A 55-year old illiterate woman, Sabavath Chilkamma, who volunteered as a clinical trial subject from Bhavanikunta tanda of Wardhannapeta mandal in Warangal district of Andhra Pradesh, had lost her life due to multiple organ failure. The unknown clinical trial company had offered to pay her Rs.10,000 for volunteering as their subject for the drug trial.

According to sources, it is believed that 20 people from Bhavanikunta thanda of Wardhannapet mandal have volunteered for drug trials together with Chilkamma. All of the volunteers were offered a sum of Rs.10,000 per each person by an unknown clinical trial company to participate in the drug trial.

When contacted and asked how many companies in the district are carrying out clinical trials in the district, the district medical and health officer Dr P Sambasiva Rao told Pharmabiz that he has no records of the number of companies carrying out drug trials or of those enrolled for clinical trials in the district.

He said, “The clinical trial companies work secretly and target poor illiterate people by luring them with money to undergo drug trials.”

In spite of such incidents by the clinical trial companies, the government has taken no concrete action against any clinical trial organizations in the state, because of which these companies are not mending their ways to comply with ethics of clinical trials and taking illiterate poor women for their drug trials, said a source from the Lambada Hakkula Porata Samiti.

Meanwhile, Telangana Tribals joint action committee has demanded stringent action against those responsible for the death of Sabavath Chilkamma. As a precautionary measure the district health administration is planning to conduct a health camp to find out any medical abnormality in the four tribal hamlets of Wardhannapet mandal to avoid any further deaths.

It is believed that since restrictions on drug trials were relaxed in 2005, the clinical trial industry in India has grown hugely and today more than 150,000 people are involved in at least 1,600 clinical trials, by various firms in India on behalf of leading foreign pharma companies like AstraZeneca, Pfizer, Merck, etc.

Though there are no available official records, some estimates suggest the clinical industry may be worth as much as above Rs.1400 crore in India. Regulators have struggled to keep pace with the explosion. Between 2007 and 2010, at least 1,730 people have died in India while, or after, participating in such trials.