Comprehensive Clinical Trial Solutions for your smooth drug launch in India

Credentials

Our success stories to tell

Approval For 15+ FDCs
Approval For 6 months
Gastroenterology Gynaecology and Respiratory

FDCs must be based on convincing therapeutic rationalization and be carefully justified and clinically relevant. We helped our sponsor to prove the therapeutic rationale for various FDCs by conducting PIV clinical trials in India for gastroenterology, Gynaecology and Respiratory therapeutic areas

Approval For 2 Drugs

PMS/PSUR being conditioned for Market Authorization and licensing in India. The PSURs are to be submitted every six months for the first two years of the approval and for subsequent two years annually. We have conducted/conducting PMS studies for our sponsor as per “New Drugs and Clinical Trials Rule, 2019”. This has helped the sponsor to meet the prerequisites as per the regulations

Approval For 4 SNDs

To claim marketed drugs with modified or new claims including indication, route of administration, dosage and dosage form. A subsequent new drug (SNDs) approval required from CDSCO. Here, CliniExperts supported our client to conduct PIII, PIV and PMS studies as per CDSCO guidelines

Approval For 3 Drugs
Gynaecology Dermatology and Respiratory

Clinical trials for phytopharmaceutical drugs to be conducted as per applicable Rules and guidelines for new drugs. CliniExperts Research conducted three PIII clinical trials for three therapeutic conditions in India

Approval For 4 FDCs
GastroenterologyGynaecology Dermatology and Respiratory

CliniExperts has helped in conducting PII, PIII and PIV clinical trial in diversified therapeutic categories like Polycystic Ovary Syndrome (PCOS), Recurrent ascites with liver cirrhosis, Premenstrual Syndrome, Primary Dysmenorrhea and Alopecia Areata in children and adolescents

Approval For 1 Supplement
Gastroenterology

Most of the patients in intensive care unit (ICU) with impaired oral food consumption, present nutritional challenges which needs to be compensated using enteral tube feeding (ETF). We have successfully conducted safety and tolerance of nutritional supplements via tube feeding in hospitalized patients

Approval For 1 Supplement
Endocrinology

Functional food supplements has grown exponentially in India and to prove their claims, feasibility and safety evaluation studies are required. CliniExperts Research has conducted various studies to prove their claims like Glycaemic Index evaluation of product on Diabetic and Pre-diabetic population and many more

CliniExperts can empower the sponsors to conduct successful clinical trials
and drug launches that follow the correct procedures and compliances

Drug categories for which clinical trials
can be conducted in India:

New Drug

A drug or substance or drug delivery system of any drug which is not yet recognized by the Central licensing authority as safe and effective for certain proposed and modified claims including indication, route of administration, dosage and dosage form.

Fixed Dose Combinations

Refer to products containing two or more active ingredients in a fixed ratio used for a particular indication.

Investigational New Drug

Means a new chemical or biological entity or substance that has not been approved for marketing as a drug in any country. In other words, IND is a potential drug whose safety and efficacy need to be established in human

Subsequent New Drug

A pre-approved drug that has been modified to improve the treatment for already approved indication or additional indication and is going for a subsequent trial or a drug which is under the period of 4 years.

Clinical Trial for Drug

CliniExperts provide full spectrum services for following types of Drug Clinical Trials:

Local Clinical Trial & Global Clinical Trial

Clinical trial, conducted as part of national & multi-national clinical development of a drug

Phase 1
  • Aims to find the best dose of a new drug with the fewest side effects
  • Tested on group of 15 to 30 patients
  • Test’s a drug’s safety
Phase 2
  • Assess safety as well as if a drug works.
  • Done in larger groups of patients compared to Phase 1
  • Often, new combinations of drugs are tested.
Phase 3
  • Compares a new drug to the standard-of-care drug.
  • Assess the side effects of each drug and which drug works better.
  • Enrolls 100 or more patients.
  • Often, these trials are randomized
  • Needed before the FDA will approve the use of a new drug for the general public.
Phase 4
  • Tests new drugs approved by the FDA
  • The drug is tested in several hundreds or thousands of patients.
  • Allows for better research on short-lived and long-lasting side effects and safety

Click here to know more about our expertise in phase 3 clinical trial

Our clinical trial solutions,designed to address your specific needs and deliver a smooth development pathway

Efficiently manage your Drug Trials with CliniExperts

Conducting high quality trials in line with ethical and regulatory compliance

Frequently Asked Questions

Organized information about the concerns regarding Drug Clinical Trial

What is an “orphan drug” as per the New Drugs and Clinical Trial Rules, 2019?

“Orphan drug” means a drug intended to treat a condition which affects not more than five lakh persons in India.

The extrapolation of the safety and efficacy data of a particular clinical indication (for which clinical studies has been done) of a similar biologic to other clinical indications may be possible if following conditions are met: Similarity with respect to quality has been proven to reference biologic Similarity with respect to preclinical assessment has been proven to reference biologic Clinical safety and efficacy is proven in one indication Mechanism of action is same for other clinical indications Involved receptor(s) are same for other clinical indications New indication not mentioned by innovator will be covered by a separate application.

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.

Clinical investigation in India are typically required for risky medical devices (Class B, Class C and Class D) without predicates and may also be required for Class A medical devices.

FORM MD-24 is an application for grant of permission to conduct, clinical performance evaluation of new in vitro diagnostic medical device.

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.

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

The three tier mechanism comprises the following authorities: 1. Institutional Biosafety Committee (IBSC) at the Institute/ company – To ensure biosafety on-site 2. Review Committee on Genetic Manipulation (RCGM) in the Department of Biotechnology - Managed genetically engineered cell banks 3. Genetic Engineering Appraisal Committee (GEAC) in the Ministry of Environment & Forests (MoE&F)- for genetically modified organisms/ living modified organisms

Any person or institution or organisation having permanent establishment in India who intends to conduct clinical trial of a biological product can submit application for clinical trial.

The clinical performance evaluation shall be initiated within a period of one year from the date of grant of permission.

After obtaining permission in CT-11 or CT-14 or CT-15 as the case may be, the person, who intends to manufacture the biological product for CT, shall make an application for grant of license to manufacture the biological product by the respective State Licensing Authority (SLA) in accordance with the provisions of the Act and the Drugs and Cosmetics Rules, 1945.

No. For biological product and 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 biological product.

“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;

Every person, sponsor, clinical research organisation, any other organisation or investigator conducting a clinical investigation or his agent holding a permission shall maintain the related data, record, registers and other documents for a period of seven years after completion of such investigation and shall furnish such information as may be required by the Central Licensing Authority or any other officer authorized by it in this behalf.

In India, genetically modified organisms (GMOs) and the products thereof are regulated under the “Rules for the manufacture, use, import, export & storage of hazardous microorganisms, genetically engineered organisms or cells, 1989” (referred to as Rules, 1989) notified under the Environment (Protection) Act, 1986.

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 biological product manufactured under Form CT-14 & Form CT-15 shall be kept in containers bearing labels, indicating the name of the biological product or code number, batch or lot number, wherever applicable, date of manufacture, use before date, storage conditions, name of the institution or organization or the center where the CT is proposed to be conducted, name and address of the manufacturer, and the purpose for which it has been manufactured.

The permission granted in Form CT-11/CT-14/CT-15 to manufacture a biological product or substance to conduct CT shall remain valid for a period of 3 years from the date of its issue, unless suspended or cancelled by CLA. In exceptional circumstances the CLA may extend the period of the permission granted for a further period of 1year.

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.

“Clinical investigation” means the systematic study of an investigational medical device in or on human participants to assess its safety, performance or effectiveness.

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

The permission to conduct clinical performance evaluation for a new in vitro diagnostic medical device is granted in Form MD-25 by the Central Licensing Authority.

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 application submitted to CLA for grant of permission to conduct clinical trial of a biological product discovered in India or research and development of the biological product 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.

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.

Form MD-22 is an application for grant of permission to conduct clinical investigation for investigational medical device.

The rationale for the choice of the reference biologic should be provided by the manufacturer of the similar biologic in the submissions to the DBT and CDSCO. The following factors should be considered for selection of the reference biologic: The reference biologic should be licensed in India and should be innovator product. The reference biologic should be licensed based on a full safety, efficacy and quality data. Therefore another similar biologic cannot be considered as a choice for reference biologic. In case the reference biologic is not marketed in India, the reference biologic should have been licensed and widely marketed for 4 years post approval in innovator jurisdiction in a country with well-established regulatory framework. In case no medicine or only palliative therapy is available or in national healthcare emergency, this period of 4 years may be reduced or waived off. The same reference biologic should be used throughout the studies supporting the safety, efficacy and quality of the product (i.e. in the development programme for the similar biologic) The dosage form, strength and route of administration of the similar biologic should be the same as that of the reference biologic. The active substance (active ingredient) of the reference biologic and that of the similar biologic must be shown to be similar.

CDSCO regulates the manufacture and import of biologicals in India. The organization is responsible for: ● Approving clinical trials ● Granting permission to import biologicals for local trials ● Authorizing firms to export biologicals for biochemical and immunological analysis

A “clinical investigation plan” means a document which contains the information about the rationale, aims and objective, design and the proposed analysis, conduct, methodology including performance, management, adverse event, withdrawal and statistical consideration and record keeping pertaining to clinical investigation.

A “clinical trial” in relation to a biological product means any systematic study of such biological products 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

Pilot clinical investigation is defined as those clinical investigations which are used to acquire specific essential information about a device before beginning the pivotal clinical investigation. Pilot clinical investigation is exploratory study which may be conducted in a few numbers of patients with the disease or condition being studied before moving to large population and scope that give insight into the performance and safety of a device but cannot provide definitive support for specific mechanistic or therapeutic claims. The pivotal clinical investigation is a definitive study in which evidence is gathered to support the safety and effectiveness evaluation of the medical device for its intended use. Pivotal clinical investigation is confirmatory study that may be conducted in large number of patients with disease or condition being studied and scope to provide the effectiveness and adverse effects.

Prior to CDSCO, Genetically Modified Organisms (GMOs) and products thereof in research and application are required to ensure safety of the biological to the users as well as to the environment

The Central Licensing Authority, if satisfied, may grant permission to conduct clinical investigation for an investigational medical device in Form MD-23.

An application for grant of permission to conduct clinical trial of biological product 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

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.

The products, where the reference biologic is not authorized in India shall be considered on a case by case basis if such products have been granted marketing approval in countries with well-established regulatory systems such as US FDA, EMA etc. and have been in wider use for a minimum of four years.

In general, the timeline for disposal of an application for conduct of clinical trial for biological products is 90 working days from the date of receipt of application. However, if the biological product is discovered in India or research and development of the biological product are being done in India and also the biological product 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.

No. The information to initiate clinical trial of new drug or investigational new drug shall be made required to be submitted to CDSCO in Form CT-04A duly filled and signed before initiation of the clinical trial. As per the requirement, any sponsor or investigator shall before initiating the clinical trial is required to inform the CDSCO in Form CT-4A. On the basis of the said information the CDSCO shall take on record the Form CT-4A which shall become part of the official record and shall be called automatic approval of the CLA

Medical devices are classified as Low risk - Class A; Low moderate risk- Class B; Moderate high risk- Class C; High risk- Class D.

A “similar biologic” means a biological product which is similar in terms of quality, safety and efficacy to reference biological product licensed or approved in India, or any innovator product approved in International Council of Harmonization (ICH) member countries

A Biological Product means a vaccine, r-DNA derived product, living modified organism, monoclonal antibody, stem cell derived product, gene therapeutic product or xenografts, intended to be used as drug. Biological products, or biologics, are medical products made from a variety of natural sources (human, animal or microorganism) intended to treat diseases, prevent or diagnose diseases. Examples of biological products include vaccines, blood and blood products, human cells and tissues, gene therapies and cellular therapies.

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.

An investigational medical device in relation to a medical device, other than in vitro diagnostic medical device, means a medical device specified (i) which does not have its predicate device (ii) which is licensed under Manufacturing/Loan License/Import License and claims for new intended use or new population or new material or major design change

Any medical device or new in vitro diagnostic medical device imported or manufactured, for the purpose of clinical investigation or clinical performance evaluation, test, evaluation, demonstration and training, shall be kept in containers bearing labels, indicating the name of the product or code number, batch or lot number, serial number wherever applicable, date of manufacture, use before date, storage conditions, name and address of the manufacturer, and the purpose for which it has been manufactured.

The application for a test license to import a medical device is filed under form MD-16.

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.

Any person or institution or organization who intends to import a biological product or substance for clinical trial shall make an application in Form CT-16 to the CLA. The application shall be accompanied by a fee specified in the Sixth Schedule and such other information and documents as specified in Form CT-16.

If the biological product manufactured for purposes of CT is left over or remains unused or gets damaged or its specified shelf life has expired or has been found to be of sub- standard quality, the same shall be destroyed and action taken in respect thereof shall be recorded.

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.

The license pertaining to the import for test, evaluation, clinical investigations is granted using form MD-17 by the Central Licensing Authority.

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.

For Phase I Clinical Trials: Systemic Toxicity studies: - Single dose toxicity studies Dose Ranging Studies Repeat-dose systemic toxicity studies of appropriate duration to support the duration of proposed human exposure. Male fertility study: In-vitro genotoxicity tests, – Relevant local toxicity studies with proposed route of clinical application (duration depending on proposed length of clinical exposure). Allergenicity or Hypersensitivity tests (when there is a cause for concern or for parenteral drugs, including dermal application). Photo-allergy or dermal photo-toxicity test (if the drug or a metabolite is related to an agent causing photosensitivity or the nature of action suggests such a potential). For Phase II Clinical Trials: Provide a summary of all the non-clinical safety data (listed above) already submitted while obtaining the permissions for Phase I trial, with appropriate references. In case of an application for directly starting a Phase II trial - complete details of the nonclinical safety data needed for obtaining the permission for Phase I trial, as per the list provided above must be submitted. Repeat-dose systemic toxicity studies of appropriate duration to support the duration of proposed human exposure. In-vivo genotoxicity tests. Segment II reproductive or developmental toxicity study (if female patients of child bearing age are going to be involved). For Phase III Clinical Trials: Provide a summary of all the non-clinical safety data (listed above) already submitted while obtaining the permissions for Phase I and II trials, with appropriate references. In case of an application for directly initiating a Phase III trial – complete details of the non-clinical safety data needed for obtaining the permissions for Phase I and II trials, as per the list provided above must be provided. Repeat-dose systemic toxicity studies of appropriate duration to support the duration of proposed human exposure. Reproductive or developmental toxicity studies Segment I (if female patients of child bearing age are going to be involved), and Segment III (for drugs to be given to pregnant or nursing mothers or where there are indications of possible adverse effects on foetal development). Carcinogenicity studies (when there is a cause for concern or when the drug is to be used for more than 6 months). For Phase IV Clinical Trials: Provide a summary of all the non-clinical safety data (listed above) already submitted while obtaining the permissions for Phase I, II and III trials, with appropriate references. In case an application is made for initiating the Phase IV trial, complete details of the non-clinical safety data needed for obtaining the permissions for Phase I, II and III trials, as per the list provided above must be submitted. Application of Good Laboratory Practices (GLP) – The animal studies be conducted in an accredited laboratory. Where the safety pharmacology studies are part of toxicology studies, these studies should also be conducted in an accredited laboratory

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.

“Investigational new drug” means a new chemical or biological entity or substance that has not been approved for marketing as a drug in any country.

Clinical performance evaluation in India are typically only required for risky IVD (Class B, Class C and Class D) without predicates and may also be required for Class A IVD’s.

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.

The results of clinical investigation may not be required to be submitted where the investigational medical device is approved by the regulatory authorities of either the United Kingdom or the United States of America or Australia or Canada or Japan or EU and the said device has been marketed for at least two years in that country and the Central Licencing Authority is satisfied with the data of safety, performance and pharmacovigilance of the device.

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.

No. Medical devices requiring clinical investigation but claiming substantial equivalence to a predicate device shall not be marketed unless the Central Licensing Authority has approved it. A device shall be deemed to be substantially equivalent in comparison to a predicate device, if it has: (i) the same intended use and technological characteristics; or (ii) same intended use and different technological characteristics, and demonstrate that the device is as safe and effective as the predicate device. A claim of substantial equivalence does not mean that the proposed medical device and predicate device are identical. Substantial equivalence shall be established with respect to intended use, design, energy used or delivered, materials, chemical composition, manufacturing process, performance, safety, effectiveness, labeling, biocompatibility, standards, and other characteristics, as applicable.

A three-tier mechanism has been established for granting approval for research and development activities on recombinant DNA products and monitoring and evaluation of research activities involving recombinant DNA technology.

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.

Clinical performance evaluation means the systematic performance study of a new in vitro diagnostic medical device on a specimen collected from human participants to assess its performance.

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.

Class wise list of medical devices is published on the website of the CDSCO. Provided that the Central Licencing Authority (CLA) may, from time to time, make additions or deletions in such list of medical devices or modify the class of any medical device.

Any person who intends to manufacture a biological product as well as substance for CT shall submit application in CT-10 for obtaining permission from the CLA to manufacture such biological product. Any person who intends to manufacture a formulation of a biological product after obtaining biological substance from an approved source for CT shall submit application in CT-10 for obtaining permission from the CLA in Form CT-11 to manufacture such biological product. Any person who intends to manufacture a biological product after obtaining biological substance from an unapproved source for shall submit application in CT-12 for obtaining permission from the CLA in Form CT-14 to manufacture such biological product. In such case, the biological substance manufacturer is also required to submit application to CLA in Form CT-13 for obtaining permission in Form CT-15 to manufacture and supply the unapproved biological substance to the formulator for development of the biological product. Any person who intends to manufacture an investigational biological product after obtaining the unapproved biological substance from another manufacturer for CT shall submit application in CT-12 for obtaining permission from the CLA in Form CT-14 to manufacture such investigational biological product. In such case the biological substance manufacturer is also required to submit application to CLA in Form CT-13 for obtaining permission in Form-CT15 to manufacture and supply the unapproved biological substance to the formulator for development of the investigational biological product.

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