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- This is required by law in order to obtain a license from Central Drugs Standard Control Organization in India in order to manufacture drugs.
- The license is issued under the Drugs and Cosmetics Act, 1940 & Rules, 1945.
- Other than the mentioned, the units should comply with the Schedule M and the principles of Good Manufacturing Practices (GMP).
- This is undertaken by the CDSCO before the approval is finalized.
- The license ensures that the drugs produced satisfy the required standards concerning issues of safety, efficacy, and quality.
Introduction| Drug Manufacturer
The CDSCO License for Drug Manufacturer is an obligatory government license, which is mandatory by law for eligibility for the manufacture of drugs in India. The license for the manufacture of drugs is issued by the Central Drugs Standards Control Organization in India, under the auspices of the Drug and Cosmetics Act, 1940, which approves that the units of the drug manufacturer comply with the prescribed standards with regards to quality, safety, and efficiency. Additionally, this license approves that the unit for the drug manufacturer also complied with the prescribed standards with regards to Good Manufacturing Practices, qualified personnel, and quality control standards.
What is CDSCO License?| Drug Manufacturer
CDSCO License for Drug Manufacturer Official license issued by the Central Drugs Standard Control Organization (CDSCO), which allows the manufacturing companies, importers, sellers, as well as the distributors of a certain organization, to manufacture and distribute drugs/devices, cosmetics, as well as perform clinical trials in the Indian market. A license, having been accorded under the Drugs & Cosmetics Act, 1940, ensures that the medication meets certain standards in relation to safety, quality, and efficacy prior to being allowed in the market.
Key Points:
- This is released by the CDSCO License for Drug Manufacturer of India to control drugs and medical devices.
- No person or firm shall be exempted from this by not doing or performing any of the following acts: Manufacturing, Importing, Selling or
- The license ensures that the requirements stipulated under the Drugs & Cosmetics Act, 1940, are complied with.
- It ensures that products meet the necessary levels of safety, quality, and effectiveness.
- Inspections and approvals are carried out by the CDSCO before issuing the license.
Why is CDSCO Certification Mandatory
The certification from the CDSCO is mandatory as it helps ensure all drugs, devices, and cosmetics available in India are safe, efficient, and of standard quality. It aids in protecting public health by allowing access to only such goods that are in compliance with the provisions under the Drugs and Cosmetics Act, 1940. Moreover, the certification issued by CDSCO helps to ensure that the manufacturer follows Good Manufacturing Practices and maintains a proper quality control system. In addition, because it assists in regulating manufacturing, import, and distribution of such goods, it helps prevent substandard hazardous and/or counterfeit products.
Key Reasons:
- This is released by the Central Drugs Standard Control Organization of India to control drugs and medical devices.
- No person or firm shall be exempted from this by not doing or performing any of the following acts: Manufacturing, Importing, Selling .
- The license ensures that the requirements stipulated under the Drugs & Cosmetics Act, 1940, are complied with.
- It ensures that products meet the necessary levels of safety, quality, and effectiveness.
- Inspections and approvals are carried out by the CDSCO before issuing the license.
Importance and Benefits of CDSCO Certification
| Importance | Benefits |
| Ensures compliance of the Drugs and Cosmetics Act, 1940. | Enhances credibility for the manufacturers as well as brands. |
| Controls the quality and safety of drugs and medical devices in India. | Permits legal manufacturing, importation, and sale of the drug in India. |
| It prevents substandard as well as unsafe products from reaching the marketplace. | Enhances the acceptance of the drug in the marketplace. |
| Verifies that the manufacturer complies with “Good Manufacturing Practices.” | Aids in export clearance and international acceptance. |
| Public health from uncontrolled production and distribution. | Reduces the risk of receiving fines and product recalls. |
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
Selecting Certifications from Diligence Certifications will enable you to have a seamless, trustworthy, and fully compliant process from application through certification acquisition at CDSCO. At Diligence Certifications, our team at Diligence Certifications brings together extensive regulatory acumen coupled with experience from years of working in the pharma and medical devices sector. We at our team at Diligence Certifications fully grasp every facet of Drugs and Cosmetics Act, 1940, CDSCO guidelines, or GMP regulations.At Diligence Certifications, we are fully committed to providing you with all the assistance needed in documentation preparation and submission and interacting with the relevant authorities to ensure you are able to concentrate on your operations.
Conclusion
The CDSCO license is a factor that remains pivotal in ensuring that the medications and equipment sold in the Indian market are safe, efficient, and of standard quality. The license helps in meeting the requirements of the regulations prescribed under the Drugs and Cosmetics Act, 1940, and helps in public health monitoring as well. At the same time, the right license helps in the manufacture, importation, and distribution of the equipment without violating any regulations whatsoever.
Frequently Asked Questions (FAQs)
What is CDSCO?
The full form of the abbreviation “CDSCO” is: Central Drugs Standard Control Organization.
Do pharmaceutical companies have to be approved by the CDSCO?
The production of drugs is allowed in India, of course.
In which law license for the CDSCO license is granted?
The law has come into effect via Drugs & Cosmetics Act, 1940 & Rules, 1945.
Which of the Following issues a License in CDSCO?
This license is granted by CDSCO, which is commonly known as Central Drugs Standard Control Organization.
What does the CDSCO license ensure?
The license guarantees drug safety, quality, and efficiency.
GMP compliance necessary for CDSCO license?
In fact, the companies must abide by Good Manufacturing Practices (GMP).
How long does CDSCO approval take?
CDSCO approval typically takes 20-30 working days, depending on the product.
Is product testing necessary?
Testing must be done in approved labs, yes
Exactly how long is this CDSCO license valid?
On average, it is valid for a maximum of 2 years
Is it possible to renew the license needed by a drug manufacturer
Yes, it has to be renewed before its expiry date for the company to carry on its operations.
