After microfinanciers, Andhra Pradesh trains guns on clinical trials

After reining in rogue microfinance companies, Andhra Pradesh is now scrutinising clinical research organisations (CROs) in order to curb unethical practices while conducting drug trials on humans.

There have been unconfirmed reports of the rural poor being lured by some CROs to act as guinea pigs in return for money.

State sources said there have been half-a-dozen cases of such volunteers complaining of sickness that required emergency medical attention.

A team from the Drugs Controller General of India (DCGI) conducted an inquiry into these allegations recently and suspended the licence of an unidentified CRO in Hyderabad.

“Today, we have no role in the entire process. We have requested the Centre to involve the states too to enforce standards,” P V Ramesh, principal secretary, health, government of Andhra Pradesh, told DNA Money.

Currently, the conduct of clinical trials is in the purview of the Centre and is regulated by the DCGI.

But each time a trial goes wrong, where volunteers suffer from side-effects including fatalities, the state is under pressure to take action against the erring CRO.

Andhra Pradesh sees 300-400 trials at any given point in time, making it the largest such ‘market’, but the state has no idea about who is doing what.

The state should be allowed to maintain a registry of the trials and volunteers, Ramesh said.