The production of DPT, DT and TT vaccines at the Central Research Institute (CRI) in Kasauli is likely to be resumed in June next year. The institute is now vigorously engaged in the task of finishing the first phase of modernisation by developing a GMP facility to produce the DPT group of vaccines. CRI will be the first unit out of the three closed vaccine manufacturing labs on quality concerns last year, to re-start functioning, said Dr K R Mani, director of the Unit.
After the visit of the Union Health Ministry's team along with WHO consultants to the Unit a few months ago, the World Health Organization granted 160 days to upgrade its production standards conforming to GMP norms. The upgradation work will be completed on March 10, 2010 and it will be validated by the DCGI soon. There will be some more formalities, which will be carried out in the Months of April and May. However, Dr Mani said, the Research Institute had attempted to comply with the norms of GMP since 1995 itself as the DPT group of vaccines was considered most important.
"Now we have initiated the renovation work. As per WHO's GMP norms, the old buildings have to be demolished and new ones to be constructed in its place. For this alone, a minimum period of two years is needed. But right now we are concentrating on DTP Group only. For the production of each type of vaccine, we need separate GMP facility and for one facility alone, Rs 35 to 40 crore will be required. As a first step, the government has sanctioned as budgetary allowance Rs 15 crore for renovation and Rs 7 crore for machinery. We have submitted a plan for Rs 290 crore to the ministry," the director told Pharmabiz.
According to sources the Unit will submit its renovation report to the DCGI office in March next year. Following it the central team will once again visit the facility for the final inspection. "We are in regular communication with the Ministry. We are the first unit having granted the go ahead signal, and we will be the first one to re-start production also," a senior officer in CRI said. He said the Unit was manufacturing all kinds of vaccines like DPT, DT, DAT, ARV, Yellow Fever Vaccine, TT, TAT, JE Vaccine, Anti-D and Hepatitis-B Vaccine. He added that the major challenge before the institute was to accomplish the renovation work with in a period of 160 days.
Apart from bacterial & viral vaccines and sera, the Institute, which was established in 1905, was engaged in research and development in the field of immunology and vaccinology and teaching & training in the field of microbiology, production and quality control of vaccines and sera. It has been one of the most reliable sources of the supply of vaccines & sera to Government of India.
After the closure in January last year, the health ministry team had visited the Unit four times. In August this year, the Union health minister Gulam Nabi Azad also visited CRI and conducted an inspection.