Even as the small and medium pharma companies in the country are finding it difficult to get licenses for the FDC drugs from the state drug controllers as the DCGI has made the BA/BE study mandatory for FDC licenses, the Confederation of Indian Pharmaceutical Industries (CIPI) will soon conduct a national seminar on the FDC issue to assist these companies on how to go for an FDC license.
CIPI chairman T S Jaishankar said that though the exact date has not yet been finalised for the national seminar, it will be done soon in Delhi. Dr Y K Gupta, chief pharmacologist at AIIMS and one of the key members of the expert panel on FDC issue, will be the main speaker in the seminar which will go a long way in clearing doubts about the FDC issue.
Presently, the companies are not getting the licenses for the fixed dose combination (FDC) drugs from the state licensing authorities (SLAs) because even though the expert panel on FDC headed by DCGI had cleared 236 of the total 294 controversial combination drugs as 'good', the DCGI did not send the list to the SLAs. In the absence of a written directive from the DCGI, the SLAs are directing the companies to DCGI office in Delhi for getting the license renewal of drugs which have been in the market for as long as 10 to 15 years.
Interestingly, some of the old FDC drugs, which have been in the market for 10-15 years, have overnight become New Drugs as some of the big companies have done the BA/BE studies and have received the license from the DCGI office as new drugs. Since they have received the license as New Drugs, no company will receive license for the same drug for the next four years.
It is to avoid such a situation in future that the CIPI is conducting the seminar. All the apprehensions and doubts about the filing of BA/BE documents for the FDC drugs will be cleared in the seminar, Jaishankar said.
The expert panel on FDC, headed by the DCGI Dr Surinder Singh and consisting of Dr Y K Gupta and Dr Sanghavi of IDMA as members, had so far cleared 236 of the total 294 controversial combination drugs as 'good'. But, the DCGI is yet to officially communicate the same to the SLAs in writing, leaving the industry to approach the DCGI office for licenses. And the DCGI office has made it clear that clinical trials are mandatory for license renewal.