The Center has approved the maximum trade markup sizes for 137 unregistered anti-cancer medicines, setting them at 30 percent of the Maximum Retail Price (MRP). This decision was made to ensure the accessibility of oncological treatments through publication in the official gazette.
According to the National Pharmaceutical Pricing Authority (NPPA), the list will include both patented and non-patented drugs, based on recommendations from the Expert Committee (EC) of the Directorate General of Health Services (DGHS).
The notification, dated October 17, lists drugs such as Nivolumab, Olaparib, Denosumab, and Topotecan. However, this measure does not apply to the quantity of medicines supplied under Patient Assistance Programs (PAP) implemented by manufacturers for individual patients.
NPPA clarified that this list will be updated regularly, and the trade markup restriction will be included in Paragraph 19 of the Drug Price Control Order (DPCO) 2013. This paragraph grants NPPA the power to review or fix ceiling and retail prices for any drug in exceptional circumstances and in the public interest.
In the minutes of the 284th meeting of NPPA, held on October 16, it was noted that 'the Authority deemed it necessary to set the trade markup limit at 30 percent of MRP, excluding GST, which corresponds to a markup of 42.86 percent on Price for Distributor/Price for Wholesaler (PTS/PTD), to maintain a reasonable trade markup, preventing excessive price hikes.'
The NPPA's intervention is expected to reduce the Maximum Retail Prices (MRP) of identified unregistered anti-cancer drugs to 70 percent, depending on their current pricing structure, and provide an estimated annual saving of 2500 crore rupees. The new prices will come into effect on November 9, 2026.
According to sources familiar with the matter, manufacturers are required to post price lists on their websites and widely distribute them among all retail outlets and hospitals. Furthermore, all manufacturers must notify NPPA of their revised prices within seven days of the official notification being published.
The October 17 notification emphasizes that since significant volumes of anti-cancer drugs are supplied directly to hospitals and medical institutions, they are obligated to monitor the MRP of formulations and ensure compliance. State drug controllers must take necessary steps to ensure compliance from manufacturers and dealers, including retail outlets, hospitals, and medical institutions.
Pharmaceutical companies will also be required to maintain current levels of production and supply for notified formulations to guarantee timely and uninterrupted access for patients. The notification warns that manufacturers who fail to comply with the provisions of this order may be liable to pay the overcharged amount along with interest in accordance with the provisions of DPCO 2013 combined with the Essential Commodities Act of 1955.
Previously, officials told Business Standard that the EC had found trade markups on unregistered anti-cancer drugs ranging from 170 to 700 percent at various points of sale. Unregistered drugs are pharmaceutical formulations that do not fall under the price restrictions of DPCO 2013. Manufacturers of such formulations and devices can increase prices by up to 10 percent over a 12-month period.
These drugs constitute approximately 82 percent of India's domestic pharmaceutical market. This decision is the first step towards rationalizing the Trade Markup Rate (TMR), even as the Department of Pharmaceuticals (DoP) and NPPA consult with the industry regarding price increases for essential medicines.
Under TMR, the difference between the price set by the manufacturer for the distributor and the price paid by the consumer is regulated, unlike traditional price control which fixes a ceiling price on the formulation.
Previously, the Center restricted trade markups for 42 types of cancer drugs in 2019, resulting in an announced annual saving of 984 crore rupees across 526 brands. Officials noted that future markup restrictions could be extended beyond anti-cancer drugs to other unregistered formulations, medical consumables, and devices such as intravenous (IV) kits and catheters.
This move also comes amid intense scrutiny from the Supreme Court regarding high markups on essential medicines. A bench comprising Justices Vikram Nath and Sandeep Mehta questioned the regulatory distinction between scheduled and unscheduled drugs under DPCO and whether drugs classified as non-essential should remain outside price control mechanisms.