[india-drug] Committee to study drug regulatory system and pricing

[Sunitha Srinivas <s.srinivas@ru.ac.za>]

(From http://www.pharmabiz.com/article/detnews.asp?articleid=19652
Thanks?..SS)

Karnataka constitutes expert committee to study drug regulatory system
and pricing
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Monday, December 29, 2003 08:00 IST 
Nandita Vijay, Bangalore

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.



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