Following widespread criticism and strictures from the Parliamentary panel, the health ministry is likely to accelerate the process of reviving the three public sector vaccine manufacturing units and may go for a Rs 500 crore package to resume operations.
The ministry has already got the report from the expert panel headed by DCGI in this regard and is considering the proposals, sources said.
The government has also categorically made it clear that it had not taken any decision to close down the units --the Central Research Institute, Kasauli, Himachal Pradesh, the Pasteur Institute of India, Coonoor, Tamil Nadu and the BCG Vaccine Laboratory, Chennai, Tamil Nadu.
In so far as PII is concerned, the expert committee has recommended production of tissue culture anti-rabies vaccine (TCARV) and anti-sera like anti-snake venom serum (ASVS), ant- tetanus Serum (ATS), anti-diphtheria serum (ADS), anti-rabies serum (ARS), etc. The committee also recommended development of the institute as a Central Testing Laboratory for testing of medical devices and turning it into a training centre for training in production and testing of anti-serum, sources said.
Regarding CRI, the committee has recommended new manufacturing facilities for yellow fever vaccine, influenza vaccine (seasonal and pandemic), acetone killed typhoid vaccine and tissue culture anti-rabies vaccine (TCARV), new anti-sera facility, developing measles surveillance centre in addition to existing polio, influenza and rabies surveillance centre. It also suggested expansion and modernization of existing animal house as National Animal Breeding Centre, expansion of Central Drugs Laboratory (CDL) to have separate wings for bacterial and viral vaccines by utilizing area used for production of vaccines. The panel also called for independence of CDL for administrative and financial powers.
In the case of BCGVL, the committee has recommended its conversion into Central Drugs Laboratory for BCG vaccine testing under CDL Kasauli, development as a Central Testing Laboratory for testing of cosmetics, expansion and modernisation of the existing animal house for supply of animals to various research institutes in the country, and making it a training centre for BCG production and testing. A proposal for upgradation of the facilities at CRI Kasauli to make them GMP compliant has now been received. This proposal is currently under consideration of the Government, sources said.
The manufacturing licenses of these three institutes were suspended by the DCGI in January, 2008, since they were not found in compliance with the GMP. The expert panel was set up in April to study the existing infrastructure/facilities available with these institutes and explore the feasibility of conversion of existing laboratories into testing laboratories, utilisation of the existing facilities for setting up a residential training facility, and having some of the vaccines/anti-sera production at these institutes complying with GMP.
Last week, the government faced much heat on the topic with the Parliamentary panel on health coming down heavily on the laxity in resuming the operations and the Supreme Court sending notice to the Centre on a PIL in this regard. If the proposals of the expert panel are accepted, the government will be spending Rs 500 crore to revive these institutes.