Public-Health Experts Call for Compulsory Licensing and Tighter Pricing Checks on Cancer Drugs in India

Public-health advocates have called for stronger legal interventions, including provisions under the Patents Act, to improve patient access to expensive patented medicines. This follows observations that several high-cost cancer drugs have recorded no price reductions under the government's 30 per cent trade-margin cap.

During a recent discussion on the National Pharmaceutical Pricing Authority’s (NPPA) price-control measures, Gopakumar of the Third World Network urged the government to use Sections 92 and 100 of the Patents Act, 1970, where justified. He argued that the government should not wait for patents to expire when essential medicines remain unaffordable. Section 92 provides for compulsory licenses during national emergencies, extreme urgency, or public non-commercial use, while Section 100 empowers the government to use a patented invention for government purposes under statutory conditions.

The discussion highlighted that the NPPA’s 30 per cent trade-margin cap has led to an uneven impact on cancer drug prices. While several generic and biosimilar brands showed substantial price reductions, many expensive originator and single-source medicines saw little or no change. For instance, AstraZeneca’s anastrozole remained priced at ₹3,541, while a competing Cipla brand dropped from ₹784 to ₹146. Similarly, Roche’s originator bevacizumab, sold as Avastin, remained at approximately ₹1.23 lakh, compared to competing versions priced at ₹12,668 and ₹8,956.

Gopakumar noted that the trade-margin cap does not address the initial price set by manufacturers when introducing medicines to the market. He called for tighter scrutiny of companies' self-declared price and margin calculations, along with verification of actual transaction prices used for stockists. Additionally, concerns were raised regarding financial relationships between hospitals and pharmaceutical companies. Experts pointed out potential incentives for hospitals to stock expensive originator brands because a 30 per cent margin on a higher-priced drug yields a larger financial return than the same margin on a lower-priced generic.

Chetali Rao, Senior Scientific Advisor at Third World Network, pointed to a Kerala High Court judgment recognizing that the Centre can invoke Section 100 of the Patents Act for cancer drugs to fulfill the state's constitutional duty to improve public health. Unlike compulsory licensing, which requires a generic company to approach the Controller of Patents and navigate potential litigation, the government-use route under Section 100 does not depend on a generic firm taking the first initiative. India has previously used compulsory licensing only once, permitting Natco Pharma to manufacture Bayer’s cancer drug sorafenib.

Rao also noted that assessing unmet public needs has become more challenging due to changes in Form 27, which previously required patent holders to report quantities manufactured, imported, and supplied in India. Consequently, she stated that the government would need to collect direct data on medicine prices, out-of-pocket expenses for patients, and actual clinical demand to establish inadequate access.

"The debate over cancer drug pricing highlights the complex balance between intellectual property rights and public health accessibility in the Indian market. When regulatory mechanisms like trade-margin caps yield uneven results across originator brands and generics, policymakers must evaluate alternative legal frameworks, such as provisions under the Patents Act, to ensure essential treatments remain affordable. For healthcare startups and pharmaceutical enterprises alike, regulatory compliance, transparency in pricing, and affordability will remain critical factors influencing market access and long-term business sustainability." — Dr. Shishir Gupta, Founder & CEO, StartupLanes