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The Multidisciplinary Committee (MDC) of experts with the National Pharmaceutical Pricing Authority (NPPA) has recommended retail price of combinations containing diabetes drug empagliflozin, for which patent for German drug major Boehringer Ingelheim is expected to expire in March, 2025.
The retail prices have been fixed based on applications from Mankind Pharma, for certain strengths of empagliflozin in combination with certain strengths of other drugs. The calculations show that the price of the patented component has been reduced by 50 per cent as per the methodology arrived at by the Authority earlier.
Retail price of a drug combination of empagliflozin 5 mg and metformin hydrochloride 850 mg has been recommended at Rs. 11.51 per tablet as against a claimed retail price of Rs. 42 per tablet, another formulation of empagliflozin 5 mg and metformin hydrochloride 1000 mg at Rs. 11.38 per tablet as against claimed retail price of Rs. 43 per tablet, and another formulation of empagliflozin 12.5 mg and metformin hydrochloride 850 mg at Rs. 17.24 per tablet against claimed retail price of Rs. 47 per tablet, in a MDC meeting held on August 14, 2024.
The date of expiry of patent protection for empagliflozin is March 10, 2025, according to the Committee and three drug majors - Lupin, Cipla and Torrent - are the license holders for the drug in India.
The Committee arrived at the price of empagliflozin 5 mg based on the retail price of empagliflozin 25 mg tablet as per the formula recommended in the Pronab Sen Committee report. The retail price of empagliflozin 25 mg excluding Goods and Services Tax (GST) based in the Moving Annual Turnover or Price to Retailer for the month of November 2023 was at Rs. 47.73 per tablet and based on this, the retail price of 5 mg was calculated as Rs. 17.18 per tablet.
The Committee reduced the price of empagliflozin by 50 per cent, to Rs. 8.59, in line with its established methodology to calculate the price of drugs which have recently gone off-patent or expected to go off-patent in near future, under which it reduce the price of the patented component by 50 per cent.
It may be noted that the methodology was arrived by the Authority in a meeting held on March 24, 2022 based on the recommendation of the Committee of Experts in a meeting held on March 14, 2022 for calculation of retail price of the FDC which has a component which has become or is on the verge of becoming off-patent.
The methodology was developed considering that if the retail price is calculated based on six month prior market data, the price of the patented period would be taken into consideration and the benefit of price reduction due to medicines which become off-patent would not pass on to the consumers.
Considering the issue related to fixing of the retail price of an FDC with Sitagliptin as a component, the MDC on March 14, 2022, recommended, "The Committee deliberated upon the matter in detail and is of the opinion that the price of drugs be reduced in respect of the drugs which has become/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 to be allowed on the patented component of FDCs (i.e Sitagliptin) to arrive at the retail price".
In a meeting held in January, 2023, it followed the methodology for fixing the prices of patented components, while fixing the retail price of FDCs with dapagliflozin, sitagliptin and vildagliptin.
After arriving at the decision to reduce the price by 50 per cent of the patented compound which has expired the patent exclusivity, the MDC in April, 2022, has said that it is looking at whether the benchmark of the 50 per cent reduction may be examined on case-to-case basis by the Committee for medicines which has become or is on the verge of becoming off patent.
Several pharma companies and associations approached the Authority against the methodology, raising contentions that state that certain drugs have become off-patent almost two to three years back and the prices of the drugs that have become off-patent have since been reasonably reduced as compared to the patent price due to market forces.
Accordingly, they requested the NPPA that 50 per cent reduction on prices of patented components should not have been carried out and pricing should have been carried out as per the Drugs (Prices Control) Order provisions, which is the average price of the manufacturer having market share of more than one per cent.
The Department of Pharmaceuticals (DoP) has then amended the the Drugs (Prices Control) Order, 2013 to include provisions by which the retail price of new drugs with ingredients that have become off-patent or about to become off-patent will be arrived at by reducing fifty percent of the price calculated as per the provisions of the price control order. Similar provision has also been notified by the DoP for the revision of ceiling price of scheduled formulation after expiry of patent issued under the Patents Act, 1970.
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