The Central Drugs Standard Control Organisation (CDSCO)'s long-pending attempt to amend the Drugs and Cosmetic Rules by inserting a new Schedule to guide the entire gamut of activities in the clinical trial sector may get further delayed as it has set up a new panel to study the inputs from the stakeholders on the draft rules.

The CDSCO, which has been implementing regulatory reforms in patches by way of guidelines and instructions but required the back-up of rules for stringent implementation, has now set up a 23-member expert panel for finalizing draft notification after examining the suggestions and comments sent by the stakeholders.

However, with no deadline fixed for the submission of the report or no date fixed for the meeting of the exhaustive panel, the finalization of the new draft is bound to take more time.

“The Ministry of Health and Family Welfare published a gazette notification on January 19, 2011 on the recommendations of the DTAB, inviting objections and suggestions from public for the amendment of the Drugs and Cosmetics Rules for registration of clinical research organization conducting clinical trial and introductory of Schedule Y 1 giving requirements and guidelines for the purpose. A large number of comments were received on the proposed draft rule. The Ministry of Health desired that a committee having balanced representation of all stakeholders may be constituted and meeting convened at its earliest for finalization of the draft rules,” according to an official notice.

As the initiative to include new Schedule to put comprehensive rules in place for the sector was getting delayed, the CDSCO has taken many steps to streamline the trials, including registration of CROs from June 2009. Besides, in the recent past, guidelines were issued for inspection of trial sites and also to calculate the quantum of compensation. However, the amendment to D&C Act would help the authorities to implement them stringently.

The main feature of the amendment is the insertion of Schedule Y1 which covers 'all organisations, individuals, institutions, and companies that take the responsibility of conducting clinical trials including those who seek permission for clinical trial from licensing authority'.

“These guidelines are not stand alone guidelines and are not in derogation of any other rules or guidelines applicable to the clinical trials, e.g. Schedule Y of the rules, Indian good Clinical Practice (GCP) guidelines and ethical guidelines for biomedical research on human participants by the Indian Council of Medical Research,” the draft said.