The Central Drugs Standard Control Organization (CDSCO) is the top organization in India (governing) official body in charge of preparing, overseeing and controlling drugs, medical devices, and cosmetics. The CDSCO was established as per the advice from the Director-General of Health Services as it is the one which is in charge of road tests, they have healthy effects on the patients if not, they are introduced in India through selling all over the country.
Importance of CDSCO Registration
CDSCO registration is the main requirement for Indian companies which want to import, manufacture or distribute pharmaceutical products and medical devices in India. CDSCO registration is not done in a correct way, the companies can't legally offer their products for sale in the Indian market. The only guarantee of safety and compliance with the rules is that it is obligatory in India.
Who Can Apply for CDSCO Registration
The applicants listed below are qualified to register on the CDSCO online portal:
- Importers
- Indian Agents
- Foreign Enterprises holding Indian Subsidiary
- Corporates
Types of CDSCO Registration
1. Drug Registration:
Pharmaceutical Companies: If the Company wishes to market or manufacture drugs in India must obtain CDSCO registration. Accordingly, an application for evaluation with the necessary documents and samples is to be filed with the department.
2. Medical Device Registration:
Medical Devices: CDSCO approval is required for medical devices, such as diagnostic kits, implants, and surgical tools. The objective of this registration to ensure that the products meet regulatory requirements for safety and effectiveness.
3. Cosmetics Registration:
Cosmetics: CDSCO approval is required for Cosmetics manufacturers to ensure that their products meet safety standards before reaching the consumer.
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CDSCO Registration Process
Initial Application Submission
An application along with the requisite information/documents such as product and manufacturing details, and proof of clinical trial or research (if applicable) shall be filed.
For imported items, the applicant shall submit a Certificate of Pharmaceutical Product from the country of origin.
Review
The filed application will be reviewed by CDSCO and will ensure that the product complies with Indian regulations. It may involve scientific evaluation and technical assessments.
Approval and Certification
After thorough review and evaluation of documents, CDSCO grants approval to the product as import licenses, manufacturing licenses and sales certificates depending upon the type of product.
Post approval Compliance
After obtaining the approval, the Company has to comply with regulatory compliance along with the the conditions laid down by CDSCO such as product quality control, packaging requirements, and report adverse events/defects.
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Documents Required for Registration with CDSCO
- Application Form: A filled application with all the required details.
- ID & Address Proof Document
- Product Information: Detailed composition and manufacturing process.
- Data from clinical studies: Where new medicine or devices are concerned.
- Certificate of Pharmaceutical Product: For imported drugs.
- Good Manufacturing Practice (GMP) Certificate: For manufacturers.
- Test Reports certifying the safety and quality of the product issued by a reputable lab.
- Labeling and Packaging Information complying with Indian guidelines.
Benefits of CDSCO Registration
- Going to Market: For marketing in India, CDSCO allows a company to open its gates to one of the largest fastest developing pharmaceutical markets.
- Consumer Acceptance: Trust from consumers for products with safety standards and quality proof through its certification from CDSCO.
- Regulatory Compliance: All that the Indian drug laws and rules need is to be adhered to.
- Global Recognition: This will serve as a reference in international acceptance and will be a plus factor for the marketability of your product in the global setting as well.
How do SKMC Global Help with CDSCO Registration?
- CDSCO Registration Assistance: A comprehensive support of registration of drugs, medical devices, and cosmetics.
- Document Preparation and Submission: To ensure that all the necessary documents are prepared and submitted directly to the respective regulatory standards.
- Consultancy and Guidance: Expert recommendations on issues of compliance, approval processes, and regulatory requirement.
- Services for Compliance after Approvals: Continually support in ensuring compliance with CDSCO regulations.
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