Plan to allow compassionate use of unapproved drugs

NEW DELHI: In a move that may help severely-ill Covid-19 patients to access experimental drugs from abroad, the health ministry has issued a notification proposing to allow import of unapproved new drugs by hospitals or medical institutions for compassionate use in treatment of patients.
The drug has to be in phase 3of clinical trial in the country from where it is being imported or in any other country, the proposed changes in the New Drugs and Clinical Trials (Amendment) Rules said. Besides, the hospital or the medical institution will have to make an application to the central drug regulator seeking permission for the same.
The Centre has sought stakeholders’ comments on the draft rules within 15 days, after which it will be considered for final notification.
According to a gazette notification of the draft rules published on June 5, a hospital or medical institution may import a new drug for com passionate 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.
The move assumes significance in the current situation because many drugs are being re-purposed for treatment of Covid-19 and are under advanced clinical trial stage globally. However, since these are not approved for manufacture and sale in India, patients are unable to access them.