Insights
Healthcare and pharma
Notes on Indian law as it applies to healthcare and pharma. The sector itself is described on its own page.
In a drug company's insolvency resolution the licence and trial permission continue on payment of current dues, and the data retention clocks keep running
When a pharmaceutical or biotechnology company enters the corporate insolvency resolution process (CIRP) under the Insolvency and Bankruptcy Code, 2016 (the Code), its drug manufacturing licence and clinical trial permission are not suspended or terminated on the ground of insolvency while current dues are paid, under the Explanation to section 14(1) inserted in 2020.
A ceiling price for a scheduled drug is the average price to retailer plus a 16 per cent margin, and an overcharge is deposited with interest
A ceiling price for a scheduled formulation under the Drugs (Prices Control) Order, 2013 (DPCO), made under section 3 of the Essential Commodities Act, 1955, is the simple average of the prices to retailer of every brand and generic version with a market share of at least one per cent of total market turnover, plus a retailer margin of 16 per cent, revised each 1 April by the annual wholesale price index (WPI), which for the revision from 1 April 2026 was 0.64956 per cent, the index for 2025 over 2024.
A telemedicine product in India answers to three regulators at once, and only the doctor may prescribe
A telemedicine product in India answers to three regimes that do not share a regulator.
A deepfake of your chief executive runs on a seven day clock, unless you hold a court order
The February 2026 amendment to the Information Technology Rules is reported as a three hour takedown rule.
An AI vendor's indemnity moves the money, not the responsibility: contracts, diligence and disclosure
Contracts for AI tools are usually drafted as if a warranty and an indemnity settle who answers for the tool.
AI and patents, trade secrets and training data in India
Where Indian law stands on patenting AI, naming an AI as inventor, protecting models as trade secrets, and using copyright works as training data.
There is no AI statute in India, and the one AI rule that binds you today is about labels
A business buying or building AI in India is usually told it faces a new compliance regime.
Revised Schedule M gave smaller drug makers one extension, and it ran out on 31 December 2025
Every manufacturer licensed under rule 74, 76 or 78 of the Drugs Rules, 1945 has been bound by the revised Schedule M since 31 December 2025 at the latest: since 28 June 2024 above INR 250 crore, and since 28 December 2024 for a smaller manufacturer that did not file Form A.
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