Legal Compliances & PC PNDT ACT

In India all genetic tests have to be carried out at the place and by the doctor/geneticist recognised by the Government of India under PCPNDT act.

Genetic Tests can be performed based on proper indication Genetic counselling needs to be done prior to the tests by qualified genetic counsellor/doctor registered under the PCPNDT act. The prenatal and pre implantation tests has to be conducted after a self-referral or a third party referral is done by a qualified doctor.

A referral chit mentioning the patients name, age, last menstrual period, indication, type of test, date of the referral, name of doctor, name of medical council and registration number of the doctor should be there. For invasive procedures such as amniocentesis, CVS, embryo biopsy, NIPT, one needs genetic Clinic licence. In certain states special permission may have to be taken for embryo biopsy and NIPT/NICS .For all these procedures home collection is illegal.

For doing the actual tests such as cytogenetics such as karyotyping, FISH, CGH Microarray &molecular test such as PCR & NGS Genetic Laboratory permission is necessary Form D,G,F and E has to be filled wherever indicated prior to the test. All forms should be filled prior to conducting the test. Pre conceptional sex selection, prenatal sex selection and disclosure of the sex of the child is illegal in India and both patient as well as the doctor may face fines and imprisonment