Delhi HC allows sale of the existing stock of banned FDC drugs

In an interim relief to almost ten major pharmaceutical players, the Delhi High Court today stayed the Central government ban on 328 Fixed Dose Combination (FDC) drugs so far as the sale and distribution of “already manufactured stock” is concerned..To ascertain the quantity, the companies were directed to file an affidavit with the Court indicating the ‘batches already manufactured’ by them..The Court further ordered that no coercive action would be initiated against the manufactures, stockists as well as dealers of the banned FDC drugs, in light of the order allowing the sale of the FDC drugs for the time being..The High Court, however, directed the companies to cease all manufacturing operations with regard to the banned FDC drugs, which was readily agreed to by the companies..The pharmaceutical companies which were before the High Court today, against the September 7 notification of the Union Health Ministry, are Coral Laboratories Ltd, Lupin Ltd, Obsurge Biotech Ltd., Mankind Pharma Ltd, Koye Pharmaceuticals Private Ltd, Glenmark Pharmaceuticals Ltd, Wockhardt Ltd, Alkem Laboratories Ltd, Macleods Pharmaceuticals and Laborate Pharmaceuticals..FDCs are two or more drugs combined in a fixed ratio into a single dosage form..Additional Solicitor General Maninder Kaur Acharya, appearing for Centre, informed the Court that the Sub-committee of the Drugs Technical Advisory Board (DTAB) had banned these FDC drugs due to “Pharmacokinetic mismatch” between the drugs..She explained that each drug is prescribed and its dosage is recommended keeping in mind its reaction with the body, amongst other things. However, in the case of the banned combination drugs, it was not possible to reconcile the adequate dosage for each component drug. Hence, “this would lead to either over-exposure or low-exposure of one of the combined drugs“, she submitted..At times, Acharya stated, “the body may not even need all the combined drugs simultaneously“..Justice Vibhu Bakhru, after hearing Wockhardt and Alkem Laboratories at length, directed the Centre to “specifically indicate”, for each ailment and its respective FDC, how its consumption would result in “lower” or “higher” dose. The Court also directed it to submit any material which was relied upon by the Sub-Committee to arrive at a conclusion that an FDC had no therapeutic value, and was instead harmful..Stating that the Court would not “supplant its own views” over that of an expert body, Justice Bakhru said that the Court would nonetheless inquire if the sub-committee “went into the requisite in-depth examination” while arriving at the conclusion..All India Drug Action Network also sought for the Court’s permission to be impleaded as a party to the batch of petitions..ASG Acharya also informed the Court that given the multiplicity of litigation over the FDC ban across various fora in the country, Central Government may move a transfer application before the Supreme Court..Wockhardt and Alkem Laboratories were represented by Senior Advocates Parag Tripathi and Sudhir Chandra, respectively..Senior Advocate Amit Sibal appeared for Macleods Pharmaceuticals and Labrorate Pharmaceuticals..Senior Advocate Rajiv Nayer appeared for Lupin and Mankind Pharma..Satvik Varma appeared for Obsurge Biotech..All India Drug Action Network was represented by Senior Advocate Colin Gonsalves..Earlier this week, the Supreme Court allowed the sale of Saridon and two other drugs by Piramal Healthcare in a similar challenge to the September 7 notification..The matter would be next heard by the High Court on October 9..Read the order: