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.

[KASTURI SETHI]

Drug includes bulk drugs and formulations. See the judgement in the case of Balakrishna Pillai Vs. Matha Medicals - 1991 (1) TMI 465 - SUPREME COURT, . This an extract from a dictionary.

Also see the definition of "drugs" and "substances" under Section 3 (b) of Drugs and Cosmetics Act, 1940.

[MK Singh]

Sir, if we count drugs and bulk drugs as same then what is the purpose of the Notification No. 50/2017 at Sr. No. 167(A) and (B). It renders the notification related to bulk drugs null and void. Please comments.

[KASTURI SETHI]

Both are not the same. Bulk drug is one of the kinds of drugs. As per dictionary, the definition of "Drugs" is comprehensive enough to take in not only medicines but also substances. It is an umbrella which have so many drugs, medicines & substances.

Also see Section 3 of Drug & Cosmetics Act, 1940

[Raghunandhaanan rvi]

Active pharmaceutical ingredients (APIs) are commonly referred to as bulk drugs. These are the primary ingredients or raw materials that provide therapeutic effects to a drug or medicine. The process of mixing these ingredients (bulk drugs) to produce a specific drug or medicine is known as formulation.

AI Summary

Definition of drugs: umbrella concept includes bulk drugs, but bulk drugs (APIs) are a distinct subset for regulatory treatment. The term drugs functions as an umbrella category that includes bulk drugs and formulations, while bulk drugs (APIs) are a specific subset serving as primary therapeutic raw ingredients; thus an import notification directed at bulk drugs requiring IGCRD certification targets that subset and remains distinct from general references to drugs.