Madras High Court (HC) in its recent order has directed Wockhardt Ltd to restrain from manufacturing, marketing and selling the drug dextyropropoxyphene under the brand name Proxyvon and Spasmo Proxyvon against the writ petitions filed by the company to get interim stay of operation of the notification on the ban. HC passed the order taking in view of the recommendations of Drugs Technical Advisory Board (DTAB).

Wockhardt Limited and its distributors had requested for a judicial review in respect of the notification issued on May 23, 2013 by the Government of India to ban the manufacture and sale of the drug till the drug is proved safe, rational and efficacious through a well designed, multi-centric, statistically powered clinical trial in India. The drug has been banned in the US, UK, Canada and New Zealand considering the fact that the benefits of the drug do not outweigh its risks in recommended doses.

DTAB in its 60th meeting on October 10, 2011 accepted the recommendation made by the sub committee constituted to examine Fixed Dose Combination (FDC) that clinical trial should be conducted with the drug dextyropropoxyphene to establish its safety and efficacy.

The deliberations in the said meeting and the follow up action taken thereafter resulted in issuing the impugned notification.

The petitioners wanted interim stay of all further proceedings pursuant to the notification dated May 23, 2013. The HC did not grant interim stay of operation of the notification and has issued notices to the Government of India and Drugs Controller General of India (DCGI) to continue with the ban and get details of the inventory of drugs stored at the warehouses of the company.

The petitioners have contended that the Government has not taken any expert opinion before the suspension of drug. As per the petition, Wockhardt Ltd has been manufacturing and selling these drugs for the last forty years without any complaint. The abrupt action taken by the government of India resulted in substantial loss not only to the manufacturer but also to the distributors.

As per the contentions made by the Government of India against the petitioner, the court is not an expert to decide as to whether a particular drug is dangerous in nature and it is unfit for human use. It is for the expert committee entrusted with the said task to decide the issue. The experts have taken a decision to suspend the drug for the time being till a close study is conducted with regard to its adverse affects on human beings.

The counter affidavit filed by the Drugs Controller General of India (DCGI) shows that the expert body has arrived at a conclusion that dextyropropoxyphene and its formulations need to be examined and evaluated with respect to its safety aspect.

As per the HC order, the company and its distributors have also been directed to inform the DCGI and concerned State Drug Controllers about the stocks available with them and details of warehouses where the drugs are stored.