Daijiworld Media Network - New Delhi
New Delhi, Sep 6: India’s apex drug regulator has alerted states to remain vigilant against a suspected counterfeit batch of the widely used Abhayrab rabies vaccine after samples failed a potency test and were found to be misbranded.
The Central Drugs Standard Control Organisation (CDSCO) has asked State Drugs Controllers to closely monitor the movement, distribution and availability of Abhayrab batch KE25012 and take appropriate regulatory action wherever necessary. The directive was issued by Drugs Controller General of India (DCGI) Rajeev Singh Raghuvanshi in a communication dated August 27.
The samples were collected from an unlicensed residential premises in Delhi and were subsequently found to be “Not of Standard Quality”. Laboratory testing raised concerns over the authenticity of the vaccine, including its potency and packaging.
Several discrepancies were reportedly detected in the packaging, including differences in the company logo, fonts, text spacing, QR code, cap colour, licence details and other labelling elements. One spelling difference involved “L Pasteur” being printed as “L Posteur”.
Indian Immunologicals Ltd (IIL), the manufacturer of Abhayrab, has said the seized vials were not manufactured by the company. The manufacturer identified 17 differences between the seized samples and its retained reference samples for the same batch, strengthening concerns that the products may be counterfeit or spurious.
IIL said the genuine batch consisted of 83,370 vials distributed through authorised channels and maintained that vaccines supplied through licensed pharmacies and hospitals were unaffected. The company said it was cooperating with the investigation.
The regulator has confirmed that the suspected batch was not exported from India. Four people have been arrested by Delhi Police in connection with the case, while further investigation and legal action are underway.
The latest alert comes less than two years after another counterfeit Abhayrab batch, carrying batch number KA24014, was detected in India. The earlier case prompted health authorities in countries including the United States, United Kingdom and Australia to issue warnings to travellers who may have received the suspected vaccine.
Abhayrab is one of the most widely used human rabies vaccines in India and accounts for nearly 40 per cent of the country’s rabies vaccine market. Rabies is almost invariably fatal once symptoms develop, making timely and effective vaccination following exposure critical.
The CDSCO’s nationwide alert is aimed at preventing any further circulation or use of the suspected batch while authorities investigate its source and distribution network.