Before the much awaited second meeting on the fixed dose combination (FDC) issue on October 1, Indian Drug Manufacturers Association (IDMA) has called a meeting of major pharma associations representing small and medium scale units to thrash out strategies to be adopted in the next DCGI-Industry meeting. The IDMA executive committee meeting, for which it has invited other associations to discuss the FDC issue, will be held in Chandigarh on September 26.
This is for the first time that the IDMA is taking the initiative on the FDC issue. So far, CIPI has been spearheading all the actions on the FDC issue including the legal action. When former DCGI Dr M Venkateshwarlu asked the state drug authorities to withdraw licenses issued to 294 combination drugs, it was the CIPI which moved the Madras High Court against the DCGI order and it obtained stay which is yet to be vacated by the court. Though the members of the IDMA are also manufacturing FDC drugs, the IDMA so far shied away from direct action on the FDC issue.
According to sources, IDMA has invited all the major pharma associations representing small and medium industries including CIPI, FOPE and SPIC for the September 26 executive meeting in Chandigarh. The meeting is expected to discuss threadbare the strategies to resolve the FDC issue which has been hanging in balance for the last more than a year. Though the new DCGI Dr Surinder Singh has taken the initiative to resolve the vexed issue by calling a DCGI-industry meeting in July this year, the delay in taking the follow-up action is irking the industry.
The industry is upset over the DCGI's delay in issuing formal minutes of the first DCGI-Industry meeting held on July 14, in which a consensus was reached in the case of 138 combination drugs. Despite industry's repeated reminders in this regard, the DCGI is yet to issue the minutes of the meeting to the state licensing authorities (SLAs). The industry is particularly disturbed over the fact that the state drug authorities are not accepting the renewal letters for the 294 contentious FDC drugs in the absence of new directives from the DCGI.
After finding a consensus on 138 of the total 294 contentious combination drugs, the DCGI had asked the industry in the July 10 meeting to submit the scientific data of the remaining 156 drugs to take a final decision on them. Sources said that the industry is yet to prepare the scientific data of the remaining 156 drugs as it is waiting for the minutes of the first meeting before going ahead further on the issue.