Published 13:55 IST, June 9th 2020
COVID-19: Centre may soon allow import of treatment drugs under trial in other countries
In the view of the COVID-19 pandemic, the government may soon allow the import of drugs that are undergoing trial in other countries, according to reports
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In view of the COVID-19 pandemic, the government may soon allow the import of drugs that are undergoing trial in other countries. According to reports, this decision may be taken for 'compassionate use' for infectious diseases such as COVID-19, rare pediatric disorders, and genetic diseases. As per the Central Drugs Standard Control Organisation (CDSCO), the compassionate use clause has been added to give early access to patients who are suffering from serious diseases.
As per reports, the process for the approval of medicines has been made simpler. According to the report, the medical institution will have to explain the reason for 'compassionate use' over 'available therapeutic options' to the Drug Controller General of India (DCGI). Further, the Health Ministry will soon be making amendments to the New Drugs and Clinical Trials Rules 2019 that will make the medicines more accessible for the patients. Earlier, in May , the European Medicines Agency (EMA) had recommended the 'compassionate use' of Remdesivir drug in order to treat severe COVID-19 cases.
India Approves Emergency Use Of Remdesivir
On June 2, the Health Ministry approved the emergency use of Remdesivir to treat COVID-19 patients. Remdesivir is the first drug that showed positive results in COVID-19 patients in formal clinical trials, even as Hydroxychloroquine's use as a prophylactic continues to be debated. It was granted emergency use authorization by the US Food and Drug Administration last month and has received approval by Japanese health regulators.
Lav Agarwal, Joint Secretary, Health Ministry, at a press conference said that Central Drug Control Standard Organisation (CDCSO) has given permission for emergency use of the drug to treat COVID-19 patients based on the available evidence.
"The Central Drug Control Standard Organisation (CDCSO) has given permission for emergency use to treat COVID-19 patients based on the available evidence. Remdesivir has been approved for emergency use to treat COVID-19 patients. In terms of what protocol, what doses, it is not available with me now. Particular organizations produce available evidence based on that permission for use is given," he had said.
13:55 IST, June 9th 2020