Clinical trial registry yet to take shape

Even as India is yet to put together a comprehensive database on the clinical trials happening within the country, information available with United States National Institutes of Health (NIH) indicates that pharmaceutical companies, mostly overseas multinational corporations, are currently recruiting human volunteers for at least 250 clinical trials in the country.

Almost all major pharmaceutical companies such as Pfizer, Hoffman La Roche, Eli Lilly, Bristol Myers Squibb, Astrazeneca, Biogen, Merck and Novartis have active clinical trial programmes in India. The diseases for which trials are being conducted vary from lifestyle disorders such as diabetes and cancer to tropical diseases specific to the country. These trials cover all major cities and towns.

According to NIH data, 164 clinical trials are in the third phase where the experimental drug or treatment is given to about 1,000-3,000 people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments and collect information that will allow the product to be used safely.

Another 71 are in the second phase where the drug or treatment is given to a 100-300 people to see if it is effective and to further evaluate its safety. Only 12 ongoing studies are in the first phase where researchers test a drug in a small group (between 20 and 80) of people for the first time to evaluate its safety, determine a safe dosage range and identify side effects.

While some of these studies are being conducted by Indian drug manufacturers and research institutes, the phase IV studies, where medicines that are currently being approved for use are monitored for long term effects, are being conducted only by multinational firms.

The data also indicates the number of patients recruited, the diseases for which treatments are attempted and the centres where such trials are being conducted.

On the other hand, India is yet to have a comprehensive clinical trial registry of its own. The recently-launched national clinical trial registry of the Indian Institute of Medical Research (ICMR) is facing teething problems.

"We have just launched this initiative. The researchers have been asked to submit clinical trial data on a voluntary basis. We have also sought more information than what is recommended by World Health Organisation to bring in complete transparency in the system. The coming months will see more entries in the registry", a senior ICMR official said.