By Dr. (Prof.) Mahesh Baldwa,
M.D, D.C.H, FIAP, MBA, LL.B, LL.M, PhD (law)
SENIOR PEDIATRICIAN & MEDICOLEGAL ADVISOR
Formerly Assistant Professor of Pediatrics at T.N. Medical College and Nair Hospital, Mumbai-
400008
Ex. Asst. Professor JJ Hosp, Grant medical college
Ex. Professor, paper setter & examiner of law to postgraduate students of University Department of
Law, University of Mumbai
Baldwa Hospital, Sumer Nagar, S.V. Road, Borivali (West) Mumbai 400 092
2. Dr. Sushila Baldwa, MBBS, MD, consultant, Apollo clinic (part of Apollo Hospital),
Kandivali west, Mumbai
3. Dr Namita Padvi, MBBS, MD,DNB, PGDML, Fellowship in pediatric anesthesiology,
Assistant Professor of Pediatric medical s at T.N. Pediatric medical College and Nair
Hospital, Mumbai-400008
4. Dr Varsha Gupta, MBBS, MD, PGDML, Senior resident in department of pathology,
Government medical college, kota, Rajasthan
INTRODUCTION
A case can be registered against doctors for performing a test and revealing the sex of the foetus to the mother and also for not putting up notices that sex determination tests are illegal, not filling the mandatory F-form and not maintaining records.
BACK GROUND
In the last 10 years, only in three cases the guilty were awarded both rigorous imprisonment and fine after they were caught red-handed carrying out pre-natal sex determination tests in sting operations. Hence Voluntary Health Association of Punjab Vs. Union of India & Others, Writ Petition (Civil) No. 349 Of 2006, a NGO filed a writ petition in the Hon’ able Supreme Court of India in 2006 against Union of India and Ors., for effective implementation of Pre-conception and Pre-natal Diagnostic Techniques (Prohibition of Sex Selection) Act, 1994. As for one reason or the other, the practice of female infanticide still prevails. Saying the authorities concerned should take steps to seize the machines which have been used illegally and contrary to the provisions of the Act and the Rules there under and the seized machines can also be confiscated under the provisions of the Code of Criminal Procedure and be sold, in accordance with law. It further said various Courts in this country should take steps to dispose of all pending cases under the Act, within a period of six months. Communicate this order to the Registrars of various High Courts, who will take appropriate follow up action with due intimation to the concerned Courts. Therefore a decision to the effect of punishing state AA if not implementing the PC PNDT Act correctly was taken by the State Advisory Committee constituted for curbing female foeticide by implementing the PCPNDT Act. The Civil Surgeons are AA under the PCPNDT Act in the districts and they are empowered by the Act to take action against the hospital or ultrasound centers not obeying the law or not maintaining the records according to law – Ss. 217, IPC, states that any public servant disobeying directions of law with intent to save person from punishment or property from forfeiture shall be punished with imprisonment of either description for a term which may extend to two years or with fine, or with both.
ACTION TAKEN IN MAHARASHTRA
The Maharashtra Medical Council (MMC) has found nine radiologists from across the state guilty of performing sex-determination tests in the last three months. It also found that 55 USG centers were not maintaining proper records as prescribed under the Pre-Conception and Pre-Natal Diagnostic Techniques (PCPNDT) Act.
After issuing suspension orders against 21 doctors for flouting provisions of the Pre-Conception and Pre Natal Diagnostic Techniques (PC-PNDT) Act, the Maharashtra Medical Council (MMC) now plans to hold a special meeting to decide on the other 48 pending cases. “Of the 4,293 USG centers across Maharashtra only 2,000 have been complying with the norms. The rest have not been submitting forms online,” said a health department official. “Of the defaulters nearly 1,195 are from Mumbai. The city has 1,200 USG centres which means only five have been filing reports online,” he added.
Form F (FF) IS BIGGEST STUMBLING BLOCK
In a majority of the cases, Doctors are upset about being pulled up for technical lapses and incorrect filling of forms. Doctors have not being able to maintain records and other technical requirements under the PC-PNDT Act. FF under the PCPNDT Act records the medical history of a pregnant woman.
For instance, not filling FF properly is regarded as an offence related to sex determination. While doctors were filling the forms as per the rules, some lapses occur inadvertently, such as spelling mistakes. These technical errors should not amount to an offence like sex determination.
However, lower courts have passed conviction orders and more than 40 per cent of the doctors have appealed against the judgment. According to the Act, the punishment is three-year RI and Rs 10,000 fine.
They have also protested about the rule under which no sooner is the charges are framed against a doctor under the Act, his/her name is sent to the Maharashtra Medical Council (MMC). The council can take stern action like suspension or cancellation of the doctors’ registration.
Introduction: The Benefits and Burdens of Ultrasound Technology
The distribution of compact, portable ultrasound technology in India offers significant potential health benefits to millions who suffer from diseases, such as breast cancer, uterine fibroids, other gynecological disorders.
Ultrasound is also uniquely powerful in that it is the only imaging technology that can be transported to a patient or used where a patient is in rural and urban populations in India From public health point of view portability is good but from PCPNDT act point of view portability is bane. Over the last decade, however, some civil society groups have focused on ultrasound technology as a cause of increased rates of female feticide in India. In India, as in certain other countries and cultures, there exist deeply rooted historical preferences for male children. Observers have noted that these preferences are driven by a combination of cultural and economic factors. Traditionally, Indian parents are expected to pay heavy dowries to get daughter married hence economically it is considered bad choice.
Indian society’s male child preference
In a country without a social security system, male children are often viewed as their parents’ long-term security when girls are expected to marry and eventually leave home. Yet, the economic concerns are only one part of the story. In fact, the numbers of female vs. male births have been dropping most quickly among wealthy, urban populations, specifically in northern India. This trend suggests that economic security alone will not safeguard female fetuses. ultrasound technology is considered to be misused since it become cheap and easy way for sex determination to facilitate female feticide.
law that prohibits sex selection
“Pre-Natal Diagnostic Techniques” (PNDT) Act of 1994, a law that prohibits any person or body from using equipment or techniques for the purpose of detecting the sex of an unborn child. There are exceptions for diagnoses of specified sex-linked diseases or disorders. The law also prohibits anyone from communicating the sex of the fetus if it is detected during a pre-natal examination or diagnostic test. The law requires, among other things, that all practitioners, clinics, genetic counseling centers, etc. that perform pre-natal diagnoses register with the government, obtain a certificate of registration, and display a notice regarding the prohibitions on fetal sex detection. Then in 2004, the government implemented the 2002 amendments to the PNDT Act, explicitly recognizing the responsibility of manufacturers and distributors to assure proper use of ultrasound equipment, prohibiting them from selling, renting, permitting or authorizing the use of ultrasound machines for fetal sex determination, and imposing criminal punishment such as fines and jail. Manufacturers must confirm that the customer has a valid PNDT Certificate and has signed an affidavit stating that the equipment shall not be used for sex determination. Manufacturers also must provide the government with a quarterly report disclosing to whom the equipment has been sold. female feticide are still commonplace, if not increasing, and that other reports point to declining numbers of female live births relative to male live births in many areas of both rural and urban India.
Human rights
It is criminal if one knowingly ignores human rights and knowingly provides practical assistance or encouragement for violation of human rights abuse.
Medical practitioners with post graduation degrees in gynaecology and obstetrics are qualified for conducting ultrasounds in a genetic clinic / ultrasound clinic / imaging centre, a recent circular issued by the union ministry of health and family welfare.
Gynecologists can perform ultrasound
“Several queries had been forwarded to the union health ministry over whether gynecologists’ are qualified to conduct ultrasound procedures under the PCPNDT (Pre-conception and Pre-natal Diagnostic Techniques) Act,”
“In response, the Centre issued a circular that categorically mentions that medical practitioners with post graduation education in gynaecology and obstetrics are qualified for conducting ultrasounds,” later is appended at the end of the chapter
Important points in the PC-PNDT Act
The act was formulated in 1994 specifically for pre–natal diagnostic techniques (invasive procedures) and centers were termed as genetic clinics. When the Supreme Court of India in 2001 gave a verdict on a petition filed by an NGO that ultrasound clinics should be brought under the act, the Government just added the term ultrasound clinic everywhere along with genetic clinic. Most of the problems gynecologist face are a result of this addition.
The Pre-Conception and Pre-Natal Diagnostic Techniques (Prohibition of Sex Selection) Act 1994
Section 2. Definitions (d) genetic clinic: Explanation:
For the purposes of this clause, a Genetic Clinic includes a vehicle, where ultrasound machine or imaging machine or scanner or other equipment capable of determining sex of the fetus or a portable equipment which has the potential for detection of sex during pregnancy or selection of sex before conception, is used.
If Vehicle, e.g. car carrying the machine (even when not used for doing ultrasound) is to be registered and monthly report needs to be sent.
portable ultrasound is banned by the high court in Maharashtra and many other states by the appropriate authorities.
Section 2. Definitions (i) “pre-natal diagnostic procedures” means all gynecological or obstetrical or medical procedures such as ultrasonography, fetoscopy, taking or removing samples of amniotic fluid, chorionic villi, blood or any other tissue or fluid of a man, or of a woman 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.
Explanation: Ultrasound is pre-natal diagnostic procedure as well as pre-natal diagnostic test.
Section 2. Definitions (p) “Sonologist or imaging specialist” means a person who possesses any one of the medical qualifications recognized under the Indian Medical Council Act, 1956 or who possesses a postgraduate qualification in ultrasonography or imaging Techniques or radiology. Here Radiologist and registered medical practitioner (MBBS) as well as gynecologist have been equated.
Section 4 (v) Provided that the person conducting ultrasonography on a pregnant woman shall keep complete record thereof in the clinic in such manner, as may be prescribed, and any deficiency or inaccuracy found therein shall amount to contravention of provisions of section 5 or section 6 unless contrary is proved by the person conducting such ultrasonography.
Onus of proving not-guilty is on radiologist/ Sonologist/ gynecologist and NOT on the authorities. In other criminal cases the prosecution has to prove that the accused is guilty.
Section 5. 1. No person referred to in clause (2) of section 3 shall conduct the pre-natal diagnostic procedures unless —
a. He has explained all known side and after effects of such procedures to the pregnant woman concerned;
b. He has obtained in the prescribed form her written consent to undergo such procedures in the language which she understands; and
c. A copy of her written consent obtained under clause (b) is given to the pregnant woman.
Ultrasound being pre natal diagnostic procedure gynecologist need to take patient declaration in local language and give a copy to patient. In fact authorities in Maharashtra are insisting on it.
Section 23. Offences and penalties.- (1) Any medical geneticist, gynecologist, registered medical practitioner or any person who owns a Genetic Counseling Centre, a Genetic Laboratory or a Genetic Clinic or is employed in such a Centre, Laboratory or Clinic and renders his professional or technical services to or at such a Centre, Laboratory or Clinic, whether on an honorary basis or otherwise, and who contravenes any of the provisions of this Act or rules made thereunder 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. Even if a gynecologist / radiologist is attached as honorary/ namesake basis to a ultrasound clinic, he is equally responsible for any contraventions of provisions of PCPNDT law done in the center and thus is equally liable for punishment like imprisonment and fine.
Section 31 Protection of action taken in good faith: No suit, prosecution or other legal proceeding shall lie against the Central or the State Government or the Appropriate Authority or any officer authorized by the Central or State Government or by the Authority for anything which is in good faith, done or intended to be done in pursuance of the provisions of this Act. The AA has full immunity if he states that he has taken any action in good faith.
The Pre-Conception and Pre-Natal Diagnostic Techniques (Prohibition of Sex Selection) Rules 1996
Rule 3. Minimum Requirements 3. (1) Any person having adequate space and being or employing:
a. Gynecologist having experience of performing 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 supervision of an experienced gynecologist in these fields, or
b. a Sonologist, Imaging Specialist, Radiologist or Registered Medical Practitioner having Post Graduate degree or diploma or six months training or one year experience in sonography or image scanning, or
c. A medical geneticist may set up a genetic clinic/ ultrasound clinic/imaging centre.
Gynecologist / Radiologist is at par with Registered Medical Practitioner having six months training or one year experience in sonography or image scanning,
Controversy: The term sonologist has two separate definitions one as per chapter I.2.p. And other as per above rule 3.3.1 b.
Rule 9. Maintenance and preservation of records. – (1) Every Genetic Counseling Centre, Genetic Laboratory, Genetic Clinic, Ultrasound Clinic and Imaging Centre shall maintain a register showing, in serial order, the names and addresses of the men or women given genetic counseling, subjected to pre-natal diagnostic procedures or pre-natal diagnostic tests, the names of their spouses or fathers and the date on which they first reported for such counseling, procedure or test. an ultrasound clinic have to keep such a register which was to be maintained by a genetic clinic or laboratory?
Rule 10. 1A. Any person conducting ultrasonography/image scanning on a pregnant woman shall give a declaration on each report on ultrasonography/image scanning that he/ she has neither detected nor disclosed the sex of fetus of the pregnant woman to anybody. The pregnant woman shall before undergoing ultrasonography/image scanning declare that she does not want to know the sex of her fetus.
patients’ declaration required on each report of ultrasound. There is confusion as per chapter 3.5.1. Ultrasound being diagnostic procedure declaration has to be taken in language patient understands and copy to be given to patient. Thirdly form F also has declaration of patient as well as doctor. How many declarations are needed to be given and in what language is not clear!
Rule 13. Intimation of changes in employees, place or equipment.
– Every Genetic Counseling Centre, Genetic Laboratory, Genetic Clinic, Ultrasound Clinic and Imaging Centre shall intimate every change of employee, place, address and equipment installed, to the Appropriate Authority within a period of thirty days of such change.
Change in equipment and radiologist gynecologist do report, however change in other employees, like say an attendant or nurse, radiologist/gynecologist needs to report.
Rule 17. Public Information – (2) at least one copy of act and these rules shall be available on the premises of every Genetic Counseling Centers, Genetic Laboratories, Genetic Clinics, Ultrasound Clinics, Imaging Centers and shall be made available to the clientele on demand. the copies should be kept, one each in reception room, consulting chamber and ultrasound room.
Rule 18. Code of conduct. Code of Conduct to be observed by persons working at Genetic Counseling Centers, Genetic Laboratories, Genetic Clinics, Ultrasound Clinics, Imaging Centers etc. – All persons including the owner, employee or any other person associated with Genetic Counseling Centers, Genetic Laboratories, Genetic Clinics, Ultrasound Clinics, Imaging Centers registered under the Act/ these Rules shall display his/her name and designation prominently on the dress worn by him/her. Every staff member of an ultrasound clinic has to wear name batch. Additional points gynecologist must understand clearly:
RELEASE OF SEALED MACHINE IS NOT THE END of problems – In maximum cases ultrasound machines have been seized by the AA for trivial paperwork deficiency. The offence being cognizable, non-bailable and noncompoundable, they put up a criminal case. Even if court releases the machine in a period of 2-3 moths, the criminal case continues and radiologist is liable for 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.
IN ADDITION to fine and jail term– The name of the RMP/ sonologist is reported to the State Medical Council concerned for suspension of the registration if the charges are framed by the court till the case is disposed-off and on conviction 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.
Hence safe practice of ultrasound by gynecologist can be summarized as below:-
- Centre should be registered.
- Each and every ultrasound machine new/old are even bought for future use should be registered by filling form “A” and getting registration under form “B”. the requirement of registration is prior to starting the centre meant for ultrasound.
- Display form B in one each in reception room / waiting room consulting room and ultrasound room along with one copy of PCPNDT act in each room.
- Display “sex determination is not done along with helpline no. of government agencies for complaining sex determination:” and in one each in reception room / waiting room consulting room and ultrasound room along with one copy of PCPNDT act in each room.
- Each time any change in staff member, gynecologist, radiologist must be informed prior to continue with ultrasound.
- Never carry ultrasound machine out of the ultrasound room and keep it under the lock and key.
- Never carry the machine in car or any vehicle.
- Fill each and every column of form F meticulously without leaving them blank. There should not be any overwriting. Each and every form F should be signed and sealed by doctor performing ultrasound.
- A duplicate copy of declaration form, in local language that no sex determination is done should be given to the patient along with ultrasound report mentioning no sex determination is done.
- Fill online F form for each and every patient.
- Send monthly report on or before 5th of every month
- Do not allow any person other than who is authorized as per, form B to perform sonography.
- Each and every person staff member, gynecologist, radiologist should wear white coat with name and designation plate pinned to the white coat. Inform about change of employee, place, address and equipment if any immediately to appropriate authority.
- Maintain record of all patients for a period of three year
