The National Pharmaceutical Pricing Authority (NPPA) has fixed retail prices of 20 formulations under Drugs (Prices Control) Order, 2013 based on the decision of 93rd Authority meeting dated 15.11.2021. The drug candidate Dapagliflozin and metformin extended release is included in 17 formulations out of 20 for which price fixation is applied. Dapagliflozin was patented by AstraZeneca and there are sixteen USA patents protecting this drug and one Paragraph IV challenge.
Pharma Industries like Anthem Biopharma, Blue Cross Laboratories, Cadila Pharmaceuticals, Morepen Laboratories, Panacea Biotec, Synokem Pharmaceuticals, Troikaa Pharmaceuticals, Unison Pharmaceuticals are affected from this price fixation. These Pharma companies are dealing with formulations of Dapagliflozin and Metformin Hydrochloride which are included in DPCO 2013.
Other formulations include Atrovastatin with Aspirin formulated by Tristar Formulations and Lupin Pharma and Ondansatron (rapid dissolving tablet) formulated by Amenan Therapeutics and Delvin formulation.
The manufacturer may add Goods and Services Tax (GST) only if they have paid actually or it is payable to the Government on the retail price fixed by the Authority. The retail price for a pack of these formulations shall be arrived at by the concerned manufacturer in accordance with the retail price specified in the list as per provisions contained in paragraph 11 of the DPCO, 2013.
Manufacturers are advised to issue a price list to NPPA from the date of notification in Form V under paragraph 24 of the Drugs (Prices Control) Order, 2013 and issue a copy to the State Drug Controllers and Manufacturers Distributors. In accordance with the provisions of 24(4) of 2013, every retailer and distributor shall have a conspicuous view of the premises where the business is being carried on in such manner as to be accessible, as given by the manufacturer.
The above non ceiling price (retail price) is applicable only to the above mentioned manufacturer / marketer as submitted on Form I for pricing / revision as stipulated under the Drugs (Prices Control) Order, 2013 and issued by the Government All the applicable statutory compliance that the concerned Manufactures/Marketing companies are concerned under the Manufacturing License clearance by the Competent Authority of the Central/State Licensing Authority.