In the backdrop of more and more formulations coming out every day and continuous rise in the consumption of medicines, the Kerala Institute of Drugs Studies (KIDS) has observed that a new system to strengthen the central and state regulatory agencies is necessary, for which a Training and Research Academy has to be set up in each state jointly by central and state governments.
The Academy should be able to hold continuous training programmes for the officials of the departments and update them with the latest knowledge in the field of drugs and policy matters.
In this regard, KIDS has made some innovative suggestions and forwarded them to the Department of Pharmaceuticals (DoP), government of India, in order to strengthen the operations of the central regulator, the Central Drugs Standard Control Organisation (CDSCO), and state drugs control departments.
The Institute suggests that the training academy should have facilities for holding basic training, continuous education programmes, skill development, knowledge upgradation, specialized coaching, higher education and research oriented studies including M Phil and Ph D programmes of approved universities. The Centre should also be capable to impart basic training and continuous education to officials working in the enforcement agencies at centre and state levels, and also to those working in academic and research sides.
It expresses the idea that the drugs control departments in each state can be strengthened by way of modifying and establishing strong drug safety infrastructures such as pharmacovigilance centres, computerized drug registry, R&D wing, etc with competent and qualified personnel at the state level. It has been proposed that for providing training to the officials, and to monitor the approved clinical researches and trials, the state needs a training and research centre.
Another suggestion is that a computerized drug registry should be set up at the national level and its operations should be extended to all states with the objective of ensuring drug safety in the country. Such registries are working effectively in many developed countries. Once the national registry is established, the pharmaceutical companies in India can register their firms and products for considering approval for marketing in foreign countries.
“It is sad to note that in this era of computer awareness and information technology, our drugs control departments are not having the details of the licensed manufacturers and their approved products. We don’t have any information on the use of medicines at national or state levels. Even for imported medicines we don’t have a registry, so, a lot of illegal and unethical activities are going on with such medicines”, says the proposal.
The drug registry system will also help generate money for the government through its registration process and marketing of medicines. It will support to identify fake medicines and unethical practices in the trade.
Strengthening of drug safety infrastructure at CDSCO offices, installing total e-governance including computerized drug registry from manufacture/import to dispensing, maintenance of orange book (list of approved drug products with therapeutic equivalence evaluations) for approved medicines in India, networking of central and state drugs control departments, etc are some of the major suggestions put forward by the Institute of Drugs Studies to the central and state governments.