India: Life Sciences, Biotechnology & Nanotechnology

The Union Ministry of Health and Family Welfare (the “Ministry”) has recently published a Draft Notification[1] in the Official Gazette proposing amendments to the Medical Devices Rules, 2017[2] (the “Rules”), promulgated under the Drugs and Cosmetics Act, 1940. The proposed amendments specifically target the statutory timelines prescribed for processing manufacturing licence applications across the four risk-based classifications of medical devices.

Patent pendency remains one of the most significant challenges in U.S. patent prosecution. Average first-action wait times range from approximately 20 to 29 months across Technology Centers, creating real costs for startups seeking investor credibility, life sciences companies racing toward product launches, and technology firms defending competitive market position.

On 22 June 2026, the Ministry of Health and Family Welfare published G.S.R. 506(E), enacting the Drugs (Seventh Amendment) Rules, 2026. This notification fundamentally alters Schedule H2 of the Drugs Rules, 1945, expanding on-pack 2D barcode and QR code mandates from a static list of 300 brands (Table 1) to entire therapeutic classes under a new Table 2.

The life sciences and healthcare industry in India continues to evolve through regulatory and policy developments. In March 2026, key developments included proposed frameworks for post-approval...

On March 25, 2026, the National Pharmaceutical Pricing Authority (NPPA), operating under the aegis of the Ministry of Chemicals and Fertilizers (Department of Pharmaceuticals), Government of India...

On 9th March 2026, the Ministry of Health and Family Welfare, Government of India, published a significant draft amendment to the Drugs Rules, 1945, by way of Gazette Notification G.S.R. 164(E).

The Hon'ble Delhi High Court in the matter of Samarendra Das v. Win Medicare Pvt. Ltd., 2025 SCC OnLine Del 6347, reaffirmed that a medical or sales representative employed in the pharmaceutical sector does not qualify as a "workman" under Section 2(s) of the Industrial Disputes Act, 1947 ("Act").

Welcome to the August 2025 edition of our Life Sciences and Healthcare Newsletter, where we delve into the latest developments shaping the industry.

Welcome to the July 2025 edition of our Life Sciences and Healthcare Newsletter, where we delve into the latest developments shaping the industry and its impact on the various stakeholders.