Public comments invited by the Health Ministry on the draft New Drugs and Clinical Trials (Amendment) Rules, 2022 till 7th December, 2022
The Ministry of Health has proposed New Drugs and Clinical Trials (….Amendment) Rules, 2022 with a view to further amend the New Drugs and Clinical Trials Rules, 2019. Changes have been proposed to Schedule I (which prescribes the General Principles and Practices for clinical trials), to include the following non-clinical testing methods to assess the safety and efficacy of a new drug or an investigational new drug:
• Cell-based assay;
• Organ chips and micro physiological systems;
• Sophisticated computer modeling;
• Other human biology-based test methods and
• Animal studies.
Objections and suggestions in this regard must be addressed to the Under Secretary (Drugs), Ministry of Health and Family Welfare, Government of India, Room No. 434, C Wing, Nirman Bhavan, New Delhi – 110011 or emailed at (drugsdiv-mohfw@gov.in) by 7th December, 2022.
Source: Ministry of Health and Family Welfare
