What is the meaning of DCGI approval?

Query: What is the meaning of DCGI approval? Sir some companies are manufacturing DCGI approval and non approval products what about quality?


There is two type of approvals for manufacturing of pharmaceutical products in India. One is by State Drug Control authority and second is by Drug Controller General of India (DCGI).

Any new molecule of formulation, new drugs or combinations or new FDC’s (Fixed Dose Combinations) approval is handled by DCGI whereas State Drug Control Authority handles work of giving approval for manufacturing of already approved medicines to manufacturing unit.

The approvals that is given by Drug Controller General of India is known as DCGI approvals.

Quality doesn’t matter in both case. DCGI approval or non approval doesn’t affect the quality.


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