The Karnataka government has constituted an expert committee to study the existing regulatory systems and mechanisms in the state for effective implementation of quality standards and pricing of drugs.
According to the government order No HFW 69 IMM 2003, the commissioner of health and family welfare chairs the expert committee comprising of ten members. It will have Karnataka drugs controller as its member-secretary. In addition, there will be eight members in the committee including an officer not below the rank of joint drugs controller from the Central Drugs Standard Control Organization, president, Karnataka Drugs and Pharmaceuticals Manufacturers Association (KDPMA), two officials from the pharma industry nominated by the KDPMA, an official from the National Pharmaceutical Pricing Authority (NPPA), New Delhi, an official from the Department of Industries and Commerce, government of Karnataka, nominated by the principal secretary, to Department of Commerce and Industries, an official from the Chemexcil, Karnataka Pollution Control Board and the department of central excise and customs.
The main objective of the committee is to encourage development of the pharma industry in the state. Procedures will be discussed to ensure constant quality of drugs produced within the state and outside. Further, discussions will be held to suggest the requirement of special rules for the state, if the current regulations are found inadequate to control the quality of drug production and procurement of the medicines particularly state medical supplies.
The committee will meet once in three months to ascertain the progress of the activities in the pharma sector, stated G Chomanayak, under secretary to government, department of health and family welfare.
According to Chomanayak, the pharmaceutical industry is regulated by statutes like the Drugs & Cosmetics Act, Drug Price Control Order, Central Excise and Customs Act, Pollution Control Act, Commercial tax, Labour laws including factories Act and various other allied legislations applicable to factory and industry. Yet the industry has equal responsibility in eradicating the menace of spurious drugs. In this direction, product identification by means of bar coding, holograms or other innovative techniques would have to be incorporated in the packaging. The drugs control administration has to be kept informed about it to help them to investigate the spurious drugs racket, he added.
Although the pharma industry is knowledge-based with technically qualified personnel and regulated by legislation for self-compliance, it can survive only if the public has the confidence in the drugs produced and marketed. While there can be no second opinion that quality is the most important criteria, the hardship faced by the industry needs to be addressed comprehensively to take remedial measures. With this in view the government of Karnataka has decided to constitute an expert committee, he averred.