Clinical trials hit by slow approvals, stringent norms

The story goes that on this day - May 20 - in 1747, Dr James Lind, a Scottish physician, conducted the first controlled clinical trial on a group of sailors suffering from scurvy. Through their participation in  the study, the sailors contributed to the discovery that Vitamin C was an effective treatment for scurvy. The day is now commemorated as International Clinical Trials Day.

As is apparent, data on the effectiveness of a medicines is very important and clinical trials are the vehicles to arrive at that set of data.

However, off late, few approvals are being given for holding clinical trials in India. The norms, according to industry representatives, have either become too stringent or impractical. Suneela Thatte, President, Indian Society for Clinical Research (ISCR), a not-for-profit association of people involved with clinical trials (professionals and individuals in India),says: "India has 16 per cent of the global population, 20 per cent of the global disease burden (meaning one out of every five or six diseased person in the world is in India)  and as against this our participation in global clinical trials, which are the only way to launch drugs suited for the Indian population, is less than 1.5 per cent of the total number of clinical trials being conducted globally."

She also points out that approvals for holding clinical trials have also come down significantly. "Going by the ministry of health figures, there were only 13 approvals which were given for clinical trials last year and this means, in a sense, we have gone back to the levels at which we were back in 2005." But then, are not stringent norms required to ensure that patients are not treated as guinea pigs by some unscrupulous elements? To this, Thatte says: "The only answer lies in robust regulations backed by robust governance systems and not in norms which are impractical or in regulations that are knee jerk reactions to environmental factors (read: relying purely on media reports or reactions from non-governmental organisations)."

She says, "While we have robust regulations, we also need to review norms that are impractical." For instance, she says, insisting that a patient or a clinical trial volunteer be videographed. This may not be practical as there could be cultural and social challenges and may come in the way of individual privacy.

Plus, there cannot be blanket provisions on matters such as study / clinical trial-relating injuries. For instance, if a patient or a clinical trial volunteer has to undergo a heart operation or any procedure that has no correlation to the clinical trials that he or she is participating in, then the sponsor / drug company that is undertaking the trials need not be made to pay for the health management of the patient.

Says Harish Iyer, CEO, Shantha Biotechnics, a Sanofi company: "Clinical trials are very important for bringing new drugs to market and India is a country with large unmet medical needs and therefore it is important that clinical trials are held and done in an efficient manner that takes care of the interests of all the stakeholders."

At the moment, the norms and their implementation seem to be hardly encouraging. The industry and companies seem to be wanting to shift trials out of India.  Satish Reddy, president of the Indian Pharmaceutical Alliance (an association that has many Indian pharma companies as its members) and the chairman of Dr Reddy's laboratories, for instance, also recently pointed to this concern: "Some companies are shifting conduct of clinical trials outside of the country. This is a big concern," he said.