Injection deaths: PGI chemist served show-cause notice

Tribune News Service

Chandigarh, September 8

Days after five deaths were reported at the PGIMER, apparently due to adverse drug reactions of “Propoven” (Injection Propofol IP 10 mg/ml), manufactured by Becure (Biovenice Criticure), the hospital administration on Thursday issued a show-cause notice on Gupta Medicos, a chemist shop located in the Emergency Block from where the drug was reportedly procured by patients and attendants.

May lose licence for breach of norms

• The PGI has asked Gupta Medicos to explain its position regarding sale of injection Propofol and as to why action may not be initiated against it
• The notice has been served as per terms and conditions of licence deed, which mandates sale of only quality products, medicines and drugs
• The breach of conditions entails cancellation of licence. The chemist pays a hefty monthly rent of Rs 1.57 crore to the PGI

The notice has been served as per the terms and conditions of the licence deed, which mandates sale of only quality products, medicines and drugs, etc. and restricts sale or stocking of spurious, soiled items.

The breach of these conditions entails cancellation of the licence. The products are required to conform to the rules and laws of the government regarding their sale.

As per the show-cause notice issued with the approval of competent authority, Gupta Medicos has been directed to explain their position within a week from the date of issue of the notice regarding sale of the drug and also as to why action may not be initiated against it as per the terms and conditions of the licence deed.

Chandigarh Tribune had reported that private chemists at the PGI stocked up brands that offered higher margin, thereby compromising with the quality of medicines, which was apparently seen in the case of Propofol.

Interestingly, the chemist who sold the anaesthetic injection pays a hefty monthly rent of Rs 1.57 crore to the PGI.

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.

It was learnt that ever since the batch of anaesthetic drug was stopped from being used at the PGI, no adverse event of the sedative had been reported in the patients during surgery.

Propofol injection is an anaesthetic/sedative used to help relax or sleep before and during surgery or other medical procedures. Abuse/recreational use could cause death due to rapid onset of unconsciousness and apnea.

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