The Mashelkar Committee for drug regulatory reforms will favour the establishment of a mechanism at the central level to audit the functions of the state drug regulatory agencies (DRA) by a panel of independent experts. It would recommend an amendment in the Drugs and Cosmetics Act in order to empower the central DRA to issue directions to state licensing authorities and to review the orders passed by them and if necessary, to revoke any permission granted by them.

The committee also calls for the setting up of a structured mechanism to enable interstate exchange of regulatory officials to bring about better understanding of processes adopted in different states.

The recommendations, if implemented, would allow the Central Drug Standard Control Organisation (CDSCO) to have a firm grip over the functioning of the state DRAs. "In case, the functioning of any state DRA is found below the accepted performance indicators, the central government should have the powers to take suitable action", the committee feels. It is known that Mashelkar Panel has partially considered the suggestion from the All India Drugs Control Officers' Confederation (AIDCOC) and thereby recommended the amendment of Section 33 P of D&C Act to give powers to DCGI to issue directives to state licensing authorities to review the orders passed by them and if necessary, to revoke "any permissions" granted by them.

The committee has called for the review/revision of schedule H, schedule K and also the practice of issuing licenses to the wholesalers and retailers at the earliest. The panel also suggested a review and examination of all its recommendations concerning the amendment to D&C Act by a sub committee of Drugs Consultative Committee (DCC) before making necessary changes.

The call for the setting up of a mechanism for interstate exchange is expected to help in harmonizing the enforcement practices and bring in an improved uniformity in the implementation of various rules and regulations. The committee wanted the state governments to enhance their budgetary allocations to the drug regulatory department. Need for providing adequate infrastructure for the office of state DRA and the field officers including funds for vehicles and purchase of samples were emphasized.

The panel has taken note of the failure on the part of the centre to fill up the existing sanctioned posts, which are lying vacant for years now. It wants the government to fill up these posts immediately and also sanction the additional posts recommended by the committee.