Untested COVID 19 Drugs Under Trial | Government May Soon Allow For Testing Patients
COVID-19 pandemic, the government may soon allow the import of COVID 19 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.
However, Officials said the process for approvals is simple. The medical institution will have to apply to the Drug Controller General of India (DCGI) explaining the rationale for ‘compassionate use’ over ‘available therapeutic options.
Further, the Health Ministry will soon be making amendments to the New COVID 19 Drugs and Clinical Trials Rules 2019 that will make the medicines more accessible for the patients.
India Approves Emergency Use Of Remdesivir COVID 19 Drugs
On June 2, the Health Ministry approved the emergency use of Remdesivir to treat COVID-19 patients and can be used as COVID 19 Drugs. 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 a debate.
“The clause has been added to help patients suffering from serious diseases. This gives early access to patients suffering from rare diseases, especially children with spinal muscular atrophy or orphan diseases,” said a Central Drugs Standard Control Organisation (CDSCO) official. “This has been introduced as it also provides a safety net to doctors prescribing these medicines.”
The medicines are expensive and are manufactured sparingly by drug manufacturers, sometimes costing over ₹1 crore per vial.
If a hospital prescribes a new COVID 19 drugs unavailable in India, a manufacturer could also apply for a special license and manufacture it in limited quantities.
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