The Central Drugs Standard Control Organization (CDSCO) has issued Guidance document on common submission format for import and registration of Active Pharma Ingredients (APIs) and finished formulations in India.

The main purpose of the document is to provide guidance for submission of application in Form 40 to the CDSCO for registration certificate and issuing license for import of drugs into India. The document is intended to provide non-binding guidance for use in the import and registration of bulk drugs and finished formulations in India.

The scope of the guidance is applicable to those drugs manufactured outside India, and the import registration to be issued (under Form 41) by the CDSCO.

As per the 82-page guidance document, an application shall be made to the licensing authority in Form 40, either by the manufacturer himself, having a valid wholesale license, for sale or distribution of drugs or by his authorized agent in India either having a valid license to manufacture for sale of a drug or having a valid wholesale license for sale or distribution of drugs.

In India, import, manufacturing, sale and distribution of drug is regulated under Drugs and Cosmetics Act 1940 and Drugs and Cosmetic Rules 1945 made thereunder. At present, bulk drugs and finished formulations are regulated under the said Act. Any substance falling within the definition of drug (Section 3b of the Act) required to be registered before import into the country. Not only drugs but the manufacturing site also need to be registered for import.

If the drugs fall within the definition of New Drug (Rule 122 E of the Act), the new drug approval is the pre-requisite for submission of application for registration and or import of drug. The application for registration and import can be made to the licensing authority under the Act, i.e. to the Drugs Controller General of India (DCGI) by the local authorized agent of the foreign manufacturer having either manufacturing or sale license or by the foreign manufacturers‘ having a wholesale license in the country.

The CDSCO has asked all the stakeholders likely to be affected by the  proposed Guidance document to make their comments on the document within 20 days.