New Delhi: 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
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