Four samples of Propofol injections among 21 drugs declared substandard

Ambika Sharma

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Solan, October 17

Four samples of Propofol injections manufactured by Kala Amb-based Nixi Laboratories, including two drawn from the contentious batch which caused five deaths at PGIMER Chandigarh, were declared substandard by the Central Drugs Standard Control Organisation (CDSCO) in the monthly alert issued on Monday.

These samples were drawn by the CDSCO’s sub zonal office at Baddi and Drug Control Administration, Himachal Pradesh. They were tested at Regional Drug Testing Lab Chandigarh and Central Drug Laboratory, Kolkata. Both labs have declared all four samples comprising two of the erring batch (220316) and two others (220418, 220419) not of standard quality.

According to the lab reports, the injection samples did not confirm to the Indian Pharmacopoeia 2018 with respect to Description, pH, Propofol dimer, free fatty acid, Bacterial Endotoxins, Sterility and assay content.

Pharma experts opine that issues like bacterial endotoxins, sterility, assay content are considered serious flaws for an injection as it is administered intravenous and can have an immediate adverse reaction in a patient.

Assistant Drugs Controller-cum-Licensing Authority has already directed the firm, Nixi Laboratories, Kala Amb, to stop manufacturing of the said injections on September 28. While all samples of the said injections were withdrawn from the market after the CDSCO declared the erring batch substandard in September, the officials were awaiting other lab reports before finalising further action.

Navneet Marwaha, State Drugs Controller, while confirming the development said, “Further action as per the Drugs and Cosmetics Act would be taken against Nixi Laboratories, Kala Amb, following an inspection report of the field staff which was probing its various aspects. More reports were awaited to finalise the report.”

Detailed investigations into the firm’s compliance of Good Manufacturing Practices, which ensures that products are consistently produced and controlled as per quality standards, were underway.

In the monthly drug alert issued by the CDSCO, of the 1,456 drug samples drawn from various states, 1,397 were found of standard quality while 59 were declared not of standard quality. Out of them 21 pertain to 16 drug firms of Himachal.

They comprise four batches of Propofol injections manufactured by Nixi Laboratories, Kala Amb.