Last Updated on January 8, 2024 by The Health Master
Download the notification: The National Pharmaceutical Pricing Authority (NPPA) has approved retail prices of 25 new drugs under the Drug Price Control Order (DPCO) 2013, in a meeting held in the end of July, 2021. The Authority meeting also opined that compulsory registration and standardisation of the products are required, for better compliance and enforcement of price regulation related to the trade margin capping of medical devices.
In a meeting held on July 29, 2021, under the Chairmanship of Shubhra Singh, chairman, NPPA, the Authority decided to fix retail price of new drugs including budesonide respule for Softdeal Pharmaceuticals (Rs. 17.79 per unit), paracetamol + caffeine tablet for Micro Labs (Rs. 2.81), metoprolol succinate (extended release) + cilnidipine telmisartan tablet for Pure & Cure Healthcare Pvt Ltd and Alembic Pharma (Rs. 10.16) and the combinations involving anti-diabetes drug dapagliflozin, among others.
The meeting, appraising the outcome of the price capping of five medical devices namely pulse oximeter, blood pressure monitoring machine, nebuliser, digital thermometer and glucometer, asked on the trade margin rationalisation (TMR), observed that 91 per cent of more than 1,000 brands of these devices have dropped prices up to 89 per cent.
The downward revision of maximum retail price has been reported by imported and domestic brands across all the categories, it said.
“The Authority noted with satisfaction that price capping of medical devices based on TMR will result in passing on the benefits in price reduction to the consumers,” it said.
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“The Authority deliberated upon the matter in detail and opined that for better compliance and enforcement of the price regulations, compulsory registration and standardisation of the product is required and CDSCO may initiate action on the reference already made in this regard,” added the minutes of the 223rd (overall ) and 91st meeting of the Authority under the DPCO.
It also suggested that State Drug Controller and Price Monitoring Resource Units (PMRUs) may take necessary steps for ensuring compliance and publicity for awareness generation.
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The Authority noted that regarding the retail price of new drugs which were earlier approved based on the recommendation of the multidisciplinary committee of experts, the same are again placed before the Committee for subsequent application since the market based data is not available even after approval of the retail price of the formulations earlier.
“The Authority took cognisance of Para 15(2)(j) of DPCO 2013 in which it provides for fixation of retail price on principles of ‘Pharmacoeconomics’ in respect of those new drugs which are not available in the domestic market. The Authority deliberated upon the matter in detail and opined that options may be explored for rationalising the issue,” added the minutes.
The Authority also approved a revised price of Rs. 30.39 per strip excluding GST for Cadila Pharmaceuticals’ vitamin D3 (cholecalciferol) 60000 IU orally disintegrating strips, for which the Authority in April 28, fixed retail price at Rs. 20.16 per strip excluding GST.
Following the Authority fixing the retail price, Cadila filed a review application before the Department of Pharmaceuticals (DoP) stating that the calculation was based on erroneous data and the correct data submitted by AIOCD-AWACS Pharmatrac shows that the revised retail price comes to Rs. 30.39 per strip excluding GST. The Authority deliberated upon the matter and revised the prices upwards.
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