Bringing a new drug to market in India involves navigating a highly regulated approval pathway designed to ensure safety, efficacy, and quality. The process is governed primarily by the Central Drugs Standard Control Organization (CDSCO) under the Ministry of Health and Family Welfare, along with oversight from the Drugs Controller General of India (DCGI).
Based on the latest regulations, this guide provides a comprehensive step-by-step overview of the new drug registration and approval process in India.
Key Regulatory Framework of India
The CDSCO is the primary regulatory authority responsible for drug approval and registration in India. State drug control authorities oversee regulatory compliance at the regional level.
Key regulations governing drug approval include:
- New Drugs and Clinical Trials Rules (NDCTR), 2019
- Drugs and Cosmetics Act, 1940 and Rules, 1945
These frameworks define the requirements for the registration and approval of new drugs in India.
Complete Process of New Drug Registration and Approval in India
Ensuring the safety, efficacy, and quality of a new drug requires navigating a detailed regulatory framework. The key steps include:
Steps following For New Drug Registration in India
- Pre-Submission Planning
- Prepare the application dossier in Common Technical Document (CTD) format for new drug applications (NDAs) or Abbreviated New Drug Applications (ANDAs) for generics.
- Arrange all necessary documents per CDSCO guidelines.
- Conduct preclinical (animal) studies to evaluate pharmacology and toxicity.
- Compile Chemistry Manufacturing and Control (CMC) data.
- Develop the clinical trial plan, especially for drugs being introduced in India for the first time.
- Determine if clinical trial data is required or if a waiver may be applicable.
- Review by CDSCO and Subject Expert Committee (SEC)
- CDSCO screens applications for completeness and compliance.
- Technical evaluation includes quality, safety, and efficacy data.
- Inspections of manufacturing facilities may be conducted to verify Good Manufacturing Practices (GMP) compliance.
- Clinical Trial Application
- Submit documentation via the SUGAM portal.
- Apply using Form CT-04 for clinical trials.
- Register the study with the Indian Clinical Trials Registry (CTRI).
- Conduct trials in accordance with:
- NDCTR 2019
- Good Clinical Practices (GCP)
- ICMR Ethical Guidelines
- Conduct Clinical Trials (Phase I–III)
- Ensure clinical trials follow GMP and GCP standards.
- Obtain approval from the Institutional Ethics Committee for every trial.
- Collect data according to Schedule Y requirements.
- Report adverse events promptly to CDSCO.
- Submission for Market Authorization (NDA)
- Submit Clinical Study Reports (CSRs) and all supporting documents through the SUGAM portal in CTD format.
- Submit Form CT-21 for market authorization (import or manufacture).
- Sample testing may be required by Indian Pharmacopoeia Commission (IPC) labs.
Steps for New Drug Approval in India
Drug Approval Certificate
- Ensure drug’s labelling and packaging comply with Indian regulations.
- SEC and CDSCO examine the complete package.
- DCGI grants final approval.
- Manufacturer receives Import License (Form 10) or Manufacturing License (Form 46).
- State Licensing Authority issues Manufacturing License (Form 25/28).
- Drugs can be marketed per approval under Form CT-23 or Form 46.
- Regulatory inspections may occur to verify ongoing GMP compliance.
Approval Documentation
- Conduct post-market surveillance to monitor safety and efficacy.
- Submit three batches of Certificates of Analysis (COAs) along with stability and CMC data.
- Ensure ICF, IB Labeling, and other documentation comply with NDCTR 2019.
Post-Marketing Surveillance
- Submit Periodic Safety Update Reports (PSURs):
- Every six months for the first two years
- Annually for the following two years
- Report adverse drug reactions (ADRs) to the Pharmacovigilance Programme of India (PvPI).
- Conduct Phase IV studies if required for long-term safety.
- Maintain ongoing GMP compliance.
Limitations of Drug Registration in India
- Incomplete dossiers or missing data
- No registered Ethics Committee
- Trial sites not compliant with GCP
- Delays in sample testing or batch release
- Lack of follow-up data on ADRs
- Delays due to queries from CDSCO or SEC
Recent Updates for Drug Registration in India
- SUGAM portal: Online submission for import, registration, and clinical trials
- Efforts to reduce timelines: Priority review for oncology, rare diseases, and public health emergency drugs
Special Cases
- Drugs approved abroad: CDSCO may accept foreign clinical data under specific conditions.
- Fixed Dose Combinations (FDCs): Special rules apply; clinical trial permission may be required.
- Emergency use / public health urgency: Fast-track approval available for pandemic or rare disease drugs.
Documents Submitted with Form 44
- Form 44 with applicable fees
- Full CMC data
- Preclinical pharmacology and toxicology data
- Published literature (if available)
- Clinical trial protocol (if applicable)
- Regulatory status in other countries
- Submission in CTD/eCTD format recommended
Specific Timelines for CDSCO Drug Approval
Activity | Estimated Time |
Preclinical Studies | 6–12 months |
Clinical Trials (Phases I–III) | 1–3 years |
Review by CDSCO | 6–12 months |
Total Time for Approval | 2–5 years (on average) |
Fast-track approval is available for drugs of national importance or rare diseases.
Conclusion
India’s regulatory environment for new drug approval is complex but well-defined. Adhering to CDSCO and NDCTR 2019 requirements ensures compliance, patient safety, and timely access to new treatments. With strategic planning, pharmaceutical companies can introduce innovative medicines efficiently.
How DDReg Can Help
DDReg supports pharmaceutical companies through every stage of the drug registration and approval process in India. From dossier preparation in CTD/eCTD format to managing clinical trial submissions, regulatory interactions, and post-marketing safety reporting, our team ensures complete compliance with CDSCO and NDCTR 2019 requirements. With expertise in handling both new drug applications and complex cases such as fixed-dose combinations, biologics, and priority reviews, DDReg helps companies achieve faster approvals and seamless market access.