Overview of CDSCO Drugs Import License
Chapter III of the Drugs & Cosmetics Act of 1940 and Part IV of the Drugs and Cosmetics Rules of 1945 govern the import of drugs into India. Drug registration certificates and import license applications are processed in accordance with Rule 24(A) and Rule 24 of the Drugs & Cosmetics Rules 1945. According to CDSCO, the following are considered as drugs:
Under the Drugs & Cosmetics Act 1940 and Rules 1945, the import, manufacturing, sale, and distribution of drugs are all regulated in India. Currently, the Act regulates both finished formulations and bulk drugs (active pharmaceutical ingredients). Before being imported into the country, any substance that meets the definition of “drug” under Section 3(b) of the Act must be registered with CDSCO. The manufacturing facility must also be registered for import in addition to the drug. The local authorised agents of foreign manufacturers with manufacturing or sale licenses or foreign manufacturers with wholesale licences in the country may submit applications for registration certificates and CDSCO drugs import licenses to the licensing authority designated by the Act.
Benefits of CDSCO Drugs Import License
The manufacturer or importer of drugs can benefit greatly from a CDSCO Drugs Import License. The intended population is protected, and the seller is free from any legal repercussions when they sell drugs in India. Some of the benefits of a CDSCO drugs import license are-
Eligibility to Import Registered Drugs in India
Documents Required for CDSCO Drugs Import License
The Central drugs standard control organisation, which operates under Directorate general of health services, Ministry of Health & Family Welfare Government of India, requires the following documents for CDSCO Drugs Import License in India:
Procedure to Obtain CDSCO Drugs Import License
Prohibition of Import of Certain Drugs
According to Section 10 of the Drugs and Cosmetics Acts, 1940, there are certain drugs that are prohibited from being imported to India. The prohibited drugs are as follows-
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Offences Related to Drug Import License
CDSCO allows Imports of Drugs by providing a CDSCO Drugs Import License to the Foreign Manufacturers. However, there are certain drugs that are prohibited and importing them may lead to offences causing imprisonment and penalties. The offences and penalties are as follows-
- Import of adulterated or any kind of spurious cosmetics- Punishment for importing any kind of adulterated drug or any spurious cosmetic may lead to imprisonment for a term which may extend to three years or a fine up to Rs.5000, or both.
- Import of any drug prohibited under Section 10- Import of any drug prohibited under Section 10 of Drugs and Cosmetics Act, 1940 may lead to imprisonment for a term of six months or a fine up to Rs. 5000, or both.
- Import of any drug against the provisions of section 10 A- Importing any drug against the provisions of Section 10 A of The Drugs and Cosmetics Act, 1940 may lead to imprisonment for three years or a fine up to Rs. 5000, or both.