A plea by drug maker Sun Pharmaceuticals Industries Ltd and medical devices maker Meril Life Sciences Pvt. Ltd to seek a rare exemption from government-set price caps for two products has failed to find favour with India’s drug pricing regulator.
Mumbai-based Sun Pharmaceuticals is seeking an exemption for its anti-cancer gemcitabine hydrochloride injection while Gujarat-based Meril Life Sciences wants a similar exemption for its first locally made biodegradable cardiac scaffold, a naturally dissolving stent that clears blockages in arteries.
The National Pharmaceutical Pricing Authority (NPPA), in a meeting on 21 February, has referred the matter to an overarching expert committee headed by the director-general of Indian Council of Medical Research (ICMR) to see if both the products have any therapeutic advantage to merit a price exemption.
The exemption, if granted, will be valid for five years. Both the companies have been trying to seek an exemption under para 32 of the Drug Price Control Orders (DPCO) that says the price cap won’t apply if a new drug developed through a unique and indigenous process is patented under the Indian Patents Act and is not produced elsewhere.
An earlier multi-disciplinary committee of experts met on 7 February and found that both products are eligible for exemption. The pricing regulator verified the committee’s submission and referred the applications to the Standing National Committee on Medicines.
The NPPA, which deliberated the matter noted that a decision on exemption has to be taken from a “holistic perspective". It found that the expert committee did not apply itself to the important yardstick of public interest and, hence, sent the matter for further examination.
“In public health, choice of consumer is impeded by information asymmetry and lack of knowledge regarding quality and efficacy of drugs/medical devices. Often, high-priced items are prescribed/preferred on the premise of improved quality. It is, therefore, important that pricing policy is not operated in silos. Any decision to exempt drugs from price regulation has to be taken in holistic perspective," reads the minutes of the meeting.
“The authority noted that the expert committee had not applied itself fully to the important agenda pertaining to public interest... It was decided to refer both applications to Standing National Committee on Medicines for revision of NLEM (National List of Essential Medicines) with a request to examine the products from the perspective of any significant therapeutic advantage and increased efficacy that may merit exemption under para 32 of DPCO, 2013," added the minutes. Mint has reviewed a copy of the minutes.
Malini Aisola, co-convenor, All India Drugs Action Network, said NPPA is correct in requiring a holistic consideration of the impact on public health. However, she was strongly critical of the exemption clauses, saying, “They remove essential medicines from price control, undermining the objective of the DPCO."
The stents developed by Meril are known as MeRes100. However, the year they were granted approval by the Drug Controller General of India—in 2017—was also when prices were slashed. This prompted Meril to hold back from launching the stents. The company says its stents are biodegradable, and an alternative to traditional metal stents.
“Abbott’s BVS (bioresorbable vascular scaffold) that introduced the technology on which Meril’s stent is premised was found to be associated with higher risk of major adverse cardiac events and subsequently withdrawn globally. Therefore, it is our position that a price exemption for a risky, inadequately tested technology is unwarranted and the application should be rejected," she said.
A stent is a wire-like mesh inserted into blood vessels to remove blockages. Abbott’s Absorb was a dissolvable stent which did not leave a residual metal in the body like other cardiac stents. However, Abbott said their stents called Absorb were withdrawn due to low commercial uptake.