Why in news?

The government has waived the requirement for clinical trials of certain categories of drugs in India if they are approved in the US, the UK, Japan, Australia, Canada and the European Union.

What’s in today’s article?

• Clinical Trials in India
• India waives clinical trials for several drugs

Clinical Trials in India

• About
  • Clinical trials in India are crucial for evaluating the safety and efficacy of new drugs, medical devices, and treatment protocols.
  • These trials are conducted in phases and are essential for the advancement of medical science and patient care.
  • India, with its diverse population and vast pool of medical conditions, is an attractive destination for clinical trials, providing valuable data that can be generalized across various populations.
• Regulatory Framework
  • The regulation of clinical trials in India is primarily governed by the Central Drugs Standard Control Organization (CDSCO) under the Ministry of Health and Family Welfare.
  • The Drugs and Cosmetics Act, 1940, and its subsequent amendments, along with the New Drugs and Clinical Trials Rules, 2019, provide the legal framework for the conduct of clinical trials in the country.
• Institutions Involved
  • Central Drugs Standard Control Organization (CDSCO)
    • The apex regulatory body for drug approval and oversight of clinical trials.
  • Indian Council of Medical Research (ICMR)
    • Plays a significant role in setting ethical guidelines and standards for clinical trials.
  • Drug Controller General of India (DCGI)
    • The head of CDSCO, responsible for granting approvals for clinical trials and ensuring compliance with regulatory standards.
  • Clinical Trial Registry of India (CTRI)
    • CTRI was established in 2007 as a key initiative by the Indian Council of Medical Research (ICMR).
    • It is a national online registry where all clinical trials conducted in India must be registered before the enrollment of the first participant.
    • The primary objectives of CTRI include ensuring transparency, accountability, and public access to information about clinical trials conducted in the country.
• Ethical Oversight and Committees
  • Ethics Committees (ECs): Every institution conducting clinical trials must have an Ethics Committee to review the trial protocols, ensure participant safety, and protect their rights. The ECs must be registered with the CDSCO.
  • Institutional Review Boards (IRBs): Similar to ECs, these boards are established within institutions to review and monitor the ethical aspects of clinical trials.
  • Independent Ethics Committees: For trials conducted outside the institutional setup, independent ethics committees ensure adherence to ethical standards.
  • ICMR National Ethical Guidelines for Biomedical and Health Research Involving Human Participants:
    • These guidelines emphasize informed consent, confidentiality, and the protection of vulnerable populations.
  • The New Drugs and Clinical Trials Rules, 2019, further strengthen ethical oversight by mandating compensation for trial-related injuries or deaths and ensuring faster approval processes while maintaining stringent safety protocols.

India waives clinical trials for several drugs

• About the news
  • The Indian government has waived the requirement for local clinical trials for certain categories of drugs already approved in the US, UK, Japan, Australia, Canada, and the EU.
  • The waiver applies to five categories:
    • orphan drugs for rare diseases,
    • gene and cellular therapy products,
    • new drugs used in pandemics,
    • new drugs for special defense purposes, and
    • new drugs with significant therapeutic advances.
  • This move aims to expedite the availability of advanced medicines in India, particularly for conditions like cancer, rare diseases (e.g., Spinal Muscular Atrophy and Duchenne Muscular Dystrophy), and autoimmune disorders.
• Rule under which this was done
  • Under Rule 101 of the New Drugs and Clinical Trials Rules, 2019, the Drugs Controller General of India (DCGI) has the authority to grant this waiver.
• Benefits
  • This will align India with global markets, reduce delays in drug availability, lower costs for pharmaceutical companies, and decrease public procurement costs for the government.
  • The waiver is expected to promote research and innovation in India by providing earlier access to advanced medicines and patient data, shifting the focus from volume to value in the pharmaceutical industry.
• Concerns
  • India previously permitted waivers for local clinical trials.
  • However, in 2012, a parliamentary standing committee expressed concerns in its 59th report about approving certain new drugs in the country without conducting local clinical trials.
  • In this context, public health advocates have called for strict scrutiny before every waiver.
    • This is due to the fact that there may be certain medicines that require local clinical trials due to Indian conditions and genetic factors.