Health Ministry drafts rules to help COVID-19 patients acces
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Seeking to facilitate the availability of experimental drugs for severely-ill COVID-19 patients, the Union Health Ministry has issued a draft notification for "compassionate use" of any unapproved drug that is in the phase-III clinical trial globally.

According to a gazette notification of the draft rules published on June 5, a hospital or medical institution may import the new drug for "compassionate use for the treatment of patients suffering from a life-threatening disease or disease-causing serious permanent disability or disease requiring therapy for unmet medical need", which has not been permitted in the country, but under Phase-III clinical trial (human trial) in the country or abroad, by making an application to the Central Drug Regulator.

The new draft rules will be applicable for 15 days during which people can send their objections and suggestions to be considered by the Central Government after which the final amended rules will be published in the Gazette of India.

Under section 96C of the draft says that the hospital or medical institution shall submit to the Central Licencing Authority, a quarterly report which was half-yearly under the previous rules about the status and stock of new drugs imported, utilized, and destroyed.

Source: https://health.economictimes.indiatimes.com/news/polls/centre-brings-fresh-rules-for-import-of-unapproved-new-drug-for-compassionate-use-to-treat-patients/76252610
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