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  • Govt mulls making vaccine prod units autonomous

    Published on November 21, 2010

    Government is considering giving autonomous status to three public sector vaccine production units besides setting up an advisory board to help improve the production of vaccines.

    The proposal is being mulled following the submission of a report by a committee set up to look into the manufacturing practices being followed by these units.

    The panel recommended that the health ministry consider making these units autonomous by registering them as companies under the Companies Act/Societies Registration Act.

    It also recommended that the government consider constituting a National Vaccine Security Advisory Board comprising stakeholders like public health specialists, pediatricians, vaccine technologists and social activists to advise it on important issues relating to the National Vaccine Security Policy, officials said.

    The manufacturing licenses of Central Research Institute, Kasauli; Pasteur Institute of India, Coonoor; and BCG Vaccine Laboratory, Chennai — were suspended by the Drugs Controller General of India in January 2008 since they were not found in compliance with Good Manufacturing Practices (GMP) as provided under Schedule M of Drugs and Cosmetic Rules, 1945.

    The Committee had submitted its interim report this February. Its recommendations included that the Ministry of Health and Family Welfare consider revoking the suspension orders issued against the three vaccine manufacturing units.

    Following this, the ministry had ordered revocation of suspension of the licenses of these institutes.

    They were also asked to ensure that the production line is made fully compliant with GMP standards within three years.

    The units were also ordered to dispose off existing stock of finished products as well as raw material and to ensure that prior approval of a competent authority is obtained to the effect that finished products and raw material for preparation of vaccines are fit for human consumption.

    The three units have since then initiative the vaccine manufacturing process.