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Three laboratories charged for prenatal testing without necessary permission

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Ipsita Pati    24 August 2021

Gurgaon: Health department officials raided a private laboratory in Sector 63 to find that it was conducting non-invasive prenatal testing (NIPT) without the required permissions. 

This test can be used to determine the sex of a fetusvia further genetic testing. NIPT is legal in the country but it is allowed to be used only to identify genetic disorders in the embryo. 

Dr Virender Yadav, chief medical officer, Gurgaon, said that blood samples of pregnant women were taken to carry out NIPT at labs. This procedure can only be done at registered genetic clinics, by qualified and registered persons under the Pre-Conception and Prenatal Diagnostic Techniques Act & Rules 1994 /1996 (PCPNDT Act/Rules). Yadav stated that this collection center at the private lab was not registered under PCPNDT Act/Rules. A sample was taken by unqualified personnel at the lab, which is violation of Section 3 of PNDT Act.

The raid was conducted based on a tip-off that the center had not maintained a record of pregnant women and the lab had not taken consent of pregnant women before carrying out the genetic study. A pregnant woman was sent to the lab for NIPT. Her blood sample was taken at the lab and it was sent for further processing to two labs in Sector 14 and in Delhi’s Rohini. The labs which processed the samples did not follow the protocol for sample collection, testing procedure and the necessary documentation as mandated under PNDT Act. The lab was found to charge Rs 15,000 to Rs 25,000 per test.

A case has been registered against the three labs at Sector 65 police station under sections 3, 4, 5, 29 read with rules 9, 10, 14, 18 PCPNDT Act/Rules.

Source: ET Healthworld

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