Central Drugs Standard Control Organization

( CMDSCO )

Central Drugs Standard Control Organization (CDSCO) is the national regulatory body in India responsible for ensuring the safety, efficacy, and quality of drugs, medical devices, and cosmetics. It operates under the Ministry of Health and Family Welfare and regulates the approval of new drugs, clinical trials, and the manufacture and sale of pharmaceuticals and medical devices. CDSCO also monitors the quality of imported drugs and ensures compliance with national standards to protect public health. It plays a critical role in maintaining the integrity of the healthcare system in India.

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Requirement Document For CMDSCO

Benefits of CMDSCO

1. Legal Compliance:

It is mandatory under Indian law for anyone involved in the manufacture, sale, or distribution of drugs. Operating without a valid license is illegal and can result in severe penalties, including fines and imprisonment.

2. Operational Legitimacy

Provides legitimacy to your business operations and helps in gaining trust from customers, suppliers, and other stakeholders.

3.Business Expansion

A valid drug license can facilitate business growth, including expanding into new regions or product lines, as it demonstrates regulatory compliance.

4. Avoiding Legal Issues

Prevents legal complications and interruptions in business operations by ensuring adherence to drug laws and regulations.

FAQ ( Frequently Asked Questions )

CDSCO stands for the Central Drugs Standard Control Organization. It is the national regulatory body for overseeing the quality, safety, and efficacy of drugs and medical devices in India.

CDSCO is responsible for: - Granting licenses for manufacturing and selling drugs. - Approving new drugs and clinical trials. - Regulating the import of drugs and medical devices. - Ensuring drug quality and safety through inspections and enforcement.

To apply for a drug license, visit the CDSCO website and follow the guidelines provided in the online application system. You will need to provide necessary documents and details about the manufacturing or trading entity.

Application form (Form 27 for manufacturing or Form 28 for selling) - Proof of identity and address of the applicant - Manufacturing or business premises details - Details of technical staff and their qualifications - Certificate of good manufacturing practices (GMP)

You can check the status of your application on the CDSCO online portal. You will need to log in with your credentials and navigate to the application status section.

ADRs can be reported through the CDSCO’s Pharmacovigilance Programme. You can submit reports online via the CDSCO portal or contact the nearest CDSCO office for guidance.

To import drugs or medical devices, you need to apply for an import license from CDSCO. You will have to provide: - Importer’s license - Details of the drug or device - Certificate of analysis - Proof of compliance with Indian standards

If you lose your DSC, report it immediately to the Certifying Authority to revoke it and apply for a new one.

If you wish to appeal a decision made by CDSCO, you should follow the formal procedure outlined on the CDSCO website. This typically involves submitting a written appeal with supporting documents to the appropriate CDSCO authority.

Yes, CDSCO charges fees for various services, including licensing, registration, and approvals. The fee structure is available on the CDSCO website and is subject to change.

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