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14 more drug majors get HC relief from Centre ban on FDC meds

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Press Trust of India New Delhi
Fourteen more healthcare majors, including Cipla, Lupin, Wockhardt, Glaxosmithkline and Mankind Pharma, were today granted interim relief by Delhi High Court which stayed till March 21 the ban imposed by the Centre on sale of some of their fixed dose combination (FDC) drugs.

Apart from these five, Justice Rajiv Sahai Endlaw also provided relief to Dr Reddy's, Laborate Pharmaceuticals, Alkem Laboratories, Ajanta Pharma, Khandelwal Laboratories Pvt Ltd, Micro Lab Ltd, FDC Ltd, Coral Laboratories Ltd and Eris Lifesciences Pvt Ltd.

The court passed the same order as was issued in the pleas filed by the eight other companies, including Pfizer, Procter and Gamble (P&G), Glenmark and Reckitt Benckiser in the past three days.
 

"The same order. We will hear on Monday (March 21)," the court said and added that government should file its affidavit before that date.

Till date, the interim stay order of the high court is being enjoyed by 22 companies which also include Abbott Healthcare, Alembic Pharmaceuticals, Piramal Enterprises and Macleods Pharmaceuticals.

Some of the well-known medicines on which the ban on sale has been lifted include 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 22 healthcare companies have sought quashing of the government's March 10 notification banning over 300 FDC drugs, including cough syrup compositions on the ground that they involve "risk" to humans and safer alternatives were available.

The companies have contended that the decision was taken by the government without issuing them a show cause notice or granting them a hearing.

They have alleged that the notification was silent on the aspect as to which expert committee was appointed by Health Ministry to examine the safety and deficiency of the FDCs.

As per the notification, "On the basis of recommendations of an expert committee, the central government is satisfied that it is necessary and expedient in public interest to regulate by way of prohibition of manufacture for sale, sale and distribution for human use of said drugs in the country.

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First Published: Mar 17 2016 | 7:13 PM IST

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