New Delhi: The National Pharmaceutical Pricing Authority (NPPA) has notified the retail price of 33 new drugs based on applications filed by the pharma companies including Sun Pharmaceuticals, Zydus Healthcare, Cipla, Torrent Pharmaceuticals, J B Chemicals and Pharmaceuticals, Sanofi India, among others.
The NPPA, based on the 118th Authority meeting held on November 8, 2023, under the chairmanship of Kamlesh Kumar Pant, chairman of NPPA, has also notified the extension of special ceiling prices applicable for the IV fluid injection formulations in non-glass packaging with special features for different dosage forms of products from Biosynergy Lifecare Pvt Ltd, and IV fluid sodium chloride 0.9% 100 ml of Puerto Life Science Pvt Ltd.
Among the 33 new drugs, the retail prices has been fixed for combination drug formulations including sitagliptin phosphate, metformin hydrochloride and glimepiride tablets manufactured and marketed by Sun Pharma Laboratories; budesonide glycopyrronium and formoterol fumarate dihydrate inhaler and ibuprofen injection from Cipla, insulin glargine 100U/ml and lixisenatide 50 mcg/ml and insulin glargine 100IU/ml and lixisenatide 33 mcg/m from Sanofi India; telmisartan and bisoprolol fumarate tablets from Zydus Healthcare, among others.
Special prices has been approved for different dosage forms and strengths of Biosynergy Lifecare’s glucose injection 5%, glucose 5% and sodium chloride 0.9% injection, sodium chloride injection 0.9%, ringer lactate injection 500 ml and 1000 ml, dextrose (glucose) injection 25% w/v, metronidazole injection 0.5% w/v and mannitol injection 20%, following the recommendation from the Multidisciplinary Committee (MDC) of experts in a meeting held on October 23, 2023. A total of 12 formulations are included in the special pricing, according to the notification by the Authority.
The company claimed that the special features of the non-glass packaging include self collapsibility and self-sealability, not having air-vent, and there is no chance of contamination during manufacture, infusion or admixing levels.
Similarly, it has also approved the application by Puerto Life Science for extension of special ceiling price for IV fluid sodium chloride 0.9% 100ml with packaging in non-glass with special features. This was also based on the MDC recommendation and the claims of the company regarding the packaging are also similar to that of Biosynergy Lifecare.
According to the Para 11 (3) of the Drugs (Prices Control) Order, 2013, in the case of injections or inhalation or any other medicine for which dosage form or strength or both are not specified in the Schedule-I of the Drugs (Prices Control) Order, 2013, the Government may fix and notify separate ceiling price or retail price for such formulations with specified therapeutic rationale, considering the type of packaging or pack size or dosage compliance or content in the pack namely liquid, gaseous or any other form, in the unit dosage as the case may be, conforming to Indian Pharmacopoeia or other standards as specified in the Drugs and Cosmetics Act, 1940 (23 of 1940) and the rules made thereunder for the same formulation.
The NPPA has in the past notified the prices of the medicines in special packages that enjoy the benefits of the Para 11(3) and the list of manufacturers of those medicines. According to a latest notification revising the prices, the medicines which are under the special ceiling price include dextrose (glucose) Injection 25% w/v in 100 ml pack for packages in non-glass container (four companies), various dosage forms of ringer lactate injection (18 companies with the addition of Biosynergy Lifecare), glucose and combination of glucose and sodium chloride (25 companies with the addition of Biosynergy Lifecare), metronidazole injection IP (0.5% w/v) and mannitol injection 20% in 100 ml pack (5 companies each with addition of Biosynergy Lifecare), among others.