HC stays prosecution over multidose diclofenac

The Madras High Court today stayed prosecution initiated against a pharma company over multi-dose vials of anti-inflammatory drug diclofenac injection manufactured prior to a new norm prohibiting its sale came into force from July 17, 2015.
A bench comprising Chief Justice Sanjay Kishan Kaul and Justice Pushpa Satyanarayana passed the order on a petition by Panipat-based Laborate Pharmaceuticals India Limited, which has its regional office here, challenging the 4th Proviso to Sub Rule (2) of the Drugs and Cosmetic Rules notified by the Centre on July 17, 2015.
The proviso restricts sale of diclofenac injection to single unit dose of 3 ml only on the ground that the multidose vial was being misused.

Issuing a notice to the Union Health Ministry, the bench directed it to file counter affidavit within four weeks.
The petitioner prayed the court to declare the 4th proviso as arbitrary, invalid in law and unenforceable and, in an interim plea, sought a stay on the prosecution initiated.
The company submitted that the Health Ministry in consultation with the Environment Ministry published a Gazette notification on July 17, 2015 regarding the restriction on packaging of multi-dose vial of diclofenac to single dose for human use.

The restriction was imposed on the ground that the multi-dose variant of the drug administered to cattle got ingested by vultures causing fatalities as they routinely fed on carcasses.

The bench also directed the counsel for the ministry to produce records relating to the decision making process for insertion of the 4th proviso including the report of the Drug Technical Advisory Board.
Counsel for the company submitted that the drug had been prohibited for animal use from July 2008 on the alleged ground of vulture deaths.
It was not made clear as to why the multi-dose package had been prohibited while the medicine was permitted for human use as an essential drug, he said.
The petitioner also said the claims about vulture deaths due to the drug did not appear to have been substantiated by any systematic, scientific, long-duration study and documented by any reliable government agency.

The court in its interim order said: "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 is alleged to be causing death of vultures, the packing's prior to the insertion of 4th proviso prima facie, cannot invite prosecution and thus the prosecution initiated, if any in this behalf is stayed," the bench said.
The matter was adjourned to February 18 next for further hearing.