Karnataka  Drugs Controller, Dr BR Jagashetty, will head the Committee for Amendments to the Drugs & Cosmetic Rules constituted by Drug Controller General of India. A preliminary meeting of the Committee has been called on May 5, 2011 to discuss the plan of action with regard to the amendments  pertaining to the Drugs & Cosmetics Act 1940.

The five member team headed by Dr Jagashetty has M Mitra deputy drugs controller CDSCO HQ , New Delhi as the convenor, and Drugs controller, National Capital Territory, Delhi, Commissioner, Food and Drugs Administration, Gujarat; Joint Commissioner, Food and Drugs Administration, Maharashtra as other members.

“We intend to discuss and assess the pros and cons  to bring in new provisions in  the D&C Rules. The Committee will look at the need for amending the Rules or even alter the entire structure of the Act and Rules,” Dr. Jagashetty told Pharmabiz.

“Considering the transformation in the pharmaceutical industry and trade over the years, there is a need to make certain modifications in the existing D&C Rules to keep pace with the latest developments and giving  the public health paramount importance,” he added.

Among the additions which will need to be incorporated are computerization which is mandated in the present circumstances as a yardstick to maintain transparency and efficiency. Another topic of interest advocated by the Karnataka drugs controller has been the inclusion of Good Distribution Practices (GDP) which will provide clear cut norms to the industry and trade with respect to distribution, recall and management of the date expired/discarded drugs within a given time frame. The Committee is expected to come out with the amendments in three to six months, said Dr Jagashetty.

From the state perspective to bring in more stringent norms in the area of manufacture and sale of pharmaceuticals, the Karnataka drugs control department has sent in a proposal to government constituting a committee to suggest and frame necessary rules under the D&C Act 1940.

The state drugs department has been conducting surprise inspections at production plants and trade outlets to check adherence to Good Manufacturing Practices (GMP), sale of spurious and not of standard quality drugs, sale of drugs without prescription and issue of dummy bills etc., said Dr Jagashetty.