Ndct rule 2019 (manisha)

NDCT STANDS FOR NEW DRUG CLINICAL TRIAL RULE. HERE YOU WILL GET TO KNOW ABOUT THE NDCT RULE HISTORY, FORMATION, CHANGES AND FEATURES

1. NDCT RULES 2019 By-Manisha Chauhan (Apeejay Stya University)

2. INTRODUCTION Ministry of Health and Family Welfare [MoHFW] has notified the “New Drugs and Clinical Trials Rules, 2019” on 25th March 2019. The new rules aim to promote clinical research in the country and will change the regulatory landscape for the approval of new drugs and conduct of clinical trials in the country. The rules will apply to all new drugs, investigational new drugs for human use, clinical trial, bioequivalence study, bioavailability study and Ethics Committee. The new rules will supersede Part XA and Schedule Y of Drugs and Cosmetics Rules, with immediate effect. If there is any inconsistency between these rules and any other rule made under the Drugs & Cosmetics Act, the provisions of these rules shall prevail over such other rules.

3. LEGISLATIVE HISTORY OF 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) which concerns regarding patient safety and compensation provided to patients in cases of adverse effects.  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, innovation vis-a-vis existing therapeutic options and unmet medical need in the country. In 2013, certain amendments were made to the D&C Rules, to regulate the clinical trials conducted in India. Rule-122DAB was inserted into the D&C Rules,  vide  the Drugs and Cosmetics (First Amendment) Rules, 2013[3].

4. Rule-122DAC was inserted into the D&C Rules,  vide  the Drugs and Cosmetics (Second Amendment) Rules, 2013, which lists out the conditions for the conduct of clinical trials.  Further, the guidelines in relation to composition and registration of ethics committees were notified  vide  the Drugs and Cosmetics (Third Amendment) Rules, 2013 . Deficiencies in regulation of clinical trials had been observed in the 59th Report of the Parliamentary Standing Committee on Health and Family Welfare on the functioning of the Central Drugs Standard Control Organisation (CDSCO). I t took the MoHFW a long time to consider the Rules and finalise them. The Supreme Court took notice of this delay, and in an order dated December 4, 2018, noted the Government’s submission that the rules will be finalised within two months.  T he Government assured the Court that, if possible, the NDCT Rules could be finalised even before that[8]. They were finally notified on March 19, 2019.

5. FEATURES OF NDCT RULES The NDCT Rules have come into force from March 19, 2019 onwards, except for Chapter IV, which shall come into effect 180 days after publication in the Gazette, i.e. 180 days after March 19, 2019. Rule 2(w) defines a “new drug” to include,  inter alia,  ‘a drug, including active pharmaceutical ingredient or phytopharmaceutical drug, which has not been used in the country to any significant extent’, ‘a drug approved by the Central Licensing Authority for certain claims and proposed to be marketed with modified or new claims’, ‘a fixed dose combination of two or more drugs, approved separately for certain claims and proposed to be combined for the first time in a fixed ratio’, ‘a modified or sustained release form of a drug or novel drug delivery system of any drug approved by the Central Licensing Authority’, or ‘a vaccine, recombinant Deoxyribonucleic Acid (r-DNA) derived product, living modified organism, monoclonal anti-body, stem cell derived product, gene therapeutic product or xenografts, intended to be used as drug’. Stem cell based products are, therefore, also deemed to be “new drugs” under the NDCT Rules. The NDCT Rules are applicable to, and regulate, all new drugs, investigational new drugs for human use, clinical trials, bioequivalence studies, bioavailability studies and Ethics Committees.

6. GENERAL PROCEDURE OF GRANT OF APPROVAL TO CONDUCT CLINICAL TRIALS IN INDIA Application must make registration in form CT-04 accompanied by relevant documents to Central Licensing Authority (CLA). Permission is granted in form CT-06 Application is rejected Complies with rules Does not complies with rules Within 90 days Applicant must submit required information within specific period of time as suggested by CLA In case of deficiency of info in application Permission is granted in form CT-06 Application is rejected Complies with rules Does not comply with rules

7. Within 60 days Request for reconsideration by applicant After review Approve Appeal to central government within 45 days Rejected

8. COMPENSATION PROCEDURES IN CASE SERIOUS ADVERSE EVENTS AND DEATH DURING THE CLINICAL TRIALS 1. In case of serious adverse events Investigator Within 24 hours CLA, sponsor or its representative and Ethics Committee 2. In case of serious adverse event of death Reports shall be forwarded by sponsor or investigator Ethics Committee with its opinion Within 14 days Within 30 days Central Licensing Authority Chairperson of Expert Committee Central Licensing Authority Within 60 days

9. Decide the compensation and pass the orders to the sponsor and its representatives Within 90 days sponsor Shall pay the compensation within 30 days of the receipt of the order

10. THREE TIERED REGULATORY PROCESS TO REVIEW CLINICAL TRIAL APPLICATIONS Applicant must submit the application accompanied by executive summary to DCGI. Commencement of review process Application is initially reviewed by Subject Expert Committee (SEC). This committee emphasizes on the scientific rationale of the proposed study and also highlights on the risk benefit ratio. Consequent review is carried out by Technical Committee which is headed by Director General for health sciences who has the authority to overrule the decision made by the SEC and can appeal them to reconsider the decision. The final review is done by Apex committee. If the application is accepted the final approval will be given by DCGI.

11. CONCLUSION The notification of a dedicated, comprehensive set of rules to regulate “new drugs” and clinical trials will lead to greater clarity and synchronisation in the regulatory requirements to conduct clinical trials in India. The attempt to prescribe a system for compensation to trial subjects in cases of death and injury may be seen as an attempt by the executive to surpass its mandate and cross over into the domain of the judiciary. This is especially so because provisions of the D&C Act do not provide for payment of compensation in such cases. The D&C Act is silent on the issue of compensation, and the compensation formula contained in the NDCT Rules can be seen as the rules going beyond the scope of the D&C Act.

12. THANK YOU