Racket involving supply of spurious raw material by Baddi firm busted
In a significant breakthrough achieved in busting spurious drug raw material supply racket, the Baddi-based Drugs Control Administration (DCA) today seized 950 kg of Active Pharmaceutical Ingredient (API) Sucralfate, a critical drug used in the treatment and prevention of duodenal ulcers.
The racket was involved in the supply of spurious Active Pharmaceutical Ingredient, which is drug raw material, into the state.
A team led by Dr Manish Kapoor, State Drugs Controller, Himachal Pradesh, achieved this breakthrough following a complex set of lab tests to corroborate the spurious API.
Acting on credible intelligence inputs, Drug Inspectors Vikas Thakur and Akshay Kumar had inspected the premises of M/s Adinath Healthcare, Baddi first on July 15, 2024 and again on July 24, 2024 where they found 30 drums of API labelled as Sucralfate (claimed to be manufactured by M/s Legend Industries, Gujarat) and eight drums of Sucralfate (labelled as manufactured by M/s Par Drugs and Chemicals Ltd, Gujarat).
To ascertain the authenticity of the said APIs, 11 samples were drawn and sent to Central Drugs Laboratory (CDL), Kolkata’s Government Analyst. Shockingly, lab analysis revealed zero content of Sucralfate in the samples, indicating that the APIs were grossly spurious. The concerned manufacturing firms, however, challenged the findings under the Drugs & Cosmetics Act, 1940, following which the samples were forwarded for retesting to the Director, Central Drugs Testing Laboratory (CDTL), Kolkata, through the court.
Five conclusive reports received yesterday from the apex drug testing laboratory, conclusively confirmed zero content of Sucralfate. Out of this four reports pertain to API labelled as manufactured by M/s Par Drugs & Chemicals Ltd, Gujarat while one pertains to API labelled as manufactured by M/s Legend Industries, Gujarat.
“Sucralfate is a critical drug used in the treatment and prevention of duodenal ulcers. It acts by forming a protective barrier over ulcers, shielding them from gastric acid and aiding in healing. Presence of a spurious form of such a therapeutic drug poses a serious risk to the patient safety,” explained Kapoor.
Considering the gravity of the violation, the DCA officials today seized its entire stock amounting to a total of 950 kilograms today. The said stock had earlier been freezed by the officials to prohibit its use.
Dr Kapoor stated that further action under the Drugs & Cosmetics Act will be initiated against the offenders upon completion of the ongoing investigation. He reiterated that they follows a zero-tolerance policy towards spurious drugs and are fully committed to safeguarding public health.
He highlighted that during the previous financial year, 19 cases involving spurious drug formulations falsely showing Himachal-based manufacturers were reported. Four such cases have already been identified in the current financial year. He urged regulatory authorities in other states to act decisively, as such activities tarnish the image of Himachal Pradesh, which otherwise holds a prestigious position as Asia’s hub for pharmaceutical manufacturing.
Himachal Tribune