Drug Hotspots: Lab reports of Propofol samples vary on sterility; other parameters not up to mark

Ambika Sharma

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Solan, November 21

There are contradictory lab reports of Propofol injections, manufactured by Kala Amb-based Nixi Laboratories Private Limited. The Kolkata-based Central Drug Laboratory (CDL) recently declared the samples had passed the sterility test while the Chandigarh-based Regional Drugs Testing Laboratory had said in September the samples failed the test and other parameters.

Both labs tested the samples of the suspect batch (PNL-220316) of Propofol after five deaths were reported at the PGIMER, Chandigarh, following the administration of this injection in September. Propofol is an anaesthetic given to patients before surgery. Subsequently, the firm came under the scanner of the State Drug Control Administration (SDCA), and was directed to stop manufacturing the injections on September 28.

The SDCA will now rely on the report of the CDL for further action. As per the CDL, the injection samples have failed in parameters like pH, Propofol dimer, free fatty acid, etc. Pharma experts opine that issues like 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. But since samples have passed sterility, the other parameters in which the samples have failed are not considered life-threatening.

Garima Sharma, Assistant Drugs Controller-cum-Licensing Authority, confirmed that as per the CDL, the samples had passed the sterility test. They have, however, failed to meet other parameters as prescribed by Indian Pharmacopeia, 2018. The firm has been apprised of these findings and it has been directed to submit its reply following which further action will be taken.

The authorities had ordered the withdrawal of all batches of Propofol after the PGIMER incident. While three samples of the suspect batch (PNL-220316) were drawn from the firm soon after the PGI incident, 18 more samples have been drawn from several batches recalled from the market. This was done to ascertain the quality of all injections available in the market. Garima said about 54,000 vials of the said injection pertaining to various batches had been withdrawn from the market.

The PGIMER has not shared any in-depth report on the exact cause of mortality and since the CDL has found the injection samples fit in sterility as well as assay, it doesn’t seem there were serious manufacturing flaws, she added.

The SDCA is now awaiting the reply of the firm.

Reports of Kolkata, Chandigarh labs differ

• Kolkata-based Central Drug Lab recently declared samples of Propofol, manufactured by Kala Amb-based firm, passed sterility test
• Chandigarh-based laboratory had in September said samples failed test