The import, manufacturing, sale and distribution of drugs in India is regulated under Drugs and Cosmetics Act 1940 and Drugs and Cosmetic Rules 1945 and New Drugs and Clinical Trials Rules 2019. At present, bulk drug (Active Pharmaceutical Ingredients) and finished formulations are regulated under the said Act.
A Marketing Authorization Application (MAA) is an application submitted by a drug manufacturer seeking permission to bring a newly developed medicinal product (for example, a new medicine) to the market. It is a term used by the countries from the Europe Union seeking permission to bring a newly developed medicinal product to the market. In India, there is officially no term such as Marketing Authorization Holder.
In the present scenario, India has stringent regulatory requirements for approval of a new drug. The CDSCO is the national regulatory authority in India that evaluates safety, efficacy and quality of drugs in the country. The marketing authorization is given by CDSCO to different types of drugs under the provision of Drugs & Cosmetics Act 1940 and Rules 1945 and New Drugs and Clinical Trials Rules 2019.
Any substance falling within the definition of drug (Section 3b of the Act) is required to be registered before import into the country. Not only drug but the manufacturing site needs to be registered for import. If the drugs, fall within the definition of New Drug (Rule 2 (w) of the Act), the new drug approval is the pre-requisite for submission of application for Registration and or import of drug.
An applicant is required to file application in Form CT-18/CT-21 along with prescribed fees in the form of Bharatkosh challan and all relevant data as per Second Schedule of New Drugs and Cosmetics Rules 2019, for seeking permission to import or manufacture of new drug substances and its formulations for marketing in the country or conduct of clinical trials in India.