NEW DRUG & CLINICAL TRIAL RULES
Abstract
The new drug and clinical trials rules 2019 (New rules) was introduced on 19th march 2019 by government of India. These rules have come into force from date of publication in the official gazette. New rules have set specific requirements for ethics committee (EC). The EC is required to follow requirements set as per New rules and to forward their report to Central Licensing Authority (CLA).This documents is divided in two different part such as 264 pages, 13 chapters, 107 rules, 8 schedule, 27 forms with several tablets. They shall apply to all new drugs, investigational new drugs for human use, clinical trial, bioequivalence study, and bioavailability study and ethics committee.
Introduction
India’s Ministry of Health and Family Welfare has published the final version of New Drugs and Clinical Trials Rules, 2019. The new regulations cover provision for promoting clinical research as well as complex topics such as orphan drug, post-trial access, and pre and post submission meeting.
The new rules are structured around 13 chapters (including 107 rules) and eight schedules. The new rules will apply to all new drugs, investigational new drugs for human use, clinical trials, BE and BA studies and ethics committees. The new rules will supersede Part XA and Schedule Y of Drugs and Cosmetics Rules, 1945, and go into effect immediately. Drugs for veterinary use, earlier regulations and schedule Y will continue to be applicable.
New Drug: A drug, including active pharmaceutical ingredient or phytopharmaceutical drug, which has not been used in the country to any significant extent, except in accordance with the provisions of the Act and the rules made there under, as per conditions specified in the labeling thereof and has not been approved as safe and efficacious by the Central Licensing Authority with respect to its claims or a drug approved by the Central Licensing Authority for certain claims and proposed to be marketed with modified or new claims including indication, route of administration, dosage and dosage form.
Legislative History of the NDCT Rules
Clinical trials were earlier conducted in accordance with the requirements set out in Schedule Y of the Drugs and Cosmetics Rules, 1945 (D&C Rules). However, there were concerns regarding patient safety and compensation provided to patients in cases of adverse effects suffered by them due to participation in clinical trials.
In 2012, a Public Interest Litigation (PIL) was filed by a patient-centric NGO before the Hon’ble Supreme Court of India, alleging malpractices in the conduct of clinical trials by government and non-governmental organizations, as well as by independent investigators. While hearing this matter, regulatory aspects of clinical trials were discussed by the Court. In an order dated October 21, 2013, the Hon’ble Supreme Court opined that approvals for clinical trials should be based on all relevant aspects of safety and efficacy, particularly in terms of assessment of risk versus benefit to the patients.
Objectives of the NDCT Rules
• The new rules aim to promote clinical research in India by providing for a predictable, transparent and effective regulation for clinical trials and by ensuring faster accessibility of new drugs to the Indian population.
• New rules have reduced the time for approving applications, which has now come down to 30 days for drugs manufactured in India and 90 days for those developed outside the country.
• Drug Controller General of India will decide the compensation in cases of death and permanent disability or other injury to a trial subject.
• Ethics committee will monitor the trials and decide on the amount of compensation in cases of adverse events.
• It has been mandated that in case of injury to the clinical trial subject, medical management will be provided as long as required as per the opinion of the investigator.
NEW DRUG AND CLINICAL TRIALS RULES (NDCT) 2019 COMPRISES OF:
• CHAPTERS - 13
• RULE - 107
• SCHEDULES - 8
• FORM - 27
IMPORTENCE OF RULES
Schedules- There is 8 schedules which contains General principles and guidelines along with rules while conducting clinical trials.
Analysis and Conclusion
The NDCT Rules replace Part XA and Schedule Y of the D&C Rules. The earlier regime, which these NDCT Rules have replaced, was made up of multiple stop gap measures and, therefore, the notification of a dedicated, comprehensive set of rules to regulate “new drugs” and clinical trials will lead to greater clarity and synchronization in the regulatory requirements to conduct clinical trials in India.
Reference:
• https://www.researchgate.net/publication
• https://youtu.be/hpOqHldwc9w
• https://youtu.be/2Z1C4ZZG0KM
• https://youtu.be/arCGDxfg3XY
• https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7034142/
BY:
- Md Inzmam Uddin
mohdinzmamuddin1999@gmail.com
- Abu Zaid usmani
abuzaedusmani1997@gmail.com
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