SHIMLA: The only institute in the country which has been producing yellow fever vaccines for decades has stopped making the drug. Reason: A defunct machine at the prestigiousCentral Research Institute (CRI) at Kasauli.
A snag in the machine has forced the Union government to import yellow fever vaccines for the past one year.
CRI boasted of being the only manufacturer of these shots in south-east Asia since 1960. It used to produce around 60,000 vaccines annually. Apart from India, these vaccines are being made in China, Europe and the US.
Between January 15, 2008 and February 2010, not a single vaccine could be manufactured as CRI’s lab licence was suspended by the Union health ministry. Later, the machine developed a snag and has been rendered useless.
Yellow fever vaccination has been made compulsory by many countries under WHO guidelines at international airports. It is administered by the health authorities. Each shot costs around Rs 100.
Founded in 1904, CRI has been carrying out large-scale production of bacterial and viral vaccines. Earlier, the yellow fever vaccine was also being exported to many countries from Kasauli.
A senior CRI official said that after production stopped at Kasauli, the Union government is now procuring the vaccines through WHO to ensure their availability at the international airports in the country.
Sources said the dry section of the machine in which the vaccine was being manufactured has stopped working. To save the prepared liquid from deterioration, authorities have sent it for preservation at Bacillus Calmette-Guerin (BCG) Vaccine Laboratory, Guindy. Despite raising the issue with the Union health ministry many times, the plant has not been made functional yet.
CRI director Dr Sunil Gupta said, “We are arranging for the defective part from abroad. I had joined CRI in January and production had stopped before that.”
“The machine has developed a snag. In India, only one company in Delhi can repair it. But problem is that the spare parts needed for it is not available in India and now we are trying to import it,” Gupta added.On January 15, 2008, the then Union health minister A Ramadoss had suspended the licences of CRI, BCG Vaccine Laboratory and Pasteur Institute of India, Coonoor, on the grounds that they did not comply with the WHO’s norms on good manufacturing practices.But the Union government exercising its powers under sub rules (3) of Rule 85 of the Drugs and Cosmetics Rules, 1945, ordered revocation of the suspension in February, 2010. These institutes have also been asked to ensure that the production line follows the WHO standards within three years.
My comments: It is sad to note that India’s premier vaccination production institute has, instead of scaling new heights, gone down to such a poor state that it is unable to even maintain the WHO GMP standards which many private manufacturers are adhering to already. My personal concern regarding Yellow Fever vaccination is that in this situation, cheap quality vaccine is likely being procured from non WHO authorized manufactueres in China/ Central Asia to be given at Government centers at discounted prices. I would urge the Government of India to directly authorize reputable private centers to provide the Yellow Fever vaccination of International standard in this situation, on its behalf, to affording International travelers.