Overview of CDSCO Registration Certificate

CDSCO Registration Certificate is a legal document that is issued in India under the Drugs and Cosmetics Act, 1940. CDSCO certificate is essential for bringing in drugs, medical items, and some special types of cosmetics into India. The document here guarantees that such Items are within the safety, quality as well as efficiency requirements set by the Indian authorities.

CDSCO certificate requires the people applying for registration must submit documents such as product models and descriptors, production and processes, services, and sales details. Additionally, the importer is also required to seek the assistance of an Authorized Indian Agent (AIA) who incorporates the requirements of the CDSCO.

CDSCO certificate limits the chances of unhealthy living among citizens as well as impairment by dangerous or low-quality items. If one fails to meet the registration requirements, then there are applicable legal consequences as well as import bans.

Applicable rules and regulations for CDSCO Registration Certificate

• Drugs and Cosmetics Act, 1940: The most important Indian law regulating the production, distribution and marketing of drugs, medical devices and cosmetics.
• Drugs and Cosmetics Rules, 1945: Rules made under the Act that contain the regulation identifying procedures and other conditions relating to approval of products and licensing of businesses.
• Medical Devices Rules, 2017: Regional specific rules for the classification, registration and licensing of medical devices in India was not administered and lacked a well-defined code.
• New Drugs and Clinical Trials Rules, 2019: Particular requirements for new drugs registration, clinical trials and ethics committee.
• Drugs and Cosmetics Rules (Second Amendment) Rules, 2022: New information about standards for medical devices and registration procedures.
• Pharmacovigilance Guidelines: Federal standards that would allow tracking ADRs and reporting safety post-marketing.
• BIS (Bureau of Indian Standards) Act, 2016: Eligible for medical devices which fall under the regulatory requirements of India with regard to particular standards.
• Foreign Trade Policy of India: Applicable for import/export licenses and to comply with CDSCO for export and import business.
• Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954: Regulates claims and advertisements that are to do with health products.
• Legal Metrology Act, 2009: Prescribes the right quantity and quality weights and measures of the drugs, devices, and cosmetics and the right labelling of the same.

Importance of CDSCO Registration Certificate

• Public Health and Safety

Guarantees that products meet prescribed standards of quality, safety, and efficacy, protecting public health.

Reduces risks associated with substandard or counterfeit products in the market.

• Market Access

Mandatory for the importation and sale of regulated products in India.

Opens opportunities for foreign manufacturers to legally sell their products in the Indian market.

• Product Credibility

Enhances consumer trust and credibility by ensuring products are approved by a recognized regulatory authority.

• Facilitation of Trade

Enables smooth customs clearance for imported goods.

Helps Indian manufacturers and importers align with global regulatory standards, boosting exports.

• Regulatory Oversight

Enables the CDSCO to keep up with effective monitoring by way of audits and inspections in addition to periodic renewal to make sure constant compliance.

• Encourages Innovation

Supports the entry of new molecules particular new pharmaceuticals, new biologics and novel medical devices by way of New Drug Regulation and Clinical Trial Regulations.

• Ethical Advertising and Labelling

Ensures that marketed claims are scientifically validated and labelling complies with Indian regulations.

Who can apply for CDSCO Registration Certificate in India?

• Indian Manufacturers
• Importers
• Foreign Manufacturers through an Authorized Indian Agent (AIA)
• Foreign Enterprises holding Indian Subsidiary

Types of CDSCO registration

• Medical Device Registration: Required in case a device or its reporting manufacturer seeks registration as a medical device in India. The classification of devices into A, B, C, or D depending on risk levels; devices in a higher risk category have more stringent standards.
• Pharmaceutical Product Registration: Must be provided for the drug, formulation, active pharmaceutical ingredients (API) or the vaccine proposed for importation and sale.
• Cosmetic Product Registration: Essential for imported cosmetics for compliance to safety and quality standards provided for under the Drugs and Cosmetics Act.
• Biological Product Registration: Such products are therapeutic products such as monoclonal antibodies and recombinant proteins and blood derivatives-containing strict safety policies.
• Clinical Trial Approval: In India to find, for conducting clinical research that needs approval for drug and medical device trial for safety of patients.
• New Drug Approval (NDA): To market new drug formulations incorporated for new chemical entities, fixed dose combinations or modified use in various countries particularly India.
• Test License Registration: For importing small quantities of drugs, devices, or cosmetics for testing and evaluation purposes.

Eligibility and mandatory pre-requisites for obtaining a CDSCO registration

• Importers/Manufacturers: Only entities registered as importers, manufacturers, or distributors under the applicable rules are eligible.
• Authorized Indian Agent (AIA): Foreign manufacturers are required to register an AIA holding a valid license in order to represent them in India.
• Compliance with CDSCO Standards: They should be standardization of the products in accordance with Act of drugs and cosmetics 1940 and rules there under.
• Product Classification: Classification of the product in terms of CDSCO guidelines which include whether the product is drug, cosmetic or medical device.
• Dossier Preparation: Turning in technical documents that include the following information:
• Product specifications
• Manufacturing details
• Stability and safety data
• Labelling and packaging information
• Free Sale Certificate (FSC): Issued by the regulatory authority of the country of origin, indicating the product is approved for sale there.
• Testing and Validation: Certain products require testing in India for quality and safety.
• Clinical Data: For new drugs or medical devices, clinical trial data or performance evaluation reports may be mandatory.
• Labelling Compliance: Products must meet India-specific labelling requirements, including language, batch number, and expiry details.

Documents Required for CDSCO Registration Certificate

• Identity Verification
• Applicant Address Verification
• Applicant Undertaking
• Copy of CDSCO approved BA or BE Site
• Registration Manufacturing License or Wholesale License
• Technical Specifications
• Manufacturing Information
• Certifications for Quality Management System
• Clinical Data (if relevant)
• Evidence of Conformity
• Labelling Information
• Supporting Documents as specified by CDSCO

Process of obtaining CDSCO Registration Certificate

Step 1: Application Submission- The first stage is the submission of a comprehensive application for CDSCO registration to the competent authority. This application should include product specification, manufacturing processes, quality management systems, clinical data, and other required details.

Step 2: Document Evaluation- Upon application submission, CDSCO thoroughly evaluates the documents submitted, determining the safety, efficacy, and quality standards compliance. It also ensures compliance with regulatory requirements.

Step 3: Information Clarification- Start of the step where the applicant shall reply to the CDSCO authorities by providing all the required information and clarifications. The purpose of this is to resolve any deficiencies and defects in the documentation noted during assessment.

Step 4: Regulatory Review and Decision- If the evaluation results are satisfactory and compliance requirements are met by CDSCO, it shall proceed to approve permission to market the product in India. Contrarily, the authority by virtue of its statutory function retains the right and power to deny such approvals for products that do not meet compliance standards or do not provide adequate evidence.

Step 5: Registration Certificate Issuance- CDSCO shall give the Registration Certificate (RC) to the applicant upon approval. This certificate from CDSCO serves as formal permission for the marketing and sale of the product across India.

Validity and Renewal of CDSCO Registration Certificate

Generally, the validity of the issued CDSCO Registration Certificates varies depending on the type of the product and the category generally it 3-5 years from the date of issue. All renewal applications for the instance certificate must be made six months before the expiry date of the existing certificate to support continued operation.

Why you should choose Whizseed?

• End-to-End Service: From first consultation through to certification and renewal, Whizeed provides a holistic and hassle-free service for all CDSCO registration needs.
• Experienced Team: With extensive experience in Indian regulations, we comprehend the intricacies of CDSCO requirements, ensuring correct and timely submissions.
• Customized Solutions: Our team offers business solutions according to your requirements, whether you are a small manufacturer or importer, or a multinational looking for entry into the Indian market.
• Transparent Communication: We always keep our clients updated through the process, eliminating any chance of unpleasant non compliances.
• Faster Approvals: With meticulous planning and expert handling, we minimize errors and delays, facilitating faster approval of your CDSCO certificate.