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- Regulatory Authority: This has been made possible through an authorized power from the Central Drugs Standard Control Organization (CDSCO), under the Drugs & Cosmetics Act of 1940.
- Product Categorization: The products are classified in relation to whether they are Ayurvedic & Herbal products, Proprietary medicines, or Cosmetic products.
- ”Safety & Composition Review: The reviewers examine the components, then the composition, then the status concerning listed herbal constituents.”
- Manufacturing Compliance: The manufacturing companies are expected to be compliant with GMP guidelines. They require a license of AYUSH, if applicable.
- Market Authorization The product would be allowed to be made, imported, commercialized, and then sold inside India.
Introduction
CDSCO Approval for Ayurvedic and Herbal Products is an governmental requirement to guarantee that the concerned product adheres to the safety, quality, and legal requirements of India to be sold within the Indian market. The CDSCO Approval for Ayurvedic and Herbal Products assessment, as per the Central Drugs Standard Control Organization and the Drugs & Cosmetics Act 1940, aims to confirm the constituents and allowable constituents of the product as well as its manufacturing process and labeling. The CDSCO Approval for Ayurvedic and Herbal Products aims to guarantee the safe and legal manufacturing and distribution of Ayurvedic and Herbal Products within India.
What is CDSCO License?
CDSCO License is the approval letter issued by CDSCO that permits the manufacture, importation of goods and services such as drugs and devices, and sales and distribution of health products such as cosmetics in India.This ensures that the licensed products satisfy the Drugs & Cosmetics Act, 1940, and its regulations, in respect to the fundamental parameters of a drug, which include its safety, quality, and effectiveness. The possession of a valid CDSCO license is imperative if any company intends to operate in the Indian market of pharmaceuticals, medical devices, and other regulated health care products.
Key Points:
- Licensing by Regulatory Authority: A license by CDSCO is given by the “Central Drugs Standard Control Organization,” and this is done as per the “Drugs and Cosmetics Act, 1940.”
- Legal Requirements:It is mandatory to acquire this license before engaging in the production, import, sale, or distribution of drugs, devices, cosmetics, and notified products in the territory of India.
- Safety and Quality Assurance: This department ensures that the final product or the goods produced meet the standards in respect to the aspect of safety and quality.
- Compliance Verification: This includes document verification, process verification, and labeling regulations.
- Market Authorization: Allows the permission at law for placing approved products in the Indian market and further keeping them compliant with the regulatory aspects.
Why is CDSCO Certification Mandatory
Acquisition of the CDSCO is quite necessary to ensure that drugs, medical devices, cosmetics, and notified health products sold in the Indian market would establish prescribed standards with regard to safety, quality, and efficacy. Issued by the Central Drugs Standard Control Organization (CDSCO) under the Drugs & Cosmetics Act, 1940, this certification helps in avoiding the circulation of unsafe or substandard products, for compliance with regulatory requirements, protection of public health, and granting of legal permission for manufacture, import, and sale in the Indian market..
Key Reasons:
- It protects the public health by ensuring that a drug, device, or cosmetic is meeting certain standards of safety, quality, and efficacy.
- Statutory Requirement: Bound under the Drugs & Cosmetics Act, 1940, and implemented by the Central Drugs Standard Control Organization
- Averts Unsafe Products: Regulates the flow of substandard, counterfeit, and non-compliant products in India.
- Authorizes Market Entry: This authorizes manufacturing, importation, sale, and distribution into the Indian Market.
- Strengthens Customer Trust and Confidence: Provides assurance of regulatory conformity and reliability of products.
Importance and Benefits of CDSCO Certification
| Importance | Benefits |
| It Safeguards Consumer Safety by ensuring that medications, devices, and cosmetics are secure as well as of high quality as per acceptable standards. | Ensuring the Safety of the Product : The objective of the provision is to make sure “drug products,” “medical devices,” and “cosmetics” are authorized as far as “safety and quality.” |
| Statutory Requirement: It is a mandate under the Drugs and Cosmetics Act, 1940, as regulated by the Central Drugs Standard Control Organization (CDSCO). | Legal Market Access: Facilitates the legal production, import, sale, and distribution of products in India. |
| Protects Consumer from Substandard Products: It acts as a shield for Indian consumers against substandard or unsafe, counterfeit, or non compliant products. | Regulation and Compliance: Helps the company in complying with the Drugs & Cosmetics Act, 1940, as per the Central Drugs Standard Control Organization. |
| Legal Market Authorization: Refers to the legal approval to manufacture, import, and distribute specific products. | Enhancing Credibility of the Brand: Builds trust between the company and customers, healthcare associates, and regulatory authorities. |
| Improves Market Authenticity: Causes consumers, physicians, and the government to trust them. | Legal Risk Reduction: This is a relaxation of the rules surrounding recall, enforcement as well as failing to comply with the law. |
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 reliable regulatory consultancy that offers complete support for CDSCO, BIS, AYUSH, and other regulatory requirements in India. On the other hand, expert professional services may be accessed by Diligence Certifications for faster approvals, avoiding risks associated with compliance, and achieving full compliance for seamless market entry into India.
Conclusion
Certification by the concerned regulator helps in ensuring the safety of the product, its compliance with laws, as well as smooth entry into the India market.On the achievement of correct documentation, proper guidance, and compliance by the concerned companies, it will not only reduce the issue of delayed approvals, but the concerned companies will gain market credibility.
Frequently Asked Questions (FAQs)
Is the approval of CDSCO required in any Ayurvedic or herbal product?
Yes, the CDSCO approval is required if the Ayurvedic & Herbal product is linked to the categories of Drugs, Proprietary Medicines, Cosmetic, and Notified Health Products under the Drugs and Cosmetics Act, 1940.
Which body gives approval for the sale of their product in the country, in the case of India?
Approval of CDSCO is provided by CDSCO. CDSCO is abbreviated as Central Drugs Standard Control Organization. Central Drugs Standard Control Organization is the governing authority of drugs and cosmetics in the country named India.
AYUSH approval v/s CDSCO approval : How are these two different from each other?
The approval of the AYUSH has been known to be associated with the traditional Ayurvedic medications, whereas the approval of the CDSCO is required for the establishment of regulatory control over medications, proprietary herbal substances, and health supplements.
Is it necessary that any Ayurvedic imports and herbal imports require approval from CDSCO?
Yes, for the product to be marketed inside India, the export herb/premium product must obtain CDSCO Registration and must have an Authorized Indian Representative..
What documents does one need to provide for the CDSCO certification?
The key documents include business registration, product composition details, manufacturing licenses, GMP compliance, test reports, labeling information, and authorization letters.
Is product testing mandatory for approval through CDSCO?
Yes, product testing is required. Samples have to be tested in NABL-accredited or BIS-recognized laboratories to ensure safety, quality, and conformity.
How many days will it take to get approval from CDSCO?
The average time for the approval process to be completed is 20 to 30 working days, depending on the category of the product.
How long is the validity period of a CDSCO license?
The license by CDSCO can remain valid for a period of up to 2 years.
Can CDSCO approval renewed after expiration?
CDSCO approval is renewable, but it requires a renewal application prior to the expiration date to prevent the halting or withdrawal of approval.
What if the product is sold without the approval of CDSCO?
Selling such products without CDSCO approval will lead to punishment in terms of seizing products, canceling licenses, legal proceedings, etc., as per Indian law.
