Indian pharma industry is developing at a very rapid pace, and the development demands proper regulatory compliance according to drug, medical device, and cosmetic clearance on the quality and safety aspects. Central Drugs Standard Control Organisation (CDSCO) is the central regulating body in India that sanctions and licenses cosmetics, pharma, and medical devices. Any company ready to trade in India will be forced to learn in order to get CDSCO registration.
Here we are going to take you through the minute-to-minute, step-by-step process of CDSCO registration from all the steps, procedures, and documents of CDSCO so that you are in compliance and there is no holdup. We will also address some of the most common questions later.
What is CDSCO Registration?
CDSCO registration is the obligatory process through which Indian as well as foreign drug, medical device, or cosmetic firms are entitled to market their drug, medical device, or cosmetic in India. It's a certification of the Indian quality, safety, and effectiveness of the product.
CDSCO licenses have been segregated into various classes based on classes of products, i.e.,
- Pharmaceuticals and drugs
- Medical devices
- In-vitro diagnostic equipment
- Cosmetics
Who Requires CDSCO Registration?
The following are required to register with CDSCO:
- Foreign controlled product manufacturers making exports to India
- Indian importers and distributers of healthcare commodities
- Indian domestic manufacturers making imports of new drugs or healthcare devices
- Contract manufacturers exporting to licenced companies
CDSCO Guidelines That You Should Know
For it to be easy for you to register with CDSCO, you should know the following CDSCO guidelines:
- Class classification: Medical devices are of Class A, B, C, and D based on the risk. Registration process in terms of varies.
- Import License: Product of all nations except India needs a valid CDSCO import license.
- Indian Authorized Agent (IAA) as appointment of local agent: Foreign firms need to appoint IAA as the local agent.
- Adverse to Indian Pharmacopoeia (IP) or other appropriate standards.
Step-by-Step Guide to CDSCO Registration
Step 1: Categorize Your Product
The first step is to categorize whether your product is to be registered under CDSCO or not. Not everything can be registered, i.e., devices or cosmetics, so refer to the officially mentioned list by CDSCO or consult the regulatory expert.
Step 2: Create an Indian Authorised Agent (Foreign Manufacturers)
The foreign manufacturers need to have an Indian Authorized Agent (IAA) to act on their behalf in order to deal with CDSCO and submit documents to it.
Step 3: Document Required Preparation
The documents required for preparation for CDSCO registration are:
- Application letter and c1over letter
- Power of Attorney (on behalf of the foreign manufacturer)
- Certificate of Free Sale of the export country, for CDSCO registration and India import license
- Product description and labeling of the product
- Manufacture License, ISO/CE certificates
- Test report and clinical evaluation report wherever required for CDSCO license where required
- Site Master File, Plant Master File
Step 4: Submission of application on SUGAM Portal
All the CDSCO applications are to be filed online on the SUGAM portal, the online license application government-authorised portal. You have to register yourself on the portal so that you are able to view and track your application.
Step 5: Fee Payment
Fee is model/variant number and class of product-based. Payment is done online through the portal.
Step 6: Scrutiny of CDSCO Application
CDSCO reviews the application on receipt. Clarification or further data may be requested, as required. Technical evaluation or site visit can be done for high-risk products during CDSCO approval stage.
Step 7: CDSCO License Grant
Once all the above is complied with, CDSCO license will be granted by CDSCO and can be:
- Import License (Form 10) – import
- Manufacturing License – granted by Indian manufacturers
- Test License – to test or to carry out clinical trials
CDSCO sanction will be 4–12 weeks depending upon product category and on the complexity of application.
CDSCO Import License Process
CDSCO import license needs to be obtained for foreign made products imported. The process is:
- Appointment of IAA (Indian Authorised Agent)
- Filing of Form 10 and supporting documents
- Indian product safety and product compliance
- Product import license grant for Indian market sales
CDSCO Approval Advantages
CDSCO approval guarantees a series of benefits:
- Timely compliance with Indian legal terms
- Improved credibility and reputation
- Being able to access India's all states for selling
- Improved ability to bid for government tenders and sell to institutions
- Improved competitiveness in the regulated pharma/healthcare business
Validity and Renewal
CDSCO license will normally be valid for 3 years subject to the nature of the product and the regulation.
Conclusion
It is difficult to imagine that how CDSCO registration can be done, but because you have idea about the CDSCO scheme and policies, so it is not difficult. You are Indian health exporter or startup abroad in India; there is genuine demand for the right CDSCO license so that products get successful in India.
Having a regulatory consultant by your side would make application leaps and bounds faster and reduce the chances of rejection.