Even after a month since five patients allegedly died at the Post Graduate Institute of Medical Education and Research (PGIMER) after being administered with the Propofol drug, the institute is yet to ascertain the cause of death and fix responsibility.
In the Chandigarh and Central Drugs Standards Control Organisation (CDSCO) report which was received on September 27, the drug was declared “not of standard quality” , as it failed checks on various parameters including sterility, free fatty acids, pH, Propofol dimer and bacteon.
On October 4, a high-level internal committee constituted by PGIMER submitted its final report to the director, but the institute is yet to reveal its findings.
PGIMER director Dr Vivek Lal, said, “The CDSCO report had confirmed our suspicion that the substandard drug was responsible for the deaths. However, I have not yet read the internal committee’s report and have asked the institute’s deputy director administration-cum-spokesperson to take further action.”
PGIMER is also yet share the internal committee’s report with UT health department and Himachal Pradesh, due to which no criminal action has been taken against Himachal Pradesh based firm Nixi laboratory which manufactures the drug.
Navneet Marwaha, state drugs controller (SDC) of Himachal Pradesh, said, “After receiving information from CDSCO and Chandigarh, Nixi Laboratory at Kala Amb in Himachal’s Sirmaur district was directed to stop manufacturing Propofol by the assistant drug controller-cum-licensing authority of the area. In addition, the effective recall of all the batches has been ordered and the stocks of the drug in question are also being received from throughout the country.”
{{/usCountry}}Navneet Marwaha, state drugs controller (SDC) of Himachal Pradesh, said, “After receiving information from CDSCO and Chandigarh, Nixi Laboratory at Kala Amb in Himachal’s Sirmaur district was directed to stop manufacturing Propofol by the assistant drug controller-cum-licensing authority of the area. In addition, the effective recall of all the batches has been ordered and the stocks of the drug in question are also being received from throughout the country.”
{{/usCountry}}He added, “After we receive PGIMER’s report, we may register an FIR against the firm if needed.’”
Meanwhile, UT director of health services Dr Suman Singh, said, “So far, PGIMER has not shared the committee’s report or confirmed if the deaths were caused due to substandard drugs. Though the drug was sub-standard, committee findings must ascertain the cause of death. We can take further action or can recommend action against the manufacturing firm to the CDSCO only after getting the institute’s report.”