CDSCO Registration

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• Determine product class and CDSCO standards compliance
• Obtain CDSCO certificate/online registration
• Analyze product requirements for clear guidelines
• Conduct virtual pre-audit for manufacturing unit compliance
• CDSCO consultants coordinate with authorities for follow-ups
• Ensure reliable and punctual service delivery
• Visit CDSCO office on behalf of clients if needed

An Overview of CDSCO Registration

The Central Drugs Standard Control Organization (CDSCO) in India oversees the regulation and registration of pharmaceuticals, medical devices, cosmetics, and diagnostics under the Drugs and Cosmetics Act, of 1940. The CDSCO laid down the standards for Drugs, control over the imported Drugs’ quality, coordination of the activities of SDCO (State Drug Control Organisation) and facilitating expert advice with an outlook of the regularity in the enforcement of the Drugs & Cosmetics Act. Any organisation that manufacturers or imports or exports drugs & cosmetics conducts Research & Development activities regarding drugs, imports drugs for the purpose of examining conducts BA (Bioavailability) & BE (Bioequivalence) studies in drugs for export purposes need to obtain CDSCO Registration through its online registration portal.

Applicable Rules/Acts/ Regulations

Following are the applicants who can apply for online CDSCO Registration in India:

• CDSCO operates under the Drugs and Cosmetics Act, of 1940, and the Medical Device Rules, of 2017, governing the registration and supervision of pharmaceuticals, medical devices, cosmetics, and diagnostics

What is the Eligibility/Pre-Licensing/Mandatory Pre-Requisites

Legal Entity or Authorized Representative :

Manufacturers or their authorized representatives intending to market pharmaceuticals, medical devices, cosmetics, or diagnostics in India are eligible.

Compliance with Quality Standards :

Entities seeking registration must adhere to stringent quality management systems and standards specified by CDSCO. This includes compliance with Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), and other applicable norms.

Necessary Testing Data:

Submission of comprehensive testing data and documentation verifying the safety, efficacy, and quality of the product is mandatory. This includes detailed information on formulation, manufacturing process, stability data, and clinical trial results, if applicable.

Conformity with Regulatory Norms :

Demonstrating conformity with regulatory requirements specific to the category of the product (pharmaceuticals, medical devices, cosmetics, etc.) is essential. This involves compliance with relevant Drugs and Cosmetics Act provisions, Medical Device Rules, and other applicable guidelines.

Quality Management System (QMS) Certification :

Having a robust QMS in place is mandatory. Obtaining certifications such as ISO 13485, which outlines requirements for a quality management system for medical devices, is often necessary for medical device registration.

Documentation and Data Integrity :

Providing accurate and comprehensive documentation that maintains data integrity throughout the regulatory process is fundamental. Any falsification or misleading information can lead to the rejection or cancellation of the registration application.

Labeling and Packaging Compliance :

Ensuring compliance with labeling and packaging regulations set by CDSCO is critical. Clear and accurate labeling with essential information, such as product composition, dosage, instructions for use, and warnings, is mandatory.

Clinical Trial Data (If Applicable) :

If the product requires clinical trial data, providing evidence from well-designed and conducted trials is essential. This data substantiates claims regarding the product’s safety and efficacy.

A description of products/services Involved

The CDSCO (Central Drugs Standard Control Organization) in India oversees the registration and regulation of various products and services falling under its purview. The products/services involved in CDSCO registration are:

Pharmaceuticals:

This category includes drugs and medications used for therapeutic purposes. Pharmaceuticals encompass a wide range of formulations such as tablets, capsules, injections, syrups, ointments, and more. CDSCO regulates their manufacturing, import, export, sale, and distribution in India.

Medical Devices:

Medical devices cover a broad spectrum of equipment, instruments, implants, and apparatus used for the diagnosis, treatment, monitoring, or prevention of diseases or medical conditions. It includes items like cardiac implants, diagnostic machines, surgical instruments, prosthetics, and more. CDSCO oversees its registration, import, and manufacturing standards.

Cosmetics:

Cosmetics involve products used for personal care and beautification purposes, including skincare, haircare, makeup, perfumes, toiletries, and more. CDSCO ensures the safety, quality, and labeling compliance of cosmetics marketed in India.

Diagnostics:

Diagnostics encompass a range of products used for diagnosing various diseases, conditions, or infections. This category includes medical tests, reagents, kits, imaging devices, laboratory equipment, and other diagnostic tools. CDSCO regulates their import, manufacturing, and distribution to ensure accuracy and reliability.

Clinical Trials:

CDSCO oversees the approval and regulation of clinical trials conducted on pharmaceuticals, medical devices, or other healthcare-related products in India. This involves assessing trial protocols, participant safety, and ethical considerations.

Import/Export Licensing:

The CDSCO grants licenses and approvals for the import and export of pharmaceuticals, medical devices, cosmetics, and diagnostics to ensure compliance with international standards and regulatory requirements.

Manufacturing Approvals:

CDSCO provides manufacturing approvals for facilities producing pharmaceuticals, medical devices, or related products. This involves verifying compliance with GMP (Good Manufacturing Practices) and other quality standards.

Regulatory Approvals and Certifications:

Various regulatory approvals and certifications such as New Drug Approval (NDA), Import Licenses, Manufacturing Licenses, Product Registrations, and Certifications (such as ISO 13485 for medical devices) are managed by CDSCO to ensure adherence to regulatory norms and standards.

Types and Distinctions of Licenses/Services Involved

The primary registration required is the Registration Certificate (RC). Other licenses may include import licenses, manufacturing licenses, and approvals for clinical trials, contingent on the product classification.

Who can apply for CDSCO Registration in India?n

Following are the applicants who can apply for online CDSCO Registration in India:

• 1: Indian Agents
• 2: Corporates
• 3: Importers
• 4: Foreign Enterprises holding Indian Subsidiary.

Documents Required/Paperwork from the Client for CDSCO Registration

Documents encompass technical details, manufacturing information, quality management system certifications, clinical data (if applicable), conformity evidence, labeling details, and supporting documentation as specified by CDSCO.

CDSCO Registration Process

Here’s an overview of the CDSCO registration process in India: CDSCO oversees the evaluation, approval, and regulation of drugs, medical devices, cosmetics, and diagnostics to ensure their safety, efficacy, and quality before being made available in the Indian market.Manufacturers, importers, or their authorized representatives are typically involved in applying for registration to market their products in India.

1: Submission of Application:

Manufacturers submit applications containing comprehensive details about the product, manufacturing process, quality management systems, clinical data (if applicable), and other relevant information to CDSCO.

2: Evaluation and Review:

CDSCO conducts a thorough review of the submitted documents, assessing compliance with regulatory requirements, safety, efficacy, and quality standards.

3: Query Resolution:

If necessary, CDSCO may request additional information or clarification from the applicant to complete the evaluation.

4: Approval or Rejection:

Upon satisfactory evaluation, CDSCO approve for marketing the product in India. In case of non-compliance or inadequate documentation, the application may be rejected.

5: Issuance of Registration:

Successful applicants receive a Registration Certificate (RC) from CDSCO, allowing them to market and distribute their product in India.

What is the procedural timeline of the service involved?

The registration process involves document submission, CDSCO evaluation, potential queries for additional information, review periods, and final approval or rejection. Timelines vary based on application complexity.

Cancellation / Validity / Renewal of Service

The Registration Certificate’s validity ranges from 1 to 5 years, subject to renewal before expiration to maintain market access.

Cancellation / Suspension / Revocation of Service

CDSCO holds the authority to cancel, suspend, or revoke the Registration Certificate due to non-compliance, safety concerns, or inadequate surveillance

Mandatory Compliance Attached with Service

Manufacturers must comply with post-market surveillance, adverse event reporting, labeling, and manufacturing standards, and maintain an effective quality management system.

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