The Central government in January 2008 had ordered the closure of three vaccine manufacturing units namely BCG Vaccine Laboratory in Chennai, Pasteur Institute of India, Coonoor and Central Research Institute at Kasauli. The main reason for the order to shut down the units was the non compliance of GMP norms set by WHO. The Pasteur Institute has been making DTP and anti rabies vaccine for more than a century. Whereas, BCG Lab has been producing BCG vaccine for more than six decades. The anti-TB vaccine produced in the BCG Lab was being supplied to the entire country for the national immunization programme. And CRI Kasauli was the only unit producing Japanese Encephalitis vaccine other than China. The vaccine is used for brain fever due to JE virus. After the stoppage of production, the JE vaccine is being currently imported from China. The decision to cancel the licences of the two Chennai based vaccine units was subsequent to two rounds of inspections of these establishments one in August 2007 and the second in January 2008 by a GMP assessment committee constituted by the Union health ministry. Then, in December 2007 the Pasteur Institute was served a show-cause notice as to why its licence should not be suspended. And on January 15, 2008, BCG, Chennai and PII Coonoor were ordered to stop manufacturing of vaccines. Along with this, the Central Research Institute at Kasauli was also asked to stop production.
The national immunization programme in the country has been seriously affected with the stoppage of production at the three vaccine units as the government had not taken any alternate measures to keep up the supplies to public health institutions. These are basic vaccines badly required mostly by the poor. Many states have been reporting shortages of these vaccines in various government hospitals and medical centres. No doubt, the GMP norms have to be followed in the case of vaccine manufacturing especially the PSU units much before private companies did. Why that has not been attended to years after Schedule M was notified is a question to be answered by the Union health ministry. Now, after an year of the closures, the government could not decide what to do with these plants and how to meet the shortfall of these vaccines in the country. The Parliamentary Standing Committee on health & family welfare had a meeting with the Secretary of health ministry on this issue last week but nothing came out of it. The closure of these plants, in fact, are benefiting some of the private pharma companies. If helping the private vaccine makers is not the intention of the government, the health ministry should not lose any more time in ordering modernisation of these plants on a war footing and restart the production of these essential vaccines.