No clinical trials in India for new drugs approved in select developed markets

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  1. Union Ministry of Health and Family Welfare has issued Drugs and Clinical Trials Rules,2019.
  2. The new rules say that new drugs approved for use in the EU,UK,Australia, Japan and the US will be automatically allowed in India provided clinical trials included Indian patients.The move is expected to reduce the time taken by pharma firms to introduce drugs in India and prevent duplication of studies.
  3. Further,it has also removed a clause in the clinical trials that mandated the sponsor(the entity initiating the trial) to pay 60% of compensation upfront in case of death or permanent disability of a patient.Now companies will pay the total amount once it is proven that the injury occurred because of the trial.
  4. Clinical trials are research studies that explore whether a medical strategy,treatment or device is safe and effective for humans.Before a drug is launched in the market,it has to be tested for its safety and efficacy. Central drug Standard Control Organisation(CDSCO) regulates clinical trials under Drugs and Cosmetics Act,1940.
  5. The Central Drugs Standard Control Organization (CDSCO) is the national regulatory body for Indian pharmaceuticals and medical device.It functions under the Drugs and Cosmetics Act,1940.CDSCO comes under Directorate General of Health Services,Ministry of Health & Family Welfare.
  6. CDSCO is responsible for (a)approval of New Drugs (b)Conduct of Clinical Trials (c)laying down the standards for Drugs (d)control over the quality of imported Drugs in the country and (e)coordination of the activities of State Drug Control Organizations by providing expert advice with a view to bring about uniformity in the enforcement of the Drugs and Cosmetics Act.