The National Pharmaceutical Pricing Authority (NPPA) has said that it is not mandatory for the oncology drug manufacturers who are revising the drug prices as per the recently announced Trade Margin Rationalisation (TMR) to recall, re-label or re-sticker the label of stocks released in the market prior to the implementation of the revised Maximum Retail Price (MRP), on condition that the manufacturer should ensure price compliance at the retailer level.
The drugs price regulator has ordered Trade Margin Rationalisation (TMR) of 137 identified non-scheduled anti-cancer drugs on October 17, in public interest to address excessive trade margins, make cancer treatment more affordable, and improve access to anti-cancer medicines. The revised prices will be effective from November 9, 2026.
Clarifying on the order, the Authority has said, “Recalling, re-labelling or re-stickering on the label of container or pack of stocks released in the market prior to implementation of revised MRP is not mandatory, if manufacturer is able to ensure price compliance at the retailer level”.
It added that following a request from the stakeholders, it has decided that the direction to create dedicated Drugs (Prices Control) Order (DPCO) matters section on the homepage of the company websites should be complied with not later than November 9, 2026.
The batch-wise production details and stock position of the formulations held by the company and distributors at the time of the publication of the Order should also be submitted before November 9, and the information should be provided for as on October 31, 2026, it added.
According to the order, all the manufacturers are required to compulsorily report Price-To-Stockist/Price-To-Distributor and MRP of their formulations in the IPDMS portal of NPPA. Besides, the manufacturer shall, upon demand by NPPA, produce documentary evidence demonstrating sufficient effort at disseminating the revision in price to all stakeholders including through advertisement, circulation of list to the dealers and retailers, creation of dedicated DPCO matters section on the homepage of the company website, and submitting batch-wise production details and stock position of the formulations held by the company and distributors at the time of the publication of the TMR order.
NPPA will not allow adjustment on account of sales return while calculating net sales for PTS/PTD, it said.
Certain undertakings regarding the quantities supplied under the Patient Assistance Programme (PAP), which is eligible for exclusion from the calculation of PTS/PTD and MRP for the purpose of capping of trade margin, should be submitted initially by all manufacturers before October 29, and also every time whenever there is a revision in MRP.
Considering that the revised prices for the 137 drugs will come into effect from November 9, the manufacturers of these drugs shall be eligible to have an annual price increase under the Para 20 (1) DPCO, 2013, from the date of implementation of the revised price.
If there is no revision in MRP, the manufacturer shall be eligible to avail the annual price increase under the same provision after expiry of 12 months’ period from last revision in MRP.
Paragraph 20(1) stipulates that the government should ensure that no manufacturer increases the maximum retail price of a drug more than 10 per cent of MRP during preceding twelve months and where the increase is beyond the prescribed limit, it shall reduce the same to the level of 10% of maximum retail price for next 12 months.
TMR for non scheduled formulations shall be applicable for all strengths and dosage form (whether individual or in combination, irrespective of dosage strength, dosage form and route of administration) containing any of the drugs listed in the order, even if the formulation is being used for other therapeutic uses.
The newspaper advertisement is required to be given for all products where there is reduction in prices. The advertisement must mention pre-revised MRP and revised MRP. The companies can choose to mention those products where there is no revision in MRP, said the Authority.
Manufacturers need to submit information in Form-V and prescribed format in Annexure-I through IPDMS within seven days of publication of the Order, irrespective of whether there is change in MRP or not, it added.
The 137 identified non-scheduled anti-cancer drugs include Immunotherapy drugs used for treating over 20 type of cancers, Denosumab used by breast and prostate cancer patients, pegfilgrastim which is used to prevent neutropenia in cancer patients and bevacizumab, which is the approved drug to treat colon, ovary and cervical cancer.
With this notification, MRP of widely used anti-cancer drugs such as pembrolizumab, durvalumab and osimertinib is expected to become more accessible for cancer patients, said the Authority while notifying the TMR.
