Clinical Research Regulation in India

Clinical Research Regulation in India

It is always necessary to assess the effectiveness and safety of medication research on humans, but one must be careful and diligent about how the participants in this sector carry out the procedure. The conduct of research involving human subjects must adhere to the principles of good clinical practises, or Good Clinical Practices (GCPs), including providing proper protection for such subjects.

According to the new Drugs and Clinical Trials Rules, 2019 (CT Rules, 2019) the Central Drugs Standard Control Organization (CDSCO) is the regulatory authority, which is responsible to perform duties including clinical trial oversight, approvals, and inspections in India.  The Drugs Controller General of India (DCGI) is the Central Licensing Authority, which heads the CDSCO, and accountable for granting permission for clinical trials, and regulating the sale and importation of drugs for use in clinical trials. Additionally, as per Handbook for Applicants & Reviewers of Clinical Trials of New Drugs in India, Subject Expert Committees (SECs), which comprise experts dealing with relevant therapeutic areas, review the submitted clinical trial applications, study protocols and investigators’ brochures.

The majority of nations have made rules or regulations based on the principles of GCP. It is advised that people in India follow the GCP regulations set forth by the CDSCO.

Which law and regulation deal with clinical trial?

The Drugs and Cosmetics Act, 1940, CT Rules, 2019, Schedule Y for clinical research by CDSCO, ICMR and GCP guidelines are the legal enactments, which deal with clinical trials in India.

The CT Rules, 2019 are divided into 13 chapters (each including 107 provisions), and eight schedules. Clinical trials, bioequivalence and bioavailability studies, ethics committees, and experimental novel medications for human use are all covered by the new regulations.

By creating a time-bound application review process, increasing predictability and transparency of the regulatory system, and offering clarity on numerous complex topics, such as post-trial access, the new rules also aim to promote clinical research in the country.

What are the fundamentals of conducting a clinical trial in India?

In order to conduct clinical research, below mentioned steps are needed to be followed: –

  1. To seek approval from the DCGI
  2. To obtain permission from particular Ethics Committee where the clinical study is designed.
  3. Lastly, mandatory registration on the ICMR website.

What procedure is followed to approve the clinical trial?

In 2013, ‘three-tier’ review process has been implemented for approving clinical trials, so that time can be saved. According to the newly introduced process, Technical Committee is the authority, where application is reviewed at the beginning. Thereafter, Apex Committee scrutinizes the same after an initial approval from Subject Expert Committee. In the end, after receiving approval from all the three stages, DCGI will grant permission to conduct clinical trial.

What is the timeline for approval of clinical trial?

Previously, the timeline for approval of clinical trial from DCGI, was 06 months. However, as per CT Rules, such timeline has been reduced to 30 days where the clinical trial has to be conducted inside India. In case of clinical trial to be conducted abroad, period of 90 days is required.

What documents are required?

The following documents are needed for clinical trial in India: –

  • Clinical trial application form
  • Treasury challan
  • Source of bulk drugs
  • Information of chemicals and pharmaceuticals drugs
  • Pharmacology and Toxicology date of animals
  • Clinical pharmacology information
  • Regulatory conditions in other countries
  • Protocol for quality control and clinical study
  • Investigator’s brochure
  • Case report form
  • Patient data sheet and informed consent form
  • Investigator list in India and site address

Clinical Trial agreements:

Before the commencement of clinical trials, sponsor has to enter into clinical trial agreement with the investigator. The agreement must include the clauses such as financial support, fees, payment, and honorium. In addition to this, it must also state duties of sponsor towards GCP compliance, data reporting and recording and procuring necessary documents relating to trial.

Ethics Committee’s approval for review and approval for clinical trials:

It is compulsory for sponsor to obtain confirmation of EC analysis and approval for clinical trial. Before embarking upon the clinical trial, sponsor should collect the following information: –

  • Profiles of members of EC including name, address, qualification and experience.
  • GCP compliance confirmation.
  • Documented approval.
  • Copy of EC’s approvals in case it is based on changes
  • Copy of EC’s documents involving re-evaluation alongwith suggestions, any removals or suspensions of favorable opinion.

Registration for clinical trial:

Prior to starting a clinical study, the sponsor is required to register for one. The Indian Council of Medical Research’s Clinical Trials Registry, India (CTRI), received a clinical trial registration. Once the sponsor registered with the CTRI, the assigned REF number signifies that the clinical study was successfully registered.

Reporting clinical trial progress:

Periodically, study progress updates can be submitted to the EC by researchers, sponsors. The investigator may submit a periodic study report. There are two types of progress report i.e. annual report and final report.

Annual Report: – Sponsors are required to submit an annual clinical trial status report to DCGI. In the event that the trial was terminated early for whatever reason, the sponsor must provide a summary report within three months. The executive summary of the report comprises study information, the total number of participants exposed to the drug, the duration and dose of exposure, information on adverse drug responses that occurred in any circumstance, and the justification for stopping the trial.

Final report: – The final report is sent to the institution with the investigator’s signature and date on it along with a declaration that the study has been terminated. The EC and the sponsor also have to verify the veracity of the data. The entire data along with signature can be sent to sponsor and EC. For specific cases or if specified in the protocol, the presence of a coordinating investigator is taken into account when conducting a multicenter study.

Compensation and monitoring:

By keeping in view the primary objective of patient safety, compensation must be provided in case of any adverse event. Moreover, strict monitoring should be done against the same. Additionally, informed consent must state the process of monitoring as well as compensation in case of unfavorable event.

Apart from this, medical management should be provided to the subject in case any injury caused during the clinical trial due to the same. DCGI will decide the amount of compensation in cases such as permanent disability or death occurred during the clinical trial.

Conclusion: –

On the whole, the new regulations are thorough and well-balanced. They are also likely to raise the ethical and quality requirements for clinical trials nationwide, which will further benefit both the industry and patients. These regulations will assist in granting patients in India earlier access to medications by waiving local clinical trials. Local drug development will be encouraged by the presumed approval for clinical trials in 30 working days for indigenous medicines, which will help hasten the clinical trial process. It would increase predictability and confidence in the system to include provisions for rapid product approval under certain circumstances as well as pre and post submission with the CDSCO office.

-Kiranpreet Kaur

Associate at Aggarwals & Associates, S.A.S. Nagar, Mohali