Several drugs across the country are in phase III clinical trials for COVID-19. (File)
New Delhi:
The Union’s Department of Health has drafted rules for new drugs and clinical trials (modification), including provisions for “compassionate use” of any unapproved drug that is part of the trial phase III clinic, in India or abroad, by import or manufacture.
The move aims to facilitate the availability of new drugs during phase III clinical trials (human trials) for seriously ill COVID-19 patients in the country.
According to a notification in the Official Journal of the draft regulation published on June 5, a hospital or a medical establishment can import the new drug for “compassionate” purposes for the treatment of patients suffering from a fatal disease or from a severe permanent disability or causing illness requiring therapy for unmet medical needs, “which was not authorized in the country, but as part of a phase III clinical trial in the country or abroad, by making a request from the Central Drug Regulator.
In addition, if a hospital prescribes a new drug for the same purpose, it may be approved for manufacture in a limited quantity, subject to the provisions of the regulations.
The manufacturer intending to manufacture a new drug must obtain the written consent of the patient to whom the drug was prescribed or of his legal heirs and make a request to the ethics committee of the hospital or medical establishment for get his specific recommendation for making this new drug.
After obtaining the recommendation of the ethics committee, the manufacturer must request authorization from the Central Licensing Authority to manufacture the new drug for compassionate purposes, according to the draft rules.
“The manufacturer to whom the authorization is granted must use the new medicinal product only for the purposes specified in the authorization and no part of it must be sold on the market or supplied to any other person, agency, institution or place, “said.
The new draft rules will be applicable for 15 days during which people can send their objections and suggestions to the central government for consideration, after which the final amended rules will be published in the official gazette of India.
The set of new rules has been inserted in article 96 which deals with the filing of an application, the granting of the license to the importer or the manufacturer, the conditions and the suspension of these licenses, among others .
Both for manufacture and for import, the license remains valid for a period of one year from the date of issue.
If an importer or manufacturer to whom the license is granted does not comply with a provision of the law and these rules, the Central Licensing Authority may, after having had an opportunity to be heard, suspend or cancel the license for the period considered either fully or for some of the substances affected by the violation.
The quantity of any new drug manufactured or imported on the basis of an authorization granted must not exceed one hundred average doses per patient, according to the draft rules.
But in exceptional circumstances, on the basis of the doctor’s prescription and the recommendation of the ethics committee, the Central Licensing Authority may authorize the manufacture of these new drugs in larger quantities.
In both cases, for import or indigenous manufacture, the request must contain details, including the justification for the use of the new drug for compassionate purposes in relation to the available treatment options, the criteria for selecting patients with description of the patient’s disease or the state and mode of administration of the drug, the dose and duration of treatment.
It should also include a description of the manufacturing facility and a description of clinical procedures, laboratory tests or any other monitoring necessary to assess the effects of the drug and minimize its risks, among others.
Several drugs across the country are in phase III clinical trials for COVID-19. The antiviral drug Remdesivir, last week, was approved for “restricted emergency use” in severe COVID-19 patients.
The Indian drug regulator has granted the American pharmaceutical giant Gilead Sciences a marketing authorization for the drug “restricted emergency use” on COVID-19 hospitalized because of the crisis posed by the pandemic.
