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Stay on Trial of Diclofenac Manufacturing Pharmas

Published: 29th December 2015 02:48 AM  |   Last Updated: 29th December 2015 02:48 AM   |  A+A-

CHENNAI: Criminal proceedings against certain pharmaceutical companies in the country for manufacturing, packing and selling Diclofenac above the mandated limits was stalled by the Madras High Court last week.

The main reason for the restriction of the pain-killer injection used largely on animals was to protect vultures, the population of which has dwindled drastically, as they fed on  carcasses of the animals that had died of excessive use of the injection.

By making an amendment to the Drugs and Cosmetic Rules on July 17 last, the Union Ministry of Health and Family Welfare department in New Delhi restricted the quantity of supply in each unit of the injection to 3 ml only.

Holding that the medicine produced and packaged prior to July 17 would not amount to violation of the amended rule, the first bench of Chief Justice SK Kaul and Justice Pushpa Sathyanarayana granted the injunction, while passing interim orders on a writ petition from Laborate Pharmaceuticals India Ltd in Panipet. The firm has its regional office in Choolai, Chennai.

“We are of the view that since the matter really pertains to the alleged misuse of the large pack sizes for animals, which in turn, were alleged to be causing the death of the vultures, the packaging prior to the insertion of the 4th proviso to sub-rule (2) of Rule 105 of the Act, prima facie, cannot invite prosecution and thus, the prosecution initiated, if any in this behalf, was stayed,” the bench said.

According to the petitioner, the very basis for this change arose on account of what was discussed in the 63rd meeting of the Drugs Technical Advisory Board on May 16, 2013.

The bench noted that the meeting allegedly discussed in length the decline in the vulture population. It was also pointed out at the meeting that there was misuse of Diclofenac Sodium injection on animals. The multiple dosage of such injection in pack size of 30 ml was alleged to be misused for the treatment of cattle because of lower cost, even though an alternative treatment in the form of Meloxicam is available. The meeting resolved also to examine this and formulate a panel of three experts for this purpose. “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 pointed out and stayed the prosecution proceedings and posted the matter for further hearing on February 18, 2016.

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