Marketing Authorization in India (CDSCO & DCGI)

1. Marketing authorisation is the process of reviewing and assessing the evidence to support a medicinal product, such as a drug, in relation to its marketing, finalised by granting of a licence to be sold. This process is performed within a legal framework defining the requirements necessary for successful application to the regulatory authority, details on the assessment procedure (based on quality, efficacy and safety criteria), and also the circumstances where a marketing authorisation already granted may be withdrawn, suspended or revoked.

2. NDA & ANDA

2.1. To import, market, or manufacture a new drug", any drug which has not been used in India before requires filing of NDA/ ANDA

3. ROLE

3.1. proper pharmacovigilance and risk management systems

3.2. responsible for the product's quality,

3.3. efficacy and safety

4. Liscence-

4.1. licenses to sell, stock, exhibit or offer for sale or distribute drugs are categorized mainly as wholesale license, retail license, and restricted license with validity of 5 years unless suspended or cancelled

5. Rules that provide information-

5.1. The Rules 122A,122B and 1220 122DA, 1220DAA,122E and Appendix I,IA and VI of Schedule Y of the Drugs & Cosmetics Act, 1945

6. 3 TYPES OF MARKETING AUTHORIZATION APPLICATION

6.1. 1. Products containing now APIs 2.Now marketing authorization holders 3.Variations to existing marketing authorization