PGI Chandigarh Propofol Deaths: Drugs sold as per norms, not expired claims pharmacy in reply
In reply, the private pharmacy has stated that they sold the drugs according to the prescribed norms, adding that they were not expired. A copy of the license, certification of good manufacturing practices, certification of good laboratory practice, and other related documents were submitted by the pharmacy shop-in-charge
Chandigarh: Days after the health officials seized the anaesthetic medicine Propofol injection from the hospitals and pharmacies in Chandigarh amid allegations that it contributed to five deaths at the Post Graduate Institute of Medical Education and Research (PGIMER), the officials have decided to wait for reports of the propofol injection samples before taking any action against the seller.
The propofol drug was acquired from a private chemist shop at the Emergency Block by the patients and attendants. Five patients were slated to undergo orthopaedic and neurosurgeries after receiving the aesthetic medicine Propofol injection, which is suspected to have caused their deaths, and it was earlier reported by the Medical Dialogues team.
Also Read:Batch of anaesthetic withdrawn from Chandigarh pharmacies after 5 PGI deaths
On September 1, the PGIMER officials stated that the deaths might have occurred due to adverse reactions to the drug "Propoven" (Inj. Propofol IP 10 mg/ml) manufactured by Becure (Biovenic Criticure). Following that, a show-cause notice was served to the M/s Gupta Medicos, the chemist shop at Emergency Block by the terms and conditions of the license deed that mandates the sale of quality products, medicines, and drugs. The license of the seller could be canceled if the conditions are broken.
In reply, the private pharmacy has stated that they sold the drugs according to the prescribed norms, adding that they were not expired. A copy of the license, certification of good manufacturing practices, certification of good laboratory practice, and other related documents were submitted by the pharmacy shop-in-charge, reports the Hindustan Times.
The shop-owner as quoted in the reply states, "No bill has been attached with the show-cause notice nor has a complaint by any specific patient/attendant been provided 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 letter further stated, "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 a GLP certificate. The same drug, manufactured by the same company, is also approved/sourced for government supply at GMCH-32."
Noting that their role ended with procuring and selling it, the letter said, "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."
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."
The injection was given to around 75 patients during that time, and adverse reactions were seen in nine patients who had received the drug manufactured by Becure, according to the PGIMER's internal committee's preliminary findings. A joint team of drug inspectors of UT Chandigarh and the Central Drugs Standard Control Organisation (CDSCO) collected the samples from the chemist shop which had sold the drug to the patient's attendants. The health department hasn't received the sample reports even though they were collected on September 2.
Propofol is an injection to help sleep before and during surgery or other medical procedures, and it is an anesthetic and a sedative. In an interview with anesthesiologists reported in the Times of India, three possible reasons were stated as the possible cause behind the death. They were overdose, believed to be the least likely since PGI has been using this drug for many years; the second was contamination after the purchase which happens if we use the drug after 6 hours of opening the seal, and the third cause, which is the suspected one, could be contamination from the manufacturer, as other company drugs are also being used and this suspected drug was from a Panchkula based manufacturer.
