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LATEST NEWS UPDATES | Slander row over vaccine -GS Mudur

Slander row over vaccine -GS Mudur

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published Published on May 31, 2015   modified Modified on May 31, 2015
-The Telegraph

New Delhi: The Union agriculture ministry is probing the circumstances under which a senior government scientist purportedly tried to malign vaccines used to protect livestock from foot-and-mouth disease outbreaks that can threaten India's milk yields.

An expert panel from the Indian Council of Agricultural Research has told the agriculture ministry that Bhoj Raj Singh, a microbiologist at an ICAR research centre, has "caused damage" to the reputation of India's foot-and-mouth disease (FMD) control programme by raising unsubstantiated claims about its vaccines.

Singh, based at the Indian Veterinary Research Institute (IVRI) in Izatnagar (Uttar Pradesh), now faces a Rs 100-crore lawsuit from India's largest supplier of FMD vaccines.

Singh had last November posted a report on a social networking website for scientists and researchers, outlining a series of tests he had conducted on samples of FMD vaccines from three domestic manufacturers.

It claimed that none of the 52 batches of FMD vaccines tested had the desired stability, while 10 batches failed sterility tests.

Singh's report, posted to resemble an official government document with the words "Government of India, Ministry of Agriculture" at its top, raised concerns that "poor quality" vaccines may be to blame for FMD outbreaks even among vaccinated livestock.

It surprised sections of ICAR scientists and the vaccine manufacturers, including Indian Immunologicals Limited (IIL), a wholly owned subsidiary of the National Dairy Development Board that has orders to supply about 200 million of the 328 million FMD vaccine doses the control programme will use in 2015-16.

Scientists say that FMD is a highly contagious viral infection that can cripple animals and halve their milk yields. They say Singh's report has international ramifications as Europe, North America and Australia have eradicated FMD while India is among the Asian and African countries that are still trying to do so.

"This is an airborne, trans-boundary disease - countries that are already free of FMD will have reason for worry if it is shown that India's FMD control programme is poorly managed," said Kollengode Balasubramaniam, managing director of the IIL.

The IIL, which exports the FMD vaccine to other South Asian countries, has sent a defamation notice to Singh, claiming Rs 100 crore in damages for hurting its reputation and causing business losses.

Two IIL officials, who requested anonymity, said they suspected the company had lost an order from Sri Lanka after Singh posted his report on the website.

Singh has denied any wrongdoing and claims he is being questioned for raising issues about the vaccines.

Senior ICAR scientists, requesting anonymity, said Singh's action seemed an effort to tarnish the reputation of the decade-old FMD control programme, which provides the vaccines to cattle and buffaloes in over 220 districts. India has about over 190 million cattle and 110 million buffaloes.

"Wherever we've introduced the vaccine, FMD outbreaks have declined - this pattern is clear," Gaya Prasad, ICAR additional director-general, said. "But we're still expanding. Many states such as Bengal, Bihar, Odisha and the northeastern states are not covered yet."

Prompted by Singh's report, the agriculture ministry had asked a three-member panel to conduct quality tests on the FMD vaccines and investigate Singh's role in posting the report on a website without internal consultations.

Senior ICAR scientists say the appropriate route to raise issues of quality would have been for Singh to bring them to the notice of his peers, who could determine whether his tests had been appropriately carried out under scientific protocols.

The expert panel, chaired by Prasad, observed that Singh's report on the vaccine samples' stability and sterility was based on tests conducted by "inexperienced laboratory workers" that did not follow the established protocols.

In its report submitted to the ministry in January, the panel said the test results were "highly questionable" as the same batches of the FMD vaccine had passed sterility tests at the IVRI. The Telegraph has a copy of the expert panel's report.

Singh told this newspaper he had informed the agriculture ministry about the test results before posting them on the website.

He claimed the ICAR panel had asked the three manufacturers to provide fresh batches of the vaccines rather than test the vaccines that had already been released in the field.

In a subsequent post on the social networking website for researchers, Singh said it appeared that the ICAR panel "wanted to give opportunity to the firms to produce good quality vaccine".

Singh had in his report also questioned the vaccine-testing protocols the IVRI had been following. He had claimed that the IVRI's vaccine-testing laboratory in Bangalore used only three to five vials per batch instead of the required 20.

But the panel has described his report as a "fraudulent" one based on "scientifically and technically unsound" data that has cast aspersions on the reputation of the IVRI.

The panel has raised concerns that Singh's report may hamper vaccine exports by the Indian manufacturers. It has recommended that "such unscrupulous scientists... holding responsible positions must be punished appropriately so that such deliberate acts of mala-fide are prevented in future".

But Singh asserts he has followed the testing protocols specified by international regulatory agencies. He has also cited the FMD control programme's own data to raise questions about vaccine quality.

The FMD project directorate's 2013-14 annual report says that nearly 50 per cent of FMD outbreaks in the country occurred in Andhra Pradesh, Karnataka, Kerala and Tamil Nadu. The four states are fully covered by the FMD control programme.

But scientists caution that outbreaks cannot be linked only to vaccine quality.

"This vaccine needs a cold chain (continuous refrigeration); it needs to be inoculated into animals in the right manner; and a sufficient proportion of animals need to be vaccinated to prevent outbreaks, a scientist said.

"All these factors influence the number of infections."

The Telegraph, 29 May, 2015, http://www.telegraphindia.com/1150529/jsp/frontpage/story_22759.jsp#.VWqirFL38xZ


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