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CIPI to meet new DCGI on Feb 8 to have a 'settlement' on FDC issue

Ramesh Shankar, MumbaiTuesday, February 5, 2008, 08:00 Hrs  [IST]

In an effort to find an amicable and possibly an out of court settlement on the vexed fixed dose combination (FDC) issue, a delegation of Confederation of Indian Pharmaceutical Industries (CIPI) will soon meet the new DCGI Dr Surinder Singh, who has already made his intention clear by stating that he will have an 'interactive approach' with the industry. The delegation may meet the new DCGI on February 8. The CIPI's main agenda in the meeting would be to convince the new DCGI, who took charge as the new DCGI only on February 1, about the circumstances under which the industry association, representing mostly small and medium industries, moved court on the FDC issue. "The association will make it clear to the new DCGI that the industry is not against weeding out irrational combination drugs from the market. But, it is against the way it was enacted by the former DCGI", a senior association leader said. The entire method in which former DCGI dealt with the FDC issue was wrong. After all, a whopping Rs 3,500 crore of products were in the market when the DCGI ordered to immediately stop selling of these combination products which did not do any harm to the patients so far. The industry should have given some time before withdrawing these products from the market. Now, the CIPI delegation will explain all these facts to the new DCGI. "We are not at all for confrontation with the department. We will try for an amicable settlement on the FDC issue, including an out of court settlement", the leader said. Another major issue is that of product licensing by the state drug controllers. Ever since the FDC issue began in June 2007, the state drug controllers have stopped issuing licenses to pharma companies. Even for license renewing or product licenses for very old products also, the companies are being directed to approach DCGI office in Delhi. This has resulted in shutting down of a large number of small pharma companies. The CIPI delegation will also take up this issue with the new DCGI , he said.

 
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