The All India Drug Action Network (AIDAN), a national network of organizations working on pharmaceutical policy issues, is weighing various options including the legal action to restrain Union health ministry from closing down the three public sector vaccine manufacturing units, of which the licenses were cancelled for non compliance with World Health Organisation (WHO) manufacturing standards.
The Network, which expressed dismay over the government move, will decide further action in an executive committee meeting to be held on July 3, 2008. The committee is expected to weigh various options to ensure the revival of these three public enterprises, the 103-year-old Central Research Institute (CRI), Kasauli, the 100-year-old Pasteur Institute of India (PII), Coonoor and the 60-year-old BCG Vaccine Laboratory (BCGVL), Chennai, according to Dr Gopal Dabade, co-convener, AIDAN.
"The vaccine manufacturing units were operating in a very good condition and were catering to the increasing public need for immunisation programmes for several years. We cannot allow the government to shut down these plants for no reason and we are considering all options including a legal opposition. The government should support these units to comply the good manufacturing practice norms instead of closing them down," said Dr Dabade.
AIDAN has also criticised the ministry and the Union health minister Dr Anbumani Ramadoss for taking severe action against these units instead of extending support. Even as the government is planning to spend Rs 3000 to Rs 5000 billion for the upcoming vaccine and medical park near Chennai which will become operational in 2012, it is not providing a smaller fund of at least Rs 600 crore for upgradation of the three existing vaccine manufacturing plants, alleged the Network.
Once upgraded, the existing units could supply vaccines for government supported immunisation programmes at least up to 2012, till the 400-acre vaccine and medicine park in Chengalpattu, Chennai is commercialised. "The closure of vaccine production in the three units comes at a time, when the demand-supply in vaccines for India's Expanded Programme for Immunization (EPI) is widening, private companies are pushing expensive cocktails of the EPI vaccines with other vaccines in the market, and coverage of immunization against these crucial vaccine preventable diseases is declining. The closure of production of these vaccine producing units will have enormous implications for the cost and access to these vaccines in the future," expressed AIDAN in its recent announcement.
The Network also alleged that the ministry is not taking action on several issues including lack of adequate drug quality testing laboratories, settling the issues on numerous fixed dose combinations (FDCs) on which the Drug Controller General of India (DCGI) has initiated action on low availability of essential medicines in public health facilities and inexplicable price difference of competitive medicine brands, while it is proceeding with hurried move to close down the vaccine plants.
The protest of AIDAN comes at a time when the health minister is defending the plan to close down the vaccine manufacturing units at Kasauli, Coonoor and Chennai claiming that the WHO informed the ministry that it would de-recognise the National Regulatory Authority (NRA) if the government did not cancel the licences. However, the ministry revealed that it has appointed a committee to investigate if a restructuring was possible for the three plants to conform to Indian Good Manufacturing Practices (GMP), which is expected to submit its report within three months from May, 2008.
AIDAN, in the beginning of this month, has called for the Government to reverse its decision to close down the plants with immediate effect and to ensure all assistance to make them compliant with newer norms.