The special team of the Union Health Ministry, led by the DCGI that visited Pasteur Institute of India (PII) at Coonoor in Tamil Nadu last week is understood to have given its consent to go ahead with the standardization work of the plant necessary before the beginning of production of vaccines.
The team comprising Dr Surinder Sing, the DCGI, Dr Avinash Mishra, director of vaccines in the Health Ministry, Anil Chawla, WHO consultant, one microbiologist from the DGHS and some architects visited the Institute last week to inspect the ongoing standardization work following the government's decision to revive the Lab. The officials held detailed discussions with the scientists and other staff members at the institute.
Pasteur Institute was closed down on January 15 last year along with other two vaccine producing laboratories in the public sector. Following the closure of the vaccine units, the previous government was facing flak over halting production of essential vaccines in the country.
Whereas, following a decision taken by the present Union government to revive the closed units, it has made World Health Organization the consultant for the revival.
Accordingly, a health ministry team comprising joint secretary, two deputy secretaries, DCGI and other officials of the department visited, as a first step, the Central Research Institute in Kasauli in July to take stock of the situation there. The team has not yet divulged the content of the report they submitted to the government either to the media or to the public, but expressed satisfaction over the standardization work going on in the institute.
Later, the Union health minister, Gulam Nabi Azad visited the Lab on August 28, held discussions with the officials there, and promised them that the unit would not be closed down. It is expected that CRI would be the first unit to resume manufacturing, by June next year.
According to sources from the Pasteur Institute, they have the revival plan involving Rs 280 crore to start the production of DTP vaccines, vero-cell-derived rabies vaccine and tissue culture anti-rabies vaccines. For meeting the norms of good manufacturing practices specified by Drugs and Cosmetic Act of 1940, and the World Health Organization, a senior officer in the unit said that the unit has to procure state-of-the -art equipment, develop modern infrastructural facilities, establishment of international GMP facilities. The infrastructural facilities include more buildings which are to be constructed soon.
He said the ministry will form a Core Committee to monitor the developmental work and it will submit its report to the ministry. Afterwards the DCGI team will once gain visit the site for a final inspection. The official order for starting production will be issued in the end.
To a question how long will it take to fulfil all the norms, the official expressed hope that the Lab could start manufacturing the vaccines in another 18 months. The visit of the health officials has obviously raised the expectations of the unit staff.
Prior to the visit of the health officials to CRI Kasauli in July this year, the officials there had submitted a proposal to the directorate general of health services to invest Rs 14 crore in CRI to resume the production. The ministry is yet to approve it. CRI was the main contributor of the DPT group of vaccines to the Immunization Programme of the country before it downed its shutters.
When contacted Usha Soren Sing, the director of BCG Lab in Chennai said that so far no health official team has visited the Lab. She said the team was supposed to visit the vaccine unit in the first week of September, but had to be postponed due to some technical reasons in the ministry. When asked about the revival plan, the director replied that it is all with the government and so many procedures are to be done before that. When the news about the visit of the officials to the PII Coonoor was apprised to her, the BCG director retorted, 'they are an autonomous body, we are part of the government'. The BCG Lab was manufacturing anti-tuberculosis Bacillus Calmette-Guerin vaccine (BCG vaccine).
The three public sector units had provided more than 60-70 per cent of the country's immunization requirements at lower costs.