FDC Drugs: Delhi HC sets aside ban on Wockhardt’s anti-inflammatory drug

In one of several challenges to the ban on the manufacture, sale or distribution of 328 Fixed Dose Combination (FDC) drugs in India, the Delhi High Court today set aside the Centre’s decision to ban an FDC manufactured by Wockhardt Ltd..The said FDC is a formulation of Aceclofenac + Paracetamol + Rabeprazol, and is sold under the brand name ‘Ace Proxyvon Tablet 10 T’. The FDC is typically administered for relief of pain and inflammation associated with Rheumatoid Arthritis, Osteoarthritis and Ankylosing Spondylitis..Wockhardt had challenged the September 7, 2018 notification of the Central government on the ground that it was issued in violation of principles of natural justice. It argued that the Report of the Sub-Committee of the Drug Technical Advisory Board (DTAB), based on which the notification banning FDCs was issued, indicated no reason for recommending why the said FDCs should be proscribed. It was also alleged that in spite of the petitioner submitting extensive material on the therapeutic justification for the said FDC, the report of the Sub-Committee made no reference to it..The Centre, on the other hand, argued that the powers exercised by it under Section 26A of the Drugs and Cosmetics Act, 1940 Act were legislative powers and, therefore, necessarily exclude the principles of natural justice. It thus contended that it was not necessary for it or for the Sub-committee to give any reason for banning the said FDC. It was also argued that since the Sub-Committee was constituted by experts in the given subject, its findings cannot be subjected to judicial review..Delivering the verdict, a Single Judge Bench of Justice Vibhu Bakhru stated that although the powers under Section 26A are legislative in nature, it can be exercised once the Centre “is satisfied that it is necessary to exercise the same in larger public interest“..Such satisfaction, the Court stated, would be required to be based on relevant considerations, cogent material, and by excluding irrelevant considerations..Therefore, rejecting the contentions put forth by the Central government, the Court observed that the material on which the decision was based, i.e. the Sub-Committee Report, must provide a clear justification for issuing an order proscribing manufacture and sale of a drug. The Centre, howeve,r may not be under an obligation to spell out the reasons while issuing a notification to give effect to the same, it observed..“Thus, notwithstanding whether the principles of natural justice are applicable, the report of the Sub-committee was required to give sufficient reason for its recommendation, as that report was required to be considered by the Central Government for determining the question whether to proscribe or restrict an FDC.”.Although the Sub-Committee is “not expected to give detailed reasons and elaborate explanation” while rejecting a drug manufacturer’s contention, it is incumbent on the Sub-Committee to indicate that it had considered the party’s claim for therapeutic justification and then briefly indicate why the same was not acceptable, the Court held..The Court further acknowledged that it cannot embark upon the inquiry into the therapeutic justification of an FDC or supplant its opinion over the concerned authorities. It, nonetheless, would ascertain whether the Sub-Committee had applied its mind to the justifications provided by the petitioners (drug manufacturers), it clarified..Referring to the December 2017 order of the Supreme Court that led to the formation of the Sub-Committee to examine the issue of FDCs in India, the Court cited the directions given by the Supreme Court “to offer parties a hearing cannot be an empty formality“..As per the directions of the Apex Court, the Sub-Committee was required to apply its mind as to whether it was necessary in larger public interest to regulate, restrict, or proscribe the manufacture, sale and distribution of specific FDCs. In addition, the Sub-Committee was also required to indicate as to why restriction or regulations were not sufficient to control the manufacture and use of the FDCs in question in case the same were recommended to be proscribed. The Centre was then expected to “take an informed decision” on the issue by applying its mind to the parameters set out in Section 26A of the Act, having due regard to the report of the Sub-Committee or any other relevant information..In the present case, the Court noted that the Sub-Committee had received representations from Wockhardt and had also afforded them a hearing. Their report, however, did not indicate that any of the representations were considered, and no reason, whatsoever, was also recorded while rejecting their explanations..The Court therefore opined that the notification with respect to the FDC of the formulations Aceclofenac + Paracetamol + Rabeprazol could not be sustained..While remanding the matter to DTAB/Sub-Committee to examine the issue regarding the said FDC in accordance with the directions issued by the Supreme Court, the Court decreed that the notification is set aside..Pursuant to the report submitted by the Sub-Committee, “the Central Government may take an informed decision whether to restrict or approve the said FDC”, the Court decreed..Wockhardt was represented by Senior Advocate Parag P Tripathi with Advocates Saman Ahsan and Sanjeev K Kapoor..The Central government was represented by Additional Solicitor General Maninder Acharya with Standing Counsel Kirtiman Singh and Anil Soni, and Advocates Waize Ali Noor, Prateek Dhanda, Shruti Dutt, Sahil Sood, Viplav Acharya and Harshul Choudhary..Read the Judgment: