Delhi HC grants more pharma firms legal relief on combination drugs | Mint
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Business News/ Companies / Delhi HC grants more pharma firms legal relief on combination drugs

Delhi HC grants more pharma firms legal relief on combination drugs

HC stays govt order banning combination drugs made by Reckitt Benckiser, Glenmark, Piramal, Alembic, P&G

The government banned 344 FDC drugs last week after a panel of experts found they posed a health risk. Photo: MintPremium
The government banned 344 FDC drugs last week after a panel of experts found they posed a health risk. Photo: Mint

New Delhi: The Delhi high court on Wednesday stayed a government order banning combination drugs made by five companies—Procter and Gamble Hygiene and Health Care (P&G), Glenmark Pharmaceuticals Ltd, Reckitt Benckiser, Piramal Enterprises Ltd and Alembic Pharma Ltd.

Earlier this week, Abbott India, Macleods Pharma and Pfizer India, too, were given relief by the court.

Last week, the government banned 344 fixed-dose combination (FDC) drugs and Wednesday’s order comes ahead of a decision on another 600 FDCs soon. An FDC is a cocktail of two or more active drug ingredients in a fixed ratio of doses.

The government is set to come up with a fresh list based on recommendations of a six-member panel headed by Chandrakant Kokate. The Kokate panel, which submitted its report on 20 January 2015, recommended 963 FDCs as “irrational" or posing health threats after reviewing 5,518 applications.

“Out of this, 344 are banned and the government is planning to come up with more. However, neither the Kokate panel nor the Central Drugs Standard Control Organization (CDSCO) had consulted the firms. Some firms were not even issued a show-cause notice. We appeal to the government to roll back this decision," said S.V. Veeramani, president of lobby group Indian Drug Manufacturers’ Association.

The current ban on drug combinations, along with the price cap based on the National List of Essential Medicines 2015 and the negative Wholesale Price Index, is set to bleed the 1 trillion-Indian pharma industry by about 4,500 crore, according to AIOCD AWACS, a market researcher.

“The decision (on 344 combinations) was based on a report by an expert panel. And the government has taken a good step in favour of the common man as most of these drug combinations were harmful. However, a proper procedure was not followed as many of these companies were not even aware about the ban," said an industry body official, who does not want to be named.

Responding to the allegation by the industry body, Kokate said, “Show-cause notice was issued to all the companies. We had followed a systematic procedure and had not gone through any brands. The list of irrationals was based on the merit of a particular product. We looked for safety, efficacy and rationality and based on that the irrational list was recommended. Now, it is upon CDSCO to initiate action based on this."

The current interim stay will apply to FDC prescription drugs, including P&G’s cold and cough drug Vicks Action 500 Extra, Pfizer India’s Corex, Piramal’s Saridon, Reckitt’s D Cold Total and Glenmark’s Ascoril-C.

The case is up for hearing next on 21 March.

Meanwhile, P&G on Wednesday informed BSE that the company will resume manufacturing and selling Vicks Action 500 Extra.

“We would like to reinforce that the health, safety and well-being of our consumers is our No.1 priority at Procter and Gamble Hygiene and Health Care. All Vicks products, including Vicks Action 500 Extra, are backed by research to support their safety quality and efficacy," the company said in a statement.

The stocks of almost all these companies were down on BSE on Wednesday, with shares of P&G down by 0.74%, Pfizer by 1.21%, Abbott India by 1.43%, Piramal Enterprises by 0.1% and Alembic by 0.27.

However, shares of Glenmark Pharmaceuticals zoomed by 1.77%.

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Published: 16 Mar 2016, 10:35 PM IST
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