450 FDSs related to vitamins, minerals and micronutrients declared as ‘rational’

The DCGI has also approved them and allowed the state licensing authorities (SLAs) to grant product licenses without the DCGI`s no-objection certificate (NOC).

The government has declared more than 450 new fixed-dose combinations (FDCs) related to vitamins, minerals and micronutrients as rational.

An FDC drug contains two or more active ingredients in a fixed dosage ratio. The drugs are deemed rational when claims for their benefits are supported by evidence-based data and well designed clinical studies.

According to a letter by the Drug Controller General of India (DCGI) dated August 3, the state drug controllers (DCs) have been directed to ask pharmaceutical companies to get manufacturing licenses of these 471 new FDCs.

The DCGI has also approved them and allowed the state licensing authorities (SLAs) to grant product licenses without the DCGI`s no-objection certificate (NOC).

The manufacturers, however will have to submit periodic safety update reports (PSURs) to the central licensing authority. "Failure to submit the PSURs shall be considered as contravention to the rules," the DGCI letter said.


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