The Central Drugs Administration (CDA) being proposed by the expert committee headed by Dr R A Mashelkar will have a dream team of qualified pharmaceutical and pharmacological scientists, legal and other competent officials at the headquarters, zonal offices and drugs testing laboratories to perform their functions more effectively and expeditiously. CDA would be an independent office under the Union Ministry of Health and Family Welfare and will have 10 exclusive regulatory wings, it is learnt.
The committee is known to have decided to recommend 10 separate divisions for regulatory affairs and enforcement, new drugs and clinical trials, biological and biotechnology products, pharmacovigilance, medical devices and diagnostics, imports, organizational services, training and empowerment, quality control affairs and legal and consumer affairs in its headquarters at New Delhi.
The Division for Regulatory Affairs and Enforcement would deal with drug consultative committee issues, central licensing, zonal/sub-zonal and state offices, inspection (domestic and international), guidelines and directives, interstate issues, drug recalls, investigations, regulation of promotion of medicines and product information, legal affairs, international cooperation and exports.
The Division for New Drugs and Clinical Trials will be in charge of clinical trial approvals, which includes regulation and registration of investigation sites, ethics committees and investigators. Inspection of clinical trial sites, sponsor sites and ethics committees, efficacy and safety evaluation of new drugs including INDs, pharmaceutical and quality evaluation, biostatistics, veterinary new drugs, issues related to border-line products and screening of existing drug formulations would also be under the particular division.
Vaccines and sera (human and veterinary), blood and blood products, recombinant and other biotechnology products will be under the division of biological and biotechnology products.
Formation of National Pharmacovigilance Advisory Committee and safety monitory of drugs and devices would be the responsibilities of yet another division. The Division of Medical Devices and Diagnostics will focus on the evaluation of devices and diagnostics, its imports, licensing and enforcement. While Imports Division will be in charge of registration of overseas manufacturing, overseas inspections, managing port offices, issue of licenses and quality monitoring of imported products, Division for Quality Control Affairs will manage central drug laboratories, monitor state and private laboratories and would be involved in audits and accreditations, drug standards, Indian pharmacopea and international harmonization.
The committee has found it necessary for CDA to have a press and public relations wing under its Division for legal and consumer affairs. The division will also handle court cases, parliament affairs, consumer information, publication and will be in charge of implementation of Drugs and Magic Remedies Act.
Interestingly, most of these divisions are expansions of already existing organizational provisions under Central Drug Standard Control Organisation (CDSCO). These provisions came into existence after the Pharmaceutical Research & Development Committee (PRDC) headed by Dr Mashelkar had recommended comprehensive strengthening of CDSCO. However, many of the divisions never got functioning due to lack of expert manpower. As the committee had pointed out in its interim report, "three years have lapsed from the acceptance of the PRDC report by the government, no infrastructural improvement whatsoever in respect of manpower had occurred in CDSCO". The latest committee report is to reaffirm the importance of strengthening the manpower of CDSCO in the context of post 2005 scenario.