Health Ministry drafts rules to help COVID-19 patients access new drugs

Seeking to facilitate availability of experimental drugs for severely-ill COVID-19 patients, Union Health Ministry has issued a draft tification for "compassionate use" of any unapproved drug that is in phase-III clinical trial globally. 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 tification of 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 rapy for unmet medical need", which has t been permitted in country, but under Phase-III clinical trial (human trial) in country or abro, by making an application to Central Drug Regulator.

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

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

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

" manufacturer to whom permission is granted shall make use of new drug only for purposes specified in permission and part of it shall be sold in market or supplied to any or person, ncy, institution or place," it stated. 

new draft rules will be applicable for 15 days during which people can send ir objections and suggestions to be considered by Central Government after which final amended rules will be published in gazette of India. 

set of new rules have been inserted under section 96 which deals with filing an application, granting license to importer or manufacturer, conditions and suspension of such licenses among ors. For both manufacturing and importing, licence shall remain valid for a period of one year from date it has been issued. If an importer or manufacturer to whom license is granted fails to comply with any provision of Act and se rules, Central Licensing Authority, may, after giving an opportunity of being heard, suspend or cancel license for such period as considered appropriate eir wholly or in respect of some of substances to which violation relates.  quantity of any new drug manufactured or imported on basis of permission granted shall t exceed one hundred aver doss per patient, draft rules stated. But in exceptional circumstances on basis of prescription of medical officer and recommendation of Ethics Committee, Central Licensing Authority may allow manufacture of such new drug in larger quantity.  

In both cases, for import or indigeus manufacturing, application should have details including rationale for use of new drug as compassionate use over available rapeutic options, criteria for patient selection with description of patient's disease or condition and method of ministration of drug, dose, and duration of rapy. It should also mention description of manufacturing facility and a description of clinical procedures, laboratory tests, or or monitoring necessary to evaluate effects of drug and minimize its risks among ors. Several drugs across country are in phase III clinical trials phase for COVID-19. Anti-viral drug Remdesivir, last week, was approved for "restricted emergency use" on severe COVID-19 patients. India's drug regulator granted US pharma giant Gile Sciences marketing authorisation for drug for "restricted emergency use" on hospitalised COVID-19  in view of crisis posed by pandemic.