New Delhi: The National Pharmaceutical Pricing Authority (NPPA) has notified retail price of 42 new drugs under the provisions of the Drugs Prices Control Order (DPCO), 2013, including anti hypertensive, anti diabetic, anti inflammatory drugs, and various formulations of a combination drug to treat heavy menstrual bleeding, among others.
The Authority considered the applications of individual manufacturers for retail price of new drugs falling under the purview of paragraph 2(1)(u) of DPCO, 2013, in its meeting held on April 30, and fixed the prices of the drugs.
While 43 applications were considered during the recent meeting, application of Zydus Lifesciences for price fixation of immunosuppressant formulation tacrolimus prolonged release capsule was deferred after the Authority received a representation from the company against the draft working sheet.
Out of the 42 formulations, for which the retail prices has been fixed now, include six formulations of combination of relugolix, estradiol and norethindrone acetate tablets with each tablet containing relugolix 40 mg, estradiol hemihydrate USP eq. to estradiol 1 mg, norethindrone acetate USP 0.5 mg, marketed by Alembic pharmaceuticals (Rs. 120.62 per tablet), same formulation from Zydus Healthcare (Rs. 116 per tablet), Intas Pharmaceuticals (Rs. 110 per tablet), and the same formulation marketed by Emcure Pharmaceuticals, Jagsonpal Pharmaceuticals, Aristo Pharmaceuticals (all Rs. 107.22 per tablet).
It may be noted that the prices for the same combination was fixed for Dr Reddy’s Laboratories in a previous meeting. The combination is patented by Sumitomo Pharma, marketed globally under the brand Myfembree and Ryeqo. The drug is a once-daily oral combination to treat heavy menstrual bleeding and pain related to uterine fibroids.
Some of the other formulations for which prices has been notified by the Authority include antiparasitic formulation ivermectin and albendazole tablet from Wockhardt Ltd., chronic obstructive pulmonary disease (COPD) drug levosalbutamol and ipratropium bromide respiratory solution from Mankind Pharma, antidiabetic formulation lobeglitazone sulfate and metformin hydrochloride (extended release) tablets from Zuventus Healthcare Ltd, antidepressant combination olanzapine and fluoxetine tablets from Cadila Pharmaceuticals, atorvastatin and ezetimibe tablets from Aristo Pharmaceuticals, and atorvastatin and clopidogrel capsules from Corona Remedies to treat high cholesterol, among others.
As reported earlier, the Authority has fixed the price of 31 new drugs in the previous meeting held on March 24, of 20 new drugs on February 27, and 37 new drugs in its meeting on January 30, this 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.
