Drug fails lab test, says DHS, central agency must conduct final investigation


The Chandigarh Regional Drug Testing Laboratory has found that Propoven (propofol injection), an anesthetic given to patients before surgery, is not of standard quality.

The lab report, received Sept. 27, states that the drug failed sterility, free fatty acids, pH, propofol dimer, and bacterial endotoxin.

“After this report, the Central Drug Standards Organization will conduct the final investigation and we will await its report on the way forward,” said Dr. Suman Singh, UT Director of Health Services (DHS). .

On September 2, a high-level committee of IGP Chandigarh doctors had contacted the UT Health Department to test the drug as a few deaths and its serious side effects have been reported to the institute. According to sources at PGI, these patients underwent surgery and were sedated with propofol.

On September 1, complications such as unexplained hypotension (low BP) during the intraoperative period (during the operation) with anuria (decreased urine production) and/or jaundice during the postoperative period in a few patients as well that deaths have been reported. in the opinion of the medical superintendent by two department heads. Acknowledging the situation, the director of the PGI set up a high-level committee under the chairmanship of Professor SK Gupta, head of the department of neurosurgery, to investigate the matter.

According to Kumar Gaurav Dhawan, Deputy Director (Administration), PGI, the report on the matter from the PGI committee is awaited.

“The substandard medicine clearly proves that it was the cause of the catastrophic events. Deterrent and appropriate measures will be taken in due course,” said Dr. Vivek Lal, Director of PGI.

Listing the precautionary measures, DHS said a joint investigation team comprised of drug inspectors from the Drug Control Wing, Chandigarh, and the Central Drug Standards Control Organization, Deputy Baddi area, took samples of the drug on September 2 and sent the samples to regional drugs. Testing Laboratory, Chandigarh.

Retailers, wholesalers and distributors of the drug have been asked to recall the drug or freeze drug stocks, Dr Singh said. Further, the National Drug Controller, Haryana, and the National Drug Controller, Himachal Pradesh, were instructed to take appropriate action as the distributor and the manufacturer of the drug were respectively within their area of ​​jurisdiction.

The four available injections of the particular lot have been removed from the pharmacy. The distributor of Panchkula has been instructed to ensure that injections of the particular lot are not sold/used until analysis is complete.

According to DHS, no more injections of the particular batch are available at any of the UT pharmacies.
In view of the suspected adverse drug effect, the PGI administration had issued a show cause notice to M/s Gupta Medicos, Emergency Block Pharmacy, PGI, from where the drug was allegedly purchased by patients and attendants .

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