Since long the battle between pharmaceutical manufacturers and DCGI and FDA is going on for the issue of fixed dose combination of 2 or more drugs. The main issue was these fixed dose combination were marketed without any clinical trials. However the pharma companies were arguing that individual compounds are safe and effective and available in the market since long so the combinations are also safe.
Initially so many irrational combinations was banned by DCGI and now in the line of same, DCGI has issued a guidance for getting marketing approval of the fixed dose combinations. These guidelines apply to manufacture, import and marketing approval of fixed dose combinations as a finished pharmaceutical product considered as new drug as per Rule 122(E) of Drugs and Cosmetics Act & Rules. Appendix VI of Schedule Y (Drugs & Cosmetics Rules 1945) specifies the requirements for approval for marketing of various types of FDCs. The same is further described in the draft to provide a detailed guidance for industry. Finally for such FDCs clinical trials is required to be carried out right from Phase I and in order to get permission for marketing the new drug of such FDCs, along with other required documents.
So now onwards no one can manufacture such fixed dose combinations without any clinical trials data.
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