The Delhi High Court, on January 01, 2019, set aside the Central Government's ban on Wockhardt's anti-inflammatory medicine 'Ace Proxyvon', a Fixed Dose combination (FDC) of Aceclofenac 100 mg, Paracetamol 325 mg and Rabeprazole 10 mg, indicated for the relief of pain and inflammation associated with Rheumatoid Arthritis, Osteoarthritis and Ankylosing Spondylitis1. The Court judgement states that the center's decision of banning the drug is violation of principles of natural justice. The ban issued under Section 26A of the Drug and Cosmetics Act, 1945, was administrative and, therefore, the principles of natural justice could not be excluded.

About the Matter

The Center Government (Respondent), in exercise of powers conferred by section 26A of the Drugs and Cosmetics Act, 1940, has notified ban on the manufacture for sale or distribution for human use, of 328 Fixed Dose Combinations (FDCs) with immediate effect from September 12, 2018. It has also restricted the manufacture, sale or distribution of six FDCs subject to certain conditions.

Wockhardt (petitioner) had challenged the impugned notification on several grounds including:

  1. that the same has been issued in violation of principles of natural justice;
  2. that the impugned notification is based on the recommendations of the sub-committee of Drug Technical Advisory Board (DTAB), which has been made without application of mind;
  3. that the impugned notification has been passed without following the directives issued by the Supreme Court in Union of India v. Pfizer Limited and Ors. : 2018 (II) SCC 39; and
  4. that the said FDC has a sound therapeutic justification and poses no risk to human beings.

The petitioners contended that the impugned notification had been issued in violation of principles of natural justice. He submitted that the report of the Sub-committee indicates no reason for recommending why the said FDCs should be proscribed. Although, it is concluded that there is no therapeutic justification for the said FDC, the said conclusion is not supported by any reason. He referred to the detailed submissions made by the petitioners before the Sub-committee for establishing the therapeutic justification for the said FDC.



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