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DCGI to hold talks with industry on FDC issue from next week, hopes to settle issue by July
Joseph Alexander, New Delhi | Thursday, May 8, 2008, 08:00 Hrs  [IST]

Determined to settle the vexed issue of FDC drugs once and for all and latest by July, the Drug Controller General of India (DCGI) will begin a series of formal consultations with the industry, especially the Confederation of Indian Pharmaceutical Industries (CIPI), from next week to examine their suggestions.

"It is a very crucial issue. We have to put a lid on it for ever at the earliest. I am looking to set the ball rolling to solve the issue by holding formal interactions with the industry in this regard. We will formally invite them for talks and dates for the meetings will be fixed most probably by next week,'' DCGI Dr Surinder Singh told Pharmabiz.

He is also weighing the options of allowing manufacturing and marketing of 150 FDC drugs of `need for further examination' category and placing them under surveillance or put through trials to prove the efficacy. However, it is just a proposal from the industry at this juncture and nothing was decided yet, he said, adding that he would like to see a consensus within the industry and with the authorities to hammer out a scientific and logical solution.

The DCGI also made it clear that he would not want to refer the issue any more to a committee as the DTAB subcommittee had experts including pharmacologists. The consultations are expected to begin once pharmacologist at AIIMS Dr Y K Gupta, who is away on a foreign trip, comes back.

He also claimed that the issue would be taken on a priority basis to settle it in a couple of months, even as case in this regard was going on in Chennai High Court involving the DCGI office and the CIPI which got a stay on the implementation of the former DCGI order to withdraw the 294 FDCs from the market.

In the earlier interactions, the industry had suggested that the 150 FDCs needing further examination be allowed for marketing and would be withdrawn in case of any adverse reactions. They also offered to withdraw voluntarily the 110 drugs in the category of `absurd' or `banned.' This formula, first proposed by SPIC and later supported by many other associations, was however not acceptable to former DCGI, Dr Venkateshwarlu, who cracked the whip on irrational FDCs in June last, triggering a protracted battle in the court and outside.

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