An FIR, a copy of which was reviewed by FE, claims that Wockhardt sold allegedly illegal Spasmoproxyvon capsules post its ban on May 23.
According to sources, the value of drugs sold was R47,15,990 which the company sold through 166 invoices to dealers and stockists.
Maharashtra Food and Drug Administration through the FIR states that the company sent letters to its stockists and dealers to inform about the ban instead of a faster method of communication like email or fax, which further delayed the process of recall.
As a precautionary measure, Wockhardt applied for bail application of its board of directors in lieu of the FIR filed by Maharashtra FDA. The latter has asked for the arrest of four of the company officials in the distribution and sales department.
Sources have claimed that the drugs are still available in market in remote areas and that the company has not initiated a proper recall of the banned drugs.
The FIRs had been lodged under the provisions of Drugs & Cosmetics Act, 1940, and Indian Penal Code 328 on July 29 and 30 in Kolhapur. The centre, through its notification of May 23, has suspended the manufacture, sale and distribution of Dextropropoxyphene under the Section 26 of Drugs & Cosmetics Act, 1940.
Wockhardt did not receive any communication from the FDA on the May 23, 2013, about the ban on Dextropropoxyphene-based product sales. As such, Wockhardt was not aware that the ban became effective on the same day. As a principal supplier, Wockhardt was intimated about the ban only on the June 10, 2013, and that too through a public mail. Following this, Wockhardt immediately stopped the manufacture and sale of these products. The company also initiated action to recall the product from the market, the company said in an emailed response to FEs query.
Wockhardt also states that under Indian drug laws, when a drug is banned, there is a transitory period during which the drug is withdrawn from the market; Wockhardt complied with these laws in letter and in spirit. The company mentions that Maharashtra FDA did not follow the due process before taking coercive steps.
The company has stated that it had already contested the ban. Dextropropoxyphene is a drug used in Proxyvon, Spasmo Proxyvon and Parvon and are allegedly misused by addicts. Maharashtra FDAs move comes close on the heels of the seizure of these capsules by customs officials at the Chhatrapati Shivaji International Airport and from two warehouses situated in the Mumbai suburbs.
Wockhardt stock closed 4.99% down to Rs 422.45 on the BSE on Friday.