The union health ministry will soon constitute an expert committee to scientifically assess the facilities at the three vaccine manufacturing institutes in the country and a comprehensive inspection will be carried out by the committee early next month, it is learnt.
Apart from the health ministry officials, the committee will consist of officials from DCGI, GMP experts and scientists from pharma industry.
On completion of the inspection of the three vaccine labs (BCG LAB, Chennai, PII, Coonoor and CRI, Kasauli), the committee will submit its report to the health ministry. A decision to re issue the suspended licenses will be taken then. The Institutes were ordered to stop manufacturing of vaccines citing non-compliance to GMP norms set by the WHO.
Dr Venkitaramanan, additional director of the Pasteur Institute of India, the autonomous Institution at Coonooor, told Pharmabiz that oral assurances about restarting were already given by the Health Ministry and hoped they would get the nod for go-ahead after the visit of the assessment team was over. The committee will look into the feasibility of the production of all the six primary vaccines and will also identify measures to be taken in future.
Meanwhile certain political parties, especially CPI(M), has urged the Union Ministry to restore the licenses and help resume production of vaccines in all the three public sector units.
In a letter to the Union Health Minister, the CPI(M) Tamil Nadu State Secretary Varadarajan pointed out that 26 million babies were born every year in India and they require immunization against preventable diseases before the age of nine months. He said that the three Institutes have met the standards set by the 'Universal Immunization Programme' and the closure will be a deathblow to indigenous vaccine and R&D.
The letter of Varadarajan said that these Institutes contributed to 60 to 70 per cent of the country's primary vaccine requirement against many diseases including polio, measles and childhood tuberculosis. Vaccines for rabies, typhoid and snakebites too were produced in these units.