Legal Battle to remove the stay on the ban on Multi Dose Vials of Diclofenac

Abstract:

The drug controller general, government of India had banned the veterinary use of diclofenac in the way back on July 4th, 2008. It sparked fresh hopes for the survival of the critically-endangered vulture species, the nature’s clean-up crew! But the drug was still available in large multi-dose vials of 30 ml labeled ‘not for veterinary use’, facilitating the illegal veterinary use of the drug, which caused a further decline in vulture populations. To avoid this, the Ministry of health and family welfare, Government of India, passed a blanket ban on multi-dose vials (MDV) of diclofenac, through a notification issued on July 17, 2015. But, this ban was challenged by a pharmaceutical company and the stay was issued on 29th December 2017 by the Madras High Court. It took 2 years for the hearings to be completed and a judgment for upholding the ban was passed by the High Court in 23rd October 2017 which reinstated the sense of hope to vulture conservation.

Keywords:

Vulture, multi-dose vials of diclofenac, impugned provision, petition, affidavit, critically endangered, conservation

Introduction:

A notification issued on July 17, 2015, by the union health ministry states that the diclofenac formulation for human use will henceforth be available only in a single dose pack. This brought relief to vulture conservationists, but that relief was short-lived. While I made a casual visit on the early morning of 29-12-2015, to meet Dr.Vijaykumar, a veterinary doctor, he showed me the news item titled “High Court Stays the prosecution over the ban of Multi-Dose Vials of diclofenac”.

It was a shock and I was speechless for a moment. Then I shared the sad news with fellow conservationists and they expressed their concern over the news.

I was started thinking, “Large organizations can engage in court proceedings against large drug companies, but what I can do in this situation? The task was humungous - limited resources, lack of legal expertise, the urgency of conservation of vultures all in front of me and a formidable adversary in the form of the pharma companies.

Finally, I decided to face the situation head-on.

First of all, I wanted to collect the case details based on this news but I had no previous experience in court proceedings.

Way forward overcoming constraints

I contacted Lajapathirai, an Environmentalist Advocate known to me. Since he is practicing in the Madurai High Court, he directed me to contact an Advocate Thilakeswaran, who practices in the Madras High Court.

When I contacted him, he asked me to come in person. I traveled to Chennai (Madras) the very next day and explained to him about vultures and the urgent need to save them. He wanted to know the details of the writ petition filed by the drug company for preparing a petition for impleading and said that this might take a few weeks and he would call me after collecting the details. His words encouraged me when he said, he would not demand fees, and accept what I can afford, as he wanted to be part of this good cause.

He called me within a week and informed me that he had collected the case documents. He also informed me that the document copy could be collected from his office before 6 pm. It was already 5 pm then.

I called Nagaraj, my friend, who was near the advocate’s office and I requested him to collect the documents. He collected the documents within an hour and called me. After that, I contacted another friend Britto to scan and send the documents to my mail id. It was already 8 pm and he could not do it. Then I contacted Ragunath Krishna, a volunteer of Arulagam. He agreed to help and sent the scanned copy to me by email the same night.

I went through the details. But, I was not able to grasp most of the points raised by the petitioner. I was kept on reading and got some ideas. The following points were noted from the affidavit filed by the company.