The Maharashtra Food & Drug Administration (FDA) has filed an first information report (FIR) against Wockhardt Ltd at Loni Kalbhor Police Station, Pune for the delayed recall of banned drug dextyropropoxyphene.
Fourteen FIRs have also been filed by the state FDA at several police stations of Kolhapur, Raigad, Bhiwandi, Alibaug, Mahad and Mumbai against its distributors across the state as over Rs. 45 lakhs worth of drug have been sold across the state despite the ban on May 23, 2013 prohibiting its manufacture and sale.
According to FDA Officials, FIRs have been lodged at several police stations across the state as there was a delayed recall of the drug which led the state drug regulators to take coercive action on account of its sale for the period from May 23, 2013 to June 19, 2013.
Wockhardt Ltd had moved the Mumbai High Court in the month of August 2013 to seek an anticipatory bail when the FIR was lodged against the company at Loni Kalbhor Police Station, Pune in the month of July. The company has its own warehouse at Loni Kalbhor where the banned drug was stocked. The case is likely to come up for hearing on November 19, 2013.
Following a series of action on offenders for selling drugs illegally, Maharashtra FDA also recently booked a Bhiwandi based wholesaler in violation of Drugs and Cosmetics Act under section 26 A for selling dextyropropoxyphene.
Girish Vakhariya, assistant commissioner, FDA Thane, informed, "Drugs worth Rs. 10, 000 were sold to the retailers despite the drug being banned by Bhiwandi based wholesaler Jagdish Birla through his agency Deepali Drug Distributor." Wholesaler has got anticipatory bail but the investigations will continue.
The company has been manufacturing the dextyropropoxyphene Napsylate under different brand names like Proxyvon and Spasmo Proxyvon. These two brands were launched in the year 1976. The products were widely used analgesic and antipyretic drug used primarily for high fever, headaches, extremely acute pain due to cancer and other similar oncological conditions or acute pain arising out of acute colic and abdominal pains and also out of extreme orthopaedic conditions and complex fractures.
The ban was introduced on May 23, 2013 through a government notification to prohibit stock, manufacture and sale of dextyropropoxyphene under different combinations, based on the recommendations by the expert committee constituted under Drugs Technical Advisory Board (DTAB). 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.