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Delhi High Court Strikes Down Ban on 344 Fixed Dose Combination Drugs

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The Central Government, vide 344 notifications dated March 10, 2016 had banned the sale, manufacture and distribution of 344 fixed dose combination drugs (“FDCs”) on the ground that these FDCs lacked therapeutic rationality or justification. The ban had enormous impact on the Indian Pharmaceutical Industry as these FDCs make up almost half the market share of the Indian Pharmaceutical Industry.

Economic Laws Practice (“ELP”) Delhi, with a team led by Ashish Prasad, Partner, advised leading associations of the Pharmaceutical Industry viz., Federation of Pharma Entrepreneurs (“FOPE”), Indian Drug Manufacturers Association (“IDMA”), and Confederation of Indian Pharmaceutical Industry, (“CIPI”) in challenging all 344 notifications on the ground inter alia, that the notifications, which banned all 344 FDCs citing identical reasons, had been issued without the due process of law. ELP also filed over 25 separate writ petitions for individual Indian Pharma companies including Biocon Limited. Other Pharma Companies also challenged individual notifications. A total of 454 petitions were filed before the Delhi High Court.

Arguments were heard for over two months. After reserving verdict on June 2, 2016 Rajiv Sahai Endlaw J. has today pronounced judgment allowing all the petitions and quashing all 344 notifications. The operative part of the 82 page long judgment reads as follows:

“The petitions thus succeed. All 344 Notifications dated March 10, 2016 purportedly in exercise of power under section 26A of the Drugs Act are found to have been issued without following the procedure statutorily prescribed to be followed prior to issuance thereof and resultantly it is held that the Notifications are not based on satisfaction of the Central Government prescribed to be on the advice of an in consultation with the DTAB and DCC. Resultantly the said Notifications are quashed."


ELP Litigation & Dispute Resolution Team

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