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- The application of AI to enable expedited approval processes for regulatory submissions and review of Impact of AI And Digital Health in the form of electronic solution
- More defined and formalised regulations have been put into place for AI technologies that are used as medical devices (SaMD).
- Enhanced methods of surveillance and monitoring of digital health post market through the collection, aggregation and dissemination of digital health data on a timely basis.
- Increased attention to enhance regulations regarding data protection, cyber security, and patients’ safety.
- Promotion of innovation through alignment of CDSCO regulations with International Standards on Digital Health.
Introduction
The presence of AI and Digital Health within the regulations by CDSCO is a major turning point for India’s regulations. With an ever-increasing use of AI, software medical devices, and Digital Health platforms, changes in Impact of AI And Digital Health ensure alignment and adherence by innovators through appropriate approval, risk classification, and post-market surveillance requirements related to Impact of AI And Digital Health platforms used in India.
What is CDSCO License?
The CDSCO License, as issued by CDSCO on behalf of the Indian Government to manufacturers, provides authorization to manufacture, import or distribute pharmaceutical products e.g. drug devices etc. (in addition to Cosmetic Products) within India. The authority associated with the Central Drugs Standard Control Organization CDSCO License originates from both the provisions of the Drugs and Cosmetics Act of 1940 and the Medical Devices Regulations of 2017. Manufacturers with a CDSCO License have protections against counterfeit goods while providing consumers with the level of assurance that the products they purchase meet specific requirements for safety, quality, and effectiveness. Given these factors, any product not manufactured under a CDSCO License cannot be marketed in India’s Healthcare Industry legally.
Key Points:
- Published by: The Central Drugs Standard Control Organization, to standardize drugs, medical equipment, and cosmetics sold in India
- Mandatory approval pertaining to the production, importation, sale, or distribution of controlled healthcare goods
- It provides for safety, quality, and performance requirements.
- Drug & Cosmetics Act, 1940 & Medical Device Rules, 2017 Licensed
- Enables the market access of enterprises while safeguarding public health
Why is CDSCO Certification Mandatory
India requires CDSCO certification for all drug, device and cosmetic markets to be certain they comply with safety, quality and effectiveness in accordance to established guidelines once they reach the consumer marketplace. The certification process should prevent the distribution or sale of products that may be unsafe or below acceptable quality standards, and confirm regulatory compliance with the Drugs and Cosmetics Act of 1940. The certification creates an additional layer of protection for public health, establishes confidence in the products being produced or imported into the Indian healthcare system.
Key Reasons:
- Provides safety, quality, and efficacy assurances regarding drugs, medical devices, and cosmetics
- It prevents the spread of low-quality, unsafe, or unapproved products within the market
- Mandatory legal compliance under Drugs & Cosmetics Act, 1940
- Ensuring Public Health And Patient Safety In India
- Enhance Market Trust & Credibility for the Manufacturers & Importers
Importance and Benefits of CDSCO Certification
| Importance | Benefits |
| Obligatory legal requirement under the Central Drugs Standard Control Organization in India | Assures it meets high standards of safety, quality, and effectiveness of healthcare products |
| Validates that products meet approved standards for safety, quality, and performance | Allows manufacturing, importing, and selling to be done legally in India |
| Protects against the manufacturing, importation, and sale of unsafe and substandard healthcare goods | Creates trust and confidence in consumers as well as healthcare professionals |
| Ensures the protection of public health as well as patient safety in the Indian market. | Lowers regulatory risks, penalties, and product recalls |
| Adds to credibility, trustworthiness, and market acceptability of the regulated product | Makes it easier to enter the market and have sustained business growth under the regulations of 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
It has opted for the services of Diligence Certifications owing to the competence they possess in the area of regulatory compliance & overall certification solutions. They ensure that the risks associated with compliance are mitigated to the best extent, along with the facilitation of seamless market entry in India.
Conclusion
Consultation would ensure that we have the appropriate expertise for regulation requirements, appropriateness for the product, and appropriate documentation from the outset. This would ensure that we get appropriate approaches for avoiding mistakes, delays, and areas concerning compliance for good certification processes.
Frequently Asked Questions (FAQs)
Can You Explain CDSCO?
Central Drugs Standard Control Organization is India’s national regulatory authority that regulates drugs, medical devices, cosmetics, and diagnostics. It is entrusted with the duty of ensuring public safety in terms of drug standards.
What products need certification with CDSCO?
All drugs, medical devices, including the category of IVD devices, cosmetics, and some forms of AI medical products, must get approval from the CDSCO prior to their launch in the Indian market.
Must the imported products bear the necessary certification by CDSCO?
Import drugs, medical devices, and cosmetics are required to obtain registration from CDSCO. An Authorized Indian Representative, hereinafter referred to as an AIR, has to be appointed to legally sell products in the country.
How does AI and Digital Health impact CDSCO regulations?
CDSCO has laid out more defined instructions for AI, powered medical devices and digital health products, emphasizing aspects such as risk classification, cybersecurity, data protection, and post market surveillance.
What is the validity of a CDSCO license?
In most cases, a CDSCO license or registration certificate is valid for a period of two years, contingent upon compliance with regulatory requirements and renewal being done on time.
To what extent is the CDSCO process time-consuming?
The period takes approximately 20 to 30 working days. This may vary according to various categories of products, testing, and clarification of certain regulatory queries.
What if the item is marketed lacking approval from CDSCO?
Unauthorised sale of such products may result in penalties, seizure of such products, cancellation of the license, or lawsuits in accordance with the Drugs & Cosmetics Act, 1940.
IS PRODUCT TESTING COMPULSORY FOR CDSCO CERTIFICATION?
Well, being able to test your product from NABL-accredited or BIS-recognized labs may be mandatory in many cases to ascertain the safety, quality, and performance
Can CDSCO licenses be renewed?
CDSCO licenses are definitely eligible for renewal. The renewals are done through the submission of updated documents, test reports (if required), and payment of the government fees, and this must be before the expiry of the license.
Why is professional consultation important for CDSCO certification?
Professional consultation is of great help, particularly in the areas of proper classification of the product, preparation of accurate documents, obtaining approvals quickly, and lessening the risk of compliance, thus, giving a smooth certification process.
