New Delhi: The Union health ministry has issued a draft notification to allow import and manufacturing of certain unapproved drugs on compassionate grounds in small volumes based on a prescription from a medical institution. The move is aimed at making experimental drugs for treating coronavirus disease (Covid-19) accessible for severely-ill patients in India.
In the draft gazette notification issued on June 5, the health ministry amended the New Drugs and Clinical Trials Rules, 2019, in consultation with the Drugs Technical Advisory Board, which advises the government on all drug-related matters.
“…Application for import of unapproved new drug for Compassionate use for treatment of patients by hospitals or and medical institution… a medical officer of a hospital or medical institution may import new drug for compassionate use for treatment of patients suffering from 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…” says the notification.
The rules will also be applicable to the manufacturing of such drugs in the country.
However, only those drugs will be allowed to be imported or manufactured that are under phase-III clinical trial either in India or in any other country. The medical superintendent of a hospital or head of a medical institution will have to certify an application before sending it to the central licensing authority for approval.
“This rule already existed and was applied on a case to case basis... keeping the Covid situation in mind... the rules now have been amended to allow import or manufacture of an unproved drug to treat seriously-ill patients based on a prescription by the authority concerned,” said an official in the drugs controller’s office. “The prescription will be given to manufacturer or importer who will attach it with the application for approval to the central drugs controller. Many drugs are being approved for trials and there may be a need to get these drugs to our patients.”
The official said the condition related to phase-III the clinical trial is to have the safety and efficacy data in place, which is important to know when you are giving an experimental drug to a patient.
The rules will be applicable 15 days after the final draft is published in the gazette of India. “As per protocol, we have to wait for a particular time for responses on the proposed amendment. If there is no objection, then the draft is finally gazette notified and implemented,” the official said.
Drugs controller general of India, VG Somani, last week approved “emergency use” of Gilead Sciences Inc’s anti-viral drug remdesivir to treat Covid-19 patients.