DCGI, industry settle vexed FDC issue
Joseph Alexander, New Delhi

The year-long impasse over the fixed dose combination (FDC) issue resulting into court battles and cold war between the industry and the authorities has finally been broken, after a fruitful meeting between the DCGI Dr Surinder Singh and the pharma associations. While decision has been taken on the status of 138 combination drugs, the decision on the rest will be taken later.

The cordial meeting, described by the industry as one of the best ever with the authorities, arrived at conclusion on as many as 138 combination drugs out of the total 294 FDCs which were listed last year by the former DCGI to be withdrawn from the markets. The remaining 156 FDCs will be examined based on the scientific data and a final decision will be taken in course of time, sources said.

In the meeting, which went into detail over each drug, the industry agreed to withdraw 28 FDCs from the market voluntarily. It was also found that as many as 31 drugs were duplicated in the list of 294 FDCs. And 15 drugs earlier banned, but continued to appear in the medical reference books in the country, will also be kept out. Besides, the DCGI has informed the meeting to write to the book publishers not to include them and make confusions.

As many as 28 FDCs which got approval after the issue broke out would be permitted for manufacturing and marketing. The authorities also agreed to approve the FDCs which came under the same molecule family which has been already cleared. Thus a decision over 138 FDCs was taken and would be pruned from the contentious list. After submitting the outcome and revised list to the DTAB and later to the DCC, a final list of 156 FDCs which needs to be examined would be published, sources informed.

The industry has agreed to come out with scientific data over these drugs and would be cleared based on the data. If there are strong supportive data, it would be cleared while the complex cases would be dealt with slowly and appropriate decision would be taken.

Apart from DCGI, the meeting was attended by well-known pharmacologist Dr Y K Gupta, some state drug controllers, officials in the CDSCO and a few academicians on the part of the authorities. The industry was represented by representatives of CIPI, SPIC, OPPI, IDMA, IPA and four experts led by Dr R K Sanghavi who headed a panel for the industry to prepare the rationality profiles of the 294 drugs.

Terming the meeting as `one of the best and well-organised', CIPI chairman T S Jaishankar told Pharmabiz that it was the right approach. Expressing happiness over the outcome, he said the writ petition filed by his organisation in the Chennai High Court would automatically withdrawn once the final list is ready and published.

Indian Pharmaceutical Alliance secretary general D G Shah said the meeting made a very good progress to solve the issue and it could remove the existing `confrontationist' attitude between both the sides and now the industry and authorities could work jointly and cordially.

SPIC secretary general Jagdeep Singh, expressing satisfaction over the meet, said now there would not be much issue as only a very few out of the remaining 156 FDCs would finally go off the list after examination.

Determined to settle the issue forever, Dr Singh had called for a preliminary meeting between both the sides on June 10, which finally paved way for the crucial meeting today. Apart from breaking the ice between both the sides, the meeting also saw that the tag of `irrational' has been taken away, in a big relief to the industry and restoring faith of the public.

Source: www.pharmabiz.com
15th July 2008

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