After giving exemption, NPPA asks Meril Life Sciences for MRP of its stent
New Delhi: Just days after giving exemption to cardiac stent maker Meril Life Sciences, the apex drug price regulator has asked the company to inform about the price that it is going to fix for the said product.
Medical Dialogues team had earlier reported that Meril Life Sciences had applied to the NPPO with a price exemption application from the provisions of DPCO, 2013 under para 32 (ii) of the said order in respect of drug Coronary Stent namely "Sirolimus-Eluting Bioresorbable Vascular Scaffold System (MeRes100)" which was duly approved by the office of Central Drugs Standard Control Organisation (India) as 'new drug' under Rule 122(E) of the Drugs and Cosmetics Act and Rules thereunder, and patented by The Patent Office, India under the Patents Act, 1970 (Patent No. 296768 and Date of Grant: 14.05.2018).
After series of deliberations and recording of objections by stakeholders, NPPA at its 73rd meeting dated 25.02.2020 noted that M/s Meril Life Sciences Pvt. Ltd meets the requirement of para 32(ii) of DPCO 2013 and decided that exemption may be granted to M/s Meril Life Sciences Pvt. Ltd under para 32(ii) of DPCO 2013 for their drug Coronary Stent namely "Sirolimus-Eluting Bioresorbable Vascular Scaffold System (MeRes100)
With the decision, the said stent has now been an exemption from price capping for a period of five years from the date of the commencement of its commercial production in the country with the authorities now directing the company to inform about the price that it plans to fix for the stent
"The company shall inform NPPA of the Maximum Retail Price fixed by the company in respect of above said formulation by issuing a price list in Form V under DPCO, 2013," NPPA stated in its recent order
The order was issued by Prasenjit Das Asst. Director, NPPA.