For the past many months, India has been importing the Yellow Fever Vaccines. As lone manufacturer of the same in South-East Asia since 1960, Central Research Institute (CRI) Kasauli, has stopped production due to some fault in its machine. Busy in repairing the fault, CRI Kasauli is likely to miss the February 2013 deadline to ensure functional production line fully compliant with Good Manufacturing Practice (GMP) standards. While deadline is approaching fast, Central Research Institute, Kasauli is yet to comply with directions, thus putting a question mark over the production of yellow fever vaccine in future as well.
On January 15, 2008, the then Union health minister A Ramadoss had suspended the licenses of many functional research and development centers including Central Research Institute (CRI), Kasauli, on the grounds of non-compliance with the GMP norms of World Health Organization (WHO). Later, on February 26, 2010, Union government exercising its powers of the Drugs and Cosmetics Rules, ordered revocation of suspension of licenses of these institutes including the CRI Kasauli. These were asked to ensure that production line was made fully compliant with GMP standards within three years.
As yellow fever vaccination has been made compulsory by many foreign countries under WHO guidelines. At all international airports it is being administered by health authorities. CRI, Kasauli, had annual production of approximately 60,000 vaccines which were being supplied to all 17 international airports of our country. Ever since the machine developed the fault, not even a single vaccine has been produced at Kasauli forcing government to import it. Apart from India, yellow fever vaccines are being manufactured in countries like China, Europe and US.
The CRI Kasauli, director Dr Sunil Gupta said yellow fever vaccine is not being produced as the company assigned the repair work has failed to detect the fault. When asked whether failure to comply with GMP norms in the production of vaccine would result into suspension of production, Dr Sunil Gupta said it depends on the decision of the Union ministry of health and he cannot comment further on the same. He said that they have time till February 2013, but after that it would be the discretion of the Centre whether or not to allow the production of the vaccine.
Gupta, however, claimed that as far as DPT vaccines were concerned, validation trial run of their production under GMP norms is going on and in couple of months CRI Kasauli will be the first government sector unit to have GMP facility.