HC turns down plea of pharma firms in Diclofenac case

Upholds ban on drug citing the threat it poses to vultures that are endangered

Close to extinction: Vultures are considered to be declining in population mostly due to consumption of carcasses of livestock and cattle injected with Diclofenac File photo

The Madras High Court on Tuesday came to the rescue of vultures, a critically endangered species considered to be declining in population mostly due to consumption of carcasses of livestock and cattle injected with Diclofenac, a painkiller, within 72 hours before their death.

The HC dismissed writ petitions filed by two pharmaceutical companies challenging a ban imposed by the Centre on the sale of the drug in multiple dose packs.

Chief Justice Indira Banerjee and Justice M. Sundar refused to interfere with a gazette notification issued by the Union Ministry of Health and Family Welfare on July 17, 2015, amending certain provisions of the Drugs and Cosmetics Rules of 1945 and thereby making sure that Diclofenac (a non-steroidal anti-inflammatory drug) injection for human use was sold only in single dose pack containing a maximum of three millilitre in each vial.

After recording the submission of Additional Solicitor-General G. Rajagopalan that there were chances of multiple dose packs, each containing as much as 30 ml of the drug, being diverted for veterinary use on cattle which require administration of 11 to 14 ml at one go, the judges refused to buy the argument of Laborate Pharmaceuticals of Haryana and Alpa Laboratories of Madhya Pradesh that sale of multiple dose packs for human use would be economical.

Authoring the judgment for the Bench, Mr. Justice Sundar said: “Gyps bengalensis, Gyps tenuirostris and Gyps indicus are what were concerned with in these writ petitions. The aforesaid three are zoological names for three different species of vultures in the world, more commonly known as white-backed vulture, slender-billed vulture and long-billed vulture... There is no dispute amongst the parties to the lis before us that the aforesaid vultures are critically endangered species.”

A sanitary worker’

Further, preferring the term ‘sanitary worker’ to ‘scavenging bird’ when it came to describing vultures in the judgment, the judge pointed out that the Centre had banned Diclofenac for veterinary use way back in 2008 and also suggested an alternative drug that could be administered to livestock and cattle suffering from pain. The drug was allowed for human use alone. After a few years, complaints of pilferage of the drug for veterinary use became rampant leading to the 2015 notification.

Pointing out that an expert committee had been constituted, after the filing of the present writ petitions in 2015 and 2016, to analyse the issue, the judge said that as many as three representatives of one of the two pharmaceutical companies presented their view points before the committee. However, they failed to submit data related to production of Diclofenac injection, their market share, financial loss due to restriction of pack size and so on.

“Therefore, the attack of the report of the committee, by the writ petitioners, as a post decisional enquiry, loses steam and writ petitioners not being forthcoming qua queries from committee takes the wind out of the sails of the writ petitioners’ attack on the report. Writ petitioners’ plea before us about the importance of multi dose packs for treatment of human beings also deserves to be negatived as untenable.

“As we are accepting the precautionary principle theory advanced as an argument by the learned Solicitor, lack of decline in vulture population post 2012 argument of writ petitioners also pales into insignificance,” the Bench concluded.