In the conduct of clinical trials and associated regulatory procedures in India, timely approvals and compliance with Central Drugs Standard Control Organization (CDSCO) requirements are essential. At Lambda Therapeutic Research, we facilitate a streamlined regulatory process for our partners across the clinical research continuum, ensuring alignment with all statutory mandates.
Key Regulatory Approvals in India
Approval for Conducting Clinical Studies
- Bioequivalence No Objection Certificate (BENOC)
Authority: CDSCO, Delhi
Timeline: 6–8 weeks - Clinical Trial No Objection Certificate (CT-NOC)
Authority: CDSCO, Delhi
Timeline: 3–4 months - Registration in Clinical Trials Registry of India (CTRI)
Authority: CTRI
Timeline: Within 45 days
Note: Mandatory for all clinical studies conducted in India
Approval for Import of Investigational Medicinal Products (Test License)
- Authority: CDSCO, Zonal Office (e.g., Ahmedabad)
- Timeline: 7–10 working days
Approval for Export of Biological Samples to Overseas Lab (Export NOC)
- Authority: CDSCO, Delhi
- Timeline: 30 days (post-BENOC)
Approval for Import/Export of Narcotic Drugs/Psychotropic Substances
- Authority: Central Bureau of Narcotics (CBN), Gwalior
- Timeline: Approx. 120 days (post-BENOC/Test License)
Note: Recent improvements have shortened approval timelines with sustained follow-ups
Approval for Transfer of Human Biological Material Overseas
- Authority: Indian Council of Medical Research (ICMR), Delhi
- Timeline: Approx. 4–6 weeks
Note: Current experience indicates faster approvals from the Zonal office
Reporting of Serious Adverse Events (SAE) and SUSARs
- Authority: CDSCO, Delhi
- Timeline: Initial report within 24 hours; detailed report within 14 days
Document Requirements for Key Regulatory Submissions
For BA/BE Studies
- CT-05 with treasury challan of Rs. 2,00,000 (Incase is a new drug in India)
- Undertaking by PI, Protocol, Informed Consent Form and other study related documents
- Sponsor’s original authorization letters (Delegation & Declaration)
- Original Undertaking letter from the sponsor/applicant stating that to provide complete medical care as well as compensation for the injury or Death
- CMC data of test product including stability data
- COAs of test & reference product and comparative dissolution data
- Published literatures on safety of the drug product
- Non-clinical and clinical data (Incase of a new drug)
- Regulatory status of drug product & prescribing information of reference product
- Sub acute toxicity data on at least 2 species (For injectables)
- Scientific justification with special emphasis on Safety of subjects with a proper Risk Mitigation Strategy (For Cytotoxic drugs, Hormonal preparations, Narcotic and Psychotropic substances ).
Submission of protocol approval letter from Independent Ethics Committee/Institutional Ethics Committee would be either parallel or at the time of applying for BE NOC.
Institutional Ethics Committee approval required only for New molecule (New Chemical entity) not approved in India but approved in other countries.
For Test License Application:
- Form 12 for old drug and CT-16 for new drug with treasury challan of Rs. 5000/- (incase of import of one product)
- Undertaking by PI, Protocol, Informed Consent Form and other study related documents
- Sponsor’s original authorization letters (Delegation & Declaration)
- Regulatory status of drug product & prescribing information of reference product
- Justification and break up of the importing products
About CDSCO
The Central Drugs Standard Control Organization (CDSCO) serves as India’s central regulatory authority under the Drugs and Cosmetics Act. With a structured network of zonal, sub-zonal, and port offices, along with designated laboratories, CDSCO governs regulatory functions across the pharmaceutical and clinical research ecosystem.
Key Departments within CDSCO:
- BA/BE
- Clinical Trial
- Biologics
- Cosmetics
- Drug Technical Advisory Board (DTAB)-DCC
- Drugs
- International Cell
- Medical Devices & Diagnostics
Core Functions of CDSCO:
- Approval of new drugs and clinical trials
- Import registration and licensing
- License approving of Blood Banks, LVPs, Vaccines,
- r-DNA products & some Medical Devices (CLAA Scheme)
- Amendment to D & C Act and Rules
- Banning of drugs and cosmetics
- Grant of Test License, Personal License, NOCs for Export
- Testing of New Drugs
- Oversight and market surveillance through Inspectorate of Centre Over and above the State Authority
At Lambda, our regulatory affairs team brings extensive experience in managing these complex approval pathways efficiently, enabling uninterrupted clinical development. Our proactive engagement with regulatory authorities ensures timely submissions, ongoing updates, and transparent communication to support sponsors at every stage.
For more information or tailored support, please connect with our experts at BD@Lambda-cro.com
About us
Lambda & Novum delivers comprehensive, end-to-end clinical research services to the innovator, biotech, and generic pharmaceutical industries worldwide. With a strong global presence in India, the USA, Canada, the UK, Spain and Poland, we bring specialized expertise to every project. Our focus on secure IT infrastructure and automation ensures timely project delivery and strict adherence to international regulatory standards. Lambda’s exemplary regulatory track record includes over 60 successful inspections and audits by esteemed authorities, including the USFDA, EMEA, MHRA, EU member states, and other global regulatory bodies, in the past five years.
Lambda’s commitment to excellence has garnered significant recognition, including the ‘Best Indian CRO’ award from Frost & Sullivan (USA) and the ‘Great Indian Workplace’ title from UBS Transformance. Recent accolades include the ‘Regulatory Excellence’ Award at the CPhI Pharma Awards 2023 and the ‘Industry Partner of the Year’ Award at the Global Generics & Biosimilar Awards 2023.
