Drugs and Clinical Trials Rules, 2019

On 26th March, 2019, the Government notified the new Drugs and Clinical Trials Rules, 2019, reducing the time for approving applications to 30 days for drugs manufactured in India and 90 days for those developed outside the country.

Nodal Ministry: Ministry of Health & Family Welfare

Aim

  • The aim is to promote clinical research in India, have predictable, transparent and effective regulations for such trials and to make faster accessibility of new drugs to the Indian population.

Reason for Such Move

  • According to the Central Drugs Standard Control Organisation (CDSCO), the number of patients with rare diseases is quite low, making ....

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