The drug regulator has alerted states regarding a batch of Abhayrab, the rabies vaccine used in India. A sample from this batch failed the required potency test. It has been declared Not of Standard Quality. An investigation is underway to determine whether it is counterfeit.
According to officials, some vials from this batch were recovered from an unlicensed premises in Mukherjee Nagar, Delhi. These samples were then sent to a government laboratory for testing. Tests conducted at the Central Drugs Laboratory in Kasauli revealed that the samples did not meet the required potency criteria.
Indian Immunologicals Limited, the company that manufactures Abhayrab, has clarified that the vials found in the tests were not manufactured by it. According to the company, the recovered vials bore the Abhayrab name and the KE25012 batch number. However, when compared with company records and the original sample, several discrepancies were discovered.
The company stated that discrepancies were found in the label, packaging, QR code, cap color, license information, and package details. According to the company, the investigation revealed a total of 17 discrepancies. Consequently, it is investigating whether the recovered vaccine was manufactured and marketed in a counterfeit manner.
In light of the matter, the Drugs Controller General of India has directed state drug controllers to closely monitor the sale and distribution of Abhayrab batch KE25012. Officials have been instructed to take appropriate action.
According to the CDSCO, the Delhi Police has taken action in this case and arrested four individuals. Investigating agencies are trying to determine where these vials originated and where they were delivered.
Indian Immunologicals has stated that the Abhayrab vaccine supplied through its authorized channels is not affected by this incident. According to the company, every batch undergoes government scrutiny before being sent to the market.
The company also stated that the original batch of KE25012 contained 83,370 vials, which were distributed through authorized channels. However, the government has not yet clarified the total number of vials subject to scrutiny and how many of these reached the market.
According to the company, authorized supplies are not affected
Indian Immunologicals has stated that the Abhayrab vaccine supplied through its authorized channels is not affected by this incident. According to the company, every batch undergoes government scrutiny before being sent to the market.
The company also stated that the original batch of KE25012 contained 83,370 vials, which were distributed through authorized channels. However, the government has not yet clarified the total number of vials that came under scrutiny and how many of them reached the market.