NPPA Fixes Retail Prices Of 23 New Formulations, Including Drugs For Hypertension, Diabetes And Depression

The National Pharmaceutical Pricing Authority (NPPA) has fixed the retail prices of 23 new drug formulations, including medicines used to treat hypertension, diabetes, cardiovascular diseases, anxiety and depression, under the provisions of the Drugs (Prices Control) Order (DPCO), 2013.

The decision was taken at the Authority's meeting held on July 30 after examining applications submitted by pharmaceutical companies seeking retail price approval for new drugs covered under Paragraph 2(1)(u) of the DPCO, 2013. The notified prices will apply to the applicant companies and, under certain conditions, to other manufacturers launching identical formulations.

Among the formulations approved are combination therapies for secondary prevention of cardiovascular diseases, including two strengths of atorvastatin, clopidogrel bisulphate and aspirin tablets manufactured by Sun Pharmaceutical Industries. These fixed-dose combinations are commonly prescribed to reduce the risk of recurrent heart attacks and strokes.

The Authority has also approved retail prices for several psychiatric medicines. These include two strengths each of clonazepam and paroxetine controlled-release tablets and desvenlafaxine extended-release with clonazepam tablets manufactured by Mankind Pharma for the treatment of anxiety, panic disorder and depression. It has also fixed the retail price of escitalopram oxalate 5 mg and clonazepam 0.5 mg tablets manufactured by Ipca Laboratories for patients with anxiety disorders and depression associated with anxiety.

Several anti-hypertensive formulations also figure in the latest notification. These include two strengths of telmisartan, chlorthalidone and metoprolol succinate extended-release tablets from Mankind Pharma, two strengths of telmisartan and metoprolol succinate extended-release tablets from FDC Ltd., and a fixed-dose combination of nebivolol hydrochloride and telmisartan tablets manufactured by Torrent Pharmaceuticals.

For diabetes management, the NPPA has fixed the retail prices of two strengths of sitagliptin, glimepiride and metformin hydrochloride extended-release tablets manufactured by Sun Pharma, Torrent Pharmaceuticals and Alkem Laboratories. The Authority has also approved the retail price of dapagliflozin, pioglitazone and metformin hydrochloride sustained-release tablets manufactured by Eris Lifesciences.

The latest notification is part of the NPPA's continuing exercise to regulate the prices of new formulations covered under the National List of Essential Medicines (NLEM). Under Paragraph 2(1)(u) of the DPCO, 2013, a "new drug" includes a formulation introduced by an existing manufacturer by combining scheduled drugs with another medicine or by changing the strength or dosage of an existing scheduled formulation.

The price regulator said the retail prices had been determined in accordance with the methodology prescribed under Paragraphs 5 and 15 of the DPCO, 2013, after evaluating applications submitted by individual manufacturers.

The Authority had earlier clarified that once the retail price of a new drug is fixed for an applicant company, the same notified price would also apply to other existing manufacturers launching an identical formulation within 12 months of the notification. Such manufacturers will not be required to seek separate retail price approval from the NPPA. However, they must inform the Authority of the product launch by submitting Form IA within one month.

The clarification is intended to streamline the pricing approval process for scheduled formulations while ensuring that manufacturers market identical products at uniform regulated prices during the stipulated period.

The NPPA has been regularly notifying prices of new formulations this year. It fixed the retail prices of 39 formulations at its July 7 meeting, 30 new drugs in May, 42 formulations in April, 31 in March, 20 in February and 37 formulations in January, reflecting its continuing oversight of the pricing framework for scheduled medicines.

The DPCO, 2013, empowers the NPPA to regulate prices of essential medicines included in the National List of Essential Medicines to improve affordability while ensuring their availability in the market. Manufacturers are required to market these formulations at or below the notified retail price.

The Authority cautioned that failure to comply with the notified prices would attract action under the provisions of the DPCO, 2013, read with the Essential Commodities Act, 1955. Any manufacturer or marketing company found charging more than the approved retail price would be required to deposit the overcharged amount along with applicable interest.

The latest price notifications are expected to provide greater pricing certainty for manufacturers while ensuring that commonly prescribed medicines for chronic conditions such as hypertension, diabetes, cardiovascular diseases and mental health disorders remain available at regulated prices for patients across the country.