India’s apex drug pricing control body, the National Pharmaceutical Pricing Authority (NPPA), has asked all state drug controllers (SDCs) to strictly monitor industry compliance with revised maximum retail prices (MRPs) of cancer drugs after trade margin capping.
This comes four days after an NPPA-backed 30 per cent trade margin cap for 137 non-scheduled cancer drugs, translating to 1,391 brands and dosage forms, came into effect on November 9.
The list includes both patented and non-patented drugs based on a list recommended by an expert committee (EC) under the Directorate General of Health Services (DGHS).
The NPPA added that the list would be updated periodically, with the trade margin being incorporated under Paragraph 19 of the Drugs (Prices Control) Order (DPCO), 2013.
“SDCs have been directed to strictly monitor compliance by manufacturers, dealers, hospitals and medical institutions to ensure that the benefits of revised MRPs are passed on to patients,” the NPPA said on Friday.
Officials in the know said that SDCs had been asked to submit action-taken reports by November 16. “Any violation may attract overcharging proceedings under the provisions of the DPCO, 2013,” the pricing body added.
According to Section 15(2) of the DPCO, 2013, any manufacturer found selling drugs at a price higher than the retail price (plus local taxes, as applicable) fixed by the government shall be liable to deposit the overcharged amount along with interest from the date of overcharge, in addition to the penalty.
Every retailer, dealer, hospital and medical institution is required to prominently display the revised and supplementary price lists at their respective business premises and on their websites, according to a DoP office memorandum dated November 11.
“Since substantial supply of anti-cancer drugs is directly made to the hospitals and medical institutions, they are required to monitor the MRPs of formulations and to ensure compliance,” a gazette notification introducing the margin cap had stated.
The NPPA’s intervention is expected to bring down the maximum retail prices (MRPs) of the identified non-scheduled anti-cancer drugs by up to 70 per cent, depending on their existing price structures, and generate estimated annual savings of ₹2,500 crore.
