New Delhi: The National Pharmaceutical Pricing Authority (NPPA) has notified the retail price of 39 new drug formulations, including anti-diabetic combinations, antibiotics and painkillers, among others. The Authority has also extended the special ceiling prices for seven formulations of Promea Therapeutics Pvt Ltd, based on the special features of their packaging.
The drugs for which retail prices are fixed through the notification include various strengths and combinations of anti-diabetic drugs Linagliptin, Sitagliptin Phosphate, and Dapagliflozin combined with Metformin Hydrochloride and Glimipiride including some extended release forms.
These drugs are approved based on applications from drug majors including Sun Pharma Laboratories, Abbott Healthcare Pvt Ltd, Mankind Pharma, Lupin Ltd, Micro Labs, Glenmark Pharmaceuticals, Emcure Pharmaceuticals, Eris Lifesciences, Torrent Pharmaceuticals, Dr Reddy’s Laboratories, and USV Pvt Ltd, as marketing firms.
The Authority has also approved the prices of combinations of Paracetamol 325mg with Dicyclomine Hydrochloride 20 mg tablets, and Cefuroxime Axetil and Potassium Clavulanate tablets from Torrent Pharmaceuticals, Albendazole 200 mg with Ivermectin 3 mg from Indoco Remedies Ltd, Amoxicillin 600 mg with Potassium Clavulanate diluted equivalent to Clavulanic Acid 42.9 mg Oral Suspension from Aristo Pharmaceuticals, and Amoxycillin 875 mg with Potassium Clavulanate diluted IP equivalent to Clavulanic Acid 125 mg from German Remedies Pharmaceuticals, as marketers.
The prices were fixed in a recent Authority meeting and were notified in the beginning of this month along with the special ceiling prices. The meeting also fixed the prices of Abbott India’s insomnia drug Zolpidem Tartrate prolonged release tablets at 12.50 mg and 6.25 mg strengths, antibiotic combination meropenem and sulbactam injection from FDC Ltd, heart attack prevention drug combination of Rosuvastatin 20 mg and Clopidogrel 75 mg from Dr Reddy’s Laboratories, arthritis drug combination Diclofenac Diethylamine, Virgin Linseed Oil, Methyl Salicylate, Menthol & Capsaicin Gel from J B Chemicals Pharmaceuticals, and a combination of Omeprazole and Domperidone Capsules from Eris Healthcare to treat diseases including gastroesophageal reflux disease (acid reflux) and peptic ulcer disease.
The Authority, while approving the retail prices, noted that it has received representations from Abbott India for correction in the Price to Retailer (PTR) of one of the line items related to the Zolpidem Tartrate prolonged release tablets considered in the draft worksheet. However, the same was not considered as the revision in the PTR in the Pharmatrac data (the data from the market research agency AWACS which is relied by the Authority to calculate the prices), as contended by the company, was done in June 2023 whereas the PTR for the retail price fixation of the subject formulation has been considering the data for the month of May, 2023, that is six months prior to the date of application.
“Hence the Authority decided that no change is required in the draft worksheet uploaded,” it noted, fixing the price of Zolpidem Tartrate 12.50 mg prolonged release tablets at Rs 14.12 per tablet.
Similarly, noting a representation from USV Pvt Ltd stating that higher retail price has been recommended by the Multidisciplinary Committee (MDC) of experts for the same formulation for other two manufacturers/marketers by considering the different ceiling price for Metformin modified release 1000 mg tablet, the Authority observed that the price was done considering the prices as applicable for the month of March 2023 in case of the company, since the date of receipt of the complete application is October 5, 2023 (month ending immediately before six months of receipt of application). The Authority fixed the price of the combination of Linagliptin 5 mg and metformin hydrochloride 1000 mg extended release at Rs 14.37 per tablet.
The Authority also considered the application from Telangana-based Promea Therapeutics Pvt Ltd for extension of separate ceiling price of IV fluids with packaging in non-glass containers with special features as the MDC recommended special prices for seven formulations.
Based on this, it has extended the special ceiling prices to various strengths and packs of Sodium Chloride and Dextrose Injection, Sodium Lactate Injection, Dextrose Injection, Sodium Chloride Injection and Metronidazole Injection.