The Drug Controller General and the DGHS have come under fire again from the Parliamentary Standing Committee on Health and Family Welfare for their ‘sudden action’ on the three public sector vaccine manufacturing units leading to their closures.

The Panel headed by Brajesh Pathak in its latest report has categorically stated that the office of the DGHS and the DCGI cannot absolve themselves from the responsibility of the manner in which the case of the vaccine-producing PSUs was dealt with. “The Committee finds the tenor of the action taken note, which is inclined towards absolving the top authorities of the responsibility for singling out the three PSUs while sparing the private players, to be unacceptable. The Committee observes with anguish that by trying to defend its decision to close down the three PSUs, the Department has sought to deviate from the core concerns expressed by the Javid Chowdhury Committee,” it said.

In view of the provisions of the Drugs & Cosmetics Act, the mandate of the DCGI ensuing there from and the action of suspending the licenses of the PSUs, the Department’s argument that a fair treatment was meted out to them is a specious one which only seeks to skirt the issue raised by the Javid Chowdhury Committee. It is apparent that effective corrective measures need to be initiated so that such a precarious situation does not recur in future, the report said.

The comments come based on the action taken report on its earlier report which clearly held that the closure of PSUs was a ‘classic example of total lack of accountability of all concerned.’ It is time that a fool-proof mechanism for regulating the manufacturing units of all categories- both in the private and public sector, was evolved, it had said.

“The Committee fully agrees with the Department’s contention that sudden death approach is not legally allowed in the implementation of the Drugs and Cosmetics Act and Rule including GMP through its inbuilt provisions. The Committee, however, notes that this line of action was not followed in letter and spirit in the instant case. The Committee would like to cite here that in its 34th and 38th Reports it had made abundantly clear that the replies filed by these Institutes were not given reasonable consideration in the light of the rectifications carried out by them nor due consideration was given to the Department’s role and responsibility in making them GMP compliant,” the new report said.

The Panel also quoted from the final report of the Javed Chowdhury committee which was set up to go into the issue of the suspension of licences to the three PSUs. “When reviewing the recent history of the three public sector vaccine manufacturing units, one aspect is eye-catching - that these units have received an exceptional degree of attention from the regulatory authorities. Over the years, the units have been inspected by the state and central drug control authorities time and again (BCG, Guindy (5/2001 to 2/2008) – 10 inspections; PII, Coonoor (10/99 to 3/2008) – 9 inspections; and CRI, Kasauli (9/2002 to 1/2008) – 5 inspections). The NRA has itself inspected the units in 2001, 2004 and 2007,” the report of Javed Chowdhury panel said.

While diligence in the regulatory duties is something which should be commended, it must not take the shape where it is perceived that these units are particularly targeted. There are over 10,000 drug and vaccine/ sera units in the country. Out of which all but 350 are in the small-scale sector. DCGI has 40 drug inspectors under him who carry out statutory inspections on his behalf, the report said.

In 2004-05, it held 1163 inspections and the number went down to 847 in 2005-06 and again to 775 during 2006-07. The number picked up slightly to 889 during 2007-08 but again slipped down to 764 during 2008-09, according to the details collected by the panel.

“The Committee is surprised to note the role allotted to itself by the DCGI. Though it has a supervisory responsibility over the entire range of drug manufacturing units, it has withdrawn itself from the inspection of the drug units, except on request. Considering that it has jurisdiction over 10,000 manufacturing units, the above table reveals that a paltry number of manufacturing units were inspected. Given that in year 2007-08, the year in which the licenses of the pubic vaccine units were suspended, the central inspectors only carried out 889 inspections, it is remarkable that the regulatory authority found it possible to spare so much attention for the three public sector vaccine manufacturing units,” the panel said.

“The Committee is surprised to note the procedure adopted by the DCGI after the receipt of the representations in response to the show-cause notices.  The action of the DCGI in ordering the suspension of the licenses without even going through a ritual of considering the representation, and the subsequent inspection report, is plainly illegal.  With disappointment, the Committee is constrained to note that at no level was the duty – of ensuring a rigorous and objective analysis - discharged with the necessary diligence.  In fact, evidence on record indicates that, in the midst of the administrative process, the decision was being treated as pre-judged,” it said. The panel also came down heavily on DCGI for not providing details of number of units closed down during the period.