‘New Stent Prices Leave Enough Margins for Industry to Grow’
The National Pharmaceutical Pricing Authority (NPPA) recently slashed the prices of coronary stents by over 75%. NPPA chairman Bhupendra Singh explains the rationale behind the move and speaks to ET Pharma on its tough stance to ensure compliance. Edited excerpts:
How did NPPA calculate the ceiling prices for these stents? What impact do you expect? A detailed record of proceedings of NPPA meeting shall be uploaded on Monday. NPPA considered all available options of price fixation of stents, including the landed cost, cost of production, the price to distributors, etc. We have tried to stop profiteering through our latest notification and leave only reasonable profits to all stakeholders in the trade channel. Para 19 provides for flexibility to not confine only to PTR (price to retailer) method.NPPA has not considered price to hospitals as PTR for pricing purpose—or hospitals as retailers. Price capping will make stents more affordable and accessible to patients and new prices leave enough margins for the industry to grow, innovate and come out with new products as well.
How will NPPA ensure compliance to the ceiling prices? The Drug (Prices Control) Order, 2013, and E.C. (Essential Commodities) Act have adequate provisions to ensure compliance. NPPA works closely with the State Drug Controllers (SDCs), who have been sensitised to the compliance issues surrounding stents. I have already written letters to Chief Secretaries of all the States. Our 24x7 helpline is working and complaints can be sent on “Pharma Jan Samadhan” and “Pharma Sahi Daam”. Department of Pharmaceuticals have also been requested to invoke powers under Para 3, of DPCO. Stents are now essential commodity. Any violation to defeat the objective of making cardiac stents affordable to people will be dealt with a firm hand.
How will NPPA deal with an artificial shortage of these stents? Some companies have reportedly withdrawn batches for relabeling… DPCO prohibits withdrawal of any product without approval from NPPA and following due process, which includes six months prior notice to public. NPPA is monitoring these reports and acts swiftly with the help of State Drug Controllers. Regarding withdrawals for changing MRPs, it has been clarified that relabeling is not mandatory by manufacturers. If a revised price list is issued immediately and sent to NPPA, SDCs, all distributors and retailers and the patient is not charged over the new MRP by hospital, compliance will be accepted.
BHUPENDRA SINGH Chairman, NPPA
Global stent companies argue your move would prevent access to further innovation in stents. Your response? New ceiling prices have enough margins for present profits and future growth. The NLEM committee of (health ministry) found that clinical 'superiority' of bioresorbable vascular scaffolds is not established and all drug eluting stent variants are medically & clinically same. The Department of Pharmaceuticals also accepted the NLEM committee's recommendations and notified all DES, including BVS, as one category. NPPA is not competent and authorized to change that. However, as far as innovation is concerned, there is a provision of Para 11(3)(4) under the Drug Prices Control Order for separate and preferential pricing if its 'therapeutic superiority' is clinically proven. We are open to such requests and applications.