Raising concerns on the passive manner in which the central health ministry executes the revamping of the three public sector vaccine manufacturing units in the wake of rocketing vaccine prices, the department-related parliamentary standing committee has come down heavily on the action taken so far, or to say, the lack of it in its latest report submitted to Rajya Sabha.
The committee, considering the action taken note (ATN) submitted by the ministry on revival of the three vaccine making units - the Central Research Institute (CRI), Kasauli, the Pasteur Institute of India (PII), Coonoor and the BCG Vaccine Laboratory (BCGVL), Chennai – reports that it's pointed recommendations and observations on quite a few pertinent and crucial issues have “either simply remained unanswered or are circumlocutory in nature and lack conviction”, belying the very idea of the ATN.
The ministry failed to provide up to date information on the revival activities in CRI, Kasauli and PII, Coonoor and to submit any concrete information on the revamp of BCGVL, Chennai, even as a query regarding measures to curb price hike of vaccines for Universal Immunisation Programme (UIP) in the ATN, observes the committee.
The parliamentary panel chaired by Amar Singh relied more on an interim report submitted by the a committee appointed by the health ministry, set up under the chairmanship of Javed Chaudhary, former secretary under the Ministry of Health and Family Welfare, for its assessment in the new report. The Javed Chaudhary committee was appointed to determine the reasons for the suspension of the manufacturing license of the three vaccine producing units and to draw a road-map for their revival and its interim report was submitted on February 5, 2010.
As per the calculations of Choudhary committee report, the full manufacturing capacity of CRI, Kasauli must have been restored by now. After its inspection of the PII, Coonoor from December 19 to 22, 2009, the said committee has also reported that the existing production line could resume operations for fresh production in 6 months, which has also not been presumably completed.
The parliamentary panel also comments that “...as no concrete information on the progress of work relating to BCGVL, Guindy has been furnished in the ATN, the Committee has no other alternative but to conclude that the rectification exercise - as envisaged to make these units fully functional, has not been completed. The Committee, therefore, apprehends that if such is the case then production of vaccines by the unit is bound to be stalled further”.
“It seems that Committee’s repeated efforts to draw the attention of the Ministry in this regard during the last two-three years have gone unnoticed. The Ministry has not considered it important enough to initiate any action so far. This is the case when two of the units, i.e. CRI, Kasauli and BCG VL, Guindy are subordinate offices of DGHS while PII, Coonoor is an autonomous body under the Ministry,” critisises the report.
The interim report of Javed Chaudhary committee reveals that out of the total of 129 deficiencies raised in the reports, about 71 observations are of minor nature, not significantly affecting the manufacturing standards. The remaining 58 issues call for improvement or upgradation, such as walls not having a smooth surface, junctions, corners, window or 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.
About 60 per cent of this second category of work has already been completed. The remaining work in this category can comfortably be completed within two months, said the report submitted in February, this year. However, the ministry has not informed the current stage of revival of any of these units though reiterates its targets to restart the operation without much details.
During 2008-09, a number of states like Orissa, Bihar, Jharkhand, Madhya Pradesh, Assam, Punjab, West Bengal and Kerala, which usually are the flagship states of the UIP project faced shortfall of BCG, DPT, TT, OPV and Measles vaccine. If the ministry does not take pro-active measures to equip these existing vaccine units to revamp and upgrade manufacturing facilities, the drug shortage and vaccine price increase could be higher in near future, warns the report.