The ministry of health and family welfare is amending the New Drugs and Clinical Trials Rules 2019, enabling any government or private hospital, or a medical institution to import medicines required for the treatment of patients suffering from life-threatening diseases, those that cause serious permanent disability or people requiring therapy for unmet medical needs. The rules are likely to come into effect within two weeks, said people with knowledge of the matter.
This will help in the treatment of critically ill Covid-19 patients as it will give them access to drugs that may be unavailable in India and are undergoing clinical trials in other countries.
The process for approvals has been made simple, officials said. 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.’ Also required will be a description of the patient’s disease, criteria for selection of the patient and pharmacology and toxicology information adequate to conclude that the new drug is reasonably safe at the dose and duration proposed for compassionate use. The application will need to be addressed within 30 days. The draft amendment says: “The central licensing authority may, after scrutiny of information and documents enclosed with the application… if not satisfied with the requirements… reject the application, for reasons to be recorded in writing, within a period of 30 days from the date of application.”
Full text at GMPnews.Net