
A parliamentary panel rejected the government's response on drug pricing and demanded a permanent cap on trade margins for anti-cancer medicines, citing inordinate delay since Covid.
A parliamentary committee has rejected the government's response on drug pricing and demanded an urgent permanent cap on trade margins for anti-cancer medicines, a move that could squeeze margins for Indian pharmaceutical companies that sell those drugs.
The Standing Committee on Chemicals and Fertilizers, in an action taken report tabled Monday, said it was not satisfied with most of the government's replies. Only four of 11 earlier recommendations were accepted, the panel said. Seven recommendations – including those on regulating non-scheduled medicines, capping trade margins and reining in excessive mark-ups on anti-cancer drugs – were rejected and needed to be reiterated.
The committee told the Department of Pharmaceuticals to give the "highest priority" to amending the Drugs (Prices Control) Order, 2013. It said the amendment should create a permanent legal basis for Trade Margin Rationalisation on life-saving drugs. Relying on temporary extraordinary powers under existing law was not enough to guarantee long-term affordability, the panel added.
The department told the committee it had held extensive consultations with drug makers and industry associations. The proposal was still under review after stakeholders raised concerns about the scope of margin caps, exemptions for low-priced medicines, implementation methodology and the impact on small and medium enterprises.
The government pointed to its 2019 decision to cap trade margins at 30% for 42 non-scheduled anti-cancer medicines. That move cut prices of 526 brands by an average of about 50% and saved patients an estimated ₹984 crore a year, the department said.
The committee was not impressed. It said the issue had been under consideration since the Covid-19 pandemic and criticised the "inordinate delay" in making the framework permanent. Addressing manufacturer concerns was fine, the panel said, patient affordability had to come first.
The report also pushed back on the broader pricing framework. Nearly 82% of the pharmaceutical market consists of non-scheduled medicines that escape direct price control, the committee noted. Under current rules, manufacturers set the initial price of those drugs and are only barred from raising the MRP more than 10% annually. The panel said that system should be reviewed and asked for details on medicines where trade margins top 100% over the distributor price.
The committee recommended giving the National Pharmaceutical Pricing Authority stronger powers to regulate excessive pricing of non-scheduled drugs. It also sought specific responses from the department on regulatory gaps, transparency in price-to-stockist data and pricing of non-scheduled fixed-dose combinations.
Another recommendation focused on "trade generics" – drugs sold mostly through rural and remote channels. The department argued that higher logistics and inventory costs explained the wide gap between distributor prices and MRPs. The committee rejected that justification and called for urgent price regulation of trade generics to protect patients in rural areas.
The panel also asked the department to disclose details of stakeholder consultations held over the past three years, including recommendations from industry groups, NGOs, health experts and medical practitioners on pricing of non-scheduled medicines, and to explain how those suggestions had been addressed.
The government defended the current framework under the National Pharmaceutical Pricing Policy, 2012, saying it balanced affordability with industry growth. Analysis of roughly 98,000 stock-keeping units showed that about 87% of the non-scheduled market had weighted average trade margins of up to 45%, the department said. Only about 4% had margins exceeding 100%, indicating that very high mark-ups were limited to a small segment.
The committee has asked the department to respond within three months.
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