Drugs Consultative Committee (DCC) sub-committee for Amendments to the Drugs & Cosmetic Rules constituted by Drug Controller General of India (DCGI) which is headed by the Karnataka Drugs Controller, Dr BR Jagashetty will convene a meeting on February 28 and March 1, 2013 to discuss on the revision of norms.

There are six state drugs controllers coming in for this meeting representing states of Maharashtra, Gujarat, Delhi, Andhra Pradesh, Nagaland and J&K. The drugs controller of Tamil Nadu will be a special invitee to the meeting. “There are  169 Drugs & Cosmetics Rules which would require to be analyzed by the Committee to be  able to devise the  amendments within a span of six months. Since viewing each of the rules will be a time consuming task, we would evaluate the important ones to be prepare the proposals for revision”, said Dr Jagashetty, told Pharmabiz.

It was in June 2011, that the then DCGI Dr Surinder Singh who formed the committee to look at the revision of D&C Rules and appointed Dr Jagashetty to chair the DCC sub-committee.

The new rules are to meet the current pharma industry requirements which has moved ahead in the country and achieved a strategic position in the global drug development and research space, keeping in mind public health at large.   In this context the  D&C Rules are to be updated and a new set of norms are needed for the approval of  manufacture and distribution of medicines. Therefore, the Committee would consider either amendment of Rules or even revising the complete structure, he said.

A preliminary meeting of the Committee was held on May 5, 2011 to discuss the plan of action with regard to the amendments pertaining to the Drugs & Cosmetics Rules 1945. Subsequently, there were replacements and substitutions  of DCGIs  which  stalled the Committee to work on the amendments of the Drugs & Cosmetic Rules.

The first meeting in 2011  did provide a broad framework on the required revisions in the D&C Rules. Among these covered compulsory computerization networking to maintain transparency and efficiency. The Good Distribution Practices (GDP) which were then proposed is now in a draft guideline. “Over the last few months, there have been a couple of efforts and   therefore we need to see how the new rules can be included to meet the current changes which will definitely require  brain storming sessions for the entire two days”, said Dr Jagashetty.