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- Regulatory Expertise: Offers expert advice on the regulations of the CDSCO Certification Consultant
- thereby assisting clients in complete compliance with the Drugs & Cosmetics Act.
- End to End Support: It deals with the overall process of approval of the CDSCO, starting from the classification of the product to the obtaining of the approval.
- Faster Approvals: Reduces waiting time by processing queries, gaps, and deficiencies faster.
- Documentation and Liaison: It does documentation for technical files and also liaises with the CDSCO authorities on your behalf.
- Risk Reduction: Assists in evading penalties, product failures, and license revocations by conducting active checks on compliance.
Introduction
A CDSCO Certification Consultant is a regulatory expert who assists the manufacturers, importers, and marketers in receiving approval from the Central Drugs Standard Control Organization. The consultant will make sure that the drug, device, cosmetology, or any other relevant products are in compliance with the regulatory requirements for the Indian government under the Drugs & Cosmetics Act. Through a process of document handling and regulatory coordination, a CDSCO consultant can make the entire approval procedure much simpler for the manufacturers.
What is CDSCO License?
A CDSCO license, also called an Import/Export, Manufacturing, Sales, and Distribution license, is an official approving authority permit from CDSCO, which allows licensing to manufacture, import, and sell drugs, devices, and other products. This license ensures the product is compliant with the standards of safety, quality, and performance required in India under the Drugs & Cosmetics Act, 1940. It is a mandatory requirement for companies to have a CDSCO license to market the regulated healthcare product in the Indian market.
Key Points:
- Approval: It is the regulatory approval from the Central Drugs Standard Control Organization regarding the intended act of manufacturing, importing, selling, or distributing the regulated drug in India.
- Obligatory Compliance: Drugs, devices, and cosmetics, and notified healthcare products as defined under the Drugs and Cosmetics Act 1940.
- Safety and Quality Assurance: The mechanism of verifying that products intended for use fulfill the pre-determined standards of safety, quality, and performance.
- Market Authorization: This facilitates the legal entry and subsequent sale of products in the Indian market.
- Legal Protection: It tries to avoid punishment in the form of confiscation of goods and loss of license
Why is CDSCO Certification Mandatory
The CDSCO Certification Consultant is a must in order to ensure that all drugs, medical devices, and cosmetics, if marketed in India, are safe and conform to the criteria of quality and standards as determined by the Central Drugs Standard Control Organization. It safeguards public health, avoids the sale of adulterated products, and avoids prosecution and revocation of licenses as provided in the act of Drugs & Cosmetics, 1940.
Key Reasons:
- Public Health Protections: Satisfies requirements on safety, quality, and efficacy.
- Legal Requirement: It is mandatory as per Drugs & Cosmetics Act, 1940 for regulated products in India.
- Market Authorization: Enables the legal production, importation, and marketing of the product within the Indian market.
- Quality Control: safeguards against the distribution of low-quality, counterfeit, and harmful merchandise.
- Regulatory Compliance: It assists in preventing any form of punishment, product seizure, license revocation, and prosecution from the Central Drugs Standard Control Organization.
Importance and Benefits of BIS Certification
| Importance | Benefits |
| Protects Consumer Safety: The aforementioned products-including drugs, medical devices, and cosmetics-must meet the necessary safety and quality standards set by the bureau. | Legal Market Access: Facilitates the legal production, importation, and marketing of goods in the country of India. |
| Statutory Requirement: The Drugs & Cosmetics Act, 1940 stipulates its observance in India. | Guaranteed Safety and Quality This process ensures that all individuals and/or equipment involved in the program comply with applicable standards for safety, |
| Legal entry market: Necessary for manufacturing, importation, distribution, or selling of regulated products. | Regulatory Protection: Reduces risk of fines and confiscation of products as well as loss of licenses by authorities. |
| Regulatory Action Avoidance: Helps avoid penalties, product bans, license cancellation, and legal prosecution. | Increased Credibility of the Brand: The brand is considered credible because it has made use of the blockchain technology, which is linked |
| Market Trust: Builds more trust; products approved by the Central Drugs Standard Control Organization are easily acceptable. | Smoother Business Expansion: It facilitates a smooth process of approvals and expansions based on 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
Diligence Certifications is an reliable certification and regulatory consultancy for businesses seeking licenses and approvals from the CDSCO, necessary for doing business in the Indian market. Their expertise, experience, and understanding of the rules and regulations related to the CDSCO make it easier for them to avail the needed approvals without any complexity. Diligence Certifications deal with their work with honesty, transparency, and complete assistance so that their clients find it easy and convenient to enter the Indian market.
Conclusion
The CDSCO certification is a very important factor when it comes to product safety and market entry. If a company follows the right guidelines set by the CDSCO, it can avoid legal issues related to market entry, ensuring easy approval with the help of the right documentation, thus gaining the trust of consumers. Organizations should adopt the right regulatory strategies to ensure easy market entry in the Indian healthcare market.
Frequently Asked Questions (FAQs)
What is CDSCO?
It is short for Central Drugs Standard Control Organization. It serves as the national controlling organization in India and is involved in the assessment of drugs, devices, cosmetics, and many more.
What are the entities requiring CDSCO license?
Persons involved in the manufacture, import, distribution, and marketing of drugs, devices, cosmetics, and notified healthcare products are required to have a license from the CDSCO within the Indian market.
Is CDSCO Certification mandatory in India?
Yes, it is mandatory to take the certification of CDSCO under the Drugs & Cosmetics Act of 1940 after which the product can be manufactured or imported into the country.
What kinds of products does CDSCO regulate?
Drugs, medical devices, IVDs, cosmetics, and some notified healthcare products are regulated by CDSCO.
How long does it take to obtain a CDSCO license?
The usual time for processing is about 20–30 days, depending on the product category, accuracy of documentation, testing requirements, and query resolution.
What kind of files need CDSCO certification?
The list of required documentation comprises business registration documents, the license for the manufacture or import of the product, product specifications, test reports, letters of authorization, and other documents.
Is product testing compulsory for CDSCO approval?
Yes, as a generalization, it can be stated that, in most cases, there has been an emphasis on the requirement of products being tested for their safety, quality
What will be the effect on the company that doesn’t have a license from CDSCO?
Failure may result in fines, confiscation of products, suspension/cancellation of licenses, or prosecution as an offense under Indian laws.
What is the validity of a CDSCO license?
The CDSCO licensing/registration number or registration/licensing certificate is normally valid for a maximum period of 2 years.
Can a CDSCO license be renewed?
The CDSCO Yes, the CDSCO license needs to be renewed before the date of expiration by submitting the updated documents and test reports (if applicable) along with the fees as prescribed by the government.
