Sectors · Healthcare and pharma
Healthcare and pharmaceuticals
Hospitals, healthcare groups, pharmaceutical and device manufacturers and individual practitioners sit at the meeting point of medical regulation, consumer protection and professional liability, where a single incident can produce proceedings in more than one forum at once.
Reviewed
What this covers
- Defence of medical negligence claims before consumer commissions
- CDSCO and drug regulatory compliance
- NPPA pricing disputes and price control litigation
- Clinical trial regulatory matters
- Hospital and healthcare group governance
- Medical device regulatory compliance
- Insurance and third-party administrator disputes
- Employment and professional misconduct proceedings
The notes behind these capabilities
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. The only relief we have found is G.S.R. 127(E) of 11 February 2025. It let a manufacturer with turnover under INR 250 crore apply, within three months and with an upgradation plan, for time to 31 December 2025, the last date any instrument we have found gives. As at 14 October 2026, that date is more than nine months past.
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 manufacturer that sells above it is liable to deposit the overcharged amount with interest. A price order can go to the Central Government for review within thirty days, a demand has no appeal under the Order and may be brought before a High Court under Article 226 of the Constitution, and contravention is an offence under section 7 of the Act.
A telemedicine product in India answers to three regimes that do not share a regulator. The Telemedicine Practice Guidelines of 25 March 2020, Appendix 5 to the Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002, let only a registered medical practitioner counsel or prescribe, and bar a platform built on artificial intelligence from doing either. The National Medical Commission (NMC) put its own 2023 conduct regulations in abeyance and adopted those 2002 Regulations by a notification of 23 August 2023. Software that diagnoses, monitors or treats is a medical device under the Medical Devices Rules, 2017 (MDR) and falls into Class A, B, C or D by its intended use. Patient data comes under the Digital Personal Data Protection Act, 2023 (DPDP Act), whose main duties begin on 13 May 2027.
Reference
Regulators in this sector
Forums
Practice areas that apply
Advocates in this sector
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