Phase 3 Drug Clinical Trials in India

Outsourcing clinical trials, especially the enormous administrative parts of research and the regulatory steps, can significantly reduce time and cost. Due to its large domestic market, product development skills, and scientific workforce, India is well-positioned for the conduct of clinical trials.


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Phase 3 Drug Clinical Trials in India

Clinical trials – One of the final milestones in drug development

A clinical trial is one of the final milestones of a long and tedious research process that starts with drug discovery, formulation development and several preclinical toxicology studies.

Clinical trial means a systematic study of any new drug(s) in human subject(s) to generate data for discovering and/or verifying the clinical, pharmacological (including pharmacodynamic and pharmacokinetic), and/or adverse effects with the objective of determining safety and/or efficacy of the new drug.

Strategically planned clinical trials are the safest and best way to find therapies that work in people. For any company considering trial of a new drug, it's vital that the risks or benefits of the drug are thoroughly researched and that the chosen trial option is scientifically sound and ethically justified.

Phases of clinical trial

Most clinical trial for a new drug progresses through a series of steps, called phases during which various research questions are asked. Each phase builds on the results of previous phases. Most clinical trials consist of four phases – I, II, III and IV.

Phase I trials are conducted to estimate the safety and tolerability with the initial administration of an investigational new drug into humans. Phase I trials are conducted in healthy subjects or specific groups of patients.

Phase II trials evaluate the effectiveness of a drug for a particular indication in patients with the condition. This help to identify the common short-term side-effects and other risks associated with the drug. Patients in these studies are selected by following relatively narrow criteria, and hence the study population comprises a reasonably homogeneous population. The dose and regimen of the drug for Phase III trials are also determined in phase II trials.

Phase III trials are designed to confirm drug safety and potential efficacy established in prior studies. Phase III trials are thus also known as confirmatory trials.

Phase IV or post-marketing trial of new drugs are performed after the drug's approval and are related to the approved indication.

The primary purpose of Phase III trials is the confirmation of the therapeutic benefits of the given drug. Phase III trials studies should be planned in such a way as to provide an adequate basis for marketing approval.

Apart from confirming the safety and efficacy of the new drug, Phase III trials may also be used to establish the dose-response relationships. These trials may also be used to test the drug in broader populations and in different stages of a disease. The drug's safety and efficacy in combination with other drugs can also be established in phase III trials.

The New Drugs and Clinical Trials Rules, 2019, the following applies to conducting Phase III trials in India:

  • For new drugs approved outside India, Phase III trials may need to be carried out if scientifically and ethically justified, primarily to generate evidence of efficacy and safety of the drug in Indian patients when used as recommended in the prescribing information.
  • Before the conduct of Phase III trials in Indian subjects, Central Licencing Authority may require pharmacokinetic studies to be undertaken to verify that the data generated in the Indian population conforms with the data already generated abroad.
  • In case of an application of a new drug already approved and marketed in another country, where local clinical trial in India is waived off or not found scientifically justified for its approval for manufacturing first time in the country, the bioequivalence studies of such drug, as appropriate, is required to be carried out and the test batches manufactured for the purpose shall be inspected before its approval.

Outsourcing clinical trials to improve efficiency

The need to improve efficiency and reduce research and development costs are the most important drivers for the observed increase in outsourcing clinical trials. Outsourcing allows a company to leverage the Clinical Research Organization's therapeutic area and operational expertise, geographic reach and well-established processes and tools.

CliniExperts can help you through the numerous regulations and steps involved in clinical trial management. Our services are tailored to ease the process of getting your products ready for the market. We provide end-to-end services covering every aspect of clinical development. We can help you with clinical project management, clinical site management, clinical trial vendor management, clinical data management, medical writing and medical monitoring.

Summary

For new drugs approved outside India, Phase III trials needs to be carried out if scientifically and ethically justified. Before conducting Phase III trials in Indian subjects, Central Licencing Authority may require pharmacokinetic studies.

In case of an application of a new drug already approved and marketed in other country, where local clinical trial in India is waived off or not found scientifically justified for its approval for manufacturing first time in the country, the bioequivalence studies of such drug is required to be carried out.

References

  1. New Drugs and Clinical Trials Rules, 2019, Ministry of Health & Fam. Welfare, Notification, G.S.R. 227(E), (March 19, 2019).

  2. Saxena P, Saxena R. Clinical trials: changing regulations in India. Indian J Community Med. 2014;39(4):197-202. doi:10.4103/0970-0218.143018

  3. Secondary IDs (if any) - Secondary ID includes any Protocol Number or any other Trial Registry Number, registered in a registry other than the CTRI (for example ClinicalTrials.gov).

  4. Manavalan S, Sinfield C.Conducting Clinical Trials In India: Opportunities And Challenges. 2017. Clinical Leader. Available at: https://www.clinicalleader.com/doc/conducting-clinical-trials-in-india-opportunities-and-challenges-0001. Accessed on: 26 February 2021.

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Frequently Asked Questions

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.

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.

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;

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.


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