Karnataka government is now working to frame a dedicated State Drugs and Cosmetic Rules under the Drugs & Cosmetics Act 1940. In this regard, the state government has gone ahead to form a committee to structure the Rules. The three-member committee is chaired by former deputy drugs controller Rajashekariah. The other two members are a deputy drugs controller and an assistant drugs controller from the Bangalore headquarters of the state drugs control department.

“We have been looking at methods to further strengthen the monitoring of quality of drugs  and ethical trade practices in the state. This led us to propose to the state government on the need for a separate State Drugs and Cosmetic Rules. The state government has immediately taken cognizance of the same and called for the formation of a three-member committee,” Dr BR Jagashetty, Karnataka Drugs Controller, told Pharmabiz.

This is probably the first initiative by a state government to go in for an independent Drugs and Cosmetic Rules, although the Maharashtra  government had framed rules for fee structure on drug licensing. There are several areas which the State Drugs & Cosmetic Rules will need to focus covering spurious drugs, not of standard quality medicines, mushrooming of pharmacy outlets and the non-presence of a qualified pharmacist at outlets and the need to introduce shifts for pharmacists at chemist shops, besides look into various fee structures, he added.

The time frame set aside for the draft of the Karnataka Drugs & Cosmetics Rules is three months after which it would circulate to seek comments from stakeholders. The industry and the pharmacy trade among others will be called for discussion to ascertain the plan of action to devise the rules. The whole process is expected to take six months before the Rules would be tabled for clearance before the state and Union governments, he said.

The key purpose of the Karnataka Drugs and Cosmetic Rules would be to bring in a strict and rigorous system of audit, inspection and book violators of the law. The creation of an efficient state regulatory system is viewed as an integral component in public health. The new rules are now indispensable going by the changes in the pharma and biotech industry. While it will mandate the need for computerization as a benchmark to maintain transparency and efficiency, it is also expected to include Good Distribution Practices (GDP) which will provide clear cut norms to the industry and trade on distribution, recall and management of the date expired / discarded drugs within a given time frame.

Incidentally, Dr Jagashetty is also the chairperson of Committee for Amendments to the existing Drugs and Cosmetic Rules 1945 formed by government of India through the Drugs Control General of India (DCGI). Further he has also been selected as member of sub-group on spurious and adulterated drugs which will support the Task Force constituted to formulate a long term policy and strategy for strengthening of drug sector in the country. The newly formed three-member committee will also take the required direction from the State drugs controller.