Govt to amend New Drugs and Clinical Trials Rules 2019 (NDCTR)

Download notification GSR No. 364(E) dt 11-05-2023 Draft New Drugs and Clinical Trials (Amendment) Rules, 2022, the link is given below

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Clinical Trial Research
Clinical Trial

Last Updated on January 6, 2024 by The Health Master

Download notification GSR No. 364(E) dt 11-05-2023 Draft New Drugs and Clinical Trials (Amendment) Rules, 2022, the link is given below: The Union health ministry is planning to amend the New Drugs and Clinical Trials Rules (NDCTR), 2019 to define clinical research organisations (CROs) and to lay down rules for registration, inspection and renewal of registration for these organisations.

The Ministry has issued a draft notification with rules and new chapters added to the NDCTR and seeking suggestions and objections from the public in 15 days’ time.

The draft rules suggest registration for CROs, once approved, valid for a period of five years from the date of its issue, unless suspended or cancelled by the Central Licensing Authority (CLA).

The amendment rules suggest inserting the definition of Clinical Research Organisation in Rule 2, sub-rule (1) after clause (i) of the NDCTR, 2016.

The amendment defines, “Clinical Research Organisation means a body commercial or academic or of other category owned by an individual or an organisation having status of legal entity by whatsoever name called to which the sponsor may delegate or transfer some or all of the tasks, duties and/or obligations regarding clinical trial, such transfer or delegation of contractual transfers or obligations must be in writing”.

The draft rules also insert a new Chapter VA under the Chapter V, to deal with the registration and related matters of CROs.

According to this, no CRO shall conduct any clinical trial or bioavailability or bioequivalence study of new drug or investigational new drug in human subjects except in accordance with the registration granted by the Central Licensing Authority under the rules.

According to the rules, the CROs for the purpose of conducting clinical trials or bioavailability or bioequivalence study with Central Licensing Authority should submit the application for registration in a new form inserted into the rules through the draft amendment.

The bioavailability/bioequivalence study centres already registered under Rule 44 of the NDCTR shall be considered as Clinical Research Organisation as per the newly inserted definition of CROs under the rule, for bioavailability/bioequivalence study and registered under Rule 38A of these Rules.

Such institutions shall not be required to make any application under this rule for bioavailability/bioequivalence study, it said.

The CLA may, after scrutiny of the information and documents furnished with the application in the new form and such further enquiry, and if satisfied that the requirements of these rules have been complied with, grant registration to the applicant within a period of 45 working days from the date of receipt of its application.

If not satisfied, the Authority may reject the application by recording reasons in writing. In case, where the CLA considers that there are some deficiencies in the application and the same are to be rectified, it shall inform the application within the period and the applicant may rectify the deficiencies within the specified period.

Once the deficiencies are rectified, the CLA shall scrutinise the application again and if satisfied, grant registration to the applicant.

If not satisfied, the CLA shall reject the application within a period of 90 days reckoned from the day when the required information and documents were provided.

Provided that in case of rejection, the applicant may request the CLA, to reconsider the application within a period of sixty days from the date of rejection of the application on payment of fee as specified in the Rules.

The applicant, if aggrieved by the decision of the CLA, may file an appeal within 45 days from the date of receipt of such rejection before the Central Government and the Government may, after such enquiry and giving opportunity of being heard to the appellant, dispose the appeal within a period of 60 days.

The registration is valid for a period of five years from the date of its issue, unless suspended or cancelled by the CLA and the CRO shall make an application for renewal of registration in the prescribed form along with documents prior to the date of expiry of its registration.

If the application for renewal is received by the CLA prior to the date of expiry, the registration shall continue to be in force until orders are passed by the authority on the application.

The conditions or registration include that the organisation shall maintain the facilities and adequately qualified and trained personnel as specified in the ninth schedule for performing its functions, and it shall initiate conduct of any clinical trial of bioavailability or bioequivalence study of any new drug or investigational new drug in human subjects after approval of the protocol and other related documents by the ethics committee, and permission of such study granted by the CLA.

The CLA shall be informed about the approval of the ethics committee for clinical trial or BA/BE studies and the study shall be registered with the Clinical Trial Registry of India.

The CLA should also be informed if the study is terminated prematurely, with detailed reasons for such termination.

If there is any change in constitution or ownership of the CRO, it shall initiate it in writing to the CLA within 30 days.

The organisation shall maintain data, records and other documents related to the conduct of the clinical trials for a period of five years after completion of such study or for at least two years after the expiration date of the batch of the new drug or investigational new drug studies, whichever is later.

The CRO shall allow any authorised officer of CLA, accompanied by an authorised officer from the State Licensing Authority (SLA) to enter the premises with or without prior notice, to inspect any record, statistical observation or results or any documents related to clinical trials and furnish information to the queries raised by such authorised person.

The CLA can impose additional conditions in writing with justification, in respect of specific clinical trials regarding the objective, design, subject population, subject eligibility, assessments, conduct and treatment of such specific study.

The amendment also lays down the rules for inspection of the CRO, conditions for suspension or cancellation of registration, among others.

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