The Working Group of the Planning Commission on drugs has recommended a total financial outlay of Rs. 6256 crore for strengthening the drugs and regulatory system, including that in the states and creation of a separate authority for medical devices, during the next five year plan period.
The Working Group recently submitted the recommendations to the Planning Commission which is discussing them to finalise the plans for the period 2012-2017, sources said.
Main contents of the outlay for CDSCO are manpower creation (Rs. 630 crore), new offices (Rs. 35 crore), upgradation of existing offices (Rs. 60 crore), mini-labs at port offices (Rs. 160 crore), new central drug testing labs (Rs. 320 crore), upgradation of existing labs (Rs. 90 crore), running/maintenance of labs (Rs. 92 crore), national training academy (Rs. 50 crore), mobile labs ( Rs. 250 crore), pharma research labs (Rs. 50 crore), CDSCO Overseas Country offices (Rs. 175 crore), E-governance/archiving (Rs. 250 crore), pharmacovigilance (Rs. 250 crore), overseas inspections (Rs. 25 crore), manpower for medical devices sector (Rs. 934 crore), training for regulators (Rs. 50 crore), cosmetic labs (Rs. 200 crore), and spurious drug survey and samples cost for testing of drugs, cosmetics, medical devices etc (Rs. 20 crore). For strengthening the State drug regulatory systems, the expert group has suggested that the Centre should share 60 per cent of the expenditure and it will be around Rs. 1920 crore.
“Strengthening of Drugs Regulatory Mechanisms is one of the major public health interventions. This ensures that safe, efficacious and quality drugs are made available to the people. Keeping in view the recommendations of the Mashelkar Committee, it is important that the infrastructure, both physical and human resource, both at the Centre as well as in the states is substantially augmented,’’ the Working Group report said.
Inadequate manpower at the State and Central level, inadequate or weak drug control infrastructure at the State and Central level, inadequate testing facilities, non-uniformity of enforcement of law and regulation, lack of training to regulatory officials, lack of data base, and inadequate IT services were cited as the problems in the field of regulatory sector.
As its recommendations, the Working Group has called for strengthening the CDSCO by creating additional posts for uniform and effective implementation of Drugs and Cosmetics Act and Rules thereunder. The additional posts are required to comply with recommendations of Dr. Mashelkar Committee report (one drugs inspector for 50 manufacturing units and one drugs inspector for 200 sale premises).
CDSCO would require 1045 additional posts, to regulate the pharmaceutical market in the country. For this, Rs. 45 crore is required per annum. Additional personnel are required also to regulate the medical devices sector, the clinical trials, implement pharmacovigilance programme and implement the proposed antibiotic policy, the report said.