Updated on 5 June 2012
Whether it be public or private sector units, the adherence to the required standards of quality is a necessity in a sensitive area such as vaccines. The successful revival of the PSUs that were closed on similar accounts, thus hinges on the presence of a strong national regulatory authority that can oversee the adherence of the Good Manufacturing Practices (GMP) standards of the units.
The policy calls for an authority focused only on vaccines, as an alternative to the current situation where the Central Drugs and Standards Control Organization, headed by the Drugs Controller General of India, is the national regulatory authority. The presence of such a body can not only allow faster approvals, but also ensure that the quality of the proceedings is maintained for public as well as private units.
Nata Menabde, World Health Organization (WHO) representative to India, says, "In 2009, Indian authorities lost the right to issue approvals and regained it the next year after much difficulty. In 2012, this will be very crucial, given the fact that recently WHO declassifed three manufacturers to whom the national body had given approvals. This raised questions on whether the authority can do justice to the licensing procedures. Without proper license of the licensing authority, you cannot have the credibility regarding your vaccines. It is very shameful to see different standards for vaccines meant for domestic use and for export purposes."
14 Point Plan to Success