IN COLLABORATION WITH GOVERNMENT OF INDIA GOVERNMENT OF KARNATAKA & UNITED NATIONS POPULATION FUND (UNFPA)

Item

Title
IN COLLABORATION WITH GOVERNMENT OF INDIA
GOVERNMENT OF KARNATAKA & UNITED NATIONS
POPULATION FUND (UNFPA)
extracted text
IN COLLABORATION WITH GOVERNMENT OF INDIA
GOVERNMENT OF KARNATAKA & UNITED NATIONS
POPULATION FUND (UNFPA)

SOUTHERN STATES’ WORKSHOP
WITH APPROPRIATE AUTHORITIES

ON
PNDT ACT 1994

ON 20-04-2002
AT

HOTEL CAPITOL, BANGALORE

(COOR

TUT'

Regional Workshop of Appropriate Authorities appointed at Karnataka,
Kerala, Tamil Nadu and Pondicherry under the PNDT Act
at Bangalore - in collaboration with UNFPA
(20th April, 2002)

Background Note

*>

In order to check female foeticide, the Pre-natal Diagnostic Techniques
(Regulation and Prevention of Misuse) Act, 1994, was enacted and brought into operation
from 1st January, 1996. Rules have also been framed under the Act. The Act prohibits
determination and disclosure of the sex of the foetus. It also prohibits any advertisements
relating to pre-natal determination of sex and prescribes punishments for its
contravention. A person who contravenes the provisions of this act is punishable with
imprisonment upto five years and fine upto Rs. 50,000.

Under the Act, pre-natal diagnostic techniques and genetic counseling may be
provided only by facilities/clinic registered under the Act. Use of these techniques is
permissible solely for the detection of specified abnormalities subject to specified
conditions.
Under the Act, the Central Government shall appoint one or more Appropriate
Authorities for each of the UTs and State Government shall appoint one or more
Appropriate Authorities for whole or part of State. The Appropriate Authorities are the
instruments for the implementation of the Act. As the implementation of the Act was not
satisfactory in various States/UTs, a PIL was filed by CEHAT and Ors. and the Hon’ble
Supreme Court gave directions in its order dated 4-5-2001 to Central and State
Governments for effective implementation of the Act by appointing Appropriate
Authorities at district and sub-district levels also in all the States and U fs. Some of the
directions of the Supreme Court to the Appropriate Authorities are as under:-

> To take prompt action against any person or body who issues or causes to be
issued any advertisement in violation of section 22 of the Act.
> To take prompt action against all Genetic Counseling Centres, Genetic
Laboratories and Genetic Clinics as also against persons who aie operating
without a valid certificate of registration under the Act.
> To furnish quarterly returns to the CSB giving a report on the implementation and
working odhe Act. .These returns should inter-alia contain specified information
about:

1

1. Survey of Genetic Counseling Centres, Genetic Laboratories and Genetic
Clinics
2. Registration of Genetic Counseling Centers, Genetic Laboratories and Genetic
clinics including bodies using ultra-sound machines.

3. Action taken against non-registered bodies operating in violation of section 3
of the Act, inclusive of search and seizure of records.
4. Complaint received by the Appropriate Authorities under the Act and action
taken pursuant thereto.
5. Number and nature of awareness campaigns conducted and results flowing
there from.

Immediately after the Court’s directions, a meeting of the Appropriate Authorities
appointed in States/UTs including the Appropriate Authorities appointed at district and
sub-district level was held on 30-6-2001 to review and monitor the implementation of the
Act at grassroots level. The meeting was well represented from all States/UTs except
from South States. Since the Appropriate Authorities who are generally the District
Health Officers have been made responsible to implement the Act in the districts and sub­
district level it has become essential to sensitize them about the seriousness of the actions
to be taken as per the provisions of the PNDT Act and Rules made there under. The
Government of India in collaboration with the UNFPA decided to hold regional
workshops. The workshop, which is scheduled to be held in Bangalore on 20-4-2002,
will be the first regional workshop, wherein Appropriate Authorities at State and district
levels form the States/UTs of Karnataka, Kerala, Tamil Nadu, and Pondicherry will be
participating.
Though the sex ratio among the child population in the age group 0-6 years in
these States/UT is more than All India level, both in 1991 and 2001 Census but there is
decline in child sex ratio in 2001 Census as compared to 1991 Census except Kerala.
Unless the corrective measures are taken by the State Governments child sex ratio may
decline further. Therefore, there is need to strengthen the Act by holding regular
workshops, meetings, seminars to mount effective awareness campaign about the Act.

Latest position on the implementation of the Act, according to the
quarterly progress reports received and affidavits filed in the Court is
as under:Karnataka

Appropriate Authorities and Advisory Committees have been set up only at
district level.
> 1090 Centres have been given registration.
> Appropriate Authorities have sealed and seized five equipments.
> Five cases have been filed in the Court under the violation of the PNDT Act.
>

Kerala
> Quarterly Reports received from Government of Kerala are never received in

time.
Appropriate Authorities and Advisory Committees have been set up both at
district and sub- district levels.
> Out of 562 centers surveyed, 496 Centres have been given registration.
> No violation of the provisions of the PNDT Act has been reported from Kerala.
>

Tamil Nadu
>
>
>
>
>

Appropriate Authorities and Advisory Committees have been set up both at
district and sub-district levels.
Survey of 1631 Genetic Counseling Centres, Genetic Laboratories and Genetic
Clinics has been conducted.
Out of 1631 Centres 1625 have been given registration.
Appropriate Authorities have sealed and seized 51 scan equipments.
There were 5 cases of suspension/cancellation of registration after conducting
raids. These five cases are filed in the Judicial Magistrate Court, Chennai.
Pondicherry

Appropriate Authorities and Advisory Committees have been set up both at
district and sub- district levels.
> There are 29 registered Clinics using ultrasound machines in the UT of
Pondicherry.
> No violation of the provisions of the PNDT Act has been reported from the UT of
Pondicherry.
>

Actions need urgent attention of the Appropriate Authorities:
> Survey of all bodies using ultrasound machines has to be completed, immediately.
> Ultrasound machines/imaging machines using by unregistered centers are to be
sealed and seized.

>
>
>

>
>
>

>

Intervening period between meetings of Advisory Committee should not exceed
60 days.
Quarterly Reports regarding the implementation of the Act to be submitted to the
Department of Family Welfare, regularly, by 15th of the preceding month.
Details given in the reports submitted by the States/UTs do not indicate whether
the figures are up to the quarter or for the particular quarter only. To avoid
confusion the report must indicate both the figures i.e. up to the quarter and
during the quarter. Revised format has already been sent to the States/UTs.
The consolidated report of the State/UT should indicate whether the details given
in the report include details from all districts.
Details of the Court cases, if any, should be attached to the Quarterly Reports.
The report received from the States/UTs normally give total figures of registered
facilities, fresh application received and fresh registration granted, but does not
give break up of Genetic Councilljientres, Genetic Clinics, Genetic Laboratories,
combination thereof, and bodies using ultrasound machines. They should give­
category wise break-up.
The Appropriate Authorities may comply with all directions of the Supreme
Court.

REVISED FORMAT

QUARTERLY REPORT ON IMPLEMENTATION AND WORKING OF
THE PRE-NATAL DIAGNOSTIC TECHNIQUES (REGULATION AND
PREVENTION OF MISUSE) ACT, 1994

Report for the quarter ended on 31.12.2001
Name of the State/Union Territory
1.

j.

i

i
i

I

4.

■i

Number of registered facilities existing in the State/UT

(a) Genetic Counselling Centres
(b) Genetic Laboratories
(c) Genetic Clinics
(d) Jointly as Genetic Counselling Centre/Genetic
Laboratory/Genetic Clinic or any combination thereof
(e) Any other Body/person using Ultrasound Machine
Of the number shown in item (1) above, number of
Government facilities in the State/UT (including Central
Government of India/State Govt./UT Admin./Zila
Parishad/Municipal):
(a) Genetic Counselling Centres
(b) Genetic Laboratories
(c) Genetic Clinics
(d) Jointly as Genetic Counselling Centre/Genetic
Laboratory/Genetic Clinic or any combination thereof
(e) Any other Body/person using Ultrasound Machine
Number of fresh applications received for registration as:
(From public as well as public sectors)
; (a) Genetic Counselling Centres
i (b) Genetic Laboratories
i (c) Genetic Clinics
(d) Jointly as Genetic Counselling Centre/Genetic
Laboratory/Genetic Clinic or any combination thereof
(e) Any other Body/person using Ultrasound Machine
Number of fresh registrations granted as:
(a) Genetic Counselling Centres
, (b) Genetic Laboratories
i (c) Genetic Clinics
(d) Jointly as Genetic Counselling Centre/Genetic
Laboratory/Genetic Clinic or any combination thereof
(e) Any other Body/person using Ultrasound Machine

During
the
quarter
ending
31.12.01

Total up
to
31.12.01

w
■ x ■

5.

Number of application for registration rejected, in respect
of:
(a) Genetic Counselling Centres
(b) Genetic Laboratories
(c) Genetic Clinics
(d) Jointly as Genetic Counselling Centre/Genetic
Laboratory/Genetic Clinic or any combination thereof
(e) Any other Body/person using Ultrasound Machine

6.

Number of renewals of registration in respect of:
(a) Genetic Counselling Centres
(b) Genetic Laboratories
(c) Genetic Clinics
(d) Jointly as Genetic Counselling Centre/Genetic
Laboratory/Genetic Clinic or any combination thereof
Any other Body/person using Ultrasound Machine_______
Number of premises inspected by the Appropriate
Authorities or person authorized by the Appropriate
Authorities during the quarter in respect of:
(a) Genetic Counselling Centres
(b) Genetic Laboratories
(c) Genetic Clinics
(d) Jointly as Genetic Counselling Centre/Genetic
Laboratory/Genetic Clinic or any combination thereof
Any other Body/person using Ultrasound Machine_______
Number of suspensions or cancellations of registrations
under section 20 of the Pre-natal Diagnostic Techniques
(Regulation and Prevention of Misuse) Act, 1994 in the
State/UT in respect of:
(a) Genetic Counselling Centres
(b) Genetic Laboratories

7.

I

nr

(c) Genetic Clinics

(d) Jointly as Genetic Counselling Centre/Genetic
Laboratory/Genetic Clinic or any combination thereofI (e) Any other Body/person using Ultrasound Machine
(Please give details on a separate sheet)__________ ____
Action to create public awareness against the practice of
pre-natal determination of sex and female foeticide
through:
(a) Print Media.
(b) Electronic Media.
(c) Hoarding.
i
(d) Other appropriate means.
| (Please give details on separate sheet)

10

11

12

13

r

14

15

16.

(a) Action taken to ensure that the intervening period
between.meetings of Advisory Committees does
not exceed 60 days.
(b) Dates of the meetings of the Advisory Committees
held after 4.5.2001.

(Please give details on separate sheet)
________
Action taken to appoint Appropriate Authorities and
Advisory Committees at district and sub-district levels.
(Please give details on separate sheet including
appointment Of such persons on Advisory Committees
who can devote some time)_________________________
Action taken to publish list of Appropriate Authorities
through:
(a) Print Media
(b) Electronic Media
(c) Hoardings
(d) Any other appropriate means
(Please give details on separate sheet)
_______
Action taken against any person or body who issued or
caused to be issued any advertisement in violation of
section 22 of the Act.___________________________
Action taken against all bodies specified in section 3 of
the Act i.e. Genetic Counseling Centres, Genetic
Laboratories. Genetic Clinics (including bodies using
ultrasound machines), as also against the person who are
operating without a valid certificate of registration under
the Act._________________________________________
Information/Report on survey of bodies specified in
Section 3 of the Pre-natal Diagnostic Techniques
(Regulation and Prevention of Misuse) Act. 1994 i.e.
Genetic Counseling Centres. Genetic Laboratories,
Genetic Clinics (including bodies using ultrasound_
machines).
(Please give details on separate sheet)_______________ _
Action taken against non-registered bodies operating in
violation of Section 3 of the Pre-natal Diagnostic
Techniques (Regulation and Prevention of Misuse) Act.
1994 i.e. Genetic Counseling Centres. Genetic
Laboratories. Genetic Clinics (including bodies using
ultrasound machines) inclusive of search and seizure of
records.
(Please give details on separate sheet)

/

!18

I
i 19
i

Number of complaints received by the Appropriate
Authorities under the Act and action taken pursuant
thereto.
(Please give details on separate sheet)
Number and nature of the awareness campaigns
conducted and results flowing therefrom.
(Please give details including details of advertisements/
posters/ handbills etc, on separate sheet)-----------------Number of complaints filed in the court in the State/UT
under the Pre-natal Diagnostic Techniques (Regulation
and Prevention of Misuse) Act. 1994 (by Appropriate

Authorities or by others).
(please give details on separate sheet)

__________ .

Certified that all bodies/persons using ultra-sound machines capable of
detecting sex of foetus in my area of jurisdiction have been registere
under the Pre-Natal Diagnostic Techniques (Regulation and Prevention ot
Misuse) Act. 1994 and prosecution has been launched against those who
have not got themselves registered.
(Signature)
Name and Designation
(On behalf of State Government/U.T. Administration)

Date:
Place
N.B.

1. All bodies/persons using ultra-sound machines capable of detecting sex
of foetus are to be registered under the Pre-Natal Diagnostic Techniques
(Regulation and Prevention of Misuse) Act, 1994 in terms of section o
read with sub-sections (i) and J) of section 2 thereof irrespective of
whether they are actually determining sex of foetus or not. If any such
body/person operates without registration, he/she/it is punishable under
section 23 of the Act. Case against such body/person should be filed m
Court under section 28 of the Act.

The Appropriate Authority should certify that all bodies/persons using
ultra-sound machines capable of detecting sex of foetus in his area ot
jurisdiction have been registered under the Pre-Natal Diagnostic
Techniques (Regulation and Prevention of Misuse) Act. 1994 and
prosecution has been launched against those who have not got themselves
registered.

Regional Workshop of Appropriate Authorities appointed at Karnataka,
Kerala, Tamil Nadu and Pondicherry under the PNDT Act
at Bangalore - in collaboration with UNFPA
(20* April, 2002)

Brief background on sex ratio:

The provisional figures of Census 2001 have revealed that sex ratio in the country has
improved in the last decade. The national figures of 927 females per 1000 males in the
Census 1991 has moved to 933 in 2001. In contrast the child sex ratio for the age group
of 0-6 years in 2001 is 927 girls per thousand boys against 945 recorded in 1991 Census.
The encouraging trend in the sex ratio during 1991-2001 was marred by the decline of 18
points in the sex ratio of children below the age of 6 years.
The Census 2001, further reveals that the situation is worse in respect of child population
in the age group 0-6, particularly in the affluent regions of Punjab (793), Haryana (820),
Chandigarh (845), Delhi (865), Gujarat (878) and Himachal Pradesh (897). State/UT
wise position of sex-ratio is shown in Annexure.
Sex Ratio of Child Population by Districts:

The distribution of all the 591 districts in India on the basis of sex ratio of the child
population according to 2001 Census is given below:
Range

Number of
Districts
______ 16
33
72
213
245
12

Less than 800
800-849
850-899
900-949
950-999
1000-1049

Percentage

3
6

12
36
41
2

In 16 out of 591 districts, 10 from Punjab, 5 from Haryana and 1 from Gujarat, less than
800 girls below age six were reported for every 1000 boys of that age. The lowest girlsboys ratio of 754 was recorded in Fatehgarh Sahib district of Punjab followed by
770 in Patiala district of Punjab and Kurukshetra district of Haryana.
In 33 districts, the sex ratio of child population are between 800 to 849. Of these, 12
districts are from Haryana and seven districts are from Punjab, three districts each from
Gujarat and M.P., two each from HP and UP and one each from Chandigarh, Delhi and

1

Tamil Nadu and J&K. The Salem district from Tamil Nadu known for the practice of
female infanticide is a member of this group.

The largest group comprising 43% of the total districts in India i.e.257districts with
ratio of 950 or more girls to 1000 boys is represented largely by districts from Southern,
Eastern and North-Eastern States. Out of the 76 districts of 8 North Eastern States
including Assam, 62 districts have sex ratio of child population above 950. Also in 17
out of 18 districts of West Bengal the sex ratio of child population is above 950. In
States from east and south India, the sex ratios of child population age 0-6 years are not
very much different from those observed all over the world. In the States from north
and west parts of India the sex ratios are much lower than the normal levels of sex
ratio.
The table given below gives a comparison between child sex ratio (0-6 years) during
1991 and 2001. It shows that there is a sharp increase in the number of districts having
child sex ratio below 800. There was not a single district in this range in 1991 while as
per 2001 Census, 16 districts are now having less than 800 girls/1000 boys. As per 2001
Census there are as many as 48 districts where the child sex ratio is under 850, while
there was only one such district in 1991. Sharp decline in the sex ratio is also noticed in
950-999 and above 1000 categories.
Ranges of
__________ 1_991
child
No.
of Share of
Sex ratio(0-6)
Population(%)
districts*
Total_______
577
100.00
Less than 800
800-849
__ 1_
0.31
850-899
68
9.98
900-949
181
34.41
950-999
306
54.27
1000-1049
21
1.04
* Note: Total number of districts exclude J&K State

__________ 2001
Number of
Share of
Population(%)
districts*
______ 577 _______ 100.00
_______ 16 _______ 2.18
_______ 32 _________ 4.72
_______ 71 ________ 15,34
______ 208 ________ 37.59
______ 242 ________ 39,80
0.38
8

The sharp decline in sex ratio is a matter of serious concern as it is expected to lead
to serious demographic imbalances and social consequences. Several reasons are
adduced to explain the consistently low levels of sex ratio. Some of the reasons
commonly put forward are:
>
>
>
>
>
>

Son preference
Neglect of the girl child resulting in their higher mortality at younger age
Higher maternal mortality
Female infanticide
Female Foeticide
Male bias in enumeration of population.

2

The Pre-Natal Diagnostic Techniques (Regulation Prevention and Misuse) Act,
1994:

In order to check female foeticide, the Pre-natal Diagnostic Techniques (Regulation and
Prevention of Misuse) Act, 1994, was enacted and brought into operation from 1st
January, 1996. Rules have also been framed under the Act. The Act prohibits
determination and disclosure of the sex of foetus. It also prohibits any advertisements
relating to pre-natal determination of sex and prescribes punishment for its contravention.
The person who contravenes the provisions of this Act is punishable with imprisonment
upto 5 years and fine upto Rs.50,000.
Under the Act, pre-natal diagnostic techniques and genetic counseling may be provided
only by facilities/clinic registered under the Adt. Use of these techniques is permissible
solely for the detection of specified abnormalities (like Chromosomal abnormalities,
genetic metabolic diseases, sex linked genetic diseases, etc.) subject to specified
conditions.

The pre-natal diagnostic techniques like amniocentesis and sonography are useful for the
detection of genetic or chromosomal disorders or congenital malformations or sex linked
disorders, etc. However, this technology is misused on a large scale for sex
determination of the foetus and mostly if the foetus is pronounced as female, this prompts
termination of the pregnancy and brings to an end the unborn child.
Simultaneously, techniques are also being developed and refined to select the sex of the
child prior to conception. Large-scale dissemination of these technologies may, in future
precipitate a severe imbalance in the male-female ratio. It has, therefore, become
necessary to enact and implement a legislation that will ban the use of both sex selection
techniques before conception as well as the misuse of pre-natal diagnostic techniques for
sex selective abortions.
Keeping in view the directions of the Hon’ble Supreme Court’s Order dated 4th May,
2001, the present Act needs to be amended to incorporate therein certain emerging
technologies like selection of sex prior to conception as well as those in current use
which are being misused for pre-natal determination of sex of the foetus.

It is also proposed to make punishments prescribed under the Act more stringent, so that
they serve as a deterrent, which will minimize violations.
Implementation Instruments:

The PNDT Act provides for two main instruments for implementation of its provisions
viz.,
a)
b)

The Central Supervisory Board at the Central Govt, level and
The Appropriate Authorities assisted by Advisory Committees in States and
UTs for whole or parts thereof

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Central Supervisory Board (CSB):

The CSB consists of 23 members including representatives of States/UTs, non-official
members from amongst medical geneticist, gynaecologist and obstetricians,
pediatricians, social scientists, women activists and women Members of Parliament.
The main functions of the CSB are to advise the Govt, on policy matters relating to use
of pre-natal diagnostic techniques, to review implementation of the Act and Rules and
recommend changes therein to create public awareness against the practice of pre-natal
determination of sex.
The Seventh meeting of the Central Supervisory Board presided over by the Cabinet
Minister for Health and Family Welfare was held on April 2, 2002. Amendments to the
Pre-Natal Diagnostic Techniques (Regulation and Prevention of Misuse) Rules, 1996
were deliberated in this meeting, and a decision taken that the amendments to the Rules
may be examined in detail by the Technical Sub-Committee of the Central Supervisory
Board.

Appropriate Authorities and Advisory Committees:

Appropriate Authorities and Advisory Committees are appointed at State/UT, district and
sub-district in most of the States and UTs.

fl

The main functions of Appropriate Authorities are to grant, suspend or cancel registration
of the Genetic counseling Centres, Genetic laboratory or Genetic Clinic, to enforce
standards to investigate complaints of breach of provisions of the Act/Rules to seek and
consider the advice of the Advisory Committee for consideration of applications for
registration or complaints for suspension or cancellation of registration.
Sub-Committees of CSB:- The CSB has constituted the following two sub­
committees :1.

Technical Sub-Committee

The Technical Sub-Committee has been constituted to examine and suggest amendments
to the Pre-natal Diagnostic Techniques (Regulation and Prevention of Misuse) Act,
1994/Rules to cover (i) changing technologies such as pre-conception sex selection, (ii)
matters connected with the registration of ultra-sound clinics, radiological laboratories,
etc. who conduct tests for detection and disclosure of sex of foetus and (iii) provisions in
other related Acts. The Committee met on 26.5.2001, 9.6.2001, 14.8.2001 and
2.4.2002.
The Technical Sub-Committee deliberated in detail the amendments to the PNDT Rules
in its last meeting held on 2.4.2002 and suggested some changes, modifications and
additions. It was decided in the meeting that the Department of Family Welfare may
modify the draft amendments in the Pre-natal Diagnostic Techniques (Regulation and
4

Prevention of Misuse) Rules incorporating the suggestions of the Members. The
modified draft has been sent to the Members of the Technical Sub-Committee again for
final suggestions, before the same is forwarded to Ministry of Law for final vetting. The
comments are being received.

2.

Sub-Committee on Implementation Strategy

The sub-Committee on Implementation Strategy has been constituted to (i) evaluate the
implementation of the Pre-natal Diagnostic Techniques (Regulation and Prevention of
Misuse) Act, 1994 (ii) evolve a suitable mechanism to identify agencies doing good
work for effective implementation of the Pre-natal Diagnostic Techniques (Regulation
and Prevention of Misuse) Act, 1994, (iii) collection of-* data related to
implementation/violation of the Act, (iv) to conduct independent study through qualified
people, medical research centers/institutions for collection of authentic infonnation, (v)
sensitizing the people about the provisions of the Act, (vi) strengthening the
Information, Education and Communication activities, (vii) to implement the direction
of the Supreme Court for implementation of the Act and (viii) any other activity found
necessary by the Central Supervisory Board for the effective implementation of the Pre­
natal Diagnostic Techniques (Regulation and Prevention of Misuse) Act, 1994. The
Committee met on 26.5.2001, 9.6.2001 and 10.9.2001.
Groups:

The CSB has also constituted two groups viz. (i) Group for considering proposals for
research studies on sex ratio and female foeticide and (ii) Group for considering the
proposals for creating video films, TV spots etc.
The Group constituted for considering the proposals for research studies on sex
ratio and female foeticide met on 16th November, 2001 It has recommended the
following three research study proposals for consideration.

1. “Missing Girls: A Case Study of Delhi” submitted by Prof (Mrs.) Usha Nayar,
Chairperson, Tinnari, The Third World Centre for Comparative Studies, New
Delhi.
2. “A Preliminary Investigation into the sharp decline in the female-male ratio in
the age group of 0-6 years: Policy implications for restoring gender balance”
submitted by Shri Alok Mukhopadyay, Chief Executive, Voluntary Health
Association of India, New Delhi.
3. “Impact of Gender-Bias on Population Aged 0-6 Years” submitted by Shri Alakh
N. Sharma, Director, Institute for Human Development, New Delhi.

The Department of Family Welfare has sanctioned financial assistance for carrying out
all these research studies. Grant-in-aid has also been released
The Group constituted to examine and consider proposals on audio-video programs
for generating awareness about the importance of girl child and provisions of the PNDT

5
$

Act has met four times. In its meeting held on 14.1.2002, the Group has constituted a
sub-Group consisting of Dr. Mira Siva, Dr. Nalini Abraham and Mrs. Bhamati.
In the last meeting held on 19.3.2002, 11 films were short listed. Thereafter, the SubGroup members once again examined these 11 scripts keeping in view the messages in
the scripts, duration, rural/urban background and specific treatment of subject matter.
Finally 4 scripts were short-listed. They are being processed for funding.

ACTIONS TAKEN TO IMPLEMENT THE ACT
The States/UTs have been advised by the Central Government to mount effective
awareness campaign to make the public and service providers aware of the provisions of
the Act. The States/UTs have also been advised to provide protection to social activists
and Non-Governmental Organizations giving information or filing complaints of
violation of provisions of the Act.
After the Census 2001 figures became available, letters have been addressed to the Chief
Ministers of all States/UTs for giving focussed attention to the issue of female foeticide
leading to adverse sex ratio. Chief Secretaries of all the States/UTs have also been
addressed for implementation of the provisions of the PNDT Act. The Minister for Health
and Family Welfare has also addressed a D.O. letter to more than two lakhs doctors all
over the country requesting them to extend their help and co-operation for eradication of
the evil of female foeticide.
Shri A.R. Nanda, Secretary, Department of Family Welfare, Ministry of Health and
Family Welfare addressed letters on March 13, 2002 to the Principal Secretaries and/or
Secretaries in charge of the Department of Health and Family Welfare of all States/UTs
directing that immediate action be taken to implement the provisions of the Pre-natal
Diagnostic Techniques (Regulation and Prevention of Misuse) Act, 1994 in compliance
with the directions of the Hon’ble Supreme Court.

Attention was drawn in the said letter of March 13, 2002, to the gaps in the number of
bodies surveyed by the Appropriate Authorities, the number of bodies registered under
the Act and the number of ultrasound machines/scanners seized and sealed by different
States and UTs in compliance with the Hon’ble Supreme Court’s Order dated 29th
January, 2002.

The State/UT level Appropriate Authorities have been asked to organize the conduct of
raids in the ultrasound clinics operating in all the districts and sub-districts of the
State/UT by deploying decoy customers. For this purpose they may use the services of
the staff available in the offices of the district and sub-district level Appropriate
Authorities. They have also been advised to complete the registration inter-alia, of all
those clinics and centres using ultrasound machines whose lists have been supplied to
them by the Department of Family Welfare, Government of India.

6

Involvement of NGOs:

Workshops/seminars are being organized at State/regional/district/block levels to create
awareness about the provisions of the Act. Voluntary Organizations are also being
involved to carry out projects for creating awareness about the provisions of the Act.
Grant-in-aid has been released to the following NGOs for creating awareness about the
provisions of the PNDT Act:-

4

1. Orissa Voluntary Health Association (Area: Orissa).
2. Voluntary Health Association of India, New Delhi (Area: of Punjab, Madhya
Pradesh, Uttar Pradesh, Himachal Pradesh, Rajasthan and Tamil Nadu).
3. MaharashtraVoluntary Health Association, Maharashtra (Area: Wardha).
4. Uttar Pradesh Voluntary Health Association, Lucknow (Area: U.P.).
5. SAMNAVAY, C-234, Sector A, Mahanagar, Lucknow (Area: Uttaranchal).
6. Family Planning Association of India, Mumbai [Area: Madhya Pradesh (Bhopal,
Gwalior, Indore and Jabalpur), Bihar (Patna), Jharkhand (Gomia), Rajasthan
(Jaipur), Haryana (Panchkula and Yamunanagar) and Punjab (Mohali)].
7. Kerala Voluntary Health Services, Kottayam (Area: Kerala).
8. Family Planning Association of India, Madurai (Area: Madurai).
9. Rural Education and Development Society (REDS), Sivagangai District, Tamil
Nadu (Area: South Tamil Nadu).

Other Activities:

Religious leaders’ meets were organised at New Delhi (organised by National
Commission for Women, IMA and UNICEF) and at Fatehgarh Sahib(Punjab) against
the practice of female foeticide where this practice was widely condemned and pledge
was taken stop it. Akai Takhat in Punjab has issued a Hukumnama to Sikh community to
stop the practice of female foeticide.
Various activities are being undertaken regularly for creating public awareness through
Government media viz. Radio, TV and other media units. Various stations of AIR are
broadcasting spots, group discussions, talks and panel discussions on PNDT Act in
various languages.
Two spots are being telecast once a week on National Network and a film
‘NIRANKUSH’ is being telecast on Punjabi Channel. NFDC has been asked to produce
a small film on female foeticide. A film ‘ATMAJA’ produced by Plan International
India on female foeticide is being telecast on National Channel of Doordarshan.

7

Reports from the States:

All States/UTs have been advised to register all organizations using Ultrasound
machines, failing which their machines may be sealed and seized in terms of the
Supreme Court’s Order dated 29.1.2002. Quarterly returns are being received from the
States/UT, in terms of Supreme Court’s Order dated 4.5.2001.
According to the reports received from the States/UT Govts, about 14,000 bodies are
registered. As part of the compliance of the orders of the Hon’ble Supreme Court, more
than 80 machines have been sealed and seized in States like Haryana, Karnataka,
Maharashtra, Oirssa, Punjab, Rajasthan, Tamil Nadu, Uttar Pradesh and Delhi. 191
complaints have been filed against the violators of law by various States/UTs. State/UT
wise details are given below:SI.
No.

State/UT

1
2
3
4_
5
6
7

15

Andhra Pradesh
Bihar_________
Gujarat
Haryana______
Karnataka_____
Madhya Pradesh
Maharashtra
Orissa________
Punjab________
Rajasthan_____
Tamil Nadu
Uttaranchal
Uttar Pradesh
West Bengal
Chandigarh

16

Delhi_________

8
9
10

11
12

13
14

Number
of
Complaints
filed in the
Court/Police
7_________
7_______
7_________
_8_____
5 _________

Number
of
Ultrasound
machines seized
and sealed

8
5

6 _________

41__________
7

1

1
3
2

2
5_________
51
1__________
10_______
3
46_________
2_________
40_________
1
191
81

Total

National Monitoring and Implementation Committee:

A National Monitoring and Implementation Committee has also been constituted at the
Centre to take stock of the ground realities by field visits. The Committee will visit the
problem States and will submit their report along with suggestions for effective action to
implement the Act, eradication of female foeticide and improvement of sex ratio. The

8

Committee has already visited Chandigarh on 4.1.2002, Faridabad (Haryana) on 2.2.2002
and Muzaffarnagr (U.P.) on 26.3.2002.

SUPREME COURT’S DIRECTIONS

a

The Supreme Court has issued certain directions to both Central and State Governments
in a Public Interest Litigation filed by the Centre for Enquiry into Health & Allied
Themes (CEHAT) & Others vs. Union of India and others. The directions include among
other things wide publicity both at national and state levels for generating awareness
about the Act.
I.

Directions dated 4.5.2001:
Directions to the Central Government

> To create public awareness against the practice of pre-natal determination of sex of
foetus and female foeticide through appropriate releases/programs in the print and
electronic media.
> To implement with all vigor and zeal the PNDT Act and the Rules framed in 1996.
> The intervening period between the two meetings of the Advisory Committees
constituted to advise the Appropriate Authority should not exceed 60 days. It would
be seen that this Rule is strictly adhered to.

Directions to Central Supervisory Board (CSB)

A

> To ensure holding of meetings of the CSB at least once in six months.
> To appoint those eminent medical practitioners including eminent social scientists
and representatives of women welfare organizations in the CSB, who can genuinely
spare time for implementation of the Act.
> To review and monitor the implementation of the Act.
> To issue directions to all State/UT Appropriate Authorities to furnish quarterly
returns to the CSB giving a report on the implementation and working of the Act.
These returns should inter-alia contain specific information about:
1. Survey of bodies specified in section 3 of the Act.
2. Registration of bodies specified in section 3 of the Act.
3. Action taken against non-registered bodies operating in violation of section 3
of the Act, inclusive of search and seizure of records.
4. Complaints received by the Appropriate Authorities under the Act and action
taken pursuant thereto.
5. Number and nature of awareness campaigns conducted and results flowing
therefrom.

> To examine the necessity to amend the Act keeping in mind emerging technologies
and difficulties encountered in implementation of the Act and to make
recommendations to the Central Government.
9

> To lay down a code of conduct under section 16(iv) of the Act to be observed by
persons working in bodies specified therein and to ensure its publication so that
public at large can know about it.
> To require medical professional bodies/associations to create awareness against the
practice of pre-natal detennination of sex and female foeticide and
> To ensure implementation of the Act.

Directions to State Governments/UT Administrations
> To appoint fully empowered Appropriate Authorities and Advisory Committees at
State/UT, district and sub-district levels with such members of Advisory Committees
who can devote sometime for the work assigned to them.
> To publish a list of appropriate authorities in the print and electronic media.
> To create public awareness against the practice of pre-natal determination of sex and
female foeticide through advertisement in the print and electronic media by hoarding
and other appropriate means.
> To ensure that State/UT Appropriate Authorities furnish quarterly returns to the CSB
giving a report on the implementation and working of the Act. These returns should
inter alia contain specific information about -

a

1. Survey of Genetic Counselling Centres, Genetic Laboratories and Genetic
Clinics
2. Registration of Genetic Counselling Centres, Genetic Laboratories and
Genetic Clinics
3. Action taken against non-registered bodies operating in violation of Section 3
of the Act, inclusive of search and seizure of records.
4. Complaint received by the Appropriate Authorities under the Act and action
taken pursuant thereto.
5. Number and nature of awareness campaigns conducted and results flowing
therefrom.
Directions to Appropriate Authorities

> To take prompt action against any person or body who issues or causes to be issued
any advertisement in violation of Section 22 of the Act.
> To take prompt action against all Genetic Counseling Centres, Genetic Laboratories
and Genetic Clinics as also against persons who are operating without a valid
certificate of registration under the Act.
> To furnish quarterly returns to the CSB giving a report on the implementation and
working of the Act. These returns should inter-alia contain specified information
about:-

1. Survey of Genetic Counseling Centres, Genetic Laboratories and Genetic
Clinics
2. Registration of Genetic Counseling Centres, Genetic Laboratories and Genetic
Clinics including bodies using ultra-sound machines

10

3. Action taken against non-registered bodies operating in violation of Section 3
of the Act, inclusive of search and seizure of records.
4. Complaint received by the Appropriate Authorities under the Act and action
taken pursuant thereto.
5. Number and nature of awareness campaigns conducted and results flowing
therefrom.

II.

Directions dated 11.12.2001:
The Supreme Court of India in its Order dated 11th December, 2001 had directed

that>
(i) States/UTs should furnish district wise information about the implementation of
the Act.
(ii) Information about buyers of ultrasound machines may be obtained from the
manufacturers, importers, suppliers etc. of such machines.
(iii) Rules should be framed restricting sale of ultrasound machines to clinics
registered under the PNDT Act.
Directions dated 29.1.2001:

III.

The Supreme Court of India in its Order dated 29th January, 2002 has directed

that:
(i) State Govemments/UTs should seal and seize the ultrasound machines/ scanners
used by such organizations as have not got themselves registered under the PreNatal Diagnostic Techniques (Regulation and Prevention of Misuse) Act, 1994.
(ii) The mandatory procedure prescribed for registration of any person or organization
using the ultrasound machines/scanners should be followed.
(iii) Help of Indian Medical Association (IMA), Indian Radiologists Association and
The Federation of Obstetrics and Gynaecologists Societies of India (FOGSI) may
be taken to identify the users of ultrasound machines/scanners.

Action taken on the directions of the SC:
The Central Government have requested all the State/UTs for ensuring strict compliance
of the directions of the Hon’ble Supreme Court of India. Quarterly returns as directed by
the Supreme Court are being obtained from States/UTs about the implementation of the
Act.
A list of over 11,000 buyers of ultrasound machines received from the manufacturers,
importers, suppliers, dealers, service providers etc. of such machines has already been
forwarded to the States/UTs for ensuring registration of the clinics using the same and for

prosecution of those found misusing these machines for detection of sex of foetus.

11

Further, list of Members of Indian Radiological & Imaging Association and list of State
level Presidents/Secretaries of Indian Medical Association (IMA) have also been
forwarded to the States/UTs with the request to obtain from them the list of their
members using ultrasound machines/imaging machines/scanners.

They have also been requested to launch prosecution against those persons who are using
ultrasound machine/scanner/imaging machine without getting themselves registered
under the Act and also against those who are found violating the provisions of the PreNatal Diagnostic Techniques (Regulation and Prevention of Misuse) Act, 1994.

Amendments:
Action is being taken to amend the Pre-Natal Diagnostic Techniques (Regulation and
Prevention of Misuse) Act, 1994 in the light of the directions of the Supreme Court. The
proposed amendments inter-alia include -

1. bringing of the technique of pre-conception sex selection within the ambit of this Act
so as to pre-empt the use of such technologies which significantly contribute to the
declining sex ratio;
2. to bring the use of ultrasound machines within the purview of this Act more
explicitly so as to curb their misuse for detection and disclosure of sex of the foetus
lest it should lead to female foeticide;
3. to further empower the Central Supervisory Board for monitoring the
implementation of the Act;
4. to introduce State level Supervisory Board for monitoring and reviewing the
implementation of the Act in States/UTs;
5. to constitute a multi member State Appropriate Authority for better implementation
and monitoring of the Act in the States;
6. to make punishments prescribed under the Act more stringent so as to serve as a
deterrent for minimizing violations of the Act;
7. to empower the Appropriate Authorities with the powers of Civil Court for search,
seizure and sealing the machines, equipments and records of the violators of law
including sealing of premises and commissioning of witnesses;
8. making mandatory the maintenance of proper records in respect of the use of
ultrasound machines and other equipments capable of detection of sex of foetus and
also in respect of tests and procedures leading to pre-conception selection of sex.
Keeping in view the proposed amendments to the PNDT Act and directions of the
Supreme Court, the PNDT Rules, 1996 are tilso being amended to inter-alia provide
for restricting sale of ultrasound machines/scanners capable of detection of sex of foetus,
prescribe code of conduct for persons working in such clinics, etc. in accordance with
directions of the Supreme Court.

The amendment to the PNDT Act, which was sent to the Ministry of Law for vetting, has
been sent by them to Legislative Department for preparing the draft Bill. On receipt of
the same, the proposed amendments to the PNDT Act will be placed before the Cabinet
for approval.
12

$

Annexure

Sex Ratio among the Child Population in the age group 0-6

4

Sl.No. States_____________
_L___ Punjab____________
2. ___ Haryana___________
3. ___ Chandigarh________
4. ___ Himachal Pradesh
5.
Jammu & Kashmir
'
Delhi________
6.
. 7,
Rajasthan__________
_8.___ UP.______________
9. ___ Bihar_____________
10.
Orissa_____________
11.
Madhya Pradesh____
12
Uttranchal_________
13
Jharkhand_________
14
Chhatisgarh________
15
Sikkim____________
16.
Arunachal Pradesh
17.
Nagaland__________
Manipur___________
18.
19.
Mizoram__________
20.
Tripura____________
21.
Meghalaya_________
Assam____________
22.
23.
West Bengal________
24.
Gujarat____________
25.
Daman & Diu_______
26.
Dadra & Nagar Haveli
27.
Maharashtra________
28.
Andhra Pradesh_____
29.
Karnataka_________
30.
Goa______________
31.
| Lakshadweep_______
32.
Kerala____________
33.
Tamil Nadu________
34.
Pondicherry________
35.
A & N Islands______
All India

13

1991
875
879
899
951
N.A.
915
916
927
953
967
941
948
979
984
965
982
993
974
969
967
986
975
967
928
958
1013
946
975
960
964
941
958
948
963
973
945

2001 ,

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975
975
964
963
925
973
917
964
949
933
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THE GAZETIE OF INDIA : j EXIRA ORDINARY

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18

THE G?UETTE OF INDIA EXTRAORDINARY
■■■■-

___________

~

-•

MINISTRY OF HEALTH AND FAMILY
WELFARE

(Department of Family Welfare)
NOTIFICATION

[Part

T---...-------- •—-------- —--------------------------------------

receipt of the application for registration, in _ the
ack 'jovviedgement slip provided at tl£/ bottom of
Form A:1 immediately if delivered at the office of the
Appropriate Authority, or not later than the next
working day if received by post.

New Delhi, the 1st January, 1996
G.S.R. 1(E).—In exercise of the powers conferred
by section 32 of the Pre-natal Diagnostic Techniques
(Regulation and Prevention of Misuse) Act, • 1994
(57 of 1994), the Central Government hereby makes
the following rules, namely:—
1. Short title and commencement.—(1) These
rules may be called the Pre-natal Diagnostic Tech­
niques (Regulation and Prevention, of Misuse) Rules,
1996.

(2) They shall come into force on the date of their
publication in the Official Gazette.
2. Definitions. In these rules, unless the context
otherwise requires,—
(a) “Act” means The Pre-natal Diagnostic Tech­
niques (Regulation and Prevention of Mis­
use) Act, 1994 (57 of 1994);
(b) “employee” means a person, working in or
employed by a Genetic Counselling Centre,
a Genetic Laboratory or a Genetic Clinic,
and includes those working on part-time,
contractual, consultancy, honorary or on any
other basis ;
(c) “Form” means a Form appended to these
rules;
(d) “Schedule” means a Schedule appended to
these rules;
(e) “section” means a section of the Act ;
(D words and expressions used herein and not
defined in these rules but defined in the Act,
shall have the meanings, respectively, assig­
ned to them in the Act.

3. Minimum requirements.—(I) The minimum
qualifications of the employees, the minimum
equipment and minimum place for a Genetic Coun­
selling Centre, Genetic Laboratory and Genetic
Clinic shall be as specified in Schedules I, II and III

(2) Where an institute, hospital., nursing home,
or any place, by whatever name called, provides
services jointly of Genetic Counselling Centre, Genetic
Laboratory and Genetic Clinic, or any combination
of these, *t shall conform to the requirements as
specified io Schedules I, II and III.
4. Registration of Genetic Counselling Centre.
Genetic Laboratory and Genetic Clinic.—(J) An
application or registration sb.aH be made to the Appro­
priate Authority, in duplicate, in. Form A.
(2) The Appropriate Authority, or any persen in
his office authorised in this behalf, shall acknowledge

:j. Application Fee.—(1) Every application for
registration under rule 4 shall be accompanied by an
application fee of
(a) Rs. 2000.00 for Genetic Cpunscllmg Centre;

(b) Rs. 3000.00 for Genetic Laboraiory;
(c) Rs. 3000.00 for Genetic Clinic; ind

fd) Rs. 4000.00 for an institute, hospital, nursmg
home, or any place providing jointly the services of a
Genetic Counselling Centre, Genetic Laborator/ and
Genetic Clinic or any combination of such Centre,
Laboratory or Clinic.

2) The application fix shall be paid by a
demand draft drawn in favour of the Appropriate
Authority, on any scheduled bank heated at the
headquarters of the Appropriate Autliority.
5. Certificate of registration.—(1) The Approprk te Authority shall, after making fuch enefuiry
and after satisfying itself Khat the applicant has com­
plied with all the requirements, place the application
before the Advisory Committee for it; advice.

<2) Having regard to the advice of the Advisory
Cor-unitwe the Appropriate Authority shall, grant a
certificate of registration, in duplicate, in Ferm B
to ; be applicant. One copy of the certificate of
registration shall be displayed by the registered Gene­
tic Counselling Centre, Genetic Labcratc ry or Genetic
Clit ic at a conspicuous place at its place of
bus ness.
Provided that the Appropriate Authority may
grant a. certificate of registration to a Genetic Labo­
ratory ora Genetic Clinic to conduct one pr more
specified pre-natal diagnostic tests or procedures,
depending on the availability of place, equipment
anc qualified employees, and standards maintained
by such laboratory or clinic.
(3) If, after enquiry and after giving an oppor­
tunity of being heard to the applicant and having
regard to the advice of the Advisory Committee, the
Apj-Jippriate Authority is satisfied that the applicant
has not complied with the requirements of the Act
and these rules, it shall, for the reasons to be
recorded in writing, reject the application for
registration and communicate such - rejection to
the applicant as specified in Form C

<4) An enquiry under sub-rule (1), including ins­
pection at the premises of the Genetic Counselling
Centre. Genetic Laborator/ or Genetic Clinic, shall

3(i)] .

be carried out only after due notice is given to the
applicant by the; Appropriate Authority.
(5) Grant of certificate of registration or rejection
of application for registration shall be communi­
cated to the applicant as specified in Form B or
Form C, as the case may be. wiihin a period of
ninety days from the date of receipt of application
for registration.

(6) The certificate of registration shall be nontransferable. In the event of change of ownership
or change of management or on ceasing to function
as a Genetic Counselling Centre, Genetic Laboratory
or Genetic Clinic, both copies of the certificate of
registration shall be surrendered to the Appropriate e
Authority.
(7) In the event of change of ownership or change
of management of the Genetic Counselling Centre,
Genetic Laboratory or Genetic Clinic, the new owner
or manager of such Centre, Laboratory or Clinic
shall apply afresh for grant of certificate of regis­
tration.

7. Validity of registration.—Every certificate of
registration shall be valid for a period of five years
from the date of its issue. ,
8. Renewal of registration.-—(I) An application
for renewal of certificate of registration shall be made
in duplicate in Form A, to the: Appropriate Authority
thirty days before the date of expiry of the certificate
of registration. Acknowledgement of receipt of suchapplication shall be issued, by the Appropriate Autho
rity in the manner specified in sub-rule (2) of rule 4.

(2) The Appropriate Authority shall, after holding
an enquiry and after satisfying itself that the applicant
has complied with all the requirements of the Act and
these rules and having regard to the advice of the
Advisory Committee in this behalf, renew the certi­
ficate of registration, as specified in Form B, for a
further period of five years from the drate of. expiry
of the certificate of registration earlier granted.
(3) If, after enquiry and after giving an oppor­
tunity of being heard to the applicant and having
regard to the advice of the Advisory Committee, the
Appropriate Authority is satisfied that the applicant
has not-complied with the requirements of the Act
and these rules, it shall, for reasons to be recorded in
wilting, reject the application for renewal of certi­
ficate of registration and communicate such rejec­
tion to the applicant as specified in Form C.
(4) The fees payable fbr renewal of certificate
registration shall be one half df the fees provided in
sub-rule (1) of rule 5.
I

19

(5) On receipt of the renewed certificate of regis­
tration in duplicate or on receipt of communication
of iejection of application for renewal, both copies
of they earlier certificate of registration shall be sur­
rendered Immediately to the Approripate Authority
by the Genetic Counselling Centre, Genetic Labora­
tory or Genetic Clinic.

(6) In the event of failure of the Appropriate
Authority to renew the certificate of registration or to
ec nimurifcate rejection of application for renewal of
registration within a period of n'netj'days from the
date of receipt cf application for renewal of regis­
tration, the certificate of registrat on shall be deemed
to have been renewed.
9. Maintenance and preseiwaticr of records.—
(I'l Ever/ Genetic Counseli ng Ccntfe, Genetic Lab­
oratory and Genetic Cl.nic shall maintain a register
showing, in serial order, the names and addresses
of the women given genetic counsellire, subjected to
pre-natal diagnost.-c procedures or pre-natal ' dia­
gnostic tests, the names of their husbands or fathers
and the date on which they first reported for ( such
counselling, procedure or test.
(2) The record to be maintained by every Genetic
Counelling Centre, in respect of each woman counsel­
led, shall be as specified in Form D.
(3) The record to be maintained by every Genetic
Laboratory, in respect of each v/omin subjected to
any pre-natal diagnostic test, shall be as specified in
Form E(4) The record to be maintained by every Genetic
Clinic, in respect of each woman subjected to,any pre­
natal diagnostic procedure, shall be as specified in
Form F.

(5) The Appropriate Authority stall maintain a
pe rmanent record of applications for grant or renewal
of certificate of registration as specified in Form H.
Letters of intimation of every change of employee,
place, address and equipment installsd shall also be
•pieserved a permament records.
(6) All case related-records, forms cf consent,
laboratory results, microscopic pictures, sonogaphic
•pl'ites or slides, recommendations and letters shall
be preserved by the Genetic Counselling Centre,
Genetic Laboratory or Genetic Clinic for a period of
tv o years from the date cf completion o:f counselking, pre-natal diagnostic procedure or pre-natal
diagnostic test, as the case may be. In the event cf any
iej.’.ai proceedings, the records shall be preserved till
the final disposal of legal proceedings, er till the expiry
ol the said period of two years, whichever is later.

(7) In case the Genetic Counselling Centre or
Genetic Laboratory or Genetic Clinic maintains
. scorch on computer or other electronic equipment.

. ... ......
5

20

THE GAZETTE OF INDIA : FXTKAORDINARY

a printed copy of the record shall bo taken and pre- "d
served after authentication by a person responsible |
for such record.
10. Conditions for conducting pre-nataldiagno- J
stic picedures. (1) Before conducting any pre-natal- jj
diagnostic procedure, a written consent, as specified ?
in Form G, in a language the pregnant woman understands, shall be obtained trom her:
Provided that where a Genetic Clinic has taken a
sample of any body tissue or body fluid and seat it jto a Genetic Laboratory for analysis or test, it stall
not be necessary for the Genov'c Laboratory to obtain
a fresh consent in Form G.

(2) All the S tate Govern merits and Union terri­
tories may issue translation of Form G m languages
used in the State or Union territory and where no
official translation in a languge understood by the
pregnant woman, is available, the Genetic Clinic may
translate Form G into a language she understands

1L Facilities for inspection.—Every
Genetic
Counselling Centre, Genetic
Laboratory and
Genetic Clinic shall afford : reasonable facilities
for inspection of the place, equipment and records
to the Appropriate Authority or to any other
person authorised by the Appropriate Authority in
this behalf.

12. Procedure for search a nd seizure—.(1) The
Appropriate Authority or any officer authorised in
this behalf may enter and search at all reasonable
times any Genetic Counselling Centre, Genetic Lab­
oratory or Genetic Clinic, in the presence of two or
more independent and respectable persons, for the
purposes of section 30.

(2) A list of any document, record, register, book,
pamphlet, advertisement or any other material object
found in the Genetic Counselling Centre, Genetic
Laboratory or Genetic Clinic and seized shall be pre­
pared in duplicate at the place of effecting the seizure.
Both copies of such list shall be signed on every page
by the Appropriate Authority or 1he officer authorised
in this behalf and by the witnesses to the seizure:
Provided that the list may tw prepared, in the pre­
sence of the witnesses, at a place other than the place
of seizure if, for reasons to ta recorded in writing,
it is not practicable to make the list at the place of
effecting the seizure.
(3) One copy of the list itefisrred to in sub-rule (2)
shall be handed over, under acknowledgement, to the
person from whose custody the document, record,
register, book, pamphlet advertise inent or any other
material object have been seized:

Provided that a copy of the list of such document,
record, register, book, pamphlet, advertisement or

[Part II—Sec. 3(i)]

"other material object seized may be delivered under
acknowledgement, or sent by registered post to the
o wner or manager of the Genetic Counselling Centre,
Genetic Laboratory or Genetic Clinic, it no person
acknowledging custody of the document, record,
register, book, pamphlet, advertisement or other
material object seized is available at the place of e fleet­
ing the seizure.
(4) If any material object seized is perishable in
nature, the Appropriate Authority, or the officer aut­
horised in this behalf sha ll make arrangen ents prom­
ptly for sealing, identification and preservation
of the material object and also convey it to a facility
for analysis or test, if analysis or lest be required:

Provided that the refrigerator or other equipment
used by the Genetic Counselling Centro, Genetic
Laboratory or Genetic Clinic for preserving such
perishable material object may be soiled until such
time as arrangements can be made for safe removal
of such perishable material object and in such event­
uality, mention of keeping the material object seized,
on the premises of the Genetic Counselling Centie oi
Genetic Laboratory or Genetic Clinic shall be made
in the list of seizure
(5) In the case of non-completion of search and
seimre operation, the Appropriate Authority or the
oflicer authorized in this behalf may make ajrangements, by way cf mounting a guard or sealing ot
the premises of the Genetic Counselling Centre.
Genetic Laboratory or Ge netic Clinic, for safe keeping,
Us:mg and removal of documents, records, book cr
any other material object to be seized, and to pre­
vent any tampering with such documents, records,
books or any other material object.

13. Intimation of changes in employees, ptae or
equipment.—-Every Genetic Counselling Centre,
Genetic Laboratory or Genetic Clinic stall intimate
every change of employee, place, address trnd equip­
ment installed, to the Appropriate Authority within a
juried of thirty days of such change
14. Conditions for analysis or test and pre-natal
di'ignostic procedures. (1) No Genetic laboratory
shall accept for analysis, or test any sample, unless
referred to it by a Genetic Clinic.

(2) Every pre-natal diagnostic procedure shall
invariably be immediately preceded by locating the
feetus and placenta through ultrasonography, and
the pre-natal diagnostic procedure shall be done
under direct ultrasonographic monitoring so Jis to
prevent any damage to the foetus and placenta.

15. Meetings of the Advisory Committees. The
intervening period between any two meetings of
A dvisory Committees constituted under sub-sectiOD

ft

[^rll-w^ 3(i)[

'_____ _

HiXiil 3iT

21

: WitTK’t

:s===s=ss===== ===------------

7$) of section 17 to advise the appropriate Authority
shall not exceed sixty days.
16. Allowances to members of the Central Super­
visory Board.—(1)The ex-oflicio members, and other,
Central and State Government officers appointed to’
the Board will be entitled to Travelling Allowance and
Daily Allowance for attending the meetings of the
Board as per the Travelling Allowances rules appli­
cable to them.
(2) The non-oflicial members .appointed to, and
Members of Parliament elected to, the Board will be
entitled to Travelling Allowance and Daily Allowance
for attending the meetings of the Board as admissible
to non- officials and Members of Parliament, as the
case may be, under the Travelling Allowances rules
of the Central Government.
17. Public
Information —(1) Every Genetic
Counselling Centre, Genetic laboratory and Genetic
Clinic shall prominently display on its premises a

notice in English and in the local language or langu­
ages for the informatton of the public, to the effect
that disclosure of the sex of the foetus s prohibited
under law.
(2) At least one copy each of the Act and these
rulit, shall be available o:n the prcrnfceu cf every Ge­
netic Counselling, Centre, Genetic Laboratory and
Genetic Clinic, and shall be made available to the
clientele on demand for persuai.
(3) The Appropriate Authority, the Central
Gc vernment the State Government, and the Goventnie nt/Ad ministration of the Union territory may
publish periodically lists cf registeted Genetic Counsel­
ling Centres, Genetic Itabprator es and Genetic
Clinics and fadings from the reports and other infor­
mation in their possession, for the information of the
public and lor use by the experts inr rtie field.
iNo. 2301 ./5^/94~PLY I
K. S. SUGATHAN, Jt.Secy

SCHEDULE I
[See iide 3 (I) J
REQUIREMENTS FOK RE GIST RATION. OF A.

GENCTIC COUNSEL LING CENTRE

A. PLACE
A room with an area of seven (7) square metres.
B.

EQUIPMENT

Educational charts/models.
C. EMPLOYEES :

Amy one of the following

(1) Medical Geneticist.
(2) Gynaecologist with 6 months experience, in genetic ccunsellmg, or having completed 4 weeks’ tra jattig in
genetic counselling.
or having completed 4 weeks' training in
(3) Paediatrician with 6 months experience in genetic counselling,
genetic counselling.
SCHEDULE II
[See rule 3{1)]

REQUIREMENTS FOR REGISTRATION OF A
GENETIC LABORATORY
A. PLACE
A room with adequate space for carrying out tests.
B. EQUIPMENT
These are categorised SL^iaratcly for each of the unc ermeutioricd studies.
Chromosomal studies :

(t) Laminar llow hood with ultraviolet and fluorc,s xni; 1 •-ght or other suitable culture hood.
(2) ^hoto-fnicroscope witii fluorescent source of light.

22

________ __

THE GAZETTE OF INDIA : EXTRAORDINARY

[P/IAT LI—Sec. 3(01

(3) Inverted microscope.
S STdiXOincnubat<>r or closed system with 5% CCH atmosphere.

(6) Autoclave.
(7) Refrigerator.
(8) Water bath.
(9) Centrifuge.
(10) Vortex mixer.
(11) Magnetic strirrcr.

S!
’".TX mi—
(14) Double distillation apparatus (glass).

•“ "** “f "-1

Biochemical studies .
(lequirements according to tests to be carried out)
other suitable culture hood.
with ultraviolet and fluorescent light, or
(1) Laminar flow hood
(2) Inverted microscope-

(3)
o. dosri QM. **
«>• —
(4)
(5) Autoclave.
(6) Refrigerator.
(7) Water bath
(8) Centrifuge.
(9) Electrophoresis apparatus and power supply.
-inwnaassay system (withga:aima beta-counter) or fiuoro(10) Chromatography chamber.
(H) Spectre-photo meter and Elisa reader or Radio
meter for various biochemical tests.
(12)
(12) Vortex mixer.
13) Magnetic stirrer.

!!S
KX ». ft—»•— ”lh
(16) Double.distillaticn appratus (glass).
(17) Liqu id nitrogen tank.
Molecular studies :
(1) Inverted microscope.
(2) Incubator.
(3) Oven.
(4) Refrigerators
Autoclave. (4 degree and minus 20 degree Centigrade)
(5)
(6) Water bath.
Microcentrifuge.
P) Electrophoresis
appratus and power supp y.
(8)
(9)
Vorte*
raixer.
C,
(10) Magnetic stirrer.

SS Double
KX
—»—y
distillation apparatus (glass)
t

'

_

«(

j:»4.:no+ir»Ti 5ir»naratUS (glass)

"•



(13.
(14) P.C.R. machine.
(15) ^muXalor^Tphotographic attachment or other documentation system.
(16) U.V.
micropipettes.
(17) Precision
1- ’

C. EMPLOYEES :

rtnr H-w 3(i.)]
'SCHEDULE ill
[See rule 3(1)]
FEOVIREMENTS for registration of a
GENETIC CLINIC

A. PLACE
of twenty (20) square metres with appropriate aseptic arrangements.
A room with an area

B mb’ ”

obster tician/gyn aeco-

J’fi. :j:

logist.

(2) Equipment, accessories, materials and other facili ties« quired for operations envisaged in the Act.
♦(a) An ultra-sonography machine.
and equipment for carry ing out chorionic villi aspirations per vagina or per
♦(b) Appropriate calfcethers
abdomen.
Appropriate sterile needles for amniocentesis or cordocentesis.
♦(c) Appropriate
A suitable foetoscope with appropriate accessories for foetoscqpy, foetal skin or organ b.opsy or foetal
(d)
blood sampling shall be optional.
, .r.<;

(3) Equipment for dry and wet sterilization.
■>.
..y;
Equipment for carrying out emergency procedures sech as evacuation of uterus or resuscitation in case
(4)
of need.
C. EMPLOYEES

J

,

m * „;r~ t
»—,te! “
B above).
A Radiologist or Registered Medical Practitioner for carrying out ultrasonography
The required ex(2) A j^nce shall be 100 cases under supervision of a sindlarly qualified person cxper.enced m these techniques.

------ ^^stLtoTemWrmwlmmLLfequiimterttforccntducti
FORM A
[See rules 4(1) and 8(1)]

(TO BE SUBMITTEE1 IN DUPLICATE)
WITH SUPPORTING DOCUMENTS AS ENCLOSURES, ALSO IN DUPLICA TE
prntM OF APPLICATION FOR REGISTRATION OR RENEWAL OF REGISTRATION OF A GENETIC

form of APPL^^^LLn,JG centre/genetic LAWRATORY/GENETIC CLINIC*

1. Name of the applicant
(specify Sh./Smt./Kum./Dr.)
2. Address of the applicant
applying
3. Capacity in which
■/partner/mac aging director/other-to
(specify ovmer/partner/nian
d hector /other-1 o be
stated)
4 Type of facility to ba registered
(specify Genetic Counselling Centre/Genetic Labo­
ratory/Genetic Clinic/any combination of these)
5

Full name and address/add cesses of Genetic Courtselling
Centre/Genetic Laboratory/Genetic Clinic with Tele phone/TelegraphicTelx/FaxE-mail numbers.

THE GAZETTE OF INDIA : EXIIiAORDINARV

24;

[Part

6. Type of ownership and organisation (specify individual
ownership/partnership/company/c o-operative/any other).
In case of type of organisation other than individual
ownership, furnish copy of articles of association and
names and addresses of other persons responsible for
management, as enclosure.

7. Type of Institution (Govt Hospital/Municipal Hospital/
Public Hospitall/P'rivate Hospital/Private Nursing Horne/
Private Clinic/Private Laboratory/any other to be stated.
8. Specific prenatal diagnostic procedures/tests for which
approval is sought (for example amniocentesis, chorionic
villi aspiration/chromosomal/biochemical/molecular
studies etc).
Leave blank if registration sought for Genetic Councelling
Centre only
9. (a) Space available for the Counselling Centre/Clini:,'
Laboratory give total work: area excluding lobbies,
waiting rooms, stairs etc. and enclose plan)
10. Equipment available with the make and model of each

equipment. List to be attached on a separate sheet).

11, (a) Facilities available in the Counselling Centre.
(b) Whether facilities are available in the Laboratory/
Clinic for the following tests;
<i) Ultrasound
(ii) Amniocentesis
(iii) Chorionic villi aspiration
(iv) Feet osco py
(v) Foetal biopsy
(vi) Cordocenteus
(c) Whether facilities are available in the Laboratory
Clinic for the following :
(i) Chromosomal studies
(ii) Biochemical studies
(iii) Molecular studies
12, Names, qualifications, experience and registration num­
ber of employees. May be furnished as an enclosure
(Refer Schedules I, Il or HI)
13 State whether the Genetic Counselling Centre,Genetic
Laboratory/Genetic Clinic* qualifies for registration, in
terms of minimum requirements laid down in Schedule
I, II and III and if not, reasons therefor.
14. For renewal applications only :
(a; Registration No.
)b) Date of issue and date of expiry of existing certi­
ficate of registration.
15. List of Enclosures :
Please attach a list of enclosures giving the supporting
documents enclosed to this application.

Date :
Place :

(------------—--------------------------- )
Name and signature of applicant

.3(0j

25

: ’Tfrunm'

[’RH U-sw 3(i)]

DECLARATION
son/

I, Sh./Smt/Kumr/Dr
daughter/wife of
years resident of

aged

hereby declare that I hav: read and understood the Pre-natal Diagnostic Techniques (Regulation and Prevention of
Misuse) Act, 1994 (57 of 1994) and the Pre-natal Diagnostic Techniques (Regulation and Pievention of Misuse),
Rules, 1995.

(ii) I also undertake to explain the said Act and Rules to a I employees of the Genetic Counseldng Centre/
Genetic Labora.tr ry/Gonedc Clinic in res pec* of Which registration is sought and to ensure that Act and rul. s are fully
complied with

(-------------------------------------- —------- )
Name and signature 01 applicant

Date :
{

Place :

*Strike out whichever is not applicable or not necessary,
oi the applicant.

2A.ll enclosures are to be authenticated bV signatui6

ACKNOWLEIXjEMENT
[See rules 4(2) and 8(1)]
The application in Form A in duplicate for grant*/renewal<: of registration of Genetic Counselling Centre*/
Genetic Laboratoiy^/Genetic Clinic* by
(Maine and address of applicant) lias
been received by the Approprate Authority

(date).

*The list of enclosures attached to the application in Form A has been verified with the enclosures submtted
and found to be correct.
OR
*On verification it is found that following documents meDtior^d in the list of enclosures are not actually
enclosed.
This acknowledgement does not confer any rights on the apj4 cant for grant or renewal of registration.

(----------------------------------------

)
Signature and Designation of
Appropriate Authority, or authorized
person in the office of the Appropriaie
Authority.

Date :

SEAL

♦Strike out whichever is not applicable or not necessary.
1 GI/96—4

[Pab.t 11— Sue. Xi)l

THE GAZETTE OF INDIA ; EXT ^ORDINARY

26

ORIGINAL*
DUPLICATE FOP DISPLAY

FORM. B
[Sec rules 6(2), 6(5) ar.d 8(2) ]
CERTIFICATE OF REGIS'fRATION
tTo be issued in duplicate)

1. la exercise of the powers conferred under sect ion 1 S'C I) cl the Prenatal Diag.no>t c Techniques (Regulation
and Prevention of Misuse) Act, 1994 (57 of 1994), the Appropriate Authority...
be eby f rants registration to the Genetic Counsel­
ing Cent re^/Genetic Laboratoiy’/Genetic Clnic* named bJow l:c r pu-pores of carrying out Genelk Counsdl ng*/
Pr natal Diagnositic Procedures ‘/Prenatal Diagnostic Tests* as defined in the aforesaid Act fora jjenoci of five
years ending on

...............

2. This registration is granted subject to the aforesaid Act and Rules thereunder, and any conti ave vtion thereof
shall result in suspension or cancellation of this Certificate of Registration before the expiry of the said period ot
five years.

A. Name and address of the Genetic Counselling Centre*/Genetic Laborarory*/Genetic Clinic*
B. Name of Applicant for registration
C. Prenatal diagnositic procedures approved for (geneli: clin. c)

(i) Ultraaound
(ii) Amr iocenteiis
(iii) Chorionic Villi biopsy
(iv) Foetoscopy
(v) Foetal skin or organ biopsy
(vi) Cordocentesis.

(vii) Any other (specify)
D. Prenatal diagnostic tests* approved (for Genetic Laboratory)

(i) Chromosomal studies
(ii) Biochemical studies

(iii) Molecular studies
3. Registration No. allotted
4. For renewed Certificate of Registration, only
Period of validity of earlier CertificateFrom

To

of

Registration.
Signature ,name fand designation of the
Appropriate /Authority
..
Date :
SEAL

♦Strike out wliichever is not ajpplicable or necessary.
DISPLAY ONE COPY OF THIS CERTIFICATE AT A CONSPICUOUS PLACE AT THE PLACE OF
BUSINESS.

. ■ .. - ---»jerfv^xvxA'-w"***

•• .

»

27

vi tww ; onnr»r

[wmll-rw 3(i)l

-————

form c
[See rules 6(3), 6(5) sirid ®(-01

REJECTION of APPLICATION FOR REGISTRATION OR
RENEWAL OF REGISTRATION

mb. TO)«'«»

In exercise c,tu»

»«”>■“ T“tol’"“

Clinic* named below for the reasons stated.
Name and address of the Genet c Coonsell ng Centre‘-/Gehel.ic

Laboratory*/Genetic Clinic®
Name of Applicant who has appl.ed foi registrat on
Reasons for rejection of t.plication for registration

Signature, name and designation of
Appropriate Authority.
.
Date

SEAL

•Strike out whichever is not applicable or necessary.

FOR M D

[See rule 9(2)1
NAME ADDRESS AND REGISTRATION.
COTWlLW^CEriTRE
RECORD TO BE MAINTAINED BY THE CENEJ1C COUNSELLING CLAIRE

1. Patient’s name

2. Age
3. Husband’s/Father’s name
4. Full address; with Tel. No. if any
5. Referred by (Full name and address of Doctor(s) with registration
No.(s) (Referral note to te preserved carefully
with case papers)
6. Last menstrual peri cd/
weeks of pregnancy
7. History of genetic/medical disease in the family (specify)
Basis of diagnosis :
(a) Clinical
(h) Bio-Chemical
(c) Cyto-genetic
(d) Other (e.g. radiological)

8. Indication for prenatal diagnosis*
A. Previous child/children. with:
(i) Ctu'cmosomal disorders
(ji) Metabolic disorders
(iii) Congenital anomaly

28

THE GAZETTE OF INDIA : EXTRAORDINARY

[Paf.t II—Sec. 3(i)]

(iv) Mental retardation
(v) Haemoglobinopa thy
(vi) Sex linked disorders
(vii) Any other (specify)
B. Advanced maternal age (—35 years)
C. Mother/father/sibling has genetic disease (specify)
D. Others (specify)

9. Procedure advised*
(i) Ultrasound
(ii) Amniocentesis
(iii) Chorionic Villi biopsy
(iv) Foetoscopy
(v) Feetal skin or organ biopsy
(vi) Cordocentesis
(vii) Any other (specify)
10. Laboratory tests to be carried out
(i) Chromosomal studies
(ii) Biochemical studies
(iii) Molecular studies
11. Result of prenatal diagnosis:
If abnormal give details.

Normal/ Abno rma 1

12. Was MTP advised?

13. Name and address of Genetic Clinic*
to which patient referred..
14. Dates of commencement and completion of genetic coun sell. cig.
Name, Signature and Registration No.
of the Medical Geneticist/Gynaecologist/
Paediatrickn.

Date

♦Strike out whichever is not applicable or not necessary.
Form E
[See rule 9 (3)J

NAME, ADDRESS AND REGISTRATION NO. OF GENETIC LABORATORY
RECORD TO BE MAINTAINED BY TM3 GENETIC LABORATORY
1. Patient’s name
X Age
3. Husband’s/Father’s name
4. Full address with Tel. No., if any
5. Referred by/sample sent by (full name and address
of Genetic Clinic (Referral note to be preserved care­
fully with case paper).
6. 'I'yps of sample : Maternal blood/Chorionic villus
Mmpte/amniotic fluid/Foeul bfood or other foetal tiosue
(Specify)

29
-

_________________



■.<■■!■

'

----------------------------------------------------------——

saes "f—■ ::sa«tKX=zr =-.s:=±

7. Specify indication for prenatal diagnosis
(A) Previous Child/cliildren with:

(i) Chromosomal disorders
(ii) Metabolic disorders
(iii) Malformation(s)
(iv) Mental retardation
(v) Hereditary haemolytic anaemia
(vi) Sex linked disorder
(vii) Any other/(specify)
(B) Advanced maternal age (-—35 years)

(C) Mother/father/sibling has genetic disease
(specify)
(D) Other /speiefy)

8. Laboratory tests carried out (give details)

(i) Cromosomal studies
(ii) Biochemical studies
(iii) Molecular studies

Normal/A.bnormal

9, Result of pre-natal diagnosis :
if abnormal give details
10 Date(s) on which tests carried out
The results of the pre-nataldiagnostic tests were conveyed to....

on

bame, sagnature and Registration num1>er of the
Medical Geneticist

Date

Form F
[See role 9 (4)]

■MAMF ADDRESS AND REGKSTRATILON NO. OF GENETIC CLINIC
S® TO BE MAINTAINEC BY THE GENETIC CLINIC
1. Patient5s name

2. Age
3. Husband’s/Father’s name
4. Full Address with Tel. No., if any
. Referred by (full name and address of doctor(s)/Genetic
Counselling Centre (Referral note to be preserved
carefolly with case papers).
6. Last meustro-al period/'

weeks of prognaney.

7. History of genetic/medical disease in the family
(specify).

Basis of diagnosis:

(a) Clinical
(b) Bio-Chemical
:

(e) Cytogenetic
(d) Other (e-g. radiological-specify)

THE GAZETTE OF :[NDIA.

30

[Part II—Sec. 3(i)]

EXT'.^ORDINARY

8. Indication for prenatal diagnosis

(A) Previous cliild/children with:
(i) Chromosomal disorders
(ii) Metabolic disorders
(iii) Congenital anomaly
(iv) Mental ratardation
(v) Haemoglobinopathy
(vi) Sex linked disorder
(vii) Any other (specify)
(B) Advanced maternal age (— 35 years)
(C) Mother/father/sibling has genetic disease (specify)
(D) Other (specify)
9. Procedures carried out (with name and registration No,
of Gynaecologist/Radiologist/Registered Medical
Practitioner) who performed it
(i) Ultrasound
(ii) Aminiocentesis
(iii) Chorionic Villi aspiration
(iv) Foetal biopsy
(v) Cordocentesis
(vi) Any other (specify)
10. Any complication of procedure—please spxify

J1. Laboratory tests recommended*
(i) Chromosmal studies
(ii) Biochemical studies
(iii) Molecular studies
12. Result of pre-natal diagnostic procedure and specify
abnormality detected, if any.

Normal/Abnormal

13. Was MTP advised/conducted
14. Date(s) on which, procedures carried out.

15. Date on which MTP carried out.
16. Date on which, consent obtained.
17. The result of pre-natal diagnostic procedure were
conveyed to
..................
cm
Name, signature and Regstration number of the
Date
Gynaecologiist/Radiologist/Registcred
hledical PracPlace
tvtio'icr
* Strike out whichever is not appliable or not necessary.

FORM G
(See rule ' O)]
FORM OF CONSENT

I,

vdfe/dftughter of
•••>•’...................................................................................

ago

.years

residing at

hereby state that 1 have betni explained fully the probable side eifoctei and after effects of the pre-natal diagnostic

31
• vwavr7T________ _____ ====—±1===-===

W

the absence of deformity or d.sotders.

tbe pr(:..natal Dia.

Signature

Date

Place

. lhe nark nt and her companion (Name
,nsent to the pauc nt
Address
L have explained the contents of the above co:
iagnague'she/they understand.
) in a

relationship

Name, signature
cohgist

Date

Ns me, address
xic Clinic

and Registration number of Gynae-

and Registration number ot Gene-

form h
I See ru!l« 9(5))

PERMANENT record of
rejection of .-----

roAK'T OF REGISTRATION,
«"T,w
RENEWALS OF

1. SI. No.
Authority.
2. File number of Appropriate
for grant of rogistraton.
3. Date of receipt of application
of Applicant.
4. Name, Address, Phono/Fax etc.
■tic Counselling Centre*' Gaelic
5. Name and ^tess<6S>^M'
Laboratoy*/ Genetic Clinic.
6. Date on which case
J
ctmStS^summary,
and recommendation of Advisory

of issue of orders).

allotted and date ol expiry of re8. Registration number
gistration.
9. Renewals (date of renewal and renewed upto)

10. File number in which renewals dealt.

H. Additional information, if any.
Authority

4

32

THE GAZBTTE Of INDU : ILNT RAO RD1NARY

.-i-r-iriuiiMin i ri ririTiri^iirfii—ri>~ r-r-r-—;—-m-----r~

[Part JI—Src. 3(i)]

n - r----- - ------*--------------- r',T------- - -------------------

Guidance for Appropriate Auihority
(a) Form H is a permament reoerd to be maintained as a register, in the custody of the Appropriate Authority.

(b) *means strike out wcllier is not applicable.
(c) Against item 7, record date of issue of order in Form B c r Form C.
(d) On renewal, the Registration Number of the Geneti : Corbelling Centre/Genetic Laboratory/Gonetic Clinic
will not change. A fresh registration Number will be allotted in the event of change of ownership or management.

(e) No registration number shall be allotted twice.
(f) Each Genetic Counseling Centre/Genetic La-boratory/Geaetic Clinic

maybe allotted a folio consisting

of two facing pages of the Register for recording Form H.

(g) The space provided for ‘additional information’ may b> used for recording
rejection of application for renewal, change of ownership/management, outcome of any legal proceedmgB,
etc.
(h) Every folio (i.e. 2 pages) of the Register shall bo authenticated by signature of the Appropriate Authority,
with date, and every subsequent entry shall also be similarly authenticated.

Printed by the Manager, Govt, of India Pnwa, Ring
Majfli Pun. New Delhi-110064
and IPabliH&ed by the «ta*troHor ♦!? P-jblicR ion«, Delhi-110054, 1996

r-

<*

Tfasft ho xtoqn0-33004/94

REGISTERED Na DL-33004/S4

-'^fce Gazette <rf.£$v.dia
Hs-TURq

EXTRAORDINARY
Mhi IT
1
PART 11—Section 1

snfHwrrr $ jrwnfn<r
PUBLISHED BY AUIHOR1T)
HO 74]
No. 74]

I

nf fcHT,
20, 1994/TO 29, 1916
NEW DELHI. TUESDAY, SEPTEMBER 20, 1994TJHADRA 29, 1916

vpt if'Srrr to

hwjhhw?i

<n

Separate piiRinq t« piven to bus Part in order th*t it may be filed as a separate compUatiou.

MINISTRY OF LAW. JUSTICE AND COMPANY AFFAIRS
(Legislative Department)

New Delhi, the 2Qth September, 1994/Bhadra 29. 1916 (Saka)

i he following Act of Parliament received the assem of the President
on the 20th September. 1994, and is hereby published foi general infor­
mation: —
|PRE-NATAL DIAGNOSTIC
_
TECHNIQUES (REGULA.

T1ON AND'PREVENTION OF MISUSE} ACT.' 1994
No 57 of ln94
[201h September, 1994.]

An Acr 10 provide for the regulation of the use of pre-natal diagnostic
techniques for the purpose oi detecting genetic or metabolic dis­
orders or chromosomal abnormalities or certain congenital mal­
formations or sex linked disorders and for the prevention of tlie
misuse of such techniques for the purpose of pre-natal sex deter­
mination leading to female foeticide, and for matters connected
there with or incidental thereto.
Be it enacted by Parliament in the Forty-fifth Year of the Republic of
India as follows: —

CHAPTER I

Preliminary
1. (1) This Act may be called the Pre-natal Diagnostic Techniques
(Regulation and Prevention of Misuse) Act. 19^4.
extent and
commcoca*

(2) It shall exiena to Ute whole of India-except—tlie-State-of-Jxuumu —nlcnt__
and Kashmir.
€A L T N

L-1 co z

07394"

*?J
,j

'‘V <•'

>



THE GAZETTE OF INDIA EXTRAORDINARY

[Pakt II—

(5) It Bhall come into force on such dsto as the Central Government
a^y.. by notiheguon in the Official Gazette appoint.
DefLni-

2. In thia Act, unless the context otheiwise requires,

11OD3.

(a) ‘Appropriate Authority" means the Appropriate
appointed under section 17;

Authority

(b) “Board" means the Central Supervisory Board constituted
unaei section 7;
(ci “Genetic Counselling
means—an
« Centre"
- - -------i institute, hospital,
nursing home orr any place, by whatever name called, which provides
lor genetic counselling to patients;
<d) “Genetic Clinic" means a clinic, institute, hospital, nursine
home or any place, by whatever name called, which is used for con­
ducting pre-natal diagnostic procedures;

(e) "Genetic Laboratory" means a laboratory and includes a
place where facilities are provided for conducting analysis or tests
of samples received from Genetic Clinic for pre-natal diagnostic test;
■.•) “g^’naccoiogist" means a person who possesses a
'.iur.te qualification in gynaecology and obstetrics;

posugra-

(p) "medical geneticist” means a person who possesses a degree
ir diploma or certificate in medical genetics in the field of pre-natal
diagnostic techmoues or has experience of not less than 'wo years in
such field after obtaining—

any nne of the med;cal qualifications
the Incuan Medical Council Act, 1956; or

recognised

under

102 of 1350.

(^) a post-graduate degree in biological sciences:

•GC “pjediatncian" means a verson who possesses a posi-graduaJe
aualificaimn in naeaiatncs:
in •■pre-nata; diatmostic procedures” means all gynaecological or
ocstetrical or medical procedures such ns ultrasonography foetoscopy,
taking or removing sampies of amniotic fluid, chorionic villi, blood
or any tissue cf a nr^^nni woman for being sent m a Genetic Labora­
tory or G?r.euc Clinic for conducting pre-natal diagnostic test;

•j) “pre-natai diagnostic techniques”
includes all
diagnostic procedures and pre-natal diagnostic tests:

pre-natal

Uc) "rre-naial diagnostic test" means ulirasonoginphy or any <cs'
or analysis of amniotic fluid, chononic villi, blood or any tissue of a
precnant woman conducted ;o cietcct gencur o»- metabolic disorders o«
Chruni soma! acnormninic^
r-’nqcnua] nnomniirs or nncnioqlobinooathics or sex-lrr.kcd diseases:
*7) • pres: red" .’ncar.s prescribed bv rule? made unde’ 'his Act(»n i * rc?is:crrn mcd'crl i ractdioner” means a medical practitioner
•x hn nnssc^ci: any recognised medical qualification ns defined in clause

(hi of section
of th? Indian Medical Council Act. 195G. and
■•■nose name has beer entered m a State Medical Resister:

102 011350

S£C. 1]

THE GAZETTE OF INDIA EXTRA ORDINARY

3

(n) “regulations” means regulations framed by the Board under
this Act.
CHAPTER II
Regulation of

Genetic Counselling Centres Genetic L
/. a bun awr it's
and Genetic Clinics

3. On and from the commencement oi this Act —

Regulanoa of

(1) no Genetic Counselling Centre, Genetic Laboratory or
Genetic Clinic unless registered under this Act, shall conduct or
associate with, or help in, conducting activities relating to pre-natal
diagnostic techniques;

<»eDeiic

(2) no Genetic Counselling Centre, Genetic Laboratory or Gene­
tic Clinic shall employ or
cause to be
employed any person
who
does not possess the prescribed qualifications;

Counsel­
ling
Centres,
Genetic
La bo ra­
te nes anj
Genetic
Clinics.

(3) no medical geneticist, gynaecologist paediatrician registered
medical practitioner or any other person shall conduct or cause to
be conducted or aid in conduchnc by himself or through tny other
person, any pre-natal diagnostic techniques at .a place other than a
place registered under this Act.
CHAPTER III

Regulation of pre-natal djagnosuc ieciiniques

4. On and from the commencement of this Act,—
(1) no place including a registered Genetic Counselling Centre
or Genetic Laboratory or Genetic Clinic shall be used or caused to
be used by’ any’ person for conducting pre-natal diagnostic terhni.
ques except for the purposes specified in clause (2) and after satis­
fying any of the conditions specified in clause (3);

(2) no pre-natal diagnostic techniques shall be conducted except
for the purposes of detection of anv of the following
abnormalities.
namely:—

(Z) chromosomal abnormalities;
(u) genetic metabolic diseases;

(hi) haemoglobinopathics;
(iv) sex-linked genenc diseases;

(v) congenital anomalies;
(v:) any other abnormalities or diseases as in iv be specified
by the Central Supervisors Board;

(3) no pre-natal diagnostic techniques shall be used or conducted
unless the person qualified to do so is’ ■"satisfied-flint any oi Tfic Tdl^
lowing conditions are fulfilled, namely: —
(i ) apo

tlio precnnnt woman is above thirty-five years;
r

Repulatioa
of pre­
natal
difnosdc
techniques.

4

THE GAZETTE OF INDIA EXTRAORDINARY
Ltle PreS2ni woman has undergone of
spontaneous abortions or foetal loss;

two

l*\*T

or

more

(iu) the
pregnant woman had been exposed to pountially
teratogenic agents such as drugs, radiation, infection or chemicals;

pregnanl wo^n has a

retarX

°r
other genetic disease;

deformities

family history of mental
such as spasticity or any

(v) any other condition as
may be specified by th® Central
Supemsory Board;
(•H no
j----- being a relative
person,
or the husband of the pregnant
woman shall seek
------ °r encourage the
conduct of any prc-ruml diagnosuc techniques on her except for the
purpose specified in clause
(-).
VVnurn
codscd:

pregnant

5. (I) Mo person referred to in clause (2) of
* he ore-natal diagnosuc procedures unless—

ano
prontciuon
of commu.
’iicating •*'c

rcx cf
fort us

section 3 shall conduct

2’ oe has expla.ned all knovvn side and
after effects of
proccnurcs to the pregnant woman concerned;

such

(b) he has obtained
m the presen bed form her
written consent
<o undergo sucn procedures in
the
language
which
she
understands:
and

(c) a copy of her
wrtiicn cunscm outaincd under du use (bi ix
Civen to the pregnant
woman

(-) No person conducting pre-nata]
diagnostic procedures
shall
communicate to ne pregnant woman concerned
or
her
relatives
the
of the foetus by words
sex
signs or in any other manner.
. Lk rim.
-j.ion <

^nc from -\e .ommencemvn;

b

of this Act,—

nu •>eneiir C

'Ui

Centre or Genetic 1-aboratory
'
or
Genetic Chmc snal| conuJk,
• cause to be conducted in its Centre,
Cj oora ton. or Clinic,
prr-nat-l diagnostic techniques including ultrasonogrnDr.’.- for *‘’r
— no>r cf
of determining
dctermm.nr the
th. scx
B foetus;
(bi r.o person, ^nall conduct or cause
to be conducted env
any preta; thaz:n03.»c ’.eenniqurs .nciudmg u
’trasonography for the
—‘ puroosc rf determining the
...? »ex cf a foetus

t


S7!ArTER JV
.—
t•

• ntro

Eoara.

T (?)
■ nenvr.

•C

'rr:r’—

. _• n

•’

I KA.

'

r• k\

CT.


F ip'

n-ill
constitute a Board to be
Ho^rd to exercise the powers
and
: t- r Board under this Act.

'*•'

r'r' mnic-’-c

T:'- B

ccnik; ef —
.-.in’Ste-

•• no

:r.

'finI! t ,



r»- "f

the Mimstrv nr Department of

' <•.urman. rr of/iriy;

.Cv

Sec. IJ

5

THE GAZEITE OF INDIA FXIRAORD1NARY

'^e
VD) the Secretary to the Government of India in charge
be
Uie
Vlce-Cludnunu.
Department of Family Welfare, who ahull
ex-officio;
(c) two members to be appointed by the Central Government
■ o represent the Ministries of Central Government in charge of
Woman and Child Development and of Law and Justice, ex-offxcio:
(d) the Director General of

Health

Services of

the

Centre!

Government, ex officio;

(e) ten members to be appointed by
two each from amongst—

the Central Government.

(i) eminent medical geneticists;
i

(it) eminent gynaecologists and obstetricians;
(iii) eminent paediatricians;

(iv) eminent social scientists; and
(v) representatives of women welfare organisations:

(f) three women Members of Parliament, of whom two snail he
elected by the House of the People and one by the Council of States:

(g) four members toj be appointed by the Central Government
States and the Union territories, two in
by rotation to represent the
t,
the alphabetical order and two in the reverse alphabetical order:
“ under this clause shall be made
Provided that no appointment
the
recommendation
of the State Government Or. as the
except on
case may be, the Union territory;
(h) an officer, —
noti below the rank of 3 Joint Secretary <>r
Government, in charge of Fnm»lv Welfare.
equivalent f1 the
— Central
who shall be the Member~5yi-cretary> ex officio.

8. (1) The term of office of a member, other than an er
shall be.—

officio mem­

(a) in case of appointment under clause (e) or
sub-section (2) of section 7. three years; and

clause (f) uf

sub(b) in case of appointment under clause io) of the said
section, one year.
----- r occurs in the office of nny » other members,
(2) If a casual vacancy
’lhy m discharge his
his death, resignation or inab
i
whether by reason (of
------shall be filled
functions owing to illness or other incapacity, such vacancy
making a fresh appointment and i he
bv ihe Central Government
by
shall hold office for ‘hr remainder of thr term of
member so anoomted
office of the person in whose place he is so appointed.
as mav he
<3} The Vice-Chairmani s’nall perform such functions
£he_Chairma
n from time to <’me.
assigned to him. hy_L-~
—- ---(4) The procedure to be followed 'byr the members in the dischareo
<)f then functions s’nall be such as may he
1 prescribed.

’J erm el
ofike of
member*.

\

THL GAZETTE OF

6

[Paai II—

• '• 2 and place, and'shall observe
0. (/) The Board shall meet at such time
■ • transaction of business at its
such rules of procedure in regard to the tsuch’ meetings) us may be provided
meetings (including the • quorum at J----- in- rccui.nlions:

L'ccu-i'e
«•’

INDIA EXTRAORDINARY

the .

Lronrd.

Proviaea that the Board shall meet at least once in six months.
(2) The Chairman and in his absence the
me meetings of ihe Board.

Vice-Chairman shall preside

if for
ii
lor any
any reason
reason the
the Chairman
Chairman or
or the
the Vice-Chairman is unable
:o attend any meeting of the Board, any other member chosen by the
members present at the meeting shall preside nt the mcctinc.
14 • Al.
Al. questions
questions which come up before any meeting of the Board
email be Qecidea by a majority of the votes of the members present and
voting, and in the event of an equality of votes, the Chanman. or in his
absence, me person presiding, snail have and exeicise a second or casting

vote.
.5, Memeers other than ex off.cm members shall receive such allowar.ces.
anv. from the Board as may be prescribed.
Board shall be invalid merely
.\o act or proceeding of the
reason of—
defect in the constitution of,
(n» any vacancy in, or any
10

■'IO1

1

nvjiiJJ* -

r.rccocd.
mgs
or the
Board

by
the

Board: or

(b) anv defect in the appointment of a person acting as a memher of the Board:

or

to any irregularity in the procedure of the Board not affecting
the merits of the case.

Ji
The Board
associate with itself, in such manner and for
.
irnosvr
may
oe
oeieimined
by regulations,, anv person whose
2UCF. C J
assistance or scvice it mav desire in cnn>ing out
t- any of the provisions
11

■•eriv n.

rf this Ac;

i:>r

EO.'IJ

t

CJFUCUlV
r umo’C’

\ppotr.;ment r’
□ibcrri
and
other eni.
FJOVCtA

nf

(21 A oerson associated with it bv the Board under sub-section (/ )
take part in the discussions relevant
lor anv purpose siiall have a right to
i right to vote at a meeting of the
to that purpose, but shall not have a
any other purpose.
Board and shall no: be a memoer for
f

' 12 U) For the purpose of
of enabling it efficiently
eiucicm-.y to discharge
its
functions under this Act. the Board may, subject to such regulaUonsw
on deputation or othermay be made in. this bahalf. appoint (whether
employees as it may consider
such
number
of
officers
and
other
wise) t----- ---------necessorw

of such category of officers, as may
Provioeci that the zpoointment
such retniiatrons. shall be subject to the approval of the
be specified, in
Centra. Government.
F.verv officer or other emoiovee appointed by the Board sbaB be
subject to such condit.ons of ^ervie^and-ShalLbe entitled to such re-

muneiatior. - ..ia.

be rocuned in the regulations.

I
Sec. 1]

THE GAZEFTE OF INDIA EXFRAORDINARY

13. All orders and decisions of the Board shall be authenticated by A ulhcDii ca­
*die signature of the Chairman or any other member authorised by the rion of
orders and
Board in this behalf, and all other instruments issued by the Board shall other inoe authenticated by the signature of the Member-Secretary or any other sirnmctiK
<»r ihe
olliccr of the Board authorised in like manner in this behalf.
Board.

14. A person shall be disqualified for being appointed as a member
d, he—

(a) has been convicted and sentenced to imprisonment for an
•'•lienee which, in the opinion of the Central Government, involves
moral turpitude; or

Disquaiiiicttioits
lor
.inpointmcnc as
mcmlH'i.

(b) is an undischarged insolvent; or
(c) is of unsound mind and stands so declared by a competent
court; op

(d) has been removed or dismissed from the service of
the
Government or a Corporation owned or controlled by the Govemmeat; or

(e) has. in the opinion
of the Central Government,
such
financial or other interest in the Board as is likely to affect pre­
judicially the discharge by him of his functions as a member; or
(f) has. in the opinion of the Central Government, been asso­
ciated with the use or promotion of pre-natal diagnostic technique
for determination of sex.

15. Subject to the other terms and conditions of service as may be
prescribed, any person ceasing to be a member shall be eligible for re­
appointment as such member.
!C. The Board shall have the following functions, namely: —

ii) to advise the Government on policy matters relating to use
"i pre-natal diagnostic techniques;

I Hphilily
”f member
for re.
uppointni» nt.
Func­
tions
of the
Board.

(ii) to review implementation ?f the Act mid the rules made
tiiercunder and recommend changes in the said Act and rules to the
Central Government;

(hi) to create nubhc awareness against inc practice of pre-natal
Jetermination of se:: and female foeticide;
(iv) to lay down code of conduct to be observed by persons
working nt Genetic Counselling Centres. Genetic Laboratories and
Genetic Clinics;
(”) any other functions as may be specified under the Act.
CHAPTER V

AppnorniATZ Authority’ and Advisory Committee
17. (/) The Central Government shall appoint, by notification in the
^’:Tic:al Gazette, one or more Appropriate Authorities for each of the
Union territoric.’ for the purposes of this Act.

f

Appro­
priate

riiy and
\dvisory

THE GA7FITE OF INDIA EXTRAORDINARY

S

[PamtU—

(2) The State Government shall appoint, by notification in the Offi­
cial Gazette, one or more Appropriate Authorities for the whole or port
of the State for the purposes of this Act having regard to the intensity
of the problem of pre-natal sex determination leading to female foeti­
cide.
(3) The officers appointed as Appropriate
section < • ) or sub-section (2) shall be.—

Authorities under

sub-

(a i wnen appointed for the whole of the State or the Union
territory, of or above tlie rank of the Joint Director of Health and
Family Welfare; and

(b) when appointed foi any part of the State or
the Union
:2Tr::or\, of such other rank as the State Government or the Cen­
tral Government as the case may be. may deem fit.
The Appropriate Authority shall have the following functions,
name!'.-. —
(a) to g«ant. suspend or cancel registration of a Genetic Counselling Centre. Genetic Laboratory or Genetic Clinic;

(ui to enforce standards presciibed for the Genetic Counselling
Centre. Genetic Laboratory and Genetic Clinic;
(c » to investigate comolaints of breach of the provisions of this
.Act or the rules mnae thereunder and take immediate action; and

to ieeK and consider the advice of the Advisory Committee,
consututcc under sub-section (fi). on application for registration
cn-i on complaints for suspension tn cancellation of registration.
(d i

(5i The Central Government or the State Government, as the case
max be. sr.r.all constitute an Advisory Committee for each Appropriate
Autnoritv to am Snd advise the Appropriate Authority in the discharge
shall appoint one of the members of the Advisory
of its funchnns and
:
Comrr.ir.v? *o oc its Chairman.

(6)

Aa-.isorx

Committee shall consist of—

j-rce medico, experts from amongst gynaecologists, obstericians. paediatricians ano mtuical geneticists;
i

( b > one legal expo*’:
(Ci one officer to represent the department dealing with iniormanor, and pubheitv of the State Government or the Union territory as the case may be:

id) three eminent social workers of whom not less than one
snail he from amongst representatives of womens organisations.
-j of the Central Government or the
person who. in the opinion
be.
State Government as the case may L has been associated with the use
•r rrnmotion of ore-natal diagnostic technique for determination of sex
“nail re .iomin’ec as a memoer of the Advisory Committee.
(7)

\’o

Acvisorv Committee m.iv meet as and when it thinks fit o»
cues;
of the Appropriate Authority for consideration of any^
lllv
application for registration or □ nv complaint for suspension or ’canccllai s i

*.;or.

rer::••ation and t<x rive advice thereon:

Sec. 1]

THE GAZETIE OF INDIA EXTRAORDINARY

9

Provided that the period intervening between, any two meetings shall
not exceed the prescribed period.
(9) I’lie terms and conditions subject to which a person
mny be
appointed to the Advisory Committee and the procedure to be followed
by such Committee in the discharge of its functions shall be such as
may be prescribed.

CHAPTER VI
Registration of Genetic Counselling Centres, Genetic Laboratories
and Genetic Clinics

18. (1) No person shall open any Genetic Counselling Centre, Genetic
Laboratory or Genetic Clinic after the commencement of this Act unless
such Centre, Laboratory or Clinic is duly registered separately or jointly
under this Act

(2) Every’’ application for registration under sub-section (2), shall be
made to the Appropriate Authority in such form and in such manner and
shall be accompanied by such fees as may be prescribed.

Regiitration
of Genetic
Counselling
Centres,
Genetic
Laboratories
or
Genetic
Clinics.

(3) Every Genetic Counselling Centre, Genetic Laboratory or Genetic
Clinic engaged, either partly or exclusively, in counselling or conduct­
ing pre-natal diagnostic techniques for any of the purposes mentioned in
■ section 4, immediately before the commencement of this Act, shall appty
for registration within sixty days from the date of such commencement.
(4) Subject to the provisions of section G, every Genetic Counselling
Centre. Genetic Laboratory' or Genetic Clinic engaged in counselling or
conducting pre-natal diagnostic techniques shall cease to conduct any
such counselling or technique on the expiry of six months from the date

’l Centra.
Centra, Laboratory or Clinic
of commencement of this Act unless
such
has" applied for registration and is so registered separately or jointly or
till such application is disposed r:. f,
f. whichever is earlier.

*
(5) No Genetic Counselling Centre. Genetic ■Laboratory
or• Genetic
this
Act
unless
the
Appropriate
AuthoClinic shall be registered under
satisfied
that
such
Centre.
Laboratory
or
Clinic
is
in
position
to
r‘ty is
such
eau

pment
and
standards
as
may
provide such facilities, maintain
be prescribed.
‘j shall, after holding an inquiry
19. (/) The Approonatu Authuuly
and after satisfying itself that the aoplicant has complied with all the
rules made thereunder and having
requ'rements of this Act and the
r Committee in this behalf, grant a
regard to the advice of the Advisory
he pi escribed form jointly or separately to
certificate of registration in th_
Clinic,
Counselling Centre. Genetic Laboratory or Genetic
the Genetic <_
as the case may be.

opportunity of being
(2) IT. after the inauirv and after giving an
advice
of the Advisory
heard to the applicant and havind regard to the
Committee, the Approonate Autliorai.s. ?U
t

„„pU.d W,th th=
for reasons to be recorded m wnunu. reject
♦ration.

A« . fe n ’.
me

Certificate
of regis­
tration.

1 HE GAZETTE OJ INDIA EXTRAORDINARY

IO

(Part n—

(3) Every certificate of registration sliall be renewed in such manner
and after such period and on payment of such fees as may be prescribed.

(4) The certificate of registrav.on shall be displayed by the registered
Genetic Counselling Ccnne. Genetic Laboratory or Genetic Clinic in a
conspicuous place at its place of business.
Cancella­
tion or
suspen­
sion o:
registration.

20. (1) The Appropriate Authurilv may suo moio, or on complaint,
issue a notice to the Genetic Counselling Ccntie, Genetic Laboratory or
Ger.ct.j Cinnz to snow cause wny its registration
should not be suspended or cancelled for the reasons mentioned in the notice.

(2) If. after giving a reasonable opportunity of being heard to the
Genetic Counselling Centre. Genetic Laboratory’ or Genetic Clinic and
naving regard to the advice of the Advisory Committee, the Appropriate
Autnonty is satisfied that there has been a breach of the provisions of
this Act or tne rules, it may. without prejudice to any criminal action
that it may take against sucn Centre. Laboratory or Clinic, suspend its

registration fur ^uch period as it may think fit or cancel its
as the cjic may be.

registration,

Nut a lULktaaduiy jiivifiiiig
cunijincd
in
sub-scctions (1) and
-if me Appruprum: Aulhornv is. of the crpinion that it is necessary
or expedient >□ to do in the public intcicst, it may. for reasons to be
recorded in writing, suspend the registration of anv Genetic Counselling
Centre. Genetic Laboratory or Gvnetic Clinic without issuing any such
notice reicrrcG to in sub-section (1).
Appeal

The Genetic Counselling Centre. Genetic Laboratory or Genetic
wdntn tnir\\ da\3 from the date of receipt of the order of
sujocnsion or cancellation of reg-str 'lion passed by the
Appropriate
Autfioui v jr.ucr section 20 prefer an appeal against such order to—

21

Clinic mat,

<: j n«e Ccntui
orccr
:r.o Central

u.ernmen’.. wnere the appeal is
^pronriate Authority; ann

i

oruv»

jie

•"•j' -

against

the

■•.here the appeal is against
•Xumority,

tlie

tnc presenoeu manner

chapter VII
CnrtSTL. AND PINAL71LS

Prnliiiiiiion
of auvernsemcn:

rciannc to
prr-ntiiid
Jcicrinina
lion of sex
□ nd punish­
ment for
c.mtri^en'•or.

22. ( J ) L-» nyi SUN
’!fm. .n.tn l.vncuc Counselling Centre, Genetic
La bora to - * or G .•n*?t:. Ln.i ".a.
issue or cause to be issued any advertKcmcn: ir an-, m.-.riu ’
’’ninr firiiiijrs of pre-nntnl dclorniinnlion
S-' . VT' -I.I,.
: xUcJ
.-•horniory. Clinic or any other place.

l-J

?»i

i
.. * r iJO
n •:
i-'f
1:

:

., f, •

♦.

.•.n: ••.•r .

faedr.-pr ■
nr'*-r.aiirtc.-r
Coun.-ie: mLeneuc
rlacc

•r

-nai; publish or distribute or cause to

• nertisement in any manner regarding
c. scy
available at anv Genetic
Laoorainrv.- Genetic Clmic“or"any other

Fxc. 1]

THE GAZE] IE OH INDIA EX i RADRD1NARY

11

(3) Any person who contravenes the provisions of sub-section (I) or
sub-section (2) shall be punishable with imprisonment for a term which
may extend to three years and with’ fine which may extend to ten thousand
rupees. •

Explanation.—For the purposes of this section, “advertisement” inclu­
des any notice, circular, label wrapper or other document and
also in­
cludes any visible representation mode by in’-'nns of any Hfjht, sound,
smoke or gas.
23. (1) Any medical geneticist, gynaecologist, registered medical prac­
titioner or any person who owns a Genetic Counselling Centre, a Genetic
Laboratory or a Genetic Clinic or is employed in such a Centre, I«nboraor at
tory or Clinic and renders hig professional or technical services to
such a Centre, Laboratory or Clinic, whether on an honorary basis or
otherwise, and who contravenes any of the provisions of this Act or
a
rules made thereunder shall be punishable with imprisonment for
term which may extend to three years and with fine wh'ch may extend
to ten thousand rupees and on any subsequent conviction, with imprison­
ment which may extend to five years and with fine which mav extend to
fifty thousand rupees.

OfTc—ts
and
penalJcs.

has been
(2) The name of the registered medical praciitiono’- who
the
convicted by the court under sub-section (1), shall be rcporicd by
Appropriate Authority to the respective State Mrd;cnl Council for taking
necessary action including the removal of his name from the register of
the Council for a period of two years for the first offeree and permanently
for the subsequent offence.

c

(3) Any person who seeks the aid of a Genetic Councclling Centre.
Genetic Laboratory or Genetic Clinic or of a medical geneticist, gynaeco­
logist or registered medical practitioner for cond^ctinr nrr-natal diagnostic
techniques on anv pregnant woman (including such woman unless she wag
compelled to undergo such diagnostic techniques) for purnoses other than
those specified in clause (?) of section 4. shall,
nunishable with impri­
sonment for a term which mav extend to thrr*0 vmrr nnd with finewhirh
mav extend to ten thousand rupees and on any s'Vib’Cqucnt conviction with
imprisonment which may extend to five years and with fine which may
extend to fifty thousand rupees.

1 of 1872.

24. Notwithstanding anything in the Indian evidence Act, 1072, the
court shall presume unless the contrary is proved that the pregnant
undergo
been compelled by her husband or the relative to
woman has
1
pre-natal diagnotic lechniquc anti such perron sni’ll be lia.uc for• abetshall bo punishment of offence under sub-section (>) of section 23 and
:
able for the offence specified under that section.

Pre-umplion in the
case of
conduct of
pre-natal
diagnostic
techniques.

25. Whoever contravenes any of ihc provisions m‘ this Act or any Prunlty
prorules made thcrouncler. for which no penalty b " ’ rrn <’: V‘whcre
ven( ion of
nirn? fo’'
? >term
vided in this Act. shall he punishable with env
tlw pruvtwhich may cxfcrvl to three months o’ with fine, which may extendI to vions of tho
contrn- Act or ruler
one thousand rupees or with both and in the erwe of continuing


-TTve
hutrJred-tep
eeswhich
vention with an additional Tine which may cxtrmv
for even’ day during which such contravention r^n’:nu?g after conviction
for the first such contravention..

provide^

_________________________________ .

■_______________________________________________________________________________________________________________________

TllE GAZETTE OP INDIA EXTRAORDINARY

12

Offences
by. com­
panies.



(Ramt H—

26. (1) Where any offence, punishable under this Act has been commined by a company, evetv person who. at the time
the offence •wa3
committed was in charge of. and •was ics»»onsibie to. the company for the
conduct of the business of the coiup mv a- v- ’l a* the company, .shall ixi
deemed 10 be cuiltv of the offence and shall be Hable 10 be proceeded
against and punisned accordingly:
Provided that nothing contained in thH sub-section shall render any
sucn person liable ro nnv punishment, if Im nrnvrs ihnt the offence WAR
committed without }>•«> know
knowledt
’e or thn' hi- h-td exercised all due <U1U
led tx
ccr.cc to prevent the commission of such offence.

(2) Notwithstanding anything con-ained in sub-section (/). where
any offence punishable under this Act has been committed bv a company
and :: is proved that the offence has been committed with the consent
or connivance or. or is attributable to nnv neelect on the part
of. any
director, manager, secretary or other officer of the company, such director
manager, secretary or other officer shall also be deemed to be guilty
Of
the: offence and shall be liable ’o be proceeded against and punished
□ ccordinEly.

HrDinnc.'ion.—For the purposes of ibis section.
(ci "company” menne nnv bod-- crrpcinte and includes a firm
or
other nssocntion of individuals, and

1 k)

Offence to
tc COgQJzanic. dod-

director . in relation to a firm, mesns a partner in the firm.

27. Ever;, olicncc under
nor.-ccmTTouncahlc

tin

An -h ll Ik- corni7:ihlc. non-haii.iblc :ind

t a U a Cue
eno noncu£3 poundct t.

Cocnxraccc
c: oJcncc:.

28 f.’) ?7n m-«-* <-bnl! •n!rr <-^70:7.1000 nf .-.n oTcnce under this
excent or 3 comoln-nt made bv —

Act

(a) the Annr^pnate Authcruv ronmrnec. or nnv officer nuthonsen in thm. behalf ’*v *hr Con’rnl Government nr State Government,
ns th<» case mnv be. or tne Aonronriate Au’horitv; or

fb) a person who h»s
nnt-rr* «»f H<'t
than thirty
days
in the manner nre^rnbr^4 tn ihr
Arnrnnr;n»e Authoritv.
nf ihr
alleged offence and nf hi«; -n’r-vinn tn m-»’rP n romplninf to the court.

—For thP "ornnep. of »h:s House, “perron”
rocial orrnrusn’-rn

includes n

(2) Nn enurr nrher »hnn ’’n nf •> AAnirnnn’-tnn Vnnttnlr nr n Judfria] /.'amstrn'e of the rir?f r'-'«>r c5-»u tr»- nnv r>nrenrr nun’shnblc
under
’hrs Act
,
•tnfJnr r’MKr p»Y of
rnK^er’-on
’nn
—n« Pr» t'pmpnd kv cur’s nor^nn direct the Aopmnmvp A'Jt.hnrw to mn’m nvndah’c ron;nc of the rclcv.inr iceord.s in
pn^ecemr m «-t;rp

1

1
Sec. 1]

THE GAZETTE OF INDIA EXTRAORDINARY

13

CHAPTER VllI

Miscellaneous

all
29. (/) All records, charts, forms, reports, consent letters and
other documents required to be maintained under this Act and the rules
shall be preserved for a period of two years or for such period as may lx?
prescribed:
I

Mainte­
nance of
records.

Provided that, if any criminal or other proceedings
pnxzccdings are instituted
against any Genetic Counselling Centre, Genetic Laboratory or Genetic
Clime, the records'and all other documents of such Centre, Laboratory of
Clinic shall be preserved till the final disposal of such proceedings.

(2) All such records shall, at all reasonable times, be made available
for inspection to the Appropriate Authority or to any other person autho­
rised by the Appropriate Authority in this behalf.
30. (7) If the Appropriate Authority has reason to believe that an
offence under this Act has been or is being committed at any Genetic
Counselling Centre, Genetic Laboratory or Genetic Clinic, such Authority
dr any officer authorised thereof in this behalf may. subject to such rules
as may be prescribed, enter and search at all reasonable times with such
assistance, if any, as such authority or officer considers
necessary, such
Genetic Counselling Centre, Genetic Liboratory or Genetic
Clinic and
examine any record, register, document, book, pamphlet, advertisement or
any other material object found therein and seize the same if such Autho­
rity or officer has reason to believe that it may furnish evidence of the
commission of an office punishable under this Act.
2 of 1974.

Power to
search and
seize records,
etc.

(2) The provisions of the Code of Criminal Procedure, 1973 relating
to searches and seizures shall, so far as may be. apply to every search oi
seizure made under this Act.

against
31. No suit, prosecution or other legal rrcxrccding shall lie
the Central or the State Government or the Appropriate Authority or any
officer authorised by the Central or State Government or by the Authority
for anything which is in good faith done or intended to be done in pursu­
ance of the provisions of this Act.

Protection
of action
taken in
good faith.

i

f
32. (1) The Central Government may make rules for carrying out the
provisions of this Act.

(2) In particular and without preiudicc. to the generality oT the fore­
going power, such rules may provide for—
(i) the minimum qualifications for persons employed at a regis­
tered Genetic Counselling Centre. Genetic Laboratory or Genetic
Clinic under clause (/) of section 3;

f/7) the form in which consent of a pregnant woman has to be
obtained under section 5:

(f/’f) the procedure to be followed “by-the-members-of-thc—Central
Supervisory Board in (lie discharge of their functions under sub­
section (4) of section 8;

Power to
make rule*.

-A
the gazette of INDIA EXTRAORDINARY

14

(fv) allowances for members other than r.v u[tieio
admissible under sub-section (5) of section 9>

IPawt II—

r

members

(v) the pericxl intervening Imtwren nny 1w<» nirrtiuj’s of Ihr
Advi.soiy Coiiiniiucc uiklci the pitniimi |o
.- sub
- scvlmii (/ ) <>l scclion 17;
(v/) the terms and conditions subject to which a person may be
appointed to the Advisory
Committee and the
procedure to be
followed by such Committee under sub-section (-9) of section 17.

(vii) the form and manner in which an
application shall be
made for registration and the fee payable thereof under sub-section

(T) of section 18;
(viii) the facilities to be provided, equipment and other stanthc Genetic Counselling Centre. Genetic
dards to be maintained by
Laboratory’ or Genetic Clinic under rub-section (5) of section 18;

certificate of registration
(zx) the. form in which a
of
section
19;
issued under sub-section (/)

shall be

nn<l the periiul after which ;> certificate
(x) the manner in which
’ a shall be rented and the fee payable for -uch renewal
of* registration
under sub-section (3) of section 19.
be preferred under
(xi) the manner m which an appeal may
section 21;
m uhich r-cords. charts, etc., shall lx? pre(xii) the period up
served under sub-section (I> «'f section 29;
which the seizure of documents, records,
the manner in
in which seizure fist shall
objects, etc shall he made and the manner
from whose custody such
delivered
tn
the
n^o
n
be prep'red and
■'biccts ver? 'rized under sub-section (1) of
documents record*
(TUI )

section

*0.

< .tn i anv oilier mailer that is
cribed.

Power
to nuie
rcjruiauor*.

rcuuircd to be. or may be* pres

sanction of the Central Gov33 The Board mav with the previous
rrgnlations not
OfTirml Gazette, make
emment. bv notification m th'*
made thereand
the
rules
inconsistent with the provisions of this Act
under to preside for—
of the meetings of the Board nnd the
(a) the time nnd pl-ice
lor the transaction of business at such
. procedure io be
which shall form the quorum
m.embers
1
meetings and the numt»rr «'
under sur>-M?ction t I ) <»l section 9.

be lempomrily associathu
(bl the manner ... "r,
nib .>: person m iv

•)
i
cd unh the Hood

i •• »nh-M*ci«'n (11 ,vf section 1 I.

il»c <'ondnions of service and
• r i inr me*h»»d ■ ' .t iHfiimcn1
ofTiccr aud other employees
jncvx of the
the ‘calcs
pav .md i
of the Board appointed under section .12;------------------------------------------nfTnirs of tbo Board.
I J) gcncrallv hr •• v rfluivnt conihicl of the

i

Sec. 1)
1

J

15

THE GAZE/ IE OF INDIA EXTRAORDINARY

34. Every rule and every regulation made under this Act shall be laid,
as soon as may ue alter it is made, before each. House of Parliament,
while it is m session, for a total period of* thirty days which may be com­
prised in one session or in two or more successive sessions, and if, before
the expiry of tho session inunediatciy following the session or the succes­
sive sessions aforesaid, both Houses agree in making any modification in
the rule or regulation or both Houses agree that the rule or regulation
should not be made, me rule or regulation shall thereafter have effect only
in such modified form or be of no effect, as the case may be; so, how­
ever, that any such modification or annulment shall be without prejudice
to the validity of anything previously done under that rule or regulation.

K. L. MOHANPURIA,
Secy, to the Govt, of India*

I

PRINTID DY THB MANAGtJU GOVERNMr.NT UF INDIA PRESS. MINK) MHO
»ND PUDLlSllED BY TILE CONTROLLER OF PUBLICATIONS, DELHI,

NEW
19^4.

DEUll

Rufes and
regula­
tions to
bo laid
before
Parlia­
ment.

b f/

DRAFT
GOVERNMENT OF INDIA
MINISTRY OF HEALTH AND FAMILY WELFARE
DEPARTMENT OF FAMILY WELFARE
Proposed Amendments in PNDT Act 1994

1.

TITLE

Existing Title:

The Pre-natal Diagnostic Techniques (Regulation and Prevention of Misuse) Act.

1994.
Suggested Title:
"The Sex Selection and Pre-Natal Diagnostic Techniques (Prohibition and

Regulation) Act, 2002"

LONG TITLE (PREAMBLE)
Existing Long Title :

An Act io provide for regulation of the use of pre-natal diagnostic
techniques for the purpose of detecting genetic or metabolic disorders, chromosomal
abnormalities or certain congenital malformations or sex-linked disorders and for the

prevention of misuse of such techniques for the purpose of prenatal sex determination
leading female foeticide and for matters connected therewith or incidental thereto.

Suggested Lon" Title:

An Act to provide for prohibition of sex selection, before or after conception,
and for regulation of and pre-natal diagnostic techniques for the purposes of detecting

genetic abnormalities or metabolic disorders or chromosomal abnormalities or certain

congenital malformations or sex linked disorders and for the prevention of their
misuse for sex determination leading to female foeticide and for matters connected
therewith or incidental thereto.

I

c>

CHAPTER 1
PRELIMINARY

3.

Add the following to sub-section (b) of section 2:-

or Statc/UT Supervisory Board constituted under Section 16 A

4. Add the following explanation below sub-section (d) of Section 2:-

"Explanation - Any place, including a vehicle, where ultrasound
machine/imaging machine (capable of determining sex offoetus) or any other
equipment including portable equipment which has the potential for detection
of sex during pregnancy or selection of sex before conception, is used shall fall
within the above definition of Genetic Clinic.

5. Add the following explanation below sub-section (e) of Section 2:"Explanation - Any place, where ultrasound tnachine/iniaging machine
(capable of determining sex of foetus) or any other equipment including a
portable equipment which has the potential for detection of sex during
pregnancy or selection of sex before conception, is used shall fall within the
above definition of Genetic Laboratory. ”
6.

Substitute Sub Section (g) of Section 2 with the following: -

"medical geneticist"* includes a person who possesses a degree or diploma in
genetic science in the fields of sex selection and pre-natal diagnostic techniques
or has experience of not less than two years in any of these fields after obtaining (i) any one of the medical qualifications recognized under the Indian Medical
Council Act, 195o: or
(ii) a post gradual? degree in biological sciences"’;

7.

Substitute sub-section (i) of sub-section (2) with the following:-

“(i) “pre-natal diagnostic procedures” means all gynaecological or obstetrical or
medical procedures such as ultrasonography, foetoscopy, taking or removing
samples of amniotic fluid, chorionic willi, embryo, blood or any other tissue or
fluid of a men, or of a woman before or after conception, for being sent to a
Genetic Laboratory or Genetic Clinic for conducting any type of analysis or pre­
natal diagnostic tests for selection of sex before or after conception;”

Add to the definitions, the following

2

In sub-section (k) of section 2 add “orfluid” after the word “any tissue” and "or
conceptus” after the words “pregnant woman".

.Add the following definition

8.

(o) "Sonologist/Imaging Specialist” means a person who possesses any one of
the medical qua'ifications recognised under the Indian Medical Council Act
1956 or who possesses a post graduate qualification in ultrasonography/
imaging tech niq ues/radiology \


Add the following definitions

9.

(p) "Sex selection ”
includes any procedure, technique, test or administration or prescription or
provision oj anything for the purpose of ensuring or increasing the
probability that an embryo will he of a particular sex.
(q) "Embryo ”
means a developing human organism after fertilization till the end of eight
weeks (56 days).
(r) "Foetus ”
means a human organism during the period of its development beginning
on the 57i'1 day following fertilization or creation (excluding any time in
which its development has been suspended) and ending at birth.
(s)

"'Conceptus”
The product of conception at any stage of development from fertilization
until birth including extra embryonic membranes as well as the embryo, or
foetus.

CHAPTER II

REGULATION OF GENETIC COUNSELING CENTRES. GENETIC
L \:-ORATORIES AND GENETIC CLINICS.
10.

Amendment of section 3:

Existing sub-section (2)
(2)

no genetic counseling center, genetic laboratory or genetic clinic shall employ or
cause to be employed any person who does not possess the prescribed
qualifications

J

Suggested sub-section (2)

(2) no genetic counseling center, genetic laboratory or genetic clinic shall employ or
cause to be employed or take services of any person whether on honorary basis
or on payment who does not possess the prescribed qualifications:
Justification: Unqualified person should not be employed by the centre/ clinic/
laboratory.
Add: Following explanation may be added after sub-section (3) of Section 3 of
the Acl.:“Explanation - Any person/body/institution, by whatever name called, using
ultrasound machines/imaging niachine/scanner or other equipment capable
of detecting sex of foetus of a pregnant woman or capable of selection of sex
before or after conception shall be treated as a genetic clinic and shall be
registered as such clinic under this Section”

11. Add the following chapter: CHAPTER II A
PROHIBITION OF SEX SELECTION

“3 A. No person, including a specialist or a team of specialists in the field of
infertility, shall conduct or cause to be conducted or aid in conducting by
himself/themselves or by any other person, a sex selection technique on a
woman or a man or on both or on any tissue, embryo, conceptus, fluid or
gametes derived from either or both of them^
Justification: Include prohibition of pre-conception sex selection
Ref: SC order, ref to emerging technologies.
CHAPTER III

REGULATION OF PRENATAL DIAGNOSTIC TECHNIQUES

I
12.

Amendment of Section 4:
Existing Sub-Section (3)

(3) no prenatal diagnostic techniques shall be used or conducted unless the person
qualified to do so is satisfied that any of the following conditions are fulfilled
namely:
age of the pregnant woman is abox'e 35 years.
( i)
the pregnant woman has undergone of two or more spontaneous
(ii)
abortions or foetal loss;

4

(iii)
(iv)
(v)

the picgnant woman had been exposed to potentially teratogenic
agents such as drugs, radiation, infection or chemicals:
the pregnant woman has a family history of mental retardation or
physical deformities such as spasticity or any other genetic disease:
any other condition as may be specified by the Central Supervisory
Board.
Suggested Sub-Section (3)

(3) no prenatal diagnostic techniques shall be used or conducted unless the person
qualified to do so is satisfied for reasons to be recorded in yvriting that any of
the following conditions are fulfilled namely:

( i)
(ii)
(iii)

(iv)

(v)

ag ? of the pregnant woman is above 35 years.
ihc pregnant woman has undergone of two or more spontaneous
abortions or foetal loss:
the pregnant woman had been exposed to potentially teratogenic
agents such as drugs, radiation, infection or chemicals:
the pregnant woman or her spouse has a family history of mental
retardation or physical deformities such as spasticity or any other
genetic disease:
an\ other condition as may be specified by the Central Supervisory
Board.

Add: The following proviso may be added below Section 4(3):-



^‘Provided that the person conducting ultrasonography on a pregnant woman
shall keep complete record thereof in the clinic in prescribed manner and
any deficiency or inaccuracy found therein shall amount to deliberate
contravention of the provisions of Sections 5 and 6 punishable under Section
23 unless contrary thereto is proved by the person conducting
ultrasonography.”
13.

Existing Sub Section (4)

(4) no person being a relative or husband of the pregnant woman shall seek or
encourage the conduct of any pre-natal diagnostic techniques on her except for the
purpose specified in the clause (2).
Suggested Sub Section (4)

(4) no person including a relative or husband of the pregnant woman shall seek or
encourage the conduct of any pre-natal diagnostic techniques on her except for the
purpose specified in the clause (2).
Justification: to include people other than husband or relative

5

*

14.

Add: 4(5) no person, including a relative or the husband of a woman shall seek
or encourage the conduct of any sex selection technique on her, of him or both.
Justification: Including pre-conception sex selection

15.

Amendment of Section 5

Prohibition on communicating the sex of foetus:
Existing Sub Section (2)
(2) No person conducting prenatal diagnostic procedures shall communicate to the
pregnant woman concerned or her relatives the sex of the foetus by words, signs,
or in anv other manner.
Suggested Sub Section (2)

(2) No person including the person conducting prenatal diagnostic procedures
shall communicate to the pregnant woman concerned or her relatives or anv other
person the sex of the foetus by words, signs, or in any other manner.

Justification: Violation of law often takes place through the agent of gynecologist/
sonologist, rather than the specialist himself / herself.
16.

Add sub-section (3) to section 5:

[the proposed adcition of sub-section (3) to Section 5 has been dropped in view of
Ministry of Law's suggestion - para No. 2(v)]

17.

Amendment of Section 6

Add clause (c)
"(c) No person
by whatever means, cause or allow to be caused selection of
sex before or after conception. "

Justification: To include pre-conception sex selection.
17A

Amendment of Section 7

The existing Section 7(2)(c) may be substituted as under:
u(c) three members to be appointed by the Central Government to represent
the Ministries of Central Government in charge of Women and Child

6

6

Development, Law and Justice and Indiiin System of Medicine and
Homeopathy, ex-officio;”

The existing section 7(2)(e)(ii) may be substituted as under:
u(ii) eminent gynaecologist and obstetricians/experts of Stri Roga/Prasuti
Tantra;”

CHAPTER. IV

CENTRAL SUPERVISORY BOARD
DISQUALi: ICATION FOR APPOINTMENT AS MEMBERS:

18.

Amendment of Section 14 (f)
Existing clause (f)
(f) Has. in the opinion of the Central Government, been associated with the use
or promotion nf pre-natal diagnostic technique for determination of sex.

Suggested Clause (f)
(f) Has. in the opinion of the Central Government, been associated with the use or
promotion of pre-natal diagnostic technique for determination of sex or of any sex
selection techniq ue.
Justification: Inclusion of sex selection technique.
19.

Add the following proviso below section 15:-

’Provided that no member other than ex-officio members shall serve the
board for more than two full terms”
20.

Amendment of Section 16

Existing Clause
16(i) To advise the government on policy matters relating to use of prenatal
diagnostic techniques,

Suggested Clause
16(i) To advise the government on policy matters relating to use of prenatal
diagnostic techniques, sex selection techniques and their misuse.

7

21.

Existing clause
16(ii) to review implementation of the Act and rules made thereunder and
recommend changes in the said Act and rules to the Central Government.

Suggested Clause
16(ii) to review and monitor implementation of the Act and rules made
thereunder and recommend changes in the said Act and rules to the Central
Government.

Justification: To implement the direction of the Supreme Court
22.

Existing clause
16(iii) To create public awareness against the practice of prenatal determination
of sex and female foeticide.
Suggested Clause
16(iii) To create public awareness against the practice of sex selection_and
prenatal determination of sex leading to female foeticide.

Justification:

23.

Avoid antiabortion terminology
Aud pre-conception sex selection

Add the following sub-section (v) to section 16:“(v) To oversee the performance of various bodies constituted under this
Act and take appropriate steps to ensure its proper and effective
implementation’'

Re-number the existing sub-section (v) as sub-section (vi) in section 16.
24.

Add :

CHAPTER IV-A

aCHAPTER IV-A^
Add Section 16A:
U16-A.
(1)

Government of each State/UT with legislature shall constitute a Board
known as the State/UT Supervisory Board which shall have the
following functions in respect of the areas falling under the State/UT:
(i)

to create public awareness against the practice of pre-conception
sex selection and prenatal determination of sex offoetus leading
to female foeticide in the concerned State/UT;

8

(ii)

(»)

to review the activities of the Appropriate Authorities functioning
in the State and take appropriate action against the Appropriate
Authorities, as provided in their conduct rules, in case of
dereliction of duty;
to monitor and review implementation of the provision of the Act
and Rules in the State/UT; and
to send consolidated reports as may be required under the rules,
in respect of the various activities under this Act to the Central
Supervisory Board and the Central Government.
Any otherfunctions as may be specified in the Act.

(2)

The State/UT Supervisory Board shall consist of

(Hi)
(iv)

(a)
<7;/

(c)

(d,.

(e)

(f)

(h)

(2)

The Minister incharge of Health/Famiiy Welfare in the
State who shall be the Chairman, ex-officio
Secretary incharge of Department of Health/Famiiy
Welfare who shall be the Vice-Chairman, ex-officio
Secretaries/Commissioners in-charge of Departments of
Women and Child Development, Social Welfare, Law and
Indian System of Medicines and Homeopathy(ISM&H),
ex-officio or their representatives
Director of Health and Family Welfare/ISM&H of the
State Government, ex-officio
Three women members of Legislative Assembly
Ten members to be appointed by the State/UT
Government two each from amongst:eminent social scientists including legal expert
(i)
fi) eminent women activists/NGOs
eminent gynaecologian & Obstetricians/ Stri
(Hi)
Roga/Prasuti Tantra
(iv)
eminent pediatrician
em in ent radiologists/sonologist
(v)
An officer not below the rank of Joint Director incharge
of Family Welfare will be Member Secretary, ex-officio

The Board shall meet at least once in four months.

The terms of office of a member, other than an ex-officio
(4)
member, shall be three years.
If a vacancy occurs in the office of any non-ex-officio member, it
(5)
shall be filled by making fresh appointment.
(6)
If an MLA/MLC who is a member of the State/UT Supervisory
Board becomes Minister or Speaker/Deputy Speaker of the Legislative

9

I

Assembly or Chairperson/Deputy Chairperson of the Legislative
Council, she shall ceased to be a member of the Board.

(7)
(8)

(9)

One-third of the total number of members of the Board shall
constitute the quorum.
The Board may co-opt member as and when required, provided
that the number of co-opted members does not exceed one third
of the total strength of the Board. The co-opted members shall
have the same powers and functions as other members, except
the right to vote and shall abide by the same rules and
regulations as others.
In matters not specified in section 16 A, the board shall follow
procedures and conditions as applicable to the Central
Supervisory Board.

Justifiesn:
A Supervisor}- Board is considered necessary at the
State/UT level to review and monitor the activities of the Appropriate
Authorities and to ensure that quarterly reports/returns are filed to the
Central Supervisory Board correctly and timely.
CHAPTER V

APPROPRIATE AUTHORITY AND ADVISORY COMMITTEE
25.

Amendment of Section 17

Existing Section 17(3)

17(3): The officers appointed as appropriate authorities under sub-section (1) or
sub section (2) shall:
(a)

when appointed for the whole of the State or the Union Territory of or
above the rank of Joint Director of Health and Family Welfare, and

Suggested Section 17(3)

17(3): The officers appointed as appropriate authorities under sub-section (1) or
sub section (2) shall: ,
(a)

when appointed for the whole of the State or the Union Territory consist
of the following three members an officer of or above the rank of the Joint Director of Health
0)
and Family Welfare when appointed for the whole of the State
or Union Territory or an officer not below the rank of Civil
Surgeon/District Health Officer (when appointed for a part of
State or UT - Chairperson;

10

(H)
(Hi)

«u

an eminent woman representing yeomen fs organization; and
an officer of Law Department of State/UT concerned.

Provided that it shall be the duty of the Government of the
State/UT concerned to constitute the multi-member State/UT
level Appropriate Authority within three months of coming
into force of the amended provisions of this Act and that
vacancies occurring therein shall be filled within three months
of occurrence thereof.”
Justification: to make it more efficient with the support of women member and a
legal expert

26.

Add the following clauses to sub-section (4) of section 17:
(O

(f)
(g)
(b)

(i)

to take appropriate legal action against the use of sex selection
techniques by any person at any place, brought to its attention or suo
moto and also to initiate independent investigations in such matters.
to create public awareness against the practice of sex selection or pre­
natal determination of sex
to supervise the implementation of the provision of the Act and Rules,
to recommend to the Central Supervisory Board and State Supervisory
Board modifications required in
the Act or Rules in accordance
with changes in technology or social conditions.
to take action on the recommendations of the Advisory Committee on
the complaint received and investigated by the Advisory Committee.

Justification:

27.

I) Define functions clearly.
11; Include pre-conception s$x selection.

Add: Section 17A - Powers of Appropriate Authorities:

17-A. The Appropriate Authority shall have the same powers as are vested in a
civil court under the Code of Civil Procedure, 1908 (5 of 1908), while trying a
suit in respect of the following matters, namely:
(a)

(b)
(c)
(d)
(e)

(f)

The summoning and enforcing attendance of any person and
examining him on oath or on solemn affirmation;
The discovery and production of any document or material object
producable as evidence;
The reception of evidence on affidavits;
Issuing of any commission for the examination of any witness;
Issuing search warrantfor any place suspected to be indulging in
sex selection techniques or pre-natal sex determination; and
Any other matter which may be prescribed.

11

*

Justification: without these powers, appropriate authority will not be able to
discharge its func; ions.

28.

Add: Sub-Section 17(6B) -

[the proposed addition of Section 17(6B) has been dropped in view of Ministry of
Law's suggestion - para No. 2(viii)]
29.

Existing Section 17(7)
17(7) No person, who in the opinion of the Central Government or the stale
government, as the case may be. has been associated with the use or promotion of
prenatal diagnostic techniques for determination of sex shall be appointed as a
member of the Advisory Committee.
Suggested Section 17(7)

17(7) No person, who in the opinion of the Central Goxernment or the state
government, as the case may be. has been associated with the use or promotion of
prenatal diagnostic techniques for determination of sex or sex selection shall be
appointed as a member of the Advisory Committee.

Justification - include pre-conception sex selection.

CHAPTER VI
REGISTRATION OF GENETIC COUNSELING CENTRES, GENETIC
LABORATORIES AND GENETIC CLINICS

30.

Amendment of Section 18(1)

Existing Section 18(1)
18(1) No person shall open any Genetic Counselling Centre. Genetic Laboratory
or genetic clinics after the commencement of this Act unless such. Centre.
Laboratory or Clinic is duly registered separately or jointly under this Act.

Suggested Section 18(1)
18(1) No person shall open or render services to any Genetic Counselling
Centre, Genetic Laboratory or Genetic Clinic,, including clinic, laboratory or
centre having ultrasound /imaging machine/ any other technology capable of
undertaking determination of sex of foetus and sex selection, after the

12

commencement of this Act unless such Centra Laboratory or Clinic is duly
registered separately or jointly under this Act.
Justification: Registration of ultrasound machines which have the potential of
determining sex of the foetus.

CHAPTER VII

OFFENCES AND PENALTIES
31.

Amendment of Section 22

Existing Section 22(1)
22.(1): No person, organization, genetic counseling centre, genetic laboratory or
genetic clinic sh;f 1 issue or cause to be issued any advertisement in any manner
regarding facilities of pre-natal determination of sex. available at such centre,
laboratory, clinic or any other place.

Suggested Section 22(1)
22.(1): No person, organization, genetic counseling centre, genetic laboratory
or genetic clinic, including clinic, laboratory or centre having ultrasound
machine or any other technologies capable of undertaking determination of sex
offoetus or sex selection shall issue or cause to be issued, publish or cause to
be published any advertisement in any form including Internet regarding
facilities of pre-natal determination of sex or sex selection before conception
available at such centre, laboratory, clinic or at any other place.

Justification: To include ultrasound machines and pre-conception sex selection
and advertisement thereof on Internet.
32.

Add Section 22( 1 A):

[the proposed ad lition of Sections 22(1 A) and 22(2A) have been dropped and
sub-sections (1) end (2) of Section 22 modified in view of Ministry of Law’s
suggestion - para No.2(ix)]
Existing Section 22(2)
22(2): No person or organization shall publish or distribute or cause to be
published or distribute any advertisement in any manner regarding facilities of
pre-natal determination of sex available at any genetic counseling centre, genetic
laboratory, genetic clinic or any other place.

13

Suggested Section 22(2)
22(2): No person or organization including genetic counseling centre, genetic
laboratory or genetic clinic shall issue, publish, distribute or communicate or
cause to be issued, published, distributed or communicated any
advertisement in any manner regarding pre-natal determination/preconception selection of sex by any means scientific or otherwise.

34.

Explanation below Section 22(3) may be modified as under:
Explanation.- for the purpose of this section ’advertisement’ includes any notice,
circular, label, wrapper or any other document including through Internet or
any other media in electronic or print format and also includes any visible
representation made by means of any hoarding, wall painting, signal, light,
sound, smoke or gas.

35.

Add Section 22(-l i:

[the proposed addition of Section 22(4) has been dropped in view of Ministry of
Law’s suggestion - para No. 2(x)J
36.

Amendment of Sub Section 23(2)

Existing Sub Sec Jon 23(2)

The name of the registered Medical Practitioner who has been convicted by the
Court under Sub-Section (1). shall be reported by the Appropriate Authority to
the respective State Medical Council for taking necessary action including the
removal of his name from the register of the Council for a period of two years for
the first offence and permanently for the subsequent offence.
Suggested Sub Section 23(2)
The name of the registered Medical Practitioner, shall be reported by the
Appropriate Authority to the respective State Medical Council for taking
necessary action including suspension of registration till the disposal of the
complaint, if the charges are framed, and for removal of his name from the
register of the Council for a period of five years for the first offence and
permanently for the subsequent offence if convicted.

37.

Amendment of Section 23(3)

Existing Section 23(3)
I

23(3): Any person who seeks the aid of a genetic counseling centre, genetic
laboratory or genetic clinic or of a medical geneticist, gynecologist or registered

14

I

medical practitioner for conducting prenatal ’diagnostics techniques on any
pregnant women (including such woman unless she was compelled to undergo
such diagnostic techniques) for purposes other than those specified in clause (2)
of section 4 shall be punishable with imprisonment for a term which may extend
to three years and with fine which may extend to ten thousand rupees and on any
subsequent conviction with imprisonment which may extend to five years and
with fine which may extend to fifty thousand rupees.
Suggested Section 23(3)

23(3) Any person who seeks the aid of any genetic counseling centre, genetic
laboratory, genetic clinic or ultrasound clinic /imaging clinic or of a medical
geneticist, gynecologist, sonologist/ imaging specialist or registered medical
practitioner or any other person for sex selection or for conducting prenatal
diagnostics techniques on any pregnant women (excluding such woman) for
purposes other than those specified in clause (2) of section 4 shall be punishable
with imprisonment for a term which may extend to three years and with fine
which may extend to fifty thousand rupees and on any subsequent conviction with
imprisonment which may extend to five years and with fine which may extend to
one lakh rupees.

38

Amendment of section 24
Notwithstanding anything in the Indian Evidence Act. 1872. the court shall
presume unless the contrary is proved that the pregnant women has been
compelled by her husband or the relative to undergo pre-natal diagnostic
technique and such person shall be liable for abetment of offence under sub­
section (3) of section 23 and shall be punishable for the offence specified under
that section.
Suggested Amendment of section 24
Notwithstanding anything in the Indian Evidence Act. 1872, the court shall
presume unless the contrary is proved that the pregnant women has been
compelled by her husband or the relative to undergo pre-natal diagnostic
technique for the purpose other than those specified in sub-section (2) of
Section 4 and such person shall be liable for abetment of offence under sub­
section (3) of seciion 23 and shall be punishable for the offence specified under
that section.

15

!


1

• **

39.

Amendment of Section 28(1)

Existing Section 28(1)
Cognizance of offence: Sec 28 (1)
No court shall take cognizance of an offence under this, except on a
complaint made by­

(a) the appropriate authority concerned, or any office authorized in this behalf bv
the central government or state government as the case may be. or the
appropriate authority or
(b) a person who has given notice of not less than thirty days in the manner
prescribed, to the appropriate authority of the alleged offence and of his
intention to make a complaint to the court.

Explanation: foi the purpose of this clause, "person” includes a social
organization.

Suggested Section 28(1)

Cognizance of offence: Section 28 (1)

No court shall take cognizance of an offence under this, except on a
complaint made by-

a. the appropriate authority concerned, or any officer authorized in this
behalf by the central government or state government as the case may be.
or the appropriate authority; or
b. a person w ho has given notice of not less than fifteen days in the manner
prescribed, to the appropriate authority of the alleged offence and of his
intention to make a complaint to the court.

Explanation: for the purpose of this clause, “person"’ includes a social
organization.
Justification: To curtail delay on the part of Appropriate Authority to file a
complaint in the court.
CHAPTER VIII
MISCELLANEOUS
40.

Existing Section 30(1)
Power to search, seize records etc.

30(1) if the appropriate authority has reason to believe that an offence under this
Act has been or is being committed at any genetic counseling centre, genetic

16

laboratory or genetic clinic, such authority or any’officer authorized thereof in this
behalf may. subject to such rules as may be prescribed, enter and search at all
reasonable times with such assistance, if any. as such authority or officer
considers necessary, such genetic counseling centre, genetic laboratory or genetic
clinic and examine any record, register, document, book, pamphlet, advertisement
or any other material object found therein and seize the same if such authority or
officer has reason to believe that it may furnish evidence of the commission of an
offend punishable under this Act.

Suggested Section 30(1)

Power to search, seize records etc.
30(1) if the appropriate authority has reason to believe that an offence under this
Act has been or is being committed at any genetic counseling centre, genetic
laboratory, genetic clinic or any other place such authority or any officer
authorized thereof’ in this behalf may. subject to such rules as may be prescribed,
enter and search at all reasonable times with such assistance, if any. as such
authority or officer considers necessary, such genetic counseling centre, genetic
laboratory, genetic clinic or any other place and examine any record, register,
document, book, pamphlet, advertisement or any other material object found
therein and seize or seal the same if such authority or officer has reason to
believe that it mjy furnish evidence of the commission of an offence punishable
under this Act.
Justification: offence may be committed as places other than.registered clinic /
lab/ centre.

41

xAdd: Following Section may be added after Section 34 of the Act:“35. For the purpose of avoiding any conflicting interpretations and to make
this Act harmonious, all consequential changes, which have not been
explicitly incorporated, shall be deemed to have been made.”

17

Statement of Objects and Reasons:

The prenatal diagnostic techniques like amniocentesis and sonography are
useful for the detection of genetic or chromosomal disorders or congenital
)

malformations or sex linked disorders etc..However, they are being used on a

large scale to detect the sex of the foetus and to terminate the pregnancy of the
unborn child if found to be female. Techniques are also being developed to pre­

select the sex of child before conception. These practices are wholly

discriminatory to the female sex and affect the dignity and status of women. They
also contravene the principles of medical ethics. They are violative of Article 14

of the Constitution of India, that guarantees equality before law and equal

protection of law io woman and also of Article 51A that lays down the duties of
every citizen to renounce practices derogatory to the dignity of women. The
proliferation of these technologies may. in future, precipitate a catastrophe, in the

form of severe imbalance in male-female ratio. The State is also duty bound to

intervene in such matters to uphold the welfare of society, specially of the women
and children. It is therefore necessary to enact and implement in letter and spirit a

legislation to ban the pre-conception sex selection techniques and the misuse of

pre-natal diagnostic techniques for sex-selective abortions and to provide for the
regulation of the later for the appropriate scientific use for which they are

intended.

Such a law is also needed to uphold medical ethics and initiate the

process of regulation of medical technology in the larger interests of society.
I

Accordingly, it is proposed to amend the Act with a view to include

emerging technologies such as pre-conception sex selection and ensuring
effective implementation of the Act at all levels.

18

'jf

V

o
IN THE SUPREME COURT OF INDIA
w?

CIVIL ORIGINAL JURISDICTION

0

WRIT PETITION (CIVIL) No. 301 of 2000

J

J

Centre for Enquiry Into Health
And Allied Themes (CEHAT) & Ors.

.

' Petitioners

J

Versus

)
)

>

Respondents

Union of India & Others

I

ORDER

It is unfortunate that for one reason or tlie other, tlie practice of female |

infanticide still prevails despite the fact that gentle touch of a daughter and
her voice has soothing effect on the parents. One of tlie reasons may be the

marriage problems faced iby the parents coupled with the dowry demand by

tho so-called educated and/or rich persons who are well placed in tlie

society. The traditional system of female infanticide whereby female baby
was done away with after birth by poisoning or letting her choke on husk
continues in a

different form by taking advantage of advance medical

/

/
/
/

7

I

tectaiqlleS. Unfatunauly, dev.k.p.d medical acieno. is
» misused
mumaea to
» get rid
of a girt chiid before binb.

Knowing full well

»

offence, foetus of a girl child is
unethical as well as it may amount to an
unqualified doctors or compounders. This has
aborted by qualified and
where female infanticide is
affected overall sex ratio in various States
prevailing without any liinJrance.

For controlling the situation, the Purtanent in its wisdom enacted the
)

Pm-autal Diagonstic Techniques (Regulation end Prevention of Misuse) Act,

>

19.04 (herrinafler refold to .3 "the PNDT Arf< Th, Preamble, inter alia,
)

provides that the object of the Act is to prevei the misuse of such

)

eohnirp.es for the purpose of pre-natal sex determiqarion fading <o fan*

)

frticide mid for manors connected therewith ofineidenlal thereto. 'Vhc Act

)

cute into force from 1* January'. 1996.
»

>

a large extent, die PNDT Act is not implemented
is apparent that to
by the •entrni Government or by the Slate Governments. Hence, the
petitioner, are required to approach this Court under Article 32 of th..

Cor.siirutio.of India. One of the petitioners is the Centre for Enquiry btto
Health and allied Thenxcs

3

(CEHAT) which is
IS a
3 research center cf

3
Anusandhan T™.t Wwd in Pun. ~.d Mimbni. Second MiHon.. i. M.HI.

Sarnngeeu Utkdrah MuiMl (mAsuM)

Matausta and,

the thM petitioner is Dr. Sabu M. Ow who ts

Wpencnce and

t^hnieei taxmM*. « th. fi.W-

P'**0”'

'

issued notices to the concerned partie, on M J000. It topic nearly one year
fee the various States tn tile their affidavits in rnply/written submissions. ~

Prims feci, it upp.»n. that despito th. PNDT A« being emroted by th.

_

Parliament five years back, neither the SUie Governments nor the Central

Government has mken appropriate acdons fcr its implementation. Hence,
after considering the respective submissions made at the time of homing of

this matter, as suggested by the learned Attorney General for India. Mr. Soli
;. Sorabjeo following direction, me issued on th. basis of various provision,

for the proper implementation of the PNDT Act: -

I.

Directions to the Central Government

c
£

1.

The Central Cov.ram.nt is directed to'Beate public awareness
08amct the parotic, of pra-naUl det^mibmiou of

and female

foetieide through appropriate raleases/programmes in th,:
electronic media. This shall also be done by Central Supervisor/
I

c
c
c
c

c

4

M

Board (“CSB" for abort) a. provided under Seorion 16(iii) of the
i

PNDT Act.
The Central Govemntent is directed to implement with all v.gor

2.
and zeal tire PNDT Act told th. Role, homed in 1996. Role 15
provides that the intervening period between two meetings of the

itituted under sub-section (5) oi
Advisory Committees cons:
Sooxion 17 of the PNDT Act to

snail not exceed 60 days.

advise the appropriate authority

It would be seen that this Rule is
I

strictly adhered to.

IL

DirorttoM to theCentrnISuBfrviwrYBoard (CSg

1.

ill be held at least once in six months. [Re.
Meetings of the CSB wi

Proviso to Section 9(1)]
?■

The constitution of the CSB is provided

under Section 7. It empowers

the Central Government to appoint

ten members under Section 7(2Xe) which includes eminent

medical practitioners including eminent
representativea

social scientists and

of women welCue organizations. We hope that

this power will be exercised so

as to include those persons who

erm genuinely spore some time tor implementation of the Ant.

o

5

/

^tionofthe^t.
..

2.



The CSB si

suieAJT-APP^
[Re. Section 16(ii)]issue dueouons U>
CSB s'
3. D16
i me'.Ao'- W* ietUn'S
Authorities to
, menuuio” «»
'
impletnentau
intonniio“'bo“£'
on the
Jis eouUiu sped60
ion3o£thoADt
sishould inter
tbodi«.P00^taW0“° _
n 3 of the Act.
Survey o
lf bodies spedfied,nSeC °
G)
opet^tinft in
Registration o
SO^ ^S
Cd)
r ^h and
Action taken
aottheA^®
0
'
0

1

(in)
vtaMion of
vv
Xutborities under i

seizure of «cotdS'

ivea vy

Compta®'8 recei'
(iv)

d,eA«»"'>"diOn otavwrenes3«mP^ conducted and

^umW ^Mt0'e
(v)
result flowing
4.

TheCSBSl



: »r

•’



there&ont

1

dlMA«k«pM‘n

.ecessityto"000'

the neccs^v ’
encountered in
\ .es nd *1
difficulUSs ,1-

■ L technolos1®3
'
Ration® to the
teootnmen<
mind cmer&inS xe
t and to make
•^plementetion of

•rr^ldl

ent I[Re- SecU°
Central Government

J

)

6

)
)

lf conduct under section IdlM

)

The CSB shall lay down

5.

a code o:

working in bodies specified

of ,|.e Act to be observed by persons
)

therein and in ensure its pubheatton so

j

Ijiovz about it.

.nedical professional bodiesrassooiations to

J

)

that public at large can

The CSB will require

6.

s, tire practice of pre-i»tal detemunatton
awareness against tire pra
crests
...
J to ensure implementation of the
of eox end femulo foeUC.de .md to ».»

Act.

J
j. *

ill.

Directions

M

3
C

3
0
J

to/I IT Adniinistrutions urc
AH State Govemments/U 1 *
1.

directed to

follv empowered Appropriate
by notificntion, tally e">K
appoint
d sub^iistrict levels and also Advisory

Autlioritica at district am
Committees to

the Appropriate Autltority in

aid and advise

discharge of itsi functions [&«•

Section 17(5)1 •

For the

id that members of the said
Advisor.- ConimitKo also, it is hope
,ld be such


Bn provided under section 17(«4)
Committee as provicl-.
some time tor tlte «rk assigned to
cersens who can devote
i

them,

i

I

0

7
entaAJT AdminiatraV011^ ®1® d'r’Wte<1 1
A11 St... Cov.nu».„t^r

2.

aeotronio media in to r«P«tive SuccUT.

Xu StotS
3.

Admini— -

MbUe awareness
create public awu
.
of
and
delemnMUm'

of

»

directed to


ioeUO.de

sex

• iho mint end clenttome modm by
odvortisoment >n the pnnl

4.

throuah
<b«> - ?

hoardings ,

a„d other appropriate means.
are directed to
Govemments/Ur Administrations
Ail State
A ^nnriatc Authorities furnish
StafcVT ApproP0310.
ensure that all
the
returns to the CSB giving a report
report on
quarterly

andworUngoftheM.,^—h°"U

implementation
oifie infotmation about: inter alia contain spe
Media section 3 ofthe Act.
f bodies specific m s-uv.
-..ified in section 3 of the Ast.
(0 Survey o
Registration of bodies sp«i- ,
(ii)
Action taken against non-registered bodies operating m
(iii)

■ ivc of search and

(iv)

•"
'
seizure of records.
, . K
hv me ,Appropriate Audtonues
Complantts recei
under the Act and action Uken pursuant thereto.

I

M

8

?/

Number and nature of awareness

(v)

campaigns conducted
I

and results flowing therefrom.

i

IV.

motion, <o

1.

Appropriate Authorities are
against any peraon or

directed to take prompt action | ■

body who issues or

any advertisement in violation

Appropriate Authorities are
against all bodies specified

oa.u3O3 to be issued

of section 22 of the Act.

directed to take prompt action

in section 3 of the Act as also

against persons who are operating

without a valid certificate

J
'I

of registration under the Act.

All StmcAJT Appropriate Authorities are directed to
3.

report on the
the CSB giving a
returns
to
quarterly
These returns should
Md »o'U“S °t,h’ A°’

I

imer alia contain apacifio utfonnation about: -

co

Survey of bodies specified in section 3 of the Act.
Ration of bod.ea npeoiCtsd in

(ii)
inciudiug bodies using ultrasound machines.

3 of th. Act

1
II

H
!

9
.• tered bodies operating m

Mdo„ —
violation of swoon 3 of th

(iii)

seizure of records...

of seotob sod

me AA-priW. AV^”

CompWnf rewi’c4 W
aader-rbeActandactio.^rtuant thereto.

(iv)

eruopoisM

(v)

,

d esture of
Number an'

thcrofro"1nndroeulU flowing

I

directed

itsW„ion T«»itori«

(jovenunen^

nd die Stole Uo

The CSB ui
to report

to this Court on

or before

further directions

Lis*

30th July 2001.

the matter on

at (he bottom otthcUst
l

6.82W1 for
.

.,?i q-4q

.

e,A'V7....

• (
1

Nev/ D0^’*

May 4, 2001.

?

u

’ ••< h

J.

;r
-V?

».l

'J* <T ,U

.r •

. /

J.

,x ni-t rM ••*-*■-* *1

.< .r,

’ M r

*<

*

,5 r«

•. . ,)* xl nti

11

D'. NO A47W2000/SC/PJLC

OUT TODAY

MATTER FOR
10,8.2001

■’

■ '



'■

'

■!

■■■'■

r*



. t .

s.-

DATED: 8th August, 2001

\



--

FROM :
TO







.

Inder Pai
'
-v
Assistant Registrar(PIL.CELL)



Mr. D.S., Mahra, Advocate • \
•. i'- /. ■/I.'

IN THE MATTER 0E:

•:

WRIT PETITION (CIVIL) NQ.SQI OF 2QQQ
(Under Article 32 of the Constitution of India)
Centre for Enquiry into Health and Allied
Themes (CEHAT) & Ors.
• '
: A

... Petitioners

'I-

Versus

,• . . Respondents

Union of I nd i a & Ors.
Sir,
*•

I

am

to

you

that

the

Writ

Petition

came up.for hear i ng before .‘the Court

on

August, 2001 when the Court was pleased to\pass

the

above~ment ioned
6th

i nform

fol lowing Order:-

“As per the office Report .dated
foliowihg
2001
x the
foliowihO
2nd
August,
Territories
have
not
.'filed
States/Un ion
specific
desp
ite
their
affidavits
d i rect i ons.
Arunachai
Pradesh,
of
State
Gujarat,
Chhattishgarh,
Assam, Bihar,
<
Kashmi r .»
Pradesh, Jammu
&
Himachal
Kerala,
Maharashtra,
Mapipur
,
Jharkhand,
Mizoram,
Nagaland,

Sikkim,
Megha1aya,
Uttar
Pradesh,
Tamil Nadu, Tripura,
Un
i
on
Ter
r
i
tory
of
Andaman
&_
Uttaranchal ,
_________ —__
*
Dadah
&
Nicobar Islands^ Chandigarh,.
Nagar Have Ii and Lakshadweep.

However, learned counsel
after 2nd
of the States submit that on or tendered
2001 some States have
August,

...2/-

i

35

V

t .

2

•J

z

• C

office to prepare
the i r a
af.i.Hence
f i dav i t.
fresh
Report
and
submt
t; to th is Court
a
10th
August,
2001.

./ (
i.
on
In the meanwhile, learned counsel .
appearing for the Union of . I ndia to
prepare
a
chart
stating how -tany
States/Union Territories have complied
with the directions issued by this Court
and also to state specifically 'Which
directions are not comp I I ed. wi th . >> For .
the time being Registry to supply copies
of the affidavits to- the counselfor
Union of India as well as to tho counsel
for the pet i t ioner.

Adjourned to 10.8.2001.

you ace requested
As per directions of the Court,
file for thw i t h, a chart stating how many States/Union
by
Territories have comp I i ed with the directions issued
to

this

Cour t

and

a I so

to,

state

specifically

d irec t i ons are not complied with.
X

'••• *
Yours faithfully,

ASS ISTANT REG ISTRAR

I. •
?

1

which

i

SECT I,ON PIL
A/N MATTER

Court No.

i I i-M No &

I
■- - 4
SUPREME,

COURT
OF
RECORD OF PROCEEDINGS
$

J

I

N 0 I A

f

w r 11 Pet 1tion(C1vi I) NO.301/2000

Petitioner ( s )

CEHAT & OHS.

VERSUS
;'N ! i.)N OF
i

Respondent (8)

INljHA AND ORS.

to submit additional documents )
with App In(sl. for permission
fi ling 0.
inn exemption from
i
( for further directions )

Petition

O7£]J/2aQl Th i s

<)ate

CORAM

HON’BLE MR.
HON'BLE MR.

‘■t>i

i-’er i r i oner

( s )

For Respondent (s)

UOI :

tor Gujarat State:
tor Orissa State:
r c>' jnarkhand State:
for Rajasthan State:
r r Kerala State:
I o <-

H a r v a n a State:

t o r Goa State:

r < ■ i

Kymata State:

r «• t

Puniah State:

I

finQ.i I and State :

JUSTICE M.S.
JUSTICE B.N.

was

called on for hearing today.

SHAH
AGRAWAL

i

Ms.indirn jaising.Sr.Adv.,
Mr.San.lay Parikh.Adv..
Mr.R.R. Chandrachud,Adv.,
Ms.Javna Kothary.Adv.

Attorney General

for India (N/PJ

Krishan Mahajan.Adv.,
Ms.Sunita Sharma.Adv..
Mr.D.S.Mahra,Adv.
Me.Hemantika wahi.Aov.
Mr.Radha Shyam Jena.Adv.
Mr.Ashok Mathur.Adv.,
Mr.Raiesh Pathak.Adv.
Mr. Javed Mahmud Rao, Adv.-.
Mr.Ranji Thomas,Adv.
Mr.K.R.Sasiprabhu.Adv.,
Mr.John Mathew.Adv.
Mr.J.P-phanda,Adv..
Mr.K.P. Singh.Adv.
Mr.Bhawam Shankar Gadnis.Adv..
Mr.Shiv Sagar Tiwari.Adv..

Ms.oivya Suri.Adv.
Mr.Saniay R. Hegde.Adv..
Mr.satva Mitra.Adv.
ms.Jayshree Anand.AAG Punjab
Mr
ieev Sharma.Adv.
Mr^.v.l).
. V J). Khanna . Adv .
•.p *.;,
‘..in
n lav
i >t -V f- • Shand I Iva. Adv .
Pe slip an de . Adv .
Mr.'

r-iai r a^l i r r a S t 11 »Mr
Manipur Star. h.

hwa I r '"rkprim Nob 1 n Sinqh.Ady.

![S
(

ti

State: Ms* T*Anam^rat)hakar .Adv.

Andhra Prdesh

r or

Mr.Guntur rivn3taVjAdv.
.Ani 1

,sr.Adv.,

i or
state.

r nr

I
Chandra
State :Mr.Tara Sharma.Adv.,
Mr . A.iay -i sherma. Adv.
Pradesh:
t nr Manhv^

Bihar State:
i j t p . s ta te •
t or pondichetry.
r i-'. r nt.r.ran^a' :
cnnatisgarh:
Assam State:
1 OI

i or

I

MF.. pee I/Aqnihotri.Adv.
am
Mr.S.K.
.sekesh Kumar.Adv.
Mr
Sinqh.Adv.
Mr . B.B• verma.Adv.
Mr.H-c- Pragasam.Adv.
sri^astava.Ad/••
Mr .V • •
Ms.Rachana Chandra.Adv.
Mr.Mahesh
uach shrivastava.

.Prakash bm
^■^h^Sharma.^v.. _
}Adv.for
Mt-'v K.Sidharthan
Law
S/s corporate Lr/ Group
jaiswa1,Adv..
ms.Kamim Bakshi.Adv..
Ms.ShorniI a•a i Rao. Adv.
in Chandiaarh.
ms.aiswarya
Sinha.Adv..
kMrs.vu
4 r q v i m I a t h, Adv.
Stave:
Mr.Gopal Singni
, .Adv
. .
i r i pur a
Sharma
Mr.Naresd
K.hiAdv
.,
Pradesh ’.
Himachal
M?^rMariafputham.Adv.
’\»r
jirkim State:
Anil Suhra-rdY. Adv ,(N/P)
’'.-r

or
v

i .<•. x state:
, ni,^i- venor :

Mr

I.

Mr jav savla.Adv.,
MsRe e ma Bptrgft-’'A£1^---_-^.he'-?'olVcWro«—,

the" cpiy-t.^ade -•
cnun?e1
hearind
.•_? f!
0 R:D
for tho
the oartrifO^jtv
part^e?.^;,..
UPON
learned’ counsel
States
Heard the
some of ■ thj? f
for
appearing fc
report
Learned counseI
a Vonqwj th comp 1ianc
affidavit!
necessary
that
we^ks from.todaysubmit
a period of three
for the
Ied 11n
counsel appearing
would be fi
learned
Maha l an. the
a IS1"'
Mr .
GovernmerxJ^
I
centra
states that
I nd i a
implementation ot the
of
un i on
the
concrete steps for
Monitor inc.
rate
to
decided
inspection and
national
suaaest ed to setAO.t and
the Act*
1niplon]pl"’tat-1On of
(
(
rhe
c.oinmi ttee for
to 1;{ . 1 2 • ?001 Stand r. v e r
’,''2 f f

7<
(Vi 1 a v Kumar Shai
court Mastei

■ma ’

( k . K Ch a cin a 1
court Master

A

I

Court No.

■ stcrion pil
A/N MAI I er

6

ITEM NO.2

-■ E
c O U R I
r'
U P R'l E M
RECORD
OF PROCEEDINGS
I
f_.,

I N D 1

A

i

I
Writ

Petition<Ci v

nl )i NO. 301/2000

Potitloner ( 8 I

i

i
i

CEHAT & ORS.

VERSUS
Respondent

UNION OF INDIA ANO ORjS •

CORAH :

A

HON ‘ ,
HON Rl-F MR Justice arijit pasayat
HON1St£ Mb.

i

For peti tioner

( 8 >

' ms.Indira jaising,Sr.Adv., ■
; Hr.Sanjay parikh,Adv
i Hr.Avinash k. Miera.Adv.,
! Hr.R.R- Chandrachud,Adv. ..
I Ms.Jayna Kothari,Adv.
Mr.A.N.Bingh,Adv.

( fl )

1 Attorney General

i

For Respondent

1

for UOI:

Krishan

for India (N/P)

Mahajan,Auv>,

i

i
i

Sharma,Adv. .
Ms.sumta
I Mr.0.3-Mahra .Adv.

for Delhi Stats:
for Gujarat State:
for vy
or, les© state:

.

, Hernan ti ka Wahl.Adv.
Ms
Mr.Radhn Ghywni Jena,Adv.

.Ad* y
Mr.'.Ashok
Ashok Mathur
Mathur.Adv..

State: .I Mr.Raj^sh Pathak,Adv,
for Jharkhand'

■ Mr.Ranjit Thomas,Adv.for
_ Mahmood Rao,Adv
for Rajaethan; State:
Mr .Javed
.3.3aswrat)hu,Adv. ,
Mr.K.R
for Kora 1 a State :
Hr . J.. p
• .Ohanda,Adv. t
State
:
for Haryana
’d7.
I M r . K • P . Singh,A
Shankar Gadn'S.Adv.,
1 Mrr Bhawani
SPiv Sagar Tiwari,Adv.,
for Boa State:
Hr.
' nr.Sanjay p. Hegde,Adv.■
Kar
natak^tnte
:
f or
Mr . Satya Mitra,Adv«
Anand,AAG Punjad__
1 ms-JayshreOt or Punjab S t'a r e '
j

)

submit additionalI documented*
uno lending party)
for hearing today.
petition was oa11©d on

permission to
W1th ApplnfstiI for
fTling o.T.and
(
and exemption from
f

Thi i e
(ja t e : 11/12/P00’

I

1

/

: -* 2 : -

prdesh StatesMr1.Guntur prahhakar . Adv.
Arunachal Pradesh :Mr.Ani! Shrivastav.Adv.
Adv .
Meghalaya state : Mr.Rianjan Mukherjee
Mukherjee . Adv
Andhra
Andhra

A

or Tamil Nadu state: Mr.T,L.viswanatha iver.Sr.Adv. ,
ms . sjhweta Garg, Adv. ,
He.Rievathy Raghav^an,Adv.

>
Mr.fVN. Ramal ingam. Adv .
Meat
Bengal
St^te
:
Mr.Tara Chandra Sharma,Adv.,
for
Mt.Aljay 8harma,Adv.,

Mf .Si .K. Agnihotri,Adv..
Mr»6akesh Kumar.Adv.
Mr
.b .B. singhfAdv.
for Bihar State:
Mr
.R .0. Verma,Adv.
for U.P.State:
Mr.vi.G.
Pragaeam. Adv,
for Pondicherry:
Me.Rachana Srivastava.Adv.
for uttranchal :
Mr.Prakash Shrivastava.Adv.
for Chhatisgarh:
Ms.A.eha G.Nair,Adv. ,
for Aesam Statd:
Mr. v .K.sidharthan,Adv.for
M/S.Lcorporate Law Group
Mfj.Kamini
Jaiswal,Adv.
for UT Chandigarh:
Mfc.Ehomila Bakshl,Adv.»
M^.Aiswarya Rao.Adv.
Vimla Binha,Adv.,
Mpe.Vimla
for Tripura State:
Mf.Gopal
Singh,Adv.,
I
Mr.F?ahul Singh,Adv.
Mr.Maresh K. Sharma,Adv.
•’or Himnchal PradeelS:
Hs.A'runa Mathur,Adv.,
'or Sikkim State:
Mr.A.Mariarputham,Adv.
Mr.Anis SUhrawardy.Adv
-or j 8» K State:
Mr.Jay
Savla,Adv.,
intervenor
:
?or
Me.F(eema Bagga.Adv.,
Ms. M. ogra.Adv.
UPON hearing counsel the Court made the following
i 0 R D E R
,
Learned cojneel for the petitioners has pointed out
for Madhya Pradesh:

that

in

the

Governments

are

names oif the members of the advisory

places.

Governments

advisory
any

of

the

State

committee

not disclosed ajnd in any case are not published at

re 1 event

State

affidavits tendered on behalf

I'n this view of the matter the

'are

directed to publish

the

concerned

the- names

of

!
committee jn
various districts so-• that if there is

complaint any ditizen can approach them.

H

Further,

1

the •

statistics and information which is to be given in affidavit
_—_— -- —----------- 1
should be given district-wise.
Mr.Krishan Mahajan, the learned counsel appearing on
despite the
beha1f of the pnion of India states that
Department.
necessary warn ing by the Secretary, Hen I th

>

f

1

i

:-3:-

.... .... ....

various states . are

Secretaries of

the
Health
1 (np lenient iOS
welfare )
interested id
(Family
this Court.
an|d are not
reepo’nc ing
iesued by
not
the! various diructions
the
behalf of
as
wel
on
appearing
Act
learned counsel chart baseu on the affidavits
the
ba ecd
Today,
the
produced
is no
hae
indicates that there
titionere
pe
which
administrators to
OU® states
the
varji
filed by
concerned
theii P^rt of the
by this court.
on the |
passed ’
desire
and order©
Court,
seriously the 1ttW
paseed by this
itnplem«nt'
of the order®
are
following States
non
For
of the
Health Depar tment.)
29.1« 2002.
secretary (
Court on
before thia
remaid present
directed to
I
Rajasthan,
I
I

Punjab,

Gujarat,

(B)

(2)

Delhi,

Haryana,

(3

(7)

Bihar,

Uttar

•i

i
i

<4)

Pradesh,

(8)

(5)
-Bengal.“
t and !(9> WG8t
Maharashtra
I

the
counsel for
Alleged by the
pari dabad to
is
It
from
ferred
,Dahiya . .|0 trans
action
thaij- Dr
ropria
te
petitions-s
app
I
takind '
only I because he was
learned
,
purpose,
chandigar t
this
For
In
defaulting clinics.
tho n.-.p.P.'-.’ r’°°r''9agai net
h96 puked re^enee on
averred only
— '*‘='1US,,
counee1
I
is
tr
off leer
if eflficient
clinics then
vievj
,
defau11i ng
our
J taking action a9a inet the Government i8 unjustified
he wae
the fiction of the 'State
Hea1 th
through its
certainlv
(
o
f
Hary
ana
J
State
stating
addition, the
af f i dav i t
IP
ona .
necessary
file
i rected to
3ocretar y i 01
pahiya.
for transfer ?f or.
reason©
further
petitiotiere
the
for
course 1
I a
ad
learned

i
i

(

i

'F
I

: -4: -

are
of various State Governments
eubmi tted that the officers
verifying where ultrasound machines
ot of time in
westing
Sh6 pointed out that data of ultrasound machines
are kei|t
ia aval I able from the manufacturing
supp1 led to the id inica
: I
contract© entered by
companies as well as from the service

that

It is also pointed out
c 1 nice w^th those companies.
For
in some crises these machines are also imported.

that

aleo, names of the importers are easily available from

these

the Cuetone Department.
companies

they

l^av9

i nc1ud i ng

?

i

We^ therefore, direct the fol lowing
I

to bur>p1y the information ae to how many machines

sold to various clinics within last
their! names

contract to thoe$ clinics
_ __ ___ i;——----

and

addressee

and

years

five
a l so

service

or individual as the oase may be.

1. uma Penameshw^ran, CEO, Wipro Ge Medical Systems Ltd..
A-1, Cprporat Towers, Golden Enclave, Airport Road,
Bengal ^re -560017.
2. Toshbrs shimaidzu Ltd., Khatan Bhawan. 2nd floor,
Mumbai - 400000.

I

3. Erbie eEngineering Co.Ltd., 2E/12, 4th Jhandewalan Extn.,
New Delhij - 110005.
4.

v. Praphakar, CEO, ATL India Ltd.,

79 A 94, Developed

Plots, PertjngAdi, Chennai -600096.

Larsen & Toubfo Ltd. (Medical Equipment Dlvn.>,L*T House,
10, Clbb Hdue Road, Anna salal, Post Bag NO. 55247.
Chennai -600002.
international^Medical Services Pvt.Ltd.,
17 industrial
6.
122015.
Estate. Marut I Complex, Gurgaon
5.

7.

i

A. K . Khoslaj chairman, General Electric Co. of India
Ltd. , E-16, greater Kai lash, Part-I,New Delhi -110048.

R.

Rajee V Dayal! President A CEO, HCL Picker Ltd., 0-3,
4 Marg, vasant vihar,
Community centre, ---Poorvi
New DaIhi- 1 0057.

9.

Siemens Ltd., Mahape Workshop Shilphata Road, Behind
HIDC Area Off'Thane Belapur Road, vi11.Mahape.
Thane
40060 .

1

1

rr.-r

Si

: -5

For

iniplementation

of

the

the Act and

rules

11

appear’e that it would be desirable if the Central Government
1

frames
mach1nec

appropriate rules with regard to sale of
to var^
I

ultrasound

loue clinics and issue directions not to sell

Unregistered

machines

to

Mahajan

appear 1 ng

for

clinics.
Un i on

of

Learned

India

counse1

submi tted

Mr.
that

appropr ate action would be taken in this direction as early

as poee b 1 e.

Adjoanred to 29.i-2002.
?

J
(vijay > umar Sharma’
coip t Master

(K.K Chadha)
Court Master

1

‘1.

i
j

II
i
5

I

A

; TEM Nc-. 02

Court No.08
S U P R b M £
COURT
OP
RECORD OP PROCEEDINGS

: N

i

’At j t Pet :• t ion(Ci vi ’) No.301/2000
CEHAT s- ORO.

•-■'s r • r i oner ( s )

VERSUS
UNION OP ‘ND;A AND ORS.

Re=pendsni

(s )

•'.with app-n.
for P
• s rm i = s or:. t o s ubm it add’.
docuiTien i s
exempt•on from f i ■ i r:g 0T and
ano exemption
exemption
from
filing 0T
perm;ssion to submit add1
eno permission
OOCU;T;Sn ~ = a o a
exempt
i on
from f• j •ng 0T }
(for

:13-2-2001
toca/.

further directione)

; h • s .-et i t i on wa s oa;'ed on

nearing

CORAM :
NON'SLE MR. JUST’CP M.S. SRAM
MON'OLE MR. JUSTICE R.p. SP7R1

:-or Petitioner *. = )

Ms . Indira Jai Singh. Sr. Aov.
Mr . San jay Parikh.Adv.
Mr . NR C.handrs:chL-d , Aov.
—•—
Ms . Jayna Kothari. Adv.
--- /y;

P or Heepondent (s)
<



••or a t a t e s of Gu j scat Ms . Re-nan t i ka Wah i . Aov. J
and Mizoram
Ms . Sumita Hazarika. A
cj.7
Aa-J
. ”
.’A * —

■cr

Mr . •'•- r • s n a n Ma n a j a n . A d v .
Ms . ^tin • ta Sha r/na . Adv .
Mr . A j a y S h a r ma . .A o v .
Mr. tu i-iadn?a.-;r
HadnaKr-shnsn,
■ shnan , Adv.
Mr . Cv S . Mahra , Adv . ( NP )
Mr . RM Sa; ram Das. Adv. (NR)
•U.

Sta-e of p-njao

M r s . Jaysnree
j a y s n r e s Anand
A n a n c ,, Add
/. „ •
. .Adv.Gen’.
Mr . G. S i vaba I ainuruga.n . Ad /
Mr.p.S.duri,Adv.

• ~ r 2 t a 7 s c-r As san:
-•

.’ ssa

J
'P?

<■-'

DO

1

i

.. Sr -..A^.L/9P
2

Ms . Asha G Na i r. Adv. fcr
Ms . Kr j5n na Sharma. A d/.
Mr . vK Sidharthan. Adv.
•M/s Corporat e Lav/ Group. Ad
Mr. Radha Shyam JenarAdv.

Pb ;

^3ia

-m-.

pIlI
A

for State of Sikkim

Mr . A r^ar i ar put ham . A u .
Ms . Aruna Mathur. Adv.
Mr . Anurag D Mathur, Adv.

tor State of Rajasthan Mr. Ran j i
Thomas. Adv.
Mr . Javed M Rao. Adv.

2

for

te.-

for State of Kerala

Mr . KR Sasiprabhu. Adv.
Mr . John Ma thew. Adv.

for S tet e of Her

Mr. Mahabir Singh,Adv.

f or r?es . S t a t e of Goa

.Mr . 2havan ishankar V Gadn:s. A d v .
Mr . Shiv Sagar Tiwari. Adv.

for Stale of
Arunachal Pra^ssr:

Mr . An .• ! Shr i vas t a v . Adv.

for

“or Siaie of Karnaiaka Mr. ^aniay R. Hegde,Adv.
Mr . Sanjay Mitra, Adv.

I

for State of
Nagai and

Mr . fSan jay K Shandi I ya. Adv.
Mrs.VD Khanna. Adv.

I

for State of MP

Mr . aaiish K Agni hotri, Adv.
Mr . S a k es h Kumar. Adv.

State of Tr r pure

Mr. Goos I Singh. Adv

State of UP

Mr . R.C. Ve rma.Adv. .
Mr . ;<L Jan Jani. Adv.
Mr . Pramod Swar up. Adv.
Mr . Praveen Swarup, Adv.

-t a * s of Uttrancha■

Mr . A jay K AgrawaI . Adv.

SJ a t e of Wes t Genoa !

Ms. Rachana S r ivas t ava, Adv .
__T ~ r a_ Oh a n d r a S h a r ma . Adv.

State of 3 j har

Mr.3.3. S i ngh.Adv.

State of Man • pur

Mr . KM Nob in Singh, Adv.

State of MehgaI aya

Mr . Ran jan Muk her J ee, Adv.

State of HP

Mr . Naresh K Sharma, Adv.

State of Pond i oner
or
ry

Mr . VG Pragasa.m. Adv.

i t a t e of Ma ha r a s t h ra

Mr . SV Deshpande, Adv.

(NP)

. . . .3/-

F '

j.

I

3

State of TamH

Nadu:

Mr . TLV Iyer, Sr. Adv.
Mr . V Ba I a j i , Ad v. for
Mr . PN Rama I i ngam, Adv.

State of J & K

.Mr . An i s Suh raws rdy . Adv .

Dadar Nagar Have!i:

Ms.Sun ita Sharma.Adv.

State of Jharkhand:

Mr.Ashok Ma t hur.Adv.

State of Chha 11 i sga rh Mrs . Medhu r DadI ani , Adv.
Mr . Prakash Shrivastava. Adv.
UPON hear i ng counseI

the Court made the following

ORDER
t he

Heard

af f idavi ts

the

cons I dered

for the

parties

filed on behaIf

the sai d a f f i dav its.

Prom

States.

learned counsel

and

various

of

it appears t ha t

the

dj reciions issued by this Court are no t comp I j ed wi t h.
ths outset. we may stats that

At

7 .

by t he Adm i n i s t re tion i n

s•ackness

Some

CounseI I i ng

Cent re,

tota I

i mpI ementing the Act.

oounseI pointed out t ha t even

!earned

Genet ic

t here .* s

Genetic

though

t he

Laborstor ies

Genet io CH n i cs are not regi stared, no ac t .* on ; s taken as
prov•ded

under Section 23 of the Act. but on Iy a warning

issued.

In

our v ;■ ew,

those Centree which

are

not

regis t ersd

ars

requi red

to

prosecuted

by

t he

.-.ut hor ;• t i es

under t he pr ov i s i ons of ths Act and t hers

s

be

•s

$

cuestjon

of

issue of warning and to permit

t hem

to

son;‘nue t he i r i I !eca i acti v i t i es.

It

js

to

be

stated

that

t he

Approprlate

j

Au t nor i ti es

a n y officer of the Cenira!

t he

State

. . . .4/-

4

r


4

Government
complaint

authorised in this behaJf
under

Section 28 of

is

requirsc to fils

ths Act for prosecuting the

or fencers.
I

Further

aut hori t « es
necessary

•n

are

appointed,

t hey

mus t

appropr » a t s

carry

out

survey of Oiinics an d take apprc-p r i a t a

non ~~ r eg ;• s t r a t i on

of

case

wherever at D-strict Lave•,

s t a t ut ory

prov•s•one

author i t i es

are

no t

no n-compl ;anc e

ino Iudi ng the Rules.
o n I y em p o w e r e d

the

act ion

of

t he

Appropr;at e

to

take

c ri m i naI

Oocuments,

records,

act ion.

but

to

ob Jects

etc.

of unregistered bodies under Section 30 of

search and

se • ze

L-

t h e Act .

It

has

been pointed out

t ha t

the

States/7Un i on
%

have not submitted quarterly returns to
Can t ra :•

Supsrv isory

Soar o

P r e -:431 a •

Diagnost ic

Prevent•on

of Misuse'- Act.

as

”t.he Act").

r a t ur ns

Mance i t

c-n

• mp•emen tat ion

Technj ques

t he

of

t he

(ReguI at ion

and

.-394 1. here i naf ter referred to

is drrsctsd that t he

quarter’y

to contra- Supsrv•sory -card should be submitted

S jv;ng t he f o1 ■ow i ng • n f orm-a x i on :
(a *) Sor vey of 0an t r es . Labor a tor•e=/C• i n•cs.

(b) .Reg i st rat ion of these bc-d :

.

(c) Act ion takan against unreg i stersb bodies.
i. d) Search and Seizure.

fc.

e) Number of awareness carnzpa i gns , ana
tf) Results of camps jgns

...5/-

5

•t

P r chj t h s rec c .• d .

Un i on

of

behsIf

on

and

Chr;ax : sgarh

t ha t t.ne Sts:e

appar eni

i s

of

Terr i tory

Chand .■ gar h , a f f j oavi"s are not f i ied.

the

For

j

c oon as :•

the Act

t • i !

ens.c trrter: z ,

there i s a fn j • a r

State

e u t h o r t i e s wou I d take appropria t e ac t i on

on

o a S : --

CT

the d!rent ions wn:on may be issuec

t he

per

•/er .* ous aff i oav its.

'ee rned coons a I

for

pet:t i oners

end respondent No.

1

pointed- out

that

As
■ ha

at

the State aubmita t .ha ■

! = not app• : cab Ie t o the State of Jamoisj

However.

Kashrr; .• r .

:• as med

Kashfn j r .

and

of J.amrr.u

appear n g o r; beha■f

preaent ,
aco

State

S t a t es ha ve comp■ i ed w «t h t he d i reciione jssued

sems

are
this Court on 4th May. 2001 r but fo i * ow i ng d i rer. t i cns
no:

co.mp • i ed w • th by the States ment i ones here i n be'ow:
Por

•’ 2 )

.-.op :* opr i a t e

t he

direct .* on

at 0 : St r : Ct

Aut nor i t’es

•?.■ • t n :

Tr!pure

U-Ts

Nsga!and.

Chand•earn.
as = neeweep . P c n 0- • c n e r r

D

A

N

Not i f i oat :• on

i ssu ing

2 tares/UT s hav e n nt comp! i ec
asi’.-m••

L eve ' a .
..-ammu

States Goa.
Andaman

Have I j :

Ni conar

ano

Daman

&

uiu.

a n d Nui of De-P:.

the o’rec?ion •-agar d i ng ■ ssue of Not i f j cat ’on

1

appo ■ n t ; nu
ave ; .

A.'-'''

07

App r op r ;• a ; e Auther i t j es a t

Gub-D•s 7 r io ■

fc: !owi n g States/UTs have not co.mp • • ed w • ~ h :

I"
/1
/

w

6

Arunac.hs I

Pradesh.

Goa,

Jamsnu

and

Kashmir.

Jharkhand.

Maharashtra,

Mi soram,

Naga!and T

Pradesh,

H • .Tanha J

Kera ‘ a ,

barnataka.

S i kk i m .

Gujarat.

Haryana,

Tam i ! Nadu, Tr i pura. Uttar Pradesh

and

West Sengai .
iJTs
Andeman
Have•}.

and

Nicobar

.* s I ands . Chand/garh, D

N

Daman and Diu, Lakshadweep. Pondi cherry and

NCT

De > h j .

With

Adv * sc ry

regard

Comm i 11 ees

Aut her ;• t i es ,

to

the d i rect i on

to aid and advise

issued

the

t he

for

Appropri ate

the fol-owing States/UTs have not

comp•ied

w .• t h : -

Arunachai Pradesh., Goa. Himachal Pradesh,
Ka snmi

Jharkhand,

Nagsi and, Ra jas t han,

Anc-eman

ano

Maharashtra,

Megha I aya.

Jammu

Mi zor am,

S i k k i m. Tripura and West Bengal.

N i cobar

I sIands, Chand i gam, D

N

Have* i . Daman & Diu. Lakshadsweep, Pond i cherry and NCT of
De « n :• .
nor

cons * t ut s on

Commi 11 ees.

sons the needful:

of

t he

Sub-Di st r i st

the foI Iowing Statcs/UTs have

Levs!

not

BL-

K

I
7

Prakash. Ar unaorta I PraO&an . Goa. Gujar at.

Andhra

i mac ha ' Pradesh.

parvans.

S i k k i m.

Pajasthan.

■res t

:v: i coram,

klsgha ; ay a ,

Manar a ahfra.

.Karnstaka, Kara;a.

Jharkhand,

Or i ssa s

iiaga • and.

Tam.’ : Nad-j. Tr i pura. Uttar P r a desh a n d

Senca i .

and

Andaman

N:sobar

:s:ands. Chandi garh, 0

.N

Save' :: . Daman oc Diu. L a k s h a d s w e e p . Pondicherry and NOT c- f

t he
Poor opr :• a t s

.:ec i a . -card i ng

d r ec t i on

Authoritiss
ano other

pub : i S.h

to

Media.

Pr i nt

j n

means.

of

list

a

S•eqt ron i c

J•s
ths fo> -owing Stat ea/‘

Have not done the needfu • :

Pe:

Pr -nt

Med•a:

no action

: S

taken

by

t he

=■ o : ; c w 8 ng

Assam,

.e a ■ a .

: ssa .

Goa .

Maharasntra.

Kashmi r.

Megha■aya.

Manipur.

Naga•and,

S i k k r m. U’t tar arena • and Uttar P r a des h.

D b

Have;:. La.-csnadswsep . and NOT of De ih i .
Meo i a

Andhra

J

Jammu

r* * mac ha • Pradesh.

by

: S

Prasesn. Ar unacnai Pracesn. Assam. 5i ha r .

. .8/Ci■ J

I /

F

! •

J
8

f
I

; 4oar Gujarat, Haryana. Himachal Pradesh.

Jsrrrfnu

Kasnrr: i r ,

Jharkhand,

Kerala.

.Maharashtra,

Megha1 aya.

Manipur,

Nags •* snd.

Or:ssa.

Pun jab. S i k k ; m.

t am i i

Nadu,

Tr:pura,

;j t* a r ancna1. Uttar Pradesh and n’est Sencai.

D ~ N Have i i . Damar: and 0 i u , Laks hadweep. 3 n d NOT
of Delhi.

’. i 1)

Hoar d i nos- no action

Re:

:■ s

f c-1 I cw i ng

taken by

Gtat os :
Anohr a

Pradesh. Ar unacha I P rades h . Assam. ~ :• har .

Goa. Gu j a r a t. Rar ya na, Rimacha' Pradesh.

Madhya

Jammu &. Kashmir .

Maharasntra.

Pradesh.

Jharkhand.

Kera ; a ,

Magna 1 aya.

M i scram.

ktenipur, Nagaland. Or issa,

Pun jao.

•ami • Nadu,

•ripure, Ut tarancha 1 , Uttar

Pracesn

N

Havei i,

S • k k i m,

and ‘/rest Bengal.

•J; s:

ano

Andeman

N i cooar

1 s1 ends.

&

_ La s s n a d w e a p . and MCT of . Heihi.
in

S tats

vjew o f ths matter, we d i rect

this

Governmsn t s/Un ion Terri ter i e s t c

a! J

the

i.mp I ement the Act

ano submit the compi i ance r eport as directed by our order

cates

4th

2001

Ma y,

we I I as this order

wi th i n

six

was;-: s from today.
this matter after six weeks.

sd/(D.L. Chugn)
Court Master

sd/t.K.K. Chadha)
Court Master

I

a

i
J

F“‘

i
Court no.

ITEM NO.2

S U

I
1
f

COURT
OF
RECORD OF PROCEEDINGS
l._.

p r; e m e
I

1 hi '0 1 A

Vi r t Pet i t i on( C i v i ] )i NO. 301 /2000
I

i

i

i

L

’ SECTION PIL
A/N MATTER

o

CEHAT

Potitioner ( 8l

i

ORS.

i

VERSUS
•»

Respondent (**
•JNIO.N OF INDIA ANO ORS.
submit additional document,st

'Th AoD)n(s)L tor permission to
fi 11 ng O
O.r
. F.,and imo leading party )
*.n ex emo 11 on f rc»m filing

1

i ; / 12/200 i Th i i e
•’ \M

was

oallod on for* hearing today.

HON'81 F MR. JUSTICE H.3. SHAH
AGRAWAL
HON RTF MA ^JUSTICE 8.N.
1 JUSTICE
112 Y TF’C ARIJIT
AQ T J
PASAYAT
HON1OLE Mh.

pa r111oner

( 8 >

Re ?condent < n )
JO I :

De i h i State:
Gujarnt State:
Orissa Stare:
1 har Hiann S t « t e:
Rai asthan State:

I

petition

or Kora In State:
•or Harvann state:

Goa State:

rr harnata^tnte:
:r:r Punjab Stare:

ms.Indira Jnising,Sr.Adv., •
! Mr.Sanjay Parikh,Adv.,
s Mr.Avinash
...? k‘ ■ Mter&iAdv.,
Miera,Adv. ,
.
chandrachud,Adv.
.
Mr.R.R
ms. Jayna Kothari ,A<lv.
Mr . A.N.Singh,Adv.

Attorney General

for India (N/P)

Krishan Mahajan,Adv>,
Sharma,Adv.,
Mr.D.3.Habra,Adv.

ms,Sun1ta

Ms.Hemantika Wahi.Adv.
Mr.Radha Shyam JenaTAdv.
Mr.Aehok Mathur.Adv..
Mr.Rajeeh Path©k,Adv,
Mr.Ran.jit Thomas , Adv. for
Mr.Javed Mahmood Rao,Adv.
Mr.K.R.Sasiprabhu,Adv.,
[
Mr.J.P.Dhnnda,Adv.,
Mr. K.P. Singh^’dv.
Mrr Bhawani Shankar Gadni8,Adv..
Mr.Shiv Sagar Tiwari,Adv.,
Mr.Sanjav R- Hegde.Adv..
Mr.Satya Mitra,Adv.
Ms.Jayshree Anand,AAQ Punjab

4

I

:-2:-

I

,ra Prdesh State: Mr1. Guntur prabhakar . Adv.
.nachal Pradosh :Mr.Ani I Shri vaster/. Adv ,
Mr. Rian Jan Mukherjee . Adv .
ghalaya state:

i-

rami 1 Nadu stare: Mr.T\L,viswanatha Ivar.Sr.Adv.,
Me.S-hweta Garg,Adv. .
Ms.R&vathy Raghay^an, Adv .

Mr.^.N. Rama1 ingam.Adv.



, or We^r. Bengal State:Mr. Tara Chandra Sharma.Adv.,

Hr.A]jay Sharma,Adv.,
Mr.Sl.K. Agnihotri ,Adv. .
for Madhya Pradash:
Mr.slakeeh Kumar.Adv.
nr
.b!.b. Singh,Adv.
for Bihar State:
Mr
.r!.C. Verma,Adv.
for U.P.State:
Mr
.
vi. G. Pragaeam. Adv .
for Pondicherry:
Me.Rachana
Sr1vaetava.Adv.
for uttranchal :
Mr.Prakash Shrivastava.Adv.
for Chhatiegarh:
Me'.Ajsha G.Nair,Adv.,
for Assam State:
Mr.V.K.8 idharthan,Adv.for
I
M/e.^Corporate Law Group
I
Ms.K|aminl‘ Jaiswa), Adv.
j Hr UT Chand i garb:
Ms.Shomila Bnkahi,Adv.,
i
I
i
Ma.Aiiswarya Rao.Adv.
MreJvimla Sinha,Adv.,
Tripura State;
Mr.Gopal Singh,Adv.,
Mr.Rahul Singh,Adv,
Mr.Maresh K. Sharma,Adv,
himoonai Prad??h:
Me.Aruna Mathur,Adv.,
• k • m State :
Mr . Aj, Mari arputham, Adv.
Mr.Ajnis Suhrawardy . Adv

;< state:
Mr.Jay Savla,Adv.,
i n v j r''encr :
Me.Reema Sagga,Adv.,
■ •
Me. ;M. Ogra,Adv.
UPON hearing counsel the Court made the following
I ORDER
Loarned counsel for the petitioners has pointed out

I

in

rhfit

In this view of the matter the

places.

i

are

Governments

•S c n t a

p.nv i sory

directed to publish

committee

the

concerned
of

committee in various districts so that if there is
i

Further.

the 1

i

sratistica and. Information which 16 to be given in affidavit
should be given dietrict-wise.
;

i

Mr.Krishan Mahajan, the learned counsel appearing on
Pena 1 f

of

necessary

the

Un ion

warning

by

of India
the

states

Secretary,

that
Hen 1 th

i

»

I I

H
i
!

the=- namee

complaint any citizen can approach them.

i

State’

not disclosed and in any case are not published at

r-s 1 p van t

r. v

the

names Of the members of the advisory

GovArnments
a r -■*

of

affidavits tendered on behalf

trie

u

despite

the

Department.

i

1
:-3:-

1
i

) health Secretaries of
various state©
states
of various

We I fare

t F-'W'.i 1 y

as well as the various di rdctions

I

counse1

learned

the

issued by this Court.

appearing on

behalf

the

of

aff idav1ts

has produced the chart based on the

o? r ■ 11 one re-

the

ar.d are not interested in implementirfg

responding

fnaay,

are
<

I

indicates that there is no
ic-c by the various states which
the

on

of the

part

to

administrators

concerned

i

i

•nt seriously the law and orders passed by this Court.



Court,

th i s

by

the orders passed

of

■-c'po 1 i ance

Health Department) of the following States

are

r.orna i n present before this Court on 29.1.2002.

(0 )
; * -i .

(3) Bihar,

(2) Delhi,

Punjab.

Haryana.

( 1)

(4 )

Rajasthan,

(8)

Pradeeh,

Uttar

!

and (9> West-Benga1."

is

a 11egeo

the

by

learned

counse1

for

the

that Dr.Daniya' is transferred from Faridabad to
on I y

because he was taking

action

appropriate

3
4

oor 7-u 111 ng

cli nics.

For

this

purpose,

has placed reliance on the newspapers'

reports.

if efficient officer is transferred only


i nq

action against the defauIting

1 earned
In

because

cli nics

then

the action of the State Government is unjustified

.n

the State of Haryana through its

Hea I th

a 1 rectad to f : 1« necessary affidavit

stating

WG 111 on ,

’.rinsfer of Dr.

Daniya.

5

I

i

i
I
i

;

submitted I that th.

officers of various State Governments are

ot of time in verifying where ultrasound

wasting
ke||t

are

r

: -4 : -

I

5

machines
l

She pointed out that data of ultrasound machines

to the clinics is available from the manufacturing

supplied

these

as Well as from the service contracts entered by
j
It ie also pointed out
c 1 nice with those companies.

that

in

that

ale

companies

For

some crises these machines are also imported.

nahiee of the importers are easily available from

the Customs Department.

----- — —I-- -

Wo, therefore, direct the following

-

companies!

to supply the information as to how many machines

they' have

sold jto various c1inice within last

'.—r
i nc 1 ud 1 ng; the 1r1 names • and

addresses

and

f i ve
a l so

years
service

i

contract to those clinics
i .

2.

or individual as the case may be

!
I
Uma Psrameshwaran, CEO, Wipro Ge Medical Systems Ltd..
a-1. Cbrporate Towers, Golden Enclave, Airport Road.
Bangalore -560017.
Toshbro Shimandzu Ltd., Khetan Bhawan. 2nd floor,
Mumbai - 400020,

3. Erbie Engineering Co.Ltd., 2E/12, 4th Jhandewalan Extn.,
New Delhi - 110005.
4 .

v. Prabhakar, CEO, ATL India Ltd., 79 A 94, Developed
Plots,' Perungadi, Chennai -600096.
I
5 . Larsen & Toubro Ltd. (Medical Equipment Divn.l.LAT House,
10, Club Hous© Road, Anna salal, Post Bag NO. 55247.
Chennai -600002.

6.

1

i

J nr ernatione 1 Medical Services Pvt.Ltd., 17 Industr ia 1
Estate. Maruti Complex. Gurgaon - 122015.
Khoslaj chairman, General Electric Co.
of India
Ltd.,; E-16, Greater Kailaeh, Part-I,New Delhi -1 10048.

a.k,

p.

Ra.jeev Dayal, President & CEO, HCl Picker Ltd., D-3,
Community Centre, Poorvi Marg, vasant vihar,
New. De I hi- 1 1005 7,
. ’

9 .
J

.

I

!

Siemens l_ td . , ! Mahape Workshop Shilphata Road, Behind
MIDC Area Off Thane Belapur Road. vill.Mahape.
Thane - 40060 i.

I

I

I
f

i
I

I

tL

J
? «i

iftip lemontat ion

of

the Act and the
rules
appeafeI that it

•r would be desirable if the
Centra I Government

frames

I

appropriate rules with regard to 8q1g
of
various clinics and i es.ue

machines to Var^
**

J

'

I

macbinee
i

MA«ha j an :

i

Unregistered

to

appearing

annropr^r.e action
possible.
i

for

ultrasound

directi one not to eel]

clinics.

Un i on

of

learned

counse1

Mr.

Ind i a

sutm tted
that
would be taken Tn this
direction as early

!

'Adjounrea to 29. 1.2002.

:

;Jay Kumar Sharma 1
Olj
O'u‘

r

U^stQr

J
(K.K Chadha)

Court Macter

p
Iv

I

t

*

I

1

.xv<-’17*1 .No. 7

SECTION PIL
A/N MATTER

Court No.7

I N 0 I A

SUPREME
COURT
OF
RECORD OF PROCEEDINGS

<■

1.

V33133
Writ Petition(Civi1) No.301/2000

Petitioner (s)

& ORS.

VERSUS
Respondent (s)
UNION OF INDIA AND ORS.
'(Appln . for permission to submit addl. documents and exemption
f'ron] filing OT and impleading party and intervention &
modification and intervention)
WITH IA 13 & 14 : Appln. for intervention and clarification
Appln. for impleadment and
IA 15 :
for permission to take on record the
IA 16 : Appln.
supplementary affidavit) filed by GS Chatterjee, Adv.

Date : 05-3-2002

This

Peti ti on

was

called on for hearing today.

CORAM :
HON’BLE MR.
HON’BLE MR.

For Petitioner (s)

For Respondent (s)
UOI

JUSTICE M.B. SHAH
JUSTICE DORAISWAMY RAJU

Ms.
Mr.
Mr.
Mr.

Indira Jai Singh, Sr. Adv.
Sanjay Parikh, Adv. /RR Chandrachud, Adv:. Certified io be a t
AK Misra, Adv.

Mr. Harish N Salve, SG
Mr. DS Mehra, Adv.

Assist

Supreme Court of indie
for States of Gujarat Ms. Anu Sawhney, Adv.
Ms. Sumita Hazarika, Adv.
and Mizoram
Ms. H Wah i, Adv.

for State of Punjab

for

Mrs. Jayshree Anand, Add 1.Adv.Gen 1. Pb,
Mr. Rajeev Sharma,Adv.

For State of Assam

Ms. Krishna Sarma, Adv.
Mr. VK Sidarthan, Adv. for
M/s Corporate Law Group, Advs.
for State of Orissa

Mr . Radha Shyam Jena,Adv.

for State of Sikkaim

Mr. A Mariarputham, Adv.
Arputham Aruna & Co., Advs .

j
for St^te of Rajasthan Mr. Ranji Thomas, Adv. for
Mrs. KV Bharati Upadhyay, Adv. for
Mr. Javed M Rao, Adv.
for State of Kerala

Mr. John Mathew, Adv. for
Mr . KR Sasisprabhu, Adv.

2
for Res.State of Goa

Mr .

Bhavanishankar V Gadnis,

Mr. Shiv Sagar Tiwari, Adv.
Ms. Sumita Inna, Adv.
Ms . Divya Singh, Adv.

)

for State of
Arun^chal Pradesh

Mr.

for State of
Tamil Nadu

Mr. S Balakrishnan , Sr. Adv.
Mrs. S Revathy Raghavan, Adv.

Anil

Shrivastav,

Adv.

Adv .

for State of Karnataka Mr. Sanjay R. Hegde,Adv.
Mr. Sanjay Mitra, Adv.
for State of
Nagaland

Mr. Sanjay K Shandi1 ya, Adv. for
Mr. VD Khanna, Adv.

for State of MP

Mr.

State of Tripura

Mr. Rahul Singh, Adv.
Mr. Gopal Singh, Adv.

State of UP

Mr. RC Vermla, Adv.
Mr. Mukesh Verma, Adv.
Ms . Neeta Sinha, Adv.

Satish K Agnihotri,

Adv .

State of Uttranchal

Ms. Rachna Srivastava, Adv.
Mr. Mahesh C Kaushik, Adv.
State of West Bengal

Mr . Tara Chandra Sharma, Adv.
Mr. Ajay Ssharma, Adv.
Ms. Neelam Sharma, Adv.

State of Bihar

Mr. BB Singh, Adv.
Mr. Kumar Rajesh Singh, Adv.

State of Manipur

Mr. KH Nobin Singh, Adv.

State of Mehgalaya

Mr. Ranjan Mukherjee, Adv.

State of HP

Mr. Naresh K Sharma, Adv.

State of Pondicherry

Mr. VG Pragasam, Adv.

State of Maharasthra

Mr. SV Deshpande, Adv.

UT Chandigarh

Ms . Kamini Jaiswal, Adv.
Ms . Aishwarya Rao, Adv .

(NP)

Andaman, Lakshadweep
Mr . Ashok Bhan, Adv.
Dadar Nagar Haveli
Ms . Sunita Sharma, Adv.
Daman and Diu, & Delhi Mr. DS Mehra, Adv.

for

State of Chhattisgarh

Mr. Prakash Shrivastava, Adv..
Ms . Madhur’Dadlani, Adv.

State of Jharkhand

Mr. Ashok Mathur, Adv.
Mr. Rajesh Pathak, Adv.

For M/s WIPRO

Mr . Bhargava v Desai, Adv.
Mr . Sanjeev Kr. Singh, Adv.
...3/-

s

- 3 -

Mr.
Mr .
Mr .
Mr .

Fpr Intervenor

PK Roy, Sr. Adv.
GS Chatterjee, Adv.
Pramit K Roy, Adv.
Feroze Ahmed, Adv.

Mr. Jay Savla, Adv.
Ms. Reena Bagga, Adv.

Mr. BB Sawhney, Adv.
Mrs. Indra Sawhney, Adv.

IA No.15

UPON hearing counsel the Court made the following
ORDER

Heard the learned counsel for the parties.

Learned
the

counsel for the petitioner has drawn out attention to

affidavits of the States/ Union Territories and pointed out

that

number

of States have not complied with the directions issued by this

Court

on

purpose

29th
is

January, 2002 .

for

produced

ou r

Comparative chart for

K

l-hat

perusal.

chart

the

aforesa id

revea1s

that

necessary action is not taken against the persons who are having ultra

sound machines despite the fact that they are not registered/ licenced

4
one.

Relevant chart is as under:

Survey
conducted
by the
author i t i es

Information supplied Reg i stored
ni cs
by the manufacturing Cli
1
Companies for the sale
of ultra sound machines

S. No.

Name of
the State/
UT

1 .

Bihar

297

345

226

2.

Delhi

777

420

525

3.

Gujarat

750

813

484

4.

Kerala

562

756

496

5.

Jharkhand

No figure

1 23

81

6.

Or i ssa

No figure

210

7.

Uttar Pradesh

1096

945

625

8.

Pondi cherry

37

3

27

9.

West Bengal

No figure

462

257

...4/-

f

I
4

Still

pth

Apri1,

however, time to comply with the order is granted
2002 on which date the concerned Health

|*/pl farg-Hea 1 th

Secretary

of

the aforesaid

upto

Secretary/Fami 1y

States/UT

sha 1 1

rema in

personally present.

(D.L. Chugh)
Court Master

(K.K. Chadha)
Court Master

5

I

Z3
ITEM No.2

Gourt No%6

PIL
^atter
:;‘

SUPREME
CO (T'R
RECORD OF PROCEEDINGS

'
■■■

■■

Writ Petition(Civil ) No. 301/2000
CEHAT & ORS.

■ -

C:

(s)

VERSUS

UNION OF INDIA AND ORS.
(Appln .• Jor permission to submit add!,
documents and^xempX}
addl .
from filing OT and imp leading
j party and intervention)) ‘
Date : 29-1-2002 This Petition was
called on'for hearing today.

CORAM :

HON’BLE MR. JUSTICE M.B. SHAH
HON’BLE MR. JUSTICE B.N. AGRAWAL
HON'BLE MR. JUSTICE ARIJIT PASAYAT
For Petitioner (s)

Ms. Indira Jai Singh, Sr. Adv.
Mr. Sanjay Parikh,Adv.
’ Mr.
RR Chandrachud, Adv.
Mr. AK Misra, Adv.

For Respondent (s)
UOI

Mr.
Mr.
Mr .
Ms .

Soli J Sorabjee, Attorney General
Manish Singhvi, Adv.
Krishan Mahajan, Adv.
Sushma Suri, Adv.
Ms . Sunita Sharma, Adv.
Mr. OS Mehra, Adv.

for States of Gujarat Ms.
Hemantika Wahi,Adv.
and Mizoram
Ms . Anu Sawhney, Adv.

for State of Punjab

Mrs. Jayshree Anand, Addl.Adv.Genl. Pb
Mr. Rajeev Sharma,Adv.


For State of Assam

Ms .
Ms .
Mr.
M/s

for State of Orissa

Mr. Radha Shyam Jena,Adv.

J

for State of SikkSjm

Asha G Nair, Adv.
Krishna Sarma, Adv.
VK Si darthan, Adv. for
Corporate Law Group , Advs-r

Mr. A Mariarputham, Adv.
Ms. Aruna Mathur, Adv.
Mr. Anurag Mathur, Adv. for
Arputham Aruna & Co. , Adv’s.

for State of Rajasthan Mr. Ranj i Thomas,
Adv.
Mr. Javed M Rao, Adv.
for State of Kerala
Mr. John Mathew, Adv.
Mr . Manish Garg, Adv.
Mr . KR Sasisprabhu, Adv.
for State of Haryana Mr.
Jai Prakash Dhanda, Adv.
Mr. KP Singh, Adv.

. ..2/-

~ wii

’ 2 -

for Res. State of Goa
t

Mr. Bhavanishankar V Gadnis, Adv.
Mr. HA Raichura, Adv.
Ms. Divya Singh, Adv.

J-;-



•>

for State of
Arunachal Pradesh

Mr. Anil Shrivastav, Adv.

for State of Karnataka Mr. Sanjay R. Hegde,Adv.
Mr. Sanjay Mitra, Adv.
for State of
Naga1 and

Mr. Kailash Vasdev, Sr. Adv.
Mr. VD Khanna, Adv.
Mr. Sanjay K Shandilya, Adv.

for State of MP

Mr. Satish K Agnihotri, Adv.
Mr. Sakesh Kumar, Adv.

State of Tripura

Ms . Vimla Sinha, Adv.
Mr. Rahul Singh, Adv.
Mr. Gopal Singh, Adv.

State of UP

Mr. RC Vermla, Adv.
Mr. Mukesh Verma, Adv.
Mr. Abhishek Chaudhary, Adv.

State of Uttranchal

Mr. L.P. Naithani , Adv. Genl.
Ms . Rachna Srivastava, Adv.
Mr. Mahesh C Kaushik, Adv.

State of West Bengal

Mr. Tara Chandra Sharma, Adv.
Mr. Ajay Ssharma, Adv.

State of Bihar

Mr. BB Sihgh, Adv.

State of Manipur

Mr. KH Nobin Singh, Adv.

State of Mehgalaya

Mr. Ranjan Mukherjee, Adv.

State of HP

Mr. Naresh K Sharma, Adv.

State of Pondicherry

Mr. VG Pragasam, Adv.

State of Maharasthra

Mr. SV Deshpande, Adv.

JT Chandigarh

Ms. Kamini Jaiswal, Adv.

Andaman, Lakshadweep
Dadar Nagar Haveli
Daman z-t r>jUf &
]hi

Mr. Ashok Bhan, Adv.
Ms . Sunita Sharma, Adv.
Mr. DS Mehra, Adv.

State of Chhattisgarh

Mr . Prakash Shrivastava, Adv..

State of Jharkhand

Mr.
Mr .
Mr.

M,^ WIPRO

Mr.
Mr.

For Inntervenor

Ashok Mathur, Adv.
Rajesh Pathak, Ady.
Harvardhan Jha, Adv.

Bhargava V Desai, Adv.
Anand Kumar, Adv.
Ms. Sweta Kakkad, Adv.
Mr. GS Chatterjee, Adv.
Mr. Pramit
|
K Roy, Adv.
Mr. IFeroze Ahmed, Adv.

...3/-

r

:•: •

A

I

r
r

A

UPON hearing counsel the Court made the following
ORDER

Heard the learned counsel for the parties.

the affidavit filed on behalf of the Centra 1 - Government by

In
the

Di rector,

ti ie

1 i sts

Department of Family Welfare,

recei ved

Organ isat ions

f rom

been

have

the

compan ies

forwarded to the

that

it has been stated
and

relevant

Non-Governmental

for

States/UTs

pursuing appropriate actions in the event that the organisations using

che

u1trasound

From

th i s

Act.

it is clear that the concerned

averment

States/UTs

have

the information with regard to the purchase of the

-ecoi ved

machines
to

the concerned State Governments/UTs are directed

therefore,

rinc .

the

machines/scanners are not registered under

cake immediate action on the basis of the said information and if such

erg.an i sat i ons

are

us i ng

the

u1trasound

wi thout

machi nes/scanners

themselves registered under the Act, the said machines should

Ci ng

he sealed and seized for the time being.

It

has

that

further pointed out in the affidavit

been

• i' i o n a 1 Inspection and Monitoring Committee reported:

The

"Under Section

! Q

of the Pre-Natal Diagnostic Techniques (Regulation and

Preventi on

of

M1suse )

the

appropri ate

of

compli ance

authority

Act,

1994 there has to be an enquiry by

fol 1 owed

by the expression of satisfaction

the Act and the Rules after receiving the advice of the Advisory

1 th

Committee.

It is only by following this mandatory procedure that the

Appronr i ate

Author i ty

person
The

can grant a certificate of registration

applying for starting a genetic c1inic/1ab/counse1ing

to

a

centre.

Committee found in Chandigarh that there was a complete violation

or these mandatory provisions of the Act.
. .4/-

<7.* ’



A

4
our view, the concerned authorities are required to follow

In

grant

procedure provided under the Act and should not

the

mandatory

any

ce rtif icate

or registration to any person if the form is in,

any

way

incomp1ete .

Hence,

di rected

to

the

rollow

i

granting

!



under

the

Act

or registration to any person

or

organization

procedure

mandatory

certi f i cate

the concerned authorities are
prescri bed

before

using the said machines/scanners.

i

It

also been pointed out by the learned counsel for

'.oner that the Union of India/concerned authorities may also take

chc

help of the following Associations or Members for the purpose

informat i on

about

the user of

ultrasound

the

!

1 .

INDIAN MEDICAL ASSOCIATION (IMA)

2,

INDIAN RADIOLOGISTS ASSOCIATION

machines/

FEDERATION OF OBSTETRICS AND GYNAECOLOGISTS SOCIETY

1

OF INDIA
For
“ 3 r as

the

(FOGSI)

time being personal presence of the officers of

is dispensed with.

List this matter after four weeks.

11 H
(D.L. Chugh)
Court Master

i

j

of

s c a r. n s r s :

I

|

the

peL ■

oo- : n i ng

i

has

i Ca-

(K.K. Chadha) J) I )

Court Master

/

the

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