SRINAGAR: Cancer medicines used in India are set to become substantially cheaper from November 9, with the government’s latest price revision cutting the maximum retail prices of some brands by more than 90 per cent. But several of the most expensive patented cancer drugs, including the widely used immunotherapy Keytruda, have escaped any immediate price reduction, exposing the limits of a policy intended to make treatment more affordable.
The National Pharmaceutical Pricing Authority (NPPA) has released revised maximum retail prices (MRPs) for 543 cancer drug brands and pack sizes covering 137 identified non-scheduled anti-cancer medicines. The reductions range from marginal cuts in some formulations to more than 90 per cent in others, while the prices of a significant number of medicines remain unchanged.
The price revision follows the government’s decision to cap trade margins on the identified anti-cancer drugs at 30 per cent of their MRP under the Drugs (Prices Control) Order, 2013. The measure is expected to reduce prices by up to 70 per cent across the covered medicines, although the actual reduction varies by drug, brand, strength and pack size.
The contrast is stark. The price of Palbopro, a brand of palbociclib 125 mg used in the treatment of certain breast cancers, has fallen from Rs 40,421.33 to Rs 2,720, a reduction of 93.3 per cent. The price of a 100 mg vial of the chemotherapy drug thiotepa, sold as Samtepa, has dropped from Rs 80,071.86 to Rs 7,150.33.
Yet the listed price of Keytruda, the immunotherapy medicine pembrolizumab, remains at Rs 2,16,500 for a 100 mg vial. Alecensa, a brand of alectinib used in cancer treatment, continues to cost Rs 4,30,696, while Phesgo, a combination of pertuzumab and trastuzumab, remains priced at Rs 4,93,266. Tagrisso, the lung cancer drug osimertinib, is unchanged at Rs 1,38,830.83.
Ribociclib, sold under the brand Kryxana, also remains at Rs 24,435 for a pack of 21 tablets of 200 mg each. Other costly originator medicines, including Tecentriq, Darzalex and Imfinzi, have likewise shown no change in their listed MRPs.
The uneven outcome has renewed questions over whether restrictions on distribution and retail margins can deliver meaningful savings on medicines for which competition from alternative manufacturers remains limited.
The government’s intervention comes amid scrutiny by the Supreme Court of the large differences that can exist between the prices at which medicines are procured and the amounts charged to patients by hospitals.
On October 27, a bench of Justices Vikram Nath and Sandeep Mehta questioned the Centre and private hospitals over steep markups on medicines. The court cited the case of a medical distributor whose wife was undergoing cancer treatment. According to the account presented before the court, the distributor said he could procure a chemotherapy injection for Rs 11,000, but the hospital refused to administer the externally sourced medicine and charged Rs 1.3 lakh for the injection.
“Can you show any justification for this loot, please?” Justice Mehta asked.
The court has reserved its decision on petitions seeking tighter medicine price controls, including wider restrictions on trade margins for non-scheduled drugs. The outcome could have implications beyond cancer treatment for the broader system through which medicines are priced and sold in India.
However, the example cited in court does not, by itself, establish that every difference between a hospital’s purchase price and the amount charged to a patient constitutes a legal violation. The precise medicine, the hospital’s actual procurement cost and the applicable price ceiling would have to be established to determine whether a particular charge breaches the rules.
Under India’s drug-pricing framework, scheduled medicines are subject to government-fixed ceiling prices, while non-scheduled medicines generally have greater pricing freedom, subject to restrictions on annual MRP increases and the government’s power to intervene in the public interest.
The new anti-cancer drug order uses that intervention power to restrict trade margins. The government’s stated objective is to reduce excessive markups while preserving legitimate manufacturer revenues and ensuring that supplies are not disrupted.
The revised prices illustrate how differently the intervention is playing out across medicines.
Palbociclib provides one of the clearest examples. While Palbopro’s 125 mg formulation has fallen to Rs 2,720 from Rs 40,421.33, another brand, ISOGEN, has recorded a reduction of 91.6 per cent for its 100 mg pack. But PALENO’s price for a 100 mg pack has moved only marginally, from Rs 5,717.81 to Rs 5,624.10.
The reductions are similarly pronounced in several other medicines. WOMAZOL, a brand of anastrozole 1 mg, has fallen from Rs 458.85 to Rs 39.52. The price of Anarzole, another anastrozole brand, has dropped from Rs 695.76 to Rs 73 for a pack of 10 tablets.
Azacytin, an azacitidine 100 mg injection, has been revised from Rs 6,337 to Rs 1,495.04. Bevacizab, a 100 mg/4 ml injection, has fallen from Rs 21,767.70 to Rs 5,930.13 per vial. Dasanat 20, a brand of dasatinib, has dropped from Rs 2,812.50 to Rs 1,085.93 for a pack of 60 tablets.
Debrumab, a denosumab injection, has been reduced from Rs 22,031.25 to Rs 5,941 per pre-filled syringe. Enuta, an enzalutamide brand, has fallen from Rs 6,578.20 to Rs 2,232 for a pack of 28 capsules, while the price of ERLIB, a brand of erlotinib, has dropped from Rs 4,637.45 to Rs 2,008 for a bottle of 30 tablets. Fulbreca, a fulvestrant injection, has been revised from Rs 26,072.16 to Rs 5,491 per 5 ml vial.
The price of Hertumab, a brand of pertuzumab, has also seen a substantial reduction, falling from Rs 94,951 to Rs 30,593 for a 30 mg vial.
The savings could be substantial for patients who require repeated doses or treatment cycles. The reduction in the price of a Samtepa vial alone amounts to nearly Rs 72,922. But the ultimate benefit will depend on the medicine prescribed, the number of doses required and whether the revised price is reflected in the bill paid by the patient.
The latest list also reveals the limits of using headline reductions to measure the overall impact of price regulation. According to data reported on the revised formulations, prices remained unchanged for 146 of the 543 formulations, while another 21 saw reductions of less than Rs 100. The average price change across the formulations was reported at just over Rs 5,000, despite the very large reductions in some individual brands.
The unchanged prices are particularly significant for patients who depend on patented medicines. Pembrolizumab, marketed as Keytruda, is used across multiple cancer indications, while osimertinib is used in the treatment of certain lung cancers. The high prices of such medicines can remain a substantial burden even when other components of a treatment regimen become cheaper.
Malini Aisola of the All India Drug Action Network, a patient advocacy group, has questioned the treatment of supplies provided through pharmaceutical companies’ patient assistance programmes in calculating prices.
Under these programmes, companies may provide medicines free of cost or at heavily discounted rates to eligible patients. In some arrangements, a patient may receive an additional vial free after purchasing two.
Aisola has argued that excluding such supplies from the calculations can create opportunities for hospitals and intermediaries to retain substantial margins. The government’s order permits quantities supplied free under patient assistance programmes to be excluded from the relevant calculations, subject to safeguards, record-keeping and verification by the NPPA.
The notification requires manufacturers to maintain details of participating patients, prescriptions, medicines supplied and their use. The authority can seek further information, conduct inspections and verify the programmes. If the prescribed conditions are not met, the quantities concerned can lose the exemption.
The pricing formula itself is based on the price at the first point of sale, or the price to stockist or distributor, rather than directly on the cost of manufacturing or importing a medicine. Critics argue that the distinction matters because an inflated first-sale price can limit the reduction achieved through a cap on downstream margins.
Under the notified formula, the permissible MRP is calculated using the price to stockist or distributor and a trade margin not exceeding 30 per cent, with applicable goods and services tax added separately. Manufacturers must reduce prices where their existing MRPs exceed the calculated permissible levels. Products already priced below the calculated amount must retain their existing MRPs.
The order builds on a 2019 exercise that covered 42 non-scheduled anti-cancer drugs. According to the government’s account, that intervention led to MRP reductions of up to 90 per cent across 526 brands. The latest measure expands the exercise to 137 identified medicines following an expert committee’s assessment of available data and options for improving affordability.
The notification also requires manufacturers to submit revised price information to the NPPA and the concerned State Drug Controller, circulate price lists to dealers and retailers, and ensure that the applicable rates are prominently displayed. Hospitals, medical institutions, pharmacies and other retailers are required to comply with the notified prices and assist in monitoring.
Manufacturers must maintain existing production levels, while proposed reductions in average monthly production require prior permission. The rules also provide for recovery of overcharged amounts, with interest, in cases of non-compliance.
For patients, the immediate priority is to establish which price applies to the exact medicine prescribed to them. A reduction in one brand does not automatically mean that every brand containing the same active ingredient has undergone the same cut. Strength, dosage form, pack size and manufacturer can all affect the applicable price.
Patients and caregivers can compare the revised MRP with the price charged on their bills and check the NPPA’s Pharma Sahi Daam application or website. They can also ask hospitals for itemised bills that identify individual medicines and charges. Complaints about medicine overpricing can be submitted through the NPPA’s Pharma Sahi Daam platform or its helpline, 1800-111-255.
The November 9 rollout will therefore provide an important test of whether the revised MRPs translate into actual savings at the point of treatment. The larger question remains unresolved: whether controlling trade margins can make cancer care affordable when the prices of several high-cost patented medicines remain unchanged.
With the Supreme Court considering a wider intervention in medicine pricing, the next phase of the debate will centre on how far the government can go in curbing excessive mark-ups while ensuring that patients have access to essential medicines at prices they can afford.
