This article is written by Shristi Borthakur, of Symbiosis Law School NOIDA, where she discusses the legality of pre-natal diagnostic techniques in India.

Pre-natal Diagnostic Techniques (PND) are diagnostic or pre-symptomatic tests carried out on a developing fetus. The prenatal diagnostic techniques involve the use of technologies, such as ultrasonography, amniocentesis, chorion villi biopsy, foetoscopy, maternal serum analysis, etc. After PND is carried out, if the fetus is found to be affected by a genetic condition, both parents (or the mother) have the alternative to either (in jurisdictions where abortion is permitted) terminate the pregnancy (for medical reasons) or continue with the pregnancy and prepare for the future knowing that the child will be born with a genetic condition. There has always been an extreme discourse on the legality and morality of the use of pre-natal diagnostic techniques. There exists a divided thought process regarding the extent to which such technologies should be allowed, or whether they should be allowed in the first place, regardless of its success.

What is the law in India?

The law governing the practice of PND in India is provided for in the Pre-Conception and Pre- Natal Diagnostic Techniques Act, 1994 (PC-PNDT Act). The Act was enacted in 1994, amended and effectively implemented in 2003 and strictly amended in 2011. It was enacted with the intent to prohibit prenatal diagnostic techniques for determination of the sex of the fetus leading to female foeticide, in light of the declining sex- ratio in the country. That is to say, the preliminary object was to put a check on female foeticide.

What does the Act regulate?

Since sex determination, the act of identifying the sex of the foetus and elimination of the foetus if it is of the unwanted sex was the primary object, the regulation was laid down for both before and after contraception. The blanket protection of the Act provides that it is not possible to use pre-natal diagnostic techniques to abort fetuses whose sex and family history indicate a high risk for certain sex-linked diseases or to choose a fetus whose sex is less susceptible to certain sex-linked diseases. While it is legally permissible to abort a fetus at risk of serious physical or mental disabilities, as per the Medical Termination of Pregnancy Act, 1971, it is not permissible to select a fetus of a sex which is less likely to suffer from a sex-linked disease. Consequently, it allows the use of pre-natal diagnostic techniques only for the detection of the following discussed below.

• Genetic abnormalities
• Metabolic disorders
• Chromosomal abnormalities
• Haemoglobinopathies
• Sex-linked disorders.
• Certain other congenital abnormalities and diseases, as may be specified by the Central Supervisory Board

What is the Central Supervisory Board?

The Board is constituted by the Central Government to exercise the powers and functions for the purpose of this Act. The constitution of the Board is laid down in the Act in Chapter IV. It is also required that each State and Union Territory having a Legislature constitute a State Supervisory Board, or a Union Territory Supervisory Board respectively, for implementation of the policies of the Act, and various other purposes. Further, the Act provides that there be an Appropriate Authority for each State and Union Territory, and an Advisory Committee for every Appropriate Authority, according to Chapter V of the Act.

What are the specifications for the patient on whom such techniques/ procedures can be practised?

No points for guessing, that PND techniques cannot be performed by anyone not qualified/ authorised under the Act, and in a place that is not mandatorily registered under the Act. Further, for such a person to perform these techniques, he/she needs to necessarily record certain conditions of the patient concerned (pregnant woman). The following conditions should be satisfied to obtain a valid ground to perform such techniques.

• She should be above the age of 35,
• Should have undergone 2 or more spontaneous abortions or foetal loss,
• 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,
• Any other conditions as may be specified by the Board.

Moreover, such procedures cannot be conducted without first explaining all known side-effects, pros and cons, etc. of said procedures and a written consent for the same by the concerned pregnant woman.

Who are the qualified persons under the Act?

The Ministry of Health and Family Welfare, Government of India, brought out a Handbook on the Rules and Amendments of the PC-PNDT Act, in the year 2006. It contained the guidelines regarding qualified persons, procedures and requirements of registration, policies, etc. in accordance with the Act. The Handbook laid down the qualified persons under the  Act to perform PND techniques as follows-

• Gynaecologist
• • • For Genetic Counselling Centre– 6 months experience in genetic counselling (OR) 4 weeks training in genetic counselling
    • For Genetic Clinic- “should have performed at least 20 procedures in chorionic villi aspirations per vagina or per abdomen, chorionic villi biopsy, amniocentesis, cordocentesis foetoscopy, foetal skin or organ biopsy or foetal blood sampling etc. under the supervision of an experienced gynaecologist in these fields.”
• Medical Geneticist- possess Degree/Diploma in genetic science in the fields of sex selection and pre-natal diagnostic techniques (OR) 2 years experience in any of these fields
• Paediatrician- possess postgraduate qualification ins paediatrics.
• • • For Genetic Counselling Centre- (further qualifications) 6 months experience (OR) 4 weeks training in genetic counselling
• Registered Medical Practitioner- possess recognised medical qualification as per the Indian Medical Council Act.
• • • For Genetic Clinic- (further qualifications) should have a post-graduate degree or diploma or six months training or one year experience in sonography or image scanning.
• Laboratory technicians (in Genetic Laboratory)-
• • • B. Sc. Degree in Biological Sciences (OR) Degree/Diploma in medical laboratory courses
    • At least one year’s experience in conducting appropriate prenatal diagnostic techniques, tests or procedures.
• Radiologist
• Sonologist or Imaging Specialist – possess any recognised medical qualification under the Indian Medical Council Act (OR) postgraduate qualification in ultrasonography or imaging techniques or radiology.

All you need to know about Registrations under the PC-PNDT Act in India

Minimum Requirements

Genetic Counselling Centre

• Adequate space
• Contain educational charts/models/ pieces of equipment for carrying out genetic counselling
• Must have any one of the following
  • Medical geneticist
  • Gynaecologist
  • Paediatrician

Genetic Laboratory

• Adequate space for conducting tests
• Should have or acquire the pieces of equipment as may be necessary to conduct studies allowed for by the Rules of the Act
• Must have both a medical geneticist and a laboratory technician in its employment

Genetic Clinic

• Adequate space
• Should have or acquire necessary pieces of equipment

Procedure for Registration and Certification

• The application has to be made to Chief Medical Officer of the district, and Medical officer forming the Appropriate Authority for the sub-district.
• Should be duly accompanied by an Affidavit, containing
  • An undertaking to the effect that the Genetic Centre/Laboratory/Clinic/ Ultrasound Clinic/Imaging Centre/combination thereof, as the case may be, shall not conduct any test or procedure, by whatever name called, for selection of sex before or after conception or for detection of sex of foetus except for diseases specified in the Act nor shall the sex of foetus be disclosed to anybody; and
  • An undertaking to the effect that the Genetic Centre/Laboratory/Clinic/ combination thereof, as the case may be, shall display prominently a notice that they do not conduct any technique, test or procedure etc. by whatever name called, for detection of sex of the foetus or for selection of sex before or after conception.

• Acknowledgement of the application should be taken by Appropriate Authority
• Application fee should be submitted with application form
  • By Demand Draft
  • Drawn in favour of Appropriate Authority
  • On any scheduled bank payable at the headquarters of the Appropriate Authority concerned.

• Fees collected by the Appropriate Authority for registration shall be deposited by the Appropriate Authority concerned in a bank account opened in the name of the official designation of the Appropriate Authority concerned.
• Fees shall be utilized by the Appropriate Authority in connection with the activities connected with the implementation of the provisions of the Act and these rules.
• Appropriate Authority will transfer the application to Advisory Committee, after verification, for advice, if any.
• Appropriate Authority, after considering the advice, will grant certification. It may also reject the application, and has to accordingly lay down the grounds for rejection.
• The Appropriate Authority can, at any time, on its own or on receiving a complaint, issue show-cause notice for cancellation or suspension of registration, and should mention the grounds for the same in the notice.
• An appeal is allowed within 30 days of such cancellation/suspension/rejection.
• Every certificate of registration will be valid for 5 years since its issuance. Application for renewal should be filed 30 days before the date of expiry.

What are the offences and penalties under the Act?

• The offences under this Act are cognizable, non-bailable and non-compoundable.
• The act prohibits the advertisement, including visible representation to that effect, relating to the prenatal determination of sex, in any form, by any person or organization. Contravention of such order, by anyone, shall be punishable with imprisonment for a term which may extend to three years and with fine which may extend to ten thousand rupees.
• If any qualified person under the Act, who owns or is a part of any Genetic Counselling Centre, or Genetic Clinic, or Genetic Laboratory, contravenes any provision of the Act or rules made thereunder, will face the same penalty as above, and on any subsequent conviction, with imprisonment which may extend to five years and with fine which may extend to fifty thousand rupees.
• Further, such person will be reported to the Appropriate Authority for taking necessary action, including suspension and removal of name from the register of the Council.
• Any other person who seeks the help/assistance of qualified persons and registered places for the purpose of any procedure prohibited by the Act on any pregnant woman, shall be punishable with imprisonment for a term which may extend to three years and with fine which may extend to fifty thousand rupees for the first offence and for any subsequent offence with imprisonment which may extend to five years and with fine which may extend to one lakh rupees.
• The above penalty does not apply to a pregnant woman who has been compelled to undergo such procedure or selection.

How can you file a complaint against such offences?

• To report an offence under the Act, and file a complaint therewith, one must approach the Appropriate Authority (AA), via a written complaint.
• The AA acknowledges the receipt of the complaint.
• They are required to take action within 15 days of such complaint and file a complaint to the court of Metropolitan Magistrate or Chief Judicial Magistrate. This can also be done suo moto by the AA.
  • In certain cases, it can also issue a show-cause notice to the entity against whom the complaint has been made, before filing the complaint in court.
  • Before filing a complaint, the AA should call an Advisory Meeting, and pass a resolution for the filing of case and suspension of registration of centre.
  • They need to ensure all documents are available- statements of accused, visit and inspection report, statement of decoy and witnesses, panchanama of seized material.
• If the AA takes no action within 15 days, the complainant can go to Court with the acknowledgement receipt. Alternatively, can also approach a social organisation like an NGO working on women’s rights issues in the area or State.

Who can file a complaint with Appropriate Authority?

• Any person, who has given a notice to the appropriate authority and who had expressed his intention to make a complaint to a Court, by giving 15 days notice to the AA, could lodge a complaint. This person need not be even in any way personally connected with the incident.
• As per the definition of ‘persons’ in the Act, a complainant can also be a social organisation.
• Apart from the appropriate authority, an officer authorized by the Central Government or the State Government could also file a complaint.

Who is the Appropriate Authority?

• State Appropriate Authority- Three member team ( Officer of a rank of Joint Director or above of Department of Health and Family Welfare, Eminent women from NGO, Officer of Law and Judiciary Department)
• District AA – Civil Surgeon/ CMO
• Corporation AA – Medical officer of Health

What are the documents that need to be attached for filing a complaint by the AA (along with case sheet)?

• Notification of appointing person as AA, and authorization letter
• Inspection/visit report
• Panchnama in original
• Statement of witness
• Notice calling a meeting of Advisory Committee, and the resolution passed.
• Original registration certificate along with order suspending registration prepared at the time of inspection.
• Statement of accused and co-accused, if any
• Understand the Standard Operating Procedure (SOP) for offences under the Act from this link.
• Other supporting documents and evidence
  • F Form Register
  • OPD Register
  • Whether consent was given by of the pregnant woman, or not
  • Declaration stating sex of the foetus will not be revealed
  • Referral Slip
  • CCTV Recording
  • Computer and Printer
  • File with Ultrasonography reports