New Delhi : In continuation with its efforts to fix and regulate the retail price of fixed dose combinations (FDCs) of anti-diabetes drug sitagliptin , which is on the verge of becoming off-patent, the expert committee of the drug price regulator has recommended fixing prices of 10 FDC products based on 34 applications by generic drug makers.
The Multidisciplinary Committee of Experts (MCE) of National Pharmaceutical Pricing Authority (NPPA) in a meeting held in early June, received 34 applications based on 10 FDCs of sitagliptin and metformin tablets, including sitagliptin 50mg+metformin 500 mg tablet, sitagliptin 50 mg+metformin 1000 mg, among others.
The Committee noted that the formulation ‘sitagliptin’ is on the verge of becoming off-patent in July 2022.
The applications recommended for price fixation by the Committee were from marketers including Alembic Pharmaceuticals, Abbott Healthcare Pvt Ltd, Torrent Pharmaceuticals, Skymap Pharmaceuticals, Glensmith Labs Pvt Ltd, Micro Labs Ltd, Zydus Healthcare Ltd, among others.
The Committee opined that the price of drugs be reduced in respect of the drugs which has become or on the verge of becoming off-patent so as to pass the benefit of price reduction to the consumers and that a reduction of 50 per cent be allowed on the patented compound of the FDC, which is sitagliptin, to arrive at the retail price.
The prices were fixed despite the objections raised by the Organisation of Pharmaceutical Producers of India (OPPI), the organisation of research-based multinational pharma companies in the country, and others against the NPPA fixing the prices of generic versions of the drugs which are still under patent.
In an earlier meeting, the NPPA considering the representations by the pharma majors and the OPPI, said that it is obliged to give price to the existing manufacturer on receipt of application for price approval and patent disputes on the drug cannot affect this process as per the law.
NPPA regulates and monitors the prices of drugs in the country and has a duty to ensure the affordable medicines to the public at large within the compliance of extant Drugs (Prices Control) Order [DPCO].
When the existing manufacturer of a drug with dosages and strengths as specified in National List of Essential Medicines (NLEM) launches a new drug, they shall apply for the price approval in specific form under the DPCO. Para 15 of the DPCO, 2013 provides the fixation of retail price of a new drug for existing manufacturers of scheduled formulation and Para 15(3), mandates the government to forward the application to the Standing Committee of experts who shall recommend the retail price within thirty days from the receipt of application.
The Authority also observed an Office Memorandum from the Department of Promotion of Industry and Internal Trade, Ministry of Commerce and Industry on August 8, 2019, stating that the Indian Patents Act, 1970 does not contain any provision to link the patent rights to marketing approval for a product and the Drugs and Cosmetics Act does not require the Drug Controller General of India (DCGI) to see whether a patent existing on a drug on which application of marketing approval has been received. The DCGI is also not empowered to take that view, it said.
The Office Memorandum further states that the NPPA takes decisions for fixation of retail prices as per the provisions of DPCO 2013 and relevant laws, and may not be technically qualified to decide on the existence and scope of a patent in any proposed formulation.
In a meeting held on May 6, the Authority opined that it is under obligation to give retail price if any existing manufacturer launches a new drug and makes and application in this regard to obtain the price approval from the NPPA by producing the relevant documents such as the valid license obtained from the Central Drugs Standard Control Organisation (CDSCO).
