Spurious drugs: 2 more propofol batches declared substandard

Ambika Sharma

Solan, October 17

Two more samples of anaesthetic propofol injection, drawn from batches other than the one blamed for five deaths at the PGIMER-Chandigarh recently, have failed the safety test, according to the monthly alert issued today by apex drug regulator Central Drugs Standard Control Organisation (CDSCO). Four samples of propofol, manufactured by Nixi Laboratories in Kala Amb, Himachal Pradesh, were tested at the Regional Drug Testing Lab in Chandigarh and the Central Drug Laboratory in Kolkata. Two of the samples were from the contentious 220316 batch that caused the five deaths at the PGI while the rest two were from 220418 and 220419 batches.

The samples were drawn by the CDSCO's sub-zonal office at Baddi and the Drug Control Administration, Himachal Pradesh. Both labs in Kolkata and Chandigarh (it had earlier declared 220316 batch substandard) put the four propofol samples in sub-standard category. 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.

Propofol is used to induce and maintain sleep as part of anaesthesia during surgery. Drug experts opine that if parenteral preparations that are "intended to be administered to the body through intra-muscular or intra-venous routes fail in terms of potency, sterility, endotoxin or toxicity, these could cause adverse reactions and even prove fatal". Such drugs fall under the 'grossly sub-standard' category, as defined by the CDSCO. Parenteral preparations are solutions, suspensions or emulsions for injection or infusion; or powders for injection or infusion or gels for injection and implants.

The Assistant Drugs Controller-cum Licensing Authority had on September 28 directed Nixi Laboratories to stop manufacturing of propofol injections. While all batches of the injections were withdrawn from market, the officials were awaiting other lab reports before finalising further action.

HP Drugs Controller Navneet Marwaha said, "Further action as per law will be taken against Nixi Laboratories."

Acidity, diabetes drugs fail test

  • In the CDSCO's monthly drug alert, 59 of 1,456 samples fail test
  • 21 made by 16 firms in HP's Baddi, Nalagarh, Kala Amb, Paonta Sahib and Gwal Thai
  • Used for diabetes, asthma, acidity, urine infections, etc

PGI rules out link

The PGI, in its internal probe, has failed to establish any direct link between propofol and five deaths. It claimed injection was of poor quality, but no link with deaths could be established as autopsy wasn't conducted.

Courtesy: Tribune News Service

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