Notification benefit

[MK Singh]

What is difference between Drugs and Bulk Drugs?

In Notification Number 50/2017 at Sr no. 167(A), for availing notification benefit, IGCRD certificate is required for bulk drugs, however some importers were treating bulk drugs as drugs. Guidance is solicited.

AI Summary

Clarification on Notification No. 50/2017: Bulk Drugs Are a Subset of Drugs, Require IGCRD Certificate for Import. A query was raised regarding the distinction between drugs and bulk drugs in the context of Notification No. 50/2017, which requires an IGCRD certificate for bulk drugs. Confusion arose as some importers treated bulk drugs as drugs. It was clarified that drugs encompass bulk drugs and formulations. Bulk drugs, also known as active pharmaceutical ingredients (APIs), are the raw materials providing therapeutic effects, while formulations are the final medicinal products. The Drugs and Cosmetics Act, 1940, further defines these terms, emphasizing that bulk drugs are a subset of drugs.