Even as the clinical trials sector continued to beget controversies and complaints about irregularities, the move to amend the Drugs and Cosmetics Rules seeking to make the registration of CROs mandatory is still pending despite the clearance from the Drugs Technical Advisory Board (DTAB).

Responding to the allegations of irregularities in the trials, the health ministry said the government would soon amend the rules as planned. The draft guidelines and requirements for registration of CRO's in the country have been developed and already approved by DTAB to be incorporated as Rule 122DAB and Schedule Y1 in Drugs and Cosmetics Rules, 1945, sources said.

However, health activists have alleged that the move was initiated long back and was pending for over one year, though the government had launched some steps to streamline the sector. In order to improve transparency, accountability and accessibility in clinical trials, it has been made mandatory to register all clinical trials, permission for which have been granted by office of DCG(I) on or after June 15, 2009, in ICMR clinical trial registry. But the proposal to amend the rules did not happen yet.

Going by the records with the health ministry itself, a spate of irregularities had come up in the recent times. Alleged irregularities have been reported in conduct of a trial with Human Papilomavirus (HPV) vaccine in a post licensure observational study trial in Gujarat and Andhra Pradesh. Indian Council of Medical Research (ICMR) has suspended the trial and the Ministry has set up a high power enquiry committee to investigate the matter, sources said. Bhopal and Indore also reported some cases of irregularities. A team of officials from the Central Drugs Standard Control Organisation (CDSCO) has carried out recently an inspection of one clinical trial conducted at Bhopal Memorial Hospital and Research Centre (BMHRC). The Report of the inspection team is currently being examined by the office of DCG(I), sources added.