The Union health ministry has decided to revoke the suspension order of the production licenses of three vaccine units, BCG Vaccine Lab in Chennai, Pasteur Institute of India at Coonoor and Central Research Institute (CRI) at Kasauli, which were closed by former health minister Dr Anbumani Ramadoss on the grounds of non-compliance of GMP norms, it is learnt.
According to sources, the ministry on June 19 this year issued orders to the three units to go ahead with modification work for GMP compliance needed prior to starting production. In the order the ministry has specifically mentioned that the decision was taken on account of Para 19 of the President's speech in the joint sitting of Parliament recently.
In her address, President Prathibha Patil had said the government would revive the vaccine producing institutes in the public sector to support the immunization programme and expand the health insurance scheme to cover all BPL families in the country.
The three vaccine manufacturing institutes were closed by the previous health minister Dr Ramadoss on the ground that they did not follow the international safety norms. The units were served orders to cease their operation on January 15, 2008. The major deficiencies detected were with regard to Documentation, Infrastructure and Quality assurance (non- compliance of GMP).
According to sources, the health ministry is of the opinion that these units have to undergo Schedule M of the Drugs and Cosmetics Act, 1945. They must have the requisite facilities conforming to the prescribed standards. Accordingly these units have to conform the current Good Manufacturing Practices as validated by National Regulatory Authority of the country. Further, the vaccine units have to be validated by WHO for meeting international standards for export.
With regard to the revival, the units have to submit a proposal to the health ministry before July 8, indicating the areas of modification, rectification, restructuring and other developmental work required in the facilities. Besides rectifying the anomalies, the units have to re-organize everything including the entire structure. Certain laboratories in the units have to be removed and new ones should be installed.
They have also been advised to acquire land, if necessary, adjacent to the units for infrastructure development. The units can invite tenders for developmental works and the proposal they submit should reflect the cost expenditure of all the modernization and rectification. It should also indicate how many months it will take to complete the entire modification work.
As regards the modification of the existing facilities, the DCGI will soon issue a set of guidelines to the units to rectify the anomalies found by the inspection teams during their two rounds of visits to the facilities in August 2007 and January 2008.
"On receiving the proposal a team led by the DCGI will again inspect all the three units and if they find everything is ok, then the sanction will be given to continue with the production of vaccines," a source said. For the time being, it is learnt, the ministry will not allow the units to manufacture new vaccines, but can go ahead with what they used to produce.
BCG Lab in Chennai was producing the anti-tuberculosis Bacillus Calmette-Guerin vaccine (BCG Vaccine), the Pasteur Institute in Coonoor was manufacturing DTP vaccines, Vero-cell-derived rabies vaccine and Tissue culture anti-rabies vaccines. The Central Research Institute at Kasauli was the main contributor of the DPT group of vaccines to the National Immunization Programme of the country.