Medico Legal Problems: The Medical Practitioners of India today is scared of various Consumer Courts that have been set up by the Government of India and the Legislation by which the Medical Practitioners have been brought under the purview of Consumer Courts. The day to day invention in the Medical Science, introductions of new techniques of treatment and diagnosis and the new diseases that are coming up because of jet speed pollution, adulteration, radio-active atmospheric and environmental dis-balances have posed great challenge before the Medical Practitioners / Medical Establishments of today coupled with the increasing awareness of the Consumer Rights by the public at large. Medico-legal problems are so technical that it can be dealt or understood by the Medico legal experts only.
Litigation of Doctors! YES. Litigation against Doctors / Medical Establishments is not a new problem, but this problem has gained lot of prominence. Doctors , in general, are very sensitive people and the nature of their job make them very vulnerable to litigation. After the landmark judgement of Hon’ble Supreme Court of India in the case titled IMA Vs. V.P. Shanta in 1995, the number of cases have increased very fast and in several cases the Courts have awarded huge compensation against the Doctors. The reasons behind the increasing number of cases against the Doctors are :
Medical Negligence: Medical negligence is the breach of the duty owed by a doctor towards the patient, to exercise reasonable degree of care and skill which results in some physician, mental & financial disability or loss. Hence, it can be a civil or criminal mistake (errors) arising out of the contract between the Doctor & Patients relationship.
Consumer Protection Act: Consumer Protection Act, 1986 (widely known as CPA) is a well known Act amongst the public at large and the Medical Practitioners and Medical Establishments brought under its purview by Hon’ble Supreme Court of India is also a matter of concern for the Doctors / Medical Establishments. The main objective of this Act is to safeguard the Rights of the Consumers but misuse of this Act by the Consumers can also not be ruled out.
Victim of the Complaint:
Since the services of medical & paramedical are brought under Consumer Protection Act widely known as CPA, doctors / medical establishments must know its provisions and implications.
We would like to envisage the salient features of this Act
The Consumer Protection Act, 1986 was enacted on 24-12-1986 (as 68 Bill of 1986) to provide better protection of the interest of consumers and for this purpose, to make provisions for the establishment of Consumer Councils and other authorities for settlement of consumer disputes and for matters connected there with.
The enactment of CPA was an important milestone in the history of consumer movement in India. A rational approach and not a technical approach is the mandate of law. CPA is one of the benevolent pieces of social legislation providing alternative to civil courts system of consumer justice by summary trial.
It was enacted after thorough discussions in both houses of parliament and assent by the President of India. The bill was formulated on the lines of broad outlines suggested by the world body, United Nation in 1985.
It seeks to promote and protect the rights of consumer such as :
These objects are sought to be promoted and protected by the Consumer Protection Council at Central and State levels.
Speedy and simple redressal of dispute is provided through quasi-judicial machinery at District, State and Central level, which are to observe principles of natural justice. These quasi-judicial bodies are empowered to give specific relief and to award, wherever appropriate, compensation to the consumers, penalties for non-compliance of orders given by these bodies have also been provided.
This Act extends to the whole of India except the State of Jammu and Kashmir.
The applicable Definitions for Medical Fraternity / Medical Establishments as envisages in this Act are :
“Complainant” means –
“Complaint” means –
any allegation in writing made by a complainant that -
who hires or avail of any services for a consideration which has been paid or promised or partly paid and partly promised, or under any system of deferred payment and includes any beneficiary of such services other than the person who hires or avails of the services for consideration paid or promised, or partly paid and partly promised, or under any system of deferred payment, when such services are availed of with the approval of the first mentioned person ;
A doctor will not be guilty of negligence, if he has acted in accordance with the practice accepted as proper by a responsible body of medical men skilled in that particular art and if he has acted in accordance with such practice then merely because there is a body of opinion that takes a contrary view, will not make him liable for negligence (Vinita Ashok Vs. Lakshmi Hospital, 2001 8 SCC 731).
“Consumer Disputes” means – a dispute where the person against whom a complaint has been made, denies or disputes the allegations contained in the compant.
“Deficiency” means - any fault, imperfection, shortcoming or inadequacy in the quality, nature and manner of performance which is required to be maintained by or under any law at the time in force or has been undertaken to be performed by a person in pursuance of a contract or otherwise in relation to any service ( deficiency gives wider scope than negligence alone).
“Service” means - services of any description which is made available to potential users and includes but not limited to the provisions of facilities in connection with banking, financing, insurance, transport, processing, supply of electrical, etc., but does not include the rendering of any services free of charge or under a contract of personal services;
Please note that medical services are subject of CPA even if they are provided free in almost all private setups, because even if 1 patient is charged and 999 patients are treated free, CPA is applicable (SC IMA Vs. VP Shanta, Nov. 1995). Only free camps etc., are exempted, nominal registration fee is not considered as fees.
“Spurious Goods and Services” means – such goods and services which are claimed to be genuine, but they are actually not so.
“Unfair Trade Practice” means - a trade practice which for the purpose of promoting the sales, use or supply of any goods or for the provision of any services, adopt any Unfair method or Unfair or deceptive practice including any of the following practices name,
Establishment of Consumer Disputes Redressal Agencies :
There shall be established for the purpose of this Act, the following agencies, namely :-
Composition of the District Commission
Each District Commission shall consists of , -
Redressal Forums have been established at three different levels :-
- "District Forum" by State Government. At least one in each district or in certain cases one District Forum may cover 2 or more districts.
- "State Commission" by State Government.
- "National Commission" (National Consumer Disputes Redressal Commission ) by Central Government.
District Forum
This shall consist of :
Jurisdiction of the District Forum
The District Forum shall have jurisdiction to entertain complaints where the value of services and compensation claimed does not exceed Rupees Twenty Lakhs. Manner in which complaint shall be made
A complaint may be filed with a District Forum by -
Procedure on receipt of Complaint
The District Forum shall on receipt of a complaint -
Findings of the District Forum
If, after the proceedings, the District Forum is satisfied that any of the allegations contained in the complaint about the services are proved, it shall issue an order to the opposite party directing him to do one or more of the following things :
Appeal against orders of the Dist. Forum
Any person aggrieved by an order made by the District Forum may appeal against such order to the State Commission within a period of 30 days from the date of the order. The State Commission may entertain an appeal after 30 days if it is satisfied that there was sufficient cause for not filing it within that period.
State Commission
It shall consist of -
Jurisdiction of the State Commission
The State Commission has jurisdiction to entertain -
Procedure to be followed by State Commission
Same as for District Forum.
Procedure for hearing appeals
The State Commission may, on such terms as it may think fit and at any stage, adjourn the hearing of appeal, but not more than one adjournment shall ordinarily be given and the appeal should be decided within 90 days from the first date of hearing.
Appeals against orders of State Commission
Any person aggrieved by an order made by the State Commission may appeal against such order to the National Commission within a period of 30 days. The National Commission may entertain an appeal after 30 days if it is satisfied that there was sufficient cause for not filing it within that period
National Commission
This shall consist of -
Jurisdiction of the National Commission
The National Commission shall have jurisdiction -
Procedure to be followed by the National Commission
A complaint containing the following particulars shall be presented by the complainant in person or by his agent to the National Commission or be sent by registered post, addressed to the National Commission :-
The remaining procedure and the procedure for hearing the appeal is similar to that for State Commission.
Appeal against orders of the National Commission
Any person, aggrieved by an order made by the National Commission, may appeal against such order to the Supreme Court within a period of 30 days from the date of the order. The Supreme Court may entertain an appeal after 30 days if it is satisfied that there was sufficient cause for not filing it within that period.
Limitation Period
The District Forum , the State Commission or the National Commission shall not admit a complaint unless it is filed within 2 years from the date on which the cause of action has arisen. In case there are sufficient grounds for not filing the complaint within such period, extension may be granted.
Dismissal of frivolous or vexatious complaints
Where a complaint instituted before the District Forum, the State Commission or the National Commission, as the case may be, is found to be frivolous or vexatious, it shall, for reasons to be recorded in writing, dismiss the complaint and make an order that the complainant shall pay to the opposite party such cost, not exceeding 10,000 rupees, as may be specified in the order.
Penalties
Where a person against whom a complaint is made or the complainant fails or omits to comply with any order made by the District Forum, the State Commission or the National Commission, as the case may be, such person or complainant shall be punishable with imprisonment for a term which shall not be less than one month but which may extend to three years, or with fine which shall not be less than 2,000 rupees but which may extend to 10,000 rupees or with both. In exceptional circumstances the penalties may be reduced further.
Legal aspects of medical practice have always constituted an important component of medical education. Standard books on Medical Jurisprudence contain excellent Chapters on ‘The Law in Relation to Doctors.’ Thus, from an early stage the ‘would be doctors’ are made conversant with the legal issues inherent in medical practice. The application of the Consumer Protection Act to the Medical Professionals has only served to bring into focus some of the legal liabilities of the doctors.
Mere mention of the Consumer Protection Act at any get-together or scientific meeting of doctors evokes their instant attention and all other conversation cases, giving rise to passionate exchange of opinion, experiences, fears, etc. and questions being asked about the implications of the application of the Act to the Medical Profession.
It is these questions and fears which are sought to be discussed in the succeeding paragraphs. By going through this section of the book conscientiously, much of the dread of the ‘unknown’ that is inherent in legal aspects of medical practice, especially in relation to the Consumer Protection Act, will be mitigated.
1. What was the necessity of the Consumer Protection Act, and its application to the Medical Profession ?
This is the foremost question which comes to the mind of the doctors. This necessity arose because the existing laws of the land which provide for action in cases of medical negligence under the Law of Tort and Indian Penal Code, have some well documented problems. These include the following : (i) Delay, which, in medical negligence cases, tends to be greater ; (ii) the cost of bringing an action, which is notoriously high in relation to the sums recovered in damages ; (iii) limited access to the courts ; (iv) success depends on proof of both negligence and causation ( which can be particularly difficult in cases of medical negligence).
Hence necessity to provide for an alternate system which would be easily accessible, speed and cheap, gave birth to the Consumer Protection Act. This Act was made applicable to the doctors because there are no provisions in the Indian Medical Council Act, 1956 ;
2. Who is a consumer ?
Consumer is : (a) a patient who pays to get services of doctor /hospital ; (b) any person who pays for the patient ; (c) legal heirs /representatives of such patients ; (d) spouse, parents and children of the patient.
3. Does the service rendered by doctors / hospitals stand excluded because it is under a contract of personal service as distinguished from a contract for service ?
This is the key clause being disputed by the doctors. The judgements till date have held that the medical services rendered by doctors / hospitals for payment are covered under this Act as they are not Contract of Personal Services but Contract for Services. Contract of Personal Service involves ‘Master - Servant Relationship ‘hereunder :-
Master -Servant Relationship (as per National Commission Decision)
Doctor-Patient Relationship (as per doctors’ contention)
You can order a servant to suspend all other work and clean the utensils but cannot control his response, how quick and well he will clean the utensils, how many utensils he will break etc. We all know how much exactly, we can control the servant We all know the consequences, if we are rude, harsh, physically or verbally abusive with the servant. We have got to be polite with him and respect his sensibilities. We must distinguish between Master-Servant and Master-Slave relationship.
Medical professionals strongly feel that the relationship between Doctor - Patient is that of Contract of Personal Service, where they consider patient to be the master and themselves as servants with the exception that God has bestowed them with professional skill to serve the master (human body) with a difference. They do not deny accountability, not do they deny existence of erring hospitals, deviant doctors and malpractice. But, the percentage of this is too small to give to the general public daggers to run after doctors.
Medical professionals fully agree that efforts should continue so that the master (human body) can be served even better. If the master losses faith in them, their very existence will be threatened.
4. What exactly is the degree of control a doctor has over his patient ?
Kindly ponder over these aspects :A patient may show up very late in course of illness - some times in terminal stages. If consulting time / waiting time for consultation / treatment does not suit patient he is free to approach someone else. Patient may come without any record whatsoever of treatment already taken.
Patient may be hiding facts from the doctor. The Doctor does not have any foolproof method to know whether the history is true. Patient may question the probable diagnosis, drugs prescribed, their role, side-effects, cost, interaction etc. and may avoid taking the prescribed medicine.
After the consumer (patient ) leaves the doctor’s
clinic with the prescription, can a doctor control subsequent actions ?
Will all the prescribed medicines be purchased?
Will the prescribed doses he administered at correct intervals ?
Will the full course of treatment be given ? What if patient takes treatment for only 2 days instead of 5 ?
Will other precautions advised be taken ?
Can the doctor control follow-up of patient ? Patient may not come at all or come according to convenience. Doctor does not know he has improved / deteriorated / gone elsewhere. Follow -up, which is cardinal component of medical management is entirely beyond the control of the doctor. Irregular treatment is tubercular patients, rheumatic heart disease, epileptics etc. is well known.
Patient may comply with doctor’s prescription but concomitantly use Homeopathic, Ayurvedic or Unani medicines, the interactions of which are not known. Patient may resort to magic / faith healing. How can a doctor control this ? A case of jaundice is advised certain tests, precautions and medicines. Patient may not bother about these and after leaving doctor’s clinic may go for "Jhara" (Magic healing ).In case of deterioration, how can a doctor’s service be held deficient ?
Some patients refuse investigations without which at times correct management is not possible. Whenever a patient feels that he is not getting well with the treatment of a doctor/ hospital he is free to leave any moment, or to consult any other doctor. Most private hospitals permit consultation with any doctor the patient /attendants wish to. They can always question the rationale of treatment, progress of illness during the course of treatment.
Doctor does not guarantee a diagnosis. It may be a provisional diagnosis or a differential diagnosis on which the treatment may be based. Doctor never guarantees a cure. He makes his best efforts because he knows that much more than anything else, his professional reputation is at stake.
Indian Penal Code, 1860 sections 52, 80, 81, 83, 88, 90, 91, 92 304-A, 337 and 338 contain the law of medical malpractice in India.
A Physician can be charged with criminal negligence when a patient dies from the effects of anesthesia during, an operation or other kind of treatment, if it can be proved that the death was the result if malicious intention, or gross negligence. Before the administration of anesthesia or performance of an operation, the medical man is expected to follow the accepted precautions.
In such cases, the physician should be able to prove that he used reasonable and ordinary care in the treatment of his patient to the best of his judgment. He is, however, not liable for an error judgment. The law expects a duly qualified physician to use that degree of skill and care which an average man of his qualifications ought to have and does not expect him to bring the highest possible degree of skill in the treatment of his patients, or to be able to guarantee cures.
It has long been recognized that criminal liability of a physician may result from a high degree of negligent conduct. What the law calls criminal negligence is largely a matter of degree; it is incapable of a precise definition. To prove whether or not it exists is like chasing a mirage. It requires that any of the following to be established in a case of criminal medical negligence.
“Gross Lack of competency or gross inattention, or wanton indifferences to the patient’s safety, which may arise from gross ignorance of the science of medicine and surgery or through gross negligence, either in the application and selection of remedies, lack of proper skill in the use of instruments and failure to give proper attention to the patient.” (Hampton v State; State v Lester)
In R. v Bateman (1925), Dr. Bateman was prosecuted for manslaughter and the charges of negligence made against him were:
The trial court convicted him. But the Court of Appeal held: “ ….. in order to establish criminal liability, the facts must be such that, …. the negligence of the accused went beyond a mere matter of compensation between subjects and should such disregard for the life and safety of others as to amount to a crime against the state and conduct punishment.”
When a FIR (First Information Report) is filed
against a doctor for the death of a patient who was under his treatment, under this Indian Penal Code
Section 304-A the doctor can be arrested.
A doctor charged under this section can obtain bail and if proved
guilty, the doctor can be punished with a maximum of two years imprisonment or fine or both. But, if the
patient is alive, the doctor is charged under the Indian Penal Code Section 337 and 338.
The Indian Courts have been very careful not to hold qualified Physicians criminally (instances of quacks for criminal negligence are there) liable for patients’ deaths that are the result of a mere mistake of judgment in the selection and application of remedies and when the death resulted merely from an error of judgment or an inadvertent death.
Criminal liability for Doctors / Medical Establishments is a gray area. Criminal law is applicable to all
individuals and Doctors / Medical Establishments are no exception to it. As far as Medical practice is
concerned, patients or relatives usually do not approach the police. But now-a-days, the scenario is also
changing. In last few decades as Doctor and patients relationship has deteriorated, the complaints against
the Doctors / Medical Establishments have increased many fold.
According to the provisions of Indian Penal
Code 1860 (IPC), any act or commission or omission is not a crime, unless it is accompanied by a guilty
mind. The Acts are not punishable only because it led to some mischievous results unless associated with
intention or mental attitude of the persons. Most of the time, doctors treatment is in good faith, with the
consent of the patient and hence most of the provisions of IPC are not applicable to the Doctors / Medical
Establishments unless or until there is rashness or gross negligence. The following sections of IPC are
related to medical professions:
Section - 52: | Describes “Good Faith” |
Section - 80: | Accident in doing lawful Act |
Section - 88: | Act not intended to cause death, one by consent in good faith for person’s benefit. |
Section - 90: | Related to consent |
Section - 176: | Failure to inform police whenever essential |
Section - 269-271: | Related to spread of infectious disease and disobedience of quarantine rules |
Section - 272-273: | Related to adulteration of foods and drinks |
Section - 274-276: | Related to adulteration of Drugs |
Section - 304 – 304 A: | Deals with death caused by a negligent Act. |
Section - 306 - 309: | Area related with abetment of suicide |
Section - 312 - 314: | Related to causing miscarriage, abortion and hiding facts |
Section - 315 - 316: | Deals with act to prevent child being born alive or to cause it to die after birth |
Section - 319 – 322: | Area related to causing hurt, grievous hurt, loss of vision, loss of hearing or disfigurement |
Section - 336 - 338: | Deals with causing hurt by rash or negligent Act |
Section - 340-342: | Area related to wrongful confinement |
Section - 491: | is related to breach of contract |
Section - 499: | is related to defamation. |
Section 304 & 304-A: | There is lot of
discrepancy while applying these sections in cases of professional negligence by Doctors. Most
of the time, the police authorities register the case of professional negligence under Section
304 of IPC. According to this Section, the offence is non-bail able. This causes lot of
hardship, bad reputation and mental agony to the Doctors. In fact, the police should register the cases of death due to medical negligence Under Section 304 – A of IPC in which the offence is bailable and the Doctors can be released on bail. The judgment has been passed by Bombay High Court in criminal revision application no. 282 of 1996 (Dr. Mrs. Mridula S Deshpande Vs State of Maharashtra) dated 28-11-1998. The basic difference is that in Section 304, there is intentional act of negligence while in 304 – A, the Act is never done with the intention to cause death. |
Section 319-322 of IPC : | related to causing hurt or grievous hurt, For example, loss of limbs, loss of vision, loss of hearing or disfigurement, etc |
Section 336 –338 : | related with grievous hurt by rash negligence Act,
|
Section 340 – 342 of IPC : | related with wrongful confinement. According to this section a patient can not be detained on the grounds of non-payment of hospital charges. This may constitute the offence of wrongful confinement under Section 340-342 of IPC. Doctor can take advance of fee from patient before starting treatment. Likewise, if a Police Officer is keeping the Doctor in detention, in cases of bailable offences, he is liable for the offence of wrongful confinement under this section of IPC. |
Crime or offence means – Any act or omission or commission which is contrary to any law or statute for the time-being in force.
Summons: is the process of Court asking the opposite party to appear and answer the allegations preferred by the party who has brought action.
Warrant: means an order issued by the Court, Magistrate or a Competent Authority directing a Police Officer to make arrest, seize or search or to do any other work incidental to administration of justice.
A Warrant Case: is related to an offence punishable with death, life imprisonment or imprisonment of more than two years.
Example, if a Doctor helps a pregnant woman in getting rid of the child or cause its death after its birth.
Cases other than warrant cases are summons cases.
Example , if a Doctor acts negligently by using infected syringe or instrument resulting in an infection to an uninfected patient exemplifies a summon case.
Cognizable offences: are those in which a Police Officer may arrest without warrant according to Schedule I of Criminal Procedure Code (Cr.P.C).
Non-cognizable offences: are those in which a Police Officer can’t arrest without a warrant.
Bailable Offence: are those in which bail can be granted by any Law for the time being in force. In such case, bail is matter of right. The Court can not refuse bail and the police has no right to keep a person in custody. If any Police Officer puts a person in detention in such cases, he is liable for the offence of wrongful confinement Under Section 340 – 342 of Indian Penal Code.
Non-Bailable Offence: are offences other than the bailable offence in which bail cannot be granted. These are the serious offences in which a person may be convicted and imprisoned for terms extending more than 10 years.
Presumption of innocence: Law presumes that a person is innocent till his guilt is proved. The onus of proof is on prosecution.
Mistake of Law: “Ignorentia juris non excusat” means ignorance of Law or mistake of Law (existence of mistaken understanding) is not excusable. Erroneous or wrong conclusion of Law is not a valid defense.
Mistake of fact: is a situation where a person not intending to do unlawful act, does so because of wrong conclusion or understanding of fact. The guilty mind was never there while doing the Act. The person may not be held responsible in such cases.
Res judicata : This doctrine of Law means “the things have been decided”. According to principle of Law, once the case is completed between two parties, if can not be tried again between the same parties. Suppose a patient sues a hospital for any negligence, damages or malpractice and the things are decided, he can not subsequently sue the doctor again separately for the same negligence.
Res Ipsa Loquitor is a situation of gross negligence or rashness. The thins are so obvious that they “speak for themselves”. Most of the time there is no need for any proof of negligence in such cases.
For example, a foreign particles (cotton, surgical blade, etc.) found in the stomach of a patient immediately after the surgical procedure has been done. There is no need of any proof of negligence in this case.
A valid consent must be given voluntarily by an adult who is not of unsound mind. The consent must be given after reasonable understanding and with any mis-representation or hiding of the facts. Thus the consent should be an informed consent, preferably in writing and in presence of witnesses. All components of valid consent are applicable even for the consent in Criminal Law. According to criminal law, it is an offence to cause injury to any person even with his consent to suffer death or grievous hurt. This point has to be kept in mind specially during cases of organ transplantation. The donor may have given consent under family, social or financial pressures. In such cases of dead donors, if there is no expressed will, the body is the property of the heirs and their consent is required.
Liability:
A person who commits a wrongful Act, shall be liable for it. The crimes are public wrongs and aim of criminal proceeding is to punish the wrong doer. The law imposes liability on him, who fails to perform duty. The wrongful act may be :
Public Interest Litigation (PIL):
An aggrieved patient can directly approach the High Court or the Supreme Court when his/her grievances was not properly redressed. PILs are usually resorted when public health programmes are not implemented properly. Some of the landmark judgments on Supreme Court on health are the result of PILs.
Foot Notes
Fatal Accidents Act, 1855This has adopted the provisions of English Fatal Accidents Act of 1846 (re-enacted in 1976) with a little modification. This Act aims of providing compensation to the family of the deceased for loss occasioned by the death of a person caused by the actionable wrong. In fact, it does not specify its application to medical negligence cases but it is of wide import so as to apply to all such cases including road traffic accident cases. In Dr. Laxman Balkrishna Joshi v Dr. Trimbak Bapu Godhole and An0ther (AIR 1969 SC 128) and Amalgamated Coal Field Ltd. v Mst. (Chhotibai & Others (1973) ACJ 365), this Act was used to award damages to the heirs of the deceased patients.
Section 1-A of Fatal Accidents Act, 1855
Whenever the death of a person shall be caused by wrongful act, neglect or default, and the act, neglect or default is such, as would (if death had not ensured) have entitled the party injured to maintain an action and recover damages in respect thereof, the party who would have been liable if death had not ensued shall be liable to an action or suit for damages, not withstanding the death of the person injured, and although the death shall have been caused under such circumstances as amount in law to felony or other crime.
Section 357 of Code of Criminal Procedure 4973 (Act No. 2 of 1974)
This Act may be called “The Pre-conception and Pre-natal Diagnostic Techniques (Prohibition of Sex Selection), Act, 1994.
The PNDT Act, 1994 was enacted by Parliament on 20th September, 1994 (as 57 Bill of 1994) to provide for the prohibition of sex selection, before or after conception, and for regulation of pre-natal diagnostic techniques for the purpose of detecting genetic abnormalities or metabolic disorders or chromosomal abnormities 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.
This Act extends to the whole of India except the State of Jammu and Kashmir.
Brief & important definitions specified in this Act:
REGULATION OF GENETIC CONSELLING CENTRES, GENETIC LABORATORIES AND CLINICS on and from the commencement of this Act:
Prohibition of sex-selection :
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 or by any other person, sex selection on a woman or a man or on both on any tissue, embryo, conceptus, fluid or gametes derived from either or both of them.
REGULATION OF PRE-NATAL DIAGNOSTIC TECHNIQUES:
Regulation of pre-natal diagnostic techniques – On and from the commencement of this Act, -
a. no pre-natal diagnostic techniques shall be conducted except for the purpose of detection of any of the following abnormalities;
- chromosomal abnormalities;
- genetic metabolic diseases;
- haemoglobinopathies;
- sex-linked genetic diseases;
- congenital anomalies;
- any other abnormalities or diseases as may be specified by the Central Supervisory Board;
Written consent of pregnant woman and prohibition of communicating the sex of foetus:
Pre-natal diagnostic procedures cannot be conducted unless :
Determination of sex prohibited : On and from the commencement of this Act -
No Genetic Counselling Centers or Genetic Laboratories or Genetic Clinic or any person can conduct or cause to be conducted pre-natal diagnostic techniques including ultrasonography for the purpose of determining the sex of a foetus. No person can cause or allow to be, caused selection of sex before or after conception.
Powers of Appropriate Authorities :-
The Appropriate Authority shall have the powers in respect of the following matters, namely :-
The Appropriate Authority shall have the powers in respect of the following matters, namely:-
Registration of Genetic Counselling Centre, Genetic Laboratories and Genetic clinics:
No Genetic Counselling Centre, Genetic Laboratory or Genetic Clinic including clinic, laboratory or Centre having ultrasound or imaging machine or scanner or any other technology capable of undertaking determination of sex of foetus and sex selection can be opened unless it is duly registered under the Act.
Certificate of registration :
The Appropriate Authority shall, after holding an inquiry and after satisfying itself that the applicant has complied with all the requirement of this Act and the rules made there under and having regard to the advise of the Advisory Committee in this behalf, grant a certificate of registration in the prescribed form jointly or separately to the Genetic Counselling Centre, Laboratory or Clinic, as the case may be.
If, after the inquiry and after giving an opportunity of being head 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 this Act or the rules, it shall, for reasons to be recorded in writing, reject the application for registration.
Every certificate of registration shall be renewed in such manner and after such period and on payment of such fees as may be prescribed.
The certificate of registration shall be displayed by the registerd center, clinic or lab in a conspicuous place at its place of business.
Cancellation or suspension of Registration :
If after giving a reasonable opportunity of being heard to the Genetic Counseling Centre, Genetic Lab or Clinic and having regard to the advice of the Advisory Committee, the Appropriate Authority is satisfied that there has been a breach of the provisions of this Act or the rules, it may, without prejudice to any criminal action that it may take against such Centres, Labs or Clinic, suspend its registration for such period as it may think fit or cancel its registration, as the case may be.
Offences and Penalties:
No court other than that of a Metropolitan Magistrate or Judicial Magistrate of the first class shall try any offence punishable under this Act.