An expert committee set up by the Health Ministry to examine the decision of suspending the licences of three public sector vaccine manufacturing units has observed that the decision was made not only ill-advised but also resulted in acute shortage of vaccines.

"From the records it appears that the final decision to suspend the license was taken by the DCGI after extended consultations with the Ministry. The examination of the issue in the Ministry was extremely circumlocutory and scattered over several files. An explicit decision has not been recorded at any place based on an analysis of the issues. At one point of the record it is cryptically stated that the Minister, Health and Family Welfare has approved the issuance of the show cause notices for suspension of the licenses. This note is signed by everyone in the administrative line-of command including the Minister. However, as stated earlier, there is nothing substantial on record analyzing the grounds on which the decision was taken", according to the interim report of the four-member panel headed by Javed Chowdhary, former secretary in the ministry, some months back.

The three units - Central Research Institute (CRI), Kasauli, the Pasteur Institute of India (PII), Coonoor and the BCG Vaccine Laboratory, Chennai - were closed in January 2008 on the grounds of non-compliance of GMP norms. However, the government had ordered revocation of the order recently and the three units are being revived, based on the interim report of the Javed Chowdhary Committee.

But the interim report had many harsh observations. During the inspections, the panel had found that out of the total of 129 deficiencies raised in the reports for basing the decision to close down the units, about 71 observations are of a minor nature, not significantly affecting the manufacturing standards. Some 58 others require improvement or upgradation - walls not having a smooth surface; junctions, corners, window/door frames not being smooth and dust free; animal house requiring minor improvement; SOPs requiring revision; need for introduction of new documentation; need for calibration of different equipments; separation of different work areas; etc.

"The Committee are of the considered view that it would be absolutely safe and in public interest, to restart the manufacturing activities in the existing production lines with immediate effect. More explicitly, it is the considered view of the Committee that the operation of the units would, in the totality of the prevailing circumstances, be in compliance with the GMP standards,'' the report said.

The panel also blamed it on the government for not giving sufficient manpower to the units, before letting them to be closed down. ``For close to a decade now, these three vaccine manufacturing units have been tottering with poor continuity in the tenure of the directors. A large section of the vacant posts are those that lapsed after remaining vacant for over one year under the economy orders of the Ministry of Finance. The staff in these establishments have been so comprehensively depleted that they do not even retain the critical mass of man-power required to implement a revival programme,'' the panel said.

The panel also cautioned the government that by closing downing the existing public sector vaccine production units in advance, the country would be exposing itself to vaccine insecurity for five years or possibly, even a much longer period. As per the report, the three public sector vaccine producing units were subjected to selective scrutiny under the law.