Procedure to Take CDSCO Registration in India: A Complete Guide
Since you are exporting or manufacturing pharmaceuticals, medical devices, or cosmetics from India, CDSCO registration is mandatory. CDSCO means Central Drugs Standard Control Organisation and is the central government's regulatory organization under the Ministry of Health and Family Welfare, Government of India. CDSCO has taken it as a responsibility to make Indian medical products of quality, efficiency, and safety.
This long blog is going to walk you through CDSCO registration process and the very important CDSCO guidelines, CDSCO license application, CDSCO import license application, and finally CDSCO approval.
What is CDSCO?
The drugs and cosmetics and their import, production, sale, and distribution in India are regulated by the Central Drugs Standard Control Organization (CDSCO) under the Drugs and Cosmetics Act, 1940. It ensures good quality of all the medical products for the protection of the public's health.
Compliance with CDSCO regulations and acquiring an appropriate CDSCO license is extremely essential for such companies (foreign manufacturers) that plan to bring products into the Indian market.
When Is CDSCO Registration Needed?
CDSCO registration is needed for:
- Drug or medical device importation into India
- Production of new drug or investigational new drug
- Production or importation of cosmetics
- Clinical trials
- Bioavailability and bioequivalence studies
- CDSCO import license for foreign companies
CDSCO License Classes
It is worth noting the classes of CDSCO licenses according to the class of the product prior to learning about the process:
- CDSCO License for Pharma Medicine
- For production and import of pharmaceutical medicines
- It includes new drug approval and fixed dose combinations
- CDSCO Medical Device License
- Levied on notified medical devices
- Included are Class A, B, C, and D devices
- CDSCO Cosmetic License
- For foreign as well as Indian cosmetics
- CDSCO Import License
- For import into India by foreign companies of regulated items
Step-by-Step Procedure for CDSCO Registration
Below is step by step detail regarding how to obtain CDSCO registration in India:
- Categorize the Regulatory Class
- Drug
- Medical device
- Cosmetic
- Vaccine or biological product
- Appointment of Indian Authorized Agent (IAA)
- SUGAM Portal registration
- Online submission of application
- Document upload
- Application status
- Documents Ready
- Cover letter
- Power of Attorney (POA)
- Free Sale Certificate (FSC)
- Product formula and product label
- Site master file of the site (whenever manufacturing sites are concerned)
- CE/BIS/ISO certificate (whenever medical devices are concerned)
- Clinical trial data (whenever applicable)
- Undertaking compliance with CDSCO guidelines
- SUGAM file
- Form 40: Drugs import license
- Form MD-14: Import registration of medical devices
- Form 42: Registration of cosmetic products
- Question Clarification and Elaboration
- Inspection (As Applicable)
- CDSCO License and Approvals
- Renewals in due course (as per validity of license)
- Reporting adverse events (pharmacovigilance)
- Batch record maintenance
- CDSCO notification in case of product or process change
- Indian regulation compliant labels
- Mislabeling of the products
- Inadequate or incomplete documentation
- Lack of clarity in CDSCO guidelines
- Late response to queries
- Foreign document incompatibility/foreign translation
- Original entry of product in India's market
- Establishing customers' and physicians' trust
- Safety and effectiveness of the product
- Compliance with audit and inspection
Determine your product in respective class first:
As per CDSCO guidelines and the classification list for their classification under the corresponding, i.e., low Class A medical devices to high Class D.
Foreign firms' appointment of an Indian Authorized Agent, who shall act as the agent of the firm for regulatory purposes. The agent must have a valid Wholesale Drug License (WDL) or Manufacturing License in India.
All CDSCO registration procedures are being conducted via the SUGAM portal (https://cdsco.gov.in). Candidates would need to get a user ID and upload documents online. The portal offers:
You may need to submit some documents based on the type of CDSCO license. Standard requirement is:
Login to SUGAM portal, select the corresponding form (e.g., Form MD-14, Form 41, etc.) and upload all documents. Online fee payment wherever required.
Application forms differ based on product and purpose:
Your application would be matched by CDSCO officials. Errors will be rectified by asking questions which must be responded within the time frame. Advance submission and supporting document should be provided so that there is no delay.
For certain high-risk products like Class C and D medical devices or biologics, CDSCO can carry out a direct or indirect facility audit by an in-country auditor.
Upon confirmation of all the documents as per the CDSCO guidelines, CDSCO license or CDSCO import license shall be granted. Intimation shall be given through SUGAM portal and you can take a print of the certificate.
Approbations 4 to 6 months depending upon product type and completeness of submission.
Post-Approval Compliance
CDSCO registration is ongoing process. License holder should ensure
Battleground Areas of CDSCO Registration
It is simpler to complete and avoid expensive errors by utilizing the services of an expert regulatory consultant.
A Reason Why CDSCO Approval is Necessary
CDSCO approval is necessary in order to know:
Besides that, CDSCO registration offers another credibility and ease of doing business in India to your organization.
Conclusion
CDSCO registration is not a simple process, but yes, it would be simple if proper knowledge is gained in CDSCO documents and guidelines and one goes by a systematic process. We are an Indian manufacturer or foreign manufacturer with ambitions in the Indian market, the correct CDSCO license or CDSCO import license is the beginning to abide by the law and a lucrative business in the long run.