The parliamentary committee on health and family welfare headed by Amar Singh has lambasted the Union health ministry for its cavalier fashion with which the ministry has treated the issue of three closed PSU vaccine producing units. It has indicted the ministry for refusing to reopen these units even after these institutes rectifying the major shortcomings pointed out by the WHO inspection team.
The ministry had last year cancelled manufacturing licenses of CRI Kasauli, PII Coonoor and BCG Vaccine Laboratory Chennai after the WHO team found some deficiencies in GMP compliance.
The committee, in its report presented in Parliament on February 18, expressed surprise over the way the health ministry handled the issue. "Major shortcomings pointed out by the WHO inspection team have already been rectified by the concerned institutions. What remained was, very few drawbacks mainly pertaining to infrastructure which can be easily removed with positive support from the ministry. Not only this, committee was also given to understand that WHO had offered to upgrade the technology of these PSUs, but the ministry had declined the offer and instead preferred to cancel their vaccine producing licenses," it noted.
The Committee observed that the Ministry, being the nodal authority for these three PSUs, failed miserably in taking any concrete steps to make these PSUs cGMP compliant. The Ministry also failed to provide adequate funds for the purpose. The Committee noted the cavalier fashion with which the Ministry has treated the entire issue from the fact that the Ministry had awarded a contract to a Noida-based firm for constructing a GMP compliant structure at CR1, Kasauli without taking into account the technical competence of the firm. The entire exercise ended in failure after spending Rs 11.86 crore on the project and wasting valuable time for more than ten years.
Another disturbing development noticed by the Committee was the setting up of an Expert Committee. Mandate of this Committee, i.e, exploring the feasibility of conversion of existing laboratories into testing laboratories or training units and the scope of redeployment of existing staff in production unit in the proposed testing laboratories clearly indicates that the Ministry had already taken a decision for final stoppage of vaccines production at these institutes. All the three institutes fulfilling vaccine requirements of the country for so many decades were not given a fair chance. It may also be mentioned here that prior to the Expert Committee, neither the inspecting team of WHO-NRA nor the subsequent team of DCGI had made any recommendation for closure of these units.
The Committee also pointed out that since these units have been manufacturing vaccines for so many decades, the right course of action would have been to make sincere efforts for their revamping in accordance with the changing times. The Vaccine Park coming up at the cost of already existing units cannot be considered justified from any point of view. The Committee observed that the project could take a couple of years before manufacturing and supply of vaccines could actually take place. Till such time the Committee feels that procuring requirements of vaccines from private sector would only increase the cost of vaccines thereby adversely hitting the exchequer. Moreover, a single centralized vaccine producing park may not be able to cater to the needs of the billion plus and growing population of the country.
The Committee, therefore, recommended that the Ministry should revoke the suspension of vaccine manufacturing licenses of these PSUs at the earliest. Until such time the new infrastructure are built confirming to GMP norms, these institutes may be allowed to continue production in old structure after carrying out the rectifications either fully or to the extent possible. In view of the fact that these units have their own quality control system as also the National Quality Control Authority involved in the quality control of vaccines, there is a little likelihood of production of sub-standard vaccines by these units. These Institutes may be allowed sufficient time and provided with adequate funds for completing their rectification work under the aegis of the Ministry in order to avoid any time over run.
The Committee also recommended that all the vacancies in technical cadres should be filled up at the earliest and the recruitment rules, which are yet to be framed, should be framed immediately. The Committee further recommends that the existing scientific and technical staff should be given appropriate training to make them GMP compliant.