No detailed report from PGI, can’t file FIR against Propofol maker: DCA

Tribune News Service

Ambika Sharma

Solan, November 24

With the PGIMER, Chandigarh, failing to provide a detailed report on the death of six persons following the administration of Propofol injection, manufactured by Kala Amb-based Nixi Laboratories Pvt Ltd, an FIR could not be lodged against the firm, said the Drug Control Administration (DCA).

Killer sedative

  • Anaesthetic injection Propofol caused six deaths at PGI, Chandigarh, in August
  • Officials claim action couldn’t be taken for want of report of an in-depth probe into deaths

The authorities had ordered the withdrawal of all batches of Propofol after the deaths in September. Its product approval was withdrawn and production suspended, but no FIR was registered. Its samples drawn from the suspected batch (PNL-220316) had failed to meet the prescribed standards, following which action was taken as per norms of the Central Drugs Standard Control Organisation. Garima Sharma, Assistant Drugs Controller-cum-Licensing Authority, confirmed that as per the report of the Central Drugs Laboratory, Kolkata, the samples passed sterility test, but failed to meet other parameters as prescribed by the Indian Pharmacopoeia, 2018. “Since the PGIMER failed to provide an in-depth report into the cause of the deaths, an FIR could be filed against the firm,” she said.

However, in the case of Coldbest-PC cough syrup, which led to the death of 12 infants in Udhampur in 2020, an in-depth report was provided and an FIR was lodged against the Kala Amb-based manufacturer Digital Vision.