Three yrs after setting cap on stents, NPPA exempts Meril’s device from price control

Para 32 of the Drugs (Prices Control) Order, 2013 lists out certain conditions a product has to meet to stay out of the provisions of the regulation.

This includes new drugs developed through indigenous research and development that are patented under the Indian Patent Act, 1970 and not produced elsewhere as well as new drugs produced in the country by a new process developed indigenously and patented.

NPPA, in 2017, had slashed the ceiling prices of stents by up to 85 per cent.

Meril had approached the NPPA for exemption under this provision after it received the Indian drug regulator’s approval in 2017 for the stent, a drug-coated product called MeRes-100 that naturally dissolves over a period of time.

However, the All India Drug Action Network (AIDAN) last year had raised concerns related to the safety of the product.

“It has been our concern that the only data submitted by Meril are limited to a small, non-randomised, single-arm trial which was inadequate to prove safety. While close monitoring has been recommended, no specific plan has been drawn up for post-marketing evaluation of safety and efficacy, against the current standard of care — a DES stent,” said Malini Aisola of AIDAN.

“The safety concerns of the product in question are not required to be examined by the Authority in order to consider a case for grant of exemption under para 32 (ii) of DPCO 2013. The ‘new drug’ approval certificate of the DCGI and the grant of Indian Patent being the two essential conditions,” stated minutes of NPPA’s meeting on the issue, which The Indian Express has viewed.

However, it added that issues related to the safety concerns raised by AIDAN were referred by the authority to the Standing National Committee on Medicines and the Drug Controller General of India (DCGI) to “seek assurance in public interest”.

The authority took the decision after DCGI, which convened a meeting of experts on the issue, had found clinical data and three-year follow up data on 108 patients submitted by Meril to be “satisfactory”.

“While considering any product, the safety and efficacy is considered by experts and the committees,” added a December letter by the Standing National Committee on Medicines.

“We do not know the basis for the experts to be satisfied by the (safety & efficacy) data of the stent,” said AIDAN’s Aisola.