Diving into the Regulatory Framework: Navigating Clinical Trial Laws & Guidelines in India. This academic presentation offers an in-depth analysis of the legal landscape governing clinical research in India. Delve into the intricate web of regulations, ethical principles, and participant protection measures outlined by the Drugs and Cosmetics Act, ICMR guidelines, and recent amendments.

1. Laws and Guidelines on Clinical
Trials in India

2. Index
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• Introduction
• Regulatory bodies in India
• Regulatory frame work in India
• Understanding Regulatory Landscapes.

3. Introduction to clinical Research
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• Clinical research is a branch of healthcare science that determines the safety
and effectiveness (efficacy) of medications, devices, diagnostic products
and treatment regimens intended for human use.
• Interventions include but or not restricted to drug, cells and other biological
products, surgical procedures, Radiological procedures, Devices, behavioral
treatment, Process-of-care changes, preventive care, etc.
• Synthetic study of new drugs in human subjects to generate data for
discover and/ or verifying.
• The clinical pharmacological(including pharmacodynamics and
pharmacokinetics) effux.
• And/or adverse effects, if the objective of determination safety and/or
efficacy.

4. Clinical Research Regulations
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Why are Regulation important to clinical Research?
• Regulations has been set to Ensure integrity of data collected from clinical
trials which assure the safety, right and welfare of the subject.
• Clinical trials are the only way of establishing the safety and efficacy of any
new drug before its introduction in the market for human use. Clinical trials
(with safeguards) are necessary for introduction of new drugs for a country
like India, considering its disease burden and emergence of new variants of
disease.

5. • The regulatory bodies need to frame guidelines and regulatory approval
processes on a par with international standards. Many of the new laws, guidance
documents, notifications and initiatives for regulating pharmaceutical industry
were in the charts for quite a long time. Indian regulatory authorities have
started looking into speedy implementation and providing support in terms of
necessary infrastructure and investment.
• CDSCO which comes under the Ministry of health and family welfare Is the
main body which works On development of regulatory Procedures And
standard for drugs, cosmetics, diagnostics and devices. It lays down regulatory
guidence by amending acts and rules; and regulate new drugs approvals. Its
main objective is to standardize clinical research and bring safer drugs to
market.
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6. Clinical Research Regulations in India
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• Schedule y allows Clinical trials to be carried out in India.
• India has appropriate provisions to ensure the human subjects used
for the trails are informed Well and their participation is voluntary.
• CDSCOs priorities to enhance the current mechanism
• Establish single window clearance for approvals.
• Fix timelines for each application(2-6 weeks).
• Subject experts-reviewers – internal/external.
• Staff and infrastructure at one site.
• Continuous training for the officers.

7. Regulatory bodies in India
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• The regulatory body Central Drugs Standard Control Organization
(CDSCO) governed by drug directorate General of Health Services of Ministry
of Health and Family Welfare which regulates drugs in India
• Drugs Controller Regulatory agency General India (DCGI): Under the
government of India whose function is to assess the quality, safety and
efficacy of a drug.
• Indian Council of Medical Research (ICMR): Apex body in India that
formulates, co-ordinates and promotes biomedical research

8. • Drugs consultative committee (DCC);
Provides technical guidance to the central drug standard control organization
• Central Drugs Laboratory (CDL);
National statutory laboratory of the Indian government for quality control of drugs.
• Drugs Technical Advisory Board (DTAB)
Provides technical guidance to the CDSCO
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10. Regulatory frame work in India
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• (Text here)

11. Regulatory landscapes
• Regulators desire good proof-of-concept studies, leading to representative
clinical trials that can then, in turn, result in appropriate clinical practice
guidelines and performance measures.
• Regulators are also increasingly focused on sustainability, which may be
achievable by simplifying trials and enrolling representative populations
and through the use of real- world data or drug-product monitoring
registries. Another way to help sustainability is early health technology
assessment (HTA) evaluation.
• Integrating clinical research networks is one way to ensure more efficient
trials
• The patient's voice in particular has become increasingly important to
regulators in defining the value of a medicine, yet incorporating patients'
viewpoints into clinical trials may further increase the complexity of those
trials.

12. • Regulators have been pushing for increased data sharing to promote efficiency and
ensure continued progress.
• There is a need for new regulatory approaches for combining passive and
experimental data that would meet the needs of the 21st century.
• Drug-product monitoring registries enable tracking of longitudinal outcomes and
adverse effects.
• Randomization with a registry enables real-world testing of hypotheses.
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