New Delhi: The National Pharmaceutical Pricing Authority (NPPA) has fixed retail prices of a total of 70 new drug formulations, including 12 for which the companies launched the products without obtaining price approval from the Authority.
The 58 formulations for which the retail prices were fixed in a recent meeting held by the Authority include paracetamol infusion Ip from Dr Reddy’s Laboratories, combination of metoprolol succinate (extended release), amlodipine and telmisartan tablet from Ipca Laboratories, paracetamol tablet IP 1000 mg from Alkem Laboratories, combination of metoprolol succinate (extended release), amlodipine and telmisartan tablet from Mankind Pharma, Combikit of clarithromycin tablets, esomeprazole tablets and amoxicillin tablets from Natco Pharma, rosuvastatin and clopidogrel combination from Torrent Pharmaceuticals, and combination of fexofenadine hydrochloride and montelukast tablets from Sun Pharmaceuticals Industries Ltd, among others.
Retail price of the combination ceftazidime and avibactam powder for concentrate solution for infusion from Zyphars Pharmaceuticals has been fixed at Rs. 1,572.59 per vial, during the meeting.
Commenting on the rest of the 12 products, the NPPA said that it has noticed that the companies have launched the formulations without obtaining price approval from the Authority.
“The Authority deliberated upon the worked-out price, claimed price and launched price and approved the lowest of the three prices as the retail price of the new drugs….,” it added.
These include the combination of telmisartan and chlorthalidone tablets, combinations of sitagliptin and metformin hydrochloride from Corona Remedies, a combination of dapagliflozin, vildagliptin sustained release (SR) and metformin hydrochloride (SR) and combinations of dapagliflozin, sitagliptin and metformin hydrochloride (extended release) from Macleods Pharmaceuticals, dapagliflozin, sitagliptin and metformin hydrochloride (extended release) tablets from Unison Pharmaceuticals, combination of teneligliptin, dapagliflozin and metformin hydrochloride (SR) tablets in two different strengths from Glenmark Pharmaceuticals, among others.
The NPPA fixes the retail prices of new drug formulations based on applications from the individual companies, under the Para 5 and 15 of the Drugs Prices Control Order (DPCO), 2013 from time to time.
The new drug, as per the definition of DPCO, 2013, is a formulation launched by an existing manufacturer of a drug of specified dosages and strengths as listed in the National List of Essential Medicines (NLEM) by combining the drug with another drug either listed or not listed in the NLEM or a formulation launched by changing the strength or dosages or both of the same drug of specified dosages and strengths as listed in the list.
The DPCO also details the methodology to fix the retail price of a new drug for existing manufacturers of scheduled formulations in Para 5 of the DPCO. The price to retailers of a new drug, not available in the domestic market, shall be fixed by the government on the principles of pharmacoeconomics of the new drug, on the recommendation of a Standing Committee of Experts formed under Paragraph 15 of the DPCO. The retail price of such a new drug shall be fixed by adding 16 per cent margin to retailer on the price to retailer, it maintains.
