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Tighter norms pull down number of clinical trials

Published Aug 21, 2015, 6:58 am IST
Updated Mar 28, 2019, 3:27 am IST
Companies here claim they need the government’s support for smooth functioning
Representational image
 Representational image

Hyderabad: The clinical trial industry in India has seen a huge downslide with only 74 trials cleared in 2015 against 700 in 2009. The decline is due to the trials undergoing scrutiny after it was found that 80 deaths and around 500 serious adverse effects were noted from 2005 to 2012 by the Centre.

The Drug Controller General of India has set up an ethics committee to scrutinise proposals before clearing them. The new committee was formed in July 2015, but has still not met to look into proposals.


The recent clamour at Axis Clinicals Limited has once again brought the focus back on to the safety of people who opted for clinical trials in 2011.

A senior researcher said, “The problems faced earlier by people have been rectified by the provision for video graphing the informed consent and agreement. Now, it is imperative to track every patient till the last minute.”

It is important for the clinical trial agency to foot medical bills that may arise due to the drug’s effects.

Dr Pretti Reddy of the Mahaveer Research Foundation said, “We have been testing anti-diabetes drugs. Any life-threatening effect has to be taken care of by the company. As new drugs are required for treating patients, it is important to understand that it is not only the doctor or the company that is going to benefit. It’s a joint effort and the end result is going to help the public. This is a long drawn out process.”


While many companies follow rules, a few black sheep are ruining the industry. An insider said, “The clinical trial industry in India was estimated at $1billion. In 2005, a lot of set-ups were in place. But with several provisions and restrictions, most have shut down and moved away. Some of them have set up establishments in China, Bangladesh and Thailand where restrictions are fewer.”

Ailing volunteer for trials

It is no longer the poor who are opting for clinical trials. The industry claims that the profile of the patient depends on the stage of the disease they are suffering  from.


Dr Ashok Saraf, of Kamineni Hospital, said, “There many housewives suffering from diabetes and they complain of resistance to drugs. They are fed up and require new combinations. When they are explained about clinical trials, some of them opt for it. This works when both, the doctor and the patient, have worked towards building faith in each other and are confident that it will help the public in the long run.”

Similarly, retired doctors who have contracted cancer are coming forward for drug trials. A senior neurophysician in the city, said, “Most of them come forward knowing that they are terminally ill. If a drug is tried and it has a positive outcome it will help millions of other patients. Also the manner in which the drug reacts is explained to the investigator which is found to be very helpful.”


Location: Telangana