The notification issued by the National Pharmaceutical Pricing Authority on July 10 placed price caps on 108 formulation packs of 50 anti diabetic and cardiovascular drugs. Some of these expensive drugs which came under price control following the July order are Gliclazide, Glimepiride, Sitagliptin, Voglibose, Amlodipine, Telmisartan and Rosuvastatin, Heparin and Ramipril. These have an estimated market value of about Rs. 5,500 crore. The NPPA brought these drugs under the purview of DPCO as per a set of internal guidelines issued on May 29 allowing the Authority to control drug prices in public interest. These guidelines empowered NPPA to invoke Paragraph 19 of the DPCO 2013 and extend price control over medicines outside the DPCO list of essential medicines in “extraordinary circumstances” and in “public interest”. When DPCO 2013 was notified last year, formulations of only 348 drugs were under control keeping many widely used essential medicines outside control. The coverage of drugs under DPCO 2013, thus, impacted only a small fraction of the Rs.72,000 crore domestic pharma market. The NPPA’s move to bring more essential medicines under the purview of price control is in the context of this situation. It has observed that huge inter brand price differences exist in drugs required for treatment of deadly diseases like cancer, HIV, tuberculosis and certain other infectious diseases. NPPA decision to announce price caps again on additional 36 drugs on September 20 is in consideration of the need to make these essential medicines more affordable.
These patient friendly actions of NPPA on pricing of essential medicines did make pharmaceutical companies furious especially the MNCs and large Indian companies. And the major industry bodies already approached the high courts in Delhi and Mumbai although the matter is yet to be decided. In the meanwhile several companies started complying with the July 10 order by reducing the prices of most of the diabetic and cardiovascular drugs. At a time when industry is cooperating with the regulator, it is surprising that NPPA was made to withdraw its May 29 guidelines on last Tuesday. NPPA has given no reasons for this abrupt action. In fact, NPPA has been moving in the right direction by curbing the practice of huge inter brand price differences in life saving medicines. The latest data compiled by MIMS clearly brings out these huge difference in prices of different brands of the same drug. The price difference is over 1,733 per cent between Novartis' Femara and Biochem's Oncolet, two different brands of letrozole used for treating breast cancer. While a strip of 10 tablets of Femara (letrozole 2.5 mg) is priced at Rs 1,815, the MRP of Oncolet is Rs 99. Similarly, four tablets of Sanofi's Actonel are priced at Rs 2,000, whereas the same formulation Risedronate 35 mg is sold by Cipla as Risofos at an MRP of Rs 110 for four tablets. There are many more such cases in the market and doctors usually prescribe the expensive brands. Such price differences between the brands have to be rationalised in a country like India and that can be done only by a price regulator like NPPA with adequate powers.