Post News Network
Bhubaneswar, Oct 14: The Centre is planning to strengthen the state-based drug regulatory system through inter-linking drugs testing laboratories spread across the nation and other related facilities to ensure supply of safe and regulated drugs into the state.
The Union health and family welfare department has already prepared a draft memorandum of understanding between the Centre and the state governments concerned. According to the plan, the Centre will bear 75% of the total expenditure while the states will have to help with the 25% of the funds meant to strengthen monitoring of the drug inflow.
According to sources in the state drug regulation department, a number of limitations often pose hurdles in proper functioning of the system and the proposed well-coordinated network of testing and other aids can potentially help strengthen the overall drug monitoring and regulation system.
The state units often grapple with problems like inadequate or weak drug control infrastructure, insufficient drug testing facilities, non-uniformity in enforcement of law and the rules, lack of training to regulatory officials, lack of database and inadequate IT services.
The draft MoU prepared by the central government says, “The risk assessment component of the drug safety and quality needs to be strengthened by inter-linking drug testing laboratories. The Centre and the state governments will strengthen the existing set-up of the surveillance system and increase consumer awareness about current and new drugs safety and quality-related threats.”
The upgrade and strengthening of the system will also include setting up of new laboratories and training academy for regulatory and drug testing officials. The Cabinet Committee on Economic Affairs had approved in August the proposal for strengthening the drug regulatory system at a total cost of Rs1,750 crore. Out of the amount, it is believed that `900 crore will be spent for boosting central structures while Rs 850 crore will be made available to the states.
Under the provisions of the Drugs & Cosmetics Act, 1940 and the Drugs & Cosmetics Rules, 1945, the manufacture, sale and distribution of drugs and cosmetics are regulated by the State Drugs Control Authorities appointed by the state governments.
Even sale of imported drugs after being permitted by the Central Drugs Standard Control Organisation is monitored and regulated by state drug control departments. Accordingly, the drugs control departments of the states play a vital role in implementing the provisions of the Drugs & Cosmetics Act, 1940 and the Drugs & Cosmetics Rules, 1945.
According to official estimates, Indian pharmaceutical companies have been growing at the rate of 10-12% per annum. It is the third largest in the world by volume and 10th by value. The total size of the Indian pharmaceutical industry is about `2 lakh crore, out of which exports account for nearly 55 per cent.
