IVF Legal Guidelines in India makes you aware about Fertility Treatment in India

Though the world of medicine shows its signature panacea to every sort of medical condition, this has also been life-line contradicting every myth relied on the miracle. Yes, it is none other than having a baby after the fertility treatment sounds profitable for the intended parents. While infertility is not life threatening, but it causes to intense mental agony and trauma that can only be best described by infertile couples themselves. At us, let you know more of IVF procedures and its act in India.

As there are no detailed figures to the extent of infertility prevalent in India, but a global study carried out by WHO places the incidence of infertility between 10 and 15%. Out of a population of 1000 million Indians, an estimated 25%  may be conventionally estimated to be attempting parenthood at any given time; by extrapolating the WHO estimate, about 13-19 million couples are likely to be infertile in the country at any given time.

Most types of infertility such as reproductive tract infections (RTI) and genital tuberculosis are preventable to treatment. About 8% of infertile couples, however, need for serious medical intervention involving the use of advanced ART procedures such as IVF or ICSI.

Infertility also has far-reaching communal inferences. So, it has become imperative to ensure their safety, with the rapidly increasing use of ART in our country. Scientific societies around the world, such as the ASRM, ESHRE and IFFS, have put together guidelines for the safe and ethical practice of ART. The European Union and the Governments of several countries such as Australia, the UK and the USA have taken steps to recognize and supervise the performance of infertility clinics.

Guidelines for IVF Treatment as per Existing Law

1. Clinics to be registered


Clinics involved in any one of the following activities should be controlled, listed and managed by the State Accreditation Authority as given below:

  • Any treatment involving the use of gametes which have been donated or processed in vitro, except for AIH, and for IUI by level 1A clinics who will not deal with the gametes themselves.
  • Any infertility treatment that involves the use and creation of embryos outside the body.
  • The processing or storage of embryos.
  • Research on human embryos.

 Legal Guidelines

2. Code of Practice


This manages all aspects of the treatment provided and the research done at registered clinics. Those areas which most affect the doctors and patients, and are a part of this code are summarized below:

A ‘person responsible’ shall get full responsibility to ensure that the staff of the registered unit is adequately qualified, that proper equipment is used, that genetic material is disposed off properly, and that the center fulfills with the conditions of its registration.
This kind of features must cover the standards expected in respect to provision of clinical, laboratory and counseling care. Proper systems to assess practices and procedures are required to optimize the outcome of ART.
Any information about clients and donors must be secret. As no information about the treatment of couples given under a treatment agreement may be revealed to anyone other than the accreditation authority or persons covered by the registration, except with the consent of the person(s) to whom the information belongs, or in a medical emergency concerning the patient. It is the above person’s right to make a decision on what information will be conveyed and to whom, except in the case of a court order.
All pertinent information must be given to the patient before a treatment is given. Thus, before starting treatment, information should be provided to the patient on the limitations and results of the projected treatment, possible side-effects, the techniques involved, contrast with other on-hand treatments, the ease-of-use of counseling, the cost of the treatment, the rights of the child born through ART, and the need for the clinic to stay a register of the result of a treatment.
No treatment should be offered without the written consent of the couple to all the probable stages of that treatment, such as the likely freezing of supernumerary embryos. An average consent form suggested by the accreditation authority should be used by all ART clinics. An exact consent must be attained from couples who have their embryos frozen, in regard to what should be performed with them if he/she becomes incapable of varying or revoking his or her consent.
People looking for the registered treatment must be given an appropriate opportunity to get proper counseling about the different implications of the treatment. No one is compelled to believe for counseling but it is usually known as being beneficial, and couples should be supported to experience it.  The condition of facilities to counsel in an ART clinic is, therefore, mandatory.
No more than 3 embryos may be placed in a woman in any one cycle, despite to the procedure/s used, excepting under special circumstances which should be recorded. No woman should be cured with embryos derived from the gametes of more than one man or woman during any one-treatment cycle.
The ‘uppermost probable values’ in the storage as well as handling of gametes and embryos in respect of their security, and in regard to their identification, are to be followed.
The official approval of authority must support to all research that involves embryos created in vitro. A separate registration should be given out for each research project involving human embryos. Also the official approval of authority must not give a registration certificate unless it is fulfilled that the use of human embryos appears essential for the purposes of the proposed research and the research is in the public interest.

3. Responsibilities of the Clinic

  • To make available adequate information to the patients.
  • To give details to the patient for the basis of selecting a exacting treatment and point to the choices the patient has, with advantages and disadvantages of each choice.
  • To assist for the patient exercise a choice that may be best for him/her taking into account the individual’s situations.
  • To keep up records in an apt Performa to enable collation by a national body.
  • When commercial DNA fingerprinting becomes accessible, to continue its record, if the ART clinic wants and couple concurs, DNA fingerprints of the donor, the child, the couple and the surrogate mother should be acted.
  • To keep all information about donors, recipients and couples confidential. The information about the donor should be released by the ART clinic after suitable recognition, only to the offspring and only if asked by him/her after he/she arrives at the age of 18 years, or as and when needed for legal purposes, and never to the parents.
  • To keep up suitable, comprehensive record of all donor oocytes, sperm or embryos used, these are the manner of their use. These records must be kept for at least ten years after which the records must be moved to a central depository to be continued by the ICMR. If the ART clinic is wound up during this period, the records must be transferred to the central repository in the ICMR.
  • To have the list of all its charges rightfully shown in the clinic and announced to the patient at the commencement of the treatment. There must be no extra charges beyond what was close to the patient at the beginning of the treatment.
  • To make sure that no technique is used on a patient for which the confirmed expertise does not stand with the staff of the clinic.
  • To be totally translucent in all its operations. The ART clinics must, therefore, give permission to the patient know what the success rates of the clinic are in regard to the measures planned to be used on the patient.

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