The Parliamentary Panel attached to Health Ministry and an expert panel set up by the ministry have criticised the `sudden-death approach' to the implementation of GMP standards and the veracity of having joint inspections between the CDSCO and the WHO in the units.
The Javed Chowdhary Committee, set up by the Health Ministry in 2009 to examine the decision of suspending the licences of three public sector units on the ground of not complying to GMG standards in 2008 made the observation on implantation of Schedule M first and the Parliamentary panel headed by Amar Singh has recently endorsed the same.
"The Javed Chowdhary committee had rightfully concluded that it needs to be recognized that the sudden-death approach to the implementation of the GMP standards would serve no public purpose; it would only bring about a crisis, as the operations of a larger portion of the domestic drug sector would come to a halt. The above facts clearly indicate that so far judicious applicability of Drugs and Cosmetics Rules has been lacking. The case of the three public sector units is 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, is evolved. Simultaneously, review of infrastructure and manpower of the drug regulatory body also needs to be taken on a priority basis," the panel said.
The report also took exception to having selective inspections. Central drug inspectors are carrying out inspection of only certain categories - vaccine & sera, large volume parenterals, notified medical devices, blood banks and units applying under WHO-GMP Certification Scheme. Drug manufacturing units are being inspected only on request, the report said.
``A critical issue analysed by the Javed Chowdhary Committee is the scope of the provisions of the GMP standards notified under the Drugs and Cosmetics Act, 1944 and Rules made there under. GMP standards for drug manufacture are largely identical to the WHO-GMP standards. - A large number of standards set out in Schedule 'M' of the Rules cannot be met to the fullest extent by every manufacturing facility. Assessment of compliance of many of the standards spelt out in descriptive language would depend on the subjective perspective of the inspector,'' the report said, basing on the findings of the Javed panel.
The most important issue highlighted in the Javed Chowdhary Report relates to the jurisdiction of WHO Inspection team and the NRA team of India. Responsibilities of the Central License Approval Authority (Indian NRA) are not in any circumstances to be jointly discharged with the WHO. Accordingly, WHO was not permitted to join the Indian NRA team in its inspections carried out in 2001 and 2004. However, request of WHO was accepted by the Ministry in 2007 inspection.
Secondly, WHO in its capacity as a consultant to multi-lateral agencies (UNICEF, WB) which purchase drugs/ pharmaceuticals for their interventions in international health programmes, sets certain norms for pre-qualifying manufacturers bidding for these contracts. As a result, WHO is entitled to exclude the public sector vaccine units from their pre-qualified lists of manufacturers for international health interventions. However, NRA in India can take a differing view of the status of compliance for the very same units for its own purposes. Since WHO does not have any authority of superintendence over the Indian NRA, there can be no question of it de-recognising NRA, according to the report of the Parliamentary panel.