In this blog, we have given detailed insights into what is CDSCO, its role, divisions, and importance. Additionally, we have provided some common FAQs on CDSCO.
What is CDSCO?
The Central Drugs Standard Control Organisation (CDSCO) under the Directorate General of Health Services, Ministry of Health and Family Welfare in India, is the regulatory body for medical devices, cosmetics, and pharmaceuticals in India. Similar to the Food and Drug Administration of the US and European Medical Agencies, the CDSCO oversees that all medical devices, cosmetics, and drugs sold in India are effective and safe. CDSCO regulates the approval, manufacturing, import, and marketing of medical devices, pharmaceuticals, and cosmetics. It is responsible for ensuring the safety, efficacy, and quality of these products in India. Thus, CDSCO plays a crucial role in protecting public health and patient safety as well as improved patient outcome.
The Drug Controller General of India is the governing body of CDSCO. The CDSCO has two arms: Center Licensing Authority and State Licensing Authority. These arms are vested with different levels of power. Therefore, CDSCO ensures that all medical devices, drugs, and cosmetics in India are safe, effective, and of the highest quality.
What is the role of CDSCO?
CDSCO is India’s national regulatory authority for drugs, medical devices, and cosmetics. It ensures their safety, efficacy, and quality before they reach patients.
1. Drug regulation
- Drug manufacturing license: CDSCO grants drug manufacturing license.
- New drug approval: Reviews safety, efficacy, and quality before granting marketing authorization.
- Clinical trials oversight: Approves trial protocols and monitors ethical conduct.
- Pharmacovigilance: Tracks adverse drug reactions and enforces corrective actions.
2. Medical device regulation
- Manufacturing: Regulates and grants licenses for manufacturing medical devices in India.
- Import: Ensures imported devices meet Indian and global standards.
- Performance and safety compliance: Mandates adherence to ISO and BIS standards.
3. Cosmetics regulation
- Legal basis: Governed under the Drugs & Cosmetics Act, 1940 and Cosmetics Rules, 2020.
- Cosmetics manufacturing licensing: Issued by State Licensing Authorities under CDSCO’s framework.
- Import licensing: CDSCO acts as the Central Licensing Authority, granting Import Registration Certificates.
- Labeling and safety: Enforces rules on cosmetics labeling (MRP, manufacturer details, ingredients) and bans unsafe cosmetics.
4. Import and export control
- Issues CDSCO import licenses for drugs, medical devices, and cosmetics entering India.
- Aligns with international harmonization (ASEAN, EU guidelines) to facilitate exports.
5. Advisory and enforcement
- Provides guidance to state drug controllers for uniform enforcement.
- Can suspend licenses, ban unsafe products, or mandate recalls.
What are the divisions of CDSCO?
For a detailed understanding of what is CDSCO, let us dive into the divisions of CDSCO. The CDSCO is structured into specialized divisions that handle drugs, devices, cosmetics. Each division ensures comprehensive regulatory oversight.
- New drugs and clinical trials division: Evaluates and approves new drug applications.Supervises clinical trials to ensure ethical conduct, patient safety, and scientific validity.
- Biological products division: Regulates vaccines, blood products, sera, and other biologicals.
- Medical devices and diagnostics division: Oversees approval, registration, and quality control of medical devices.
- Cosmetics regulation division: Controls import, manufacture, marketing, and safety compliance of cosmetics. Issues Import Registration Certificates for foreign cosmetic products.
- Bioavailability and bioequivalence (BA/BE) studies division: Ensures generic medicines meet bioavailability and bioequivalence standards.
- Import and registration division: Manages licensing and registration of imported drugs, devices, and cosmetics.Ensures imported products meet Indian and global quality standards.
- Policy and advisory coordination division (DCC & DTAB): Works with the Drugs Consultative Committee (DCC) and Drugs Technical Advisory Board (DTAB).
- Pharmacovigilance division: Monitors adverse drug reactions (ADRs) and post-marketing safety data.
Is CDSCO registration mandatory?
Yes, CDSCO registration is mandatory to launch drugs, cosmetics, and medical devices in India.
What are the documents required for CDSCO registration?
Documents required for CDSCO medical device registration
- Cover letter
- Details and address proof of the applicant
- License application form depending on the CDSCO medical device license type
- Power of attorney (for foreign medical device manufacturer)
- Manufacturer’s address and details
- Undertaking proving the authenticity of the details submitted
- TR6 challan
- Site details
- Quality assurance certificate
- ISO 13485 certificate
- Free sale certificate (for medical device import)
- Plant master file
- Device master file
- CE design certificate
Documents required for CDSCO drug registration
- Land Registration Certificate
- Partnership Deed / Article of Association
- Owner’s ID Proof
- Technical Staff Documents
- Fire NOC
- Pollution NOC
- Layouts
- Fees Challan
- Form 25 or Form 28
Documents required for CDSCO cosmetics registration
- Premise ownership or rental agreement details
- Constitution of the firm, such as Certificate of Incorporation, partnership deed, UDYAM Aadhar, etc.
- Approved cosmetics plant layout
- CDSCO cosmetics license application form
- List of machinery and equipment required
- Details of the competent technical staff to be employed for manufacturing and testing cosmetics products. Furthermore, copies of the educational qualifications and experience certificates of the staff have to be furnished.
- Consent letter from the competent technical staff
- Compliance with good manufacturing practices and requirements for cosmetics manufacturing facility
- List of cosmetics products along with their composition formulas
- Trademark Registration Certificate for the brand name
- An undertaking for compliance with the Cosmetic Rules
- Fee payment receipt
- Fire NOC
- Pollution NOC
What is CDSCO license application process?
- Login/signup: Login or signup into the CDSCO official online portal, SUGAM.
- Prepare essential supporting documents: The essential supporting documents need to be prepared and collated per CDSCO regulations and submitted along with the application.
- Submit application online: The applicable form needs to be submitted on the official CDSCO online registration portal, SUGAM. The necessary license application fees need to be paid.
- Application review and facility inspection: The regulatory officials will review the application and verify the documents. If applicable, then the officials will inspect the facility.
- License grant: If all the criteria are satisfied, then the regulatory body will grant the applicable CDSCO license.
What is CDSCO? Importance of CDSCO registration
CDSCO regulates and controls medical devices, drugs, and cosmetics marketed in India. A CDSCO registration certificate is required to market and distribute these regulated products in India. CDSCO registration has the following benefits:
- CDSCO registration provides access to one of the largest healthcare markets in the world.
- CDSCO registration highlights the compliance of the manufacturer with Indian regulatory requirements, including Good Manufacturing Practice.
- CDSCO registration is a necessary requirement for manufacturers to participate in tenders and procurement by government and private institutions. Thus, it provides a competitive advantage.
- CDSCO registration improves the credibility of the manufacturer. It provides brand recognition. Products registered with CDSCO indicate that rigorous quality, safety, and efficacy standards have been met.
In this blog, we have tried to cover everything you should know on what is CDSCO. If there are any further queries, email at [email protected] or call/Whatsapp on 9996859227. Also, we provide comprehensive CDSCO licensing service for drugs, medical devices, and cosmetics.
Common FAQs on what is CDSCO
What is the cost of CDSCO registration?
The CDSCO registration cost will depend on the type of license you are applying for. For exact details on CDSCO registration cost, feel free to contact us.
What is the name of the online portal for CDSCO?
SUGAM is the official online portal for CDSCO. Applicants can directly apply for the CDSCO license on this portal as well as submit all the necessary documents. Additionally, SUGAM handles all queries.
Is CDSCO a government or private organization?
CDSCO is a government organization under the Directorate General of Health Services, Ministry of Health & Family Welfare, Government of India.
What is the difference between CDSCO & DGCI?
CDSCO is the national regulatory authority for drugs, medical devices, and cosmetics. Drug Controller General (DGCI) heads the CDSCO and is the chief regulator who leads and oversees the operation.
Who can apply for CDSCO license?
Domestic manufacturers, importers, foreign manufacturers, and authorized agents can apply for CDSCO license.
How long is a CDSCO license valid?
CDSCO license is valid indefinity. However, a license retention fee has to be paid every 5 years.
