The formation of a National Drug Authority (NDA), with elaborate powers including that of centralized manufacturing licensing for inter-state drug commerce, is fast turning into a distant possibility with the Union Ministry of Health and Family Welfare clearly stating that there is no live proposal for NDA at present.
The setting up of NDA was one of the most important recommendations of the Drug Policy 1994, the spirit of which was acknowledged in the following Policy announced early this year.
The lack of interest within the government circles was clear when A Raja, minister of state for Health and Family Welfare went on record in the Lok Sabha that the government has no such proposals to establish NDA.
He pointed out that the proposed NDA was to undertake the regulatory functions performed by the Central Drug Standard Control Organisation (CDSCO) in addition to assuming many new responsibilities. He also said that this would have required major structural changes in the existing drug regulatory system of the country. The role of state drug authorities would have changed as in a centralized licensing system, NDA would have taken up the job of issuing manufacturing licenses and the enforcement of the Drugs and Cosmetics Act, 1940 and Rules made there under. The minister said that in order to take up this additional responsibility, the existing capacity of the CDSCO should be strengthened and at present there is no proposal for the same.
It should be recalled that the Pharma Policy 1994 had looked at the proposed NDA as a panacea to all ills plaguing the drugs regulatory system of the country. Screening promotional literature, monitoring ongoing clinical trials through an Institutional Review Board, unearthing sub-standard and spurious drugs with the help of legal cum intelligence cells, centralizing all manufacturing licensees for inter-state commerce, updating good manufacturing practices and education to achieve judicious use of drugs, setting up of new analytical testing labs and formation of a Dispute Mechanism Cell were all to come under the purview of the proposed NDA.
Since the implementation of the proposal needed additional funds, it was proposed that a one per cent additional cess would be levied to mobilize the funds.
It was suggested that NDA be set up by a separate Act of Parliament to develop and define basic appropriate standards relating to the manufacture, import, supply, promotion and use of drugs. Approval and registration of pharmaceutical products for use in the country after ascertaining its real medical need, therapeutic value and safety was another major function assigned to NDA.
Monitoring standard practices in drug promotion and use, monitoring the prescribing practices, maintaining appropriate information about registered pharmaceuticals etc were also its proposed functions.
Though the centralized drug manufacturing licensing system has been considered as one of the most important steps needed to counter the problem of counterfeit/misbranded drugs, the central government is in no mood to implement the suggestions already made in its policy statement.