The Ministry of Commerce & Industries (MoC&I) on September 18, 2026, issued the Draft Guidelines for Examination of Patent Applications in the Field of Pharmaceuticals.
The following has been stated: -
•India’s pharmaceutical patent regime evolved from process-only patents under the Patents Act, 1970 to product and process patents from January 01, 2005, following TRIPS obligations.
•The framework incorporates public-health safeguards such as compulsory licensing, pre- and post-grant opposition, and provisions facilitating access to medicines.
•Amendments also address biological resources, traditional knowledge, and benefit sharing in line with international conventions.
•The updated pharmaceutical patent examination guidelines aim to incorporate judicial developments and ensure consistent and uniform examination standards by Patent Office officials.
•The guidelines supplement existing patent manuals and sector-specific guidelines, while the Patents Act, 1970 and Rules prevail in case of any conflict.
The detailed notification is given in the document below.
