Baddi Pharma Firm Loses Licence After 1,200 Kg Unauthorised Tapentadol Seized
Solan: The Drugs Licensing Authority (DLA), Baddi, has cancelled the manufacturing licence, product licences and other permissions of Sharika Biotech at Jagatkhana village in Nalagarh after around 1,200 kg of unauthorised tapentadol was seized from the company's premises.
The seizure was made during a joint raid by the Narcotics Control Bureau (NCB) and Drugs Control Administration (DCA) on September 1. The action followed the recovery of a substantial quantity of loose and unlabelled tablets from the pharmaceutical unit.
The firm was subsequently served a show-cause notice on September 4, seeking an explanation regarding the presence of the loose and unlabelled tablets, their identity and source, batch manufacturing records, and the storage of raw materials and finished pharmaceutical products at the unit and other premises without statutory authorisation.
Sharika Biotech was given three days to respond but failed to submit its explanation within the stipulated period. Laboratory analysis of the seized tablets later confirmed that the material was tapentadol hydrochloride.
Verification by the Baddi DLA established that no product licence had been issued to the company for manufacturing tapentadol. Authorities found that the activities constituted serious violations of provisions of the Drugs and Cosmetics Act, 1940, and its rules.
Officials also discovered that raw materials, finished pharmaceutical products and packaging materials were being stored at a godown near the firm and at an unlicensed premises in Baddi.
The seized tapentadol, estimated to be worth crores of rupees, consisted of loose red-coloured tablets containing 250 mg strength. Pharma experts noted that this strength is not approved for therapeutic use in India. Such tablets are generally manufactured for export to African countries after obtaining central approval.
Following the regulatory action, the firm has been directed to stop all manufacturing activities. It has also been ordered to destroy its raw materials, batches under manufacture, finished pharmaceutical products and packaging materials. A drug inspector has been entrusted with ensuring that the company complies with these directions.
Tapentadol is a prescription opioid painkiller with potential for misuse. A pharma expert cautioned that improper consumption of the medicine can pose serious health risks, making unauthorised manufacture and handling of such products a significant regulatory and public-health concern, reports The Tribune.
