Utter confusion prevails in the country over the status of the controversial 294 fixed dose combination (FDC) drugs after the DCGI's recent issuance of new guidance for marketing approval of FDC drugs, classifying the FDCs into different categories and listing various requirements for each category. Industry is baffled over the fact that there is no mention of the status of the controversial 294 FDCs for which several expert panel meetings were held over a period of two years and a decision was already taken on 236 of them.
According to the new guidance issued by the DCGI, when approval is sought for marketing investigational new drug (IND), data that are required to be submitted will be similar as per Appendix I of Schedule Y which is similar to data required for any new chemical entity (NCE). For such FDCs also clinical trial is required to be carried out right from phase I to get permission for marketing the new drug of such FDCs, along with other required documents.
During the last two years, the expert panel on FDC, headed by none other than the DCGI himself and Dr Y K Gupta, chief pharmacologist at AIIMS and Dr Sanghavi of IDMA as members, had so far cleared 236 of the total 294 controversial combination drugs as 'good and rational'.
Since nothing is specified anywhere in the new DCGI guidance about the status of the 294 drugs, there is utter confusion among the industry as well as the state licensing authorities (SLAs). The SLAs are unable to take a decision and therefore are not renewing the manufacturing licenses for these products. Besides, it is also not clear as to what has to be done regarding the remaining FDC drugs.
Meanwhile, perturbed over the indecision of the DCGI, the Confederation of Indian Pharmaceutical Industry (CIPI) has asked the DCGI to clarify the position in this regard. "It is requested that your office should come to a conclusion on the pending issue of the 293 drugs and advise the industry the course of action to be taken for our members who are holding a valid manufacturing license or pending renewal", CIPI chairman TS Jaishankar in a letter to the DCGI said.