The Madras High Court has restrained pharma major Wockhardt Ltd., from manufacturing and selling ‘Dextyropropoxyphene’ (DPP) and the formulations containing it till the disposal of two writ petitions.
Justice K.K. Sasidharan passed the interim order on petitions by the company and a distributor challenging a notification of May 23 this year of the Health and Family Welfare department suspending the manufacture for sale and distribution of the drug and the formulations containing it for human use.
The company-manufactured ‘Dextyropropoxyphene Napsylate’ and it was sold under the brand names “Proxyvon” and “Spasmo-Proxyvon” which were widely used analgesic and antipyretic drug. They were used primarily for relief of high fever, headache, extremely acute pain that arose out of cancer and other similar oncological conditions or acute pain due to extreme orthopaedic conditions and complex fractures.
The sale of “Spasmo-Proxyvon” alone fetched Rs. 168 crore in 2012-13 financial year. The turnover of ‘Proxyvon’ was around Rs. 100 crore per year. The deliberations of the meeting of the Drugs Technical Advisory Board in October 2011 resulted in the impugned notification.
The manufacturer and the distributor sought an interim stay of all further proceedings pursuant to the May 2013 notification. The pharmaceutical company contended that the notification did not contain any valid reason to suspend the drug sale. Inputs like suggestions or representations from manufacturers’ association and other experts were not taken before suspending the drug. The Deputy Drugs Controller, Chennai, contended that DPP was withdrawn from the US market in September 2010 at the instance of the United States Food and Drugs Administration on the ground that the drug could cause serious toxicity to the heart even when used in therapeutic doses. The manufacture and sale of DPP in India was considered by an expert team which wanted to conduct further study in the matter. In the meantime, to stop further manufacture and sale of DPP and formulations containing it for human use, the impugned notification was issued. Mr. Justice Sasidharan said experts had taken a decision to suspend the drug for the time being till a close study was conducted regarding its adverse effect on human beings. The counter showed that the suspension was only a temporary measure pending final decision to be taken by the government after extensive study. Therefore, it was clear that the government was yet to take a decision to ban the drug permanently. The Judge also restrained the distributor from marketing the drugs. The other directions included that in view of the direction to take inventory of the drugs and to keep it separately no penal action should be taken on account of possession of the drug.
If it was found that the manufacturer possessed the suspended drug or its preparations other than the quantity already disclosed, it was open to the Drugs Controller to seize the drug and take action. Mr. Justice Sasisdharan made it clear that the directions would be in force till the disposal of the writ petitions.