Karnataka government may soon come out with a set of dedicated State Drugs and Cosmetic Rules under the Drugs & Cosmetics Act 1940. The state government had already formed an expert committee for the purpose with the mandate to finalize these draft Rules shortly.

The three member committee is chaired by the former deputy drugs controller Rajashekariah. The other two members are a Deputy Drugs Controller and Assistant Drugs controller from the Bangalore headquarters of the state drugs control department.

“The government has been keen to frame the state specific rules within the frame work of the Central Act. These draft rules will be first passed in the State assembly and then presented to the Union government for clearance. This is the first of its kind exercise in the country,” Dr BR Jagashetty, Drugs Controller, government of Karnataka told Pharmabiz.

“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 & Cosmetic Rules. The state government has immediately taken cognizance of the same and called for the formation of a three -member committee, he said.

This is probably the first initiative by a state government to go in for an exclusive set of  state Drugs & Cosmetic Rules, although the Maharashtra government had framed rules for fee structure for drug licensing. There are several areas which the State Drugs &Cosmetic Rules will need to focus such as spurious drugs, not of standard quality medicines, mushrooming of pharmacy outlets and the absence of a qualified pharmacist at the counters and the need to introduce shifts for pharmacists at chemist shops besides review of various fee structures, said Dr Jagashetty.

The time frame set for the draft of the Karnataka Drugs & Cosmetics Rules is three months after which it would circulate the same to seek comments. The industry and the pharmacy trade among others will be called for discussion to give a final shape to 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 booking 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 extremely urgent going by the changes taking place 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. The State Drugs & Cosmetics Rules could also be relevant for the country as it is also looking to define specific area for pharmacy outlets.

Incidentally Dr Jagashetty is also the chairperson of Committee for Amendments to the existing Drugs and Cosmetic Rules 1945 formed by the Drugs Consultative Committee through the Drugs Control General of India (DCGI).

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 three member committee has also taken the required direction from the State drugs controller.