Restore licences of three vaccine-making units, says parliament panel

February 18th, 2009 - 9:55 pm ICT by IANS  

New Delhi, Feb 18 (IANS) A parliamentary panel Wednesday criticised the health ministry for cancelling the licenses of three public-sector vaccine manufacturing units, which had led to shortage of vital vaccines, and asked it to revoke the order at the earliest.
The committee, headed by Rajya Sabha member Amar Singh, said the three units - the Central Research Institute (CRI) Kasauli in Himachal Pradesh, the Pasteur Institute of India (PII) Coonoor in Tamil Nadu, and the BCG Vaccine Laboratory (BCGVL) in Chennai - be allowed to continue production.

The health ministry cancelled the licenses of the units in January last year on the ground that they do not meet the requirement set up by the World Health Organisation (WHO) on Good Manufacturing Practices (GMP).

The units produce drugs like anti-snakebite serum, Ddptheria anti-toxin (DPT), tetanus anti-toxin, anti-rabies serum, yellow fever vaccine, Japanese encephalities and BCG vaccines.

The committee, which submitted its report Wednesday to the Rajya Sabha, said the three units have their own quality control system and wouldn’t be producing non-standard vaccines.

“The committee recommends that the ministry revoke the suspension of vaccine manufacturing licenses of the three vaccine producing PSUs at the earliest,” the report said.

It also pulled up the ministry for awarding bulk purchase order to Biological E. Ltd in Hyderabad, and said they were not aware about the company’s status of producing vaccines and would like to know whether it meets international standards.

“The committee is of the firm opinion that the ministry is responsible to a large extent for the prevailing unsatisfactory situation in all the three institutes which resulted in the cancellation of their vaccine producing licenses, and thereby leading to shortage of life saving vaccines with serious impact on universal immunisation programme and child healthcare programmes in the country,” the committee said in its 23-page report.

The committee also wondered why the ministry did not take up the offer of WHO to upgrade the units, adding that it was amazed that the buildings of these 100-year-old institutions have continued to remain in their original set-up.

It said that they are also not aware that the ministry drew any plan to make these units GMP compliant.

“It is very clear that the three institutes were not given a fair chance. They did not deserve such a treatment at the hands of their administrative ministry,” it added.

The committee also drew the attention to the fact that as vaccines would be procured from private company the cost would go up.

“The committee believe that since the CRI, BCGVL and PIL are in public sector, vaccines were available to the people at cheap price. But once the manufacturing goes into the private hands there is every likelihood that the cost of the vaccines could go up in future, thus, defeating the very objective of providing highly essential drugs like vaccines to the people at affordable prices,” the report said.

India has a billion-plus population and 25 million new-borns are added every year.

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