Fixed Dose Combinations (FDCs) manufacturers are invited to present their proposal for approval of the safety and efficacy of permitted for manufacture for sale in the country without due approval from office of Drug Controller General of India (DCGI).
Manufacturers of FDCs are required to make proposal which contain, name of product with composition and indication, rationale, data on Pharmacokinetic / Pharmacodynamics interactions and Pharmacokinetic rationality (with half-life details of individual drugs, dosage schedule of individual drug along with reference etc.
As per notice from DCGI, the proposal should also contain information on published data regarding safety and efficacy of applied FDCs, original data generated by the applicant on applied FDC (if any), PMS data generated by the applicant on applied FDC, (if any), Regulatory status of FDC in-other countries, (if any) and similar FDC approved (if any by DCGI) and also write on any further studies plans.
They also instructed manufacturers to bring Drug samples in original pack as well as package insert while coming for presentation
