Health & Pharma
Regulatory, insurance and commercial disputes involving drugs, devices and healthcare.
Overview
Disputes across the health and pharma sector are handled for pharmaceutical and healthcare companies, insurers, overseas investors and individual executives. The work takes in regulatory proceedings, insurance coverage, commercial arbitration, shareholder disputes, internal investigations and advice on health data. Matters proceed before Indian courts, consumer commissions, arbitral tribunals and the Securities Appellate Tribunal.
The legal framework
The sector is governed principally by the Drugs and Cosmetics Act 1940 and the Drugs and Cosmetics Rules 1945, with the Medical Devices Rules 2017 and the New Drugs and Clinical Trials Rules 2019 made under the same Act, and drug pricing controlled by the Drugs (Prices Control) Order 2013 made under the Essential Commodities Act 1955. Challenges to regulatory action are ordinarily brought in the writ jurisdiction of the High Courts, with the Central Drugs Standard Control Organisation and the National Pharmaceutical Pricing Authority as the principal sectoral regulators. Consumer and insurance claims proceed under the Consumer Protection Act 2019 and the regulations of the Insurance Regulatory and Development Authority of India.
Scope
- Regulatory disputes on the interpretation of sectoral regulations and the extent of a regulator's powers, including writ proceedings before the High Courts.
- Enforcement action and licence suspensions by the Central Drugs Standard Control Organisation, the national drug regulator.
- Price control disputes under the Drugs (Prices Control) Order 2013, including recovery demands from the National Pharmaceutical Pricing Authority.
- Disputes under clinical trial and contract research agreements, and classification and compliance disputes under the Medical Devices Rules 2017.
- Coverage advice under product liability, product recall and clinical negligence policies, including United States class actions concerning allegedly defective drugs manufactured in India.
- Cyber insurance claims involving policyholder medical data or the disruption of pharmaceutical production, and breach response for clinical research data processors.
- Domestic arbitration for health insurance companies under master services agreements, and repudiated health insurance claims before consumer commissions.
- Shareholder disputes for overseas investors in the Indian health sector, and appeals before the Securities Appellate Tribunal for former healthcare executives.
- Internal investigations for pharmaceutical companies, with consequent employment action and petitions to quash related criminal proceedings.
