Pharmaceutical Antitrust 2019 – India

Regulatory framework and authorities

1. What is the applicable regulatory framework for the authorisation, pricing and marketing of pharmaceutical products, including generic drugs?

The legislative framework for the marketing, authorisation and pricing of pharmaceutical products in India (including generic drugs) consists of:

• the Drugs and Cosmetics Act 1940 (DCA), the Drugs and Cosmetics Rules 1945 (DCA Rules) and the Drugs (Control) Act 1950, which regulate the manufacture and distribution of pharmaceutical products;
• the Drugs (Price Control) Order 2013 (DPCO), framed under the Essential Commodities Act 1955, which regulates the pricing of certain essential medicines listed therein;