Chandigarh, September 29
Anaesthetic injection ‘Propofol’ has been confirmed to have caused five deaths at the Postgraduate Institute of Medical Education and Research (PGI) during surgical procedures nearly a month ago, says a lab report. The injection has not been found of “standard quality”.
Chemists, firm put on notice
The UT has put Gupta Medical Store, Emergency; Shiv Amrit Chemist, Sarangpur; and Biovenice Criticure, Panchkula, on noticeNixi Laboratory, the manufacturing firm, told to recall all batches of the drug, including one found not of standard qualityThe Drugs Controller General of India asked to issue alert to state drugs controllers of the country to take immediate appropriate action
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 a period of few days was reported.
As per the report received on September 27, the drug has been declared as not of standard quality by the laboratory, as it failed the sterility, free fatty acid, pH, Propofol dimer, bacteon tests the very next day of receipt of samples.
Suspicions confirmed
The report confirms our suspicion that a substandard drug was responsible for catastrophic events. Appropriate and deterrent action will be taken. —Prof Vivek Lal, PGI Director
Tests failed
Sterility | Free fatty acid | pH | Propofol dimer | Bacteon
“We have already served a show-cause notice on the chemist from whom the drug was purchased. Now, the report confirms our suspicion that a substandard drug was responsible for the catastrophic events. We will ensure this is communicated to relevant quarters. Appropriate and deterrent action will be taken,” said Prof Vivek Lal, PGI Director.
Acting under the provisions of the Drugs and Cosmetics Act, 1940, the UT has served notices on Gupta Medical Store, Emergency block, PGI; Shiv Amrit Chemist, Sarangpur village; and Biovenice Criticure, Sector 20, Panchkula. All firms were again directed to recall the batch of drug Propoven.
Nixi Laboratory, manufacturing firm, has also been directed to recall all batches of the drug, including the one found not of standard quality.
The Chandigarh Administration has also written to the Drugs Controller General of India (DCGI) to issue alert to state drugs controllers of the country to take immediate appropriate action.
After receiving complaint from the PGI on September 2, the Chandigarh Administration had constituted a joint investigation team comprising inspectors of the Drugs Control Wing, Chandigarh, and Central Drugs Standard Control Organisation, Sub Zone Baddi, which drew samples of Propoven (Propofol injection) and sent these to the Regional Drugs Testing Laboratory, Chandigarh.
As precautionary measure, retailers, wholesalers and distributors were asked to recall the drug or freeze the stock. The state drugs controllers of Haryana and Himachal Pradesh were asked to take appropriate action as the distributor and manufacturer were in their area of jurisdiction, respectively. It is learnt ever since the batch of the anaesthetic drug was stopped from being used at the PGI, no adverse event of the sedative had been reported in the patients during surgery.
Fatalities over few days
On September 1, 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 a period of few days was reported.
