KEY CHANGES IN NEW DRAFT RULES FOR CLINICAL TRIALS IN INDIA

CDSCO has published the new draft Clinical Trial Rules 2018 in Feb 2018 after consultation with the Drugs Technical Advisory Board. This draft Rules shall be taken into consideration on or after the expiry of a period of forty five days. Objections and suggestions which may be received from any person within the period specified above will be considered by the Central Government.

Ethics Committee:

• The registration granted in Form CT-02 shall remain valid for a period of three years from the date of its issue, unless suspended or cancelled by the Central Licencing Authority
• On expiry of the validity period of registration an Ethics Committee may make an application for renewal of registration in Form CT-01 along with documents as specified in Table 1 of the Third Schedule three months prior to the date of the expiry of the registration
• Provided that if the application for renewal of registration is received by the Central Licencing Authority three months prior to the date of expiry, the registration shall continue to be in force until an order is passed by the said authority on the application
• where a clinical trial site does not have its own Ethics Committee, clinical trial at that site may be initiated after obtaining approval of the protocol from the
• Institutional Ethics Committee of another trial site; or an independent Ethics Committee constituted in rule 7
• Provided that the approving Ethics Committee shall in such case be responsible for the study at the trial site or the centre, as the case may be
• Provided further that, the approving Ethics Committee and the clinical trial site or the bioavailability and bioequivalence centre, as the case may be, shall be located within the same city or within a radius of 50 km of the clinical trial site.

CLINICAL TRIAL OF NEW DRUGS AND INVESTIGATIONAL NEW DRUGS

• In case of rejection, the applicant may request the Central Licencing Authority, 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 Sixth Schedule and submission of required information and documents.
• An applicant who is aggrieved by the decision of the Central Licencing Authority under the Ministry of Health and Family Welfare, may file an appeal before the Central Government within forty-five days from the date of receipt of such decision and the Government, may, after such enquiry, and after giving an opportunity of being heard to the appellant, dispose of the appeal within a period of sixty days.

• Permission to conduct clinical trial of a new drug or investigational new drug as part of discovery, research and manufacture in India;

• Such application shall be disposed by way of grant of permission or rejection or processed by way of communication to rectify any deficiency of the application, as the case may be, as specified in rule 22, by the Central Licensing Authority within a period of forty-five days from the date of the receipt of the application
• Provided that, where no communication has been received from the Central Licensing Authority to the applicant within the said period, the permission to conduct clinical trial shall be deemed to have been granted by the Central Licensing Authority and such permission shall be deemed legally valid for all purposes and the applicant shall be authorised to initiate clinical trial under these rules.
• The applicant who has taken deemed approval under sub-rule (1) shall before initiating the clinical trial inform the Central Licensing Authority in Form CT-4A. On the basis of the said information the Central Licensing Authority shall take on record the Form CT-4A which shall become part of the official record and shall be called automatic approval of the Central Licensing Authority.

• Permission to conduct clinical trial of a new drug already approved outside India: The application shall be disposed of by way of grant of permission or rejection or processed by way of communication to rectify any deficiency, as the case may be, as specified in rule 22, by the Central Licensing Authority within a period of ninety days from the date of the receipt of the application by the said Authority.

Conditions of permission for conduct of clinical trial:

• The Central Licencing Authority shall be informed about the approval granted by the Ethics Committee within a period of 15 days of the grant of such approval. This could be informed by site i.e. P.I or CRO or sponsor.
• Six monthly status report of each clinical trial, as to whether it is ongoing, completed or terminated, shall be submitted to the Central Licencing Authority;
• the clinical trial shall be initiated by enrolling the first subject within a period of one year from the date of grant of permission, failing which prior permission from the Central Licencing Authority shall be required;

Validity period of permission to conduct clinical trial:

• The permission to conduct clinical trial granted under rule 22 in Form CT-06 shall remain valid for a period of two years from the date of its issue, unless suspended or cancelled by the Central Licencing Authority.
• In exceptional circumstances, where the Central Licencing Authority is satisfied about the necessity for an extension beyond two years, the said authority may, on the request of the applicant made in writing, extend the period of permission granted for a further period of one year.

BIOAVAILABILITY AND BIOEQUIVALENCE STUDY

Bioavailability or bioequivalence study of new drug or investigational new drug

• The Central Licencing Authority may, after scrutiny of the information and documents furnished with the application in Form CT-05 and such further enquiry, if any, as may be considered necessary, grant the permission to conduct bioavailability or bioequivalence study for a new drug or investigational new drug in Form CT-07 within a period of ninety days from the date of receipt of its application.
• In case of rejection, the applicant may request the Central Licencing Authority, 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 Sixth Schedule and submission of required information and documents.
• An applicant who is aggrieved by the decision of the Central Licencing Authority under the Ministry of Health and Family Welfare, may file an appeal before the Central Government within forty-five days from the date of receipt of such decision and the Government, may, after such enquiry, and after giving an opportunity of being heard to the appellant, dispose of the appeal within a period of sixty days.

Conditions of permission for conduct of bioavailability or bioequivalence study:

• The Central Licencing Authority shall be informed about the approval granted by the ethics committee within a period of 15 days of the grant of such approval. This could be informed by site i.e. P.I or CRO or sponsor.

Validity period of permission to conduct bioavailability or bioequivalence study:

• The permission to conduct bioavailability or bioequivalence study granted under rule 34 in Form CT-07 shall remain valid for a period of one year from the date of its issue, unless suspended or cancelled by the Central Licencing Authority.
• In exceptional circumstances, where the Central Licencing Authority is satisfied about the necessity for an extension beyond one year, the said authority may, on the request of the applicant made in writing, extend the period of permission granted for a further period of one year.

Compensation in case of death or permanent disability in clinical trial or bioavailability and bioequivalence study

• In case of death or permanent disability of a trial subject occurs during a clinical trial or bioavailability and bioequivalence study and the Ethics Committee after due analysis of the case, in accordance with the procedure, is of the opinion that the death or the permanent disability, as the case may be, is related to the clinical trial, the sponsor or the person who has obtained permission under rule 22, shall pay an interim compensation of sixty percent of the compensation payable as per the formula, to the legal heir of the trial subject in case of death and to the trial subject in case of permanent disability, within a period of fifteen days from the date of receipt of the opinion of the Ethics Committee by that Sponsor or that person.

• In case of death or permanent disability of a trial subject occurs during a clinical trial or bioavailability and bioequivalence study and the Central Licensing Authority has decided, as per rule 42, that such death or permanent disability, as the case may be, is related to the clinical trial or bioavailability and bioequivalence study, the sponsor or the person who has obtained permission under rule 22, shall pay a compensation, as determined in accordance with the formula specified in the Seventh Schedule, to the legal heir of the trial subject in case of death and to the trial subject in case of permanent disability as per order of the Central Licensing Authority, within a period of thirty days from the date of receipt of such order by that Sponsor or that person
• Provided that in case of death or permanent disability, if an interim compensation has been paid under sub-rule, in such case, the quantum of compensation to be paid shall be an amount which is less the amount paid as the interim compensation.
• The financial compensation shall be over and above any expenses incurred on medical management of the trial subject before his death or in connection with the maintenance of the body after death.

BIOAVAILABILITY AND BIOEQUIVALENCE STUDY CENTRE

• The Central Licencing Authority may, after scrutiny of the information and documents furnished with the application in Form CT-08 and such further enquiry, if any, as may be considered necessary if satisfied, that the requirements of these rules have been complied with, grant registration to the applicant in Form CT-09 within a period of ninety days from the date of receipt of its application.
• The registration granted under rule 47 in Form CT-09 shall remain valid for a period of five years from the date of its issue, unless suspended or cancelled by the Central Licencing Authority.

IMPORT OF NEW DRUGS AND INVESTIGATIONAL NEW DRUGS FOR CLINICAL TRIAL OR BIOAVAILABILITY OR BIOEQUIVALANCE STUDY

• The Central Licencing Authority may, after scrutiny of the information and documents furnished with the application in Form CT-16 grant the licence to import of new drug or investigational new drug for clinical trial or bioavailability or bioequivalence study in Form CT-17 within a period of ninety days from the date of receipt of its application
• The licence granted under rule 68 in Form CT-17 shall remain valid for a period of three years from the date of its issue, unless suspended or cancelled by the Central Licencing Authority.
• In exceptional circumstances, where the Central Licencing Authority is satisfied about the necessity and exigency, it may, on the request of the applicant made in writing, extend the period of the licence granted under rule 69 for a further period of one year.