14 samples of propofol injections declared substandard by two labs

Tribune News Service

Ambika Sharma

Solan, December 13

As many as 14 samples of propofol injections manufactured by Kala Amb-based Nixi Laboratories have been declared substandard by the Central Drugs Laboratory (CDL), Kolkata, as well as the Regional Drugs Testing Laboratory (RDTL), Chandigarh. This was revealed in the monthly drug alert issued by the Central Drugs Standards Control Organisation (CDSCO) today.

This has put a question mark over the quality of injections manufactured by Nixi Laboratories, which was already under the scanner after five deaths were reported at the PGI, Chandigarh, in September after the use of these injections. Propofol is used to induce and maintain sleep as part of anaesthesia during surgery.

Both labs have termed assay as the reason of failure in today’s alert. Thirteen samples from various batches of propofol were drawn by the Drugs Control Department (DCD), Himachal Pradesh, while one was drawn by the CDSCO’s Baddi-based sub-zonal office. These batches were withdrawn from the market in September after the PGI incident.

Pharma experts opine that the lack of assay, which is an active ingredient in a medicine, is not considered life-threatening though it affects efficacy.

Garima Sharma, Assistant Drugs Controller-cum Licensing Authority, Kala Amb, confirmed that 14 samples of propofol injection have been declared substandard in the monthly alert issued by the CDSCO. She said about 54,000 vials of propofol injection, pertaining to various batches, had already been withdrawn from the market following deaths at the PGI in September.

“Since 14 samples of propofol injection have been found to be substandard, the drug inspector will submit his report to a three-member prosecution committee, which will recommend a suitable action based on the findings,” said Navneet Marwaha, State Drugs Controller.

The company was directed to stop manufacturing of propofol injections on September 28 after the Regional Drug Testing Lab at Chandigarh had declared a particular batch used at the PGI as substandard.

According to the lab reports, the samples did not conform to the Indian Pharmacopoeia-2018 parameters with respect to description, pH, propofol dimer, free fatty acid, bacterial endotoxins, sterility and assay content.

Besides, 1,487 drugs samples were tested by various labs from across the nation and 83 were found substandard in the drug alert. This comprised 27 samples drawn from nine pharmaceutical companies located in the industrial clusters of Paonta Sahib, Kala Amb, Nalagarh and Baddi in the state. These drugs are used to control hypertension, fever, pain, worm infestation, infections, vitamin supplements, acidity, seizure and spasticity.

The firms have directed to withdraw batches of these drugs from the market while the field staff has been directed to inquire into the cause of each substandard drug.

Marwaha said companies whose samples are regularly figuring in the list of substandard drugs would be jointly inspected by the state and CDSCO officials to judge whether conditions of licence, especially pertaining to schedule M, L and U of the Drugs and Cosmetics Act, were being adhered to. Further action as per the findings would be initiated against them, she added.

Samples did not conform to parameters

• According to the lab reports, the samples did not conform to the Indian Pharmacopoeia-2018 parameters with respect to description, pH, propofol dimer, free fatty acid etc.
• Besides, 1,487 drugs samples were tested by various labs from across the nation and 83 were found substandard in the drug alert issued today

Drug inspector to submit report

The drug inspector will submit a report to a three-member prosecution committee regarding 14 samples of propofol injection that have been found to be substandard. The committee will recommend a suitable action based on the findings. — Navneet Marwaha, state drugs controller

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