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Draft Guidelines From The Health Ministry For Compassionate Use Of New Drugs

The Union health ministry plans to modify the New Drugs and Clinical Trials (NDCT) rules 2019 for E compassionate utilization of novel unapproved drugs depending on the Drugs Technical Advisory Board (DTAB) recommendations. DTAB measured the draft notification about the same dated June 5, 2020, after proper consideration is recommended to alter the rules, including some of the provisions for compassionate utilization of novel drugs that have not obtained approval. After a discussion with DTAB, the central government had released draft guidelines on June 5, 2020, about making some alterations in NDCT rules, 2019, for compassionate utilization of novel but unapproved drugs. It has also asked for suggestions on the draft guidelines from the industry. DTAB explained that the depiction of the Cure SMA foundation of India had been received to make the rules and guidelines for the compassionate use of novel but unapproved drugs in India. The whole illustration clearly mentioned that the
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