The regulator, in a notification on 5 March, directed drug manufacturers to fix the prices of formulations used in manufacturing the drugs mentioned in its latest directive.
Viranchi Shah, President, Indian Drugs Manufacturers Association, said the regulator’s decision to fix prices for drug combinations would help ensure wider compliance.
Previously, if the government fixed the price for one drug molecule, drugmakers, while manufacturing a new combination, would increase the price of other molecules that weren’t under price control, he said.
NPPA has fixed the retail price at ₹14.98 per tablet for a combination drug (acetylcysteine and acetylcysteine) used in the prevention and treatment of chronic obstructive pulmonary disease, which affects millions of people in India every year.
NPPA also fixed the retail price of bisoprolol fumarate and amlodipine besilate tablets at ₹8.54 apiece. This combination drug is used to treat people with high blood pressure, a common ailment in India.
It also fixed the price of a popular drug combination used to treat type 2 diabetes mellitus—dapagliflozin, teneligliptin, and metformin—at ₹11.60 per tablet, and the price of another anti-diabetes drug combination—metformin and sitagliptin—at ₹13.50 per 100 mg tablet.
Sudharshan Jain, secretary general of the Indian Pharmaceutical Alliance, said Indian drug prices were already among the lowest in the world.
“Intense market competition helps to ensure fair price for patients. The overall thrust in pricing policy should balance accessibility of medicines and viability of products,” he said.
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Managing critical diseases
NPPA has over the past decade introduced price controls on all essential drugs that are used to treat or manage non-communicable diseases such as cardiovascular diseases, chronic respiratory diseases, and diabetes.
In its latest notification, NPPA also asked drugmakers to submit a price list of their drugs to the government’s integrated pharmaceutical database management system, state drug controllers, and dealers. It also directed pharmaceutical retailers and dealers to display a list of drug prices at their business premises.
“The manufacturers not complying with the regulations shall be liable to deposit the overcharged amount as per the provisions of the Drugs (Prices Control) Order, 2013 and Essential Commodities Act 1955,” NPPA said.
The World Health Organization in 2022 estimated that about 200 million adults in India suffered from hypertension, which accounted for nearly 10% of all deaths in the country. The following year, the Indian Council of Medical Research estimated that about 101 million people in India were diabetic.
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India’s pharmaceutical industry was valued at $50 billion in 2023-24, with domestic consumption estimated at $23.5 billion and exports at $26.5 billion, as per the department of pharmaceuticals, which functions under the Union chemicals and fertilizers ministry.
India is the world’s largest supplier of generic medicines. The country manufactures about 60,000 generic brands across 60 therapeutic categories, accounting for 20% of the global supply of generic drugs, according to the pharmaceuticals department.
The department of pharmaceuticals did not reply to Mint’s queries.
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