Govt drafts rules to help COVID patients access new drugs

NEW DELHI: Seeking to facilitate availability of experimental drugs for severely-ill COVID19 patients, the Union Health Ministry has issued a draft notification for "compassionate use" of any unapproved drug that is in the phase-iii clinical trial globally.

The draft New Drugs and Clinical Trials (Amendment) Rules stipulate manufacture and import of unapproved drugs based on a prescription by a hospital or medical institution

According to a gazette notification of the draft rules published on June 5, 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, but under Phase-iii clinical trial (human trial) in the country or abroad, by making an application to the Central Drug Regulator.

Also, if any hospital prescribes a new drug for the same purposes then they may be approved to be manufactured in a limited quantity subject to provisions of the rules.

The manufacturer intending to manufacture a new drug will have to obtain the consent in writing from the patient to whom the medicine has been prescribed or his legal heirs and make an application to the Ethics Committee of the hospital or medical institution for obtaining its specific recommendation for manufacture of such new drug.

After obtaining the recommendation of the Ethics Committee, the manufacturer shall make an application to obtain the permission, to the Central Licensing Authority for manufacturing the new drug for the purpose of compassionate use, the draft rules stated.

"The manufacturer to whom the permission is granted shall make use of the new drug only for the purposes specified in the permission and no part of it shall be sold in the market or supplied to any other person, agency, institution or place," it stated.