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 The National Pharmaceutical Pricing Authority (NPPA) has fixed the retail price of 23 new drugs under the provisions of the Drugs Prices Control Order (DPCO), 2013, including anti-hypertensive, anti-depressant, and anti-diabetic drugs, among others.
The prices were fixed in a meeting of the Authority held on July 30, after considering the applications of individual manufacturers for retail price of new drugs falling under the purview of paragraph 2(1)(u) of DPCO, 2013.
The new drugs for which the retail prices has been fixed include a combination of two strengths of atorvastatin, clopidogrel bisulphate, and aspirin from Sun Pharmaceuticals to treat secondary cardiovascular events; two strengths of combination clonazepam and paroxetine controlled release tablets and two strengths of combination desvenlafaxine extended release and clonazepam tablets from Mankind Pharma for treatment of panic disorder, anxiety and depression; escitalopram oxalate 5mg and clonazepam 0.5 mg tablets from Ipca Laboratories for treatment of anxiety, panic disorders and depression associated with anxiety.
Two strengths of telmisartan, chlorthalidone and metoprolol succinate (ER) tablets from Mankind Pharma, two strengths of telmisartan and metoprolol succinate extended release (ER) tablets from FDC Ltd, and a combination of nebivolol hydrochloride and telmisartan tablets from Torrent Pharma are some of the anti-hypertensive medicines for which the retail prices has been fixed in the latest meeting.
Anti-diabetes drug formulation for which the retail prices has been fixed are two strengths of sitagliptin, glimepiride and metformin hydrochloride ER tablets from Sun Pharma, Torrent Pharma, and Alkem Laboratories, and a combination of dapagliflozin, pioglitazone and metformin hydrochloride sustained release tablets from Eris Lifesciences.
The Authority, in its previous meeting, clarified that the worked out price of a new drug for existing manufacturers of scheduled formulations will be notified as retail price applicable to the applicant company and other existing manufacturers launching the same new drug within 12 months from the date of fixation of the retail price.
Once retail price of a new drug has been fixed for an applicant, any other existing manufacturer launching the same new drug within 12 months of retail price fixation of such new drug under paragraph 15 shall not apply to NPPA for retail price fixation. This is provided that such manufacturer launching the new drug shall intimate the details of launch to NPPA in Form-IA within one month of the launch.
As reported earlier, the Authority has fixed the price of 39 formulations in the previous meeting held on July 7, a total of 30 new drugs on May 26, another 42 new drugs in a meeting on April 30, a total of 31 new drugs on March 24, another 20 new drugs on February 27, and 37 new drugs in its meeting on January 30, this calendar year.
These are new drugs, under paragraph 2(1)(u) of the Drugs Prices Control Order (DPCO), 2013.
Under the Paragraph 2(1)(u) of the DPCO, 2013, a new drug is defined as a 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 NLEM.
The methodology of calculating and fixing the retail price of new drugs for existing manufacturers of scheduled formulations are specified in the Para 5 and 15 of the DPCO, 2013, which is followed by the NPPA to arrive at the price against the applications submitted by the companies.
In case the retail price of any of these formulations are not complied with, as per the price notifications and notes released by the authority, then the concerned manufacturer/marketing company shall be liable to deposit the overcharged amount along with the interest thereon under the provisions of the DPCO, 2013 read with the Essential Commodities Act, 1955, added the price regulator.
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