New Delhi, Sep 5 (PTI) Drug regulatory and law enforcement agencies have intensified action against illegal manufacture and distribution of spurious drugs following the seizure of a batch of “misbranded” Abhayrab rabies vaccine, according to a Drugs Controller General of India (DCGI) notice.
The DGCI said regulatory and law enforcement agencies are maintaining “strict and continuous surveillance” against illegal manufacture, distribution and supply of misbranded and spurious drugs to identify and disrupt unauthorised drug supply networks and safeguard the quality and safety of medicines available to the public.
As part of the enforcement action, Delhi Police’s Crime Branch, along with Drugs Inspectors from the Drugs Control Department of the Delhi government,
searched an unlicensed premises in the Mukherjee Nagar area on April 22.
During the search, Abhayrab rabies vaccine bearing batch number KE25012 was seized.
The vaccine was subsequently found to be “misbranded” and “not manufactured by Indian Immunologicals Ltd.”, the notice said.
Officials from the Central Drugs Standard Control Organisation (CDSCO) were called to the premises for legal sampling, following which the samples were sent to the Central Drugs Laboratory (CDL), Kasauli, for examination.
“The product was subsequently reported as misbranded and not of standard quality by CDL, Kasauli,” the notice said.
The laboratory’s findings, including details of the misbranding detected in the seized product, were communicated by the DCGI to states and Union territories for regulatory vigilance and necessary action.
In a communication dated August 27, the DCGI asked all state drug controllers to alert their inspectorate staff and maintain strict vigilance over the movement, distribution and availability of the affected batch.
The states were also asked to take appropriate regulatory action under the Drugs and Cosmetics Act, 1940 and the rules framed under it.
As a precautionary measure, the manufacturer of Abhayrab also issued a public communication providing information about the misbranded product.
The manufacturer reaffirmed its commitment to quality and said every batch of Abhayrab is released for sale only after independent testing and batch-release certification by CDL, Kasauli.
According to the DGCI notice, vaccines administered at hospitals, clinics and government healthcare facilities, or dispensed through licensed pharmacies, reach patients through the authorised and regulated supply chain after prescribed quality-control and batch-release procedures.
It also that said no part of the batch concerned was exported to any other country.
The seizure and subsequent regulatory action are part of an ongoing surveillance and enforcement mechanism aimed at detecting unauthorised manufacturing and distribution activities and preventing the circulation of misbranded and spurious medicines, the notice said.
“Four persons have been arrested by Delhi Police” in connection with the case, it said, adding that further investigation and appropriate legal action are being taken by the competent authorities.
The development comes amid intensified scrutiny of the authenticity and quality of medicines supplied through unauthorised channels. PTI PLB DIV DIV
