Complaint to the DCGI regarding Counterfeit Abhyarub Rabies Vaccine produced by Indian Immunologicals Ltd.
To
The DCGI,
Central Drugs Standard Control Organization, Ministry of Health and
Family Welfare,
Directorate General of Health Services, Government of India
FDA Bhavan, ITO, Kotla Road, New Delhi -110002
Sub- Complaint regarding Counterfeit
Abhyarub Rabies Vaccine produced by Indian Immunologicals Ltd.
Sir,
Recently, the circulation of Fake Anti-Rabies in India created a row
after the death of a girl vaccinated with Abhayarub from Indian Immunologicals
Ltd, which is IIL, and the Australian Government has issued an advisory not to
use the Indian-origin Anti-Rabies Vaccine, and those who have been vaccinated
should get revaccinated with an appropriate vaccine. Moreover, Indian
Immunologicals Ltd clarified that the incriminated batch was counterfeit, not
produced by them, and they have filed a complaint with you. In the same
context, I request the following information-
1.
The certified copy of the complaint filed by the Indian Immunologicals Ltd, if
any, regarding the counterfeit Abhayarub vaccine batch, KA24014, manufacturing
date March 2024, and expiry date February 2027.
2.
Any action initiated by the CDSCO on the complaint mentioned at point 1.
3.
The name of the counterfeiting or suspected counterfeiting vaccine producer and
distributor firm, person, or organization, if identified at your end or at the
end of the IIL.
4.
Size in terms of doses of counterfeit and real Abhayarub vaccine batch,
KA24014, manufacturing date March 2024, and expiry date February 2027.
5.
The way ILL managed to identify that the mentioned Abhayarub batch was
counterfeit, and at the same time, ILL claims that the vials of the counterfeit
vaccine batch are not available in the market, suggests either they knew this
fact or they imagined it.
Sir, now, I also want to know from
you:
1. Could you please tell me how you
confirmed that the mentioned counterfeit vaccine batch was genuinely
counterfeit and not produced and distributed by IIL?
2. How can either your organization
or ILL compensate the parents of the affected girl and all others who received
the counterfeit vaccine batch?
3. Why has the CDSCO not checked
other batches of the Abhayarub vaccine from IIL and monitored several other
vaccines produced by IIL, which have a history of producing substandard FMD
vaccines (for which the ILL has been fined over 60 Crores)?
4. Why is the CDSCO so lenient
in sampling and testing IIL-produced vaccines and medicines, considering their
potential impact on public health? 5. Why has the CDSCO not taken action
against producers and distributors of substandard and counterfeit vaccines and
medicines in India?
5. Do you not consider the lives of
Indian people worth more than the profits of substandard vaccine producers? If
so, what steps have you initiated in the last five years?
I anticipate an early response.
Thank you.
Regards
Yours
BR Singh
Rtd. Head of Epidemiology and Principal Scientist
Indian Veterinary Research Institute, Izatnagar, Bareilly-243122, UP,
India
