An expert committee of the health ministry which looked into reviving three government vaccine units that were closed down has recommended converting two of these units into centres for producing yellow fever vaccine capable of serving global needs.
The units were shut down almost a year ago after they failed to comply with good manufacturing practice norms.
Though yellow fever affects millions of people in over 40 countries every year, very few private companies take interest in developing vaccines for the disease as most of the endemic regions are economically backward.
The committee says that Pasteur Institute of India, Coonoor, and Central Research Institute (CRI), Kasauli, which are capable of producing yellow fever vaccine, should be allowed to set up state-of-the-art manufacturing facilities that can cater to global demand.
Currently, these institutions, along with the BCG laboratory in Chennai, are producing vaccines only for government supplies. “We want these units to function with more financial autonomy. They should be allowed to generate profits through export of vaccines. The National Dairy Development Board’s professionally-run vaccine facility, Human Biological Institute, could be a model for them. This will help them maintain quality, retain their technical staff and compete in the open market,” said a senior health ministry official.
According to the official, the Kasauli unit will also manufacture vaccine for seasonal influenza and function as a national infuenza surveillance centre. Capabilities will also be developed for manufacturing vaccines for rabies and typhoid.
While Pasteur Institute will focus on the rabies vaccine, BCG Laboratories will be converted into a national facility for testing BCG vaccines.
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All three units will also produce anti-sera, a critical component in manufacturing vaccines.
The closure of the three units almost a year ago had created a temporary shortage of polio and BCG vaccines in the country. The official said the issue had almost been sorted out as private companies had started supplying vaccines for universal immunisation programmes. BCG is the only area where a shortage is being felt as the Chennai unit was the sole supplier of these vaccines for government programmes. Currently, the entire requirement is sourced from the only other manufacturer — Pune-based Serum Institute. Greensignal, a new Chennai-based firm, is in the process of getting regulatory clearance for its BCG vaccines and is expected to begin supplies by 2009-end.
“Every batch of vaccine is considered as a new drug. The regulatory requirements are tough. The new company may clear the clinical trials and prove consistency in quality by mid-2009. Until then, BCG vaccines will have to be sourced from the only private player,” the official said.
The committee was constituted in May 2008 under the chairmanship of the director general of health services. It was expected to prepare a road map for smooth transition of the three public sector units from vaccine manufacturing centres to testing and training centres as the entire vaccine manufacturing operations were supposed to be moved into the Vaccine Park that is coming up in Tamil Nadu.
However, the committee has found merit in utilising these facilities as vaccine production centres after an overhaul of their production infrastructure.