DCGI calls meeting of pharma assns to discuss FDC issue on Oct 27
Ramesh Shankar, Mumbai

In an effort to find an amicable solution to the issue of withdrawal of irrational combination drugs from the market, the Drug Controller General of India (DCGI) has ultimately decided to call a meeting of all the major pharma associations including the state associations to thrash out issue. The industry associations have been asked to send their representatives to NIPER for a meeting on October 27.

A DCGI letter to the associations asked to send 2 or 3 representatives well versed in the FDC subject for a meeting at NIPER in Chandigarh on October 27 to discuss the issue of fixed dose combinations. The meeting will be held at NIPER on October 27 at 10 a m. Apart from the DCGI, the meeting is expected to be attended by all the state drug controllers of the country.

All the major associations like IPA, IDMA, CIPI, FIPE and state units of the associations have been asked to send their delegates to the meeting.

The meeting holds significance as there was a hue and cry from the pharmaceutical industry over the DCGI's decision to withdraw irrational combination drugs from the market. The DCGI had directed the state drug controllers to withdraw licenses issued to the drug manufacturers to produce combination drugs and also to withdraw these drugs from the market. The DCGI had sent a list of more than 1000 brands of combination drugs to the state drug controllers in this regard.

The DCGI's plea was that the combination drugs come under the definition of new drugs under section 122 (E) of the Drugs and Cosmetic Rule and hence needed sanction from the DCGI office in Delhi to produce these drugs. Concerned about the rationality of the combination drugs in the absence of lack of expertise in the state drug departments to verify stability and safety of the combination drugs, the DCGI asked the state drug authorities to withdraw licenses to combination drugs and direct the drug manufacturers to get the license from DCGI office in Delhi.

This has created a flutter in the pharmaceutical industry in the country as the issue has affected all the companies cutting across its size. Though the FDC issue has been under the scanner for the last several years, the rather sudden decision of the DCGI shook the industry as an estimated around Rs 1000 crore is said to be at stake.

Source: www.pharmabiz.com
18th October 2007

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