The year-long impasse over regulating marketing of fixed dose combinations in the market between the industry and the authorities is being finally settled after a fruitful meeting between the DCGI Dr Surinder Singh and the pharma associations. A consensus has been reached in the case of 138 combination drugs.
At the meeting, described by the industry as one of the best ever with the authorities, it was agreed that 138 combinations out of the total 294 FDCs will be withdrawn from the market. 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 combination, 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.
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, FOPE, 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happiness over the outcome, he said the writ petition filed by his organisation in the Chennai High Court would be withdrawn once the final list is ready and published.
IPA 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 that 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. FOPE co-chairman Vinod Kalani said that by his unbiased attitude towards the issue the new DCGI has started a good platform which will go a long way in the government-industry relations.
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 on Monday. Apart from breaking 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.