The Central Government is seriously planning to do away with the current system of drug regulation and hand over the responsibility to a newly carved out independent authority on the lines of United States Food and Drugs Administration.

The suggestion gains strength from the fact that two key ministries, the Union Ministry of Health and Family Welfare and the Union Chemicals and Fertilizers Ministry have both recommended for the setting up of an independent authority. The expert committees set up by these ministries to suggest measures for improving the status of drug regulation in the country were also unanimous in recommending the setting up of an independent national drug regulatory body.

In the words of Anbumani Ramadoss, Union Health Minister, the government is committed to set up an Independent Drugs Regulatory Authority exactly on the lines of US FDA. The independent drugs authority would have a complete structure in the next two years and would function as a self-sustained regulatory mechanism.

In the first phase, the ministry will initiate measures to replicate the mechanisms operational in the US FDA and in the second phase, it will tie up with the US FDA, informed the minister. He has also said that he had recently met the US Food and Drug Commissioner and had a discussion in this regard.

Meanwhile, the Prime Minister's task force on drugs and pharmaceuticals, which submitted its recommendations few months ago, endorsed the proposal made by the Planning Commission in the Mid-term Appraisal of the Tenth Five Year Plan to establish a National Authority on Drugs and Therapeutics (NADT) as a long-term objective. The kind of authority envisaged by the Task Force would integrate the offices of the Drugs Controller General of India, the Central Drugs Standard Control Organisation (CDSCO) and the National Pharmaceutical Pricing Authority (NPPA), along with all the powers and functions of these bodies. The Drugs and Cosmetics Act would have to be amended for this purpose. The functions proposed to be assigned to the NADT will require a significant enhancement in both the manpower and the skill sets available in the existing organizations which are proposed to be merged.

However, the committee has said that since the constitution of NADT may take time (because it will involve resolving several interdepartmental issues and legislative enactments), a dual regulatory system may be implemented immediately. This would be a National Drug Authority (NDA) for safety, quality and efficacy aspects and a revamped NPPA for pricing and market-related issues.

The NDA proposed by the committee is again the same as that of the Health Ministry's proposed US FDA model central authority. It should be noted that all subsequent committees have taken cognizance of the Mashelkar Committee Report (2003) which detailed the requirements for the Drug Controller's office and its revamping into a central drug authority.

According to Mashelkar committee, the existing infrastructure at the Centre and States was not adequate to perform the assigned functions efficiently and speedily. The committee had suggested the setting up of a Central Drug Administraion (CDA) to undertake all the functions of a strong, well equipped, empowered, independent and professionally managed CDSCO.

"The restructured CDA should have 10 main Divisions at the headquarters manned by adequately trained manpower. Each of these divisions may have several sections depending upon the scope of the activities of the respective division. These divisions could be named as Division for Regulatory Affairs & Enforcement, Division for New Drugs & Clinical Trials, Division for Biological & Biotechnology Products, Division for Pharmacovigilance, Division for Medical Devices and Diagnostics, Division for Imports, Division for Organizational Services, Division for Training and Empowerment, Division for Quality Control Affairs and Division for Legal and Consumer Affairs" the committee had suggested. The measures that were suggested to be taken up immediately were the expansion of zonal and sub-zonal offices, creation of additional infrastructure for new offices in states, creation of considerable number of additional senior level and supporting posts, need of additional funds to set up a world class Central Drug Administration among others.

The recommendations of these committees may be considered seriously now as all the ministries have shown concern over the present state of affairs. If the health minister's plan gets through, India is certainly going to have a world-class drug regulatory mechanism guided by an independent body.