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- Online submission: Submit the application through the CDSCO SUGAM portal with the prescribed form (as per the product).
- Document filing: It includes the uploading of necessary documents like Device/m-License; Device/Drug Details; Free Sale Certificate; and technical documents.
- Fee payment: The online government fee as per the notified CDSCO schedule must be paid.
- Review & query resolution: Application is reviewed by CDSCO; respond promptly to queries or deficiencies that may have arisen.
- Grant ofRegistration Certificate: On approval, theRegistration Certificate is issued that allows legal production/import as well as sale in India.
Introduction | CDSCO License
The CDSCO License/Registration Certificate is an officially recognized approval granted by the Central Drugs Standard Control Organization that the manufacturer, importation, sale, or distribution of drugs, medical devices, and cosmetics can be carried out in India. It allows the product that the document regulates to conform to the standards of safety, quality, and performance of the Indian market. It is one of the essential documents that must be owned by any business entity that deals with the industry of pharmaceuticals and medical devices in India.
What is CDSCO License?
A CDSCO License is a regulatory approval from the Central Drugs Standard Control Organization which permits manufacturing, importing, or selling any drug, device, and cosmetic in India. This license is issued to ensure that these products meet set standards with regard to safety, quality, and efficacy as laid down in Indian laws. Holding a valid CDSCO License is mandatory for companies to legally place regulated healthcare products in the Indian market and helps protect public health and consumer interests.
Key Points:
- A CDSCO License is an approval granted by the Central Drugs Standard Control Organization.
- It enables the production, import, sale, and distribution of drugs, medical devices, and cosmetics in India.
- It provides for conformity to Indian norms regarding safety, quality, and performance.
- It is compulsory for the company to market the regulated health care products.
- This license is significant because it enables the company to protect public health by building trust between it and the relevant regulatory bodies and consumers.
Why is CDSCO Certification Mandatory
It is the case that any sale of pharmaceuticals, medical devices, and cosmetics in the Indian territory requires a mandatory certification from the CDSCO. Primarily, this is a legal document required by the Central Drugs Standard Control Organization to safeguard the health of the people by ensuring the specifications of the drug. This will ensure the prevention of substandard products and allow their entrance to the market while maintaining regulatory compliance for a business operating in India.
Key Reasons:
- It guarantees that pharmaceuticals, medical devices, and cosmetics meet standards of safety, quality, and performance.
- It is a legal mandate for the manufacture, import, as well as the sale of various regulated products in India.
- It ensures public health by not allowing danger or sub-standard products into circulation.
- It allows regulatory control, inspection, and tracing of authorized products.
- This generates trust and market credibility and adherence to Indian regulatory requirements with the Central Drugs Standard Control Organization.
Importance and Benefits of CDSCO Certification
| Importance | Benefits |
| It ensures there is adherence to the prescribed standards for safety, quality, and performance for the regulated products. | It ensures the safety, quality, and performance of products according to Indian norms. |
| Thus, the manufacture, importation, sale, and distribution of drugs, medical devices, and cosmetics are compulsorily required by law in India. | Allows manufacturing, importing, and selling of drugs, medical devices, and cosmetics in India. |
| It ensures the protection of public health in such a way that unsafe, counterfeit, or substandard products do not reach the customer. | Improves consumer confidence and credibility with regulatory authorities, health professionals, and consumers. |
| It allows effective regulatory oversight, inspection, and product traceability by authorities. | Reduces the risk of penalties from regulators, product recall, and lawsuits due to non-compliance. |
| It enhances business credibility and market acceptance in the context of the Central Drugs Standard Control Organization framework. | Enhances market entry and business expansion within the environment provided by the Central Drugs Standard Control Organization. |
Step-by-Step Process of CDSCO Certification
Step1:Documentation
- Define product category (drug, medical device, cosmetic, IVD)
- Technical dossier and product information preparation
- Obtain company registration documents and manufacturing/import licenses
- Compliance with CDSCO documentation requirements
Step2:Product Testing
- Send product samples to NABL-accredited/BIS-recognized
- Perform safety, performance, and quality tests
- Collect valid test reports
- Ensure adherence to CDSCO requirements
Step3:Application Submission
- Register yourself on the CDSCO SUGAM portal
- Submissions of Applications by CDSCO
- As mentioned in various
- All necessary documents and test reports have been uploaded
- Pay the mandated CDSCO government fees
Step4:Scrutiny and Inspection
- CDSCO evaluates submitted documentation
- Technical assessment: Product details
- Manufacturing site inspection can be performed
- Queries/ Clarifications raised, if any
Step5:Grant of License
- Application approved by Central Drugs Standard Control Organization
- CDSCO License / Registration Certificate issued
- Approved product for manufacturing/import and sale in India
- Validity of the license renewable as per regulatory terms
Documents Required for CDSCO Certification
| Category | Documents Required |
| Business Documents | Business license/registration, ISO certificate, organizational details |
| Manufacturer Details | Factory layout, process flow chart, machinery list, production details |
| Product Documents | Product specifications, component list, user manual, model details |
| Testing Documents | Test report from BIS-recognized lab, sample details, test request form |
| Legal & Compliance | Authorization letter, brand ownership proof, trademark certificate (if any) |
| Import/Foreign Manufacturer (If applicable) | AIR (Authorized Indian Representative) details, contract agreement, overseas manufacturer documents |
Timelines, Costs, Validity & Renewal
- Timelines: Processing of CDSCO certification typically consumes 20-30 working days, of which 7-15 days are required for product testing, subject to the nature of the product and resolution of inquiries.
- Expenses: Fees charged by the government differ according to product types, whether it be a drug, medical device, cosmetic, or import product. Other costs can also be incurred depending on inspection, retesting, or changing documentation.
- Validity:In most cases, a CDSCO license/registration certificate is issued with a validity period of 2 years, depending on several regulatory conditions.
- Renewal: The process of renewing a license has to be carried out before its expiry date to prevent a suspension or lapse in the license.
- Renewal Requirements:A set of updated documents, formatted test reports (if needed), and the payment of predetermined fees are the necessities for successful renewal under the Central Drugs Standard Control Organization.
Why Choose Diligence Certifications
Diligence Certifications is an expert regulatory compliance consulting firm offering end-to-end support for the necessary certifications with the CDSCO and BIS organizations in India. Diligence Certification offers documentation support, testing coordination, application filing, and approval handling that facilitates a smooth certification procedure for the respective businesses in India.
Conclusion
CDSCO Certification is an essential regulatory mandate for the safe, quality, and compliance of pharmaceuticals, medical devices, as well as cosmetics in the Indian market. By adhering to the set procedure, providing the right documentation, as well as the required standards of testing and regulation, the desired legal entry into the Indian healthcare industry along with the development of its credibility may be assured.
Frequently Asked Questions (FAQs)
What’s CDSCO?
The Central Drugs Standard Control Organization is the Indian regulatory body dealing with regulation of drugs, medical devices, cosmetics, and diagnostical products.
Who needs a CDSCO License?
In India, it is required for drug, device, cosmetics, and in vitro diagnostic manufacturers, importers, distributors, and sellers to obtain a CDSCO license/registration number.
Do imports need to be certified by CDSCO?
CDSCO certification is required when importing regulated products into India. Also, importers need to appoint their Authorized Indian Representative.
For how long does it take for the CDSCO approval?
The process normally takes 20-30 working days depending on the products and the tests involved.
What is the validity of a CDSCO License?
In most cases, the license or registration certificate issued by CDSCO is valid for a period of 2 years, subject to regulatory conditions.
Whether renewal of a CDSCO License is possible?
Yes, renewal is to be applied for before the expiry along with updated documents, test reports in case of requirements, and prescribed fees.
Is product testing a mandatory requirement for certification by CDSCO?
Product testing for many categories, specially for medical devices and drugs, has to be performed in laboratories accredited by NABL or recognized by BIS.
What will happen in the event that CDSCO certification is not acquired?
Without the approval of CDSCO, importing or sale of any of the above-listed products can lead to penalties, product seizure, withdrawal of licenses, and lawsuits.
Can a single CDSCO license apply to more than one product?
It can depend on the type and regulations surrounding it, such that a license may apply to one specific product whereas others may apply to its variants or models.
Are all cosmetic products sold in India required to be certified by CDSCO?
Yes, cosmetic products to be manufactured and then exported to India are required to abide by many conditions laid down by CDSCO and then get registered to be allowed to be sold in India.
