An Independent Evaluation of the National Pharmaceutical Pricing Policy, 2012 and Drug Prices Control Order, 2013
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- Title
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An Independent Evaluation of the
National Pharmaceutical Pricing Policy, 2012
and Drug Prices Control Order, 2013 - extracted text
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ISID
ISID-PHFI Collaborative Research Programme
An Independent Evaluation of the
National Pharmaceutical Pricing Policy, 2012
and Drug Prices Control Order, 2013
Sa
Institute for Studies in Industrial Development
4, Institutional Area Phase II, Vasant Kunj, New Delhi - 110 070, INDIA
DRAFT, NOT TO BE QUOTED WITHOUT PERMISSION
ISID
ISID-PHFI Collaborative Research Programme
An Independent Evaluation of
National Pharmaceutical Pricing Policy, 2012
and Drug Prices Control Order, 2013
Sakthivel Selvaraj, Malini Aisola & Aashna Mehta
PHR
Dinesh Abrol
ISID
in collaboration with
Pavani Nuti
Indranil Mukhopadhyay
K.S. Chalapati Rao
Nidhi Singh, Bilqeesa Bhat & Rajesh Gupta
We thank Amitava Guha and C.M. Gulati for valuable inputs and feedback. Thanks are also due to Amit
Sengupta, Kajal Bhardwaj and K.M. Gopakumar for useful comments. We are grateful to S. Srinivasan, Anurag
Bhargava, Mira Shiva, and the Chairman and several officials of the NPPA for their time and valuable
discussions. Special thanks also go to IMS Health and AIOCD AWACS. All outstanding errors are our own.
CONTENTS
Chapter 1
Introduction
1
Chapter 2
Objectives and Methods
8
Chapter 3
Access to Medicines in India
15
Chapter 4
Concentration, Competition and Price Control
23
Chapter 5
DPCO, 2013: Coverage and Its Impact
48
Chapter 6
Limitations of NPPP 2012 and DPCO 2013 in Fixing Ceiling Prices
67
Chapter 7
Innovation, Exports and Price Control
76
Chapter 8
Policymaking for Price Control Mechanism
88
Chapter 9
Conclusions and Recommendations
95
Appendices
98
CHAPTER 1
INTRODUCTION
India is often referred to as the pharmacy of the south. The Indian pharmaceutical
industry currently produces over(^l 00,000 crores (US $ 20 billion) worth of drugs, 40
per cent of which are supplied to patients in other countries. India currently boasts of
having over 350 drug producing units that are endorsed by the EU (European Union)
as Good Manufacturing Practices (GMP) complaint and several sites that are US FDA
(United States Food and Drug Authority) approved, an achievement only few
countries could dream of. Paradoxically, India is also home to where fifty to sixty-five
per cent of the people do not have regular access to essential medicines’. The majority
(70%) of healthcare expenditure is out-of-pocket expenditure of which in turn 70 per
cent is spent on medicines alone2’3. This is the result of a historic neglect of public
health institutions and continued poor investment in drug procurement and
distribution systems. This means that in a country where poverty and deprivation are
rampant, people are spending substantial proportions of their meagre disposable
income on highly priced medicines from the private sector in the absence of an
effective mechanism for price regulation. Regulation and control of medicine prices in
the private sector is therefore critical to ensure affordable access to essential
medicines for patients.
Critics of price control argue in favour of laissez-faire, leaving the market to its own
devices. The fact however is that the pharmaceutical industry is characterised by high
concentration where competition is based on market dominance, as is evident from
the fact that the sales leader is often observed to be charging the highest price;
extensive branding; and promotional practices. Moreover, because of information
asymmetry, the demand for medicines is essentially supplier-induced. This gives the
pharmaceutical firms an unfair advantage as they are able to push highly priced
brands by influencing physicians and creating attractive incentives for pharmacists. In
1
2
3
WHO (2004), The World Medicine Situation, WHO/EDM/PAR/2004-05.
Selvaraj, Sakthivel and Veena Nabar (2010), Access to Medicines in India: Issues, Challenges and
Response, ed. in India Health Report, Business Standard Publications.
Garg CC & Karan AK 2009. Reducing out-of-pocket expenditures to reduce poverty : a
disaggregated analysis at rural-urban and state level in India. Health Policy and Planning: 116-128
the face of such peculiarities of the pharmaceutical industry, price regulation is
inevitable and most countries around the world have in fact adopted price regulation,
sometimes in more ways than one, in the form of fixed margins for retailers and
wholesalers, price freezes, ceilings on promotional expenditures, to name a few.
Table 1.1 provides a synoptic view of the history of price control of medicines in
India, from 1963-2013.
In India, price control over drugs was introduced for the first time with the
promulgation of the Drugs (Display of Prices) Order, 1962 & Drugs (Control of
Prices) Order, 1963 under the Defence of India Act in light of Chinese aggression and
prices of drugs were frozen with effect from 1 st April, 1963. Subsequently, the Drugs
(Prices Control) Order, 1966 was issued under the Essential Commodities Act, 1955
and medicines were declared to be essential commodities4. Under this order, it was
obligatory for the manufacturers to obtain prior approval of the government before
. increasing the prices of all listed formulations. This was followed by the Drugs
(Prices Control) Order of 1970, aimed at reducing the prices of essential medicines by
curbing excessive profitability (over 15 per cent of sales turnover) and promoting
research and development5.
The Hathi Committee Report (1975) was the primary harbinger of pharmaceutical
policies in India, which outlined 224 recommendations spread across eight themes on
the various aspects of the pharmaceutical industry. In respect of price control, the
committee came to the conclusion that rather than controlling the prices of all
medicines, it would be desirable to be more selective in terms of size of the units,
selection of items and controlling the price of only market leaders for particular
products. The committee also recommended that ceiling prices be fixed based on an
investigation of costs of production of two or three leading manufacturers. Further, it
also endorsed the development of an effective and continuous system of monitoring
4
5
Department of pharmaceuticals, 2011, National Pharmaceutical Pricing Policy, Ministry of
Chemicals and Fertilizers, Government of India
Task Force to Explore Options other than Price Control for Achieving the Objective of Making
Available Life-saving Drugs at Reasonable Prices, 2005, Department of Chemicals &
Petrochemicals, Government of India
2
production and stocks, costs, sales, profitability, raw material availability, emerging
shortages etc. in respect of the pharmaceutical industry6.
Recommendation of Hathi Committee Report, 1975
A system of price regulation based on investigations of cost should continue for the
bulk drugs for which production has not been established and imports are necessary.
More selectivity should be adopted in the system of price regulation for formulations
in terms of
i.
size of units: units with annual turnover is < Rs.l crore may be exempted
ii.
selection of items: all formulations except those with an annual all India sale
of Rs. 25 lakhs should be under price control whether the annual turnover is <
Rs. 1 crore or not. Govt, may as an exception include any particular products
under price control in public interest
iii.
controlling the prices of only market leaders for particular: prices of only the
leading products that account for say 60 percent of the sales of the relevant
product group should be controlled on the basis of cost analysis.
An effective and continuous system of monitoring production and stocks, costs, sales,
profitability, raw material availability, emerging shortages etc. should be developed in
respect of the pharmaceutical industry should be developed.
The Drugs (Prices Control) Order 1979 following the declaration of Drug Policy,
1978 placed 347 bulk drugs and their formulations under price control. The concepts
of retention price, pooled price, Drug Prices Equalization Account (DPEA) and leader
price were introduced. However, the order following the declaration of Drug Policy,
1986 reduced the number of bulk drugs and their formulations under control to 142
and the system of retention and pooled pricing was given up and, therefore, the DPEA
stood abolished. The mechanism of ceiling price replaced the concept of leader price.
Provision for recovering the amount accumulated by charging prices higher than those
fixed or notified by the Government was made and the ceilings on pre-tax return were
retained as earlier.
Following liberalisation measures, the Drugs (Price Control) Order, 1995 further
reduced the number of bulk drugs and their formulations under control to 74 bulk
drugs (1577 formulations in total were under price control by 2012) while also
introducing for the first time, the mechanism of Cost-plus Based Pricing (CBP) for
setting ceiling prices of formulations by taking into account the raw material cost,
conversion cost, packaging material cost and the packing charges. Maximum
6
The Committee on Drugs and Pharmaceutical Industry, 1975, Ministry of Petroleum and
Chemicals, Government of India
3
Allowable Post Manufacturing Expenses (MAPE) to the extent of 100 per cent of
manufacturing costs were sanctioned7.
The formula was as follows:
Retail Price = (M.C + C.C. + P.M. + P.C.) X (l+MAPE/100) + E.D8
Where,
M.C denotes material cost including drug cost and other pharmaceutical aids
C.C. indicates conversion cost
P.M. means packing material cost of formulation
P.C. connotes packing of shipment
MAPE denotes Maximum Allowable Post-Manufacturing Expenses which includes
trade margin
E.D. indicates excise duty.
The National Pharmaceutical Pricing Authority (NPPA) was established by the central
government to monitor the prices of essential drugs in 1997. Later in 2002, a draft
National Pharmaceutical Pricing Policy (NPPP) was formulated based on the
recommendations of the Drugs Price Control Review Committee (DPCRC) set up in
1999 that sought to reduce the number of formulations under price control to less than
35 based on the criteria of (i) mass consumption nature of the drug and (ii) absence of
sufficient competition in such drugs9. It can be noted that DPCRC and two earlier
drug price policies sought to substantially reduce the number of bulk drugs and
formulations under control (347 in 1978) to the proposed 34 in 2002. It is evident that
price control over medicines in India was being gradually dismantled.
However, the 2002 draft policy was challenged in the Karnataka High Court which
issued a stay order on its implementation. The order of stay was subsequently
challenged by the government in the Supreme Court in 2003.
In the mean time, the draft pharmaceutical policy, 2006 recommended the revision of
the MAPE structure in the cost plus formula, the use of the National List of Essential
7
8
9
Department of pharmaceuticals, 2011, National Pharmaceutical Pricing Policy, Ministry of
Chemicals and Fertilizers, Government of India
Department of pharmaceuticals, 1995, National Pharmaceutical Pricing Policy, Ministry of
Chemicals and Fertilizers, Government of India
Department of pharmaceuticals, 2002, Draft National Pharmaceutical Pricing Policy, Ministry of
Chemicals and Fertilizers, Government of India
4
Medicines (NLEM), 2003 as the basis for price control of medicines, and fixing of
prices for formulations only10.
Table 1.1: Snapshot View of Key Pharmaceutical Policies in India, 1963-2013
Description
Event
Price
control
over
drugs
was
introduced
with the promulgation of the
Price control over
drugs introduced for Drugs (Display of Prices) Order, 1962 & Drugs (Control of Prices) Order,
1963 under the Defence of India Act; Prices of drugs were frozen w.e.f. Is'
the first time
April, 1963
Order issued under the Essential Commodities Act, 1955; drugs declared
1966 DPCO, 1966
to be essential commodities under the act.
Order aimed at reducing the prices of essential medicines by curbing
1970 DPCO, 1970
profitability over 15 per cent on sales turnover and promoting R&D
Recommended selectivity in price control, fixation of ceiling prices based
1975 Hathi Committee
on investigation of costs of production & the establishment of an effective
Report
and continuing system of monitoring production, profitability, costs etc.
Order
following the declaration of Drug Policy, 1978 placed 347 bulk
1979 DPCO, 1979
drugs and their formulations under price control.
Order following the declaration of Drug Policy, 1986 placed 142 bulk
1986 DPCO, 1986
drugs and their formulations under price control.____________________
74 bulk drugs identified and both the bulk drugs & their formulations
1995 DPCO, 1995
brought under price control. Cost plus pricing with 100 per cent MAPE
introduced
. ' . '
___________________________
The
National
Pharmaceutical
Authority established by the central
Pricing
of
Establishment
1997
government
to
monitor
the,
prices
essential
drugs.__________________
of
NPPA_____________
2002 Draft pharmaceutical Draft policy, taking into account the recommendations of the Drugs Price
Control Review Committee (DPCRC) 1999, sought to reduce the number
policy, 2002
of formulations under price control to less than 35. Policy challenged in
challenged in
Karnataka High Court; stay order issued.
Karnataka High
Court
2003 Stay order challenged Supreme Court directed the government to formulate appropriate criteria
in the Supreme Court for ensuring that essential and life-saving drugs come under price control
and directed a review of such drugs.
Recommended that NLEM 2003 (to be revised every 3 years) be the basis
2005 Pronab Sen Task
of medicine for price control/monitoring, that the ceiling price be based on
Force report, 2005
the weighted average price of the top 3 brands by value for single
ingredient formulations and the use of market data from IMS ORG.
Proposed that 354 drugs under the NLEM (2003) be included under the
2006 Draft NPPP, 2006
span of price control based on cost plus pricing with revised MAPE. Policy
was never implemented._________________________________________
National
List of Essential Medicines (NLEM) 2011 was notified by
NLEM,
2011
2011
MoHFW in June 2011 listing 348 essential medicines
NPPP, 2012 laid down three criteria: (i) regulation of prices based on
2012- NPPP, 2012 and
“essentiality of drugs” (dosages and strengths as listed in NLEM-201 1),
2013 DPCO, 2013
(ii) control of formulation only and (iii) Market based Pricing. The
NPPA notified ceiling prices for 432 medicines under the DPCO, 2013 as
of Dec 20,2013.
_________
Year
1963
io
Department of pharmaceuticals, 2006, Draft National Pharmaceutical Pricing Policy, Ministry of
Chemicals and Fertilizers, Government of India
5
However, the policy never saw the light of the day, while the Supreme Court
continued to hear pleas of both the parties. On March 10, 2003, the Supreme Court
directed the Government of India to come up with a drug price policy that can
accommodate all life-saving and essential medicines into the price policy net11.
As a result, the Government of India formulated the National Pharmaceutical Pricing
Policy (NPPP, 2012). The NPPP, 2012 laid down three criteria (i) regulation of prices
based on “essentiality of drugs” (i.e. 348 formulations as listed under the National
List of Essential Medicines notified by the Ministry of Health and Family Welfare in
2011), (ii) control of formulation prices only and (iii) Market based Pricing12.
While NPPP, 2012 sought to bring a number of essential drugs (formulations) under
control, the other two criteria sought to provide leeway to drug makers, creating a
laissez-faire system in drug pricing. One of the key provisions laid emphasis on only
prices of formulations. This meant that bulk drugs would remain outside the scope of
control. Finally, the policy sought to move away from Cost-plus Based Pricing (CBP)
to Market Based Pricing (MBP).
Under the new formula (MBP), the Average Price to Retailer (PTR) was computed as
follows:
Average PTR = (Sum of prices to retailer of all the brands and generic versions of the
medicine having market share more than or equal to one per cent of the total market
turnover on the basis of moving annual turnover of that medicine) / (Total number of
such brands and generic versions of the medicine having market share more than or
equal to one per cent of total market turnover on the basis of moving annual turnover
for that medicine.)
Thereafter the ceiling price was obtained by adding a 16 per cent margin to retailer
Ceiling Price = Average PTR.(l+M/100), where
Average PTR = Average Price to Retailer for the same strength and dosage of the
medicine as calculated above.
M = % margin to retailer and its value =16
11 The Supreme Court directed the Union of India to consider and formulate appropriate criteria “for
ensuring essential and lifesaving drugs not to fall out of price control should be put under price
control” and further directed the Government of India “to review drugs which are essential and life
saving in nature till 2nd May 2003.” SEP (Civil) No. 3668/2003,10 March, 2003.
12 Department of pharmaceuticals, 2011, National Pharmaceutical Pricing Policy, Ministry of
Chemicals and Fertilizers, Government of India
6
By December 20, 2013, the NPPA had notified ceiling prices for 432 formulations
under the Drugs (Price Control) Order (DPCO), 2013. Further, the policy stated that
market data from IMS Health would form the basis of computing ceiling prices and an
annual increase in price would be allowed on the basis of the wholesale price index.
Exemptions were built in for formulations developed through indigenous research and
development for a period of five years.
This report critically evaluates the National Pharmaceutical Pricing Policy, 2012 and
the Drugs (Price Control) Order, 2013. The chief argument in favour of replacing the
system of cost-based pricing with market-based pricing is that it would help fulfil the
dual objective of ‘ensuring the availability of essential medicines at reasonable prices
while at the same time supporting the growth of the pharmaceutical industry’. Is there
any truth behind this supposition? What does the evidence point towards? This report
attempts to unravel these and other questions that confront the current paradigm of
health, pharmaceutical and pricing policies in India.
7
CHAPTER 2
OBJECTIVES AND METHODS
The overarching goal of this report was to undertake an independent evaluation of the
National Pharmaceutical Pricing Policy (NPPA), 2012 and the Drugs Price Control
Order (DPCO), 2013.
The study was grounded in an access to medicines framework and the approach was
from the dual perspectives of industrial policy as well as ensuring affordable access to
essential medicines.
Specific objectives of the study were to:
•
Assess the state of competition in the Indian pharmaceutical market
•
Analyze the implications of DPCO 2013, in terms of:
•
■
the scope of coverage
■
the impact on medicine prices and market revenues
■
the potential impact on players in the pharmaceutical market
Outline key limitations of DPCO 2013 and implementation of the market based
price control mechanism
•
Recommend policy options in light of our analysis and findings
Conceptual and analytical tools
In this section we describe the terms, concepts and analytical tools that were adopted
in the study.
Market share: Market share is the percentage of the total market turnover of a
particular firm or brand.
Moving Annual Total (MAT): Moving annual total is the cumulative sales value over
the course of the previous twelve months
Market concentration: Estimates of market concentration were computed in order to
study the degree of competition in the pharmaceutical market. The four firm
concentration ratio (CR4) indicates the cumulative market share of the four
largest firms. In this report, we have adopted the following norms: 80% or
above (high concentration), 50%-79% (medium concentration and less than
50% (low concentration).
A second indicator of market concentration, the Herfindahl-Hirschman Index
(HHI), is computed as the sum of the squares of the market shares of
individual firms. Thus the HHI gives greater weightage to larger firms and is
considered to be a more comprehensive measure of market concentration. In
this report, we have adopted the following norms: 2500 or above (highly
concentrated),
>1500-2499
(moderately
concentrated),
>100-1500
(unconcentrated) and 0-100 (competitive).
Sales leader: The sales leader is assumed to be the firm or brand that holds the highest
market share
Highest priced brand: The highest priced brand is the brand that has the highest price
Lowest priced brand: The highest priced brand is the brand that has the highest price
Market based pricing formula, Price to Retailer (PTR), Average PTR, Ceiling Price,
Maximum Retail Price (MRP): The market based pricing formula is defined
under Paragraph 4 of the DPCO 2013.
The Price to Retailer (PTR) is the price of a medicine at which it is sold to the
retailer and is presumed to include duties but not local taxes. Prices to retailers
are obtained from market data available through IMS Health.
The Average Price to Retail (PTR) is computed as: (The sum of prices to
retailer of all the brands and generic versions of the medicine having market
share more than or equal to one percent of the total market turnover on the
basis of moving annual turnover of that medicine) / (Total number of such
brands and generic versions of the medicine having market share more than or
9
equal to one percent of total market turnover on the basis of moving annual
turnover for that medicine).
Under DPCO 2013, the average PTR is calculated for formulations having the
same strength and dosage.
The Ceiling Price is a price that is fixed by the Government for all
formulations coming under price control in accordance with the provisions of
DPCO 2013. It is computed as the Average PTR obtained plus a 16% margin
to retailer.
The Maximum Retail Price (MRP) of formulations coming under price control
is fixed by manufacturers on the basis of the ceiling price notified by the
Government plus local taxes as applicable.
Wholesale Price Index (WPI): The Wholesale Price Index is a measure of inflation
and means the annual wholesale price index of all commodities as announced
by the Department of Industrial Policy and Promotion, Government of India.
Sources of Data
The National Pharmaceutical Pricing Authority (NPPA) is the implementing authority
of the DPCO 2013. Policy documents on national pharmaceutical policies and drug
price control orders were accessed from the NPPA website1. Official notifications for
prices fixed between 14 June 2013 and 20 December 2013, and the worksheets related
to prices notified were also obtained. Worksheets provided detailed information about
the products considered for the fixing of prices for each formulation as well as the
calculations under the market-based price formula.
The National List of Essential Medicines, 2011 which consists of 348 medicines
classified under 27 therapeutic sections was used to identify formulations that would
fall underprice control (see Appendix 1).
1 http://www.nppaindia.nic.in/indexl .html
2 available through the official website of the Ministry of Health and Family Welfare at
http://mohfw.nic.in/WriteReadData/1892s/7364497513National%20List%20of%20Essential%20Me
dicine,%202011.pdf
2
10
Approved medicine procurement rates for 2012-13 were taken from published tender
documents from the Tamil Nadu Medical Services Corporation (TNMSC) and
Rajasthan Medical Services Corportation (RMSC). State essential medicines lists for
Tamil Nadu and Rajasthan were also obtained.
The National Pharmaceutical Pricing Policy 2012 has directed that data from IMS
Health would form the basis of fixing prices. IMS Health is a global company
operating in over 100 countries and provides information, services and technology for
the healthcare industry. IMS pharmaceutical market data for India was independently
procured by authors. The IMS dataset provides estimates of annual market sales,
disaggregated up to the medicine pack-level. Market data for various years was used
to analyse the structure of the Indian pharmaceutical market, independently compute
ceiling prices under the market based pricing policy and study the potential impact of
DPCO.
Sales data for the top selling medicines in 2012 were obtained from the PharmaTrac
database which is marketed by AIOCD Pharmasofttech AWACS, a pharmaceutical
market research company formed as a joint venture of the All Indian Origin Chemists
& Distributors Ltd. Data were also taken from The Market intelligence Report for
2013 published by AIOCD AWACS.
Methods and Analysis
Market Structure
Analyses were undertaken to characterise the Indian pharmaceutical market in terms
of its structure and competition. Using IMS data, market concentration was studied at
both the therapeutic subgroup and individual formulation level through the four-firm
concentration ratio (CR4) - and Herfindahl—Hirschman Index (HHI). Therapeutic
subgroups roughly correspond to therapeutically similar and substitutable medicines.
Because we observe that firms strategise to establish themselves within therapeutic
segments by engaging in competition at the Therapeutically similar’ level, we
consider this is to be most appropriate level at which to study firm concentration. In
addition, we looked at concentration within specific formulations coming under price
contol in order to test the Government’s assumption of competition at this level which
forms the backbone of the market-based price formula.
11
We also studied the market share of foreign companies in the Indian pharmaceutical
market in 2012 and compared the foreign firm market share among the top 20
companies in 2005 and 2012.
Author's independent calculations of ceiling prices using IMS data
Authors also attempted to calculate ceiling prices for formulations coming under the
NLEM based on the DPCO guidelines for applying the market based formula and
using market data from IMS Health. First, the NLEM was broken down into 622
formulations based on the medicines and their specific dosage forms and strengths.
Each formulation was assigned a unique identifier. Next, for each formulation, we
tried to identify the relevant packs in the IMS database and code them using the
unique identifier. Coding was re-checked at least once by a second researcher. Any
discrepancies were resolved after discussion. Challenges faced in using the market
data are discussed in Chapter 6.
Where data were available in the database, we calculated ceiling prices lor each
formulation in the following way. First, the PTR per unit was calculated for each
brand by dividing the sales value by the quanty. We observed that several brands had
more than one pack size. Therefore the sales and quantity (in units) were collapsed
across different packs of the same brand before calculating the PTR per unit for that
brand. Next, the market share of each brand was determined. The average PTR was
calculate as the simple average of the PTRs for brands having 1% or greater market
share using STATA statistical software. To arrive at the ceiling price, a 16% margin
was added to the average PTR.
Ceiling prices were calculated for 371 formulations using this methodology. We
identified 100 formulations where there was only one brand with at least 1 % market
share and noted these as cases where the provisions of DPCO paragraph 6 would be
applicable. However, we did not attempt to calculate the ceiling prices for these
formulations. We determined that data were missing in IMS for 151 formulations.
Impact of DPCO on prices
Prices fixed by the NPPA and the published worksheets were used as the basis of
studying the impact of the DPCO on price reductions. For each formulations, the
12
percentage price reduction of the ceiling price from the highest priced brand and the
sales leader price (on the basis of PTR) were calculated. The market share of the sales
leader in each formulation was also estimated.
Impact of DPCO on span of coverage
In order to study the implications of the DPCO for the span of coverage, we did an ad
hoc analysis of the the National List of Essential Medicines to identify prominent
ommissions and shortcomings. We also examined the state essential medicines lists
for Tamil Nadu and Rajasthan to determine their overlap of the NLEM, and hence
overlap with the new price control regime.
We estimated the market share of essential formulations under each therapeutic and
subtherapeutic group as per IMS classification. This did not include formulations for
which data were missing or could not be identified in IMS. We are unable to comment
on whether the formulations have fallen out of production or the IMS database failed
to capture them.
We also analysed a scenario where all additional dosages, strengths and combinations
of the antiinfectives coming under the NLEM would be included under price control.
For this analysis, the relevant packs of the additional antiinfective formulations were
coded into the IMS database as a separate exercise. In this fashion, the new market
share of antiinfectives that could be under price control were the DPCO expanded was
estimated.
We used AIOCD AWACS’s Market intelligence Report 2013 to obtain rankings of
top selling brands, top selling newly introduced brands, top selling brands used to
treat chronic and acute conditions (as classified by AIOCD AWACS). We then
classified brands as either falling under or outside the scope of price control based on
whether the molecular description corresponded with medicines on the National List
of Essential Medicines.
DPCO’s potential to provide financial relief to patients
We estimated the monetary impact of DPCO 2013 in the sample of 371 formulations
for which we had calculated ceiling prices. In each formulation, we identified brands
13
that would be affected by price control by comparing the brand PTR with the average
PTR. We adjusted their PTRs to bring them down to the average PTR and then
estimate the new market revenues assuming demand remaining constant. Hence we
were able to estimate the shrinkage in sales turnover under price control at the level of
each individual formulation as well as a percentage of the original market value.
Taking just the brands having at least 1% market share, we also explored the
relationship of the market share of the lowest priced brand to the number of
competitors in order to improve our understanding of the availability of the lower
priced brands in the market.
We examined a scenario where the average PTR in the market-based formula was
replaced with the lowest price PTR in brands having greater than or equal to 1%
market share. Results were compared with the average PTR situation on a variety of
indicators.
Methodological differences and limitations of using market based data
in implementing price control
In order to understand the differences of our approach and that of the NPPA as well as
the limitations of using market-based data, we identified discrepancies in a) the
estimates of ceiling prices and b) determing missing data or monopolies for
formulations. Data from the AIOCD AWACS PharmaTrac was also used to compare
estimates of company sales turnover and rank in 2012 with the estimates from IMS
Health.
Utility of public procurement to improve access to affordable essential
medicines
We also compared public procurement rates from TNMSC and RMSC with prices
notified under DPCO 2013 for a subset of scheduled formulations that were being
procured by the state procurement agencies. Indicators were the ratios of the ceiling
price to the state procurement rate and the percentage increase of the ceiling price
over the state procurement rate.
14
CHAPTER 3
ACCESS TO MEDICINES IN INDIA
It is paradoxical that in India, whose credentials are established as a ‘pharmacy of the
global south’, a large proportion of its population does not have access to essential
medicines. Some of the critical factors that act as barriers to access to drugs include
(i) inadequate and unfair health care financing mechanism; (ii) an inefficient
procurement and ineffective distribution system; (iii) an unaffordable prices; (iv)
production of banned, bannable, and inessential medicines, its promotion and
irrational use of medicines; (v) a patent regime that promotes access to those who can
afford to pay. This chapter attempts to draw evidence from various data sources to
demonstrate several barriers outlined here, and will eventually locate the role and
relevance of price ceilings in the Indian context.
. Poor Financial Risk Protection: Prepayment and risk-pooling mechanisms - the
bedrock of any health financing arrangements - is largely absent in India. Historically,
the public health system was underfunded, both at the central and state government
levels. Despite several major health financing interventions since the last one decade,
both on supply-side and demand-side financing, the government has been spending
around one per cent of its GDP on health care. As a result, households’ spending on
health care is not only high but accelerating rapidly and substantially in recent past. A
higher households’ OOP payment is considered to be inefficient and unfair.
Although the country currently spends about 4.2 per cent of GDP on health care,
nearly 70 per cent of those funds come from households. And a large proportion of
households’ expenditure on health care goes into buying drugs (Chart 1). Despite
recent attempts to raise the level of prepayment and risk-pooling through governmentfunded health insurance programs (such as, Rastriya Swasthiya Bima Yojana (RSBY),
Rajiv Aarogyasri in Andhra Pradesh, Chief Minister’s Health Insurance schemes in
Tamil Nadu, etc.), emerging evidence clearly shows that such mechanisms did not
bear results. While there has been a dramatic rise in health insurance coverage from
less than 50 million persons in 2007 to almost 300 million in 2011, however, the
major thrust of these programs has been on hospitalization coverage and not
outpatient coverage. Cunent evidence from nationally representative households’
survey (NSS 2011-12) suggests that outpatient care, especially the drugs component,
accounted for over 70 per cent of all household expenditure on health care.
Figure 3.1: Trends in Share of OOP Spending in India from 1993-94 to 2011-12 (As percentage of
14.0 -]
12.0 10.0 -
---- - OOP Exp
8.0 -
---- - Hosp. Exp.
6.0
OP Exp.
—— Drug Exp
4.0 2.0 0.0
.1993-94
2004-05
2011-12
Source: Estimated from Unit Level Records of respective Consumer Expenditure Rounds, NSSO
The figures in Figure 1, however, hide diverse spending patterns among states, with
wide disparities in public and private expenditure. Household expenditure on
medicines has been estimated to account for over 80 per cent of the health care
expenditure in economically poor and advanced states such as Orissa and Punjab
where the share of medicines’ expenditure as a percentage of households’ OOP
expenditure has been in the order of 75-79 per cent (Table 1). While in some of the
southern states such as Tamil Nadu, Kerala and Karnataka, with larger investments by
the public sector, it is less than two-thirds of the total household expenditure. Tamil
Nadu whose drug procurement and distribution system is known not only an efficient
procurement and effective delivery of drugs, but also has been constantly spending a
relatively large share of its public spending on drugs. As a result, OOP spending on
drugs in that state is the least, which accounted for 56 per cent in 2011-12. This is
considerably lower than the all-India share of about 66 per cent during this same
period. Significantly, states in the latter category are the ones whose health status and
health system indicators are relatively robust.
16
Table 3.1 Share of Household Expenditure on Health care and Medicines, 2011-12
States
Share of OOP
Share of Medicines
Share ofMedicines
Payments
Exp. (as%ofHH Exp.) Exp. (as % ofHH OOP
(as % ofHH Exp.)
_______ExP)________
Orissa
fr67
5.20
78.01
~
8J7
Punjab
6j 7
75.53
Rajasthan
440
186
75.16
Bihar
4JT
146
75.23
Assam
Z25
2.98
75.57
Uttar Pradesh
185
fr50
73.49
68.72
Madhya Pradesh
4J0
196
49?
Andhra Pradesh
737
66.56
62.64
124
West Bengal
6717
190
Kerala
62.29
333"
Gujarat
60.62
149
456
60.93
184
Karnataka
58.17
437
732
Maharastra
199
56.56
106
Tamil Nadu
454
66.44
184
All-India
Source: Authors’ estimate from unit level records ofNSS, 2011-12
yr?
Households’ OOP payment has been growing quite substantially in the past two
decades and now accounts for around 11 per cent of non-food expenditure (Figure 1).
Over two-thirds of that spend is on outpatient expenditure while the rest is accounted
for by hospitalization. Given the presence of substantial financial and physical
barriers, poor households either forego treatment or are forced to seek expensive
health care, thus spending a significant amount of their resources. As a consequence
of having to avail expensive health care, households become vulnerable to
catastrophic spending, which leads them into impoverishment. It is to be observed that
based on expenditure-quintiles (proxy for income). Figure 2 reveals two interesting
pattern. On the one hand, a substantial share of households’ OOP is not only spent on
drugs, while on the other hand, poorer households end up spending much more than
the relatively affluent segment of the population. This pattern is true both in rural and
urban areas.
17
___ Figure 3.2: Quintile-wise Share of Households’ Spending on Medicines, 2011-12
90.0 -I
O 80.0 -
2 70 0 -
I
b poorest
■'•Il
® 60.0 S 50.0 3 40.0 E 30.0 -
■ 2nd poorest
® middle
■ 2nd richest
h richest
° 20.0 -
b Total
s 10.0 0.0 —1
Rural
Urban
Total
While it is important to understand the trends and pattern in OOP spending of
households, it is also worth probing the impact of OOP expenditure on catastrophic
spending and impoverishment status. As far medical impoverishment is concerned,
there is clear evidence that OOP payments not only push a large number of
households below poverty line, but plunge those into deeper poverty who are already
poor. In India, while those pushed below poverty line due to OOP payments are over
50 million during 2011-12, the estimates of population below poverty due to
medicines OOP is. estimated to be 34 million (Figure 3). It is apparent that over twothirds of all medical impoverishment is due to spending on medicines by households.
The poverty impact of the OOP has been rising both in terms of proportion as well as
absolute numbers. Thus, the absolute number of population below poverty due to
OOP expenditure on medicines escalated from roughly 28 million in 1993-94 to
nearly 34 million in 2004-05, an increase of 6 million during the 20 year period.
Figure 3.3: Increase in Poverty Due to OOP Payments for Drugs (Number of Poor in Millions >
Impoverishment due to drugs (million)
All-Iindia^A 34 3
_
"4
-t*-*-------
*
.ural India
Urban India
■-£0-------------------------- -------------------------------------49 5.2
1993-94
2004-05
18
2011-12
The rise in the additional number of poor over the last decade because of OOP
payments reflects the impact of households’ OOP payments. Moreover, the impact of
OOP payments in terms of poverty headcount was higher in rural areas in 2011-12,
thus indicating increasing impoverishment impact of OOP on medicines in rural areas.
Table 3.2: State-wise Government Spending on Health care and Drugs, 2001-02 and 2010-11
State Name
State wise Government Drug Expenditure in India
Per
Overall
Drug
Overall 2010Per
Drug Exp.
(2001-02)
Capita
Exp.
11 (Lakh)
Capita
as % of HE
(Lakh)
as°/oof
HE
1530
8635
Assam
5.7
4.7
28.5
5
13350
Bihar
2203
2.6
13.8
7
3.1
2693
15431
Gujarat
5.3
3.7
26.4
7.6
6090
14.7
Haryana
9.8
24.2
3096
5.5
24861
Kerala
12420
TH
38.9
17
72.3
20305
20882
iTs ”
Maharashtra
20.8
18.7
5.2
~93
7921
12213
17.1
Madhya Pradesh
13.0
“r
1545
1.4
5.6
916 .
Punjab
3;7
93”
3854
Rajasthan
5.7
9045.
"TJ
15.9
('■)
('■)
nr
7104
31481
4.2
5.2
15.9
Uttar Pradesh
Z
43
Ts
21403
24.1
5798
West Bengal
• 7.2
“10
91”
12704
23458
16.6
27.9
Andhra Pradesh
14831
7783
Karnataka
.14.7
7.9
25.1
6.3
43657
18097
65.0
122
Tamil Nadu
28.9
253368
122
21
72649
Central Government
'7
”15
188903
503447
i?
All India
43
91
“TT
Note: Many states report drug expenditure under the category of Material & supply. Material & supply
includes the hospital accessories, bedding cloth, material supply, laboratory charges, others and Xray materials, here we have include material & supply only. Estimates for the year 2010-11 are
budget estimates. HE refers to Health Expenditure of the state/central government.
Source: Budget document, respective states and central government
n-
While underinvestment in health care services is a key reason for poor health
outcomes and distorted health sector development, one of the critical reasons for poor
financial risk protection is overreliance on OOP, especially for drugs. This is a direct
result of gross underfunding of medicine procurement by the government. It can be
observed that the government (both central and state) allocates only 10 per cent of its
funding on the procurement of drugs, supplies and consumables (Table 2). Although
this may appear reasonable, the average hides inter-state disparities in spending.
Several states spend less than 5 per cent of overall public spending on drugs. This
includes economically advanced states like Punjab and economically poor states such
as Uttar Pradesh and Assam.
19
Inefficient Drug Procurement and Ineffective Distribution Systems
Higher budget allocations per se may not suffice in the face of a system plagued by
weak institutions and poor governance. For instance, funds allocated for certain
services such as drug procurement and distribution may not reach either the frontline
service providers or the intended beneficiaries. Therefore, without a concomitant
reliable and efficient supply chain management system extending from manufacturer
to patient, the allotted funds may not reach the intended beneficiaries. This would
result in acute shortages and chronic stock-out of drugs.
One of the key components underlying access to medicines is developing a reliable
supply chain management system that includes the procurement and distribution of
drugs and vaccines. An efficient procurement supply chain management system is
predicated upon the principle of transparency in the process of selection of drugs,
quantification of drugs, procurement process (including tendering process, bid
opening process, award conditions, payment mechanism) and quality control
procedures. Inefficiency in any one of . these .areas can lead to sub-optimal
performance of the system resulting in frequent stock-outs and acute shortages of
essential drugs. In addition, poor procurement practices may lead to a noncompetitive environment with fewer choices of suppliers and higher prices of drugs
for the health system.
As evident from the accompanying Figure 4, the findings from a recent survey of
public health facilities in Tamil Nadu and Bihar clearly point to an unmistakable
pattern of drug availability in various facilities across two different drug procurement
and distribution models. The mean availability of basket of essential drugs in public
health facilities (PHCs and CHCs) for Bihar on the day of survey was about 43 per
cent as against roughly 88 per cent for Tamil Nadu, almost double than the former. It
is clear from the chart as well as from other available nationally representative
household surveys, such as, National Sample Surveys (NSS), availability of essential
medicines in Tamil Nadu has been substantially far better in relation to other states.
One of the major reasons is the time-tested model of Tamil Nadu Medical Service
Corporation (TNMSC), anchored on the model of Centralised Procurement and
Decentralised Distribution System. Its model of procurement is not only efficient, but
20
its distribution mechanism is considered effective, as the frontline public health
facilities are able to supply key essential drugs uninterrupted.
Figure 3.4: A Comparative Scenario of Drug Availability in Bihar and Tamil
Nadu
100.0
zrr
66.7
cu
ro
CD
33.3
0.0
Bihar
Tarril_Nadu
Drugs Availability on Day of Sur^y-Bihar Vs Tamil Nadu (%)
Source: Selvaraj S. Chokshi M, Hasan H and Kumar P (2011). Improving Governance and Accountability in
India's Medicine Supply System. PHFI Study, Report submitted to Results for Development Institute.
To take advantage of economies of scale and monopsony power of the institutions
(here the government), state and central governments must aim. to procure drugs at a
centralized level in each state and at the central level. Currently, the states of Tamil
Nadu, Kerala and recently Rajasthan, for instance, procure drugs at the centralized
level at rock bottom rates, closer to the manufacturer’s cost. When such a model is
replicated similar results ensue.
Summing Up
Access to medicines, can be accelerated by scaling up public spending on drugs,
vaccines and other diagnostics. The current spending of governments (both state and
central) must be scaled-up from O.l per cent of GDP to at least 0.5 per cent of GDP in
the next five years. This is expected to result in a significant reduction in household
OOP expenditure and thereby provide the much-needed financial risk protection. This
is also likely to substantially reduce the current disparities existing in inter-state and
inter-district public spending on medicines. In addition, government procurement and
distribution system must be made more efficient and reliable. This could be modeled
on the TNMSC/RMSC and could take the form of “Centralized Procurement and
Decentralized Distribution”. This would mean procuring medicines based on the EDL
21
at the centralized level in each state. Value for money could be achieved as such a
model is expected to achieve economies of scale due to use of monopsony power. In
order to obtain quality generic drugs for the system, a two-bid transparent
procurement is required across all states. In addition, each district must be equipped
with at least one warehouse, so that the centralized procurement unit and the public
health facilities are reliably linked and acute shortages and chronic stock-outs in the
facilities are avoided. However, as demonstrated in this chapter, given the poor track
record of government procurement and distribution of drugs, households currently
spend a large share of their OOP on drugs. Price ceilings of essential medicines
therefore becomes inevitable, as any attempt to throw it to market forces will only
expose people to higher financial risk and poor health outcomes.
References
Government of India (2009a), National Health Accounts-lndia (2004-05), Ministry of Health and
Family Welfare, New Delhi.
Sengupta, Amit. (2008), Economic Constraints to Access to Essential Medicines in India,
Society for Economic and Social Studies, New Delhi and Centre for Trade and Development, New
Delhi
Selvaraj, S. and Karan, A.K. (2009), Deepening Health Insecurity in India: Evidence from National
Sample Surveys since 1980s, Economic and Political Weekly, October 3, 2009, Vol xliv no 40.
Selvaraj, Sakthivel. 2005. ‘Access to Essential Drugs and Medicines in Financing and Delivery of
Health Care Services in India’, in Financing and Delivery of Health Care Services in India,
NCMH Background Papers, pp. 191-218. New Delhi: Ministry of Health and Family Welfare.
Available at http://mohfw.nic.in/Report%20on%20NCMH/Background%20Papers%20report.pdf .
Accessed on 4 May 2010.
22
CHAPTER 4
CONCENTRATION, COMPETITION AND PRICE CONTROL
Introduction
Evidence from the international experience of performance of pharmaceutical markets
is absolutely clear. A completely unregulated pharmaceuticals formulation market is
unable to produce effective and efficient competition. Some core forms of regulation
are required to be present and in force to foster healthy competition. The effects of
limited information and knowledge of consumers, retailers and doctors about the
price, quality and appropriate use of medicines tend to increase and have proved to be
detrimental for the achievement of the goals of access to medicines and health
outcomes in the pharmaceutical markets characterized by monopoly and oligopoly
wherein effective competition is lacking. A range of policies need to be in place
alongside competition law to ensure that competition is effective and efficient. Policy
tool box of the countries all over the world include the tools in the form of control
over pricing, regulation of the efficacy, quality, safety and appropriateness, public
procurement, monitoring of prescribing and dispensing, code of conduct over
advertising and promotion for industry, pharmacists and doctors. In this chapter we
assess the actual state of competition that prevail sin the Indian pharmaceutical market
and determine how effectivethe market based mechanism of price control formulated
under the Drug Price Control Order (DPCO) 2013 is actually in position to stimulate
in the retail market the force of competition and bring down the pricesof medicines.
Reality and rhetoric of competition
Competition exists in the Indian pharmaceutical market is a catchphrase utilized by
the industry to argue in favour of the relaxation of price control mechanism. Criticism
from the industry of the price mechanism under consideration from the policymakers
has been on the basis of the following two claims, one of existence of sufficient
competition in the pharmaceutical markets and two of encouragement to the
realization of sufficient investment from the firms for the benefit of export and
innovation activity. Both domestic and foreign pharmaceutical firmsseem to have
"preferred a mechanism of market based price control. Both have not been in favour of
the mechanism ofcost based regulation of prices of medicines.
Policymakers have also accepted the argument of existence of sufficient competition
in the pharmaceutical markets in India. It is implicit in the choice of mechanism of
price control. A proper assessment of the actual state of competition prevailingin the
Indian pharmaceutical market seems to be telling a very different story. Argument
that there exists sufficient competition in the Indian pharmaceutical markets is
nothing new. Also the related argument of how the mechanism of price control is an
impediment to promote the goals of efficient production.export and innovation for the
benefit of autonomous industrial development and public health has been heard by the
policymakers from the time the drug price regulation mechanism cameto be
considered as a legitimate intervention to be utilized by the government to develop the
domestic pharmaceutical industry in India.
As far as the argument of competition is concerned, first of all, the Indian rhetoric of
competition has been that there are at least now twenty thousand small and large
producers operating in the domestic pharmaceutical market in India. Although the
available industrial statistics do not confirm the actual number of producers but what
is more important is that the presence of a large number of producers does not tell us
much about competition. Second, the representatives of industry have also argued that
the market dominance is a thing of the past in India. The Indian pharmaceutical
industry is no more under the control of big western pharmaceutical firms and the
market driven by domestic investment in pharmaceutical industry is not exhibiting a
concentrated market structure characteristic of the markets of developed market
economies. The claim is that the pharmaceutical market has become competitive over
the period due to the emergence of domestic pharmaceutical business growing rapidly
during the period of last two decades of industrial and price deregulation in an
independent way in India. As a result the government does not need to use the ‘heavy
hand’ of price regulations to intervene in the Indian pharmaceutical market. This
argument has been used to oppose the cost-plus based pricing formula which the
policymakers adopted in 1979 to intervene in the pharmaceutical markets.
24
Evidence on the impact of price controls
Evidence available however about theimpact on prices of essential medicines of the
dilution of the cost based price mechanism undertaken has also been quite clear. An
analysis of the retail prices of medicines, involving 118 drugs and representing
therapeutic groups that contribute a 54 per cent share of the retail market in a ten year
period (1996-2006), indicated a greater rise in the prices of medicines that got
decontrolled. Of this, drugs in the essential drug list (EDL) represented 24 per cent of
the market and drugs under price control represented 12 per cent of the market, with
drugs not in EDL or price controlled representing 18 per cent of the market. Analysis
of the retail prices of drugs after adjustment against the consumer price index(CPI)
over the period of 1996-2006 indicated a considerable rise in the prices of all
medicines. Analysis showed that while the rise in prices of medicines in the price
controlled category in the same ten year period was nominal - .02 per cent. The rise in
prices of medicines in the essential drug list (EDL) was 15 per cent in ten years,
largely explained by the fact that several of them are in the controlled category (Amit
Sengupta, 2008) \
The rise in prices of medicines for drugs not in EDL and not price controlled was 137
per cent. The overall index for all drugs shows a rise of 40 per cent over 10 years, not
very different from the rise in prices of other commodities, as the CPI would show.
Price rise was far lower for all drugs than the rise in the CPI observed.Benefit was
obtainable to the consumers from the mechanism of price controlput in place by the
government. In the price controlled category of basket of drugs it actually meant a
reduction in prices in real terms in the same period. However, the figures, while
pointing to the effectiveness of price controls, also point to the need to continue the
same and also to enlarge the span of control significantly. Further analysis also
indicates that the prices in 1996 were already starting from a high base, resulting from
the price decontrol in the 1995 DPCO. Immediately after DPCO 1995 there was a
major spurt in the prices. Prices in both controlled and non-controlled category have
been shown to be much higher than they could be. Comparison of retail prices of the
corresponding period in India with prices of drugs in Sri Lanka (Dec.2006); with
1
For details of the study see: Society for Economic and Social Studies New Delhi; and Centre for
Trade and Development, New Delhi, Economic Constraints to Access to Essential Medicines in
India, 2008, Society for Economic and Social Studies New Delhi, India, (available at:
http://whoindia.org/en/Section2/Section5/Section446_l 683.htm )
25
generic prices in India in Dec.$006; and generic prices in India in 2004 indicated a
huge difference between retail prices and generic prices. Prices of essential medicines
were allowed to rise unchecked in the category of drugs which remained after the
mid-nineties out of the mechanism of price control. Analysis also clearly indicated
that there was still a large scope to reduce drug prices. Price control measures were
unable to affect the level of control that was possible for the government to achieve
during the period ofl 996-2006.Actual impact of the dilution of price controls carried
out by the government over the period of 1996-2006 is clearly reflected at the level of
the products in the exercise undertaken on the state of competition for the year 2012.
Historical evidence of concentration
Let us start with the issue of a proper assessment of the claims concerning
competition being made by the industry. Sufficient competition exists in the
pharmaceutical industry has been the argument of the advocates of ‘no direct price
controls’ needed in India. Concentration measures calculated at the level of industry
as a whole do not necessarily give a robust insight about the state of competition in
pharmaceutical industry. Several scholars have already brought out this point in their
recent studies. Aditya Bhattacharya and Fiyanshu Sidhwani (2013) discuss this point
by bringing out the fact that while the Indian pharmaceutical industry comprises a
very large number of small firms and a small number of large firms, and the market
share of even the largest firms is only about nine per cent, calculated at the industry
sales level, it does not mean that that the industry is competitive. Price Cost Margin
(PCM) of the Indian pharmaceutical firms to the margins is under pressure from
imports. Aditya Bhattacharya (2013) also indicates that advertising and marketing
expenditures have strong and positive impact on the PCM of the firms in the
pharmaceutical industry and the results of such expenditure are realized with a lag in
the Indian industry2.
Because as the actual competition takes place either at the level of therapeutic
segments or at the level of really the products Aditya Bhattacharya and Fiyanshu
Sidhwani (2013) point out that industry level concentration measures would
2 Aditya Bhattacharya and Finyashu Sindhwani (2013), “Competition Issues in the Indian
Pharmaceutical Sector”, Centre for Development Economics, Delhi School of Economics, CUTS
International
26
underestimate concentration. They point out*themselves appropriately for this the
following three reasons, concentration ratios should be computed for firms at the
same stage of production, imports include increasingly very expensive patented drugs
and actual competition takes place at the level of either therapeutic segments or
products. Even the calculations of the Henfindahi Hirschman Index (HHI) made by
Kaur (2012, pp318-24) for pharmaceuticals using Prowess data also show that though
the HHI declined considerably during the 1990s but the increase in concentration in
the more recent period does out far more significantly due to the enlargement of
market shares of the top four firms3.
Historical analysismade by us indicates that policymakers cannot accept the claim of
competition to be ipso facto valid on the basis of arguments that the industry
representatives are known to make on the market structure of the pharmaceutical
industry due to the emergence of domestic pharmaceutical companies in India.
Evidence from the literature is available to argue that even after the emergence of
domestic pharmaceutical companies the problem of market dominance did not go
away in India. Concentration in the Indian pharmaceutical market existed in the late
nineties. Market dominance was quite visible in 1998. Almost all the domestic
companies had entered by 1998 as significant players into the Indian pharmaceutical
markets. The claim of pharmaceutical markets in India is based on the indicators that
do not apply well to the pharmaceutical markets. Contribution made by the top 10
players declining from around 40 per cent in 1976 to 30 per cent in 1998 has been one
of the arguments. The other important argument has been that a majority of the
leading companies (7 out of 10) were multinational drug companies in 1976, but in
1998 7 out of 10 top companies were domestic companies.
Selvaraj (2005) provides the relevant evidence, and his analysis clearly suggests that
in the Indian drug industry an extreme concentration across therapeutic groups was
even persisting in 1998. Analysis of the top 300 products, which accounted for close to
half of the total retail market in India in 1998, indicates that out of 32 therapeutic
classes in 19 markets four and less than four companies retained dominant shares. In
few cases the market shares already also ranged from 30 per cent to more than 90 per
3
Kaur, Paramjeet (2012), Mergers in India: Exploiting Financial Synergies, Academic Foundation,
New Delhi.
27
cent. Closely followed by the case of these 19 markets,’another 13 therapeutic
segments also showed slightly less extreme market concentration with 5-8 companies
showing market shares in the range of 30 per cent to 70 per cent. There has never
been anything like a competitive pharmaceutical market, evidence from the historical
analysis of the state of competition prevailing in the pharmaceutical market for the
decade of nineties in India is also quite clear in this regard.
The oligopoly element had started to cut across the entire spectrum of the drugs
belonging to the essential therapeutic classes. Evidence is clear regarding the claim
that the Indian pharmaceutical markets did not become extremely competitive with
the entry of domestic pharmaceutical companies. Evidence of the persistence of
market concentration in 1998 should be viewed as indicating the impact of the failures
experienced in respect of the implementation of price controls. Evidence tells us that
ineffective price control mechanism and gradual price deregulation can also lead to
market consolidation over the period in the pharmaceutical industry.
Current state of market competition
Pharmaceutical market is not a single product market.lt is a multi-product one.
Pharmaceutical markets cannot be treated as homogeneous. Consequently as drug
manufacturers do not compete on an industry wide basis the existence of competition
cannot be deduced from the above described indicator of how many producers exist as
a whole in the case of pharmaceutical market in India. We will have to take the
indicator of the market dominance for each product or product group. Dominant
market share held by a number of companies, in terms of sales, and ultimately the
dominance of a small number of products within each therapeutic class will therefore
have to be used as the indicators of market dominance to ascertain whether the market
for pharmaceutical product is actually competitive.
In this section we deal with this issue of the current state of competition in the Indian
pharmaceutical market at the level of therapeutic segments. In India, because of the
industry being still characterized mainly by the off-patent drugs,even at the level of
therapeutic segments measures of concentration are telling us only a partial and not
the full picture of the state of competition. Beginning with an assessment of the state
of competition undertaken within distinct therapeutic segments and within particular
28
classes of medicines that are perfectly or imperfectly substitutable, our analysis also
indicates the degree of competitionthat prevails in the market to be on average at least
far more than 25 per cent. Table 4.0 indicates it by the number of brands and the
market segment being made up on average 30-100 per cent by thebrands havingat
least 1 per cent market share within each therapeutic group.
Table 4.0
Market structure in terms of number of brands having at least 1 per cent market share in a sample of
371 formulations
Market With All Brands
Market Segment Made
Up OfBrands Having
At Least 1 Per Cent
Market Share
Total Number Of
Brands With 1 Per Cent
Brands___
Market Share____
Anaesthetics________________________________________________
102
______________ 60
Analgesics, Antipyretics, Non-Steroidal Anti-Inflammatory
424
132
Medicines (Nsaims),__________________________________________
Antiallergics And Medicines Used In Anaphylaxis__________________
186
51
11
Antidotes And Other Substances Used In Poisonings________________
11
81
41
Anticonvulsants/Antiepileptics__________________________________
Anti-Infective Medicines______________________________________
2731
690
Antimigrainc Medicines_______________________________________
27
10
191
Antineoplastic, Immunosuppressives And Medicines Used
375
In Palliative Care____________________________________________
Antiparkinsonism Medicines___________________________________
45
22
127
Medicines Affecting The Blood_________________________________
49
4
8
Blood Products And Plasma Substitutes___________________________
Cardiovascular Medicines_____________________________________
628
261
44
Dermatological Medicines ( Topical)_____________________________
101
4
Diagnostic Agents___________________________________________
_ 3
29
8
Disinfectants And Antiseptics___________________________________
19
10
Diuretics__________________________________________________
89
350
Gastrointestinal Medicines_____________________________________
262
111
Hormones, Other Endocrine Medicines And
Contraceptives______________________________________________
50
39
Immunologicals_____________________________________________
14
25
Muscle Relaxants (Peripherally-Acting) And
Cholinesterase Inhibitors______________________________________
40
96
Opthalmological Preparations___________________________________
__ 97
35
Oxytocics And Antioxytocics___________________________________
Peritoneal Dialysis Solution____________________________________
3
3
' 358
129
Medicines For Mental And Behavioural Disorder___________________
14
29
Medicines Acting On The Respiratory Tract_______________________
26
16
Solutions Correcting Water, Electrolyte And Acid-Base
Disturbances_______________________________________________
10
__ 6
Vitamins And Minerals_______________________________________
6204
2083
Total______________________________________________________
Source: Authors’ calculations for 371 formulations based on IMS Health
But it should be clear that more competition, in the usual sense of more producers.
does not seem to be reflecting the actual state of affairs prevailing in respect of
competition in the market. Branding in India plays a different role compared to most
developed market economies. In India even generic drugs are branded and thus
differentiated from chemically identical substitutes. This kind of practice permits the
29
large Indian firms to maintain high prices as well as market shares. Assessment of the
state of emerging features of oligopoly and monopoly in each therapeutic group tells
the actual state of affairs. Available evidence on the state of product wise competition
indicates that the cunent situation of competition is worse in many cases. As analysed
here below, both in terms of the degree of competition at the level of sub-therapeutic
group and at the level of product, evidence of pharmaceutical markets not being truly
competitive is actually truer.Contrary to the claims of sufficient competition exists in
the pharmaceutical industry level analysis of the market structures reveals in the case
of many therapeutic groups either high or medium level of concentration. See Table
4.1 and 4.2 for the details of competition as assessed by us at the level of subtherapeutic groups in terms of Four-Firm Concentration Ratios (CR4).
Table 4.1—Total Number of sub-therapeutic segments and annual market value against different
degrees of concentration (CR4 index) in 1998
Degree of Concentration as per
No. ofSub-therapeutic
Cumulative market value in 1998
. ' CR4 index_________
Segments
(Rs. Crore)
758
High (80% or above)___________
6,039
106
Medium (50% - 79%)
4,910
4
Low (less than 50%)___________
687
868
11,636
Total
__________________
Source: Authors’ calculations based on IMS Health
Table 4.2—Total Number of sub-therapeutic groups and annual market value against different
degrees of concentration (CR4 index) in 2012__________________________________________
No. ofSub-therapeutic
Cumulative market value in 2012
Degree ofConcentration as per
__________ CR4 index_________
. Segments
(Rs. Crore)
1150
High (80% or above)
_____
30,687
Medium (50% - 79%)
276
28,452
42
12,107
Low (less than 50%)___________
1468
Total
Source: Authors’ calculations based on IMS Health; market value is based on IMS Total Sales Audit (TSA)
71,246
Degree of concentration measured on the basis of four-firm concentration ratio
already indicates the share of concentrated markets at the level of sub-therapeutic
groups to be a feature of the Indian pharmaceutical market. Analysis brings out that
many of the pharmaceutical markets are not truly competitive even at the level of subtherapeutic groups. In the year of 1998 out of eight hundred sixty-eight subtherapeutic groups seven hundred fifty-eight sub-therapeutic groups with annual
market value of Rs. 6039 crores exhibited a high degree of concentration. In the year
of 2012 out of one thousand four hundred sixty-eight sub-therapeutic groups one
thousand one hundred fifty sub-therapeutic groups with annual market value of Rs.
30,687 crores exhibit a high degree of concentration. In the year of 1998 out of eight
30
hundred sixty-eight sub-therapeutic groups, one hundred and six
sub-therapeutic
groups with annual market value of Rs. 4910 crores exhibited a medium degree of
concentration.In the year of 2012 out of one thousand four hundred sixty-eight subtherapeutic groups, two hundred and seventy-six sub-therapeutic groups with annual
market value of Rs. 28452 crores exhibit a medium degree of concentration. See
Table 4.1 and 4.2 for the details.
Evidence from the calculations made of the Herfindhal and Hirschman Index (HHI)
for the Indian pharmaceutical markets indicates that high level of concentration
existed in the case of many sub-therapeutic groups. It continues to exist in 2012 for
many of these sub-therapeutic groups. Table 4.3 shows that in 1998 high level of
concentration existed in the case of seven hundred twenty-nine sub-therapeutic
groups. Table 4.4 shows that in 2012 high level of concentration exists in the case of
one thousand seventy sub-therapeutic groups. Table 4.3 shows that in 1998 medium
level of concentration exists in the case of one hundred sub-therapeutic groups. Table
4.4 shows that in 2012 inedium level of concentration exists in the case of two
hundred thirty-three sub7therapeutic groups
Table 4.3 Total Number of sub-therapeutic segments and annual market value against different
degrees of concentration (Herfindahl Hirschman Index) in 1998___________________________
Cumulative market value
Degree of Concentration as per HerfindahlNo. ofSub__________ Hirschman Index (HHI)__________ therapeutic Segments
in 1998 (Rs. Crore)
High (2500 or above) .___________________ _______729
________________ 5,427
Moderate (>1500-2499)___________________’ _______________W0
________________ 3,256
Unconcentrated (>100- 1500)______________
40
2,954
Competitive (0 — 100)_____________________
Total____________________________________
868
11,636
Source: Authors’ calculations based on IMS Health
Table 4.4— Total Number of sub-therapeutic segments and annual market value against
different degrees of concentration (Herfindahl Hirschman Index) in 2012____________________
Degree of Concentration as per HerfindahlNo. ofSubCumulative market value
__________ Hirschman Index (HHI)________
in 2012 (Rs. Crore)
therapeutic Segments
High (2500 or above) ___________________
______________1072
_______________ 28,983
Moderate (>1500-2499) ________________
_______________233
_______________ 15,757
Unconcentrated ( >100 - 1500)____________
163
26,506
Competitive (0 — 100)___________________
Total
1468
71,246
Source: Authors’ calculations based on IMS Health; market value is based on IMS Total Sales Audit (TSA)
Market competition at product level
Evidence to the contrary on the state of competition in the market in India comes out
far more strongly at the product level. At the product level the Indian pharmaceutical
31
markets continue to exhibit a much weakerstate of competition. Avery high level of
concentrationexists at the level of product markets in 2012.Out of four hundred
seventy one (471) products four hundred fifteen (415) products are exhibiting highly
concentrated market features. Not even one product market in 2012 is showing
features of competitive market. In the case of thirty three products (33) the market
structure exhibits moderate concentration features. Only twenty two (22) products
exhibit features of un-concentrated market structure. See Table 4.5 for the details.
Analysis is absolutely clear that at the level of product markets the Indian
pharmaceutical market is highly concentrated, and the claim of markets in
pharmaceuticals in India being competitive is not true.
In the case of newer drugs market shares are quite high. There are fewer producers.
There is no true competition; the range of retail prices is also on the lower side. Of the
100 top selling brands in the Indian market, 55 of the brands fall outside the scope of
price control which together account for annual sales of Rs. 6,142 crore. See Table 4.6
for the details of the products. Of the top 20 acute brands as identified in the
Pharmatrac intelligence report, 8 .of the brands fall outside the scope of price control.
See Table 4.7 for details of the.products. Of the top 20 chronic brands as identified in
the Pharmatrac intelligence report, 13 of the brands fall outside the scope of price
control. Analysis is clear that even today how more of the top selling brands for
chronic disease, an area where India is experience a growing disease burden, are
totally immune from price regulation.
Table 4.5—Concentration (Herfindahl Hirschman Index) in 471 formulationscoming under drug
price control
Degree of Concentration as per Herfindahl—Hirschman Index (HHI) _____ No. offormulations
High (2500 or above)_____________________________________ 416_________________
Moderate (>1500-2499)__________________________________ 33__________________
Unconcentrated (>100 - 1500)______________________________ 22
Competitive (0 - 100)_____________________________________
Total__________________________________________________ 471
Source: Authors’ calculations for 471 formulations coming under DPCO 2013 for which data was available
through IMS Health
32
Table 4.6: Number of brands from top 20 new introductions under and outside the scope of price
control order_______________________________
Brands Outside The Scope OfPrice Control
Rank
(Based
On
Mats
For
Last 24
Months
)
Brand
1 Istamet
2 Silverex
Ionic
2 Biceltis
4 Pegihep
Subgroup
Sitagliptin +
Metformin
Silver Nitrate
Corporate
Rank
(Based
On Mats
For Last
24
Months)
Brands Under The Scope OfPrice
Control
Brand
Subgroup Corporate
Sun
7 VoveranGe
Ranbaxy
10 Macmika
Diclofena Novartis
c_______
Amikacin Macleods
Emcure*
Trastuzumab______
Zydus*
Pegylated Interferon
Alpha 2b_________
2 Synflorix All Other Vaccines Gsk
6 Uprise D3 Vitamin D Alkem*
Cholecalciferol
8 Cognistar CerebroproteinHydroly Lupin
sate________________
Sun
Human Chorionic
9 Fertigyn
Gonadotropin _______
Hp-5000
11 Tri vo lib
Voglibose + Metformin Sun
+ Glimepiride_______
Ranbaxy
Caspofungin Acetate
12 Casporan
Aristo .
13 Megaheal Products For Wound
Healing____________
Calcium + Calcitriol + Macleods’'
14 Bio D3
Strong
Vit K2_____________
Eris
15 Tayo 60k Vitamin D Cholecalciferol______
Reteplase___________ Abbott*
16 Retelex
Rituximab__________ Emcure*
17 Ikgdar
18 Mashyne Ferrous Ascorbate
Usv
Ranbaxy
Lamivudine +
19 Effoday
Tenoforvir 4- Efavirenz
Sun
Citocholine +
20 Piranulin
Piracetam__________
Source: Top selling brands were taken from A10DC-AWACS Market Intelligence Report 2013
Although a high level of concentration would exist, but the drug price control order
2013 has failed to bring the newly introduced drugs under its scope. Of the top 20
newly introduced brands (within last 24 months) the majority of products (18) turn
out to be outside the scope of price control. Given that the primary objective of price
control is to contain high prices of medicines, the scope of the DPCO 2013 will not
extend to new market entrants. See Table 4.6 for the details of the products in terms of
the coverage of products under price control from within the basket of top 20 selling
products in the Indian pharmaceutical market. Similarly, one expects the drug price
control order of 2013 to take into account the specific features of the market structure
33
evolving in terms of competition for the products being viewed as useful for acute and
chronic conditions, it is to be noted that under the scope of price control order of 2013
from among the newly introduced products only two products are covered at present.
The rest of eighteen products are outside the scope of price control order of 2013. See
Table 4.7 and 4.8 for the details.
Table 4.7: Number of brands from top 20 acute brands of the Indian pharmaceutical market
under and outside the scope of order_______
_______ Brands Outside The Scope Of PriceControl
Brands Under The Scope Of PriceControl
Rank
Brand
Subgroup
Corporate
Rank
Brand
Subgroup
Corporate
(Based On
(Based
Mat Jun
On Mat
13)
Jun 13)
2
Corex
Chlorpheniramin Pfizer*
1
Augmentin Amoxycilli Gsk
e + Codeine
n+
Clavulanic
Acid______
3
Revital
4
Ginseng
Ranbaxy
Monocef
Ceftriaxone Aristo
Products_______
8
Becosules Vit B Complex Pfizer*
5
Volini
Diclofenac Ranbaxy
With Vit C Only
Man force
9
Sildenafil
Mankind
6
Calpol
Paracetamo Gsk
1_______
13
14
Dexorange
Liv 52
Iron Ferrous
Hepatic
Protectors
16
Phensedyl
Cough
Linctus
Magnex
20
Franco
Himalaya
7
10
Voveran
Clavam
Chlorpheniramin Abbott*
e + Codeine
11
Betadine
Cefoperazone +
Sulbactum
12
Taxi'm O
15
17
18
Taxim
Aciloc
MoxikindC
v
Pfizer*
Diclofenac Novartis
Amoxycilli Alkem*
n+
Clavulanic
Acid______
Povidone
WinIodine
Medicare
Cefixime
Alkem*
Cefotaxime Alkem*
Ranitidine Cadila
Amoxycilli Mankind
n+
Clavulanic
Acid______
19
Zinetac
Ranitidine Gsk
Source: Top selling brands were taken from AIODC-A WACS Market Intelligence Report 2013
34
Table 4.8: Number of top 20 chronic brands of the Indian pharma market not covered by the
order________ ________________ ___________
Brands Under The Scope Of Price Control
Brands Outside The Scope Of Price Control
Subgroup Corporal
Brand
Rank
Corporate
Subgroup
Brand
Rank
e
(Based
(Based
On
On
Mat
Mat
Jun
Jun
13)
13)
Intermediat Abbott*
1 Mixtard
Usv
2 Glycomet Glimepiride
e-Acting,
Metformin
Gp
Isophane
Salbutamol Cipla
Asthalin
3
Cipla
Formoteral
+
4 Foracort
Budesonide
11 Huminsuli Intermediat Eli Lilly
Cipla
Salmeterol +
5 Seroflo
e-Acting,
n
Fluticasone
Isophane
Enoxaparin Sanofi*
Clexane
14
Novartis
Vildagliptin +
6 Galvus
Metformin_________
Met
Atorvastati Zydus*
15 Atorva
Hydroquin + Mometa Zydus*
7 Skinlite
n_____
+ Tretinoin______ ___
Atorvastati Ranbaxy
Storvas
19
Sanofi*
Ramipril
8 Cardace
n________
Atorvastati Sun
20
Aztor
Glenmark
Telmisartan
9 Telma
n
Gsk
10 Betnovate Betamethasone +
C_______ Clioquinol_______
Msd*
Sitagliptin_______
12|januvia
Msd*
Sitagliptin +
13 Janumet
Metformin______
Glenmark
Telmisartan +
16 Telma H
Hydroclorthiazide
Cipla______________________________________
17 Budecort Budesonide_____
Cipla
Levosalbutamol
+
18 Aerocort
sone _____ |___________ ______ J________ ___________ 1----Beclomethasone
Source: Top selling brands were taken
L...— from A1ODC-AWACS Market Intelligence Report 2013
Price Control and nature of impact on large firms
Inespective of their national origin, nature of ownership and control, still many large
firms capable of exercising market power in the case of their product portfolios would
be free to price a very large number of important products. Table 4.9 lists the
domestic firms along and the number of products identified against their name that
have been left free and are outside the coverage of drug price control order of 2013.
For the domestic Indian firms out of the total 200 products under their
controlfromwithin the top 300 products under sale in the marketplaceone hundred
twenty four products (124) are outside the scope of drug price control order of 2013.
For the large domestic Indian firms from within the basket of top 300 products only
seventy six (76) products under their control are under the scope of price control
mechanism.
35
Table 4.9— Company wise pattern of brands falling outside / under the scope of price control for
the segment of domestic firms in the case of Top 300brands of the Indian pharmaceutical market
Domestic Firms
Brands Outside The Scope Of Brands Under The Scope Of
______ Price Control_______ _____Price Control______
Alembic_________________________
___________3_____________ ___________1____________
Alkem Laboratories India__________
___________7_____________
6
Allergen India Ltd________________
___________ 1_____________
Aristo Pharmaceutical Pvt Ltd_______
6
£
Apex Laboratories Ltd_____________
Bharat Serum & Vaccines Ltd_______
I
Biocon Ltd_______________________
1
Biochem Pharmaceutical Inds_______
1
1
Blue Cross Laboratories Ltd________
Bins India Pvt. Ltd.________________
1
Cadila Pharmaceuticals Ltd_________
1
Centaur Pharmaceuticals Pvt.Ltd_____
1
CharakPharma Pvt Ltd_____________
1
2_
14
Cipla Ltd.________________________
8
1
Dabur India Ltd.__________________
2
6
Dr.Rcddys Laboratories Ltd________
2
Elder Pharmaceuticals Ltd__________
4
1
Emcure Pharmaceuticals Ltd________
1
Eris Life Sciences Pvt Ltd__________
1
3
Franco Indian Pharmaceuticals Pvt Ltd
1
Geno Pharmaceuticals Ltd__________
4
1
Glenmark Pharmaceuticals Ltd.______
1
Himalaya Drug Company__________
1
Indoco Remedies Ltd______________
2
2
Intas Pharmaceuticals Ltd__________
3
Ipca Laboratories Pvt Ltd.__________
2
4
Lupin Ltd________________________
2
3
8
Mankind Pharmaceuticals Ltd.______
I
Medley Pharmaceuticals___________
3
Msd Pharmaceuticals Private Ltd.
1
Organon (India) Ltd_______________
1
Panacea Biotec Ltd________________
3
Raptakos. Brett & Co. Ltd._________
4
12
Sun Pharmaceutical Industries Ltd
1
2
Torrent Pharmaceuticals Ltd.________
1
3
Unichem Laboratories Ltd__________
6
1
Usv Ltd_________________________
5
2
Wockhardt Ltd___________________
1
3
Wyeth Ltd_______________________
12
7
ZydusCadila_____________________
1
Biological E Ltd__________________
2
Fdc Ltd._________________________
3
Jb Chemicals_____________________
4
Macleods Pharmaceuticals Pvt.Ltd
1
Micro Labs Ltd___________________
1
Modi Mundi Pharma Pvt Ltd_______
Troikaa Pharmaceuticals Ltd________
1
1
Danone________
Win-Medicare Pvt. Ltd.____________
1
124
Total___________________________
76
Source: AIOCD-AWACS Market Intelligence Report 2013; top selling brands are based on moving annual total
sales for August 2013. Authors have classified brands as falling under/outside price control based on whether
the molecular description corresponds with medicines on the National List of Essential Medicines.
From within the top 300 products under sale in the marketplace out of the 100
products in the case of large foreign firms under their control only thirty seven (37)
productsare covered by the price control mechanism. From within the top 300
36
products under sale in the market place out of the 100 products under the control of
foreign firms sixty three (63) products remain outside the scope of drug price control
order of 2013. See table 4.10 for the details of the company wise pattern of brands
falling under and outside the scope of price control order.
Table 4.10 —Company wise pattern of brandsjalling outside '
firms in the case of Top 300 brands of the Indian pharmaceutical
for the segment of foreign
market
Brands outside the scope of Brands under the scope of
Foreign Firms
price control_
_
price control
~
4
Abbott Healthcare__________________ ___________ 7___________
2
~
8
______ ___
Abbott India
1
1
AstrazenecaPharma India Ltd
~
2
British Biological
__________
10
10
'
Glaxosmithkline Pharmaceuticals Ltd.
2
~
Johnson & Johnson___________ ____
1
Merck Ltd_______ _______________
5
____________
Novartis India Ltd
4 __________
1
Novo Nordisk India Pvt Ltd__________
2__________
7
Pfizer Ltd_______ ________________
5 __________
10
~
Ranbaxy Laboratories Ltd ________
2_________
11
Sanofi-Aventis_____________
2_________
Eli Lilly And Company (India) Pvt. Ltd.
37________ _
Total
_______ J___________ —---------- -—*-r—7—
' A1OCD-AWACS Market Intelligence kepoTUOisTTop selling brands are based on moving annual total
--Source.
’
■ as falling under/outside price control based on whether
sales for August 2013. Authors have classified brands
the molecular description corresponds with medicines on the National List of Essential Medicines.
Market power and price control
Large firms exercise market power in pharmaceutical markets by investing in the
activity of market promotion and advertising. Competition is stymied using the power
of brand value by the large firms. See table 4.11 showing sub-therapeutic group the
number of brands with at least 1 per cent share in a sample of 371 formulations. 197
formulations belong to the market segments where effectively the competition is
• between 2 to 4 brands. 97 formulations belong to the market segments where
effectively the competition is between 5-7 brands. Only 77 formulations belong to the
market segments where the brands competing exceed the number of 8 brands. A
narrower spectrum of 2-4 brands dominates this sector establishing that there is
virtually no scope for fair competition. This confirm, that a vast majority of the
formulations belong to the segments where large firms have the scope to exercise
market power.
37
Table 4.11— Number of brands with at least 1 per cent market share in a sample of 371
formulations
Nlem
Nlem Section
Number Of Formulations
Section
5 To 7
2 To 4
8 Or
No.
Brands Brands
>8
Brands
Anaesthetics_____________________________________
16
2
0
2
Analgesics, Antipyretics, Non-Steroidal Anti-Inflammatory
10
6
5
Medicines (Nsaims),______________________________
3
Antiallergics And Medicines Used In Anaphylaxis
2
5
1
2
4
Antidotes And Other Substances Used In Poisonings
2
Anticonvulsants/Antiepileptics______________________
Anti-Infective Medicines
Antimigraine Medicines____________________________
2
8
Antineoplastic, Immunosuppressives And Medicines Used
In Palliative Care_________________________________
Antiparkinsonism Medicines
9
Medicines Affecting The Blood______________________
10
Blood Products And Plasma Substitutes________________
11
12
Cardiovascular Medicines__________________________
Dermatological Medicines (Topical)__________________
13
14
Diagnostic Agents_________________________________
Disinfectants And Antiseptics_______________________
15
Diuretics_________________________________________
16
17
Gastrointestinal Medicines__________________________
Hormones, Other Endocrine Medicines And Contraceptives
18
Immunologicals___________________________________
19
Muscle Relaxants (Peripherally-Acting) And Cholinesterase
20
Inhibitors________________________________________
Opthalmological Preparations_______________________
21
22
Oxytocics And Antioxytocics_______________________
Peritoneal Dialysis Solution_________________________
23
Medicines For Mental And Behavioural Disorder________
24
Medicines Acting On The Respiratory Tract____________
25
Solutions Correcting Water, Electrolyte And Acid-Base
26
Disturbances_____________________________________
Vitamins And Minerals____________________________
27
Total___________________________________________
Source'. Authors’ calculations for 371 formulations based on IMS Health
6^
4
0
0
5
48
3
18
4
24
0
18
0
30
0
3
T
2
2
3
6
1
18
6
1
1
1
7
13
7
4
o
12
1
0
1
0
T
i
0
0
9
2
2
2
2
2
£
2
o
2
5_
1
1
2
o
2
2
£
2
2
3
1
2
0
10
0
0
2
197
0
97
0
77
See Table 4.12 for the details of the market share of the market sales leader for 419
formulations for which ceiling prices have been notified by the NPPA under the
DPCO 2013. Out of 419 formulations for which prices have been notified by NPPA,
in 394 cases (94%) the market leader is observed to hold a high market share (i.e., 25
per cent or greater). In fact, in 280 cases the share of market leader in the product
market is even greater than 50 per cent. But the reduction in revenue for a majority of
the market leaders would be limited to the extent of 10 per cent. In the case of 218
(48%) market leaders, shrinkage would be mere 10 per cent or less. Shrinkage to the
38
extent of 20 per cent or less would be felt in another 62 cases which is also only 18
per cent of the notified formulations.
Table 4.12 — Market Share of the sales leader for 419 formulations for which ceiling prices have
been notified by the NPPA
SNo
Number Of Percentage Of
Nlem Therapeutic Groups
Percentage Of Percentage Of
Formulations
2 Anaesthetics________________
25
23
Formulations
Where Share Of
Sales Leader Is
At Least 50%
88
83
3
7
43
57
0
4
75
25
0
14
92
3
52
100
55
67
67
0
35
33
33
0
10
0
0
3
33
4
73
75
49
10
2
4
2
2
8
9
n
ii
12
13
14
15
16
17
18
19
20
21
•22
~23
24
25
26
27
Analgesics, Antipyretics, NonSteroidal Anti-Inflammatory
Medicines (Nsaims), Medicines
Used To Treat Gout And Disease
Modifying Agents In
Rheumatoid Disorders (Dmards)
Antiallergics And Medicines
Used In Anaphylaxis_________
Antidotes And Other Substances
Used In Poisonings___________
Anticonvulsants/Antiepileptics
Anti-Infective Medicines______
Antimigraine Medicines_______
Antineoplastic,
Immunosuppressives And
Palliative Care______________
Antiparkinsonism Medicines
Medicines Affecting The Blood
Blood Products And Plasma
Substitutes__________________
Cardiovascular Medicines_____
Dermatological Medicines
(Topical)___________________
Diagnostic Agents___________
Disinfectants And Antiseptics
Diuretics___________________
Gastrointestinal Medicines
Hormones, Other Endocrine
Medicines And Contraceptives
Immunologicals_____________
Muscle Relaxants (PeripherallyActing) And Cholinesterase
Inhibitors___________________
Opthalmological Preparations
Oxytocics And Antioxytocics
Peritoneal Dialysis Solution
Medicines For Mental And
Behavioural Disorder_________
Medicines Acting On The
Respiratory Tract____________
Solutions Correcting Water,
Electrolyte And Acid-Base
Disturbances________________
Vitamins And Minerals_______
Total
Formulations
Formulations
Where Share Of Where Share Of
Sales Leader Is
Sales Leader
25%-49%
<25%
12
0
13
4
67
0
12
25
2
o
63
60
14
30
22
10
1
9
3
21
20
100
89
67
81
70
0
11
33
19
20
0
0
0
0
10
12
6
92
83
8
17
16
9
0
12
81
78
IT
19
22
T
2
o
42
50
I
5
100
0
0
5
80
20
0
3
419
100
70%
0
24%
0
6%
TT
Source: Authors’ calculations based on data from the National Pharmaceutical Pricing Authority (NPPA)
39
2
0
Thinking only from within the framework of market based price control formula the
choice of average PTR based ceilings tendsto reward those firms more who only
investment more in advertising and market promotion and build market power
through gifts and discounts to doctors and chemists their products at higher prices.
Although market based price fixation is not a best process for providing the relief to
consumers, yet it is worth noting that ceiling price has not been fixed by using the
lowest price to retail. Table 4.13 shows that had the price ceilings of DPCO 2013
been framed in terms of lowest price to retail (PTR) rather than average price to retail
(PTR) consumers would have benefitted to the extent of 20 per cent or more in price
terms in the case of another 174 more products in addition. It provides a detailed subtherapeutic groupwise breakdown of how many additional products would have
attracted the benefit of more than 20 per cent to consumers in various therapeutic
categories. Table 4.13 also gives the details of the range of market revenue shrinkage
in terms of how many products would shift from oneband of market value shrinkage
and the nature of price reduction for consumers for the firms capable of exercising
market power in the case of all the different therapeutic categories. See table 4.13 for
the number of formulations grouped sub-therapeutic group according to projected
reduction in sales due to price control (as a per cent of original market value) and the
consequent extent of change in percentage of sales from average to lowest price to
retail (PTR) scenario.
Table 4.13 —Comparison of impact on market sales under Average PTR (DPCO 2013) and
lowest PTR scenarios
Number Of Formulations Grouped According To Projected
Nlem Nlem Section
Reduction In Sales Due To Price Control (As A % Of
Sectio
_______________Original Market Value)_______________
n No.
_____ Average Ptr
Lowest Ptr Scenario (Change)
11-20%) >20%)
0-10% 11-20% >20% 0-10%
10 (+8)
12___ 4_____ 2____ 4 (-8)
Anaesthetics______________
4(0)
8 (-5)
13
H (+9)
6
2
Analgesics, Antipyretics, Non2 (-4)
2
Steroidal Anti-Inflammatory
Medicines (Nsaims),________
6 (+6)
4
4
l(-3)
Antiallergics And Medicines
3
l(-3)
Used In Anaphylaxis________
2(-l)
1(+1)
3
1
Antidotes And Other
4
1(0)
Substances Used In Poisonings
2 (-4)
2
1
4 (+3)
5
Anticonvulsants/Antiepileptics
6
3(+l)
14
32 (-29) 7 (-20)
Anti-Infective Medicines____
27
61
63 (+49)
3
Antimigraine
Medicines_____
2(-l)
2
K+1)
20
4
8
Antineoplastic,
15
5 (-10)
25 (+21)
9 (-11)
Immunosuppressives And
Medicines Used In Palliative
Care
40
Nlem
Sectio
n No.
Nlem Section
Number OfFormulations Grouped According To Projected
Reduction In Sales Due To Price Control (As A % Of
______________ Original Market Value)______________
_____ Average Ptr
Lowest Ptr Scenario (Change)
0-10% 11-20% >20%) 0-10%
11-20% >20%)
9
Antiparkinsonism Medicines
5____
J___ 3 (-2)
3 (+2)
10
Medicines Affecting The Blood 7
1
j___ 2 (-5)
5 (+4)
2(+l)
11
Blood Products And Plasma
1
1 (0)
Substitutes__________________
12
Cardiovascular Medicines_____ 17
19
3
4 (-15) 33(+30)
2 (-15)
Dermatological Medicines
4
4
13
1
7 (+6)
1 (-3)
1 (-3)
(Topical)___________________
14
Diagnostic Agents___________ 1
1 (+1)
(-1)___
15
Disinfectants And Antiseptics
1
2
1 (+1)
(-1)___
1 (0)
Diuretics____________
1
16
1
2(+l)
(-1)
Gastrointestinal Medicines
3
11
2_
17
7 (+4)
4 (+2)
5 (-6)
Hormones, Other Endocrine
17
4
1
18
6 (+2)
6 (-11)
10(+9)
Medicines And Contraceptives
2
Immunologicals_____________ 5^
3
19
3 (-2)
H-2) 6 (+4)
Muscle Relaxants (Peripherally- 4
3 (+3)
20
1 (-3)
Acting) And Cholinesterase
Inhibitors___________________
7 (+4)
2_
Opthalmological Preparations
3
6^
2 (-4)
21
2(0)
3
1
3 (+2)
Oxytocics And Antioxytocics
22
4(+l)
1 (-3)
Peritoneal Dialysis Solution
23
I (+1)
(-D
5
5
5
14 (+9)
24
Medicines For Mental And
1 (-4)
(-5)
Behavioural Disorder________
4
2
2 (-2)
1 (+1)
3(+l)
25
Medicines Acting On The
Respiratory Tract____________
2 (+2)
Solutions Correcting Water,
2
1
1 (-1)
26
(-D
Electrolyte And Acid-Base
Disturbances________________
1
27
Vitamins And Minerals_______ j__
1 (Q)
KO)
52
91 (-127) 54 (-47) 226 (+174)
Total______________________ 218
101
Source: Authors’ projections based on IMS Health
Prior to 2002 the policy on price control had also cost competitiveness as one of its
goals. Today the stage of industrial development at which India stands the
policymakers should be getting the local industry to prioritize cost competitiveness as
a strategic goal. In the case of pharmaceutical production, China is already an
important competitor of India. The goal of cost competitiveness is actively under
encouragement from the government of China. Price control mechanism should be
encouraging the investment in practices and technologies aimed at efficient
manufacturing. Tighter price control combined with the measures of tax rebate on
investment would help the country achieve better results in respect of the adoption of
improved technology and practice of efficient manufacturing by the producers.Table
4.13 also makes quite clear that if the policymakers were really interested to serve the
twin goals of affordable medicine and industrial development, then the selection of
41
mechanism based on the lowest price to retail (PTR) should have been preferred over
the average price to control (PTR) based mechanism.
Table 4.14— Foreign or Indian status of sales leader, highest price and lowest price in a sample
of 371 formulations
SNo
Therapeutic Group
Sales Leader Highest Price (1% Lowest Price (1%
Market Share)
Market Share)
Foreign Indian Foreign Indian Foreign Indian
_7___ 11
8
17
Anaesthetics_____________________
10
1___
14
5
20
7
Analgesics, Antipyretics, Non-Steroidal
16
1
2
Anti-Inflammatory Medicines (Nsaims),
6
7
1
3
5
2
Antiallergics And Medicines Used In
3
Anaphylaxis_____________________
4
0
4
0
4
0
Antidotes And Other Substances Used
4
In Poisonings_____________________
8
6
3
4
1
5
5_ Anticonvulsants/Antiepileptics_______
14
88
29
66
73
36
6^ Anti-Infective Medicines____________
1
2
2
1
2
2 Antimigraine Medicines____________ 1
6
33
13
24
26
15
Antineoplastic, Immunosuppressives
8
And Medicines Used In Palliative Care
6
3
3
£
3
3
Antiparkinsonism Medicines_________
9
6
9
£
6
3
10 Medicines Affecting The Blood______
0
2
I
0
7T
1
11 Blood Products And Plasma Substitutes
38
14
2
22
25
17
12 Cardiovascular Medicines___________
9
6
6
£
3
13 Dermatological Medicines (Topical)
1
1
£
I
V
0
14 Diagnostic Agents_________________
2
2
£
o
2
0
15 Disinfectants And Antiseptics________
2
2
£
o
2
0
16 Diuretics_____________________ __
13
14
2
15
1
2
17 Gastrointestinal Medicines__________
13
9
3
19
6
16
18 Hormones, Other Endocrine Medicines
And Contraceptives________________
4
£
10
6
2
2
19 Immunologicals__________________
0
4
2
4
o
2.
20 Muscle Relaxants (Peripherally-Acting)
And Cholinesterase Inhibitors________
£
11
9
8
2
21 Opthalmological Preparations________
2
2
7
2
2
2
2
22 Oxytocics And Antioxytocics________
£
1
£
1
2
1
23 Peritoneal Dialysis Solution_________
2
13
2
13
13
2
24 Medicines For Mental And Behavioural
Disorder________________________
5
5
1
6
1
0
25 Medicines Acting On The Respiratory
Tract___________________________
2
3
1
0
1
2
26 Solutions Correcting Water, Electrolyte
And Acid-Base Disturbances________
___1
__ 1 ____1
__ [ ___ [
27 Vitamins And Minerals_____________ __ 1
326
237
133
238
45
134
____Total________________________________________
Source: Authors’ calculations for 371 formulations based on IMS Health; identification of foreign and Indian
status based on IMS classification
Analyzed here below sub-therapeutic group, analysis of 371 formulations indicates
that sales leader in the case of 137 brands are foreign firms. Indian firms are sales
leader in the case of 234 products. In the case of highest price brands foreign firms
account for 133 brands and Indian firms account for 234brands. But what is worth
noting that in the case of lowest price brands table 4.14 shows that a vast majority of
42
brands are of Indian firms. In the case of lowest priced brands out of 371 brands 326
brands belong to Indian firms and only 45 belong to foreign firms. See also table 4.15
depicting the pattern of number of therapeutic groups with high and moderate
concentration where the strong presence of foreign firms is an important characteristic
of the pharmaceutical markets of 2012. In the segments characterised by the feature of
high market concentration 48 sub-therpeutic groups exhibit the strong presence of
foreign firms having at least 25 per cent share. In the segments characterised by the
feature of moderate market concentration 22 sub-therapeutic groups exhibit the strong
presence of foreign firms having at least 25 per cent share.
Table 4.15:-Sub-therapeutic segments in 2012 characterised by activity of foreign firms
Number of Therapeutic segment with high
Number of Therapeutic segment with moderate
concentration (Herfindahl Hirschman Index)
concentration (Herfindahl Hirschman Index)
Foreign firms have less
Foreign firms have at
Foreignfirms have at
Foreign firms have less
least 25%> market
than 25% market share
least 25%o market
than 25%) market share
______ share______
_______share______
_______ 22_______
... 48 .
51
23
Source: Authors’ calculations based on data from IMS Health; foreign firms were identified based on
• IMS classification
Impact of TRIPS on market structure
Changes introduced in the domestic patent law allow from 2005 onwards patent based
monopolies to be established. In the case of introduction of the new products this
change has affected significantly the state of competition in pharmaceutical markets
in India. Generic medicine competition increases the availability of lower-priced
products only when the market does not show the feature of market dominance of
large firms, be Indian or foreign MNC. Analysis undertaken by Sudip Chaudhury
(2012) of the sales of the basket of 180 new drugs being marketed in India which
constituted about 9.1 per cent of the total pharmaceutical market in 2010 points out
that there is a shift taking place in the market4.
4
180 drugs could be categorised into: (1) Sixty-two drugs for which patents have expired in the US
(3.8 per cent of the Indian market); (2) Sixty-seven drugs for which patents were granted in the US
before 1995 and hence not patentable in India in accordance with the TRIPS agreement (4.2%) and
(3) Fifty-one drugs for which patents were granted in the US after 1995 and hence patentable in
India subject to Section 3(d) provisions (1.2%). Five or more sellers for 43 products accounted for
97.9 per cent of the market for patent expired molecules. Analysis indicates that two TRIPS
flexibilities explain much of the level of competition. Under Section 11A(7), Indian generic ,
companies which have started manufacturing before 2005 are not required to suspend production
even if patents are granted (after 2005). Section 3(d) has played a role, but the challenge of
implementation remains. For the third category of post-1995 drugs, there are monopolies in 50 per
cent of the products accounting for 20 per cent of the market.
43
Interest in the case of new drugs centres on the behaviour of the multinational
corporations (MNCs). In India, they are involved in marketing 92 out of the 180 new
drugs. MNCs have monopolies in 33 products accounting for 31 per cent of their sales
of Rs. 517.14 crore of these 92 products. In fact, in 53 products accounting for more
than three-fourths of their sales they have a market share of 50 per cent or more. Eight
out of these 33 products, for example, anidulafungin, caspofungin, micafungin and
pegaptanib, are pre-1995 molecules or patents have expired. Prices are exorbitant due
to the market power of the MNCs. The pricing policy adopted by the MNCs for the 33
monopoly products which include life-threatening diseases such as cancer and where
essential drugs are without effective substitutes indicates that the market based price
mechanism would not be effective for a much larger basket of drugs in India.
Below we indicate the extent of problem that the patients are already facing in the
case of post-1995 molecules in the Indian pharmaceutical market. A 50 ml injection
of Roche’s anti-cancer drug Herceptin (generic name: trastumuzab) costs Rs.
1,35,200. Merck’s Erbitux (cetuximab) (Rs. 87,920), Bristol-Myers-Squibb’s Ixempra
(ixabepilone) (Rs. 66,430), Pfizer’s Macugen (pegaptanib) (Rs. 45,350), Sanofi Aventis’ Fasturtec. (rasburicase) (Rs. 45,000), Roche’s Avastin (bevicizumab) (Rs.
37,180). There are six products costing between Rs. 10,000 and Rs. 45,000 (for
example, Wyeth’s Enbrel (etanercept): Rs. 15,761), eight products between Rs. 1,000
and Rs. 10,000 (GSK’s Tykerb (lapatinib): Rs. 4,468).Prices mentioned are for a
single injection/tablet, etc. The cost of treatment per person per year would of course
be much higher. The price of a 70 mg dasatinib (lukemia) tablet is Rs. 3,905 using
100 mg per day, the cost of treatment per person per year exceeds Rs. 20 lakh. The
corresponding cost in the UK is £30,477. Bristol Myers Squibb) is essentially
charging the same price and not using differential pricing.
A similar story can also be told for the other life-extending drugs such as trastuzumab,
cetuximab, ixabepilone, etc. Similarly, we can also tell about the prices of vital drugs
such as Wyeth’s Enbrel (etanercept) (Rs. 15,761 per injection) used for rheumatoid
arthritis, which can incapacitate people, Pfizer’s Macugen (pegaptanib) (Rs. 45,350
per 90 ml injection) used for preventing loss of vision in the case of age-related
muscular degeneration, Sanofi-Aventis’ Fasturtec (rasburicase) (Rs. 45,000 per
injection) used to treat the side effects of chemotherapy for treating leukaemia and
44
lymphoma are very highly priced. The story is unending in the case of new drugs.
Take the price of pegalytedinterferons beta (Roche’s Pegasys) used for Hepatitis co
infected with HIV which costs between Rs. 14,000 and Rs. 18,000 per dose. Roche
got the product patent in India. But due to patent disputes, some Indian generic
companies are also manufacturing and marketing it.
Given the nature of post-TRIPS world it is clear that we need to analyse information
in each therapeutic group on the state of product level competition.
Public procurement, control of prices of medicines and the Indian
pharmaceutical market
The Indian pharmaceutical market has some special features. The most prominent
feature is the fact that a very large proportion of drugs consumed in India are procured
through retail sales. Retail sales of pharmaceuticals were US$ 6.2 billion while
institutional sales were estimated around USS 1.1 billion in 2006, i.e. 85 per cent of
drugs were sold through retail outlets. Institutional sales which account for 15 per cent
of the market include consumption through the public sector as well as through
private hospitals and other institutions. This is very different from what is seen in
developed country markets, where a bulk of drug consumption is through supplies
from large institutional mechanisms (hospitals, health insurance, etc., both in the
public and private sector)’. Given this, the major issues related to drug prices are
related to those that impact on retail prices.
Sufficient evidence also exists that the state governments are able to lower the costs of
financing of essential medicines for the public facilities through public procurement
of medicines in their states. Using public procurement in India a few state
governments have achieved remarkable results in terms of lowering the cost of
financing of medicines to the exchequer and ensuring the supply of essential
medicines to a larger population. Public procurement has been particularly used to
achieve successfully lower prices for off-patent, multi-source essential medicines in
Tamil Nadu, Rajasthan, Delhi, and Kerala in India. Table 4.16 presents the evidence
of greater impact of government procurement on prices of medicines using the
example of prices achieved through the system of procurement by the government in
Tamil Nadu and Rajasthan. Number of formulations having ceiling prices in the retail
45
market in percentage terms prices greater than 100-500 when compared with RMSC
rates are 109 out of 199 analysed. Number of formulations having ceiling prices in the
retail market in percentage terms prices greater than 100-500 when compared with
TNMSC rates are 41 out of 85 analysed. There is also evidence that the Central
Government has been successfully utilising the mechanism of public procurement in
the CGHS / Railways / Armed Forces for the supply of cancer drugs to bring down
the cost of financing.
Table 4.16—Comparison of ceiling prices with procurement rates of Tamil Nadu Medical
Services Corporation (TNMSC) and Rajasthan Medical Services Corporation (RMSC)
No. offormulations having ceiling
No. offormulations having ceiling
Percentage that
prices percentage greater than
prices percentage greater than RMSC
ceiling price is greater
rate
than state
TNMSC rate
procurement rates
5
-l-(-50)
TQ9
41
100-500__________
38
17
501-1000_________
20
9
1001-1500________
14
7
1001-2000________
7
4
2001-2500________
2
2
2501-3000
2
2
3001-3500________
1
3501-4000________
1
1
4001-4500________
1
4501-5000_________
5001-6000________
6001-6500________
6501-7000________
1
7001-7500_________
199
85
Total _______________________
Source: Ceiling prices notified by the National Pharmaceutical Pricing Authority (NPPA); procurement documents
from TNMSC and RMSC for 2012-13
Analysis of the above table makes it quite clear that competition is most effective
when price conscious, publicly funded state procurement agencies and institutional
purchasers are the purchasers rather than individual consumers. Both, the Government
of Rajasthan and the Government of Tamil Nadu, were able to procure drugs at much
cheaper rates from the industry. In the case of Government of Rajasthan, one hundred
nine drugs out of one hundred ninety nine drugs procured were cheaper from the
prices in retail market in percentage terms by not two or three times but by 100-500
times. Thirty eight drugs out of one hundred and nine drugs procured were cheaper in
percentage terms by 501-1000 times. Twenty drugs out of one hundred nine drugs
procured were cheaper in percentage terms by 1001-1500 times. In the case of
46
Government of Tamil Nadu, forty one drugs out of eighty five were in percentage
terms cheaper by 100-500 times.
See Table 4.16 for the details of how cheap can the process of bulk procurement
become when drugs are purchased through a transparent process of public
procurement by the governments. Strong evidence of how publicly funded state
procurement agencies and institutional purchasers of essential medicines are able to
achieve better results in respect of inducing competition is self-evident from the
figures presented in the table. When individual consumers purchase medicines out-ofpocket, pervasive asymmetry of information limits the potential for effective medicine
price competition. Since most of the patients are forced to obtain even essential
medicines from the retail market the introduction of an effective price control
mechanism
is a formidable challenge. The imperfections of uncompetitive
pharmaceutical markets are known to be devastating for the consumers when they are
uninsured. They do not have the benefit of medicine supply from public health
facilities at lower cost.
In India, mechanisms of public financing and social insurance’.are weak. Consumers
are known to pay heavily for medicines when they purchase them out of pocket.
Pharmaceutical markets functions quite imperfectly because of the practices of
promotion used by the industry for the sale of medicines. Heavily branded generics
are often sold at a high multiple of the price of low priced generics, with many people
paying more than they need to. Market does not treat branded medicines and generics
as perfect substitutes. Many factors play a role in the creation of imperfections: poor
information, risk aversion about the information on quality of low priced generics,
mistrust of drug regulatory environment, responsiveness to advertising. Lack of
availability of low cost generics in private retail outlets and greater reliance on the
advice of doctors and pharmacists who are also influenced by the practices of
promotion of drugs by the companies is an integral feature of the concentrated
markets.
47
CHAPTER 5
DPCO, 2013: COVERAGE AND ITS IMPACT
Since the DPCO was implemented, there has been wide speculation about the effects
that it will have on affordability, market sales and the industry. In this chapter, we
evaluate various aspects of the DPCO, and estimate the potential impact on access to
medicines and the pharmaceutical market. Specifically, we examine the scope of
control in the Indian pharmaceutical market, estimate the impact on medicine prices
and market sales, and highlight weaknesses of the DPCO that diminish the success in
achieving its stated goals.
Scope of coverage
‘Essentiality’ criterion is insufficient for fulfilling the Supreme Court’s
directive
The NPPP has identified 'essentiality of drugs' as the only criterion for bringing drugs
under price control. This has been operationalised as the medicines listed on National
List of Essential Medicines (NLEM) 2011. or subsequent revisions thereof. •. .
In 2003, the Supreme Court directed1 the government to “consider and formulate
appropriate criteria for ensuring essential and life saving drugs not to fall out of price
control” and“to review drugs which are essential and life saving in nature till 2nd May
2003.” Following this, the Ministry of Health and Family Welfare revised the NLEM
for the first time in 2003 and then subsequently in 2011.
Therefore, the NPPP has at most partially addressed the Supreme Court Order and
violated it by excluding life saving medicines from the oversight of price control. No
attempts have been made to identify a separate list of life saving medicines many of
which may refer to newer, highly-priced treatments (e.g., anti-cancer drugs).
Furthermore, the concept of 'essential drugs’ has been strictly confined to the 2011
NLEM. The NLEM is a key instrument in addressing the priority healthcare needs
and disease burden of India . It comprises a representative rather than comprehensive
1
2
Supreme Court Order of March 10, 2003 in SEP (Civil) No. 3668/2003
National List of Essential Medicines of India 2011
list of 348 medicines selected on the basis of safely, efficacy and cost-effectiveness
under 27 therapeutic categories, and which should be available at affordable cost and
assured quality. In order to serve as a reference for rational prescribing, only a few
model dosage forms and strengths have been mentioned for each medicine. Similarly,
single ingredient formulations are preferred over fixed dose combinations, where
appropriate. Given that the NLEM was not prepared with the explicit intention of
regulating drug prices in the private sector, defining price control according to the
NLEM is a matter of concern.
Shortcomings and deficiencies of the NLEM
Even though the NLEM purports to satisfy the priority health needs of the majority of
the population, its completeness and appropriateness has been called into question by
a
experts . Because DPCO is based on the NLEM, any ommissions of clinically
important medicines or their dosage forms, strengths or combinations will
immediately be excluded from price control.
According to the stated intent of the NLEM, “medicines used in the various national
health programmes, emerging and reemerging infections should be addressed in the
list.” However, ferrous sulphate and folic acid combination being used in the national
nutritional anemia prophylaxis programme is conspicuously absent from the NLEM in
spite of the widespread iron deficiency anemia in both adults and children.
In another instance, stavudine is listed on the NLEM even though it has been phased
out due to toxicity and replaced by tenofovir in the HIV national programme. Even
though tenofovir is being rolled out in combination with lamivudine and efivarenz
(TDF/3TC/EFV) to people living with HIV as first line treatment under the national
ART programme, it is missing from the national list. The NLEM should at the very
least reflect the treatments under national programmes and function as a tool to ensure
that prices of critical medicines remain affordable in the market.
3
Srinivasan et al, 2013, Drug Price Control order 2013 As Good As a Leaky Bucket, Economic and
Political Weekly, vol XLV11I nos 26 & 27; Bhargava, A (in print). Anomalies in the National List
of Essential Medicines and Drug Price Control Order 2013 and their serious implications for public
health in India.
49
Tenofovir in combination with lamivudine has a second indication for HBV treatment
but access to low cost generic treatment regimens (that are also used in HIV
treatment) is an issue for mono-infected hepatitis B positive patients, who are not
eligible under the national ART programme.
Furthermore, the Department of AIDS Control is planning to roll out third line
treatment for HIV/AIDS by April 2014 which will include a patented drug —
raltegravir. Under the 2011 NLEM, raltegravir will be exempted from price control
and can be sold at high prices in the private sector.
Standard-of-care medicines in several priority conditions for India are also missing
from the NLEM. Although fixed dose combinations have been recommended by the
WHO for optimal treatment of tuberculosis, none are mentioned on the essential
medicines list. The number of cases of multi-drug resistant tuberculosis (MDR-TB),
which develops as a consequence of improper use of antibiotics in drug-sensitive TB,
has reached epidemic proportions in India and is the highest in the world. Faced with
the challenge of extending access for MDR-TB patients to extremely expensive
combination treatment under lengthy regimens and given that only 5% of patients are
on treatment through the government’s DOTS-Plus (Daily Observed Treatment Short)
programme, the absence of drugs for MDR-TB on the NLEM (such as capreomycin,
cycloserine, ethionamide, kanamycin and para-aminosalicylic acid which are included
on the WHO Model Essential Medicines List) can only be construed as negligence.
The NLEM mentions neither the injection form of artesunate for the treatment of
severe ‘falciparum malaria’, even though it is recommended by the WHO, nor does it
list any alternate treatment options such as artemether-lumefantrine combination
tablets.
The number of anti-diabetic medicines missing from the NLEM is mismatched with
the burden of diabetes in India. Indeed, India has acquired a reputation as the
‘diabetes capital of the world’. The NLEM lists only metformin and glibenclamide as
oral anti-diabetics. Given that glibenclamide has been declared unsuitable for use
above the age of 60 years, there is a desperate need to expand the list of medicines to
other drugs in the sulfonylureas chemical class such as glimepiride and gliclazide.
Classes of drugs such as glitazones (e.g., pioglitazone) and gliptins (e.g., sitagliptin)
50
are also absent from the NLEM. Newer, expensive insulin analogues are also not
included.
A major shortcoming of the 2011 NLEM is the lack of sufficient dosage forms
(dispersible and chewable tablets) and preparations that are appropriate for children.
As a consequence, many children’s formulations are left out of price control.
Additionally, there are no patented medicines on the NLEM. Since India came into
compliance with the WTO TRIPS Agreement in 2005, generic competition is no
longer a reliable option to reduce prices. In the absence of any policy to regulate
patented medicines, prices are frequently unaffordable for the majority of the
population. Several new, innovative molecules are associated with valuable health
benefits and could easily be brought under the NLEM based on an assessment of their
clinical value and the unmet need.
Our discussion of the shortcomings of the NLEM 2011 has highlighted prominent
omissions of medicines and several instances where the national list is misaligned
with the accepted standard of care. There is an urgent need to plug the gaps in the list
and revise it in line with current treatment protocols.
Health being a state subject, essential medicines lists are often implemented at the
state-level and linked to the procurement and distribution of medicines in the public
health system. While the NLEM serves as a model for states during the formulation of
their state essential medicines lists, selection of drugs is often also driven by practical
considerations such as previous utilization, availability of suppliers, budget
constraints and prescribing patterns, as well as state-specific health needs. Therefore,
state lists do.not overlap perfectly with the national list. As a result, significant
number of medicines in state lists may remain outside the scope of price control
despite the fact that these states consider them to be essential.
A comparison of the Rajasthan 2013 and Tamil Nadu 2012-13 essential medicines
lists with the national list revealed that 50% of the medicines on the Rajasthan list and
43% of the Tamil Nadu list did not correspond with the NLEM and hence would not
be covered by the new price control order. Hence, there is a disconnect between the
concept of essentiality as defined by the NPPP 2012 and by individual states.
51
TPP'SOO
The NLEM should also be reviewed by taking into consideration the state lists, and be
expanded to include medicines for diseases endemic to regions or relevant for
particular minorities, so as to be truly relevant for all segments of the national
population.
Coverage under DPCO 2013
Our findings reveal that the majority of the private sector market is untouched by
DPCO. Drug pricing policy is targeted at only 17% (Rs. 11,798 crore) of the total
pharmaceutical market, worth over Rs. 70,000 crore, as per our estimates. Table 5.1
presents the share of the market coming under regulation in various therapeutic
groups.
Table 5.1 Market coming under price control
Market
Therapeutic group
Market
Market
Market
Market
value of
sales
value of
share of
share of
2012
medicines
medicines
medicines
medicines
(Rs.
under price under price
NOT under NOT under
crore)
control (Rs. control (%)
control (Rs. control (%)
crore)
crore)
Anti Diabetic_______________
4802.3
4102.3
85
700.0
15
Anti malarials______________
543.9
475.0
87
13
68.9
Anti-infectives______________
11823.7
7692.9
65
4130.8
35
Anti-Parasitic______________
314.1
158.5
155.6
50
50
Anti-TB__________________
__ 82
388.3
319.0
69.3
18
Blood Related______________
323.2
325.1
99 _______ 1.9
1
8268.0
6327.0
77
1941.0
Cardiac___________________
23
Derma____________________
3553.1
91
9
3911.0
357.9
Gastro Intestinal____________
7426.8
6541.3
88
885.5
12
4089.4
Gynaec.___________________
4736.6
86
647.2
14
Hepatoprotectives___________
711.5
711.5
100
HIV______________________
307.6
261.9
85
45.8
15
Hormones_________________
697.5
56
1254.5
557.0
44
Neuro / CNS_______________
4227.8
3549.4
84
678.4
16
Ophthal / Otologicals________
1165.5
95
65.3
1230.8
5
Others____________________
1128.7
87
166.4
1295.1
13
Pain / Analgesics____________ ' 5821.5
91
5316.4
505.1
9
Parenteral_________________
192.5
257.6
75
65.1
25
Respiratory________________
5608.7
5320.8
95
287.9
5
Sex stimulants / Rejuvenators
903.3
892,3
99
11.0
1
Stomatologicals _____________
100
378.3
378.3
VACCINES_______________
1358.8
933.3
425.5
69
31
Vitamins / Minerals / Nutrients
5350.8
5318.1
32.7
99
1
Grand Total_______________ 71246.0
83
59448.0
17 11798.0
Source'. IMS Health, authors calculations. Estimates are excluding formulations for which data was
unavailable through IMS and where relevant products could not be identified in the IMS database
52
As depicted in Figure 5.1, only 5% of the market for respiratory drugs, 23% of cardiac
drugs, 15% of anti-diabetics and 35% of anti-infectives fall under the ambit of price
control.
Figure 5.1. Market under control in selected therapeutic categories
I'2I
!
1
85 '
87
I
S■
- -
5
'16
g
88
77
fe
■
86 ;
'85 | ?84 3 '95
(■ill
IfB ■
§
z
X
- ■ ■ i
1
A
& Market share of medicines under price control (%)
m Market share of medicines NOT under control (%)
Source'. Authors’calculations based on data from IMS Health
Breaking this down to the sub-therapeutic level. Figure 5.2 shows the extent of price
control in various prominent non-communicable disease segments. Only 6% of the
oral antidiabetics segment and 7% of the antidepressants segment correspond with the
NLEM and hence fall under price control. Similarly, the reach of DPCO extends to
approximately 26% of statins, 23% of antiepileptics, 15% of antipsychotics, and 41%
of human insulin analogues.
The National Pharmaceutical Pricing Authority (NPPA) is charged with issuing
ceiling prices under the DPCO. For this purpose, the NLEM which consists of 348
medicines has been broken down into the exact strengths and dosage forms that are
mentioned in the document. By our estimation the there are approximately 622
formulations (i.e., unique strengths and dosages) that are drawn from the NLEM (see
Appendix 1).
53
Figure 5.2 Market cover of DPCO 2013 in selected sub-therapeutic segments
N06A ANTIDEPRESSANT-THYMONAL
Al OB ORAL ANTIDIABETICS
_ Rs. 196.9
crore
(6%)
Rs. 49.1
crore
(7%)
Rs.
3296.79
crore
Rs.
631.05
u% of market under price control
u% of market under price control
U% of market not under price control
□ % of market not under price control
z\10C HUMAN INSULIN N ANALOGUES
C10A STATINS
Rs.
737.72
Rs. 503.1
crore
(41%) :
Rs.
1101.44
crore
Rs. 396.2
crore
(26%)
U% of market under price control
u°/o of market under price control
u% of market not under price control
u% of market not under price control
N03A ANTIEPILEPTICS
Rs.
, ; ' 325 9
crore
; v .
Rs. (23%)
'
109295
s 7^-* crore
N05A ANTIPSYCHOTICS
Rs. 45.7
crore
(15%)
Rs.
•
249.82
I
crore
y% of market under price control
u% of market under price control
□ % of market not under price control
y % of market not under price control
Source: Authors’calculations based on data from IMS Health
In essence this means that any additional strengths, dosage forms or combinations
involving medicines on the NLEM remain outside the scope of price control. For
instance, the price of paracetamol 500 mg tablet will be regulated because it is
specified but the 650 mg strength tablet will not. Even though several dosage forms
and strengths of paracetamol are covered under the NLEM (e.g., 150mg/ml injection,
125mg/5ml syrup, 80mg and 170 mg suppositories and 500mg tablet), numerous
alternate strengths, pediatric formulations and all combinations that are being sold in
the market remain outside price control.
54
Moreover, because the NLEM includes only a handful of few Fixed-dosecombinations (FDCs), the scope of price control is disappropionately narrow within
combinations, relative to plain formulations. Plain formulations and combinations
constitute 53% and 47% the pharmaceutical market (by 2012 sales), respectively.
Whereas 73% (~ Rs. 27,000) of the plain formulations market is left untouched,
roughly 95% (~Rs. 32,000 crore) of the combinations market is excluded (see figure
5.3). In fact, combinations outside the span of price control alone make up 45%of the
full pharmaceutical market.
Figure 5.3. Scope of Price Control - Combinations & Plain Formulations
Share of combinations market coming under
price control
Share of plain formulations market coming
under price control
5% (Rs.
1,648
crore)
t'
27% (Rs.
10,150
. crore)
95% (Rs:
32,1 IS
crore)
Under DPCO
73% (Rs...
m 5 -3373 327,3304**
a Not under DPCO
Under DPCO
a Not under DPCO
Source-. Authors' calculations based on data from IMS Health
With the primary objective of promoting the rational use of medicines, the NLEM has
purposely emphasised single ingredient formulations over FDCs and reflects an ideal
scenario that is disconnected from actual utilization patterns. The DPCO, by
excluding all combinations of NLEM medicines, has completely failed to address the
reality of unfettered use of irrational combinations by patients who are often subjects
of irrational prescribing and dispensing.
Noting the need to revise the scope of control, we explored the potential impact of
broadening the scope of control by taking the example of antiinfectives. We explored
a scenario where price control of antiinfectives under the NLEM was broadened to
cover all additional strengths, dosage forms, and their combinations. The current
market value of antiinfectives covered under DPCO was estimated at Rs. 4,636 crore
or 7% of the entire market. The additional market value of anti-infectives were price
control expanded under the hypothetical scenario was estimated to be Rs. 5,925 crore
or 8% of the entire market. Hence, under the new scenario, the combined market
55
value of controlled anti-infectives as a percentage of the total market value would
increase to 15% (see Figure 5.4).
Figure 5.4 Anti-infectives market
Rs-10561
crore(is%)
Rs. 4636 crore^\,
(7%)
i
^^^Rs. 5925 crore
(8%)
»
A
'6b68D '
'
■ Combined market value of antibiotics under span of DPCO 2013
■ Additional market value of combinations, additional strengths and dosages involving
antiinfectives in the NLEM
I
■ Market outside price control if price control were expanded
• ’ ‘Source'. Authors’ calculations based in data from IMS Health
■ The case of anti-infectives clearly indicates that the market value of medicines under
price control would increase considerably if the scope of control is broadened so as to
increase coverage to all strength, dosages and combinations of formulations in the
NLEM.
The new policy shrinks the scope of control dramatically by focusing solely on
formulations. Previously under DPCO 1995, the prices of bulk drugs were being
regulated such that over 1500 formulations as of 2012. Under paragraph 2(b) of
DPCO 2013, active pharmaceutical ingredients or bulk drugs are defined as:
2(b)
"active
pharmaceutical
ingredients or
bulk
drug"
means
any
pharmaceutical, chemical, biological or plant product including its salts, esters,
isomers, analogues and derivatives, conforming to standards specified in the
Drugs and Cosmetics Act, 1940 (23 of 1940) and which is used as such or as an
ingredient in any formulation;
The NPPP has claimed that “price control in the form of formulations only ensures
more specific pricing control of the required medicine which is in the interest of the
56
consumer from the point of view of the actual prescription by the Doctor.” On the
contrary, because the NLEM has no influence or bearing on prescribing practices and
essential medicines account for only a small fraction of private sector sales, it
becomes all the more important to regulate even the 'salts, esters, isomers, analogues
and derivatives’ related to formulations on the NLEM.
Particularly for sections of the NLEM where few therapeutic equivalents have been
provided within the same class of drugs (e.g., atorvastatin is the only statin included),
close substitutes should also be brought under price control.
Limiting price regulation to formulations in the NLEM poses a clear risk that
companies will shift their production, marketing and distribution energies towards
increasing the sales of formulations that lie outside the NLEM.
In summary, the scope of coverage under current implementation of DPCO 2013 is
extremely inadequate and substantial measures should be taken to expand it. The
government-has recently conveyed an intention of revising the NLEM in 2014. We
assert that in addition to revising the 2011 NLEM to address the problems described,
an attempt should be made either separately or as part of the NLEM review to identify
life saving medicines to be brought under price control. Further, implementation of
DPCO should go beyond the literal reading of the NLEM to include a larger segment
of the market in order to be viewed as an effective policy.
Impact on Prices and Sales
Reduction in prices
By December 2013, the NPPA had notified ceiling prices of 446 formulations using
the market based formula, of which 419 were related to the NLEM and 27 were new
formulations (i.e., new strengths or combinations of essential medicines that have not
been marketed previously).
The simple goal of the DPCO and use of the market based formula is to see a
reduction in the price of the highest priced brand for the specific formulation. The
magnitude of the reduction is essentially considered to be irrelevant.
57
Yet, we observe that the reduction from the price of the sales leader is a more suitable
indicator for evaluating the impact of price control. This is because the sales leader is
the brand with the highest sales and therefore bringing about a significant reduction in
its price has the potential to provide the maximum financial relief.
In order to ascertain the prominence of the sales leader, we determined the market
share of the sales leader in 419 formulations for which the ceiling price had been
notified by the NPPA. Table 5.2 shows the market share of the sales leader for
formulations in each of the NLEM therapeutic categories. In 293 formulations, the
sales leader has a market share of more than 50%. For another 101 formulations, the
sales leader commands a market share between 25%-50%. This trend is consistent
across all therapeutic categories.
Thus, in the majority of cases (394; 94%) the sales leader has a considerable and high
market share, supporting our argument for studying the price reduction of the sales
leader.
Table 5.2 Market Share of the Sales Leader
NLEM Section ■
NLEM
Section
No.
1 Anaesthetics
______
2 Analgesics, Antipyretics, NonSteroidal Anti-Inflammatory
Medicines (Nsaims), Medicines
Used To Treat Gout And Disease
Modifying Agents In Rheumatoid
Disorders (Dmards)___________
3 Antiallergics And Medicines Used
In Anaphylaxis_______________
4 Antidotes And Other Substances
Used In Poisonings____________
2 Anticonvulsants/Antiepileptics
6^ Anti-Infective Medicines_______
2 Antimigraine Medicines________
8 Antineoplastic,
Immunosuppressives And
Palliative Care_______________
9 Antiparkinsonism Medicines
10 Medicines Affecting The Blood
11 Blood Products And Plasma
Substitutes__________________
12 Cardiovascular Medicines______
13 Dermatological Medicines
(Topical)
Number Of
Formulations
No. With
Share Of
Market
Leader
>50%
No. With
Share Of
Market
Leader
>25% But
<50%
No. With
Share Of
Market
Leader <25%
25
23
22
19
3
3
2
7
3
4
0
4
3
1
0
14
92
3
52
14
51
2
35
0
32
1
17
£
2
2
o
3
11
4
1
2
2
2
2
2
o
49
10
31
6
7
3
n
58
3
i
i
i
NLEM
Section
No.
NLEM Section
14 Diagnostic Agents___________
15 Disinfectants And Antiseptics
16 Diuretics___________________
17 Gastrointestinal Medicines____
18 Hormones, Other Endocrine
Medicines And Contraceptives
19 Immunologicals _____________
20 Muscle Relaxants (PeripherallyActing) And Cholinesterase
Inhibitors__________________
21 Opthalmological Preparations
22 Oxytocics and Antioxytocics
23 Peritoneal Dialysis Solution
24 Medicines For Mental And
Behavioural Disorder_________
25 Medicines Acting On The
Respiratory Tract____________
26 Solutions Correcting Water,
Electrolyte And Acid-Base
Disturbances________________
27 Vitamins And Minerals_______
Total______________________
Source'. IMS Health
Number Of
Formulations
No. With
Share Of
Market
Leader
>50%
No. With
Share Of
Market
Leader
>25% But
<50%
No. With
Share Of
Market
Leader <25%
£
£
£
£
14
4
£
£
£
£
12
6
11
5
1
£
16
9
0
12
13
7
0
5
3_
2_
£
£
£
£
5
5
0
0
5
4
1
0
3 '
419
293
0
101
0
25
1
9
3
21
20
1
8
2
17
1
6
2
0
1
We compared the percentage price reduction from both the highest price as well as
sales leader for the 419 formulations using data available from the NPPA (see table
5.3).
Table 5.3 Price reduction of the notified price from the highest price and the sales leader
Price reductionfrom highest
Price reduction from market
________________________________________price
________ leader_____
No. offormulations
%
No. offormulations
%
No price reduction____________
0
________________ 113
27
Limited price reduction (</=l 0%)
12
_________________ 64
15
49
Reduction is > 10% to 20 %_____
21
86
_________________ 72
17
Reduction is >20% to 30%_____
25
106
_________________ 78
19
Reduction is >30% to 40%_____
15
62
_________________ 36
9
Reduction is >40%____________
28
116
_________________ 56
13
Total______________________
419
419
Source-. NPPA price notifications
We observed that whereas the price reduction from the highest brand was greater than
40% in 116 formulations, only 56 formulations showed a price reduction of more than
40% from the price of the sales leader. There was a only a marginal reduction from
the highest price in 49 formulations. In contrast, for 113 formulations there was no
reduction in price of the sales leader and in a further 64 formulations the reduction
59
was very limited. Therefore, in 117 formulation or 42% of cases, there was limited to
no impact on the price of the sales leader.
We also noted evidence of market failure based on 193 formulations where the sales
leader was also the highest priced brand. This finding is not surprising and finds
support in the literature; however, it also indicates that the assumption of vibrant
competition that is the backbone of the market-based formula has been violated.
In the interest of undertaking an analysis and evaluation of the DPCO and its
implementation, we attempted to calculate ceiling prices formulations coming under
price control using independently procured data from IMS Health. Table 5.4 provides
an overview of our calculations.
Table 5. 4. Overview of Independent Calculations________
Authors’ independent calculations ____________________
Total number of formulations identified for the analysis______
No. of formulations for which prices have been calculated
No. of formulations for which no data is available through IMS
No. of formulations for which sales value is zero*__________
No. of formulations determined to have monopolies_________
♦May 2012, MAT
622
371
140
11
100
60%
23%
2%
16%
Ceiling prices were calculated for 371 formulations out of a total of 622 formulations
that were identified. We could not find data through IMS Health for 140 formulations
and for an additional 11 formulation no sales had been recorded in the IMS dataset.
Paragraph 6 of the DPCO 2013 describes the application of special provisions for
calculating the ceiling prices of formulations where there is only one competitor with
a market share of 1 % or greater. We identified 100 such monopoly cases but did not
attempt to calculate the ceiling prices.
The analysis discussed further is based on the sample of 371 formulations for which
we computed ceiling prices.
Reduction in market sales
We estimated the monetary impact of DPCO in the sample of 371 formulations
considering only the brands having 1% or greater market share. Assuming there
would be no change in demand (i.e., constant volumes), the reduction in sales value
60
was quantified as Rs. 1290 crore. This represents less than 2% of the total annual
sales in 2012.
Table 5. S.Monetary impact of DPCO
Category
Nlem
Number Of
Sect io
Formulations
n
Considered
j____Anaesthetics___________________________________ 18________
2 ____ Analgesics, Antipyretics, Nsaims___________________ 21_________
3 ____ Antiallergics And Medicines Used In Anaphylaxis_____ 8 _________
4 ____ Antidotes And Other Substances Used In Poisonings
4_______ __
5 ____ Anticon vulsants/Antiepi leptics_____________________ 9 _________
6 ____ Anti-Infective Medicines__________________________ 102_______
7 ____ Antimigraine Medicines__________________________ 3__________
8 ____ Antineoplastic, Immunosuppressives And Palliative Care 39________
9 ____ Antiparkinsonism Medicines_______________________ 6__________
10 ___ Medicines Affecting The Blood____________________ 9_________
JJ__ Blood Products And Plasma Substitutes______________ J______
12 ___ Cardiovascular Medicines_________________________ 39________
13 ___ Dermatological Medicines (Topical)_________________ 9_________
14 ___ Diagnostic Agents_____________
J______
Disinfectants And Antiseptics
15
2__________
16 ___ Diuretics____________________
2__________
17 ___ Gastrointestinal Medicines______
16________
Hormones,
Other
Endocrine
And 22
18
Medicines
Contraceptives________
Immunologicals_______
19
10
20
Relaxants
(Peripherally-Acting)
And 4
Muscle
Cholinesterase Inhibitors
21
Opthalmological Preparations______________________ 11
22
Oxytocics And Antioxytocics______________________ 8
23
Peritoneal Dialysis Solution________________________ 1
24
Medicines For Mental And Behavioural Disorder_______ 15
Medicines Acting On The Respiratory Tract___________ 6
25
26
Solutions Correcting Water, Electrolyte And Acid-Base 3
Disturbances___________________________________
27
Vitamins And Minerals___________________________ 2
Grand Total
371
Original
Market
Value
Monetary
Impact
Impact
As A %
106.4
11.4
423.9
44.7
44.0
0.1__
87.2
8.4_____
604.2
36.4
0.0
27.7
1.1
74.6 ,
1143.5
100.2-
11%
11%
13%
2%
13%
11%
2%
12%
22%
8%
16%
14%
28%
3%
32%
13%
12%
9%
349.8
30.9
30.2
1.1
9%
3%
75.3
314.2
0.0
289.3
21%
15%
4%
9%
114.9
62.9
15.5 '
46.4
0.0__
25.4 '
7.2 3.7
22.3
11267.9
0.4___
1290.1
2%
11%
329.1
3.9_____
235.6
4524.2
40.3
340.5
67.3
391.2
59.2
1513.3
129.1
1.0_____
31.0
480.9
0.9__
41.8
14.9
30.8
9.7__
210.1
6%
6%
Impact as a percentage of 2012 annual sales turnover
Taken as a per cent of original market value, the cumulative reduction in sales value
for 15 formulations for mental disorders was 9%. Similarly, the cumulative reduction
in sales value was 12% for 16 gastrointestinal formulations, 11 % for 102 antiinfective
formulations and 12% for 39 formulations in the anti-neoplastic, immune supressives
and palliative care category. The highest impact observed was 32% for disinfectants
and lowest impact was 2% for antidotes and substances used in poisoning.
Out of the total of 2083 brands having at least 1% market share, only 984 brands
(47%) would be affected and experience a decrease in value of sales. The market
61
1.8%
shrinkage as a percentage of the original value of affected biands varied across
formulations but was 20% on average. Thereafter, the actual loss of profits would
constitute only a portion of the decreased sales value.
However it should also be kept in mind that DPCO allows for an annual price increase
as per the WP1 for all scheduled formulations. Brands which are priced at exactly the
ceiling price can claim a higher absolute price increase than brands that are priced
lower than the ceiling as the WPI is applied as a percentage. For unscheduled
formulations which include a huge segment of irrational medicines, a 10% annual
price hike is automatically assured.
Availability of lowest priced brand
As pointed out earlier, the sales leader is frequently observed to hold a high market
share. In our sample of 371 formulations, the average market share of the sales leader
was 62%. In comparison, the average market share of the highest price (with at least
1% market share) was 35% and of the lowest price (with at least 1% market share) .
was only 19%. This indicates that the availability of lower priced brands, even those
that have a significant share of the national market, significantly lags behind the sales
leader and highest priced brand.
In order to examine this further we considering only brands having at least 1% market
share and plotted the market share of the lowest priced brand against the number of
competitors in that formulation. Figure 5.5 depicts the interaction of market
competition with share of the lowest price. We observe that in 231 formulations (of
371), the lowest price has a market share of less than 10%. Moreover, as the number
of players increases, the share of the lowest price drops dramatically. We conclude
that because of the nature of competition among firms, it is not safe to assume that the
lowest priced brand is always accessible to patients as it often captures the smallest
share of the market.
62
Figure 5.5. Depiction of the relationship between market share of the lowest
price and number of competitors in 371 form ulations
100
95
90
IF-
1
85
80
75
70
-IF— T
K
65
60
a--
55
50
45
It
40
35
Th •
30
25
20
15
10
5
0
« share of lowest price (1%) (%.oflotal value)
1
I ZU
I
r
I1
4
-L/...
u
Jiil
22222222222333333344444445555566666778889 101214161723
Number of competitors having at least 1 % market share
An alternate market-basedformula
We also explored a scenario where the average PTR is replaced with the lowest PTR
in the market-based formula and studied its implications. Table 5.6 summarises the
expected market shrinkage under both the current and lowest PTR scenarios. This is
of interest because the decrease in sales value directly translates to reduction in outof-pocket spending. We assume that the lowest priced brand holding at least 1% share
of the national market is able to serve the market while sustaining reasonable profits.
Therefore we expect the see the greatest impact on patient expenditure under a variant
of the market-based pricing that considers the lowest PTR as the basis for setting
ceiling prices.
Table 5.6. Comparison of the average PTR and lowest PTR scenarios_____
Average
Lowest PTR
PTR
____ scenario
Estimated market shrinkage in 371 formulations_____________ 1290 cr.
4205 cr.
Market shrinkage as a percent of original market value________
1.8%
5.9%
Number of 1 % brands affected_________________________ ______ 984
1711
Market shrinkage as a percent of original value of affected brands
19.8%
43.9%
Source'. Authors’estimates
63
Under the lowest PTR scenario, there was more than a threefold increase in the sales
value forfeited because of price control. Similarly, the value of affected brands would
be eroded to a larger extent (-44%) and provide greater relief to consumers, compared
with under the current formula (~20%).
As can be seen in Table 5.7, the monetary impact (percentage decrease in sales value)
is greater than 20% for 226 formulations in the lowest PTR scenario and only 52
formulations in the average PTR setting. Whereas the majority of formulations face
only a marginal impact on sales value under the average PTR price control (0-10%),
this trend is reversed in the lowest PTR scenario with the majority of formulations
facing an impact of more than 20%.
Table 5.7 Trend in decrease in sales value under two scenarios_____________________________
NLEM
Section
Number
Number offormulations (decrease in sales
value as a % of original market value)
Average PTR
Lowest PTR Scenario
>20% 0-10%
0-10%
>20°%
20°%
20%>
NLEM Section
1 Anaesthetics________________________________
2 Analgesics, Antipyretics, Non-Steroidal AntiInflammatory Medicines (Nsaims),____________
3 Antiallergics And Medicines Used In Anaphylaxis
41 Antidotes And Other Substances Used In Poisonings
5 Anticonvulsants/Antiepileptics ________________
6 Anti-Infective Medicines______________________
7 Antimigraine Medicines_______________________
8 Antineoplastic, Immunosuppressives And Medicines
__Used In Palliative Care________________________
9 Antiparkinsonism Medicines___________________
10 Medicines Affecting The Blood_________________
11 Blood Products And Plasma Substitutes__________
12 Cardiovascular Medicines______________________
13 Dermatological Medicines (Topical) _____________
141 Diagnostic Agents___________________________
15 Disinfectants And Antiseptics__________________
16 Diuretics___________________________________
17 Gastrointestinal Medicines_____________________
18 Hormones, Other Endocrine Medicines And
__ Contraceptives_______________________________
19 Immunologicals _____________________________
20 Muscle Relaxants (Peripherally-Acting) And
Cholinesterase Inhibitors______________________
21 Opthalmological Preparations__________________
22|Oxytocics And Antioxytocics___________________
23 Peritoneal Dialysis Solution____________________
24 Medicines For Mental And Behavioural Disorder
25 Medicines Acting On The Respiratory Tract______
26 Solutions Correcting Water, Electrolyte And Acid__ Base Disturbances____________________________
27 Vitamins And Minerals_______________________
Total
64
2
2
£
4
2
10
11
1
2
2
X
1
6
1
4
12
13
__ 4
6
4
3
4
1
2
1
27
14
15
4
7
1
1
2
2
1
17
4
1
19
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4_
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_5
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226
Although it may be loo early to appraise the full impact of the new price control
order, it is clear that relief to patients would be marginal at best. Reductions in the
prices of the most popular brands are mostly inadequate and the potential savings to
consumers is only a drop in the ocean given the size of the pharmaceutical market.
Problematic clauses in the DPCO 2013
In addition to the above discussion, three aspects of the DPCO 2013 appear to be
problematic in the implementation of price control.
First, the DPCO instructs in paragraph 13(2)4 that manufacturers of scheduled
formulations that are already pricing their brands below the notified ceiling price (plus
local taxes) will not be allowed to raise the existing maximum retail price.
While this provision is seemingly well-intentioned it effectively imposes different
ceiling prices for different producers. Manufacturers whose prices have been frozen
below the ceiling price will be disadvantaged because they would not be allowed to
raise prices even if the cost of production or raw materials increases (e.g., due to
exchange rate fluctuations). The policy’s impact will be disproportionately felt by
small and medium firms that lack the financial resources of large companies and
could potentially render it unsustainable for them to operate in situations where their
profitability is threatened.
Also, annual price increases which are allowed in proportion to the WPI will unfairly
result in greater increases for higher priced brands than those priced below the ceiling
price.
Second, the DPCO has weak safeguards to prevent the discontinuation of production
of essential formulations and migration to unscheduled formulations by companies.
Even if the government has the power to mandate the continued production of an
essential formulation5, which is questionable, it will only be for a stipulated period of
time during which production could easily be tapered off to minimal levels. A_
4
5
13 (2) All the existing manufactures of scheduled formulations, selling the branded or generic or
both the versions of scheduled formulations at a price lower than the ceiling price (plus local taxes
as applicable) so fixed and notified by the Government shall maintain their existing maximum retail
price.
Paragraphs 3 and 21 (b), DPCO 2013
65
producer is arguable entitled to stop manufacturing a product if it is no longer
economically viable.
Moreover, there are no controls on the prices or production of alternate forms,
strengths or combinations of essential medicines that are outside the NLEM and
already exist in the market. Whereas DPCO 2013 intends to fix the prices of new
market entrants involving essential medicines, it allows free pricing for similar
formulations that pre-date the price control order.
Therefore; there are several aspects of the DPCO which could be viewed as unduly
discriminatory and grounds to challenge the policy under Article 14 of the
Constitution of India.
Lastly, we have serious concerns about the ability of the NPPA to monitor and
enforce prices of scheduled formulations, particularly given the multiple ceiling
prices, as well as formulations falling outside price regulation. It is naive to imagine
that the NPPA can monitor prices of tens of thousands of brands without developing a
technical capacity and systematic mechanism to collect relevant data on a continuous
basis.
Summing up
In conclusion, the implementation of DCPO presents an inadequate check on
medicines prices, leaves the majority of the market untouched and is expected to
deliver only marginal financial relief to patients. Not only does it permit the presence
of a huge irrational medicines market but encourages its growth by allowing a 10%
increase in prices each year.
66
CHAPTER 6:
LIMITATIONS OF NPPP 2012 AND
DPCO 2013 IN FIXING CEILING PRICES
The National Pharmaceuticals Pricing Policy (NPPP), 2012 and Drug Prices Control
Order (DPCO), 2013 define the regulatory framework for drug pricing and establish
the principles and scope of price control. The primary implementing authority, the
National Pharmaceutical Pricing Authority (NPPA), relies on the guidelines provided
in the DPCO to notify ceiling prices for controlled formulations.
We undertook an independent exercise to estimate ceiling prices using market data
from IMS Health, based on our understanding and interpretation of the DPCO. Three
key elements of the pricing policy define the mechanism through which ceiling prices
are fixed - a) the ‘essentiality’ criterion, b) market-based pricing, and c) reliance on
market-based data. In this chapter, we highlight several limitations of the
methodology as well as use of data in arriving at reliable ceiling prices.
Calculation of ceiling prices under DPCO 2013
As discussed earlier in this report, the NPPP defines price control on the basis of
‘essentiality’ as specified in the National List of Essential Medicines (NLEM) even
though the NLEM was not explicitly prepared keeping its use in price control in mind.
The DPCO limits its control to the strengths and dosages of formulations in the
NLEM. The NPPA, however, has taken a more literal approach by considering even
the ‘form’ (e.g., tablet, capsule) in which the formulation is listed on the NLEM. For
instance, where only a tablet form has been specified, the entire capsule market is
excluded. For practical purposes no distinction is made between plain, time-released
therapies (e.g., sustained, controlled, delayed, modified) or altered versions of the
formulation. Sustained Release forms have been treated separately for price
calculations only in the cases where they are specifically mentioned in the NLEM.
By December 20, 2013, the NPPA has notified prices for 446 formulations which
include 419 formulations based on the NLEM and another 27 new formulations
involving new dosages or combinations of essential medicines that do not appear on
the NLEM. Because price regulation under DPCO 1995 is still in effect for a small
subset of formulations, NPPA is yet to release these ceiling prices.
Following a similar approach as the NPPA for identifying NLEM formulations, we
identified 622 formulations based on unique strengths, dosages and forms (See
Appendix 1). We attempted to calculate ceiling prices for all formulations using IMS
Health data because according to DPCO, the date of the data to be used in price
calculation is constant, irrespective of when the price ceiling is notified.
Methodological differences in applying
the market-based pricing formula
The DPCO has instructed that the ceiling price of a specific formulation is calculated
on the basis of the average Price to Retailer (PTR) and a 16% margin to retailer. The
average PTR is defined on the basis of brands as follows:
“Average Price to Retailer, P(s) = (Sum of prices to retailer of all the brands and
generic versions of the medicine having market share more than or equal to one
percent of the total market turnover on the basis of moving annual turnover of that
medicine) / (Total number of such brands and generic versions of the medicine
having market share more than or equal to one percent of total market turnover on
the basis of moving annual turnover for that medicine.) ” (Page 5, DPCO 2013)
However, it is frequently observed that even within the same formulation (i.e, same
strength) a company may be marketing more than one brand, at different price points.
For example, there are 134 brands for azithromycin-250mg tablet in the market which
are marketed by only 104 companies. If we consider only the brands with appreciable
market presence, i.e., that have at least 1% market share, the number of brands is 25
which are being marketed by 21 companies. Table 6.1 presents a few examples:
68
Table 6. 1 Examples of formulations with some companies marketing more than one brand
Name
NLEM therapeutic section market with all brands
segment ofmarket
made up ofbrands
having at least 1 %
marketshare
number of number of brands
number of
brands companies with 1% companies
market
share
Metoprolol - tablet 50mg Cardiovascular Medicines
45
36
21
19
Azithromycin - tablet
134
Anti-Infective Medicines
104
21
25
250mg_______________
amoxicillin+clavulinic
Anti-Infective Medicines
21
108
80
16
acid - tablet 625mg_____
Cefixime - tablet 200mg Anti-Infective Medicines
120
87
22
20
74
Diclofenac - injection
51
Analgesics, Antipyretics,
23
19
25mg/ml
Non-Steroidal AntiInflammatory Medicines
(Nsaims),
Source: IMS Health
In order to address this reality, the NPPA has chosen a strategy of applying the 1%
market share criteria to companies by combining the individual market shares of all
. brands marketed by a company. Therefore, even brands that individually might
account for less than 1% market share have been taken into consideration in the
NPPA’s calculations. Each individual pack of the companies included has been
retained separately in both the numerator and denominator of the NPPA ’s formula.
In contrast to the NPPA, our own calculations are based on aggregating sales of all the
packs of the same brand (and company) for a specific formulation to determine if it
captures at least 1% of the market share. Thereafter, the PTR for that brand is
calculated as a weighted average by volume (in units) of the various packs sold under
the brand. The average PTR is calculated as the simple average of the PTRs of the 1%
brands as specified in the DPCO.
I
Based on our reading of the DPCO, our method is a more direct implementation of the
market-based pricing compared with the NPPA. However, this does not necessarily
imply that the method used by NPPA is incompatible with DPCO as the order fails to
provide specific guidance on this issue and may be open to interpretation.
In 124 formulations, our calculated ceiling price differs from the NPPA’s ceiling price
by 10% or more. Sixty-three of these formulations show a ceiling price difference
greater than or equal to 25%. In the case of several formulations, differences emerge
69
in the number of packs considered by the NPPA and the number of brands included in
our price calculations. A few examples are presented in Table 6.2.
Table 6.2 Examples of differences in ceiling prices calculated by NPPA and authors
Name of
Unit
Issued by
Authors'
formulation
NPPA
calculation
Number of
Ceilin Number ofbrands Ceilin NPPA Differenc
Packs
g price
considered
g price ceiling e greater
considered
(Rs.)
than
(Rs.) priceAuthors ±10%
' ceiling from
price
NPPA
(Rs.)
ceiling
price
2
2
Mannitol Inj 10% ml
0.03
0.68
-0.65
2182
0.1
Chlorpheniramine tablet
7
7
0.95
-0.85
854
Maleate Tablets 4
mg
________
1.61
-1.42
4
746
Folic Acid tablets 5 tablet
9
0.19
mg_____________
3.41
-2.94
30
0.47
17
627
Metoprolol Tablets tablet
25 mg
________
4
-1.84
Cephalexin ’
capsul
9
5.25
7.09
35
Capsules ,250 mg . e____
1.91
48
7.69
23
5.78
25
Cefixime Tablets . tablet
IQOmg
‘
22
6.62
1.85
pessar
3
8.47
5
Clotrimazole
Pessary - 100 mg- y ‘
2
0.17
17
3
0.98
0.81
Terbutaline tablet
Sulphate Tablets’ ■
2.5 mg________'
22
50 11.25
9.60
1.65
15
Cefixime Tablets
tablet
200mg___________
0.97
14
7.18
8
6.21
29
Sodium Valproate tablet
Tablets 500mg
_________
Source: based on data from NPPA. IMS Health
It is important to note that the discrepancies between the NPPA and our calculations
are only partly due to the methodological differences in applying the market-based
formula. In order to estimate ceiling prices based on the market data, the relevant
brands and packs for each individual formulation must painstakingly and meticulously
be identified in the IMS Health database. Intrinsic limitations of the market-based
data from IMS Health- incomplete information such as about pack descriptions,
strengths and sales volumes- could lead to differences in selection of products that
match the specific strength or description of the formulation. .Thus, this leads us to a
discussion of the limitations and challenges of using market-based data to implement
drug price control.
70
Challenges of using market-based data
Under the shift to market-based pricing, the availability of market-based data has
become a prcquisite for regulating drug prices. Constrained by the lack of data
available with the government or ability to develop an immediate capacity to collect
market data, the NPPP stipulated that data from IMS Health 1 would be the basis for
fixing ceiling prices.
The government not only specified IMS as the source for market data, presumably
due to the long-standing relationship of the Department of Pharmaceuticals with IMS,
but even went as far as to design the DPCO around the use of these data:
“As the IMS data gives price figures for stockist level prices hence in order to
arrive at ceiling Price (which will be the maximum retail price), the IMS price
will be further increased by 16% as margin to the retailer so as to arrive at a
reasonable ceiling price chargeable from the consumers.” (Page 12, NPPP
2012)
‘
Based on our experience ’ of Working with market datasets, we observe several
challenges associated with the use of privately-owned data for implementing national
pricing policy.
First, contradicting the claim that market-based pricing will be “based on widely
available information in the public domain...which would result in more transparent
and fair pricing”, the government has chosen to rely on commercial data that are
neither available for public scrutiny nor easily accessible due to the high cost of the
database.
While it is commendable that NPPA has put all worksheets in the public domain,
these by themselves are not adequate for external verification of ceiling prices as
access to the entire raw database for essential medicines would be needed. Moreover,
the government is admittedly bound by a legal agreement not to make the raw data
publicly available and stated in the November 2013 affidavat filed in the Supreme
Court that “regarding the data available with NPPA relating to 348 drugs under
1
2
IMS Health is a multinational company that specialises in collecting pharmaceutical market data
and providing information on sales and market trends in various countries.
Department of Pharmaceuticals affidavit to the Supreme Court....[complete citation]
71
NLEM 2011, it is submitted that answering respondents are under obligation not to
share the data with third party as per memorandum of understanding with IMS
Health.”
Second, the government has depended heavily on data provided by IMS Health
without the means to assess its quality or reliability. In India, IMS collects data from a
panel of roughly 5600 stockists using a sampling approach. The IMS Total Sales
Audit (TSA) database is based on the stockists panel data which are extrapolated to
the entire universe of stockists (-25,000 total stockists). Details of the methodology or
its limitations and biases are not readily known. There is little to instill confidence in
the use of proprietary data derived from modeling methods and about which few
details are available, for price fixation.
Third, we estimated that data for more than 20% of the NLEM formulations for which
NPPA is supposed to fix price ceilings is missing in the IMS database. Appendix 2 a)
lists 140 formulations for which no data is available with IMS and Appendix 2 b) lists
an additional 12 formulations for which the operative sales value (May 2012 moving
annual total) was zero. Notably, of the 152'formulations missing data in IMS, sales
data was available for 38 formulations (25%) in an alternate market database,
A1OCD-AWACS PharmaTrac.
Similarly, on 23 November 2013, the NPPA notified a list of 99 formulations for
which no data were available through IMS. This list is likely to expand because
ceiling prices for formulations falling under DPCO 1995 are still being notified.
Under DPCO, NPPA must enable the collection of data in these circumstances. But
the fact that only a few prices have been notified on the basis of independent data
collection demonstrates a lack of foresight in prospectively setting up a mechanism
for collection and validation of market data.
We also note that a significant amount of information on pack sizes and strengths is
missing in IMS for formulations coming under price control, particularly for
parenterals and liquids. This finding has direct implications for the stability of the
data. As described earlier, Table 6.2 shows formulations where significant
discrepancies are observed between the NPPA and our independent calculations.
Some proportion of these differences are attributable to the gaps in data that lead to
72
greater subjective use of the data and necessitate greater judgement calls on the part of
the analyst.
This result is bolstered by Appendix 3 which presents evidence of further
discrepancies between the NPPA and our use of the IMS data. In 33 formulations we
observed that there was only one manufacturer holding at least 1% marketshare. The
NPPA, however, has identified more than one pack with 1% marketshare in the same
cases. For another 37 formulations, we determined that there was no data available in
IMS for the specific molecule, dose or form; or the lack of details precluded
identification of relevant products. NPPA on the other hand was able to notify prices
on the basis of IMS data. Lastly, we did not treat the sustained release forms for
Metoprolol Tablets- 50mg and 25mg as separate formulations as they are not
specified in the NLEM but NPPA has done so.
Fourth, because market estimates are modeled based on the results of stockist sales
audits, differences in methodology, survey sample size and other factors can
significantly influence the market estimates. We compared market data from IMS
Health with AIOCD-AWACS’s PhannaTrac database. AIQCD AWACS is a
pharmaceutical market research company formed by All Indian Origin Chemists &
Distributors in a joint venture with Trikaal Mediinfotech and provides market data on
pharmaceuticals through the PharmaTrac database.
Table 6.3 summarizes cases where market estimates vary widely between IMS Health
and PharmaTrac. The annual sales estimates for 2012 (at the PTR level) for the top
300 selling brands was Rs. 22,257 crore and Rs. 21,211 crore according to IMS and
PharmaTrac, respectively. At the brand level, we observed that the estimates could
differ not only in terms of annual sales value but also the rank. For example, Human
Mixtard marketed by Novo Nordisk was ranked number 4 in both datasets. However,
the sales estimates for 2012 differ by approximately Rs. 40 crore. Lantus marketed by
Sanofi-Aventis ranked number 14 in IMS Health with estimated market sales in 2012
of Rs. 151 crore. However, the same brand was estimated to have maket sales of only
Rs. 75 crore in 20 J 2 and was ranked number 91 according to PharmaTrac.
73
Table. 6.3. Glaring variations across two sources of private data -IMS Health and AIODCAWACS data on top selling brands in Dec 2012_________
BRAND
SUBGROUP
COMPANY
IMS
IMS
PharmaT PharmaT
Health
2012
rac
rac 2012
Rank*
annual
Rank*
annual
sales
sales
(Rs.
(Rs.
crore)
crore)
Phensedyl
Chlorpheniramine +
Abbott Healthcare
2
258.18
17
150.95
Cough
Codeine | R5el
Pvt. Ltd
Linctus
Human
Intermediate-Acting, Novo Nordisk India
4
4
258.62
218.67
Ispophane (Nph) |
Mixtard
Pvt Ltd
A10c4_____________
Voveran
Diclofenac | Ml al 2
Novartis India Ltd
5
241.58
6
194.66
Lantus
Mox
Azithral
Calpol
Eptoin
Pan
Sporidex
Januvia
Cifran
Huminsulin
Dilzem
Bett
Dalacin C
Zyloric
Mt Pill
Dexona
Cefolac
Other Human Insulins Sanofi-Aventis
| A10c9____________
Amoxycillin | Jlcl
Ranbaxy Laboratories
Ltd________________
Azithromycin | JI fl
Alembic Ltd
Paracetamol | N2b 1
Glaxosmithkline
Pharmaceuticals Ltd.
Phenytoin | N3al2
Abbott India Ltd.
Pantoprazole | A2c4
Alkem Laboratories
Ltd.________________
Cefalexin | J1 d 1
Ranbaxy Laboratories
Ltd________________
Sitagliptin | A10b66
Msd Pharmaceuticals
Private Ltd.
Ciprofloxacin | Jlgl
Ranbaxy Laboratories
Ltd
____________
Intermediate-Acting, Eli Lilly And
Ispophane (Nph) |
Company (India) Pvt.
A10c4____________ Ltd.________________
Diltiazem | C8a6
Torrent
Pharmaceuticals Ltd.
Tetanus | J7a2
Biological E Ltd
Clindamycin | Jlf3
Pfizer Ltd
Allopurinol | M4a4
Glaxosmithkline
Pharmaceuticals Ltd.
Mifepristone | G3x2
Cipla Ltd.
Dexamethasone |
Zydus Cadila
H2a5____________
Cefixime | Jld26
Macleods
Pharmaceuticals
Pvt.Ltd
14
151.08
91
75.78
15
166.60
55
96.84
21
38
143.50
157.78
29
7
127.75
190.52
39
47
127.16
117.03
75 •
2.8 ;
84.42'
• 128.14
50
107.09
196
46:90
61
92.55
38
■ 1.11.48
89
95.16
101
.71.22
99
78.76
53
98.35
146
58.63
272
39.35
163
181
223
68.66
53.22
43.66
180
94
152
49.28
74,93
55.00
251
260
44.23
43.29
115
123
63.68
61.45
285
47.19
274
39.25
based on December 2012 sales
Source: AIOCD-AWACS PharmaTrac; IMS Health
In conclusion, we have "highlighted several challenges with implementing the market
based calculations to fix ceiling prices under the DPCO 2013. Some of these relate to
the literal reading of the NLEM in imposing price control and further narrowing of the
scope from the DPCO guidance. Other concerns arise from the use of privately-owned
74
market data which is not available for public review. Lastly, we question the reliance
on market data which are not proven to be complete or stable for the purposes of
determining the prices patients should pay for medicines.
75
CHAPTER 7
INNOVATION, EXPORTS AND PRICE CONTROL
Besides the rationale of adequate market competition which is implicit in the choice
of market determined price control mechanism policymakers have been using the
rationale of how the activity of innovation in pharmaceuticals should not be adversely
affected. Innovation needs to be encouraged is also a key reason for the Indian
policymakers to stick to the mechanism of market led price control. But the reality is
that the extent of innovation is first of all quite low. Second, it is separately awarded
through the policy of R&D subsidies being made available anyway to the companies
undertaking R&D. Support for R&D and innovation is available in the form of
incentives as government grants, tax rebates and price exemptions. Evidence
presented here below that it would be totally counterproductive for the policymakers
to depend on the mechanism of market led price control to encourage innovation
which is nothing more than the activity aimed at product differentiation rather than
1
substantive innovative activity.
Drivers of the innovation are also the profits anticipated from the export of products
to the regulated markets of US and Europe. Para IV filings which provide 180 days of
market exclusivity to the companies that are successful in beating others in the
innovation race for entry into the markets of US and Europe have determined the
extent and nature of innovation. In the case of Indian pharmaceutical industry extent
of the efforts of product innovation have been geared to the exploitation of
opportunities available in the innovation space of formulation and dosage forms.
Evidence built on the basis of industry-wide patenting activity itself clearly shows that
as far as investment orientation toward in-house R&D of domestic pharmaceutical
companies is concerned, work seems to have been mainly focused on developing
capabilities, innovations and technological know-how for off-patent generics that the
industry thought could be exported to regulated markets of Europe and USA. See
Table for the historical time line of capability development profile mapped by the
authors on the basis of patents filed by the Indian pharmaceutical industry with the
United States Patents and Trade Mark Office (USPTO).
Tabic 6.1; Evolution of domestic pharmaceutical industry patents in USPTO 1992-2013
S.n
Nature ofpatent
1992199620002004 2008Total
o
1999
1995
2003
2013
2007
1 Process patent____________
51
11
133
176
371
2
NDDS patent_____________
18
23
10
51
3_
NCE patent_______________
3
6
10
19
4
Method of treatment
14
26
102
261
403
Dosage, Formulation
Composition, Combination &
Product Patent____________
202
5
New forms of substances
6
250
475
63
156
583
46
240
638
1521
______ Grand total_______
14
Source- Emerging patterns of pharmaceutical Patent innovations for top 15 domestic pharmaceutical firms, data
collected from USPTO of 1992-2013. Changes in the domestic to foreign firm status accounted for these firms
in the above table.
Notes-. Patent Classification (Process, product, NDDS, Method of treatment, NCE, Dosage, Formulation,
Composition, New forms of substances (Salt, Polymorphs, Derivative, Amorphous, Analog, Conjugate,
Crystalline, Esters, Isomers, Metabolite, Solvates) is done by using International Patent Classification (1PC).
Abbreviation-NDDS-New drug delivery system, NCE-New Chemical Entity
Evidence is compiled on the patenting activity of Indian pharmaceutical companies on
the basis of patents filed by them in USPTO in Table. It clearly shows that product
development is not first of all the main strength. Bulk of the “innovative outputs” still
belongs to the areas of dosage / formulation/ composition of matter and process
related R&D. Their patenting activity continues to be largely tilted in favour of the
development of processes, new forms of substances, dosages and fonnulations, new
drug delivery systems. Table shows that the chemistry driven process research leading
to non-infringing processes for active pharmaceutical ingredients (APIs), introduction
of cost effective routes, identification and characterization of impurity profiling
pertaining to APIs, reduction of impurity levels, acceptable dosage forms and
formulations came to be pursued as the main priority in the Indian pharmaceutical
industry during the post-TRIPS period.
This emphasis has continued to date. Tables 6.1, 6.2, 6.3 and 6.4 confirm that the
economic opportunity created by the Hatch-Waxman Act of 1984 has been the most
important stimulus for the domestic pharmaceutical firms to invest in the processes of
learning, competence building and innovation making activity. The other area of
R&D pertains to formulations where new drug delivery systems (NDDS) based
products are the focus of introduction by the industry in the market. The number of
patents granted to these companies for the new chemical entities (NCEs) is small.
Assessment indicates that attempts are still limited to the activity for product
development being confined to the development of analogue molecules.
77
Another major area of competence building has been related to the improvement of
good manufacturing practice. Table clearly shows the key areas of competence
building in the case of domestic pharmaceutical firms in relation to the registration of
Drug Master Files (DMFs) and Abbreviated New Drug Applications (ANDAs) prior
to registering products (generics) in EU, USA and other developing countries. Even
the assessment of Para IV filings which offer 180 days market exclusivity to the
producers of generic products in the US market and of the new drug applications
(NDAs) filed with United State Federal Drug Regulation Authority (USFDA) shows
that the number of NDAs and ANDAs related to Para IV filings have still been few
and far in the case of Indian pharmaceutical industry.
Table 6.2: DMFs filed by Indian Pharmaceuticals from 2008-2013
__________ Company name
Type 1
Type 11
Type 111
Aarti Industries Ltd______
10
13
Alembic Pharmaceuticals
37
1
Apotex Pharmachem Inc
45
1
Aurobindo Pharma Ltd
45
16
Biocon_________________
10
1
Cadila Healthcare Ltd
45
23
Dr Reddys Laboratories Ltd
60
21
21
Fresenius Kabi__________
2
Glaxosmithkline Lie______
9
Glenmark Generics Ltd
20
11
Type IV
4
15
15
2
2
5
9
1
TYPEV
1
1
1
x
2
1
Hetero Drugs Ltd___________
102
8
5
2
Hikal Ltd__________________
1
Ind Swift Laboratories Ltd
8
4
1
2
Lupin Ltd_________________
56
11
13
2
Matrix Pharma_____________
I
Micro Labs Ltd_____________
8
Novartis Pharmaceuticals Corp
3
1
1
Piramal Healthcare Uk Ltd
3
1
17
7
Ranbaxy Laboratories Ltd
1
Torrent Pharmaceuticals Ltd
9
6
4
Wockhardt Bio Ag__________
6
10
6
35
14
2
Sun Pharma________________
8
152
10
Total_____________________ ________________ 553
____ 94
____
Source'. No. of DMF Data from http://www.betterchem.com (Drug master file database) and no. of Abbreviated
New Drug Application (ANDA) from individual company website.
78
Table 6.3: ANDAs granted in US to Indian Pharmaceutical Firnis from 2008-2013
_________Company Name.
2009
2008
2010
2011
2012
2013
DR Reddy’s labs_________
4
1
5
6
6
5
Ranbaxy________________
3
1
1
1
Glenmark_______________
1
2
3
5
Aurobindo Pharmaceuticals
3
2
2
2
Sun Pharma_____________
2
5
2
4
5
5
Alembic ltd_____________
2
Lupin__________________
1
2
2
2
2
Orchid_________________
2
2
2
Torrent_________________
1
2
i
2
Wockhardt______________
11
2
Cipla__________________
J_
i
Fresenius Kabi Oncology
1
3
Matrics
1
Strides
2
TOTAL
_________________________________
22
20
9
20
36
17
Source'. No. of DMF Data from http://ww\v.betterchem.com (Drug master file database) and no. of Abbreviated
New Drug Application (ANDA) from individual company website.
Fig. 6.1: 180 Days Exclusivity received during the period 2004-08 by the generic players
16'
1412^
io-
I
!
I I
o
6
| 4
I I
2
■UI11-Blllllmumuuiu
PiiiiPHil
0-^r^r—r"
O <i i
5j I
£ V
i-n §
hi I <
D
f
<
%<
6
b
o
s
I
Table 6.4: DMFs, ANDAs and NDAs received by the top Fifteen Indian Companies
No. of
Sales turnover as of2008 in CMIE
No. of
Company
No. of
Prowess Data base (in Crores)
ANDAs
DMFs*
NDAs
78963.13
1242
1129
19
Total (Top Fifteen
Companies)
79
Similarly the assessment of the DMFs filed for molecules from India and China also
reveals that the Indian pharmaceutical industry is absent from several fermentation
and biotech products. India has presence in small molecular chemistry, and is mostly
absent in peptides, biopharmaceuticals and biotech products. According to IMSHealth the market for fermentation technology products and other biotech products is
growing at double the rate of the pharmaceutical product. See Table 6.5 for the list of
biotechnology drugs showing China’s strength in molecules where India has no
DMFs.
Table 6.5: List of biotechnology drugs showing China’s strength in molecules where India had no
DlVlFs (DMFs as on September 2008)
Molecule
SI. No.
Total no. of
DMFs by
Method of production
China
DMFs
Acarbose _____
1
4
Fermentation
2
2
Bivaluridine
1
2
Fermentation
4
Bleomycine
2
Fermentation
F
Capreomycin
2
1
Fermentation
5
Clavulanic Acid
15
1
Fermentation
6
Cyclosporine
10
3
Fermentation
2
Dactinomycin
Fermentation
1
7_
Desmopressine
8_
Fermentation
1
8
9_
Floxuridine
Fermentation
2
1
4
Flumethasone
Fermentation
10
1
Gentamicin
2
Fermentation
1_1_
3
12
Heparin
17
8
Extraction from animal
intestine______
Fermentation
13
Hydrocortisone_______
19
2
2
2_
Ivermectin__________
14
Fermentation
Monoclonal Antibody
X5
£
Cell culture ____
27
16
Mupirocin__________
1
Fermentation
6
4
Prednisolone
Fermentation
29
________
1Z
Thiostrepton
________
Fermentation
1
li
Vancomycin _________
Fermentation
19
6
2
20
4
20
Fermentation
Various salt of Penicillin
Source-. Research of data available at Drug@FDA (CDER US FDA) and as compiled and analyzed by D.K Jena,
V. Mohan, P. V. Appaji, L.Srinivas & P Balaram in Journal of Generic Medicine, Vol 6, 333-344
Even from the above analysis of the ANDAs and DMFs of D.K. Jena and his
colleagues it is also clear that while India accounts for one out of every four ANDA
approvals in the years 2007 and 2008, ranks first in total Type II active DMFs with
USFDA but the Indian firms could not enter into the areas involving cutting edge
technologies in formulations and processes developed for the markets of Europe and
the US. They could only internalize competencies needed for those market segments
which are technologically less advanced. Innovative activities from India have been
confined to a small number of highly competitive molecules. India is yet to move into
the new orbit of working in complex chemistry, Biotech based medicines, and
80
advanced formulations. They point out that India has confined to limited number of
molecules (156), whereas top generic companies like Teva, Sandoz and Watson have
presence in 200 molecules each. Of course, with 1000 molecules still left out India
has opportunity to expand in US market.
As per the Price water house Coopers report of 2010 for the Chinese pharmaceutical
industry China surpassed India in the exports of bulk drug during the year 2007.
China is a large scale producer of several bulk drug intermediates. China has the
capability to offer at competitive prices patent protected molecules up to a pre-API
stage (a strategy China uses to avoid patent violations) and exports them to other
countries. China is also lead exporter of drugs and pharmaceuticals to India. It is
becoming difficult for the Indian Bulk Drug producers to compete with China. India is
more efficient in converting active pharmaceutical ingredients (APIs) in to finished
products and is significantly ahead of China in formulation export. While it is true
that China lags behind in formulation manufacturing expertise and
Governmental support and promotion of innovation and export
The Department of Pharmaceuticals, under the Ministry of Chemicals and Fertilisers,
is already separately incentivising the firms by formulating policies and implementing
programmes for achieving growth and development of the Indian Pharmaceutical
Industry. The areas of responsibilities for the department include Pharmaceutical
Research and Development (R&D), education, training and capacity building in
pharmaceutical sector, related environment and hazard management, as well as
promoting higher exports for greater share in the global market.
The Union government in the Eleventh 5-Year Plan focused on reviving
Pharmaceutical PSUs for manufacturing critical bulk and formulation drugs, setting
up of more institutes like the National Institute of Pharmaceutical Education and
Research, introducing interest subsidy scheme for Schedule “M” compliance etc. The
Planning Commission approved a Budgetary Support of Rs 13,960 mn for various
schemes of the pharmaceutical sector during the Eleventh plan period. In FY09, an
expenditure of Rs 1,098.3 mn was incurred under various schemes of the
Pharmaceutical sector.
81
Exhibit 2: Key Drivers for Promoting Indian Generic Pharmaceutical Industry
Availability of scientists in
organic/medicinal chemistry
formulation science, biotechnology,
microbiology, etc.
•
Access to funds at reasonable
cost
•
APIs / Form development
DMFs/ ANDAs
•
Specialty Generics R&D and
filings
•
Patent filings
•
Mfg infrastructure for
Pharma/biopharmaceuticals
•
Access to market
I
•
■
Design & regulatory compliant running
of manufacturing facilities
Key
drivers
Legal capabilities and resources
■.
■'
I
Techno Marketing capabilities
I
i
The government has taken various policy initiatives for the pharmaceutical sector: the
government has offered tax-breaks to the pharmaceutical sector. Units are eligible for
weighted tax deduction at 150% for the R&D expenditure incurred. Steps have been
. taken to streamline procedures covering development of new drug molecules, clinical
research etc. Government has launched two new schemes—-New Millennium Indian
Technology Leadership Initiative and the Drugs and Pharmaceuticals Research
Programme—especially targeted at drugs and pharmaceutical research. In a bid to
promote new drug research in the country, the government is planning to create a
special purpose vehicle (SPV) with insurance cover that will be used to fund new drug
research. The Department of Pharmaceuticals is also planning to create drug research
facilities and centres that can be used by private companies for such research work on
a pay-and-use basis.
These schemes are operated by different ministries / departments of the government,
financial Institutions and others. They are intended for all categories of units’ viz.,
large, medium and small and even individuals in various subsectors. Considering the
new challenges faced by the industry from time to time on account of liberalization
and new obligations undertaken by India under the WTO, the Government of India
took active interest in supporting the following initiatives for the Indian drugs /
pharmaceutical industry:
82
•
Modification of Drug Policy (1986) in 1994 to promote accelerated growth
and to enhance the global competitiveness of the industry.
•
Recognition of the industry as the most important knowledge based industry
•
Abolition of industrial licensing except for bulk drugs produced by the
recombinant DNA and related technologies
•
100% foreign investment through automatic route
•
Extending the facility of 150% weighted deduction of R&D expenditure under
section 35 (2AB) of Income Tax Act till 31 March 2012.
•
Second Amendment to the Indian Patent act to allow product patenting in
India from 1 st January 2005
•
Pharmaceutical policy 2002 (a) to improve incentives for R&D (b) further
reduce the rigors of drug price control (c ) strengthen the quality control
system (d) provide incentive framework for attracting new investment into the
pharma industry and new technologies and (e) reduce trade barriers for
pharma exports.
•
Setting up Pharmaceutical Research and Development Committee (PRDC) for
•
Setting up Drug Development Promotion Foundation (DDPF) and Pharma
Research and Development Fund
•
Setting up a chain of National Institutes of Pharma Research and Education
(NIPERs) to achieve excellence in Indian pharmaceutical sciences and
technologies. A centre of excellence on bulk drugs will be established at
Hyderabad by the NIPER in the near future.
The DPRP programme initiated in 1994 specifically addresses the R&D needs for the
growth of the Indian drugs/pharma industry. The specific objectives of the programme
are: Synergizing the strengths of publicly funded R&D institutions and Indian
pharmaceutical industry to generate the collaborative R&D projects; creating an
enabling infrastructure, mechanisms and linkages to facilitate new drug development;
Stimulating skill development of human resource engaged in R&D and Enhancing the
nation’s self-reliance in drugs and pharmaceuticals, especially in areas critical to
national health requirements.
83
Fig. 1: Approved Projects under DPRP Scheme of DST (8 to 11 Five Year Plan)
PLAN-WISE APPROVED COST OF
FACILITY PROJECTS
:s) <■ •
160]
PLAN-WISE APPROVED COST OF
LOAN PROJECTS (SINCE 2004-05)
!
....
3-K
140-
r.f.
!2C>
:v- ?
too
^c
80
60
■x :
40
20
0-
£ t-
8'.h Pte
'C-h Fla-i
Sih Plan
-
__
■
'-■■■■___
nth Pte
"n ^r
; S M s( yat:: i ‘ke
joNo. ofjsraect b Total P’oect Cost 'Incraresj
d it; r j’t'es'
Total approved cost = 343.91 Crores
Total Project = 47;
Total approved cost =558.59 Crores
Average per project cost of Rs.8.81 crores
Average per project cost of Rs, 11,88 crores
ratio of DST : INSTITUTE = 1 : 0,40
ratio of DST : INDUSTRY = 1 : 1.04
Total Project - 39;
Source: R&D Impact on Indian Chemical Industry, Indian National Academy of Engineering,
May 2011
Fig. 2: Approved Facility Projects under DPRP Scheme (8
i . •
•S.;
y-' -
40
r
i
25 ■
B
30
20
*0
0
I
H
nJ
1
fit? Par
'
Par
1
Five Year Plan)
11
COVERAGE OF COLLABORATIVE
PROJECTS
PLAN-WISE APPROVED. COST OF
COLLABORATIVE PROJECTS
70 [ ;
to
i
K: fe
MODERN/NEW
: 58 PROJECTS
AYURVEDA
: 24 PROJECTS
SIDDHA
i
UNANI
'C*h Pan
5 PROJECTS
:
1 PROJECT
□ Me of Project 0 Pro’ect Cost »Rs r. crores)
VETERINARY
Total Project = 89;
1 PROJECT
Total approved Cost = 137.61 Crores
Average per project cost of Rs. 1.55 crores
ratio of DST : INDUSTRY = 1:1.48
Source: R&D Impact on Chemical Industry, Indian National Academy of Engineering,
May 2011
Export promotion
Like many governments elsewhere, the Government of India also has been giving
export incentives to Indian pharmaceutical exporters. Such schemes provide both
84
direct and indirect subsidies and included Cash compensatory support. Replenishment
import license, Tax exemption of export income, subsidised export credit and export
credit insurance, bonded warehouses, support for export marketing and so on. Export
incentives are primarily given by the Ministry of Commerce through its Directorate
General of Foreign Trade (DGFT), abd by the Ministry of Finance. Major incentives
given by DGFT include Export Promotion Capital Goods (EPCG) Scheme and Duty
Exemption/ Duty Remission Schemes. The Ministry of Finance tax exempts export
profits i.e. profits from exports are exempted from income tax. Export incentives to
the pharma sector are already being made separately available with a view to help
improve the quality to make the Indian export sustainable in long run. Pharmaceutical
firms do not need to be compensated doubly through the price control mechanism in
any special way.
A new facility of input combination for pharma products manufactured through NonInfringing process, allowing actual quantum of duty free inputs is also underway for
manufacturing such export product. This will facilitate, our pharma manufacturers to
work towards getting a major share of exports of such products to potential regulated
markets such as US or EU. The pharmaceutical products are being required to affix
barcodes on their export products. The provision has been effective from 1st July
2011, as per GS 1 global standards, to facilitate tracing and tracking of their products.
See Table 6.6 for the evolution of growth in exports of Indian pharmaceutical firms
from the period of 1991-2011. Analysis shows that export incentives provided by the
government have been working and the Indian companies do not need to be rewarded
doubly.
Table 6.6: Exports by Indian Pharmaceuticals from 1991-2011
CM1E Rank
Domestic companies
1991-93
1994-96
1997-99
Export as Export as Export as
a % of
a % of
a %of
productio productio productio
n
n
n
Cipla Ltd.___________ 9.97
10.53
12.27
2
Dr. Reddy’S
16.71
29.57
27.25
Laboratories Ltd.
43.05
35.88
3
Ranbaxy Laboratories
27.73
Ltd.________________
Lupin Ltd.___________ 0.00
2.84
0.00
5_
AurobindoPharma Ltd. 7.81
33.93
33.14
6
Sun Pharmaceutical
5.04
10.58
Inds. Ltd.___________
7
Piramal Healthcare
0.62
9.30
4.07
±
85
2003-05
2006-08
2009-11
Export as Export as Export as
a % of
a % of
a %of
productio productio productio
n
n
— n
42.15
51.42
54.26
56.61
66.92
66.04
67.32
73.93
69.59
45.23
47.97
23.20
52.74
58.41
33.13
56.76
67.00
38.46
9.39
18.76
24.03
CM1E Rank
9
10
11
12
13
14
15
17
18
19
21
22
23
25
26
27
29
30
31
32
33
34
36
37
38
40
41
42
43
44
45
46
47
48
49
Domestic companies
1991-93
1994-96
1997-99
Export as Export as Export as
a % of
a % of
a % of
product io productio productio
n
n
n
Ltd._________________
Cadila Healthcare Ltd.
12.05
Matrix Laboratories
15.98
Ltd._________________
Wockhardt Ltd,_______ 11.60
11.43
26.52
Ipca Laboratories Ltd.
34.39
Divi'S Laboratories
Ltd._________________
Orchid Chemicals &
98.47
Pharmaceuticals Ltd.
Alembic Ltd._________ 10.95
14.45
Ankur Drugs &Pharma
Ltd._________________
Biocon Ltd.__________
Glenmark
8.34
Pharmaceuticals Ltd.
Nectar Lifesciences
Ltd._________________
6.06
Panacea Biotec Ltd.
3.94
Surya Pharmaceutical
Ltd._________________
23.15
26.10
J B Chemicals &
Pharmaceuticals Ltd.
12.47
5.58
Unichem Laboratories
Ltd._________________
11.46
Elder Pharmaceuticals
Ltd._________________
Strides Arcolab Ltd.
9.56
F D C Ltd.___________ 4.98
Ind-Swift Laboratories
Ltd._________________
0.00
Ind-Swift Ltd.________ 0.00
29.43
38.49
Shasun Chemicals &
Drugs Ltd.___________
Plethico
Pharmaceuticals Ltd.
Dishman Pharmaceuticals & Chemicals Ltd.
Sharon Bio-Medicine
Ltd._________________
40.75
Aarti Drugs Ltd.______ 29.79
Twilight LitakaPharma 1.98
3.57
Ltd,_________________
0.00
Indoco Remedies Ltd.
Ajanta Pharma Ltd.
42.01
39.51
Neuland Laboratories
Ltd._________________
39.21
NatcoPharma Ltd,
Fresenius Kabi
Oncology Ltd.________
SMS Pharmaceuticals
Ltd._________________
87.43
Granules India Ltd.
20.44
31.26
Themis Medicare Ltd.
0.00
MarksansPharma Ltd.
86
2003-05
Export as
a % of
productio
n
2006-08
Export as
a % of
productio
n
2009-11
Export as
a % of
productio
n
11.04
12.97
12.82
56.15
20.85
62.36
50.28
81.39
16.91
35.94
29.12
37.62
52.21
83.32
37.20
46.92
90.72
38.89
49.70
90.11
87.83
77.45
79.69
13.84
0.00
19.87
0.00
23.83
0.12
32.05
0.07
3.33
52.43
15.75
53.89
40.29
44.76
27.24
7.22
20.98
42.50
36.09
21.35
18.63
4.76
12.72
42.92 • ’ 21.01
39.31
27.58
30.24
49.67
53.10
61.83
2.85
12.41
20.50
19.59
11.61
4.78
3.01
2.50
12.11
12.94
26.26
91.98
17.71
40.04
87.09
8.99
42.61
86.23
8.98
36.98
6.05
30.37
0.29
67.16
1.67
63.04
6.57
63.49
2.26
41.35
58.98
59.53
77.21
12.80
68.37
4.40
4.78
30.48
2.03
28.62
5.91
30.28
7.32
33.25
9.05
1.51
29.04
40.96
8.49
64.71
61.40
18.91
46.57
60.79
28.24
56.55
74.55
13.81
49.27
40.72
42.88
56.93
36.64
78.78
45.99
34.70
24.72
39.29
51.92
35.74
21.18
60.36
32.14
17.21
68.51
37.83
18.90
76.51
34.09
36.55
CM1E Rank
50
8
16
20
24
28
35
39
Domestic companies
Wanbury Ltd.______
Torrent
Pharmaceuticals Ltd.
Glaxosmithkline
Pharmaceuticals Ltd.
Aventis Pharma LtdPfizer Ltd._________
Abbott India Ltd.
Novartis India Ltd.
Merck Ltd.________
AstrazenecaPharma
India Ltd.
1991-93
Export as
a % of
productio
n
0.00
0.00
1994-96
Export as
a % of
productio
n
0.00
0.00
1997-99
Export as
a % of
productio
n
0.00
18.12
2009-11
2006-08
2003-05
Export as Export as Export as
a % of
a % of
a % of
productio productio productio
n
n
n
40.48
47.61
42.20
32.41
20.62
12.98
2.91
4.25
7.76
2.93
4.54
5.46
11.33
1.92
2.13
5.12
5.86
2.72
12.41
1.75
0.31
9.29
5.06
9.18
21.83
6.42
4,92
14.06
11.49
5.14
25.68
3.91
0.74
1.69
4.47
1.46
21.77
3.10
0.78
1.32
6.09
3.93
27.02
3.11
1.10
1.16
9.35
7.23
87
CHAPTER 8
POLICYMAKING FOR PRICE CONTROL MECHANISM
The Indian policymakers are best placed among the low and middle income countries
in respect of addressing the challenge of providing the population with safe, effective,
good quality drugs at the least possible cost. India is in fortunate position on account
of the better state of indigenous development of the domestic drugs and
pharmaceutical industry. Affordability is a major pharmaceutical policy challenge in
several countries. Involvement of the governments in pharmaceutical pricing is
already under practice with the aim of achieving the public health objectives in some
of the countries of developed world. Among the policy measures for keeping the
prices low and making the drugs available and affordable to the people the main ones
that can be tried count in India are the ‘national list of essential drugs’, ‘price control’,
‘public procurement’, ‘production control’ and the ‘regulation of practices of
promotion and prescription of medicines’.
Policymaking for the design of price control mechanism shall begin with the
following understanding that competition in the Indian pharmaceutical markets has
been most effective in the recent times only when price conscious, publicly funded
state procurement agencies and institutional purchasers were the purchasers rather
than individual consumers. Publicly funded state procurement agencies and
institutional purchasers of essential medicines have achieved better results in respect
of inducing competition. They have been able to speed up generic entry on the basis
of the products being manufactured by both small and large companies. They have
been able to bring down the prices. Today the practice of public procurement is under
perusal in only five states out of twenty nine states in a systematic manner.
There is also evidence from the recent experience of Tamil Nadu and Rajasthan that
when the state governments adopt the policy of strengthening of the practice of public
procurement of medicines in the states with the help of the central government they
are also able to lower the costs of financing of universal access to essential medicines
for the state exchequer. Public procurement has worked well to achieve lower prices
for off-patent, multi-source essential medicines successfully in the case of the Central
Government Health Service (CGHS). In the states like Tamil Nadu, Rajasthan, Delhi,
and Kerala in India by using public procurement they have been successful in
ensuring the supply of essential medicines to a larger population. Similarly there is
also evidence available that the Central Government has been able to utilise the
mechanism of bulk procurement in the case of patented drugs in the Central
Government Health Service (CGHS) / Railways / Armed Forces for the supply of
cancer drugs.
Domination of the market forces can play havoc with the prices of medicines when
the third party payment systems are missing. In a society where the mechanisms of
public financing and social insurance are weak and the consumers in retail market are
known to pay heavily out of pocket for medicines. In India, there exists neither social
insurance nor public delivery systems. The imperfections of pharmaceutical markets
are known to be devastating for the consumers who are uninsured and do not have the
benefit of medicine supply from public health facilities at lower cost.
Much has been written by the leaders of Federation of Medical Representatives
Associations of India (FMRAI) and Jan Swasthya Abhiyan (JSA) about the irrational
practices of promotion used by the industry for the sale of medicines in India. Heavily
branded generics are often sold at a high multiple of the price of low priced generics,
with many people paying more than they need to. The pharmaceutical markets are
known to function quite imperfectly. Market does not treat branded medicines and
generics as perfect substitutes. When individual consumers purchase medicines outof-pocket, pervasive asymmetry of information limits the potential for effective
medicine price competition.
' Policy formulation for the development of an effective price control mechanism
remains a formidable challenge for the Government of India. If the Indian State is
serious about the implementation of the policy of universal access to essential
medicines then the central government should enable the state governments to
allocate adequate sums in their own budgets for the purpose of strengthening of their
mechanism of public procurement along with the mechanism of price control
designed to promote universal access to essential medicines and indigenous industrial
development. The Central Government should enable the State governments to foster
collectively in their regions a network of medium and small scale pharmaceutical
89
firms in their own regions. The Government of India as well the Indian Supreme
Court should look into the issue of how to get the NPPA to undertake the design of
price control to simultaneously take care of the twin challenges of affordable access to
essential medicines and indigenous industrial development.
Price control mechanism needs the presence of competition from the domestic firms.
In Chapters 4 and 5 we have shown that though the impact of the entry of Indian firms
in the Indian pharmaceutical market on the behavior of producers (with respect to
price and quantity of production decisions) was initially positive but over the period
the positive influence has been on wane due to the increase in share of foreign firms
in the industry after the implementation of TRIPS. There is also the problem of
growing domination of the large Indian domestic firms on the market. See Table 8.1,
8.2 and 8.3 which indicate that the presence of foreign firms is growing. Further the
presence of large firms, both domestic and foreign firms is already a distinguishing
feature of the Indian pharmaceutical markets.
Table 8.1: Company wise Sales and Market Shares of the Top 10 Indian Companies and Top 10
MNCs in the Indian Pharmaceutical Markets
Top 10 Indian
2012 Sales value (Rs.
Top 10 MNCs
2012 Sales value (Rs.
Rank
_____ Companies
____ in crores)_____
_____in crores)_____
5068.25
Cipla __________
___________3542.67 Abbott___________
1
Sun____________
___________3067.83 Ranbaxy_________ ___________ 3008.69
2
___________2841.89 Glaxosmithkline
___________ 3004,72
Zydus Cadila
3
4
Mankind________
___________2437.12 Pfizer___________ ___________ 2287.03
5
___________2365.46 Sanofi___________ ___________ 2034,87
Alkem_________
___________2003.58 Novartis Inti._____ ___________ 1172.47
Lupin Limited
6
Macleods Pharma
___________ 1970.64 Msd Pharmaceutical ____________ 763.64
7
___________ 1765.34 Merck Limited
Intas Pharma
____________ 586.34
8
___________ 1571.74 Astrazeneca______ ____________ 361.15
Emcure _________
9
___________ 1554,71 Janssen
____________ 311.03
Aristo Pharma
10
Total
__________23120.97
__________ 18598.18
Market share (%)_____
32
26
Source: IMS Health
Table 8.2: Market Shares of the Indian Companies and MNCs in the Indian Pharmaceutical
Markets in 2012
2012 Sales
Market share (%)
Rs. Crore
Indian_______________
50706.21
71%
MNC_______________
20539.80
29%
71246.01
Total market_________
100%
Source: IMS Health
90
Table 8.3: Changes in the Patterns ol Decline in the Market Shares of the Indian Companies
from 2005 onwards and the Extent of Growth in the Share of MNCs in the Indian
Pharmac eutical Markets in 2012
____ 2012*
Compan
2005*
y rank
Company
Sales
Market Domestic Company
Market Domesti
Sales
name
(Rs. in
/MNC
name
(Rs. in
share
c/MNC
share
crores)
crores)
(°/o)
(%)
Abbott
5068.2
7.1 MNC
1339.68
5.8 MNC
1 Glaxosmit
hkline
_____5
5.0 Indian
Cipla
Indian
3542.6
1185.27
2 Cipla
5.1
_____ 7
Sun
3067.8
5.0 Indian
1158.38
4.3 Indian
3 Ranbaxy
_____ 3
Ranbaxy
3008.6
4.2 MNC
1062.11
4.6 Indian
4 Piramal
Healthcar
9
e_______
Glaxosmi
4.2 MNC
3004.7
3.7 Indian
864.34
5 Zydus
thkline
___ 2
Cadila
4.0 Indian
2841.8
Zydus
754.81
3.2 Indian
6 Sun
Cadila
___ 9
Pharma
Mankind
3.4 Indian
2437.1
3.0 Indian
7 Alkem
686.37
8
Pfizer
563.27
2.4
MNC
Alkem
9
Sanofi
Aventis
Aristo
Pharma
Dr
Reddys
Labs
Alembic
560.99
2.4
MNC
Pfizer
543.11
2.3
Indian
Sanofi
541.68
2.3
Indian
Lupin
Limited
521.25
2.2
Indian
Macleods
Pharma
Lupin
Labs
Abbott
513.81
2.2
Indian
Intas
Pharma
Emcure
10
11
12
13
480.88
2.1
MNC
Torrent
Pharma
Wockhard
t
444.19
1.9
Indian
434.75
1.9
Indian
431.67
1.9
Indian
18
Micro
Labs
Novartis
412.07-
1.8
MNC
19
Intas
382.41
1.6
Indian
usv
20
Unichem
378.91
1.6
Indian
Glenmark
Pharma
14
15
16
17
Aristo
Pharma
Dr
Reddys
Labs
Torrent
Pharma
Micro
Labs
14.4
MNC share in top 10 companies
(%)_______________________
* Sales value reflects changes in IMS sampling methodology
Source’. IMS Health
91
___ 2
2365.4
___ 6
2287.0
___ 3
2034.8
7
2003.5
8
3.3
Indian
3.2
MNC
2.9
MNC
2.8
Indian
1970.6
___ 4
1765.3
___ 4
1571.7
___ 4
1554.7
___ 1_
1436.6
6
2.8
Indian
2.5
Indian
2.2
Indian
2.2
Indian
2.0
Indian
1414.0
___ 0
1307.9
___ 6
1306.6
___ 7
1253.9
7
2.0
Indian
1.8
Indian
1.8
Indian
1.8
Indian
21.6
Cost plus formula of price fixation needed
Prices and availability of drugs are determined by market structure, the perceptions of
entry barriers and measures of market concentration, producers’ conduct (such as
collusive behaviours) and consumers conduct (such as search behaviours). Barriers to
entry and concentration of supply against the small and medium scale domestic firms
can induce prices higher than normal. Large scale firms as suppliers can also gain
market power and charge higher prices through collusion, market segmentation and
price discrimination. The customer in pharmaceutical market is a combination of the
physician, the payer / the insurer and the final patient. Product differentiation and
market power are closely correlated in the case of pharmaceutical industry.
Elements defined as the extent to which the physicians, payers and final patients are
able to distinguish and have preference between competing products also indicate that
the Indian pharmaceutical market is an imperfect market. Elements of product
differentiation are observable in the case of large firms. Market power of large
pharmaceutical firms can be controlled if the price control mechanism is appropriately
designed. We have seen that at the level of whom among the producers the DPCO
rewards to what extent and who all are outside the scope of mechanism of price
control is not at all well regulated through the selected market based price control
mechanism. Cost plus formula for price control would do a better job, allow the
consumers to gain more, encourage the small and medium scale companies to provide
more competition and incentivise better large firms to achieve higher productivity and
become more cost effective.
In Chapter 4 and Chapter 5 we have also shown that if the price ceilings of Drug Price
Control Order (DPCO) 2013 had been framed by NPPA in terms of lowest price to
retail (PTR) rather than average price to retail (PTR) in India the consumers would
have gained to the extent of 20% or more in terms of price terms in the case of
another 174 more products in addition. We can expect substantial price rise for the
regulation of prices of the formulations in the case of 74 essential drugs on account of
the shift away from the cost plus price control formula to market based price control
formula. Similarly we can expect major gains to accrue to the producers of all those
brands that were allowed to be sold beyond the ceiling price fixed by the government
of India under the earlier price control mechanism.
92
Analysis points out to the lapses and of adverse consequences likely to arise in the
future on account of the shift away from the cost plus formula of previous DPCO to
the market based price fixation mechanism of DPCO 2013. In the previous DPCO
cost plus based price control mechanism reduced the prices of controlled medicines
far more effectively. It checked sharp rise of prices due to the adoption of price
control right from the stage of bulk drugs. Availability of essential medicines would
also be better ensured through the adoption of a cost-plus price control mechanism.
The DPCO 2013 would encourage in the market the proliferation of irrational
combination medicines. Cost plus price fixation mechanism would be keeping all
fixed dose combinations under price control. The DPCO 2013 applies price control to
a limited set of specific dosage forms. We expect a lesser production of all those
dosages whose prices are controlled by the DPCO 2013. It is not desirable to confine
the price control to certain specific dosage forms. Price control mechanism should
cover all forms of drugs irrespective of their delivery system. Availability of essential
medicines would also suffer because the DPCO 2013 is ultimately going to encourage
the Indian pharmaceutical industry to distort the pattern of domestic production and
sales of pharmaceuticals. Production of irrational combinations whose market needs
to be consciously eliminated would not be built-into the market based price control
mechanism.
It is also not to be forgotten that the use of cost-plus pricing formula also eased the
entry of domestic companies in the past when the western multinationals were in total
control of the pharmaceutical industry. Although this aspect is completely ignored by
the industry leaders because their profitability would be affected to some extent, but
also it should be clear to the policymakers that the business model of the big western
pharmaceutical markets is rapidly undergoing change. This role of the cost-based
price control is once again relevant. Price controls facilitated the emergence of large
domestic pharmaceutical firms 1. As new incumbents they got the chance to build
their market power in the domestic pharmaceutical markets. These firms were able to
establish for several important drugs their own brands which are today accepted in the
1
Prices of drugs once considered to be among the highest in the world. The Drug Price Control Order
of 1970 brought all drug formulations in two categories: essential and non-essential. Essential
formulations were allowed a mark up of only 75% and the ‘non-essential’ category formulations
were allowed 150%. Because at the point of time when the domestic companies were young and
enter into the industry incumbents had less problem compared to multinationals with the lower
mark up allowed in the case of drugs identified as essential formulations.
93
regulated markets of US and EU. But using the price control mechanism they are
today interested to nip the competition from small and medium scale companies in the
bud.
In India the challenge of introduction of effective, country-specific and suitable form
of internal price control for the regulation of pharmaceutical markets comes also from
the fact that the government is now thinking of implementing the benefit of universal
health coverage. In the near future the state governments will be under pressure to
finance the expenditure on drugs from the state finances. The state governments
would be compelled to keep the health budgets in check. There must be enabling
supply side policies and complementary demand side practices of generic prescribing,
generic dispensing and generic awareness. In order to ensure a reliable system of
supply and continuous availability of medicines the nature of optimal mix of the
supply side policies and the demand side practices must be anticipated appropriately.
Ensuring policy and regulations coherence is of importance.
Evidence exists that while the public / private pharmaceutical payer / purchaser
market based perspective on price helps the policymakers to establish the upper limit
on a sustainable (viable) price range, the return on investment consideration of
pharmaceutical companies can help them to fix the lower limit on sustainable (viable)
prices. Therefore, the scheme for viable pricing will have to be determined
appropriately using the information available on how the state of efficiency,
innovation and affordable access is and would be affected by the price regulation and
associated policy measures.
94
CHAPTER 9
CONCLUSIONS AND RECOMMENDATIONS
We have made several observations about the implication of price control under the
Pharmaceutical Pricing Policy (NPPA), 2012 and the Drug Prices Control Order
(DPCO), 2013.
Firstly, one can expect the outcomes of prices of medicines in the price control basket
to remain market led since the Drug Price Control Order (DPCO) of 2013 utilizes the
formula of market determined pricing to undertake price regulation, i.e., prices of
product leaders of medicines under DPCO 2013 will continue to have no relation to
the cost of production. Rather than price competition, brand based competition will
prevail. Market will continue to be led by large firms and small and medium scale
firms will continue to be at disadvantage.
Further, the practice of market based price control mechanism has been combined
with the use of National List of Essential Medicines (NLEM) 2011, which requires
substantial revision. Restricting price control only to medicines mentioned in the
NLEM is also flawed as many chemical/therapeutic equivalents of a medicine as well
as its combinations are out of the price control net. Also out are a number of useful
drugs, including those being used in national treatment programmes, that are not in
the NLEM 2011. As a result price control under the DPCO 2013 is limited to only
about 17% of the drugs being prescribed and promoted at present in the country.
Analysis of the impact of the DPCO 2013 on the prices of market sales leaders and
those who have a share of 1% in the market indicates that the price impact outcome of
the implementation of DPCO 2013 is marginal for the consumers buying drugs from
the retail market. The absolute decrease in sales because of price control is estimated
as less than 2% (~Rs. 1300 crore) of the value of medicines sold in the country.
Therefore, not much relief can be expected to flow to the consumers. The DPCO
2013, through its shortcomings, also provides pharmaceutical companies several
escape routes from price control. It not only permits the presence of a substantial
inessential/irrational/unsafe medicines market, but also encourages its growth by
allowing a 10% increase in prices each year.
By not being logically related to the cost of production, the DPCO 2013 obfuscates
real costs and by default legitimizes higher prices. Paradoxically it also punishes
manufacturers who had priced their products lower than the ceiling price by freezing
it at the same levels. Many of them will be rendered unviable as raw material prices
increase, for instance with the falling rupee. The current mechanism of applying for
revision of ceiling prices is tortured and in the absence of an automatic revision
formula or an immediate response mechanism from the NPPA, genuine manufacturers
with reasonable pricing policies will be put to hardship.
Lastly, DPCO 2013 does not address the challenge of cost-competitiveness and the
challenge of the indigenous development of the bulk drug industry. Therefore, the
choice of the drug price control mechanism must be made keeping in view the
prevailing market situation and the need to safeguard regional industry networks and
scope for the development of competitive public procurement by states.
Based on these observations, our recommendations follow.
Reverting to a cost-plus price control mechanism is critical. DPCO 2013 has been
brought in defiance of the Supreme Court order of October 2012 that asked the
Government not to change the cost-based mechanism for fixing prices. Evidence
clearly indicates that market-based pricing will be unsuccessful at providing adequate
relief to patients. Keeping in mind that the share of patented drugs is growing in the
Indian market, the solution lies in the adoption of a mechanism of price control by
which policymakers can effectively address the challenges of essentiality, rationality,
affordability and availability. A suitably designed cost plus formula for price control
would allow the consumers to gain more, encourage the small and medium scale
companies to provide more competition and better incentivise large firms to achieve
higher productivity and become more cost effective.
An urgent revision of the National List of Essential Medicines is needed. Indeed the
list needs to be revised once in 2 years if not annually by a regular ongoing
committee. Members of such a committee must be clearly told that the NLEM is to be
used inter alia as the basis for price regulation. The revision should rectify prominent
omissions and misalignment with current standards of providing treatment. The
revision should also take into consideration the state lists, and be expanded to include
96
medicines for diseases endemic to regions or relevant for particular minorities, so as
to be truly relevant for all segments of the national population. A list of life saving
medicines should be identified in conjunction with the review of the NLEM and
should be brought under price control.
The implementation of the price control mechanism should not be narrowed to a
literal reading of the NLEM. The scope of coverage should be expanded to include all
additional dosages, strengths, delivery mechanisms and combinations of medicines
under the NLEM. Acknowledging that the NLEM is only a representative list of
medicines that are recommended for various therapeutic areas, the mechanism should
also include therapeutic equivalents and close substitutes of medicines in the NLEM.
The use on privately owned market data is against the principles of transparency and
evidence-based public policy making, and has led to anomalies in the implementation
of DPCO 2013 that cannot be overlooked. It is imperative that the Government
develops institutional machinery for independent collection
of data on the
pharmaceutical market.
In order to implement the cost-plus formula, the NPPA would need to be considerably
strengthened. Development of a systematic mechanism for the continuous monitoring
of production levels, costs of raw. materials and manufacturing and market prices is
necessary. An effective system for timely monitoring and enforcement of prices for
both scheduled and non-scheduled medicines must be put in place.
Finally, if the Indian State is serious about the implementation of the policy of
universal access to essential medicines then the central government should support the
state governments in replicating a ‘centraised procurement and decentralized
distribution of medicines ’ mechanism. Tamil Nadu and Rajasthan have been
recognized for their success in providing free access to generic medicines and serve as
powerful models for other states.
97
Appendix 1.
National List of Essential Medicines (NLEM) 2011 - all unique strengths and dosages identified by the
authors ________________________________
S.No. |______________Molecular Description
Strength
Description
Section 1. ANAESTHETICS
1
diazepam_____________
2 mg_____
Tablet
2
diazepam_____________
5 mg
Tablet
morphine sulphate______
3
1 Omg
Tablet
4
0.6mg/ml
Injection
atropine sulphate_______
Injection
5
atropine sulphate_______
Img/ml
0.0025
Injection
bupivacaine hydrochloride
6
0.005
Injection
bupivacaine
hydrochloride
7
5mg/ml
Injection
diazepam_____________
8
Injection
1 Omg/ml
ketamine hydrochloride
9
Injection
50mg/ml
ketamine hydrochloride
10
Injection
5% + 7.5%
lignocaine hydrochloride
11
glucose
(spinal)
Injection
0.01
lignocaine hydrochloride + adrenaline
12
Injection
2%
+
lignocaine hydrochloride + adrenaline
13
adrenaline
1:200,000
Injection
1 mg/ml
______
midazolam
14
Injection
5mg/ml
______
midazolam
15
1
Omg/ml
Injection
morphine sulphate
16
Injection
l%oil
propofol
17
suspension
Injection_____
thiopental sodium_____
Q-5g
18
Injection_____
g
powder
1
thiopental
sodium_____
19
Inhalation____
________________
ether
20
Inhalation
with
vaporizer
halothane
21
Inhalation____
____________
isoflurane
22
Inhalation
nitrous oxide
23
Inhalation
______________
oxygen
24
Inhalation
sevoflurane__________
25
Drops
0.01
atropine sulphate
26
opthamological
Ointment 0.01
atropine sulphate
27
opthamological
Cream_______
EMLA cream_________
28
Gel or Jelly
2-5%
lignocaine hydrochloride
29
Ointment_____
2-5%
lignocaine hydrochloride
30
Solution_____
2-5%
hydrochloride
lignocaine
21
Syrup_______
2mg/5ml
____________
diazepam
32
5mg/5ml
Elixir
or Syrup
promethazine_________
33
Suppository
5mg
diazepam
34
Section 2. ANALGESICS, ANTIPYRETICS, etc.
75mg
acetylsalicylic acid_________
Tablet
35
IQOmg
Tablet
allopurinol________________
36
50mg
37
azathioprine______________
Tablet
colchicin_________________
0.5mg
38
Tablet
50mg
Tablet
diclofenac________________
22
hydroxychloroquine phosphate
200mg
40
Tablet
200mg
4J_
ibuprofen_________________
Tablet
400mg
Tablet
42
ibuprofen_________________
IQmg
43
Tablet
leflunomide_______________
44
leflunomide_______________
Tablet
20mg
2.5mg
45
methotrexate
Tablet
S.No.
46___
47
48
49 ___
50 ___
51
52
53
____________ Molecular Description
methotrexate
_________________
methotrexate __________________
methotrexate____________________
paracetamol_____________________
tramadol________________________
tramadol________________________
diclofenac_______________________
fentanyl
Strength
Description
5mg______
Tablet________
7.5mg_____
Tablet________
IQmg_____
Tablet________
500mg
Tablet________
1 OOmg
Capsule______
50mg_____
Capsule______
25mg/ml
Injection_____
50ug/ml 2ml
Injection
ampoule
54
paracetamol
Injection
150mg/ml
55
tramadol
50mg/ml
Injection
56
ibuprofen
Syrup_____
100mg/5ml
125mg/5ml
57
Syrup_____
paracetamol
Suppository
80mg
58
paracetamol
170mg
Suppository
paracetamol
59
Section 3. ANTIALLERGICS AND MEDICINES USED IN ANAPHYLAXIS
100m g
Tablet
acetylsalicylic acid___________
60
Tablet
IQmg______
cetrizine___________________
61_
4mg_______
Tablet
chlorpheniramine maleate______
62
Tablet
0.5mg_____
dexamethasone______________
63
Tablet
prednisolone________________
IQmg______
64
IQmg______
Tablet
promethazine_______________
65
Tablet
promethazine_______________
25nig
66
Injection
Img/ml
adrenaline bitartrate__________
4mg/ml
Injection
dexamethasone______________
68
Injection
hydrocortisone sodium succinate
IQOmg/ml •
69
22.75mg/ml
Injection
pheniramine maleate__________
70
Injection
25mg (as ■
prednisolone
71
sodium,
phosphate or
succinate)
5mg/ml
Syrup
cetrizine_________________
72
0.5mg/5ml
Syrup
dexchlorpheniramine maleate
73
Section 4. ANTIDOTES AND OTHER SUBSTANCES USED IN POISONINGS _______
250mg______ Tablet
penicillamine
74
250mg______ Capsule
penicillamine
75
lOOmg/ml
Injection
calcium gluconate
76
1 OOmg/ml in
Injection
calcium gluconate
77
10ml ampoule
500mg______ Injection
desferrioxamine mesylate
78
50mg/ml (in
Injection
dimercaprol
79
oil)________
0. Img/ml
Injection
flumazenil______________ ____________
80
lOmg/ml
Injection
methylthioninium chloride (methylene blue)
81
N-acetylcystiene
200mg/ml
Injection
82
(5ml)
83
naloxone_________________
0.4mg/ml
Injection
84
25mg/ml
pralidoxime chloride(2-PAM)
Injection
30mg/ml
85
sodium nitrite_____________
Injection
86
sodium thiosulphate
250mg/ml
Injection
Section 5. ANTICONVULSANTS/ANTIEPILEPTICS
carbamazepine
lOOmg
87
Tablet
200mg
carbamazepine
88
Tablet
30mg
phenobarbitone
89
Tablet
phenobarbitone
90
60mg
Tablet
phenytoin sodium
50mg
91
Tablet
phenytoin sodium
50mg
92
Capsule
99
S.No.
93 ___
94 ___
95 ___
96 ___
97 ___
98 ___
99 ___
_____________Molecular Description
phenytoin sodium________________
phenytoin sodium________________
lorazepam______________________
magnesium sulphate______________
phenobarbitone__________________
phenytoin sodium________________
sodium valproate_________________
carbamazepine__________________
100
phenobarbitone__________________
101
phenytoin sodium________________
102
sodium valproate
103
Section 6. ANTI-INFECTIVE MEDICINES
acyclovir_________________________________
104
acyclovir_________________________________
105
albendazole_______________________________
106
amoxicillin________________________________
107
amoxicillin_______________________________
108
amoxicillin+clavulinic acid___________________
109
ampicillin ________________________________
110
ampicillin_________________________________
111
artesunate (to be used only in combination with
112
sulfadoxine + pyrimethamine)________________
azithromycin_____________________ _________
113
azithromycin______________________________
114
azithromycin___________________________ ___
115
116
cefixime__________________________________
cefixime__________________________________
117
cephalexin________________________________
118
cephalexin________________________________
119
chloroquine phosphate______________________
120
ciprofloxacin hydrochloride__________________
121
ciprofloxacin hydrochloride__________________
122
clindamycin_______________________________
123
124
clindamycin_______________________________
clofazimine_______________________________
125
clofazimine_______________________________
126
cioxacillin________________________________
127
cloxacillin________________________________
128
co-trimoxazole (sulfamethoxazole + trimethoprim)
129
co-trimoxazole (sulfamethoxazole + trimethoprim)
130
dapsone__________________________________
131
dapsone__________________________________
132
didanosine (ddl)___________________________
133
134
didanosine (ddl)___________________________
135
diethylcarbamazine citrate___________________
diloxanide furoate__________________________
136
doxycycline_______________________________
137
efavirenz (EFV or EFZ)_____________________
138
efavirenz (EFV or EFZ)_____________________
139
140
erythromycin estolate_______________________
erythromycin estolate_______________________
141
ethambutol________________________________
142
ethambutol________________________________
143
ethambutol________________________________
144
ethambutol________________________________
145
fluconazole_______________________________
146
147
fluconazole
100
Strength
IQOmg
IQOmg
2mg/ml
500mg/ml
200mg/ml
50mg/ml
IQOmg/ml
100mg/5ml
20mg/5ml
25mg/ml
200mg/5ml
Description
Tablet_______
Capsule_____
Injection_____
Injection_____
Injection_____
Injection_____
Injection_____
Syrup_______
Syrup_______
Syrup_______
Syrup
200mg
400mg
400mg
250mg
500mg
625mg
250mg
500mg
50mg
Tablet
Tablet
Tablet
Capsule
Capsule
Tablet
Capsule
Capsule
Tablet
IQOmg____
250mg____
500mg
IQOmg
200mg
250mg
500mg
150mg base
250mg ____
500mg
150mg
300mg
50mg_____
IQOmg
250mg
500mg
80+400mg
160+800mg
50mg_____
IQOmg
250mg
400mg
50mg_____
SOOmg
IQOmg
200mg
600mg
250mg ____
500mg __
200mg
400mg
600mg____
SOOmg
50mg_____
50mg
Tablet
Tablet
Tablet
Tablet • .
Tablet ,
Capsule. • .
Capsule.
Tablet ‘ •
Tablet
Tablet
Tablet
Tablet
Capsule
Capsule
Capsule
Capsule
Tablet
Tablet
Tablet
Tablet
Tablet
Tablet
Tablet
Tablet
Tablet
Capsule
Capsule
Tablet____
Tablet
Tablet
Tablet
Tablet
Tablet
Tablet____
Capsule
S.No.
148
149
150
151__
152
153
154
155
156
157
158
159
160
161__
162
163
164
Molecular Description
fluconazole_____________________
fluconazole_____________________
fluconazole_____________________
fluconazole_____________________
fluconazole_____________________
fluconazole_____________________
griseofulvin_____________________
griseofulvin_____________________
griseofulvin_____________________
griseofulvin_____________________
indinavir (1DV)__________________
indinavir (IDV)__________________
isoniazid_______________________
isoniazid_______________________
isoniazid_______________________
lamivudine (3TC)________________
lamivudine + nevirapine + zidovudine
165
lamivudine + nevirapine + stavudine
166
167
lamivudine + stavudine
lamivudine + zidovudine
Strength
1 OOmg_____
1 OOmg_____
150mg_____
150mg_____
200mg_____
200mg_____
125mg_____
125mg_____
250mg_____
250mg_____
200mg_____
400mg_____
50mg______
IQOmg_____
300mg_____
150mg_____
300mg+150m
g+200mg
150mg+200m
g+30mg
30mg+150mg
150mg+300m
mefloquine______________
metronidazole____________
metronidazole____________
nelfinavir_______________
nevirapine (NVP)_________
nitrofurantoin____________
nystatin_________________
ofloxacin________________
ofloxacin________________
piperazine_______________
praziquantel_____________
primaquine______________
primaquine______________
pyrazinamide____________
pyrazinamide____________
pyrazinamide____________
pyrazinamide____________
pyrimethamine___________
quinine sulphate__________
rifampicin_______________
rifampicin_______________
rifampicin_______________
rifampicin_______________
rifampicin_______________
rifampicin_______________
rifampicin_______________
rifampicin_______________
ritonavir________________
saquinavir (SQV)_________
stavudine (d4T)__________
stavudine (d4T)__________
stavudine (d4T)__________
sulfadoxine + pyrimethamine
sulphadiazine
250mg base
200mg_____
400mg_____
250mg_____
200mg_____
IQOmg_____
500,000 1U
IQOmg_____
200mg_____
4.5gm______
600mg_____
2.5mg______
7.5mg______
500mg_____
750mg_____
1 OOOmg
1500mg
25mg______
300mg_____
50mg______
50mg______
150mg_____
150mg_____
3 OOmg_____
300mg_____
450mg_____
450mg_____
IQOmg_____
2 OOmg_____
15mg______
30 mg______
40mg______
500mg+25mg
5 OOmg
168
169
170
171
172
173
174
175
176
177
178
179
180
181
182
183
184
185
186
187
188
189
190
191
192
193
194
195
196
197
198
199
200
201
Description
Tablet_______
Capsule_____
Tablet_______
Capsule_____
Tablet_______
Capsule_____
Tablet_______
Capsule_____
Tablet_______
Capsule_____
Tablet_______
Tablet_______
Tablet_______
Tablet_______
Tablet_______
Tablet_______
Tablet
Tablet
Tablet
Tablet
o
101
Tablet_______
Tablet_______
Tablet_______
Tablet_______
Capsule______
Tablet_______
Tablet (vaginal)
Tablet_______
Tablet_______
Tablet_______
Tablet_______
Tablet_______
Tablet_______
Tablet_______
Tablet_______
Tablet_______
Tablet_______
Tablet_______
Tablet_______
Tablet_______
Capsule______
Tablet_______
Capsule______
Tablet_______
Capsule______
Tablet_______
Capsule______
Capsule______
Capsule______
Capsule______
Capsule______
Capsule______
Tablet_______
Tablet
236
____________ Molecular Description
zidovudine (ZDV or AZT)_________
zidovudine (ZDV or AZT) _________
acyclovir_______________________
acyclovir_______________________
amikacin_______________________
amoxicillin+clavulinic acid_________
amoxicillin+clavulinic acid_________
amphotericin B___________________
ampicillin_______________________
azithromycin___________________ _
benzathine benzylpenicillin_________
benzathine benzylpenicillin_________
cefotaxime______________________
cefotaxime____________________ _
cefotaxime__________________ ___
^eftazidime_____________________
ceftazidime_____________________
ceftriaxone______________________
ceftriaxone___________________
chloroquine phosphate_____________
ciprofloxacin hydrochloride________
cioxacillin______________________
gentamicin____________________
gentamicin__________________ ___
jnetronidazole__________________
pentamidine isothionate____________
quinine sulphate_________________
sodium stibogluconate _____________
streptomycin sulphate ____________
streptomycin sulphate_____________
vancomycin hydrochloride_________
vancomycin hydrochloride_________
clotrimazole____________________
jftoxacillin________________ _____
amoxicillin
Strength
IQOmg_____
300mg_____
250mg_____
500mg_____
250mg/2ml
l-2gm______
600mg_____
50mg______
500mg_____
500mg_____
6 lacs______
12 lacs units
125mg_____
250mg_____
500mg_____
250 mg_____
1 g________
250 mg_____
1 g________
40mg/mI
200mg/100mI
250mg_____
IQmg/ml
40mg/ml
500mg/' 100ml
200mg_____
30()mg/rnl
IQOmg/ml
0.75g
lg________
lg________
500mg_____
0.02_______
125mg/5ml
125mg/5ml
237
amoxicillin+clavulinic acid
228.5mg/5ml
238
ampicillin
125mg/5ml
239
240
241
242
243
piperazine__________________
acyclovir___________________ _____________
________________________
albendazole
azithromycin
_______________________
co-trimoxazole (sulfamethoxazole + trimethoprim)
244
245
246
247
nevirapine (NVP)
cephalexin_________
chloroquine phosphate
erythromycin estolate
isoniazid__________
metronidazole______
ofloxacin__________
rifampicin_________
ritonavir___________
clotrimazole________
clotrimazole
750mg/5ml
400mg/5ml
200mg/5ml
100mg/5ml
40+200mg/5
ml________
50mg/5ml
125mg/5ml
50mg/5ml
J25mg/5ml
100mg/5ml
100mg/5ml
50mg/5ml
100mg/5ml
400mg/5ml
1 OOmg
200mg
‘S.No.
202
203
204
205
206
207
208
209
210
211
212
213
214
215
216
217
218
219
220
221
222
223
224
I
225
226
227
228
229
230
231
232
233
234
235
248
249
250
251
252
253
254
102
Description
Tablet_______
Tablet_______
Injection_____
Injection_____
Injection_____
Injection_____
Injection_____
Injection _____
Injection_____
Injection_____
Injection _____
Injection _____
Injection _____
Injection_____
Injection _____
Injection_____
Injection_____
Injection_____
Injection _____
Injection _____
Injection_____
Injection_____
Injection _____
Injection_____
Injection_____
Injection _____
Injection _____
Injection_____
Injection_____
Injection _____
Injection _____
Injection_____
Gel_________
Liquid_______
Powder for
suspension
powder for
suspension
Powder for
suspension
Solution_____
Suspension
Suspension
Suspension
Suspension
Suspension
Syrup
Syrup
Syrup
Syrup
Syrup
Syrup
Syrup
Syrup
Pessaries
Pessaries
S.No.
Molecular Description
255
nystatin
Section 7. ANTIMIGRAINE MEDICINES
acetylsalicylic acid
256
257
acetylsalicylic acid
acetylsalicylic acid
258
Strength
100,000 JU
Description
Pessaries
300mg
Tablet
Tablet
Tablet
325mg
350mg, 350
soluble/disper
sible_______
1 mg________ Tablet
dihydroergotamine ______
259
propranolol hydrochloride
IQmg_______ Tablet
260
Tablet
40mg
propranolol hydrochloride
261
Section 8. ANTINEOPLASTIC, IMMUNOSUPPRESSIVES, MEDICINES FOR PALLIATIVE
CARE
Tablet
busulphan_______
2mg_______
262
2mg_______
Tablet
chlorambucil_____
263
Capsule
IQmg______
ciclosporine_____
264
2 5 mg______
Capsule
ciclosporine_____
265
50mg______
Capsule
ciclosporine_____
266
IQOmg_____
Capsule
ciclosporine_____
267
Tablet
50mg______
cyclophosphamide
268
Tablet
200mg_____
cyclophosphamide
269
50mg______
Capsule
danazol_________
270
Capsule
1 OOmg_____
danazol_________
271
Capsule
1 00 mg_____
etoposide________
272
250mg_____
Tablet
flutamide_____ __
273
1 OOmg_____
Tablet
274
imatinib_________
Tablet
400mg
imatinib_________
275
Tablet
2mg
melphalan_______
276
Tablet
5mg_______
melphalan_______
277
50mg______
Tablet
mercaptopurine
278
Tablet
4mg_______
ondansetron_____
279
Tablet
Smg_______
ondansetron_____
280
5mg_______
Tablet
prednisolone _____
281
Tablet
20mg______
prednisolone _____
282
50mg______
Capsule
procarbazine_____
283
60mg______
Tablet
raloxifene_______
284
Tablet
1 Omg______
tamoxifen_______
285
Tablet
20mg______
tamoxifen_______
286
Injection
250mg/5ml
5-fluorouracil
287
Injection
0.5mg_____
actinomycin D
288
3 million IU
Injection
alpha interferon
289
15mg______
Injection
bleomycin_______
290
15 Omg_____
Injection
carboplatin______
291
Injection
450mg vial
carboplatin______
292
Injection
1 OOmg/ml
ciclosporine
293
(concentrate
for injection)
IQmg/vial
Injection
cisplatin__________
294
Injection
50mg/vial
295
cisplatin__________
500mg
Injection
cyclophosphamide
296
cytosine arabinoside
IQOmg/vial
Injection
297
Injection
500mg/vial
cytosine arabinoside
298
lOOOmg/vial
Injection
cytosine arabinoside
299
Injection
5 OOmg___
dacarbazine_______
300
Injection
20mg vial
daunorubicin ______
301
1
Omg______
Injection
doxorubicin _______
302
100mg/5mI
Injection
303
etoposide
vial
103
S.No.
Molecular Description
304
filgrastim_____________
folinic acid____________
305
306
gemcitabine hydrochloride
307
gemcitabine hydrochloride
308
ifosfamide_____________
L-asparaginase _________
309
mercaptopurine
310
mesna________________
31 1
methotrexate___________
312
mitomycin-c___________
313
314
ondansetron____________
oxaliplatin_____________
315
paclitaxel______________
316
prednisolone___________
317
vinblastine sulphate_____
318
vincristine_____________
319
ondansetron____________
320
ondansetron
321
Section 9. ANTIPARKINSONISM MEDICINES
bromocriptine mesylate_____
322
bromocriptine mesylate_____
323
carbidopa + levodopa_______
324
carbidopa + levodopa_______
325
carbidopa + levodopa_______
326
trihexyphenidyl hydrochloride
327
Section 10. MEDICINES AFFECTING THE BLOOD
ferrous sulphate/fumrate
328
Strength
1ml vial
3mg/ml____
200mg_____
1 gm_____
lgm/2ml vial
5000KU
lOOmg/ml
200mg_____
50mg/ml
IQmg______
2mg/ml
50mg vial
30mg/5ml
20mg______
IQmg______
Img/ml
2mg/5ml
2mg/ml
Description
Injection_____
Injection_____
Injection_____
Injection_____
Injection_____
Injection_____
Injection_____
Injection_____
Injection_____
Injection_____
Injection_____
Injection_____
Injection_____
Injection_____
Injection_____
Injection_____
Syrup________
Syrup
1.2 5 mg_____
2.5mg______
IQOmg+lOmg
100mg+25mg
250mg+25mg
2mg
Tablet
Tablet
Tablet
Tablet
Tablet
Tablet
Tablets
equivalent to
60mg
elemental iron
Img________
folic acid____________
329
5mg________
folic acid_______ ,
330
IQmg_______
pyridoxine___________
331
5mg________
warfarin sodium______
332
Img/ml_____
cyanocobalamin______
333
40mg_______
enoxaparin___________
334
60mg_______
enoxaparin___________
335
IQOOIU/ml
heparin sodium_______
336
50001 U/ml
heparin sodium_______
337
50mg iron/ml
iron dextran__________
338
lOmg/ml
phytomenadione______
339
IQmg/ml
protamine sulphate
340
25mg
ferrous sulphate/fumrate
341
elemental iron
(as
sulphate)/ml
Section 11. BLOOD PRODUCTS AND PLASMA SUBSTITUTES_________
0.05
albumin__________________________________
342
0.2
albumin__________________________________
343
344
cryoprecipitate_____________________________
0.1__
dextran-40________________________________
345
0.06
dextran-70________________________________
346
Dried
Factor
IX
complex
(coagulation
11,VII,
IX,
factors
347
X)______________________________________
Dried
Factor VIII concentrate______________________
348
fresh frozen plasma_________________________
349
0.06
hydroxyethyl starch (hetastarch)
350
Tablet
104
Tablet______
Tablet______
Tablet______
Tablet______
Injection
Injection
Injection
Injection
Injection
Injection
Injection
Injection
Oral Solution
Injection
Injection
Injection
Injection
Injection
Injection
Injection
Injection
Injection
S.No.
____________ Molecular Description
351
platelet rich plasma_______________
352
polygeline
Section 12. CARDIOVASCULAR MEDICINES
353
amiodarone__________________
354
amiodarone__________________
355
amlodipine___________________
356
amlodipine___________________
357
atenolol_____________________
atorvastatin__________________
358
359
atorvastatin__________________
360
clopidogrel___________________
361
digoxin_____________________
diltiazem____________________
362
diltiazem____________________
363
enalapril maleate______________
364
365
enalapril maleate______________
glyceryl trinitrate______________
366
hydrochlorthiazide____________
367
hydrochlorthiazide____________
368
hydroch lorthiazide____________
369
isosorbide 5 mononitrate/dinitrate
370
isosorbide 5 mononitrate/dinitrate
371
losartan potassium_____________
372
losartan potassium_____________
373
methyldopa__________________
374
metoprolol___________________
375
metoprolol___________________
376
377
nifedipine___________________
nifedipine___________________
378
nifedipine___________________
379
nifedipine___________________
380
nifedipine___________________
381
382
nifedipine___________________
383
nifedipine___________________
384
nifedipine___________________
procainamide hydrochloride____
385
verapamil____________________
386
387
verapamil____________________
adenosine____________________
388
amiodarone
389
390
391
392
393
394
395
396
•397
398
399
400
401
402
403
404
405
digoxin_________________
diltiazem________________
dobutamine______________
dopamine hydrochloride
enalapril maleate_________
esmolol_________________
glyceryl trinitrate_________
ligocaine hydrochloride
ligocaine hydrochloride
metoprolol______________
procainamide hydrochloride
sodium nitroprusside______
streptokinase_____________
streptokinase_____________
urokinase_______________
urokinase
105
Strength
0.035
1 OOmg______
200mg______
2.5mg_______
5mg________
50mg_______
5mg________
IQmg_______
75mg_______
0.25mg______
30mg_______
60mg_______
2.5mg_______
5mg________
0.5mg_______
12.5mg______
25mg_______
50mg_______
IQmg_______
20mg_______
25mg_______
50mg_______
250mg______
25mg_______
50mg_______
5mg________
I Omg_______
IQmg_______
1 Omg_______
IQmg_______
20mg_______
20mg_______
20mg_______
250mg______
40mg_______
80mg_______
3mg/ml______
50mg/ml (3ml
ampoule)
0.25mg/ml
5mg/ml______
50mg/ml_____
40mg/ml_____
1.25mg/ml
lOmg/ml_____
5mg/ml______
0.01_________
0.02________
Img/ml______
IQOmg/ml
50mg/5ml
7,50,000 IU
1500,000 IU
500,000 lU/ml
10,00,000
Description
Injection_____
Injection_____
Tablet
Tablet
Tablet
Tablet
Tablet
Tablet
Tablet
Tablet
Tablet
Tablet
Tablet
Tablet
Tablet
Tablet
Tablet
Tablet
Tablet
Tablet
Tablet
1 ablet
Tablet
Tablet
Tablet
Tablet
Capsule
Tablet
Capsule
SR tab
SR cap
Tablet
SR tab
SR cap
Tablet
Tablet
Tablet
Injection
Injection
Injection
Injection
Injection
Injection
Injection
Injection
Injection
Injection
Injection
Injection
Injection
Injection
Injection
Injection
Injection
Injection
Molecular Description
S.No.
verapamil
406
digoxin
407
Section 13. DERMATOLOGICAL MEDICINES
miconazole
408
409
dithranol____________________________
neomycin + bacitracin_________________
miconazole__________________________
miconazole__________________________
acyclovir_________________________ __
framycetin sulphate___________________
permethrin______________________ __
silver sulphadiazine ___________________
betamethasone dipropionate_____________
betamethasone dipropionate_____________
__________________
benzyl benzoate
calamine_________________________ __
pennethrin__________________________
permethrin__________________________
zinc oxide__________________________
coal tar___________________________ __
povidone iodine_____________________
methylrosanilinium chloride (gentian violet)
glycerin____________________________
salicylic acid
Section 14. DIAGNOSTIC AGENTS
iopanoic acid________
430
calcium ipodate______
431
meglumine iothalamate
432
410
411
412
413
414
415
416
417
418
419
420
421
422
423
424
425
426
427
428
429
sodium iothalamate
434
sodium meglumine diatrizoate
435
sodium meglumine diatrizoate
436
meglumine iotroxate
437
propyliodone
0.01
0.006
povidone iodine
433
Strength
lU/ml
2.5mg/ml
0.05mg/ml
fluorescein
lignocaine
tropicamide
barium sulphate
barium sulphate
Section 15. DISINFECTANTS AND ANTISEPTICS
443
gentian violet
gentian violet
444
438
439
440
441
442
106
0.1-2%
5mg+500IU/g
0.02________
0.02________
0.05________
0.005______
0.05________
0.01________
0.0005
0.0005
0.25
0.01
0.05
0.05
0.05
0.005
0.05
Description
Injection
Elixir
Drops opthamological
Drops opthamological
Ointment______
Ointment______
Ointment______
Cream_________
Cream_________
Cream_________
Cream_________
Cream________
Ointment______
Cream_________
Lotion________
Lotion________
Lotion________
Lotion________
Dusting Powder
Solution_______
ointment_______
Aqueous solution
Solution_______
Solution
500mg______
3g_________
60%w/v
(iodine=280m
g/ml)_______
70%w/v
(iodine=420m
g/ml)_______
60%w/v
(iodine
conc.=292mg/
ml)________
76%w/v
(iodine
conc.=370mg/
ml)________
5-8 iodine in
100-250ml
500600mg/ml
0.01________
0.04________
0.01________
100%w/v
250%w/v
Tablet
Injection
Injection
0.005
0.01
Paint
Paint
Injection
Injection
Injection
Solution for
Injection
Injection, Oily
Suspension
Eye drops
Eye drops
Eye drops
Suspension
Suspension
S.No.
445
446
447
448
____________Molecular Description
benzoin compound_______________
acriflavin+glycerin_______________
hydrogen peroxide________________
cetrimide
449
chlorhexidine
450
451
452
453
ethyl alcohol 70%_____
povidone iodine______
povidone iodine______
potassium permanganate
454
bleaching powder
455
formaldehyde solution
456
glutaraldehyde
Strength
0.06________
20% (cone.
For dilution)
5% (cone. For
dilution)
0.05
0.1
Description
Tincture______
Solution______
Solution______
Solution
Solution
Solution_____
Solution_____
Solution_____
Crystals for
solution (nonhuman use)
Powder (non
human use)
Contains not
less than
30%w/v of
available
chlorine (as
per I.P)______
Dilute 34ml of Solution (non
formaldehyde
human use)
solution with
water to
produce
100ml (as per
I-P)_________
Solution (non0.02
human use)
Section 16. DIURETICS
furosemide
457
spironolactone
458
furosemide
459
mannitol_____
460
mannitol
461
______________________________
Section 17. GASTROINTESTINAL MEDICINES
5-amino salicylic acid (5-ASA)_____________
462
aluminium hydroxide + magnesium hydroxide
463
bisacodyl______________________________
464
dicyclomine hydrochloride________________
465
domperidone_______________________ ____
466
jamotidine_______________________
467
hyoscine butyl bromide ________________
468
metoclopramide________________________
469
omeprazole___________________________ _
470
omeprazole__________________________
471
omeprazole____
472
^icyclominejiydroch^ ________________
473
hyoscine butyl bromide___________________
474
metoclopramide________________________
475
pantoprazole__________
476
promethazine______________________ ____
477
jranitidine^_________________________ _
478
aluminium hydroxide + magnesium hydroxide
479
domperidone___________________________
480
metoclopramide________________________
481
zinc sulfate_________________________ _
482
oral rehydration salts
483
107
40mg
25mg
lOmg/ml
0.1_____
0.2
Tablet
Tablet
Injection
Injection
Injection
400mg
Tablet
Tablet
Tablet
Tablet
Tablet
Tablet
Tablet
Tablet
Capsule
Capsule
Capsule
Injection
Injection
Injection
Injection
Injection
Injection
Suspension
Syrup____
Syrup____
Syrup____
Powder for
5mg
IQmg
IQing
20mg
IQmg
IQmg
IQmg
2 Ping
40mg
lOmg/ml
20mg/ml
5mg/ml
40mg
25mg/ml
25mg/ml
Img/ml
5mg/5ml
20mg/5ml
Glucose:
S.No.
Molecular Description
Strength
13.5g/L,
Sodium
chloride:
2.6g/L,
Potassium
chloride:
1.5g/L,
Trisodium
citrate
dihydrate+:
2.9g/L,
Powder for
dilution in
200ml;500ml;
1000ml (as
per I.P)
Description
solution
Granules
ispaghula
484
5mg
Suppository
bisacodyl
485
Section 18. HORMONES, OTHER ENDOCRINE MEDICINES AND CONTRACEPTIVES
5mg________
Tablet
carbimazole__________________
486
IQmg______
Tablet
carbimazole__________________
487
Tablet
50mg______
clomiphene citrate ____________
488
IQOmg_____
Tablet
clomiphene citrate ____________
489
Tablet
0.01 mg_____
ethinylestradiol_______________
490
Tablet
0.05mg_____
ethinylestradiol_______________
491 •
0.03mg+0.15
Tablet
ethinylestradiol + levonorgesterol
492 •
mg________
Tablet
0.035mg+l .0
ethinylestradiol + norethisterone
493
mg________
2.5mg
Tablet
glibenclamide_____________
494
5mg_______
Tablet
glibenclamide_____________
495'
Tablet
50microg
levothyroxine_____________
496
IQOmicrog
Tablet
levothyroxine_____________
497
Tablet
5mg_______
medroxyprogesterone acetate
498 '
IQmg______
Tablet
medroxyprogesterone acetate
499 •
500mg_____
Tablet
metformin________________
500
Tablet
5mg_______
norethisterone_____________
501
Capsule
40mg (as
testosterone
502
undecanoate)
Injection
100ml
25% dextrose______________________
503
Injection
Img/ml____
glucagon_________________________
504
Injection
40IU/ml
insulin injection (soluble)___________
505
Injection
40IU/ml
intermediate-acting (Lente/NPH insulin)
506
Injection
40mg/ml
methylprednisolone________________
507
Injection
40IU/ml
premix insulin 30:70 injection
508
25mg/ml (as
Injection
testosterone
509
propionate)
piece
IUD containing copper
510
IUD
hormone releasing IUD
511
condoms
512
Section 19. IMMUNOLOGICALS
300microg
Injection
anti-D immunoglobin (human)
513
250IU
Injection
antitetanus human immunoglobin
514
antitetanus human immunoglobin
500IU
Injection
515
Injection
BCG vaccine_________________
516
io,oooru
Injection
diphtheria antitoxin___________
517
Injection
DPT
vaccine
518
108
S.No.
____________ Molecular Description_____
Strength
Description
hepatitis B vaccine___________________
Injection_____
measles vaccine______________________
Injection_____
oral poliomyelitis vaccine (LA)__________
oral drops
polyvalent antisnake venom_____________
10ml
Injection_____
rabies immunoglobulin _________________
1501U/ml
Injection_____
tuberculin, purified protein derivative (PPP)
ITU
Injection_____
tuberculin, purified protein derivative (PPP)
5TU
Injection_____
rabies vaccine_______________________
Injection_____
tetanus toxoid
Injection
Section 20. MUSCLE RELAXANTS (PERIPHERALLY-ACTING) AND CHOLINESTERASE
INHIBITORS
15mg
neostigmine __________
528
Tablet
60mg
pyridostigmine_______
Tablet
529
IQmg/ml
Injection
atracurium besylate
530
0.5mg/ml
Injection
neostigmine__________
531
Injection
Img/ml
pyridostigmine_______
532
Injection
50mg/ml
succinyl choline chloride
533
2mg/ml
Injection
vecuronium
534
Section! 21. OPTHALMOLOGICAL PREPARATIONS
250mg
Tablet_______
acetazolamide
535
0.02
Injection_____
methyl cellulose
536
Props 0.004
chloramphenicol
537
opthamological
Ointment 0.004
chloramphenicol
538
opthamological
Props 0.01
chloramphenicol
539
opthamological
Ointment 0.01
540
chloramphenicol’
opthamological
Props 0.003
ciprofloxacin hydrochloride
541
opthamological
Ointment 0.003
ciprofloxacin hydrochloride
542
opthamological
Props 0.0025
betaxolol hydrochloride
543
opthamological
Props 0.005
betaxolol hydrochloride
544
opthamological
Props 0.003
gentamicin
545
opthamological
Props 0.02
homatropine
546
opthamological
0.05
Props phenylephrine
547
opthamological
Props 0.02
pilocarpine
548
opthamological
Props 0.04
pilocarpine
549
opthamological
Props prednisolone acetate
0.001
550
opthamological
prednisolone sodium phosphate
Props 0.01
551
opthamological
Props sodium
0.1
sulphacetamide
552
opthamological
Props 0.2
sulphacetamide sodium
553
opthamological
554
0.005
tetracaine hydrochloride
Props opthamological
519
520
521__
522
523
524
525
526
527
109
S.No.
555
____________Molecular Description
timolol maleate
Strength
0.0025
556
timolol maleate
0.005
Section 22. OXYTOCICS AND ANTIOXYTOC1CS
mehyl ergometrine
557
mifepristone_____
558
misoprostol______
559
terbutaline sulphate
560
betamethasone
561
mehyl ergometrine
562
oxytocin________
563
oxytocin________
564
terbutaline sulphate
565
Section 23. PERITONEAL DIALYSIS SOLUTION
intraperitoneal dialysis solution
566
0.125mg
200mg
IQOmicrog
2,5mg
4mg/ml
0.2mg/ml
5IU/ml
IQIU/ml
0.5mg/ml
Description
Drops opthamological
Drops opthamological
Tablet
Tablet
Tablet
Tablet
Injection
Injection
Injection
Injection
Injection
Injection
Of
approximate
composition
Section 24. MEDICINES FOR MENTAL AND BEHAVIOURAL DISORDER
0.25mg
Tablet
alprazolam____________________
567
Tablet
0.5mg
alprazolam____________________
568
25mg
Tablet
amitriptyline__________________
569
Tablet
25mg
chlorpromazine hydrochloride
570
Tablet
50mg
chlorpromazine hydrochloride
571
IQOmg
Tablet
chlorpromazine hydrochloride
572
20mg
Capsule
fluoxetine hydrochloride . • '.
573
25mg
Tablet
imipramine_____________
574
75mg
Tablet
imipramine________ •. • •
575
300mg
Tablet
lithium carbonate____ •. , ' • .
576
Tablet
5mg
olanzapine______________ •
577
Tablet
IQmg
olanzapine____________________
578
200mg
Tablet
sodium valproate_______________
579
Tablet
500mg
sodium valproate
______ •
580
Injection
25mg/ml
chlorpromazine hydrochloride,
581
Injection
5mg/ml
haloperidol___________________
582
25mg/5ml
Syrup
chlorpromazine hydrochloride
583
Section 25. MEDICINES ACTING ON THE RESPIRATORY TRACT
IQmg______
Tablet
codeine phosphate____________
584
30mg______
Tablet
dextromethorphan____________
585
2mg_______
Tablet
salbutamol sulphate___________
586
4mg_______
Tablet
salbutamol sulphate___________
587
200mg_____
Injection
hydrocortisone sodium succinate
588
Injection
400mg_____
hydrocortisone sodium succinate
589
Inhalation
50microg/dos
beclomethasone dipropionate
590
e__________
Inhalation
250microg
beclomethasone dipropionate
591
20microg/met Inhalation
ipratropium bromide
592
ered dose
1 OOmicrog/do Inhalation
593
salbutamol sulphate
se_________
15mg/5ml
Syrup
594
codeine phosphate
2mg/5m!
Syrup
salbutamol sulphate
595
Section 26. SOLUTIONS CORRECTING WATER, ELECTROLYTE AND ACID-BASE
DISTURBANCES
______________________________________
Injection
0.1______
596
glucose
Injection
0.15
glucose
597
Injection
5% isotonic
glucose
598
110
S.No.
_____________ Molecular Description
glucose with sodium chloride______
N/2 saline______________________
N/5 saline______________________
normal saline___________________
potassium chloride_______________
ringer lactate____________________
sodium bicarbonate______________
water for injection_______________
water for injection_______________
water for injection
Section 27. VITAMINS AND MINERALS
ascorbic acid_____________________________
609
ascorbic acid_____________________________
610
calcium carbonate________________________
611
calcium carbonate________________________
612
nicotinamide_____________________________
613
riboflavin_______________________________
614
thiamine________________________________
615
vitamin A_____________________________ __
616
vitamin A________________________________
617
vitamin A_______________________________
618
vitamin D (ergocalciferol)__________________
619
vitamin D (ergocalciferol)_____________•'
620
multivitamins (as per Schedule V of Drugsand
621
Cosmetics Rules)__________________;______4
•• • •
vitamin A
622
599
600
601
602
603
604
605
606
607
608
111
Strength
5%+0.9%
0.009
11.2 sol
as per IP
as per IP
10ml
2m 1____
5m 1
Description
Injection_____
Injection_____
Injection_____
Injection_____
Injection_____
Injection_____
Injection_____
Injection_____
Injection_____
Injection
IQOmg
500mg
250mg
500mg
50mg
5mg
IQOmg
100,000IU
50,0001U
5000IU
0.25mg
I mg
Tablet
50,000lU/ml
Injection
Tablet
Tablet
Tablet
Tablet
Tablet
Tablet
Capsule
Capsule
Tablet
Capsule
Capsule
Tablet
Appendix 2 a).
Formulations for which data is not available through IMS Health
S.No.
Description
Name of the medicine
Strength
Reason
1. ANAESTHETICS
1
morphine sulphate
lOmg
Tablet
2
lignocaine hydrochloride
+ adrenaline
1.0%
Injection
3
morphine sulphate
lOmg/ml
Injection
4
atropine sulphate
Img/ml
Injection
no IMS data (only FDCs
available)_______________
no IMS data for specific dose
5
ether
Inhalation
no IMS data
6
nitrous oxide
Inhalation
no IMS data
7
oxygen
Inhalation
no IMS data
no IMS data as single
ingredient____________
hard to determine relevant
products
~2. ANALGESICS, ANTIPYRETICS, NON-STEROIDAL ANTI-INFLAMMATORY
MEDICINES (NSAlMs),
8
hydroxychloroquine
phosphate
200mg
Tablet
no IMS data (only sulphate salt
is available)
9
ibuprofen
100mg/5ml
Syrup
no IMS data for syrups (susp
available, same strength)
10
tramadol
lOOmg
Capsule
no IMS’data for capsules
3. ANTIALLERGICS AND MEDICINES USED IN ANAPHYLAXIS
11
cetrizine
5mg/ml
Syrup
• no IMS data fro specific dose
(only 5rrig/5ml available)
12
prednisolone
25mg
Injection
no IMS data for specific dose
4. ANTIDOTES AND OTHER SUBSTANCES USED IN POISONINGS
13
penicillamine
250mg
Tablet
no IMS data for tablets
14
desferrioxamine mesylate
500mg
Injection
no IMS data
15
flumazenil
O.lmg/ml
Injection
no IMS data
16
methylthioninium chloride
(methylene blue)
lOmg/ml
Injection
no IMS data
17
sodium nitrite
30mg/ml
Injection
no IMS data
18
sodium thiosulphate
250mg/ml
Injection
no IMS data
19
dimercaprol
50mg/ml (in
oil)
Injection
no IMS data for specific dose
20
calcium gluconate
lOOmg/ml
Injection
no IMS data for specific dose
21
calcium gluconate
lOOmg/ml in
10ml ampoule
Injection
no IMS data for specific dose
5. ANTICONVULSANTS/ANTIEPILEPTICS
22
phenytoin sodium
50mg
Capsule
no IMS data for capsules
23
phenytoin sodium
25mg/ml
Syrup
no IMS data for syrups
24
magnesium sulphate
500mg/ml
Injection
no IMS data for specific dose
200mg
Capsule
no IMS data for capsules
6Ta NTI-INFECTIVE MEDICINES
25
nevirapine (NVP)
112
S.No.
Name of the medicine
Strength
Description
Reason
26
griseofulvin
125mg
Capsule
no IMS data for capsules
27
28
griseofulvin
250mg
Capsule
no IMS data for capsules
pyrimethamine
25mg
Tablet
29
30
31
32
33
34
diloxanide furoate
500mg
Tablet
no IMS data for single
ingredient_______________
no IMS data for specific dose
indinavir (IDV)
200mg
Tablet
no IMS data for specific dose
indinavir (IDV)
400mg
Tablet
no IMS data for tablets
isoniazid
50mg
Tablet
no IMS data for specific dose
rifampicin
50mg
Tablet
no IMS data for specific dose
didanosine (ddl)
400mg
Tablet
no IMS data for tablets
35
36
37
38
39
40
41
zidovudine (ZDV or AZT)
lOOmg
Tablet
no IMS data for tablets
clindamycin
150mg
Tablet
no IMS data for tablets
saquinavir (SQV)
200mg
Capsule
no IMS data for specific dose
stavudine (d4T)
15mg
Capsule
no IMS data for specific dose
rifampicin
50mg
Capsule
no IMS data for specific dose
piperazine
4.5gm
Tablet
no IMS data for tablets
praziquantel
600mg
Tablet
no IMS data for tablets
42
43
44
45
46
47
cloxacillin
125mg/5ml
Liquid
no IMS data for liquids
isoniazid
100mg/5ml
Syrup
no IMS data for syrup
ritonavir
400mg/5ml
Syrup
no IMS data for syrups
metronidazole
100mg/5ml
Syrup
no IMS data for syrups .
pentamidine isothionate
200mg
Injection
no IMS data
Injection
no IMS data for specific dose
Injection
no IMS data for specific dose
100,000 IU
Pessaries
no IMS data for specific dose
300mg
Tablet
no IMS data for specific dose
48
49
200mg/ 100ml
ciprofloxacin
hydrochloride___________
sodium stibogluconate
1 OOmg/ml
nystatin
7. ANTIMIGRAINE MEDICINES
50
acetylsalicylic acid
8. ANTINEOPLASTIC, IMMUNOSUPPRESSIVES AND MEDICINES USED IN PALLIATIVE
CARE
no IMS data for specific dose
Tablet
200mg
cyclophosphamide
51
no IMS data for specific dose
Syrup
2mg/ml
ondansetron
52
53
mercaptopurine
1 OOmg/ml
Injection
no IMS data
54
ifosfamide
lgm/2ml vial
Injection
no IMS data for specific dose
55
L-asparaginase
5000KU
Injection
no IMS data fro specific dose
10. MEDICINES AFFECTING THE BLOOD
56
ferrous sulphate/fumrate
25mg
elemental iron
(as
sulphate)/ml
Oral
Solution
no IMS data for oral solution
57
cyanocobalamin
Img/ml
Injection
no IMS data for specific dose
IL BLOOD PRODUCTS AND PLASMA SUBSTITUTES
58
Injection
cryoprecipitate
113
no IMS data
S.No.
Name ofthe medicine
Strength
Description
Reason
60
Factor IX complex
(coagulation factors II,VII,
IX, X)________________
fresh frozen plasma
61
platelet rich plasma
62
6.0%
Injection
63
hydroxyethyl starch
(hetastarch)___________
polygeline
3.5%
Injection
64
dextran-40
10.0%
Injection
no IMS data (only FDCs
available)____________
no IMS data (only FDCs
available)____________
no IMS data for injection
65
dextran-70
6.0%
Injection
no IMS data for injection
59
Dried
Injection
no IMS data
Injection
no IMS data
Injection
no IMS data
12. CARDIOVASCULAR MEDICINES
66
hydrochlorthiazide
50mg
Tablet
no IMS data for specific dose
67
nifedipine
20mg
SR cap
no IMS data for specific dose
68
procainamide
hydrochloride
digoxin
250mg
Tablet
no IMS data for tablets
0.05mg/ml
Elixir
no IMS data for elixirs
lOOmg/ml
Injection
no IMS data
71
procainamide
hydrochloride
digoxin
0.25mg/ml
Injection
no IMS data for relevant dose
72
dobutamine
50mg/ml
Injection
no IMS data for specific dose
69
70
13. DERMATOLOGICAL MEDICINES (topical)
73
benzyl benzoate
25.0%
Lotion
no IMS data
74
methylrosanilinium
chloride (gentian violet)
0.5%
Aqueous
solution
no IMS data
75
glycerin
Solution
no IMS data
76
dithranol
Ointment
77
zinc oxide
Dusting
Powder
no IMS data (only FDCs
available)___________
no IMS data for dusting
powder
78
coal tar
5.0%
Solution
no IMS data for solution
79
salicylic acid
5.0%
Solution
no IMS data for solution
80
framycetin sulphate
0.5%
Cream
no IMS data for specific dose
81
neomycin + bacitracin
5mg+500IU/g
Ointment
82
miconazole
1.0%
Drops opthamolog
ical
no IMS data for this
combination_____________
no IMS data for eye drops
83
povidone iodine
0.6%
Drops opthamolog
ical
no IMS data for eye drops
0.1-2%
14. DIAGNOSTIC AGENTS
84
iopanoic acid
500mg
Tablet
85
barium sulphate
100%w/v
Suspension
no IMS data (radiocontrast
media)_______________
no IMS data
86
barium sulphate
250%w/v
Suspension
no IMS data
87
calcium ipodate
3g
Injection
no IMS data
114
S.No.
Name of the medicine
Strength
Description
Reason
88
sodium iothalamate
70%w/v
(iodine=420m
g/ml)
Injection
no IMS data
89
sodium meglumine
diatrizoate
60%w/v
(iodine
conc.=292mg/
ml)
Injection
no IMS data
90
sodium meglumine
diatrizoate
76%w/v
(iodine
conc.=370mg/
ml)
Injection
no IMS data
91
meglumine iotroxate
5-8 iodine in
I00-250ml
Solution for
Injection
no IMS data
92
propyliodone
500-600mg/ml
no IMS data
93
fluorescein
1.0%
Injection,
Oily
Suspension
Eye drops
94
lignocaine
4.0%
Eye drops
no IMS data for eye drops
no IMS data for eye drops
15. DISINFECTANTS AND ANTISEPTICS
95
gentian violet
0.5%
Paint
no IMS data
96
gentian violet
1.0%
Paint
no IMS data
97
benzoin compound
Tincture
no IMS data
98
acriflavin+glycerin
Solution
no IMS data
99
ethyl alcohol 70%
Solution
no IMS data
100
hydrogen peroxide
6.0%
Solution
no IMS data for solution
101
chlorhexidine
5% (cone. For
dilution)
Solution
no IMS data for specific dose
102
potassium permanganate
no IMS data (non-human use)
103
bleaching powder
Contains not
less than
30%w/v of
available
chlorine (as
per I.P)
Crystals for
solution
(nonhuman use)
Powder
(nonhuman use)
104
formaldehyde solution
Dilute 34ml of
formaldehyde
solution with
water to
produce 100ml
(as per I.P)
Solution
(nonhuman use)
no IMS data (non-human use)
115
no IMS data (non-human use)
S.No.
105 ”
Strength
Name of the medicine
glutaraldehyde
2%
Description
Reason
Solution
(nonhuman use)
no IMS data (non-human use)
Tablet
no IMS data for specific dose
Tablet
no IMS data for tablets
17. GASTROINTESTINAL MEDICINES
l06
107
dicyclomine
hydrochloride_______
aluminium hydroxide
magnesium hydroxide
lOmg
18. HORMONES, OTHER ENDOCRINE MEDICINES AND CONTRACEPTIVES
no IMS data for specific dose
Tablet
O.O35mg+l.O
ethinylestradiol +
108
mg
norethisterone
109
hormone releasing IUD
TTo
condoms
no IMS data
IUD
no IMS data
19. IMMUNOLOGICALS
TiT
TTI
diphtheria antitoxin
113
tuberculin, purified
protein derivative (PPD)
tuberculin, purified
protein derivative (PPD)
10,000IU
Injection
cannot determine dose
Tru
Injection
no IMS data
STU
Injection
no IMS data
no IMS data for specific dose
Injection
ISOIU/ml
rabies immunoglobulin
____________ ______________
_________________
114
20. MUSCLE RELAXANTS (PERIPHERALLY-ACTING)AND CHOLINESTERASE
INHIBITORS
pyridostigmine
115
Img/ml
Injection
no IMS data fo injection
no IMS data (only FDCs
available) ___________
no IMS data for single
ingredient
21. OPTHALMOLOGICAL PREPARATIONS
716
methyl cellulose
2.0%
Injection
117
tetracaine hydrochloride
0.5%
Drops opthamolog
ical
118
chloramphenicol
0.4%
Ointment opthamolog
ical
no IMS data for specific dose
119
chloramphenicol
0.4%
Drops opthamolog
ical
no IMS data for specific dose
120
chloramphenicol
1.0%
Drops opthamolog
ical
no IMS data for specific dose
121
phenylephrine
5.0%
Drops opthamolog
ical
no IMS data for specific dose
122
prednisolone acetate
0.1%
Drops opthamolog
ical
no IMS data for specific dose
24. MEDICINES FOR MENTAL AND BEHAVIOURAL DISORDER
"123
[ 25mg/5ml
Syrup______ no IMS data for syrups
| chlorpromazine
116
S.No.
Name of the medicine
Strength
Description
Reason
hydrochloride
chlorpromazine
25mg/ml
Injection
hydrochloride________
25. MEDICINES ACTING ON THE RESPIRATORY TRACT
no IMS data for specific dose
125
codeine phosphate
1 Omg
Tablet
no IMS data for tablets
126
dextromethorphan
30mg
Tablet
no IMS data for tablets
124
26. SOLUTIONS CORRECTING WATER, ELECTROLYTE AND ACID-BASE
DISTURBANCES
N/2 saline
no IMS data
Injection
127
128
ringer lactate
as per IP
Injection
no IMS data
129
glucose
15.0%
Injection
no IMS data for specific dose
130
potassium chloride
11.2 sol
Injection
no IMS data for specific dose
131
water for injection
2ml
Injection
no IMS data for specific dose
132
N/5 saline
Injection
no IMS data
133
normal saline
Injection
no IMS data
Tablet
hard to determine relevant
products
0.9%
27. VITAMINS AND MINERALS
135
multivitamins (as per
Schedule V of Drugs and
Cosmetics Rules)_______
vitamin D (ergocalciferol)
0.25mg
Capsule
no IMS data as ergocalciferol
136
nicotinamide
50mg
Tablet
137
riboflavin
5mg
Tablet
no IMS data as single
ingredient_______________
no IMS data for specific dose
138
vitamin A
100,000IU
Capsule
no IMS data for specific dose
139
vitamin A
5000IU
Tablet
no IMS data for specific dose
140
vitamin D (ergocalciferol)
Img
Capsule
no IMS data for tablet
134
117
Appendix 2 b).
Formulations with no sales recorded in the IMS Health databse
S.
NLEM
NLEM .section name
name of
No section
formulation
number
descrip
tion
strength
1
1
ANAESTHETICS
diazepam
Syrup
2mg/5ml
2
6
nystatin
Tablet
500,000 IU
3
6
sulphadiazine
Tablet
500mg
4
7
acetylsalicylic acid
Tablet
5
8
busulphan
Tablet
350mg, 350
soluble/dispersible
2mg
6
8
folinic acid
Injectio
n
3mg/ml
7
10
pyridoxine
Tablet
lOmg
8
12
urokinase
12
nifedipine
Injectio
n_____
SR cap
10,00,000 lU/ml
9
lOmg
10
17
zinc sulfate
Syrup
20mg/5ml
12
25
ANTI-INFECTIVE
MEDICINES_____________
ANTI-INFECTIVE
MEDICINES_____________
ANTIMIGRAINE
MEDICINES_____________
ANTINEOPLASTIC,
IMMUNOSUPPRESSIVES
AND MEDICINES USED IN
PALLIATIVE CARE_______
ANTINEOPLASTIC,
IMMUNOSUPPRESSIVES
AND MEDICINES USED IN
PALLIATIVE CARE_______
MEDICINES AFFECTING
THE BLOOD_____________
CARDIOVASCULAR
MEDICINES_____________
CARDIOVASCULAR
MEDICINES_____________
GASTROINTESTINAL
MEDICINES_____________
MEDICINES ACTING ON
THE RESPIRATORY
TRACT
beclomethasone
di propionate
Inhalati
on
50microg/dose
118
Appendix 3. Discrepancies arising from differences in use of market based data
NPPA reported number of
Unit
Name ofFormulation
5. No.
packs
_____________ Formulations identified as monopolies by authors
ml___
Halothane with vaporizer Inhalation —_____
1
tablet
4
Phenobarbitone Tablets 60 mg___________
2
ml___
Quinine sulphate Injection 300 mg / ml_____
3
2
tablet
Phenobarbitone Tablets 30 mg___________
4
2
capsule
Phenytoin Sodium Capsules IQOmg________
5
2
tablet
Bisacodyl Tablets 5 mg_________________
6
2
2
Methotrexate Injection 50 mg/ml_________
7
ml___
ml
Cetrimide Solution 20% (cone, for diluti
8
2
tablet
Pyrazinamide Tab 1500mg______________
9
2
3
ml
Sevoflurane Inhalation_________________
10
2
Lignocaine Hydrochloride +Adr, 2%
ml
11
+Adrenaline 1:200,000_________________
tablet
12
Allopurinol tablets 100 mg______________
ml_____
7
Pilocarpine drops 2%__________________
13
ml_____
Sodium Bicarbonate Injection___________
14
2_
Ampoule
Water for Injection 5 ml________________
15
Ampoule
3_
Water for Injection 10 ml_______________
16
tablet
6_
Calcium Carbonate tablets 250 mg________
17
tablet
2
Clindamycin Tablet - 300mg_____________
18
ml_____
2_
Cyclosporine concentrate for Inj - 100 mg/ml
19
tablet
2_
Melphalan Tablet - 2 mg________________
20
tablet
2
Melphalan Tablet - 5 mg________________
21
tablet
22
Mercaptopurine - 50 mg________________
capsule
23
Procarbazine capsule - 50 mg____________
pack
Vinblastine Sulphate Inj - IQmg/pack______
24
pack
Daunorubicin Inj - 20 mg vial/pack________
25
tablet
Chlorambucil tablet - 2mg______________
26
2
pack
Factor VIII Concentrate Dried____________
27
2
capsule
Omeprazole Capsules 40 mg_____________
28
2
tablet
Hyoscine Butyl Bromide tab- IQmg_______
29
2
ml_____
Sulphacetamide Sodium Drops -10%______
30
2
pack
31
Mitomycin-C Inj - 10 mg_______________
2
6
Succinyl Choline Chloride Injection 500mg
32
Zl 0ml______________________________ _
3
tablet
Nifedipine Sustained release tablets IQmg
33
Formulations for which no data is available through IMS Health for the specific molecule, dose,
or form; formulations for which relevant products could not be determined_
2_______
capsule
34
Indinavir Capsules 400 mg______________
14______
ml_______
Ringer Lactate Injection________________
35
6_______
ml_______
Dextran-40 Inj - 10%___________________
36
condom
102
37
Condoms_____________________________
pack_____
monopoly
Desferrioxamine mesylate Inj - 500mg_____
38
monopoly
Praziquantel tablet - 600 mg_____________
tablet_____
39
monopoly
ml_______
40
Isoniazid Syrup - 100 mg/5ml____________
monopoly
Hydroxyethyl Starch (Hetastarch) Inj - 6%
ml_______
41
ml_______
8 _______
42
Glycerin solution______________________
ml_______
23______
43
Benzyl Benzoate lotion 25%_____________
5_______
ml
44
Benzoin Compound tincture_____________
monopoly
Potassium Permanganate crystals for solution
45
gm
cubic metre
9 _______
46
Nitrous Oxide_________________________
cubic metre
Oxygen Inhalation_____________________
9_______
47
monopoly
48
Ethyl Alcohol 70% (Gel Base)___________
ml_______
monopoly
ml_______
49
Gentian Violet Paint 1%________________
ml
50
Hydrogen Peroxide Solution 6%
monopoly
J
119
S. No.
51
52
53
54
55
56
57
58
59
60
61
62
63
64
65
66
67
68
69
70
71
72
Name ofFormulation
Unit
NPPA reported number of
packs
6_______
2_______
4 _______
11______
monopoly
5 _______
20______
2 _______
3 _______
2_______
2_______
2 _______
monopoly
monopoly
3 _______
monopoly
monopoly
Gluteraldehyde 2%____________________
ml_____
Morphine Sulphate Injection 10__________
ml_____
Morphine Sulphate tablets 10 mg___________
tablet
Hydroxychloroquine phosphate Tablets 200 mg
tablet
Digoxin Inj - 0.25 mg/ml__________________
ml_____
Dobutamine Injection 50 mg / ml___________
pack
Cetrizine Syrup 5 mg / ml_______________
ml_____
Calcium Gluconate IQOmg in 10ml Ampoule_
Ampoule
Magnesium sulphate Inj - 500 mg /ml________
ml_____
L- Asparaginase Inj - 5000 KU./pack________
pack
Rabies immunoglobin Inj- 150 1U___________
ml_____
Chloramphenicol Drops - 1%______________
ml_____
Diloxanide Furoate Tablet - 500 mg_____ ; __
tablet
Sodium Stibogluconate Inj - 100 mg/ml_______ ml_____
Ifosfamide Inj - 1 gm / 2m Vial_____________
pack
Phenytoin Sodium syrup 100 mg____________ ml_____
Beclomethasone Dipropionate______________ inhaler
Diphtheria Antitoxin Inj - 10,000 HJ/pack
pack
2_____
Lignocaine Hydrochloride + Adrenaline
pack
3
Injection 1%+1:200,000/pack______________
Busulphan Tablet - 2 mg__________________
tablet
monopoly
Sustained release forms not considered as separate formulations as per the NLEM
Metoprolol Tablets 25 mg-SR/CR/XR
tablet
32
tablet
Metoprolol Tablets 50 mg-SR/CR/XR
43
120
- Media
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