Chapter: 3.2 Pre-requisites for use of pre-natal diagnostic techniques

Pre-requisites for use of pre-natal diagnostic techniques

The pre-natal diagnostic techniques shall be used or conducted or only when any of the following conditions are fulfilled, namely for the purposes as mentioned in the Act:

(i)    age of the pregnant woman is above thirty-five years;
(ii)    the pregnant woman has undergone of two or more spontaneous abortions or foetal loss;
(iii)    the pregnant woman had been exposed to potentially teratogenic agents such as drugs, radiation, infection or chemicals;
(iv) the pregnant woman has a family history of mental retardation or physical deformities such as spasticity or any other genetic disease;
(v) any other condition as may be the Central Supervisory Board;

It is further important to note that such techniques can be applied only when the person applying such techniques has explained all known side and after effects of such procedures to the pregnant woman concerned and has obtained in the prescribed form her written consent to undergo such procedures in the language which she understands.

Registration Procedure

The Act provides that a person interested in opening any Genetic Counseling Centre, Genetic Laboratory or Genetic Clinic will have to make an application to the Appropriate Authority in such form and in such manner and shall be accompanied by such fees as may be prescribed. The application is entertained only when such Centre, Laboratory or Clinic is in a position to provide such facilities, maintain such equipment and standards as may be prescribed.

On and upon application and inquiry thereof, a certificate of registration in the prescribed is issued by the Appropriate Authority. However, the applicant fails to comply with the requisites, the application can be rejected. The registration granted once can be renewed or can also be cancelled / suspended. The Act provides that any institution aggrieved by such order of cancellation / suspension can appeal to Central Appropriate Authority or State Appropriate Authority.