TwinTech Academy`s session on Law and Clinical & Other Research in Medical Science on 13.02.2021

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In India, before the fag end of British Raj, a new law was enacted by name the DRUGS and COSMETICS Act, 1940 with the main aim of controlling and regulating Pharmaceutical activities including manufacturing, importing, distribution, stocking the drugs and to sell them in Indian market. Less importance was given for clinical trials in India at that time. Rules were framed only during 1947. The union government brought Y - schedule in the rules which stipulate guidelines for generic medicine but foreign Pharmaceutical Companies entered Indian market which paved the way for drastic changes.Y - schedule brought the following in place:
1. Definition for Phase I– IV trials.
2. Clear responsibilities for investigators; and sponsors.
3. Requirements for notifying changes in protocol.
Application of product patent in 2005 recognizing individual’s innovations through the Intellectual Property Rights, agreement was introduced. In 2013 drastic changes were made with Research Committee, Ethics Committee registration, provision for payment of compensation in case of adverse reaction of trial drugs during the trial period for the participants. In 2015, the Central Drug Standards Control Organization in New Delhi (CDSCO) was formed for all Indian Pharmaceuticals and Medical Services on the lines of USFDA and the EMA of the European Union. The CDSCO and DCGI are given wide powers for regulating every aspect of research and trials.
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