DCGI-Industry talk fails to resolve FDC issue
Ramesh Shankar, Mumbai

The DCGI-industry meeting, held at NIPER in Chandigarh on October 27, failed to resolve the contentious fixed dose combination (FDC) issue, leaving the ground for a prolonged litigation between the DCGI and the industry. While the industry appealed to the DCGI for a compromise on the issue, the DCGI refused to budge an inch from his stand that the industry should immediately stop production of all the 294 FDCs listed by him earlier, it is learnt.

According to sources, DCGI Dr M Venkateshwarlu bluntly asked the industry delegates, who had gathered in Chandigarh from different parts of the country representing different industry associations, to immediately stop production of al the 294 combination drugs. However, he assured the industry that the drug department will give some time, say 2 to 3 months, for withdrawing the products already in the market.

Sources said that the industry was so annoyed by the DCGI's rather tough and quite unexpected stance that a section of industry boycotted the post-meeting lunch hosted by the DCGI.

Prominent industry leaders who attended the meeting included BN Singh, DG Shah, IH Israni, T Jaishankar, Rakesh Arora, etc. Apart from prominent industry associations like IPA, IDMA, OPPI and CIPI, several state and regional industry associations had also participated in the meeting called by the DCGI to discuss the FDC issue.

Before the DCGI-industry meeting, the DCGI had convened a meeting of all the state drug controllers on October 25 and 26.

Meanwhile, several industry associations will be meeting soon to discuss further course of action on this issue. Indications emanating from the associations are that the associations will move court. "The industry is left with no other option. Now that all other doors have been shut by the DCGI, the only option is legal battle", a senior industry leader said.

Source: www.pharmabiz.com
29th October 2007

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