CHENNAI: THE Union Health Ministry, New Delhi has been directed by the Madras High Court to constitute a three-member expert committee to examine the issue of packaged dose of diclofenac injection and submit its report to the Drugs Technical Advisory Board (DTAB) for necessary action before August 23.
The first Bench of Chief Justice SK Kaul and Justice R Mahadevan issued the directive on June 17 while passing further interim orders on a PIL from Laborate Pharmaceuticals India Limited, Panipet, having a regional office in Chennai, challenging the criminal proceedings against certain pharmaceutical firms in the country, for manufacturing, packing and selling diclofenac above the mandated limits. The first Bench in the last week of December, 2015, had stalled the criminal proceedings.
The Bench was informed that the main reason for the restriction of the pain-killer injection, used largely on animals, was to protect vultures, whose population had dwindled drastically as they fed on carcasses of the animals that had died of excessive diclofenac injection. By making an amendment to the Drugs and Cosmetic Rules on July 17, 2015, the Union Ministry of Health and Family Welfare department, New Delhi restricted the quantity of supply in each unit of the injection to 3 ml only.
Holding that the medicine produced and packaged before July 17 would not be tantamount to violation of the amended rule, the Bench had granted the injunction.
According to petitioner, the very basis for this change arose because of what was discussed at the 63rd meeting of the DTAB on May 16, 2013. The meeting also resolved to form an expert panel to examine the issue. “However, when the matter was taken up on July 19, 2013, without even waiting for the report of the experts committee, the decision was taken to do away with multiple dose pack sizes for human use,” the Bench said. When the matter came up for hearing on June 17, the Deputy Drugs Controllers submitted that the expert panel was not formed till date. “We find this position unacceptable. We thus direct that the minutes of the DTAB meet dated May 16, 2013, should be given effect to and the committee stand constituted to submit its report to the DTAB with a copy to the Bench. The committee may also obtain the views of the petitioner. The needful be done well before August 23, the next date of hearing,’’ the Bench added.