The 3 PSUs had complied with the good manufacturing practices norms

Taking a critical view of the manner in which the manufacturing licences of three public-sector vaccine producing units were suspended, a Parliamentary panel has said it was abundantly clear that the decision was based on a major misconception and due to the misinterpretation of certain unclear signals in the communication from the World Health Organisation (WHO).

A prudent step that was blatantly missed by the Ministry of Health and Family Welfare was determining, at the outset, the WHO's exact position in this regard.

Surprisingly, it was not clarified in spite of the matter having surfaced five times in the notes at various levels in the Ministry. The Ministry's decision to recommend the closure of the three vaccine-producing public sector undertakings (PSU) was not only myopic but also exposed the nation to an unacceptable risk in vaccine security, even as several States were reeling under vaccine shortages, according to the department-related Parliamentary Committee of Health and Family Welfare on Friday.

The three units in question are the Central Research Institute (CRI) at Kasauli, the Pasteur Institute of India (PII) at Coonoor and the BCG Vaccine Laboratory at Chennai.

As was discussed in the earlier reports of the committee, in the absence of the supply of vaccines from the public sector, the cost of vaccines in the domestic market appreciated by 50-70 per cent within two years from the closure of the these units. The Committee had observed that it was “high time” that the role and locus standi of the National Regulatory Authority (Drugs Controller-General of India) vis-a-vis WHO were made clear. In the absence of any clear-cut boundary in the matter, it was left to the subjective interpretation of the officials at the helm at any point of time. According to the Committee, such a precarious situation left ample scope for such cases to recur. Hence, it strongly recommended that the Ministry, which was the prime intermediary between WHO and the NRA, take up the matter with WHO and clarify its position at the earliest.

The Committee also focussed on the issue of the Ministry's treatment of the compliance of good manufacturing practices (GMP) norms by the three PSUs. From the outset, the department, while justifying its decision to suspend the manufacturing licences of the PSUs, had said that they had failed to comply with the GMP norms specified under the Drugs & Cosmetics Act and Rules. However, as the vaccines produced by the PSUs conformed to the standards of safety, efficacy and quality — a fact admitted by the then Secretary during the course of her deposition before the Committee on October 26, 2009 — the Committee stressed that the decision to close these PSUs on the grounds of non-compliance lacked justification.

The Committee was, therefore, perturbed to note that the Ministry, rather than admit the fallacy of the decision earlier taken by them, continued to harp on the lack of compliance with GMP norms. The Committee further said that the Ministry, the office of the Directorate-General of Health Services and the Drug Controller-General of India could not evade having to take responsibility for the manner in which the case was dealt with.

The Committee found unacceptable the tenor of the action, which was inclined towards absolving the top authorities of the responsibility for singling out the three PSUs while sparing the private players.