Chennai: Multi-dose diclofenac, HC raps govt for not setting up experts

Chennai: The Madras High Court has flayed the Centre for failing to constitute an experts committee, named more than three years ago, to go into the issue of multiple-dose 30 ml diclofenac packs that was sought to be banned citing fall in vulture population, and has asked the panel to submit its report.

"After humming and hawing for the last three years, it is now finally stated that the committee was not even constituted, much less a report to be submitted by the committee. We find this position unacceptable," the court said.

The court said the committee should be set up as decided in the meeting of the Drugs Technical Advisory Board (DTAB) on May 16, 2013 and the committee to submit its report to DTAB with a copy to be placed before it.

The report should be filed well before the next hearing date of August 23, the First Bench, comprising Chief Justice Sanjay Kishan Kaul and Justice R Mahadevan, said.

The issue relates to the Centre's decision to ban manufacture and sale of multi-dose packs of diclofenac on the ground that it was chief reason for the alarming fall in vulture population.

There were allegations that the drug was fatal to vultures which feed on carcasses of cattle that had taken diclofenac injection within 72 hours (three days) before their death.

The Centre favoured only single-dose diclofenac packs, and sought to prosecute those who manufacture and sell 30ml packs. It was, however, stayed by the high court after manufacturers of multi-dose packs filed pleas, saying there was no systematic, scientific, long-duration study documented by any reliable government agency preceding the ban order.

During the earlier hearings, the bench was informed that a sub-committee had decided on May 16, 2013 to constitute an experts committee to examine issues related to use of diclofenac injection and decline in vulture population.

Members of the committee were named as Dr S D Seth, advisor, CTRI, National Institute of Medical Statistics, ICMR, New Delhi; Dr Y K Gupta, professor and head, department of pharmacology, AIIMS, New Delhi; and Dr N K Gupta, director, department of medicine, Maulana Azad Medical College, Delhi.

It was in view of this submission that the bench recently flayed the Centre on coming to know that the committee had not been constituted at all.

The bench directed the committee to prepare a report after consulting the petitioners as well. The government could substitute one of the retired members with another expert, it added.