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Published 30 Oct, 2006 12:00am

KARACHI: Experts worried over trade in spurious anti-rabies vaccine

KARACHI, Oct 29: Experts are concerned over manufacture of increasing quantity of discarded anti-rabies vaccine by the National Institute of Health (NIH), Islamabad, the sole body for preparing it and asked authorities to opt for the vaccine approved globally by the World Health Organization to treat rabies victims.

“As many as 2,000-5,000 deaths occur in Pakistan due to rabies every year but the NIH is neither manufacturing an effective vaccine nor importing it,” Dr Naseem Salahuddin, president of the Infectious Diseases Society of Pakistan (IDSP) and member of the WHO Expert Panel Committee on Rabies, told Dawn.

She said the gravity of the situation could be gauged from the fact that some 100 cases of dog-bite are referred to the hospitals in Karachi every day.

“Rabies is a serious but long neglected disease mainly affecting the poorer strata of our society. The abject failure of the NIH to provide diagnostics, statistics, and most importantly, a safe and effective vaccine, reflects the government’s failure to prioritise the severity of a public health problem at any given level,” Dr Salahuddin, also president of Rabies In Asia (RIA)’s Pakistan chapter, said.

Rabies, a positively fatal disease, is caused by a virus carried in the saliva of a rabid animal, which in turns spreads it to humans by biting them.

It is prevalent in both urban and rural areas virtually all over Pakistan.

“It is totally preventable if an animal bite is properly managed. However, if untreated or wrongly managed, the disease assumes horrific features that invariably kills the victim,” she said.

“The world’s major burden of this deadly disease continues unfortunately to be shared by Pakistan and India,” she said.

“The NIH, Islamabad, which functions under the federal ministry of health, has the mandate to regulate all aspects of rabies. However, this premier institute is taking an inordinately long period of time to implement its plan of action prepared years ago,” she said.

She said that Anti-Rabies Vaccine (ARV) of the Semple type manufactured and distributed by the NIH was declared obsolete by the WHO two decades ago as it was found to be largely ineffective. On the other hand, the modern imported cell culture vaccines (CCV) that have been recommended by the WHO are highly effective but beyond the reach of the common man as they are not produced in the public sector.

She said Semple had been discarded by the WHO two decades ago because of its ineffectiveness.

“The NIH officials had promised in March last year that the institute would gradually minimize the production of Semple and would finally give an end to it but it is shocking to learn that instead of its reduction the NIH is producing this vaccine four times more than it was producing earlier,” Dr Salahuddin said.

The NIH officials have lately told the experts that they were manufacturing more Semple because the demand for it had increased.

Dr Salahuddin said till last year three private pharmaceuticals were importing CCV but two of them wrapped up their operations in Pakistan and transferred technology to India while the vaccine provided by the sole company was unaffordable for the common people to use it and save one’s life.

“We had suggested to the NIH that they should import CCV from India because it was superior in quality and cheaper in price.”

“The NIH officials had agreed to our suggestion but no action has yet been taken to this respect,” she said.

It is learnt that NIH has got funds of Rs 160 million to manufacture effective vaccines on its own but it needed much time to be able for it as it has no infrastructure and quality control facilities so far to manufacture and provide the vital stuff to the hospitals across the country.

A survey carried out in October 2000 by a WHO consultant concluded that although rabies was endemic in Pakistan, it had failed to emerge as a public health priority. Furthermore, not being a notifiable disease, no accurate statistics of the numbers of dog-bite or rabies deaths were available in Pakistan; the diagnostic facilities were insufficient to cater to the needs of the entire country; and while the Semple type of ARV was ineffective, there was no plan to either mass vaccinate or reduce the stray dog population.

Scientific studies conducted and published have proved conclusively that the Semple vaccine produced by the NIH and repeatedly tested in the WHO-approved laboratories have been found devoid of the requisite antigen, according to Dr Salahuddin.

“Pakistan, Myanmar and Nepal are now the only Asian countries, which still manufacture and use Semple vaccine. The WHO has repeatedly recommended that it be abolished as it is usually poorly immunogenic and has serious adverse side effects,” Dr Salahuddin said.

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