India allows use of experimental drugs amid pandemic

Indian health ministry has issued a draft notification allowing manufacture, import and "compassionate use" of any unapproved drug for severely-ill Covid-19 patients.

The drugs in the phase-III of clinical trials were allowed with an aim to facilitate the availability of experimental drugs.

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.

Several drugs across India are in phase-III clinical trials phase for Covid-19 and antiviral remdesivir was approved last week for use on severely infected patients.

India's drug regulator granted US pharma giant Gilead Sciences marketing authorisation for the drug for "restricted emergency use" on hospitalised Covid-19 patients.

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" by applying 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, according to the draft rules.

After obtaining the recommendation of the Ethics Committee, the manufacturer will 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," the rules stated.

The quantity of any new drug manufactured or imported on the basis of permission granted shall not exceed one hundred average dosage per patient, the draft rules stated.