Wockhardt gets relief from HC on Center restriction to anti-inflammatory drug

The Delhi High Court on Monday set aside a Central government notification restricting the manufacture, sale and distribution of an anti-inflammatory medicine manufactured by pharma company Wockhardt Ltd.

Ace Proxyvon, a medicine manufactured by Wockhardt Ltd was part of the 328 Fixed Dose Combination (FDC) drugs whose manufacture, distribution and sale were banned by the Ministry of Health and Family Welfare in September last year.

Ace Proxyvon, which combines the dosage of aceclofenac, paracetamol and rabeprazole, is used to get relief from pain and inflammation associated with rheumatoid arthritis, osteoarthritis and ankylosing spondylitis. The high court observed that the Centre's decision to ban the drug had been taken without application of mind and order was passed without following certain procedures.

Justice Vibhu Bakhru, however, directed the sub-committee of Drug Technical Advisory Board (DTAB) to re-examine the issue regarding medicine manufactured by Wockhardt in accordance with the directions issued by the Supreme Court in Pfizer Ltd case.

After examining the issue, the DTAB sub-committee will submit a report to the Central government. On the basis of the report, the Central government can take any further decision, the court said.

This was the first plea which was decided by the court. Glenmark, Obsurge Biotech, Alkem Laboratories, Coral Laboratories, Mankind Pharma, Lupin, Macleods, Laborate and Koye Pharmaceuticals are among the other pharma companies whose pleas challenging Centre's decision are pending before the court.

The Centre, in March 2016, had prohibited the manufacture for sale and distribution of 349 FDCs, but it was contested by the affected manufacturers in high courts and the Supreme Court.

Complying with the December 2017 Supreme Court judgment, the DTAB examined the matter and, in its report to the Centre, recommended prohibition of the FDCs on the ground that there was no therapeutic justification for their ingredients and that these FDCs could involve risks to humans. Earlier, an expert committee appointed by the Centre too had made similar observations. Considering the recommendations of the DTAB and the expert committee, the Health Ministry had, through a gazette notification, prohibited the 328 of the 349 FDCs.

(With inputs from agencies.)