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Yes. Clinical trial at each site shall be initiated after the approval of the clinical trial protocol and other related documents by the Ethics Committee for that site, registered with the CLA.

An audio-video recording of the informed consent process in case of vulnerable subjects in clinical trials of New Chemical Entity or New Molecular Entity including procedure of providing information to the subject and his understanding on such consent, shall be maintained by the investigator for record.

“New drug” means, (i) 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 thereunder, as per conditions specified in the labelling thereof and has not been approved as safe and efficacious by the Central Licencing Authority with respect to its claims; or (ii) a drug approved by the Central Licencing Authority for certain claims and proposed to be marketed with modified or new claims including indication, route of administration, dosage and dosage form; or (iii) 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, or where the ratio of ingredients in an approved combination is proposed to be changed with certain claims including indication, route of administration, dosage and dosage form; or (iv) a modified or sustained release form of a drug or novel drug delivery system of any drug approved by the Central Licencing Authority; or (v) 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; Explanation: The drugs, other than drugs referred to in sub-clauses (iv) and (v), shall continue to be new drugs for a period of four years from the date of their permission granted by the Central Licencing Authority and the drugs referred to in sub-clauses (iv) and (v) shall always be deemed to be new drugs;

Yes. As per clause (w) of rule 2 of the New Drugs and Clinical Trials Rules, 2019 modified/sustained/prolonged/controlled release and NDDS of an approved drug are always considered as new drug and hence, require prior permission from CLA before obtaining the manufacturing license from the SLA for such products.

Any new drugs or investigational new drugs imported for the purpose of clinical trial shall be kept in containers bearing labels, indicating the name of the drug or code number, batch or lot number, wherever applicable, date of manufacture, use before date, storage conditions, name of the institution or organisation or the centre where the clinical trial is proposed to be conducted, name and address of the manufacturer, and the purpose for which it has been imported. Where a new drug or an investigational new drug is imported by the licencee on behalf of another person, the licencee shall indicate on the label of the container of the such drug, the name and address of the importer and the person to whom it is being supplied along with the scientific name of such drug, if known, or the reference which shall enable such drug to be identified and the purpose for which it is manufactured. No person or importer shall alter, obliterate or deface any inscription or mark made on the container, label or wrapper of any new drug imported without permission of the Central Licencing Authority.

A subsequent new drug means a drug approved by the Central Licencing Authority for certain claims and proposed to be marketed with modified or new claims including indication, route of administration, dosage and dosage form. A subsequent new drug also includes a new drug already approved in the country.

Only audio recording of the informed consent process of individual subject including the procedure of providing information to the subject and his understanding on such consent shall be maintained by the investigator for record.

Any person or institution or organisation having permanent establishment in India who intends to conduct clinical trial study of a new drug or an investigational new drug can submit application for clinical trial study

Yes. Before enrolment of first participant in any clinical trial, registration in CTRI is mandatory

If 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 ethics committee of another trial site. Provided that the approving ethics committee for clinical trial shall be responsible for the study at the trial site and the same shall be located within the same city or within a radius of 50 kms of the actual clinical trial site.

The permission to initiate clinical trial granted in Form CT-06 or automatic approval in Form CT 4A shall remain valid for a period of 2 years from the date of its issue, unless extended by the CLA.

Yes. Any sponsor or investigator intended to initiate a clinical trial for new drug or investigational new drug shall obtain permission from CLA in Form CT-06. The applicant shall submit application in Form CT-04 along with all other necessary documents specified under Second Schedule and fees as specified under Sixth Schedule of CT Rules 2019.

In general, the timeline for disposal of an application for conduct of clinical trial study is 90 working days from the date of receipt of application. However, if the drug is discovered in India or research and development of the drug are being done in India and also the drug is proposed to be manufactured and marketed in India then the timeline for disposal of an application for conduct of such clinical study is 30 working days from the date of receipt of application. In such case, if no response is issued by the CDSCO within 30 working days, the clinical trial will be considered to be deemed approved.

Minimum of seven members from medical, non-medical, scientific and non-scientific areas with at least, one lay person; one woman member; one legal expert; one independent member from any other related field such as social scientist or representative of non-governmental voluntary agency or philosopher or ethicist or theologian. At least 50% of members not affiliated with the institute or organization in which EC is constituted. Every member of the EC shall be required to undergo such training and development programs.

An application for grant of permission to conduct clinical trial of new drug or investigational new drug shall be made in Form CT-04. The application should be accompanied by the necessary documents as specified under Second Schedule along with the fees as specified under Sixth Schedule of the NDs & CTs Rules, 2019. Order issued by CDSCO on 10th Apr 2019, Form CT-04 (and other Forms) can be manually completed and uploaded in SUGAM, till all the new Forms are integrated into the online submission portal.

The drug categories for which clinical trials can be conducted in India are as follows: 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 thereunder, as per conditions specified in the labelling thereof and has not been approved as safe and efficacious by the Central Licencing Authority with respect to its claims. Fixed dose combination (FDC): 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, or where the ratio of ingredients in an approved combination is proposed to be changed with certain claims including indication, route of administration, dosage and dosage form. Investigational New Drug (IND: A new chemical or biological entity or substance that has not been approved for marketing as a drug in any country. Subsequent new drug (SND): A subsequent new drug means a drug approved by the Central Licencing Authority for certain claims and proposed to be marketed with modified or new claims including indication, route of administration, dosage and dosage form. A subsequent new drug also includes a new drug already approved in the country.

No. For new drug substances discovered or developed in countries other than India, Phase I data should be submitted along with the application. After submission of Phase I data generated outside India to the Central Licensing Authority, permission may be granted to repeat Phase I trials or to conduct Phase II trials and subsequently Phase III trial concurrently with other global trials for that drug.

As per the new provision of post-submission meetings, if the applicant desires to seek clarification in person in respect of pending application and queries related thereto, the applicant may make an application for a post-submission meeting with the officer designated by the Central Licencing Authority within a period of fifteen days from the date the query was received for seeking guidance with regards to the queries concerning pending application.

The requirement of non-clinical and clinical data may be relaxed, abbreviated, omitted or deferred under life threatening or serious disease conditions or rare diseases and for drugs intended to be used in the diseases of special relevance to Indian scenario or unmet medical need in India, disaster or special defence use e.g. haemostatic and quick wound healing, enhancing oxygen carrying capacity, radiation safety, drugs for combating chemical, nuclear, biological infliction etc. However, such relaxation, abbreviations, omission or deferment of data will be evaluated on case-by-case basis depending on the nature of the new drugs, proposed indication, etc.

A foreign sponsor (an organisation situated outside India) should appoint a local representative or Contract Research Organisation (CRO) to fulfil local responsibilities as per the guidelines, and the transfer of duties must be documented. The ultimate responsibility of the quality and integrity of data resides only with the sponsor, even if a CRO has been involved.

Any person or institution or organization who intends to import a new drug or any such substance for clinical trial or BA/BE study or for examination, test and analysis shall make an application in Form CT-16 to the CLA. The application shall be accompanied by a fees specified in the Sixth Schedule and such other information and documents as specified in Form CT-16.

The application submitted to CLA for grant of permission to conduct clinical trial of a new drug discovered in India or research and development of the drug are being done in India and also the drug is proposed to be manufactured and marketed 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 CLA within a period of 30 working days from the date of the receipt of the application. If no communication has been received from the CLA to the applicant within the said period, the permission to conduct clinical trial shall be deemed to have been granted.

No. A CLA approved clinical trials shall be initiated by enrolling the first subject within a period of 2 year from the date of grant of permission, failing which the sponsor or investigator should get prior permission from CLA before initiating the trial. The permission to initiate clinical trial granted in Form CT-06 or automatic approval in Form CT 4A shall remain valid for a period of 2 years from the date of its issue, unless extended by the CLA.

Yes. The status of enrolment of the trial subjects shall be intimated to the CLA on quarterly basis or as appropriate as per the duration of treatment in accordance with the approved clinical trial protocol, whichever is earlier. Further, six monthly status report of each clinical trial, as to whether it is ongoing, completed or terminated, shall be submitted in SUGAM portal. In case of termination of any clinical trial the detailed reasons for such termination shall be communicated to CLA.

An “investigational new drug (IND)” means a new chemical or biological entity or substance that has not been approved for marketing as a drug in any country.

SUGAM portal is an e-Governance solution for CDSCO. SUGAM enables online submission of applications requesting for permissions related to drugs, clinical trials, ethics committee, medical devices, vaccines and cosmetics. SUGAM has facility for users to possess multiple roles on the same registered ID. Applicant can register with different purposes with the assigned roles and forms.

A “clinical trial” in relation to a new drug or investigational new drug means any systematic study of such new drug or investigational new drug in human subjects to generate data for discovering or verifying its, clinical or; pharmacological including pharmacodynamics, pharmacokinetics or; adverse effects, with the objective of determining the safety, efficacy or tolerance of such new drug or investigational new drug

For drugs that are discovered in India, or research and development of the drug are being conducted in India, and if the drug is intended to be manufactured and marketed in India, the applications to conduct clinical trials will be considered approved if there are no queries raised by Drugs Controller General of India (DCGI) within 30 days of the application. However, the sponsor will still have to notify the DCGI prior to initiation of the clinical trial in Form CT-4A.

An “academic clinical trial” means a clinical trial of a drug already approved for a certain claim and initiated by any investigator, academic or research institution for a new indication or new route of administration or new dose or new dosage form, where the results of such a trial are intended to be used only for academic or research purposes and not for seeking approval of the Central Licencing Authority or regulatory authority of any country for marketing or commercial purpose.

As per the new provision of pre-submission meetings, applicants can discuss their projects with the regulators and subject experts by paying a certain fee, before making actual submission to the regulator, for seeking guidance about the requirements of law and procedure applicable for their projects.

No fee shall be chargeable in respect of application for conduct of clinical trial for orphan drugs as defined in clause (x) of rule 2 of the New Drugs and Clinical Trial Rules, 2019. The Rules exempt local clinical trials for orphan drugs permitted to be imported for sale or distribution. The phase IV study requirement could also be reduced in case of orphan drugs.