Central Drugs Standard Control Organization (CDSCO)
Introduction :
About CDSCO
The Central Drugs Standard Control Organization (CDSCO) is India's national regulatory authority (NRA) for pharmaceuticals and medical devices, operating under the Ministry of Health & Family Welfare, Government of India. As per the Drugs and Cosmetics Act, 1940, CDSCO ensures the safety, efficacy, and quality of drugs, medical devices, and cosmetics in India.
Key Responsibilities :
✅ Regulation & Licensing of pharmaceuticals, medical devices, and cosmetics.
✅ Approval of new drugs, vaccines, and clinical trials.
✅ Ensuring drug quality through testing and inspections.
✅ Pharmacovigilance & adverse drug reaction (ADR) monitoring.
✅ Control of import & export of drugs and medical devices.
Regulatory Services :
1. Drug & Vaccine Approvals:
CDSCO evaluates applications for new drugs, vaccines, and biosimilars before granting approvals for manufacturing or marketing in India.
2. Medical Device Regulation:
Ensuring safety and efficacy of medical devices through a structured approval and licensing process.
3. Clinical Trial Approvals:
CDSCO reviews and grants approvals for clinical trials in India to ensure ethical and scientific standards are maintained.
4. Pharmacovigilance Program of India (PvPI):
Monitoring adverse drug reactions (ADRs) and ensuring drug safety across India.
5. Import & Export Regulations:
CDSCO oversees the import & export of pharmaceuticals and medical devices to ensure compliance with international standards.
Below is a list of required documents for various CDSCO processes :
The documents required for the Central Drugs Standard Control Organization (CDSCO) depend on the type of application, such as drug approvals, clinical trials, import/export licenses, or medical device registration.
1. New Drug Approval (NDA) / Registration
For companies applying for the approval of new drugs, vaccines, or biosimilars, the following documents are required:
✅ Application Form (Form 44 as per Drugs & Cosmetics Act)
✅ Covering Letter with product details
✅ Drug Master File (DMF) – Technical details, raw materials, and formulation data
✅ Preclinical and Clinical Study Reports (if applicable)
✅ Quality Control & Stability Data
✅ Manufacturing Process and Batch Analysis Data
✅ Regulatory Status in Other Countries (if available)
✅ Patent Information & Labelling Details
2. Import License for Drugs & Medical Devices
For importing pharmaceuticals or medical devices into India:
✅ Application Form (Form 8 and Form 10)
✅ Authorization Letter from Manufacturer
✅ Good Manufacturing Practice (GMP) Certificate
✅ Free Sale Certificate (FSC) from the Country of Origin
✅ Test Reports and Specifications
✅ Importer Registration Certificate (if applicable)
✅ Labelling and Packaging Details
3. Medical Device Registration & Licensing
For registering and licensing medical devices under Medical Device Rules, 2017:
✅ Application Form (Form MD-14 for Import, Form MD-5 for Manufacture)
✅ Manufacturing License or Import License
✅ Quality Assurance Certificate (ISO 13485 or equivalent)
✅ List of Intended Use and Device Classification
✅ Performance & Safety Testing Reports
✅ Risk Assessment and Clinical Evaluation Report (CER)
✅ Declaration of Conformity to Indian Regulatory Standards
4. Clinical Trial Approvals
For conducting clinical trials in India:
✅ Application Form (Form 44 or Form CT-04)✅ Investigational New Drug (IND) Dossier
✅ Preclinical Study Reports
✅ Ethics Committee Approval Letter
✅ Clinical Trial Protocol & Investigator’s Brochure
✅ Informed Consent Documents
✅ Good Clinical Practice (GCP) Compliance Certificate
5. Export NOC (No Objection Certificate) for Pharmaceuticals
For exporting medicines from India:
✅ Application Form (Form 29 for NOC)
✅ Manufacturing License Copy
✅ Certificate of Analysis
✅ Free Sale Certificate (FSC) if required by importing country
✅ Details of Exporting Country’s Regulatory Approval
Process of CDSCO :
- Device Classification & Application
- Application Submission
- Evaluation by CDSCO
- Approval & Marketing Authorization
