The seminar on this issue is significant as the recent methodology adopted by the regulatory authorities in scrutinising the fixed dose combinations (FDCs)’s rationality has created extreme discomfort in the pharma industry. The current requirements spelt out by the DCGI office in terms of submitting efficacy and safety data was a major concern for the drug manufacturers, especially the small and medium pharma manufacturers in the country.
For the pharma industry, FDCs are a vital contributor to overall business and business growth. The SLA-approved FDCs have been dominating the Indian pharma space and have been well accepted by the medical professionals as well. However, the recent requirements spelt out by the DCGI office have played the spoilsport for the pharma industry in the country.
The seminar is intended to enlighten on the relevance of FDCs vis-à-vis the global practices, in the light of patients’ acceptability and understand whether there are any hurdles (real or virtual) faced by medical professionals in prescribing the same.
Drugs Controller General of India (DCGI) Dr GN Singh will be the chief guest in the seminar. Dr VG Somani, Joint Drugs Controller (India) – CDSCO(Delhi), will be the guest of honour, while Dr K Bangarurajan, Deputy Drugs Controller (India) – CDSCO West Zone (Mumbai) will be the special guest of the seminar.