The Ministry of Health and Family Welfare has through a Gazette Notification dated 5th June 2020, proposed amendments to the New Drugs and Clinical Trials Rules, 2019. The move is aimed at facilitating the availability of new drugs which are in Phase-III clinical trials (human trials) for severely-ill COVID-19 patients in the country.
The draft rules shall be taken into consideration on or after the expiry of a period of fifteen days from the date of publication in the gazette and objections and suggestions have been invited for consideration by the Central Government till the expiry of such time.
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 e-mailed at drugsdiv-mohfw@gov.in.
Key Highlights of the draft rules:
- A hospital or medical institution may import the new drug for “compassionate use for the treatment of patients suffering from a 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 in the country or abroad, by making an application to the Central Licensing Authority;
- 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 but is under Phase-III clinical trial in the country or abroad, 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/her 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 licence and the permission shall remain valid for a period of one year from the date it has been issued.
- 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.
- Where an importer or manufacturer to whom the license/permission is granted fails to comply with any provision of the Act and these rules, the Central Licencing Authority, may, after giving an opportunity of being heard, by an order, in writing, suspend or cancel the license/permission for such period as considered appropriate either wholly or in respect of some of the substances to which the violation relates;
- In both cases, for import or indigenous manufacturing, the application should have details including the rationale for the use of the new drug as compassionate use over the available therapeutic options, the criteria for patient selection with the 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 tests, or other monitoring necessary to evaluate the effects of the drug and minimize its risks among others.
Source: Ministry of Health and Family Welfare
