Habitual offenders regularly figure on this list
Solan: The quality of drugs manufactured in the state has once again come under the scanner with propofol injections manufactured by Nixi Laboratories, Kala Amb, reportedly causing five deaths at the PGI, Chandigarh, an exclusive report by Ambika Sharma in The Tribune, Chandigarh, says.
This is not the first case where drugs manufactured in the state have proved fatal. In February 2020, 12 infants had died after consuming the Coldbest-PC syrup at Udhampur.
The Central Drugs Standard Control Organisation (CDSCO) issues monthly alerts on substandard drugs nationally. An analysis of its figures for this year shows that of the 10,062 samples taken, 306 were found substandard of which 85 were manufactured in Himachal.
Some manufacturers regularly figure on this list, which has brought their operations under the scanner.
Though the Drug Control Administration (DCA) initiates action like recall of a drug batch after it is declared substandard, it has failed to deter habitual offenders who regularly figure in this list.
A section of the manufacturers blames the lack of regulation on raw material traders. “Though raw material traders avail of a licence under the Drugs and Cosmetics Act, 1940, there is little check on them. The sale of substandard or contaminated material by unregistered vendors often leads to production of substandard drugs,” explained a Baddi-based manufacturer.
PGI Chandigarh mum over 5 deaths
Despite UT’s report confirming the anaesthetic (propofol injection) used at the Postgraduate Institute of Medical Education and Research (PGI) was of “substandard” quality, the responsibility is yet to be fixed in connection with five deaths during operative procedure at the hospital over a span of few days.
Confirmation awaited
We haven’t received report from PGI confirming whether cause of deaths is linked to propofol. Nor have we got any recommendation for an FIR, said Dr Suman Singh, Director, Health Services
While the PGI’s internal committee has investigated whether the cause of deaths was the anaesthetic, the UT report on the quality check of the drug received by the Central Drugs Standard Control Organisation (CDSCO) on September 27 had revealed “the drug sample failed in sterility, free fatty acids, pH, propofol dimer, bacteon tests”.
We haven’t received report from PGI confirming whether cause of deaths is linked to propofol. Nor have we got any recommendation for an FIR, said Dr Suman Singh, Director, Health Services
As per sources, the report has confirmed blood pressure fell in some patients after propofol injection was administered, leading to kidney failure and subsequent deaths.
On September 1, a matter regarding “unexplained” hypotension (sudden drop in blood pressure) in intraoperative (occurring or performed during the course of a surgical operation) period with anuria (failure of the kidneys to produce urine) and/or jaundice in post-operative period in a few patients over the past few days had come to the fore.
Nixi Laboratories, manufacturing firm of the anaesthetic drug situated at Kala Amb (Himachal Pradesh), was directed to recall all batches of drug Propoven, including the batch of drug found not of standard quality.
As per PGI authorities, the onus of registering the FIR against the manufacturing unit of the anaesthetic drug was on the UT Administration.
However, the Director Health Services, Dr Suman Singh, said: “We have not yet received the report from the PGI confirming whether the cause of deaths is linked to the propofol injection. Neither have we got any recommendation for an FIR from the hospital. As per the quality report of the drug, we have already raised the matter with the Centre and it is under their jurisdiction to get the FIR registered.”
The Deputy Director of PGI, Kumar Gaurav Dhawan, said: “The report has been received and is being examined. Appropriate action will be taken on the findings and conclusion of the report. We are trying to issue a detailed statement tomorrow.”
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