Gujarat firm under scanner after stents kept out of price control

Indian drug price regulator NPPA has kept an indigenous cardiac stent manufactured by a Gujarat-based firm outside the price control, acceding to the company's demand of such an exemption on the ground of “innovation.”

The National Pharmaceutical Pricing Authority in its last meeting (on February 25) decided in favour of the exemption after considering reports from several expert panels including one formed by the Drugs Controller General of India and a Multidisciplinary Expert committee.

The firm had submitted three years of clinical trial data for its patented, naturally dissolving stent (Me-Res 100) for 108 patients for a review by doctors from All India Institute of Medical Sciences, Vardhaman Mahavir Medical College and Safdarjung Hospital, all in Delhi. The doctors were part of the DCGI panel.

“The Committee went through the data and after detailed deliberation, felt that the data was

satisfactory,” the NPPA said in the minutes of the meeting.

Details of the clinical trial data as well the reasoning used by the panel of doctors to arrive at the conclusion are not part of the NPPA minutes.

“We do not know the basis for the experts to be satisfied by the (safety and efficacy) data of the stent. 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,” said Malini Aisola from the All India Drug Action Network, a non-governmental organisation that opposed the company's plea before the NPPA.

The issue was hanging for nearly three years when the NPPA brought the coronary stents under price control in February 2017 ignoring the objections raised by several manufacturers.

Even though some of the world's top manufacturers sought exemptions arguing superiority in their products, the authority stood firm.

This is for the first time an exemption from the price control has been granted to a cardiac stent using a provision under the Drug Price Control Order 2013. Incidentally, Delhi High Court has admitted a petition challenging the exemption clause.

"The positive decision by NPPA confirming non-applicability of DPCO 2013 under Para 32 for MeRes100 BRS, made the post an exhaustive multi-stakeholder review, demonstrates the government's commitment to encouraging not only ‘Make in India’, but also ‘Research in India’. An extensively researched innovation, MeRes100 BRS is backed by 3-year efficacy and safety clinical trial data has received eight patents worldwide, CE mark approval and a DCGI granted 122E new drug approval that attests to its efficacy and safety for the indicated use. We are committed to introducing MeRes100 BRS in India and the world responsibly by undertaking a range of measures to ensure effective access and right use, including conducting a 2000-patient large scale randomized study, building 1000-patient Indian and global patient registries and ongoing education of interventional cardiologists.” said Sanjeev Bhatt, Vice President-Corporate Strategy, Meril Life Sciences.

AIDAN had earlier raised concerns on the safety and efficacy of the Meril Life's coronary stents (MeRes 100- Sirolimus-Eluting Bio-Resorbable Vascular Scaffold System), but NPPA ruled that such concerns didn't come into consideration while deciding on the exemptions from price control. Also the concerns were addressed by the DCGI expert panel.

The NPPA directed DCGI to ensure close safety monitoring of the MeRes-100 coronary stents in public interest.

“While close monitoring has been recommended, we are concerned that no specific plan has been drawn up for post-marketing evaluation of safety and efficacy against the current standard of care,” Aisola said.