E-Paper
Propofol row at PGIMER: Drugs sold as per norms, chemist shop in reply to show-cause notice
The drug, if sold by us, was sold in a sealed condition and stored as per recommendations and our role is confined to procuring and selling medicines, the private chemist shop at the institute’s emergency block tells PGIMER
Post Graduate Institute of Medical Education and Research (PGIMER) will wait for reports of the propofol injection samples, that are suspected to have caused the death of five patients at the institute, before taking any action against the private chemist shop at the Emergency Block, from where the drug was procured by the patients and attendants.
PGIMER authorities had on September 1 said that the deaths are suspected to have been caused by adverse reaction to the drug “Propoven” (Inj. Propofol IP 10 mg/ml) manufactured by Becure (Biovenic Criticure).
Subsequently, a show-cause notice was served to M/s Gupta Medicos, the chemist shop at Emergency Block, as per the terms and conditions of license deed, which mandated ensuring sale of quality products, medicines and drugs. Breach of these conditions entails cancellation of licence.
However, the private pharmacy has submitted a reply with the authorities claiming that the drugs were sold were as per prescribed norms and were not expired. The pharmacy shop in-charge also submitted the copy of licence, certification of good manufacturing practices, certification of good laboratory practice and other related documents.
“No bill has been attached with the show-cause notice nor has a complaint by any specific patient/attendant been provide to show that the drug has been purchased from our shop. The same drug is readily available in the market. Also, we have been functioning as per the terms of the licence deed,” the shop’s owner stated in his reply.
“Further, the inspection of the drug Propoven (Inj. Propofol) will show that it has been manufactured by M/s Nix Laboratories Private Limited and not by Becure (Biovenic Criticure), as alleged in the show-cause notice. The firm is a manufacturer of medicines, which has the certificate of good manufacturing practices issued by the health and family welfare department, Himachal Pradesh. It also has the GLP certificate. The same drug, manufactured by the same company, is also approved/sourced for government supply at GMCH-32”, the letter added.
“The drug, if sold by us, was sold in a sealed condition and stored as per recommendations. In case, the sales have been made by us, our role is merely confined to procuring the medicine and selling it” the letter further said.
Meanwhile, PGIMER director Dr Vivek Lal, said, “Authorities are examining the documents and files submitted by the pharmacy. The authorities are waiting to get the reports of the Propofol injection samples that have been sent for testing. We are also waiting for the institute’s internal committee to submit the report on the incident, before taking any action against the chemist.”
As per the PGIMER’s internal committee’s preliminary findings, Propofol injection was inoculated to nearly 75 patients during that time, but around nine patients who got the drug manufactured by Becure, got adverse reactions.
UT yet to receive samples report
After PGIMER reported health complications in post-operative period in a few patients, a joint team of drug inspectors of UT Chandigarh and the Central Drugs Standard Control Organisation (CDSCO) had taken samples from the pharmacy from where the drug was purchased by patients’ attendants.
Though the samples were collected on September 2, the UT health department is yet to receive the reports of the samples.
