The Health Ministry of the central government of India, has recently suspended the manufacturing licenses of four leading state-owned drug makers in India. The companies are named as the Pasteur Institute of India in Tamil Nadu, Haffkine Bio-Pharmaceutical Corporation in Mumbai, BCG Vaccines in Tamil Nadu and Central Research Institute in Himachal Pradesh and the reason behind suspending the licenses is the violation of good manufacturing practices (GMP) that they were bound to follow.
According to the sources from the industry, all these companies make vaccines for the diseases like malaria, cholera, rabies, polio and they also manufactures various animal vaccines. The officials of the Indian government have stated that the suspension of license was going to continue till the time when they are able to make infrastructure changes following the prescribed standards. In the words of an official, "This might take six months or a year. Making fresh investments and infrastructure changes may take some time for government companies as several clearances are required. But, till the time they do it, they will not be allowed to produce medicines".
While talking about the main reason why the Union Health Ministry has taken such a strong step against the four companies, an official said that the governments aim is to garner the repute of exports from India, particularly the vaccines. The governments move was prompted by the World Health Organisation (WHO)s statement that it has detected these companies to not following the GMP standards properly. According to the sources, the UN body did recommend the suspension of these companies licenses and it even indicated that it might drop India from its list of countries to source vaccines for its global projects. The experts from the pharmaceuticals industry commented that it that did happen, that would have been damning for the industry as most of the vaccine makers including the private sector ones have large contracts with the WHO.
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| Posted : 1/29/2008 |
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