and cosmetics on the grounds of results of a
study by the National Cancer Institute in the United States, suggesting that the substance may
be carcinogenic in rats and mice when administered over prolonged periods (Reference:
(PHADO) Administrative Order 341S ,. 1978)
DDR
Dec. 1978
Registration approval for preparations containing chloroform has been withdrawn due to a
carcinogenic potential. (Reference: (DDCI) Regulation of the Drug Control Institute . , Dec.
1978)
GBR
1979
The Chloroform Prohibition Order has prohibited the sale or supply of any medicinal product
containing chloroform. Certain exemptions apply (Reference: (GBCHL) Chloroform Prohibition
Order.. 1979)
NZL
1980
Toothpaste formulations containing chloroform have been voluntarily withdrawn from the mar
ket.
1981
Registered for veterinary use only. (Reference: (DENBH) Danish National Board of Health.
Circular Letter., Sep. 1981)
ETH
1981
Prohibited because of its carcinogenic effects.
ZWE
May 1981
Medicinal products containing more than 0.5% chloroform are prohibited because of the toxic
ity ol the drug. Certain exemptions apply. (Reference (ZWDCC) Drugs Control Council. News
Bulletin (1).. 1983)
Prohibited for use and or sale.
DEU
1982
BGD
June 1982
Use of chloroform as an excipient in pharmaceutical preparations has been banned due to
reported adverse effects
DOM
1983
Domestic manufacturers and importers have been requested to eliminate this ingredient from
their marketed products since pnarmacological studies nave shown it to be toxic to the liver and
the heart, and to be carcinogenic.
BEL
12 Feo. 1983
NGA
1 Feo. 85
Prohibited lor sale (Reference (BELAR) Arrete Royal . . Feb. 1983)
Chloroform is not allowed in cosmetic and drug products since 1 Feb 1985. From that date.
import, export and sale of products containing chloroform became illegal. The decision was
based on reports from literature of the carcinogenic effects of chloroform on animals and
possible hepatotoxic ano nephrotoxic effects after prolonged use by humans (Reference.
(AARNO) Administrative Action Reference Number MH 1856 S 3T(112).15 Sep. 1983)
. Following the action taken by the US Food and Drug Administration, the National Formulary
Commission requested removal of chloroform from pharmaceutical preparations.
THA
VEN
The use of pharmaceutical preparations containing chloroform is severely restricted.
Subject to restricted use and or sale.
WHO comment Chloroform was formerly widely used in pharmaceutical preparations as a
solvent and preservative as well as lor its anaesthetic and flavouring prooerties. By the late
1970s reservations concerning its safety, including positive results in a carcinogenicity screen
ing programme sponsored by the National Cancer Institute in the USA. had led to considerable
restrictions in its use in pharmaceutical preparations. While many pnarmaceuticai products
containing chloroform have been withdrawn or reformulatea to exclude this substance, it may
still be incorporated in toothpastes and other specified products in some countries, subject to
statutorily-imposed concentration limits. (Reference: (IARCCD) Chloroform: IARC Monograph
(Vol.20) 20.401-427 . 1979)
Bibliographical reference
*
IARC MONOGRAPH . SUPPL 4 . 64 , 1982
IARC MONOGRAPH . SUPPL 4 87 . 1982
IARC MONOGRAPH . 1 . 61 . 1972
=ARC MONOGRAPH . 20 401
1979
••ARC MONOGRAPH . 4 . 239 . 1974
...[Continued]
Legislative or regulative action
-..rrth issue
PHARMACEUTICALS IMONOCOMPONENT PRODUCTS)
449
—~~---------
Chloramphenicol ...[Continued]
and BRAND NAMES :
^ry-r<8t,n
^^Xr-.-^aiar
5r»<«/en
Ccf
*C
^
!f'a
V-sr-xern
§r«r-<8l're r
jcAXMcUWl
s,-CA-n«l:n
j^ijmo-daraxin
gc^rjjnxol
{fanomycetin
S^vcwne
c-vctog'obenicol
jt^cico^enicol
5iZ»tal supp.
Suismycetin
Sulfaglobemcol
Sulfamycetin
Synthomycetin
Synlhomycelina
Synthomycetme
Synthophtone
Tardomyocel
Tega-cetm
Tetra-phenicol oculos
Tetrachlorasone
Tetracol
Tetranfen
Tetraphemcol
Tevcocin
Tifomycme
™,an,,lk
Ii,on"'CB1,n
Toramm
Transicetina
Transpulmycm
Tribiotic
Troc
Trophen
Troymycenn
Tusoione
Tycloran
Unimycetm
Uro-gl.scai
Uro^l.scal 600
.. /
Uroietien-s
u,°P|ex 4
Ut forte
Uvomycin
V-crayoian
Vagiseot
Variolan
Vetical
Vetophemcol
Viceton
Viklorin
Virogin
V.taklorin
Vsmpozim
Wintetil
Zoppib spray blu
For regulatory information, see page 32
Chlornaphazine
494-03-1
TRADE AND BRAND NAMES :
A^wkcn
Chioronaltma
Naphthylamine mustard
Erysan
Nafticiorina
For regulatory information, see page 34
Chloroform
#7-66-3
TK*OE ANO BRAND NAMES :
Aflwtuss
Benated
Benatuss
Banyphed
8/oncho-fivo syrup
O'kx-histine
Co-specto
Codacol
Copimal dm
Cotroi-d
Cyproi expectrant
Daiet
Oectuss
Dristan
Eludril
Endal
Expec-c
^k-lussex
l,ufn|or
Histalix
Hydril
Kentuss
Linctuss
Me 3
Muflin
Nagalyn
Notose
Orthos kavident
P-m-z
Panosoma
Penta-zme
Phenacol-dm
Phenatuss
Phlogaroi
Promex
A 20
Rexahisine
Tussilene-dm
for regulatory information, see page 34
Chloroquine
54-05-7
TIUDE AND BRAND NAMES :
Aralen
Araien hcl
Aralin (diphosphate)
Artrichin
Artrochin
Avloclor (diphosphate)
...[Continued]
Manufacturer data
PHARMACEUTICALS (MONOCOMPONENT PRODUCTS!Fourth issue
110
Product name
Phthalylsulfathiazole
C.A.S number
85-73-4
Scientific and common names, and synonyms
BENZOIC ACID 2-(((4-(2-THIAZOLYLAMINO)SULFONYLPHENYL)AMINO)-CARBONYL»4--(2-THIAZOLYLSULFAMOYL)PHTHALANILIC acid
6‘-(THIAZOLYLAMINOSULFAMOYL)PHTHALANIC acid
Legislative or regulative action :
Country
Effective
Date
BGD
1932
:
Description of action taken
grounds for decision
Under the provisions of the Drugs (Control) Ordinance, this product has been banned. It nas
been found to be of little or no therapeutic value, its side effects can be harmful, and it is subject
to misuse. (Reference: (BGDCO) The Drugs (Control) Ordinance .. 1982>
WHO comment: Phthalylsulfathiazole. a sulfonamide anti-infective agent, was introduced in
1946 for the treatment of bacterial infections. The importance of sulfonamides has subse
quently decreased as a result of increasing bacterial resistance anc their replacement by
antibiotics which are generally more active and less toxic. Although phthalylsulfathiazole. which
is poorly absorbed from the gastrointestinal tract, is no longer recommended in some coun
tries. it continues to be used in others for the treatment of local intestinal infections, including
bacterial dysentery, and for pre-operative bowel preparation
Product name
Pipamazine
C.A.S number
84-04-8
Scientific and common names, and synonyms
lO-(3-{4-CARBAMOYLPlPERiD'NE)DROPYL)-2-CHLOROPHENOTHIAZINE
Legislative or regulative action .
Country
Effective
Date
Description of action taken
grounds for decision
USA
July 1969
Withdrawn from the market and prohibited for export by the Food and Drug Administration duo
to the lack of proof of efficacy and safety for use as an antinauseant and antiemetic for pregnant
women
WHO comment: Pipamazine. which is pharmacologically similar to chlorpromazine, was introouced m 1959 for the treatment of nausea and vomiting. Although it was withdrawn in 1969 by
the United States FDA on grounds ol lack of proof of efficacy and safety, it remains available in
some countries.
Product name
Piperazine
C.A.S number
110-85-0
Legislative or regulative action
Description of action taken
grounds for decision
Country
Effective
Dale
11 A
1977
Products with anthelminthic indications have oeen withdrawn aue to an unfavourable
risk benefit balance Since 1975 warnings have been added to tne labels concerning tpe
possibility of neurotoxic effects with high oosages. In 1979. the laoei was revised to advise us
*
on an empty stomach and for snort periods of time with long intervals, in order to avc interaction with nitrites
SWE
1923
tn the light of tne carcinogenic and mutagenic potential of pioerazme demonstrated in rece'studies, discussions between the manufacturers and the Department c' Drugs have led to :rwithdrawal of registration fc' this drug.
□NK
2 July 1984
Following recent evidence leading to tne possibility mat carcinogenic r.itroso-derivatives ''■ai
be generated in vivo, precarauons containing oioerazme nave been c.aced unoer prescrio--1-’
control. (Reference: (UGLAAD) Ugesknft for Laeger. 1949 . June 1984;
.
...(ContinuevJ
_____ '
Legislative or regulative action
'
pharmaceuticals imonocompqnent products.
pourthJsSHS.
Product name
Piperazine ...[continued]
islatwe or regulative action :
Effective
____________ Da,e
jsjld
1 Jan. 1985
Description of action taken
grounds for decision
The Board of Evaluation of Drugs has concluded that other anthelminthics have a more favoura
ble risk-benefit ratio than piperazine, which may also give rise to potentially carcinogenic
mtroso-derivatives. Manufacturers have been reouested to withdraw products containing
piperazine (Reference (NETJAN) Nederlands Tijdschrift voor Geneeskunde 128(41) ,, 1984)
The use of pharmaceutical preparations containing piperazine is severely restricted.
THA
WHO comment: Piperazine was first used as a treatment for gout earlier this century and its
anthelminthic activity was discovered in 1949 It continues to retain a place in the WHO Model
List of Essential Drugs because it is widely available, effective and apparently safe when used
on an occasional basis for the treatment of ascanasis infections. It is also considerably cheaper
than other anthelminthic drugs. In some countries wnere ascariasis is not endemic and where
piperazine was used predominantly for the treatment of pinworm it has been withdrawn from
use on the grounds that other more effective and less toxic drugs are now available. In other
such countries, however, piperazine remains available in over-the-counter preparations. Clini
cal dosages occasionally induce transient neurological signs and concern has been expressed
that m some circumstances the drug may generate small amounts ot mtrosamine in the stom
ach. However, it is widely considered that these trace doses are unlikely to give rise to a
significant carcinogenic potential. (Reference (WHODI) WHO Drug Information 1.5.1983)
Product name
Pipradrol
C A S number
467-80-7
Scientific and common names, and synonyms
aion3.aiona-DlPHENYL-2-PlPEAIDiNEMETHANOL
1 I -DIPHENYL-1 -.'2-P'PERlDYL)-ME7HANOL
Legislative or regulative action
Country
Effective
Date
TUR
6 Seo. 1982
Description of action taken
grounds tor decision
Banned for production, import, exoort. sale and use
DNK
Withcrawn from the market by the manufacturer
VEN
Not acoroved for use anchor sale.
WHO comment: Pipradrol a central nervous system stimulant, was introduced in 1955 fcr use
as an anorexic agent Pipradrol is controlled under Schedule IV of the 1971 Convention on
Psychotropic Substances (Reference (UNCPS) United Nations Convention on Psychotropic
Suostances (IV).. 1971)
Product name
Pituitary-chorionic gonadotropin (injectable)
Legislative or regulative act.on
Country
Effective
Date
Description of action taken
grounos lor decision
.
Juiy 1372
Gonacctrcpms of animal origin have been withdrawn from use and prohibited for export by tne
Food and Drug Administration on grounds of safety ano efficacy. In its decision tne FDA citea
tne risx of eliciting antibodies to animat orotein. leaomg to allergic reactions, and the availability
of safer and more effective alternatives. (Reference: (FEREAC) Federal Register 37(130) ,
13284 1972)
...[Continued]
USA
Legislative or regulative action
PHARMACEUTICALS (MONOCOMPONENT PRODUCTS)
435
phthalylsulfathiazole
*
S5-73AND BRAND NAMES :
£«_r-.CJn
g^a^da
r(-‘c#c-f,e'rT’es
frtc/Q-'L’d
rn!e*o-5u'l'na
£p»$ro-lo*an
Enterocalme
Enterostenl
Entexiqina
Esteraoiidm mag
Eugeniteea
Fitazil
Fiaiil-esteve
Ftahl-seotol
Ftahl-tiazol
Ftalyseot
Hentazol
Ingalipt
Inrestibla strepto
Intestiazol
lodentero-neormcina
Logical
Massotalil
Neo-sulfazon
Novosultina
Phtalazol
Phtazol
Porcijec
Seotiltalil
Sulfacetil
Sulfathalidine
Sull talyl
Syptan
Syralbina
Taleudron
Talidme
Talisulfazol
Taloudron
Tamil
Thalazole
Thalinil
Thatistanin
Thahstatyl
Thiazole
Trisulvet
Ultratiazol
Vetoryl
for regulatory information, see page 110
Pipamazine
84-04-8
TRADE AND BRAND NAMES :
Normetine
For regulatory information, see page 110
Piperazine
110-85-0
trade and brand names .
Adelminiex
Adipahs
Adipalit
i Adiprazme
Adi-.er
Ancaris thenium
Ancazme
Anielmma
Antepar
Antepar tb-w)
Anterobius
Anthaiazme
Aninelmma
Anncucs
Antiren
'Aniivermine
Anioban
^duvermm
A'pezme
^sca-troi no 3
Ascalix
^scarinex
Ascanvet
Asepar
Askaripar
^'•eramexan
9-Oioerazine
Bel-zme
S'-oxunn
Bnrel
Bryrel
Candizme
Ciperazin
Citrazme
Coopane
Dak
Demovermil
Diatesurico
Dicevermin
Dietelmin
Digesan
Dilaurazine
Dispermin
Diurazma
Divermex
Dowzene
Dyrex
Ecosan
Endorid
Entacyl
Entazin
Equizole-a
Eraverm
Escovermin
Esteropipate
Etaphylline (acetyllinate)
Exelmin
Exopin
Gentiazina
Glycopiparsol
Heksapar
Helmacid
Helmezin
Helmicide
Helmifren
Helmipar
Helmirazine (adipate)
Helmirazme (citrate)
Helmitin
Helmizin
Herb royal round worm treatment
Hexanthelin
#
ismiverm
Janes liquid permifu
Jarabe neox
Jetsan supp. (adipate)
Justalmin
Kennel-maid
Kihomato
Kontipar
Lamboxil
Lorn
Lombricida tropico
Lombrifher
Lombnkal
Lombrimade
Lumbrical
...[Continued]
Manufacturer data
144
PHARMACEUTICALS (COMBINATION PRODUCTS)
Product name
Medroxyprogesterone acetate/ethinyl estradiol
Legislative or regulative action ,
Country
Effective
Date
Description of action taken
grounds for decision
v?,
-’Ma
—'—4®
Withdrawn from the market and prohibited for export by the Food and Drug Administration aft
studies in dogs showed an increased incidence of mammary tumors from the medroxB
yprogesterone acetate component.
USA
Product name
Meprobamate/diazepines
Legislative or regulative action
Country
Effective
Date
GRC
1980
Product name
Description of action taken
grounds for decision
Withdrawn from the market since the combination is considered unacceptable having regard to
the higher incidence of adverse reactions than reported with monocomponent preparations.
Mepyramine maleate
Scientific and common names, and synonyms
PAMABROM PYRILAMINE MALEATE
PYRILAMINE MALEATE/PAMABROM
Legislative or regulative action
Country
Effective
Date
USA
1974
Product name
Description of action taken
grounds for decision
Combinations of pamabrom and mepyramine maleate (pyrilamine maleate) have been with
drawn from the market
Metoclopramide/polidocanol
Legislative or regulative action
Country
Effective
Date
PHL
Mar. 1983
Product name
Description of action taken
grounds for decision
Disapproved for use in gastrointestinal disturbances since marked liver toxicity limits its thera
peutic use.
Neomycin sulfate/polymyxin bisulfate/nystatin/acetarsol
Legislative or regulative action
Country
Effective
Date
PHL
Sep. 1977
Description of action taken
grounds for decision
This combination, for use in trichomonal vaginitis, has been disapproved due to the irrational
and potentially harmful nature of the combination, which is not shown to be more effective than
its individual ingredients given separately in appropriate doses.
Legislative or regulative action
6
PHARMACEUTICALS (MONOCOMPONENT PRODUCTS)
Product name
Acetylfuratrizine ,
C.A.S number
1789-26-0
Fourth issue
Scientific and common names, and synonyms
N-(6-(2-(5-NITRO-2-FURYL)VINYL)-1.2.4-TRIAZIN-3-YL) ACETAMIDE
Legislative or regulative action :
Country
Effective
Date
Description of action taken
grounds for decision
JPN
July 1977
Withdrawn from all marketed preparations on the grounds that it has been superseded by safer
and more effective preparations
The withdrawal of nitrofuran compounds from the market is under consideration since they
have been superseded by safer and more effective oreparations.
SAU
Not approved for use and.'or sale.
VEN
WHO comment: Acetylfuratrizine. a nitrofuran derivative, was formerly used as an antimfective
agent. It has. however, been superseded by safer compounds and WHO has no information to
suggest that it remains commercially available
Product name
Acetylsalicylic acid (paediatric)
C.A.S number
50-78-2
Scientific and common names, and synonyms
ASPIRIN
BENZOIC ACID 2-(ACETYlOXY).
SALICYLIC ACID ACETATE
Legislative or regulative action
Description of action taken
grounds for decision
Country
Effective
Date
CHE
1986
The Intercantonal Drug Control Office has decided that products containing salicylates should
bear on the package a warning against use by children under twelve years of age, except on
medical advice The package leaflets directed to both physicians and patients should addition
ally include warnings concerning Reye's syndrome tn both the sections "Limitations of use"
and "Undesirable effects". (Reference: (CHBCM) Bulletin Mensuel 8 , , 1986)
IRQ
1986
The National Board for the Selection of Drugs has decided to prohibit the sale of products
containing acetylsalicylic acid without a medical prescription. The product information should
contain a warning that acetylsalicylic acid should be avoided in children suffering from in
fluenza or chickenpox and that children under 12 years of age should receive acetylsalicylic
acid only on medical advice
Banned for use in children under the age of 12 years.
NGA
1986
ISR
Feb. 1986
The Ministry of Health has ordered that preparations of acetylsalicylic acid intended specifi
cally for children be subjected to prescription control and that all preparations should contain a
warning referring to the reported risk of Reye's syndrome in children and young adults with
fever due to viral infections.
ITA
June 1986
The Italian Health Council has decided that all products containing acetylsalicylic acid should
bear the following warning: "Consult your physician before administering this product to chil
dren and teenagers with viral diseases such as influenza or chicken pox. Discontinue use
immediately if persistent vomiting or undue sleepiness occurs.".
IRL
9 June 1986
The National Drugs Advisory Board, in agreement with manufacturers, requires that all
paediatric dosage forms be available on prescription only. All preparations should carry the
warning "This product should not be given to children, particularly those under 12 years of age,
without medical advice.".
GBR
10 June 1986
The Committee on Safety of Medicines has advised that acetylsalicylic acid should not be
administered to children under 12 years of age except on medical advice. Leading manufactur
ers have declared their intention to stop supplying paediatric preparations.
...[Continued]
Legislative or regulative action
Fourth issue
PHARMACEUTICALS IMONOCOMPONENT PRODUCTS)
Product name
Acetylsalicylic acid (paediatric) ...[Continued]
Legislative or regulative action ;
)
Country
Effective
Date
AUS
11 June 1986
The Adverse Drug Reactions Advisory Committee has warned that acetylsalicylic acid should
not be given to children and teenagers with fever. The warning does not relate to use for
disorders in children and teenagers who do not have fever
ESP
7 Aug. 1986
The Director General for Pharmacy and Health Products of the Ministry of Health has issued
guidelines for package inserts for preparations containing acetylsalicylic acid. A warning
should be included stating that the preparation should be administered to children and adoles
cents with febrile conditions such as influenza or varicella only on medical advice.
HKG
1 Seo. 1986
The Medical and Health Department requires that the product information for all preparations
containing acetylsalicylic acid must warn against its use in children under 12 years of age.
except on medical advice. Manufacturers are urged to withdraw all paediatric preparations.
DEU
Oct. 1986
The Federal Health Office requires pharmaceutical preparations containing acetylsalicylic acid
to bear a warning against use for feverish conditions in children and young people unless on
medical advice and only if other measures have failed.
OMN
Dec. 1986
The Central Drug Committee has informed doctors and pharmacists that no products contain
ing acetylsalicylic acid (aspirin) should be given to children under 12 years of age who have
chicken pox. influenza or any other febrile illness. Paediatric aspirin preparations will be avail
able only from pharmacies. Products for export containing acetylsalicylic acid should bear the
following statutory warning on new packs:"This product should not be given to children, par
ticularly those under 12 years of age. without medical advice."
EGY
1987
The Technical Committee for Drug Control has decided that the product information of all
paediatric pharmaceutical products containing acetylsalicylic acid should bear the following
warning: "Consult a physician before giving aspirin to children aged less than 12 years, espe
cially m cases of influenza and chickenpox, to avoid risk of Reye's Syndrome." (Reference
(EGYDC) Decision of the Egyptian Techmcal Committee for Drug control Vol 5(2). 1. 1987)
CHL
2 Feb. 1987
The Institute of Public Health of Chile has decided that all pharmaceutical products containing
acetylsalicylic acid should carry a warning on the label that the drug should not be given to
children under 12 years of age with febrile viral diseases without consulting a doctor
(Reference. (CHLRS) Resolution of the Minister of Health No 01042 . , Feb. 1987)
DNK
1 July 1987
The National Board of Health has decided that pharmaceutical preparations containing acetyl
salicylic acid in paediatric dosages (less than 200mg tablel) should bear the following warning:
"Not to be given to feverish children without consulting a doctor.".
SGP
1 Dec. 1987
The Ministry of Health has made it mandatory for all aspirin products to bear the cautionary
label "Caution, not to be given to persons below the age of 16 years except under the direction
of a doctor" before the products can be sold in the market. The public is advisea not to give
their children any medicine containing aspirin unless otherwise advised by the doctor
(Reference: (SGPMA) Medicines Act (Chapter 176). No.S 230 87 . 1078 . Aug. 1987)
SWE
1988
The National Board of Health and Welfare has revised the product information for preparations
containing acetylsalicylic acid to recommend that they should not be taken by febrile children
under 18 years of age and to indicate that paracetamol is the drug of choice in these cir
cumstances. (Reference: (SSLMS) Information fraan Socialstyrelsens Laekemedelsavdelning
Vol.12(6). 145. 1987)
BEL
1 Jan. 1988
The Ministry of Public Health and the Environment requires pharmaceutical products contain
ing acetylsalicylic acid to bear the following warning: "This medicine contains acetylsalicylic
acid. Do not use in feverish children without medical advice.". (Reference: (BELMD) Ministerial
Decree ,. June 1987)
USA
June 1988
The United States Food and Drug Administration has revised the labelling of products contain
ing acetylsalicylic acid to read: "Children and teenagers should not use this medicine for
chickenpox or flu symptoms before a doctor is consulted about Reye's syndrome, a rare but
serious illness, reported to be associated with aspirin." (Reference: (FEREAC) Federal Register
Vol.53,(111). 21633 , 1988)
...[Continued]
Description of action taken
grounds for decision
Legislative or regulative action
PHARMACEUTICALS (MONOCOMPONENT PRODUCTS'
Product name
Fourth issue
Acetylsalicylic acid (paediatric) ...[Continued]
Legislative or regulative action
Country
Effective
Date
Description of action taken
grounds for decision
The Board for the Evaluation of Medicines requires information for patients on products con
taining acetylsalicylic acid to contain the statement. "To be used in children with chickenpox or
influenza only on the advice of a doctor.".
NLD
WHO comment: Acetylsalicylic acid, a nonsteroidal antiinflammatory, analgesic and antipy
retic agent, was introduced into medicine in 1899 and has since been widely available in
over-the-counter preparations Recent studies carried out in the USA have shown an associ
ation between acetylsalicylic acid consumption in children and the development of Reye's
syndrome (a rare condition characterized by a combination of encephalopathy and liver dis
order and usually preceded by an acute viral illness, such as influenza, diarrhoea, or chicken
pox). Although these studies were initially criticized for their design, there is now a broad
consensus that a link between acetylsalicylic acid and Reye's syndrome has been established.
particularly since the reported incidence of Reye's syndrome in the United States has fallen
appreciably since the association was first postulated in 1980. In the interim, many drug regula
tory authorities have acted to caution against the use of tne drug in children and young adults
with febrile conditions Even within this group the risk of exposure is remote and has been
estimated to be of the order of 1.5 per million Acetylsalicylic acid retains a valuable place in
medicine and remains in the WHO Model List of Essential Drugs (Reference- (WHODI) WHO
Drug Information 1.5, 1985)
Product name
Acridine derivatives
C.A.S number
260-94-6
Scientific and common names, and synonyms
EUFlAVINE
proflavine
Legislative or regulative action
Country
Effective
Date
Description of action taken
grounds for decision
ITA
1973
These products are only available as topical disinfectants in concentrations not higher than 1%.
DNK
Sep. 1979
Proflavine was withdrawn from all dental-care products in May 1978, following demonstration of
mutagenic activity in vitro. Euflavme was similarly withdrawn as of September 1979. No direct
evidence exists of any risk to man and the extent to which these substances penetrate mamma
lian cells is uncertain. Nevertheless, the Registration Board has recommended that the restric
tion should apply to all acridine disinfectants "that many regard as obsolete and whose safety
is questionable".
Not approved for use and.'or sale.
VEN
WHO comment: Acridine derivatives with antiseptic and disinfectant activity, including acrifla
vine. proflavine and euflavme, were formerly used in the treatment of infected wounds and
burns. Such use has largely been discontinued on the grounds that safer and more effective
alternatives are now available Following demonstration of the mutagenic activity of proflavine
in 1978 it was withdrawn from dental products in Denmark. Subsequently, euflavine was simi
larly withdrawn.
Product name
Alclofenac
C.A.S number
22131-79-9
Scientific and common names, and synonyms
(4-ALLYLOXY-3-CHLOROPHENYL) ACETIC ACID
BENZENEACETIC ACID. 3-CHLRO-4-(2-PROPENYLOXY)-
...[Continued]
Legislative or regulative action
Product name
Acetylsalicylic acid/phenacetin/caffeine (APC)
CAFFEINE PHENACETIN ACETYLSALICYLIC ACIO
PHENACETIN/ACETYLSALICYLIC ACID.CAFFEINE
,^islative or regulative action :
? 5 •
!
v -
Country
Effective
Date
... THA
1983
Product name
Description of action taken
grounds for decision
Banned for manufacture for immediate effect but existing stocks may be sold for a further
period of one year. Preparations must be reformulated to contain only acetylsalicylic a&d.
Antirheumatic combinations with glucocorticosteroids
Le<jislative or regulative action
Country
Effective
Date
A)AUT
Jan. 1986
Enteral preparations have been withdrawn and parenteral preparations may only be used for
very limited indications and under strict medical supervision
DEU
1 Jan. 1986
Fixed combinations have been withdrawn since concurrent administration of such drugs potentiates adverse effects without increasing benefit.
■ '
■
:
Description of action taken
grounds for decision
Product name
Atropine
C.A.S number
51-55-8
Scientific and common names. and synonyms
alpha H. 5alpha H-TROPAN-3alpha-OL( + <-)-TROPATE (ESTER)
BENZENEACETIC ACID. alpha-(HYDROXYMETHYL)-8-METHYL-8-AZABlCYCLO(3 2 1) OCT-3-YL ESTER. ENDO (*
'-)
Legislative or regulative action
1
Country
Effective
Date
PHL
Sep. 1976
Description of action taken
grounds for decision
Combinations of atropine sulfate with difenoxylate. furazolidone and dimethylpolysiloxane have
been disapproved due to possible adverse reactions such as dysuria (from atropine and
furazolidone), tachycardia, palpitation and blurring of vision
WHO comment: Atropine, an alkaloid with anticholinergic activity extracted from Atropa bel
ladonna. has been widely used in medicines for centuries. The action taken in the Philippines
relates specifically to the use of atropine in combination products. Elsewhere, preparations
containing atropine remain available and the substance is included in the WHO Model List of
Essential Drugs. (Reference: (WHODI) WHO Drug Information 2.1. 1988)
•
Product name
Barbiturates in combination
Scientific and common names, and synonyms
ANALGESICS/BARBITURATES
ANTACIDS/BARBITURATES
antiasthmatics/barbiturates
...[Continued]
Legislative or regulative action
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Consolidated List of Drugs/fixed Dose combination of
Drugs Banned by The Central Government
Under Section 26A of the
Drugs And Cosmetics Act 1940
1.
2.
3.
4.
5.
6.
7.
Amidopyrine.
Fixed dose combinations of Vitamins with antiinflamatory agents
and tranquillisers.
Fixed dose combinations of Atropine in Analgesics and Anti
pyretics.
Fixed dose combinations of Strychnine and Caffeine in tonics.
Fixed dose combinations of Yohimbine and Strychnine with Testosterose and Vitamines.
Fixed dose combinations of Iron with Strychnine, Arsenic and
Yohimbine.
Fixed dose combinations ot Sodium Bromide/Chloral hydrate
with other drugs.
7. Fixed dose combinations of Iron with Strychnine, Arsenic Yohim
bine.
0
8. Phenecatin.
9.
Fixed dose combinations of Anti-histaminics with anti-diarrhoeals.
10.
11.
12.
13.
Fixed dose combinations of Penicillin with Sulphonamides.
Fixed dose combinations of Vitamins with Analgesics.
Fixed dose combinations of Tetracycline with Vitamin C.
Fixed dose combinations of Hydroxyquinoline group of Drugs
except preparations which are used for the treatment of diarrhoea
and dysentry and for external use only.
6
Fixed dose combinations of Corticosteroids with any other drug
for internal use.
15. Fixed dose combinations of Chloramphenicol with any other drug
for internal use.
16. Fixed dose combinations of Ergot.
17. Fixed dose combinations of Vitamins with anti-T.B. drugs except
combination of Isoniazide with pyridoxine Hydrochloride
(Vitamin Be).
18. Penicillin Skin/Eye Ointment.
19. Tetracycline liquid oral preparations.
14.
20.
21.
22.
23.
24.
25.
26.
27.
Nialamide
Proactolol.
Methapyrilene, its salts.
Methequalone.
Oxytetracycline Liquid Oral Preparations.
Demeclocycline Liquid Oral Preparations.
Combination of Anabolic Steroids with other drugs.
Fixed dose combinations of Oesterogen and Progestin (Other
than oral contraceptives) containing per table estrogen content
of more than 50mg. (equivalent to Ethenyle Estradiol) and of
progestin content of more than 3 mg. (equivalent to Norethisterone
Anetate)
28.
Fixed dose combinations of Sedatives/hypnotics/anxiolytics with
analgesic- antipyretics.
29. Fixed dose combinations of Pyrazinamide with other anti- tubercules drugs except combination of Pyrazinamide with Rifampicin
and INH as per recommended daily dose given below.
Minimum
Maximum
Drug
450mg.
600mg.
Rifampicin
400mg.
300mg.
INH
1500mg.
Pyrazinamide lOOOmg.
30. Fixed dose combination of Histamine H2-receptor antigonists
with antacids except for those combinations approved by the
Drugs Controller (India).
7
31. The patent and proprietory medicines of fixed dose combinations
of essential oils with alcohol having percentage higher than 20%
proof except preparations given in the Indian Pharmacopoeia.
32. All Pharmaceutical preparations containing Chloroform exceeding
0.5% w/w or v/v whichever is appropriate.
33. Fixed dose combination of Ethambutol with INH other than the
following: __________________________
Ethambutol
INH
600 mg.
200 mg.
800 mg.
300 mg.
34. Fixed dose combinations of Containing more than one antihis
tamine.
35. Fixed dose combinations of Anthahnintic with cathetric/purgative
except for piperazine.
36. Fixed dose combinations of Salbulamol or any other
bronchodilator with central acting anti-tussive and/or, antihis
tamine.
37. Fixed dose combinations of Laxatives and/or, antispasmodic
drugs inenzyme preparations.
38. Fixed dose combinations of Metoclopramide with other drugs
except for preparations containing metoclopramide and aspirin/
paracetamol.
39. Fixed dose combinations of Centrally acting, antitussive with
antihistamine having high atropine like activity in expectorant.
40. Preparations claiming to combat cough associated with asthrj^|
containing centrally acting anti-tussive and/or antihistamine.
41. Liquid oral tonic preparations containing glycerophosphates
and/or other phosphates and/or central nervous system
stimulant and such preparations containing alchol more than
20% proof.
42. Fixed dose combinations of Containing Pectin and/or Kaolin
with any drug which is systemically absorbed from GI tract
except for combinations of Pectin and/or Kaolin with drugs not
systemically absorbed
44. Dovers Powder LP.
45. Dovers Powder tablets LP.
46. Chloral Hydrnte as a drug
8
Consumer Awareness Series - 2
Rights and Responsibilities
of Patients
&
List of Banned drugs
Published by
CREAT
Consumer Rights, Education & Awareness Trust
239, 5th C Main, Remco Layout, Vijayanagar, Bangalore-560 040
PATIENT’S RIGHTS AND RESPONSIBILITIES
PART 1: PATIENT’S RIGHTS:
Section 1: RIGHT TO HEALTH CARE AND HUMANE TREATMENT:1 Every individual shall have access to adequate and appropriate
health care and treatment.
2. Every patient shall be treated with care, consideration, respect
and dignity without discrimination of any kind.
3. A Patient has tire right to be treated by fully qualified health
care professionals in private or public health care facilities.
A Patient has, wherever possible, the right to be treated at a
hospital of his choice and to be referred to a consultant of his
choice.
5. Every individual shall have the right to prompt emergency treat
ment from the nearest government or private medical and health
facility.
6. Patients have the right to humane terminal care and to die in
dignity.
7. A Patient can be transferred to another health care establishment
only after an explanation of the need for this transfer and after
the other establishment has accepted the patient.
8. A patient has the right to have all identifying information, results
of investigations, details of his condition and his treatment kept
confidential and not made available to anyone else without his
consent.
Section 2: CONSENT:-
4.
1.
Before any treatment or investigation, a patient shall have the
right to a clear, concise explanation in lay terms of the proposed
procedure and of any available alternative procedure. Where
applicable, the explanation shall include information of risks,
side effects, or after-effects, problems relating to recuperation,
likelihood of success, and risk of death. Informed consent of
the patient must be obtained prior to the conduct for a treatment
or a procedure. In the case of a minor, consent has to be obtained
from the parent or guardian. If a patient is incapacitated and
any delay would be dangerous, a doctor is entitled to carry out
2
any neessary treatment or operation after a second opinion is
obtained.
2. A Patient has the right to refuse treatment to the extent permitted
by law and to be informed of the medical consequences of his
decision.
Explicit, informed consent is a prerequisite for participation in
scientific experimentation. Experimentation must not be carried
out on any patient who is unable to express his will.
Section 3: RIGHT TO INFORMATION:1. Information about health services (including recent developments
in the field) and how best to use them is to be made available
to the public in order to benefit all those concerned
2. Information may be withheld from patients in cases where there
is good reason to believe that this information would affect the
patient’s health adversely but, however, the information must
be given to a responsible relative.
3. A patient has the right to know the identity and the professional
status of the individuals providing service to the patient and to
know which professional is primarily responsible for the patient s
care.
3.
Patients should have the right to seek a second opinion from
another physician.
5. Patients should upon request, be able to obtain a copy of summary
of their diagnosis, treatment and care including diagnostic results
on discharge from a hospital or other establishment. They shal'
lalso have the right to authorise another medical professional
to obtain a copy of the same and to inform the patient of the
contents.
4.
A patient shall have the right to examine and receive an ex
planation of his bill after any treatment and consultation.
Section 4: THE RIGHT TO ADEQUATE PRESCRIBING INFORMATION.1. While prescribing medication, the patient should be informed
about the following:Expected outcome, adverse and after effects, chances of success.
risks, cost and availability.
6.
3
All drugs dispensed shall be of acceptable standards in terms
of quality, efficinacy and safety.
3. All medicines shall be labelled and shall include the pharmacologi
cal name of the medicine.
Section 5: RIGHT TO REDRESS GRIEVANCES:1. A Patient shall have access to appropriate redressal procedures.
2. A patient shall have the right to legal advice as regards any
malpractice by the hospital, the hospital staff or by a doctor or
other health professional.
Section 6: RIGHT TO HEALTH EDUCATION
1. Every individual shall have the right to seek and obtain advice
with regard to preventive and curative medicine, after care and
good health.
2.
PART 2: PATIENT’S RESPONSIBILITIES:
1.
2.
3.
4.
5.
6.
7.
The patient shall ensure that he or she knows and understand
what a patient's rights are and shall exercise those rights respon
sibly and reasonably.
The patient shall ensure that he or she understands the purpose
and cost of any proposed investigation or treatment before decid
ing to accept it.
The patient shall accept all the consequences of the his/her
own informed decisions.
The patient shall provide accurate and complete information
which the health professional requires about his or her health
and ability to pay for health services.
The patient shall establish a stable relationship with and follow
the treatment determined by the health professional primarily
responsible for the patient's care
The patient shall inform the health professional if he or she is
currently consulting with or under the care of another health profes
sional in connection with the same complaint or any other complaint.
The patient shall so conduct himself or herself so as not to
interfere with the well being or rights of other patients or providers
of health care.
4
Every individual has a responsibility to maintain his or her own
health and that of society by refraining from indulging in high
risk behaviour detrimental to health.
9. Every individual has a responsibility to accept all preventive
measures sanctioned by law.
8.
Consolidated List of Drugs/fixed Dose combination of
Drugs Banned by The Central Government
Under Section 26A of the
*
Drugs And Cosmetics Act 1940
1. Amidopyrine.
2. Fixed dose combinations of Vitamins with antiinflamatory agents
and tranquillisers.
3. Fixed dose combinations of Atropine in Analgesics and Anti
pyretics.
4. Fixed dose combinations of Strychnine and Caffeine in tonics.
5. Fixed dose combinations of Yohimbine and Strychnine with Testosterose and Vitamines.
6. Fixed dose combinations of Iron with Strychnine, Arsenic and
Yohimbine.
7. Fixed dose combinations of Sodium Bromide/Chloral hydrate
with other drugs.
7. Fixed dose combinations of Iron with Strychnine, Arsenic YohimI bine.
8. Phenecatin.
9. Fixed dose combinations of Anti-histaminics with anti-diarrhoeals.
10. Fixed dose combinations of Penicillin with Sulphonamides.
11. Fixed dose combinations of Vitamins with Analgesics.
12. Fixed dose combinations of Tetracycline with Vitamin C.
13. Fixed dose combinations of Hydroxyquinoline group of Drugs
except preparations which are used for the treatment of diarrhoea
and dysentiy and for external use only.
5
Fixed dose combinations of Corticosteroids with any other drug
for internal use.
15. Fixed dose combinations of Chloramphenicol with any other drug
for internal use.
16. Fixed dose combinations of Ergot.
17. Fixed dose combinations of Vitamins with anti-T.B. drugs except
combination of Isoniazide with pyridoxine Hydrochloride
(Vitamin Be).
18. Penicillin Skin/Eye Ointment.
19. Tetracycline liquid oral preparations.
14.
Nialamide
Proactolol.
Methapyrilene, its salts.
Methequalone.
Oxytetracycline Liquid Oral Preparations.
Demeclocycline Liquid Oral Preparations.
Combination of Anabolic Steroids with other drugs.
Fixed dose combinations of Oesterogen and Progestin (Other
than oral contraceptives) containing per table estrogen content
of more than 50mg. (equivalent to Ethenyle Estradiol) and of
progestin content of more than 3 mg. (equivalent to Norethisterone
Anetate)
28. Fixed dose combinations of Sedatives/hypnotics/anxiolytics with
analgesic- antipyretics.
20.
21.
22.
23.
24.
25.
26.
27.
29.
Fixed dose combinations of Pyrazinamide with other anti- tubercules drugs except combination of Pyrazinamide with Rifampicin
and INH as per recommended daily dose given below.
______________ Drug______ Minimum
Maximum
Rifampicin
450mg.
600mg.
INH
300mg.
400mg.
____________ Pyrazinamide IQOOmg.
1500mg.
__
30. Fixed dose combination of Histamine H2-receptor antigonists
with antacids except for those combinations approved by the
Drugs Controller (India).
6
The patent and proprietory medicines of fixed dose combinations
of essential oils with alcohol having percentage higher than 20%
proof except preparations given in the Indian Pharmacopoeia.
32. All Pharmaceutical preparations containing Chloroform exceeding
0.5% w/w or v/v whichever is appropriate.
33. Fixed dose combination of Ethambutol with INH other than the
following:
INH
Ethambutol
200 mg.
600 mg.
___ _______ 300 mg.___________ 800 mg._________________
34. Fixed dose combinations of Containing more than one antihis
tamine.
35. Fixed dose combinations of Anthalmintic with cathetric/purgative
except for piperazine.
36. Fixed dose combinations of Salbulamol or any other
bronchodilator with central acting anti-tussive and/or, antihis
tamine.
37. Fixed dose combinations of Laxatives and/or, antispasmodic
drugs inenzyme preparations.
38. Fixed dose combinations of Metoclopramide with other drugs
except for preparations containing metoclopramide and aspirin/
paracetamol.
39. Fixed dose combinations of Centrally acting, antitussive with
antihistamine having high atropine like activity in expectorant.
40. Preparations claiming to combat cough associated with asthma
containing centrally acting anti-tussive and/or antihistamine.
41. Liquid oral tonic preparations containing glycerophosphates
and/or other phosphates and/or central nervous system
stimulant and such preparations containing alchol more than
20% proof.
42. Fixed dose combinations of Containing Pectin and/or Kaolin
with any drug which is systemically absorbed from GI tract
except for combinations of Pectin and/or Kaolin with drugs not
systemically absorbed
44. Dovers Powder l.P.
45. Dovers Powder tablets l.P.
46. Chloral Hydrnte as a drug
31.
7
TIPS TO CONSUMERS
1. Always buy drugs from a licenced dealer
2. Avoid self modification. Consult qualified Doctors and obtain
prescription
3. Insist on Cash bill. The dealer is required by law to issue cash
bill for every transaction.
4. Check the drugs before leaving te counter and ensure that what
has been dispensed is the one that is prescribed. Preferably go
back to the Doctor to show the drug purchased
5. Check expiry date and the maximum retail price printed on the(
label/container
6. Certain drugs have to be stored in the refrigerator to preserve
potency. The storage condition will be mentioned on the label.
Refuse to accept if the storage is improper.
7. Report any untoward reaction to your physician
8. Follow the instructions while taking the drugs. Always complete
the course of treatment. Do not discontinue in the middle unless
advised by your physician
9. Destroy the containers after use or destroy the label before dis
posing
10. In case of doubt on the quality or price charaged do not hesitate
to report to the nearest office of the Assistant Drugs Controller
or Drugs Inspector
Bangalore Address:
Drugs Controller Office,
(
Palace Road, Bangalore-560 001
Phone No: 2264760
Based on the Resulations adopted at the Workshop on
Medicine, Media and Consumer Education held at Pondicherry
and guidelines issued by Drugs Controller, Karnataka
8
Position: 988 (3 views)