Serial testers and cursory checks India’s flawed generic drug trials business
HYDERABAD: Vasudeva Prakash left his job as a mechanic in Hyderabad three years ago for what he calls a more lucrative career: taking part in clinical trials on generic drugs.
For two years, Prakash participated in trials of drugs being tested to treat HIV/AIDS and other diseases for contract research organisations (CROs) hired by global pharmaceutical companies. The drugs tested at Indian CROs have been key in getting several hundred medicines approved for sale around the world.
Yet, Prakash did not follow international guidelines for testing – and the CROs that hired him didn’t require him to. He says that to earn more money he would participate in back-toback trials on different drugs with gaps of only a few weeks or even a few days, instead of waiting the 90 days that the World Health Organization recommends.
Half of more than a dozen volunteers interviewed by Reuters across four cities – Chennai, Hyderabad, Bengaluru, and New Delhi – also said they waited much less than 90 days between trials. In the past three-to-four years, they said they spent several months at a time in different cities so that they could participate in as many studies as possible.
Prakash provided documentation proving he underwent trials with short gaps at Apotex Research Pvt Ltd, owned by Canadian drugmaker Apotex Inc; Lotus Labs, owned by US generics giant Actavis; Ethics Bio Lab, owned since last year by US drugmaker Par Pharmaceutical Inc; and India’s Semler Research Center Pvt Ltd, among others. Ethics Bio and Apotex did not respond to requests for comment. Lotus Labs and Semler said they had systems in place to check for cross- participation by trial volunteers.
The guidelines of the WHO, which decides on approvals for drugs sold in several countries dependent on United Nations programmes for basic medicines, are not legallybinding for the CROs. While India has guidelines on clinical trials, they don’t specify the length of time participants should take between trials.
Still, the serial testing of some volunteers is raising new questions about the level of oversight of India’s generic drug trials industry, after some CROs came under recent international regulatory scrutiny. Last year, the European Medicines Agency banned about 700 medicines across Europe after an investigation revealed data tampering in some trials of generic drugs in India. — Reuters