Kerala High Court Orders Reports on Ribociclib-Palbociclib Substitution by August 21

Why in news

The Kerala High Court sought expert reports from national cancer institutes and the DCGI on the interchangeability of Ribociclib and Palbociclib to address high costs of life-saving cancer drugs.

Background

The Kerala High Court directed the National Cancer Institute (Jhajjar), Chittaranjan National Cancer Institute (Kolkata), Regional Cancer Centre (Thiruvananthapuram), and the Drug Controller General of India (DCGI) to submit reports by August 21. The legal action arose from a petition regarding the high cost of breast cancer medications.

Facts for Prelims

• BodyDCGI: Drug Controller General of India is the national regulatory authority for pharmaceuticals in India.
• PlaceChittaranjan National Cancer Institute is located in Kolkata.
• FactRibociclib and Palbociclib are drugs used in the treatment of specific types of breast cancer.

For Mains

Q. Discuss the challenges in ensuring the affordability of life-saving drugs in India and the role of judicial intervention in balancing patent rights with the right to health.

Dimensions to cover in your answer

• Regulatory bottleneck: Complexity in establishing bioequivalence for substituted drugs under current DCGI guidelines
• Patent vs. Access: Conflict between pharmaceutical intellectual property rights and the constitutional right to affordable healthcare
• Institutional coordination: Need for standardized clinical data sharing between national cancer institutes and regulatory bodies

Keywords: Right to Health · Bioequivalence · Affordability · Judicial Activism · Intellectual Property

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