DNA mapping for Indian trials subjects

The Indian Government may incorporate a clause for DNA mapping of human volunteers for drug trials in Schedule-Y of the Drugs & Cosmetics Act, which deals with clinical research. The move is in line with upgrading the regulations to global standards as pharmacogenetics gains importance in drug r&d.

According to officials in the Central Drugs Standard Control Organisation (CDSCO), certain drugs, even after toxicity and preclinical studies, show adverse results in certain human volunteers during clinical trials. The aim of the initiative is to ensure accuracy of trial results and to protect volunteers.

As the coexistence of genetic polymorphisms in drug metabolising enzymes, targets, receptors and transporters in the context of drug and non-drug influences results in high frequencies of unusual drug reaction, the officials believe that more specific genetic selection of trial subjects is called for.