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DCGI open to `rational, scientific' solution to settle FDC issue with industry
Joseph Alexander, New Delhi | Monday, April 14, 2008, 08:00 Hrs  [IST]

Even though the case on the vexed issue of fixed dose combinations (FDC) is still under litigation in the Chennai High Court, DCGI Dr Surinder Singh said he was open to work it out with the pharmaceutical industry for an amicable, but `rational and scientific' solution.

Dr Singh said he already held interactions with several industry organisations at different levels on the issue. Industry should come forward with a concrete suggestion to settle the matter as the matter is under consideration of a subcommittee of the Drugs Technical Advisory Board (DTAB). The panel had already met once and the second meeting would be held soon, he said in an interview with Pharmabiz.

``I had discussions at different levels with industry associations like IDMA, CIPI and SPIC etc. The matter is sub judice and the case will take its own course. We are also simultaneously holding talks with the industry and I am open to any concrete and scientific suggestion to solve the issue from them. I understand that the industry bodies are also holding discussions among themselves and between the forums,'' he said. He was referring to the reports of a possible meeting with CIPI which had secured stay on the operation of the order by former DCGI to withdraw the identified FDCs from the market.

The DCGI also disclosed that the subcommittee of the DTAB, examining the safety and rationality of a list of 294 FDC drugs, comprised of experts including pharmacologists and there was no need to refer it to pharmacologists outside again.

The DTAB had virtually backed the stand taken by former DCGI Dr M Venkateshwarlu, observing that most of the identified drugs in controversy were `illogical', but it still constituted the nine-member subcommittee to examine these drugs as its recommendation is necessary for banning drugs under Section 26-A of the Drugs and Cosmetics Act.

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