In reference to complaint received from PGIMER, Chandigarh on 02.09.2022 regarding adverse reaction of Propoven injection, the following immediate actions were taken:
1. A Joint investigation team comprising drugs inspectors of Drugs Control wing, Chandigarh Administration and Central Drugs Standards Control organization (CDSCO), Sub Zone Baddi inspected M/s Gupta Medicos, emergency Block, PGIMER Chandigarh and Drugs Inspector CDSCO; Sub Zone Baddi collected two samples of drug Propofol on 02.09.2022. The result of samples were as under:
a) As per information received from Drugs Inspector, CDSCO, Sub Zone Baddi the drug Propofol Emulsion for injection IP, 10 mg per ml (Propoven injection) Batch no. PNL-220316, manufactured by M/s Nixi Laboratories Pvt. Ltd., Kala Amb, Himachal Pradesh was declared by the Govt. Analyst, RDTL, Chandigarh “Is Not of Standard quality”.
b) As per information received from Drugs Inspector, CDSCO, Sub Zone Baddi the drug Propofol emulsion for injection IP, 1% W/V (NEOROF injection) Batch no. 340160, manufactured by M/s Neon Laboratories Ltd., Andheri East Mumbai, Maharashtra was declared by the Govt. Analyst, RDTL, Chandigarh “Is Not of Standard quality”.
2. Immediately after getting the test reports:
a) The Drugs Control wing of Chandigarh administration ensured that the whole stock of both the drugs was recalled from the market
b) The Drugs Inspector, CDSCO, Sub Zone Baddi being investigating officer, started the investigation from retail chemist to the manufacturers level under provisions of Drugs and Cosmetics Act/Rules.
3. Further as per inquiry report shared by the PGIMER, the Director PGIMER constituted a committee under the Chairmanship of Prof. S.K Gupta, Head of Department of Neurology to look into the details in the Adverse Events reported by the Department of Neurosurgery/Neuroanesthesia. This being a internal matter of PGIMER so they would be the best to comment on findings/report of the said committee.
4. There is no further role of the Drug Control Authority Chandigarh and required actions are being taken by the CDSCO.
