Programme Introduction
About this programme
💊 Pharmacy Practice
✅ Regulatory & Clinical
📋 Case-Based Learning
The New Drugs and Clinical Trials Rules (NDCTR), 2019, notified under the Drugs and Cosmetics Act, govern how new drugs, vaccines and investigational products are approved and studied in India. Administered by the Central Drugs Standard Control Organization (CDSCO), the rules set out how clinical trials, bioavailability and bioequivalence studies may be conducted, monitored and reported, while embedding participant safety and ethical oversight into every stage of research.
For pharmacy and regulatory affairs professionals, working knowledge of the NDCTR is essential — it shapes how sponsors, contract research organisations, Ethics Committees and investigators interact with regulators, and how a promising molecule moves toward patients without compromising safety or scientific rigour.
TerraLeap’s programme walks learners through the structure of the NDCTR — permissions and approvals, Ethics Committee composition and registration, informed consent requirements, and the compensation framework for trial-related injury or death — using the language and reasoning that regulators and sponsors actually apply.
By the end, learners can read a clinical trial application the way a regulatory affairs professional does: identifying which rule governs a given situation, what documentation is expected, and where ethical and compensation obligations arise.
Clinical and regulatory expertise — built for real pharmacy practice.
Programme Scope
What this programme covers
The course maps the full lifecycle of a clinical trial under Indian law, from application to closure, with practical emphasis on ethics and compensation.
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CDSCO approval pathway
Steps and forms involved in seeking permission to conduct a clinical trial or import an investigational drug.
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BA/BE studies
Regulatory requirements specific to bioavailability and bioequivalence studies for generic and new formulations.
⚖️
Ethics Committee framework
Registration, composition and functioning of Ethics Committees that review and monitor trial protocols.
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Informed consent
Documentation standards and participant rights that must be respected before and during a trial.
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Compensation mechanisms
How compensation for trial-related injury or death is determined and disbursed under the rules.
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New drug & vaccine registration
Requirements for registering new drugs and vaccines ahead of manufacture, sale or import.
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Alignment with ICH-GCP
How Indian requirements map onto international Good Clinical Practice standards.
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Inspections & compliance
How regulatory inspections are conducted and what non-compliance can mean for a sponsor or site.
Learning Objectives
What you will achieve
This programme is built to make the NDCTR usable knowledge, not just legal text — the emphasis throughout is on applying the rules to real regulatory situations.
By the end of the course you will be able to:
01
Explain the structure of the NDCTR, 2019 and how it replaced earlier clinical trial provisions.
02
Identify the approval pathway for new drugs, investigational products and vaccines through CDSCO.
03
Describe Ethics Committee registration and duties in reviewing and monitoring trial protocols.
04
Apply informed consent requirements correctly to real trial documentation scenarios.
05
Work out compensation entitlements for participants harmed during a clinical trial.
06
Distinguish BA/BE study requirements from those governing full-scale clinical trials.
07
Compare Indian requirements with ICH-GCP to spot gaps in study documentation.
08
Anticipate regulatory inspection expectations and prepare compliant trial-master-file documentation.
Target Audience
Who can enroll
This course on the New Drugs and Clinical Trials Rules, 2019 is designed for pharmacy graduates and regulatory affairs professionals who need to understand how clinical trials, drug approvals and Ethics Committee oversight actually work in India.
It is equally useful to anyone working with pharmaceutical sponsors, contract research organisations or clinical research sites who must interpret and apply CDSCO requirements as part of their day-to-day responsibilities.
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B.Pharm, M.Pharm and Pharm.D graduates entering regulatory affairs roles.
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Regulatory affairs executives handling CDSCO submissions and approvals.
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Clinical research associates and coordinators working on trial sites.
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Ethics Committee members and administrators seeking clarity on their duties.
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Staff at pharmaceutical companies and CROs preparing trial applications.
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Pharmacy and life-sciences students preparing for careers in drug regulation.
Programme Certification
Your certificate
Upon successful completion of this programme, you will receive a digital certificate recognising your achievement and the competencies you have acquired throughout the course.
Certificates for TerraLeap programmes are issued and signed by authorised TerraLeap representatives. For programmes delivered in collaboration with universities, institutions, or industry organisations, certificates are jointly issued and co-signed by authorised representatives of both TerraLeap and the respective partner.
Each certificate carries a unique Certificate ID and QR code to enable instant authenticity verification — making it easy to share with employers, licensing bodies, or professional networks as evidence of your learning.
Note on scope. TerraLeap certificates confirm successful completion of the respective programme and recognise your professional development and continuing education. They do not constitute a professional licence or regulatory authorisation unless explicitly stated in the programme description.
TERRALEAP
Certificate ID
TL-2026-AB7K3X9P
Official
Seal
Certificate of Completion
Successfully Completed
Awarded in recognition of academic achievement
This is to certify that
XXXXX
has successfully completed the prescribed course of study, demonstrating commitment, diligence, and proficiency in
New Drugs and Clinical Trials Rules (India)
and is hereby awarded this certificate by TerraLeap, recognising the candidate's mastery of the syllabus and successful evaluation.