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- Product name, producer/importer name, complete address, and country of origin should be stated clearly as per Central Drugs Standard Control Organization norms.
- CDSCO license number for either manufacturing or importation should be easily readable on the label.
- Batch/lot no., Mfg. date, and Expiration date or Use before date must be included.
- Storage conditions, handling instructions, and legally required warning notices should be specified.
- The packaging must provide for the safety and protection of the article from damage or contamination and cannot be deceptive in nature.
Introduction
CDSCO Labeling and Packaging Rules requirements intend to ensure the safety, quality, and traceability of drugs and medical gadgets sold across the Indian market. These guidelines have been provided by CDSCO in order to ensure the proper contents on which the mandatory declarations have to be made on the package, while the packaging should be according to specifications, along with general safety information provided for consumers. This will help in preventing misuse and will ensure safe storage.
What is CDSCO License?
The Central Drugs Standard Control Organization (CDSCO) provides a CDSCO License, which provides a regulatory stamp of approval for a company to manufacture, import, sell and distribute medicinal products, medical devices and diagnostic kits across the country of India.Obtaining a CDSCO License demonstrates that a company’s Products meet all current applicable regulations established in accordance with the Drug and Cosmetics Act (1940) and Medical Device Rules (2017) along with other appropriate legislation. Upon receiving this CDSCO License a company has met all legally required minimum standards for safety; quality; performance; labeling and packaging; thus becoming legally recognized within India.
Key Points:
- A CDSCO License is a legal authorization given by the Central Drugs Standard Control Organization to control the use of drugs, devices, and diagnostic kits in India.
- It is mandatory for manufacturing, importing, sale, and distribution of controlled healthcare products.
- It also complies with the Drugs and Cosmetics Act, 1940 and the Medical Device Rules, 2017.
- It verifies the satisfaction of the necessary safety, quality, and performance criteria by the products.
- In India, it is not possible to launch any healthcare product in the market .
Why is CDSCO Certification Mandatory
This is one document that is required while the manufacturing process, sale process, distribution process, or import process of the medicinal products, the medical device, or the diagnostic kit happens in the Indian market. The document is issued by the Central Drugs Standard Control Organization to have adherence to The Drugs & Cosmetics Act 1940 & The Medical Devices Rules 2017. The document is very important for the safety and welfare of the general population because it will make sure that all the medical devices are meeting the necessary requirements concerning the safety and performances. On the other hand, the document is very important for the purposes of making sure that all the medical devices are under control. It is important to note that if a CDSCO document is not acquired for the respective medical products, no such products will be allowed entry into the Indian market.
Key Reasons:
- The certification by CDSCO is essential to guarantee that the drugs, as well as other medical devices, adhere to certain standards of safety, quality, and performance.
- It safeguards the health of the population by banning the traded health care products with potential defects.
- It is made compulsory by law under Drugs and Cosmetics Act, 1940, and Medical Device Rules, 2017.
- It allows regulatory monitoring, tracing, and efficient management of markets in India.
- It is a pre-requisite to have approval from CDSCO for manufacturing, importation, selling, and distribution of products in India according to the Central Drugs Standard Control Organization.
Importance and Benefits of CDSCO Certification
| Importance | Benefits |
| Makes sure drugs and devices meet the required standards of safety, quality, and performance. | Facilitates the legal manufacture, import, sale, distribution of products within the Indian market. |
| It safeguards public health in terms of controlling the entry of healthcare products in the Indian market. | Increases Product Credibility and Consumer/Healthcare Provider Trust. |
| Being a mandatory legal requirement under Indian regulatory laws. | Enhances market entry and entrepreneurial development in India. |
| Facilitates appropriate traceability and surveillance of the product. | Facilitates hassle-free customs clearing of imported medicines as well as devices. |
| It protects against the proliferation of counterfeit, harmful, and poor quality goods in the country monitored by the Central Drugs Standard Control Organization. | Improves the corporate image by ensuring adherence to regulatory standards. |
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 a trusted compliance consultancy that provides end-to-end support for regulatory approvals in India. The company has deep roots in CDSCO, BIS, and other statutory certifications to help organizations/Dk through the complex regulatory processes efficiently and effectively. The Diligence model is a relationship-based business model that incorporates transparency in the process, timely delivery, and customized support. The Diligence Certification ensures that the customers have a trusted partner that is dedicated to quality, regulatory requirements, and successful long-term business. Diligence Certification ensures that customers have a trusted partner.
Conclusion
Hiring a professional consultation service will ensure a smooth process for complying with regulations in India. The professional advice will not only help in documenting and submitting applications on time, and it will also make sure that all standards for filing applications are met in order to avoid any rejection or delay.. The consultancy services will take a company through a rigorous and complex process of obtaining approvals to enable it to concentrate on market entry and development.
Frequently Asked Questions (FAQs)
What is CDSCO?
The CDSCO is Central Drugs Standard Control Organization.
Is the CDSCO certification mandatory in India?
Yes, the CDSCO certification is required for any manufacturing, importation, or sale .
What are the products for which the CDSCO?
The following products need approval from CDSCO to market them: drugs, medical devices, In Vitro Diagnostic kits, Cosmetics, and Other Devices
How many working days are required for license approval from CDSCO?
Approximately 20 to 30 working days are required for getting license approval.
What is the validation of the CDSCO license?
Most CDSCO Licenses have validity for two years or less.
Are CDSCO licenses renewable?
Yes, the CDSCO license also requires renewal to prevent suspension or withdrawal.
Is product testing a requirement for CDSCO Certification?
Yes, product testing from NABL accredited and BIS recognized labs is generally necessary.
Is there certification from CDSCO for foreign manufacturers?
Yes, foreign companies are able to use the Authorized Indian Representative (AIR) option.
What if it is not obtained from CDSCO?
In the Indian government, any article that does not have the clearance of the CDSCO cannot be sold or even imported.
Is the requirement for label compliance mandatory under CDSCO?
Yes, the CDSCO imposes highly strict conditions for the labeling of products.
