Punjab: Sedative drug samples contaminated, says central agency

Chandigarh: Samples of anaesthetic drug Propofol that was suspected to have caused deaths of five patients at PGI were found to be contaminated and failed to meet standards on multiple parameters, according to a report of the Central Drugs Standard Control Organisation (CDSCO).

"The samples have failed in sterility, pH values, description and other related substances. The drug does not meet the standards and is contaminated," said an official at the Drugs Controller General of India (DCGI), New Delhi. The findings prompted the DCGI to issue an alert to state drug controllers asking them to take immediate action.


The injection was manufactured by Nixi Private laboratories in Kala Amb, Himachal Pradesh. The company, on its website, mentions it is a WHO, GMP-GLP (Good manufacturing practice and Good laboratory practice) and ISO certified manufacturing facility established in 2019.

The CDSCO has issued a notice to the manufacturer to stop and withdraw the injection from the market. State drug authorities at Himachal Pradesh, Chandigarh and Haryana were alerted about the report. "We have asked the firm to stop manufacturing the product and deposit all samples of that batch. Accordingly, we shall take action as per law," said Neeraj Kumar, special secretary, health, Himachal Pradesh.



Sources said more than 3,000 vials of the drug have been distributed across the country. The central drug officials are investigating the cause of the failure before taking further action. "The defect can be from manufacturer, or retailer, or distributor's side. The supply chain has to be investigated," said an official.

On September 5, TOI was the first to report about five deaths of patients who were administered the injection from the same company at PGI. As the hospital supply did not have the injection, it was asked to be procured from a shop, 'Gupta Medicos' at the PGI's emergency.

The PGI also had tested samples in its department of pharmacy and found them to be substandard. But the authorities are not able to conclude the injection to be the cause of the deaths. They felt that has to be determined by the doctors.

Earlier, on Wednesday, under provisions of Drugs and Cosmetics Act, 1940, the health department issued a notice to the medical store. On his disclosure, a notice was sent to supplier, Shiv Amrit Chemist, Sarangpur, and Biovenice Criticure, Sector 20, Panchkula, the same day. All the firms were again directed to recall the batch of the drug. Nixi manufacturing firm was also told to recall all batches of the drug.