The Ministry of Health And Family Welfare vide notification dated 5th June, 2020 has issued The draft of New Drugs and Clinical Trials(Amendment) Rules, 2019, to allow import of unapproved new drug for Compassionate use for treatment of patients by hospitals or/and medical institutions.
The World Health Organization defines compassionate use (CU) as a “program that is intended to provide potentially life-saving experimental treatments to patients suffering from a disease for which no satisfactory authorized therapy exists and/or who cannot enter a clinical trial. For many
patients, these programs represent their last hope.”
These new rules have been inserted under section 96 starting from 96A to 96I which deals with filing an application, granting the license to the importer or manufacturer, conditions and suspension of such license granted for the import or manufacture of unapproved new drug for
compassionate use.
Key highlights from the New Drugs & Clinical Trial (Amendment) Rule 2019:
- According to Section 96A, 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.
- Central Licensing Authority grant permission if they are satisfied with the requirement to import new drug but under clinical trial for compassionate use in Form CT-29 & if they are not satisfied ,they will reject the application and the reasons for that should be recorded in writing within 30 days from the date of application.
- According to 96D,Where any medical officer of a hospital or medical institution prescribes a 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 under Chapter X of these rules, but under Phase-III clinical trial in the country or in any other country, then, such new drug may be approved to be manufactured in limited quantity subject to provisions of these 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.
- For both manufacturing and importing, the licence shall remain valid for a period of one year from the date it has been issued.
- If an importer or the manufacturer to whom the license is granted fails to comply with any provision of the Act and these rules, the Central Licensing Authority, may, after giving an opportunity of being heard, suspend or cancel the license for such period as considered appropriate either wholly or in respect of some of the substances to which the violation relates.
- The quantity of any new drug manufactured or imported on the basis of permission granted shall not exceed one hundred average dosages per patient, the draft rules stated. But in exceptional circumstances on the basis of the prescription of the medical officer and the recommendation of the Ethics Committee, the Central Licensing Authority may allow the manufacture of such new drug in larger quantity. In both cases, for import or indigenous manufacturing, the application should have details including rationale for the use of the new drug as compassionate use over the available therapeutic options, the criteria for patient selection with description of the patient’s disease or condition and the method of administration of the drug, dose, and duration of therapy. It should also mention the description of the manufacturing facility and a description of clinical procedures, laboratory.
Objections and suggestions, if any, may be addressed to the Under Secretary (Drugs), Ministry of Health and Family Welfare, Government of India, Room No. 414 A, D Wing, Nirman Bhavan, New Delhi – 110011 or emailed at drugsdiv-mohfw@gov.in.
Click here to read the Draft Rules.
