SC issues notice to Centre on study over efficacy of current rabies vaccine in India

The Supreme Court last week, issued notice to the Central Government in a plea seeking to constitute an independent expert committee to study the efficacy of the current rabies vaccines in India filed by Kerala Pravasi Association.

A Supreme Court bench of justices led by Ajay Rastogi and CT Ravikumar issued notice after hearing Advocate Kuriakose Varghese assisted by Advocate V Shyamohan, asking for a stringent committee study on the efficacy of the Intra Dermal Rabies Vaccines (IDRVs) currently being administered to humans, on account of the number of deaths that have occurred despite timely administration of the vaccines in the Country.

These deaths have posed several questions regarding the treatment protocol, and more importantly, the efficacy of the vaccines, the plea states.

The plea has been filed by Dr. Rajendran Vellapalath, Chairman of Kerala Pravasi Association and Ms. Aswani Nambarambath, President of the Party who are also leaders of the Association through Advocates Kuriakose Varghese and V. Shyamohan, KMNP Law.

The plea highlights that ‘as per the National Centre for Disease Control, manufacturing of Rabies vaccine for humans, being a complex process, needs a minimum of three to four months for manufacturing and testing. Shockingly, there have been instances where the vaccine has reached the State within 14 days of manufacture.’

‘Non-adherence to the requisite quality checks would be a direct violation of Articles 14, 19 and 21 of the Constitution of India, apart from violations of provisions under the Drugs and Cosmetics Act, 1940 and Rules thereunder.’

The petition also seeks direction to call for the records pertaining to instances, if any, where vaccines were procured by the State Governments without statutory approvals by the Central Drugs Laboratory.

Along with this, the rise in the number of rabies infected dogs is also a matter of concern, the plea points out. This would warrant an enquiry into the quality of anti-rabies vaccines administered to dogs. It is the petitioner’s case that eliminating the risk of rabies at its source i.e., dogs, is the most effective measure to curtail the spread of rabies’

‘Further, there are studies which reveal that even a single dose of vaccine is effective in curbing rabies in dogs,’ the plea stated.

As per experts, human rabies is a 100 per cent vaccine preventable disease and the vaccines are considered to be ‘highly effective, safe and tolerated’. Perforce, without vaccination, rabies is a fatal disease, the plea adds.

‘While improper administration of IDRV is stated to be a possible reason for failure of the medicine in some cases, the recent deaths points towards the very efficacy of the vaccine.’

The petition also underscored the importance of training medical staff of how to properly deal with dog bites.

‘Moreover, it is necessary that the medical staff be trained adequately to ensure that the National Guidelines for Rabies Prophylaxis, 2019 (‘Guidelines’) can be adhered to with respect to treatment of dog bite cases. Furthermore, the Guidelines ought to be given wide publicity, especially those relating to wound management, vaccine schedule etc., to prevent high fatality,’ highlights the plea.

Apart from setting up an expert committee, the petitioners also pray for wide publicity and to ensure proper and uniform implementation of the National Guidelines for Rabies Prophylaxis, 2019, with appropriate revisions from time to time as per the latest developments endorsed by WHO.