Delhi High Court sets aside Centre's ban on anti-inflammatory medicine 'Ace Proxyvon'

The Delhi High Court Monday set aside the Centre's notification banning the manufacturing and sale of Wockhardt's anti-inflammatory medicine 'Ace Proxyvon', used in painful rheumatic conditions.

Justice Vibhu Bakhru remanded the matter to the Drugs Technical Advisory Board (DTAB)/ sub-committee constituted by the Centre to examine the issue regarding the fixed dose combination (FDC) drug Ace Proxyvon in accordance with the directions earlier issued by the Supreme Court.

The Indian pharma major had challenged the Centre's September 7, 2018 notification banning the manufacture, sale and distribution of 328 fixed dose combination (FDC) drugs.

This is the first petition, filed against the Health Ministry's notification, to be decided by the court. A batch of pleas on the same issue are pending before it.

Other pharma firms including Glenmark, Alkem Laboratories, Obsurge Biotech, Coral Laboratories, Lupin, Mankind Pharma, Koye Pharmaceuticals, Macleods and Laborate have also moved the high court against the ban on their FDCs ranging from anti-inflammatory and pain killers to antibiotics and drugs for treating bacterial infections.

FDCs are two or more drugs combined in a fixed ratio into a single dosage form.

Ace Proxyvon, sold by Wockhardt in a tablet form, is a mixture of three salts -- aceclofenac, paracetamol and rabeprazol -- a combination which was banned.

Wockhardt had challenged the notification on several grounds, including that it was issued in violation of principles of natural justice, it was based on the recommendations of the sub-committee of DTAB, which has been made without application of mind.

The firm had claimed that the notification was passed without following the earlier directives of the Supreme Court and the FDC has a sound therapeutic justification and poses no risk to human beings.

The Centre had contended that "exercise of power under Section 26A of the Drugs and Cosmetics Act is legislative in nature and principles of natural justice have no application" and there was no requirement for the sub-committee to indicate any elaborate reasons.

It had said that the government is neither obliged to afford the petitioners any hearing nor indicate any reasons for its satisfaction to issue such orders.

The high court in its judgement said the sub-committee was to provide comprehensive material for enabling the government to take such decision.

"Although, the sub-committee had received the representations from the petitioners and had also afforded them a hearing, the report does not indicate that any of it was considered and no reason, whatsoever, have been provided for rejecting the explanations provided by the petitioners," the court said.

It said the court was of the view that the notification "cannot be sustained" and it is "set aside".

"The matter is remanded to DTAB/sub-committee constituted by it to examine the issue regarding the said FDC in accordance with the directions issued by the Supreme Court... The DTAB/sub-committee shall submit a report to the Central government. The Central government may take an informed decision whether to restrict or approve the said FDC," the judgement said.

It said the sub-committee's report was required to give sufficient reason for its recommendation as the report was required to be considered by the government for determining the question whether to proscribe or restrict an FDC.

The court had reserved its order on November 15 last year on Wockhardt's petition filed in September.

In an interim order, the court had earlier said that no coercive steps be taken against Wockhardt for sale of stocks of its banned anti-inflammatory medicine which was already in the market, subject to the firm stopping production of the drug.

It had said the medicine has been in the market for past 11 years and its stocks would already be in the distribution network.

The pharma company had contended that it has not been provided with the Drugs Technical Advisory Board (DTAB) report, based on which the ministry's decision was taken.

It had claimed the only reason given in the September 7, 2018 notification was that the combination had no therapeutic value.

The medicine is reportedly prescribed for people with painful rheumatic conditions, such as osteoarthritis, rheumatoid arthritis and ankylosing spondylitis.

The Health Ministry had, through a notification of March 10, 2016, prohibited 349 FDCs for manufacture, sale and distribution under Section 26 A of the Drugs and Cosmetics Act, 1940. 

The notification was then contested by the pharma companies in the Delhi High Court and the Supreme Court.

The high court in December 2016 had quashed the ban on the FDCs, which was challenged by the Centre in the apex court.

The top court had in December, 2017 set aside the high court order and referred the banned FDCs to DTAB for re-examination.

Complying with the apex court direction, an expert panel set up by DTAB, in its report to the Centre, had stated there was no therapeutic justification for the ingredients contained in 328 of the 349 FDCs, which may also involve risk to humans.

The board had recommended that it was necessary to prohibit the manufacture, sale or distribution of these FDCs under the Drugs and Cosmetics Act, 1940 in larger public interest.

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