The central government has rejected the plea of Indian Drugs Manufacturers Association (IDMA) to exempt Penicillin G and its salts, on the basis of its wide use as intermediate, from import registration requirements. The office of the Drugs Control General of India (DCGI), which looked into the matter, concluded that Penicillin is a drug falling within the definition of a drug under Section 3 (b) of the Drugs and Cosmetics Act and needs to be registered.
IDMA had requested the government to be clear on the import registration requirements of drugs that can be of dual use, both as drug and as intermediate. The representation said that since penicillin is used as an intermediate for the manufacture of other drugs and not as a drug, registration should not be insisted upon.
While drugs, even if it is used as a raw material for the manufacture of other drugs require registration, intermediates, which are not covered within the definition of drugs and are meant for the manufacture of bulk drugs do not require registration under the Notification No GSR 604 (E) dated 24.8.2001.
The DCGI decision was based on the fact that Penicillin G is a drug that comes under the Drugs Price Control Order (DPCO). It also took note of the fact that all Penicillin G manufacturers are having manufacturing license for Penicillin endorsed by the Drug Controller and Penicillin G is used for direct manufacture of Pen-G tablets.
The Indian Penicillin Manufacturers Association, in a separate representation had argued against the IDMA plea. Unhindered import of Penicillin G was against their business interests, which made them go against the arguments of the IDMA.