Government Eases Norms To Test, Launch Drugs

In an attempt to ease norms for testing and introduction of new medicines in the country, the government has taken steps to fast-track approvals for clinical trials as well as launch of drugs already approved in other countries. Pharmaceutical companies planning to launch new drugs already approved outside India after conducting pre-clinical or toxicological studies on animals will not be required to repeat such studies in India for importing or manufacturing them here unless some specific concerns are raised, the Drugs Controller General of India, under the health ministry, said in a latest circular issued this week.

India- Great Destination For Clinical Research

India has always been a hot destination to conduct clinical trials. Many key factors of doing clinical research in India, make it a worthy place. It’s very logical for sponsors who are interested in selling their products to India’s 1.25 billion population, where demand for new medicines is increasing considerably. Approximately 17% of the world’s population and 20% of the global disease burden is in India.

There is an opportunity to recruit from a huge patient pool who may be eager to participate in trials that would give them access to life saving drugs. Availability of infrastructure and skilled young manpower, English speaking and trained talent pool to manage clinical trials, and all this at a lower cost. In recent time the licensing authority of India (CDSCO) has taken steps to fast track approvals for clinical trials and has also given more freedom and responsibilities to Ethics Committees.

These key factors to conduct clinical trials in India give sponsors an opportunity of a competitive advantage of cost effective trials with access to huge patient population, expertise and ready infrastructure.


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