While the Central Government is going ahead with its plans of setting up a revamped professional drug administration system for the country with the formation of a National Drug Authority (NDA) by December 2006, the move would necessitate the government to allocate about Rs 100 to Rs 120 crore annually to run the system.
At present expenses incurred to run the offices of Central Drugs Standards Control Organisation (CDSCO), NPPA, DCGI's office etc. are only about Rs 10 to Rs 15 crore. The envisaged NDA demands five fold increase in manpower and a majority of the expenses would be in the form of salaries to the officials. Sources also point out that unless the Finance Ministry allocates adequate funds in the forthcoming budget, the NDA is unlikely to take off in 2006. If that materialises, it would be the largest recruitment and training programme in the history of drug control administration in India. At present an implementation committee is working on the finer areas of functions and powers of NDA.
According to Dr. M Venkateswarulu, deputy drugs controller of India (west zone), the proposed NDA need not be modelled in the lines of the US FDA. "We are analysing the features of all leading drug control administrations, for example TGA Australia. The best of these administrations will be incorporated into our system," he said.
As reported earlier, the Draft Pharmaceutical Policy 2006 had announced to set up an NDA for drug administration and integration of various related offices in the long run to form National Authority on Drugs and Therapeutics (NADT). The Union Ministry of Health and Family Welfare and the Union Chemicals and Fertilisers Ministry are in favour of setting up of an independent authority. The Prime Minister's task force on drugs and pharmaceuticals also had suggested establishing NADT as a long-term objective integrating 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 Mashelkar Committee had suggested that the restructured CDA should have ten 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 and Enforcement, Division for New Drugs and Clinical Trials, Division for Biological and Biotechnology Products, Division for Pharmacovigilance, Division for Medical Devices and Diagnostics, Division for Imports, Division for Organisational Services, Division for Training and Empowerment, Division for Quality Control Affairs and Division for Legal and Consumer Affairs.
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.