Bioabsorbable stent NPPA defers price cap exemption decision cites discrepant documents

1. ‘Bioabsorbable’ stent: NPPA defers price cap exemption decision, cites ‘discrepant’ documents According to the regulator, the firm has submitted a patent document for a ‘bioabsorbable’ stent, but its licence from the Drug Controller General of India (DCGI) was for a ‘bioresorbable’ stent. • • • Written by Prabha Raghavan | New Delhi | Updated: December 17, 2019 5:04:22 am Meril Life Sciences had approached the NPPA for the exemption after it received the drug regulator’s approval in 2017 for the stent, a drug-coated product called MeRes100 that naturally dissolves over time. The drug pricing regulator has once again stalled its decision on whether it will exempt a new cardiac stent developed by Meril Life Sciences from the price caps it has imposed on other products in this category. This time, the decision has been deferred due to discrepancies the https://www.merillife.com/

2. regulator found in submissions made to it for the exemption. Meril had approached the National Pharmaceutical Pricing Authority (NPPA) for the exemption after it received the drug regulator’s approval in 2017 for the stent, a drug-coated product called MeRes100 that naturally dissolves over a period of time. NPPA, which deliberated on the matter “in detail” during a meeting held on December 9, noted that the firm submitted two separate documents which described its product using two different terms — bioabsorbable and bioresorbable. According to the regulator, the firm has submitted a patent document for a ‘bioabsorbable’ stent, but its licence from the Drug Controller General of India (DCGI) was for a ‘bioresorbable’ stent. “Accordingly, the Authority directed that the company may be asked to explain the reasons for submission of these discrepant documents for seeking price exemption under Para 32 of DPCO 2013,” read the minutes of NPPA’s authority meeting, a copy of which The Indian Express has viewed. NPPA is seeking to understand the technical differences between the two terms and will take a call on Meril’s submissions after that, a senior government official aware of the development said. “The registered process patent of MeRes100 clearly states that the words bioabsorbable, bioresorbable and biodegradable are used interchangeably throughout specification which addresses the query raised by NPPA,” a spokesperson for Meril Life Sciences told The Indian Express. “As the terms bioabsorbable and bioresorbable mean the same, we feel there is no discrepancy in our documents and we will respond to NPPA accordingly.” NPPA, in 2017, had capped the ceiling prices of bare-metal and drug-eluting stents, slashing their maximum retail prices over 75 per cent in the process. Before coming under price control, these stents used to be priced anywhere between Rs 23,000 to Rs 2 lakh. Meril had been seeking an exemption from this price cap from NPPA, asking the regulator to invoke a paragraph of the Drugs (Prices Control) Order, 2013, which 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. A multidisciplinary committee in February had found that the documents submitted by Meril showed that it met the requirements of this paragraph. The regulator is still yet to take its final call for various reasons. For instance, last month, NPPA had postponed its decision after health and safety concerns regarding the usage of the https://www.merillife.com/

3. stents were raised by a patient activist group. It had also said that the concerns had been referred to DCGI, the Director General of the Indian Council of Medical Research and the Health Ministry in October, and that their replies were still awaited. https://www.merillife.com/