Relief to pharma cos as Delhi HC stays ban on combination drugs till 28 March

21 Mar 2016


The Delhi High Court has stayed a government ban on 344 fixed dose combination (FDC) drugs of some 30 pharma companies and adjouned the hearing of the pleas of the pharma companies till 28 March, allowing the companies to continue sales of the medicines till the next hearing.

Hearing a petition filed by the pharma companies, a bench headed by RS Endlaw of the Delhi High Court also directed the government to provide the experts committee report, which recommended the ban on combination drugs of all the pharma companies and petitioners.

The government had banned 344 drug combinations over the weekend, including Abbott's codeine-based cough syrup, after a government panel found they had 'no therapeutic justification' (See: India bans Pfizer, Abbot cough syrups; shares tank).

In fact, the expert committee said the FDCs could pose threat to human lives. The committee had submitted its recommendations to the central government on the prohibition of manufacture, sale and distribution of such drugs.

The bench was hearing pleas by Glaxo SmithKline, Wockhardt and Laboratories Griffon on Aceproxyvon, Viscodyne and Viscodyne-D (Wockhardt), Crocin Cold and Flu Max (Glaxo) and Grilinctus syrup of Griffon.

The court had on 14 March gave interim relief to Pfizer's cough syrup 'Corex' and later extended the benefit to over 30 companies, which also included Glaxo Smithkline, Reckitt Benckiser, Abbott Healthcare, Piramal, Lupin, Mankind Pharma and Wockhardt.

Other companies that moved the high court include Alembic Pharmaceutical, Ajanta Pharma, Macleods Pharmaceuticals, Dr Reddy's, Laborate Pharmaceuticals, Alkem Laboratories, Khandelwal Laboratories Pvt Ltd, Micro Lab Ltd, FDC Ltd, Coral Laboratories Ltd and Eris Lifesciences Pvt Ltd.

The stay on the ban on sales of these drugs included some of the well-known medicines, including Pfizer's Corex cough syrup, Glaxo's Piriton expectorant, P&G's Vicks Action 500 extra, Reckitt's D'Cold, Piramal's Saridon, Glenmark's Ascoril and Alex cough syrups, Abbott's Phensedyl cough syrup and Alembic's Glycodin cough syrup.

The union health ministry issued a notification March 10, banning the combination drugs. The centre ordered a ban on the manufacture, sale and distribution of such drugs under Section 26(A) of the Drugs and Cosmetics Act, 1940, the notification said.

(Also see: More drug bans coming: 1,200 FDCs under scanner)

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