A set of draft rules for registration of clinical research organisations operating in the country was issued by the Drug Controller General of India some time July last year after it was duly approved by the Drug Technical Advisory Board. As per the draft, to be included in the Drugs & Cosmetics Act, 1945 as Schedule Y-1 and with the title Rule 122 DAB, the CROs can carry out their activities only if they are duly registered with the Licensing Authority defined in Clause (b) of Rule 21. The draft rules cover all organisations, individuals, institutions and companies that take the responsibility of initiation or management or coordination of a clinical trial. The clinical trial sites are however exempted from registration. The validity of registration proposed is for a period of five years from the date of issue unless the regulatory authority has not suspended or cancelled the approval within the stipulated time. The CROs are also expected to file a declaration while applying for registration stating that they should allow surprise inspections by the licensing authority in the clinical trial premises. India is one of the few countries in the world to come up with such registration criteria for CROs. And this move gives the country a dignified image among the global pharma industry and the general public that the clinical trials conducted here are being strictly monitored by the regulatory authorities.

The decision to make registration mandatory for CROs was taken in the wake of finding a spate of irregularities in conducting clinical trials in the country. Most recently reported case is that of clinical trials conducted on gas victims at Bhopal Memorial Hospital and Research Centre during 2004 and 2008. In August 2008, media reported the death of 49 infants during clinical trials conducted by All India Institute of Medical Sciences during the period of 2006 to 2008. Again in November 2008, DCGI ordered to stop the trial of a pneumonia vaccine by Wyeth after the death of an infant in Bangalore who had a pre-existing cardiac disorder. There are many more such instances which are not being reported in various parts of the country. Now even after preparing the draft rules for registration of CROs more than an year ago, what is preventing the Union health ministry in notifying and enforcing the same is rather intriguing. Credibility, quality and reliability of the trials are critical factors in this business as India is carrying out over 700 human studies. This, in fact, calls for raising the benchmark for clinical trials industry which is currently valued at $1.58 billion with 120 CROs operating in the country. India has already emerged as a hub for clinical trials in the world mainly on account of the cost advantage and overall quality of the research work carried out so far. A credible and stringent regulatory framework should be in place with no delay to enhance the growth of this industry before any further damage is done to the country's image by some irresponsible CROs.