India is a leading consumer for medical devices and cosmetic products. However, as these products are directly related to the health of the consumer, it is important to regulate the quality and supply of these products. This is done by the Central Drug Standard Control Organisation (CDSCO). It functions as a regulator for the medical devices and cosmetic products. Let’s obtain a detailed understanding of the CDSCO registration in India.
What is CDSCO Registration?
CDSCO registration certificate is important for businesses dealing with medical devices, pharmaceuticals, cosmetics and diagnostics. The CDSCO lays down the standards for these products. Whether you are a manufacturer, importer or exporter of these products, you need to apply for CDSCO registration online through the portal.
Types of CDSCO Registration Certificate
Based on the nature of your business, there are different types of CDSCO registration you can apply for. This includes:
- New Drug Approval: New drug approval is required in the case of products that are not previously marketed in India. This requires a comprehensive submission of clinical data to establish the efficacy and safety of the drug.
- Import License: An import license is important for importing pharmaceuticals, cosmetics or medical devices for commercial purposes.
- Manufacturing License: A manufacturing license is important for producing medical devices, pharmaceuticals and cosmetic products in India. The manufacturing license can be obtained by both the domestic manufacturers as well as foreign manufacturers.
- CDSCO Registration for Medical Devices: CDSCO Registration for Medical devices (Drug License) is important in the case of the manufacturing, sale or import of medical devices in India. This involves devices across different risk-based categories like class A, B, C and D.
- Cosmetic Registration: Cosmetic registration is required for cosmetic products like makeup products, skincare products, personal hygiene products etc.
- Clinical Trial Approval: Persons who are conducting clinical trials on medical devices, health care products or drugs in India shall obtain the clinical trial approval from CDSCO.
- Export License: Persons who are engaged in the export of medical devices, pharmaceutical products, diagnostic products and cosmetics shall obtain an export license and ensure that the products meet international regulations and standards.
Why CDSCO Registration?
The CDSCO license is not only important but also beneficial for businesses operating in medical and pharmaceutical sector. Here are some of the key benefits of CDSCO registration in India:
- Protection of the consumer interest as it ensures that the medical devices and products are safe and efficient
- Manages the quality of drugs and cosmetic products
- Enhances the goodwill of the manufacturer and importers in the market
- Helps in winning the trust of the consumers
- Ensures that the drugs and medical devices imported meet the prescribed quality and safety standards
- Helps the government monitor on the manufacturer and importer, having regard to the safety and health of the consumer
Who Can Apply for CDSCO Registration?
The following persons can apply for CDSCO registration in India:
- Domestic manufacturers of cosmetic products, medical devices and in-vitro diagnostic devices
- Foreign manufacturers of cosmetic products, medical devices and in-vitro diagnostic devices
- Importers of cosmetic products, medical devices and in-vitro diagnostic devices
- Authorized agent for cosmetic products, medical devices and in-vitro diagnostic devices
- The Indian subsidiary of a foreign company engaged in the business of cosmetic products, medical devices and in-vitro diagnostic devices
CDSCO Registration Process
You need to file an application for registration with CDSCO. Here’s the detailed process of CDSCO registration in India:
- The applicant needs to submit the CDSCO registration application furnishing all the relevant details and information relating to the product, quality management systems, manufacturing process, clinical data, business information etc.
- The CDSCO shall conduct a detailed review of the documents submitted and assess all the compliance with the regulatory requirements, efficacy, safety and quality.
- If the CDSCO requires any additional information or clarification, it may request for additional information or clarification from the applicant to complete the evaluation.
- After furnishing the reply, the CDSCO may approve the product if it is satisfied with the evaluation and grant the license accordingly. However, in case the application is found to be unsatisfactory or the documents are inadequate, then the application may be rejected.
Documents Required for CDSCO Registration
While furnishing the application for CDSCO registration, you need to provide the following documents along with the application:
- Identification proof of the applicant
- Address proof of the applicant
- Manufacturing license in case of manufacturing of drugs
- Import or export license in case of importer or exporter
- Undertaking issued by a government authority
- In case of BA/BE approved site registration, a copy of the BA/BE site registration as approved by the CDSCO
- Any other document as may be required
Must Check "Key registrations to start an import export business in India"
How Exim Advisory Can Help?
In case you are willing to apply for CDSCO registration, whether as an importer, exporter or manufacturer, then it is important to meet the set standards about the quality and efficacy of the products. Here’s how the Exim Advisory can help you obtain CDSCO registration, as Exim Advisors are among the top notch CDSCO Registration Consultants in India:
- Gather all the documents required for filing CDSCO registration application
- Determine the product class applicable as well as the CDSCO standards compliance
- Preparation and filing of the application for CDSCO registration applicable for your business
- Assistance in understanding the product requirements in accordance with the guidelines
- Liaising with the CDSCO authorities for resolution of queries and approval of registration
- Post registration compliances and renewal of CDSCO registration upon reaching expiry
- Assistance in obtaining any additional certifications that are mandatory for CDSCO registration like import/export license, manufacturing license etc.
Frequently Asked Questions
Q: Is CDSCO registration mandatory in India?
A: Yes. If you are a manufacturer, importer or exporter of medical devices or cosmetic products, then you are required to obtain CDSCO registration in India.
Q: What is the validity of the CDSCO license?
A: The validity of CDSCO license depends upon the type of registration being obtained.
Q: Who needs to register for CDSCO?
A: Domestic and foreign manufacturers as well as importers and exporters of medical devices and cosmetic products are required to apply for CDSCO registration.
Q: Which regulatory bodies come under the CDSCO?
A: The Drugs Controller General of India (DCGI) is the head of the department of the Central Drugs Standard Control Organisation. The DCGI is advised by the Drug Technical Advisory Board (DTAB) and the Drug Consultative Committee (DCC).