The Drugs Licensing Authority (DLA), Baddi, has cancelled the manufacturing licence, product licences and permissions of M/s Sharika Biotech at Jagatkhana village in Nalagarh after around 1,200 kg of unauthorised tapentadol was seized from its premises during a joint raid by the Narcotics Control Bureau (NCB) and Drugs Control Administration (DCA).
The firm was served a show-cause notice on September 4, seeking an explanation for the presence of loose and unlabelled tablets, their identity and source, batch manufacturing records and the storage of raw material and finished drugs at the unit and other premises without statutory authorisation.
The company failed to respond within the stipulated three-day period. Laboratory analysis subsequently confirmed the seized tablets as tapentadol hydrochloride.
Verification by the Baddi DLA found that no product licence had been issued for manufacturing the drug, constituting serious violations of provisions of the Drugs and Cosmetics Act, 1940, and its rules.
Officials also found raw materials, finished pharmaceutical products and packaging material stored at a godown near the firm and at an unlicensed premises in Baddi. The seized tapentadol, valued at crores of rupees, comprised loose red-coloured tablets of 250-mg strength. Pharma experts said the strength is not approved for therapeutic use in India and such tablets are generally manufactured for export to African countries after obtaining central approval.
“The firm has been directed to cease all manufacturing activities and destroy its raw material, batches under manufacture, finished goods and packaging material. A drug inspector has been entrusted with ensuring compliance,” a DCA official said.
A pharma expert said tapentadol is a prescription opioid painkiller that is prone to misuse and can cause serious health risks when consumed improperly.
