Maha FDA alleges Wockhardt sold banned drug; files 7 FIRs

Wockhardt’s regulatory issues are far from over as 7 FIRs have been filed against the pharma major in Pune, Kolhapur and Mumbai by Maharashtra Food and Drug Administration (FDA), reports CNBC-TV18’s Archana Shukla. The FIRs filed against the company are for selling the banned drug Spasmoproxyvon.

Also read: Drug pricing row: 7 pharma cos move HC on govt order
 
Shukla reports Opioid Dextropropoxyphene which is used in pain killers was banned by the government on May 23. However, Maharashtra FDA alleges, almost through 166 invoices, that Wockhardt continued to sell drugs based on this banned product.
The FDA has alleged in their FIRs that Wockhardt also delayed the process of recalling this drug from the market by sending hard copy letters to its stockist instead of sending mails or faxes. Maharashtra FDA has demanded the arrests of the company’s sales and distribution officials.
While Wockhardt has rejected all these claims, they say they have already contested the ban on Dextropropoxyphene with a filing before an appropriate judicial authority. It is a pain killer which is used primarily for terminally ill patients.
Wockhardt has also said that they were not even intimated by FDA about the ban on May 23 and were informed about it only through a public mail on June 10 which is when they stopped manufacture and sale of this drug and initiated recall from the market. The company claims a formal letter came only on July 12 and the company is now looking at ways to readdress this matter. This case will come up before the Bombay High Court on August 20.