Bowing to the growing criticism by the law makers as well as the NGOs against its decision to close down the three public sector vaccine units in the country, the Union Health Ministry has revoked the suspension of all the three vaccine units Central Research Institute, Kasauli, Pasteur Institute of India, Coonoor and BCG Vaccine Lab, Chennai. The ministry has asked all the institutes to fully comply the GMP quality standards within three years.
In a communication sent to the the three institutes, the ministry said "Now, therefore, the Central Government, in exercise of its powers under Sub-rule (3) of Rule 85 of the Drugs and Cosmetics Rules, 1945 hereby orders revocation, with immediate effect, the suspension of the above licence bearing number 21 MB dated 09.01.1958".
The appellant institute shall ensure that the production line is made fully compliant with GMP standards within three years from the date of the issue of this order. During the said period the institutes shall furnish quarterly progress reports to the central government indicating the action taken in this regard, the Health Ministry order said.
The Union Health Ministry on January 15, 2008 had suspended the manufacturing licenses of CRI Kasauli, PII Conoor and the BCG Vaccine Laboratory Chennai for non-compliance of good manufacturing practices (GMP) as per the WHO standards.
Since then there has been criticism from different quarters against the government decision to close down these vaccine institutes as they were the main source of vaccines for the universal immunization programme of the country. There was criticism that the government action in this regard was to help some private vaccine producing companies.
There was a general feeling among the NGOs and the general public that the the closure of these three PSU vaccine units could have been avoided if the government had taken timely action to upgrade the shortfalls in WHO GMP compliance. In any case, compliance with WHO-GMP is mandatory only for exporting vaccines or buying them through the UNICEF vaccine procurement system and not for indigenous manufacture or purchase or immunization.
There was a feeling that the govt also had the option of suspending only exports till the PSUs became GMP compliant and meet the huge indigenous demand, rather than suspending production altogether, especially since there was no complaint on the product quality of the vaccines produced in those PSUs.
In fact, some NGOs had moved the Supreme Court on the issue in February last year.