With several high-cost cancer drugs recording no price reductions under the government’s 30 per cent trade-margin cap, public-health advocates have called for stronger legal intervention, including the use of provisions under the Patents Act, to improve access to expensive patented medicines.
At a discussion on the National Pharmaceutical Pricing Authority’s (NPPA) price-control measure, Gopakumar of the Third World Network called for the government to use Sections 92 and 100 of the Patents Act, 1970, where justified, to improve access to patented medicines on public-health grounds. He argued that the government should not have to wait for patents to expire when the prices of essential medicines remain unaffordable.
He said Section 92 provides for compulsory licences in circumstances such as a national emergency, extreme urgency or public non-commercial use. Section 100 empowers the government to use a patented invention for government purposes, subject to statutory conditions.
The call comes amid concerns that the NPPA’s 30 per cent trade-margin cap has had an uneven impact on cancer drug prices. While several generic and biosimilar brands have seen substantial reductions, many expensive originator and single-source medicines have recorded little or no change. AstraZeneca’s anastrozole, for instance, remained priced at ₹3,541, while a competing Cipla brand fell from ₹784 to ₹146. Roche’s originator version of bevacizumab, sold as Avastin, remained at around ₹1.23 lakh, against competing versions priced at ₹12,668 and ₹8,956.
Gopakumar argued that the trade-margin cap does not address the price at which manufacturers introduce medicines into the market. “The trade margin is only one component. It does not necessarily address the price charged by the manufacturer,” was the concern he raised. He called for stronger scrutiny of companies’ self-declared price and margin calculations, including disclosure and verification of the actual transaction prices used to determine the price to stockists.
Gopakumar also raised concerns about the financial relationship between hospitals and pharmaceutical companies. Gopakumar argued that hospitals could have an incentive to retain expensive originator brands because a 30 per cent margin on a high-priced drug translates into a larger amount than the same margin on a cheaper generic or biosimilar. Citing the price difference between Roche’s Avastin and competing versions, he questioned whether patients were being given adequate access to lower-cost alternatives. He flagged the possibility that financial incentives could influence hospital procurement and prescribing decisions, although no evidence was presented to establish collusion between specific hospitals and drug companies.
The speakers also argued that the government should assess affordability rather than rely only on the number of brands reporting price cuts. They called for direct intervention where medicines remain unaffordable and pointed out that lower drug prices alone would not make cancer treatment accessible if hospitals continued to charge high amounts for administering medicines and related services.
Giving example of the Kerala High Court judgment which said that Centre can invoke section 100 of the patent act for cancer drugs, Chetali Rao, Senior Scientific Advisor at Third World Network (TWN), said the judgment is significant because it recognises that the government can use a patented invention under Section 100 of the Patents Act, 1970, for public-health needs.
Rao said drug companies had argued a narrow interpretation of Section 100 – as being confined to use of patented inventions for government purposes and did not permit the Government to manufacture patented medicines for free or subsidised supply to patients. However, the court held that government purposes include the State’s constitutional duty to improve public health, including manufacturing patented medicines and supplying them to needy patients on a non-commercial basis.
“Under Section 100, the government can use a patented invention for its own purposes, including allowing its manufacture, when it believes public needs are not being met,” she said.
This is different from compulsory licensing. Under a compulsory licence, a generic company can approach the Controller of Patents and seek permission to manufacture a patented medicine on specified grounds, including when the reasonable requirements of the public are not being met.
India has used compulsory licensing only once — when Natco Pharma was allowed to manufacture Bayer’s cancer drug sorafenib.
Rao said compulsory licensing can be difficult because a generic company has to come forward, be willing to manufacture the drug and be prepared for lengthy legal litigations . The government-use route under Section 100 does not depend on a generic company taking the first step.
The government would, however, need evidence to show that access to a medicine is inadequate. Earlier, patent holders had to provide information through Form 27 on the quantities of a patented medicine manufactured or imported and supplied in India. This could help assess whether supply was sufficient.
Rao said changes to Form 27 have reduced the amount and frequency of information available, making it harder to establish unmet need through patent data alone.
She said the government would therefore need to collect data on the price of medicines, what patients are paying and how many patients actually need a particular drug.
Published on October 30, 2026
