The Central Drugs Standard Control Organisation (CDSCO) serves as India’s National Regulatory Authority responsible for overseeing pharmaceuticals and medical devices. Operating under the Directorate General of Health Services within the Ministry of Health and Family Welfare, CDSCO plays a crucial role in safeguarding public health by ensuring the safety, efficacy, and quality of drugs and medical devices manufactured, imported, or distributed across the country. Its regulatory authority is derived from the Drugs and Cosmetics Act, 1940, and the accompanying Drugs and Cosmetics Rules, 1945, which empower it to approve new drugs and supervise clinical trials within India.

One of CDSCO’s core mandates is to establish and enforce quality standards for drugs, ensuring uniformity in the control of imported drugs and cosmetics. This robust regulatory framework protects consumers by preventing substandard or unsafe products from entering the market, thereby fostering greater public confidence. CDSCO’s oversight extends not only to drug efficacy but also to the safety and ethical conduct of clinical trials, as well as the manufacturing and distribution processes of pharmaceuticals and medical devices.

The organisation’s regulatory responsibilities are shared between the central and state levels. While CDSCO acts as the Central Drug Authority, it works in close coordination with State Drug Control Authorities to ensure consistent implementation of drug regulations nationwide. Together, they handle licensing for critical and specialised drugs such as vaccines, blood products, intravenous fluids, and sera — products vital to public health security.

For organisations involved in drug and cosmetic activities—whether manufacturing, importing, exporting, or research and development—registration with CDSCO is mandatory. This includes entities conducting Bioavailability (BA) and Bioequivalence (BE) studies for export or importing drugs for testing purposes. The CDSCO facilitates this process via its online registration portal, simplifying compliance and application management for stakeholders across the pharmaceutical and cosmetic industries.

Types of Registrations under CDSCO

The Central Drugs Standard Control Organization (CDSCO) mandates various types of registrations and licenses depending on the category of product and the nature of business operations. Understanding these registrations is essential for manufacturers, importers, and distributors to ensure regulatory compliance and legal operations in India.

1. Medical Device Registration for Manufacturers

Manufacturers intending to produce medical devices within India must register their products with CDSCO. This registration process requires classifying the medical devices based on their associated risk and submitting detailed technical documentation, manufacturing site information, and quality certifications. Compliance with the Medical Devices Rules, 2017 is mandatory, and the process may include inspections for conformity assessment. Successful registration authorizes manufacturers to legally produce and market their medical devices across India.

2. Cosmetic Import Registration

Entities planning to import cosmetics into India must secure an import registration certificate from CDSCO. This ensures that imported cosmetics meet the safety and quality standards as per Indian regulations. The application involves submitting Form 42 along with supporting documents such as ingredient lists, product labels, free sale certificates from the country of origin, safety data, and proof of adherence to Good Manufacturing Practices (GMP). Once approved, the registration certificate permits the legal importation and sale of cosmetic products in the Indian market.

3. Cosmetic Manufacturing License

Manufacturers producing cosmetics domestically must obtain a manufacturing license from the State Drug Control Authority under the Drugs and Cosmetics Act, 1940. This license certifies that the manufacturing facility complies with the required safety and quality standards. The application requires detailed information about the facility, machinery, trained personnel, and adherence to GMP guidelines. Product samples and labeling information must also be submitted. Periodic inspections are conducted to verify ongoing compliance before granting the license, enabling legal manufacturing and marketing of cosmetics.

4. Medical Device Import License

Importers of medical devices are required to obtain an Import License from CDSCO. The process involves risk-based classification of devices and submission of a detailed application through the SUGAM portal. Applicants must provide product details, manufacturing site certifications, and quality management system certificates, including regulatory approvals from the country of origin. CDSCO may conduct site inspections as part of the verification process. Upon approval, the Import License authorizes the distribution and sale of the medical devices within India under regulatory compliance.

5. In Vitro Diagnostic (IVD) Device Manufacturing License

Manufacturers of In Vitro Diagnostic devices such as laboratory instruments or test kits need to secure a manufacturing license from CDSCO. The application process demands comprehensive information regarding manufacturing processes, facility layout, quality control mechanisms, and adherence to the Medical Devices Rules, 2017. Compliance with quality standards such as ISO 13485 is required, and the CDSCO may carry out facility audits to ensure conformity. Approved licenses permit the lawful manufacturing and distribution of IVD devices in India.

6. In Vitro Diagnostic Device Import License

Importers of IVD devices must obtain an Import License from CDSCO, which involves classifying the devices based on risk and submitting an application through the SUGAM portal. Essential documentation includes product specifications, certificates of analysis, free sale certificates from the country of origin, and quality certifications demonstrating compliance with ISO 13485 standards. CDSCO may perform manufacturing site inspections to verify compliance before issuing the import license, allowing legal distribution of IVD devices.

7. Drug License

Any business involved in manufacturing, wholesale, or retail distribution of pharmaceutical products must possess a valid Drug License issued under the Drugs and Cosmetics Act, 1940. This license certifies compliance with quality and safety standards and includes categories specific to manufacturing, wholesale, or retail operations. Applicants must provide detailed information regarding premises, storage conditions, and qualifications of technical personnel. The licensing process involves routine inspections to ensure adherence to GMP and regulatory guidelines. A valid Drug License is mandatory for legally conducting pharmaceutical activities in India.

Eligibility Criteria for CDSCO Registration in India

Various entities are eligible to register on the CDSCO portal for drug, cosmetic, and medical device regulatory compliance. The key categories of eligible applicants include:

• Importers: Organizations engaged in the import of drugs and cosmetics into the Indian market.
• Indian Agents: Authorized representatives acting on behalf of foreign manufacturers to manage regulatory affairs within India.
• Foreign Companies with Indian Subsidiaries: Overseas enterprises operating through legally established Indian subsidiaries.
• Corporate Entities: Large business organizations responsible for manufacturing, importing, or exporting pharmaceutical and cosmetic products.

It is essential to understand that manufacturing units cannot register independently on the CDSCO portal. Instead, a parent corporate entity must first create login credentials and register on behalf of the manufacturing facility. Once this is completed, the manufacturing unit gains access to the portal to manage regulatory filings and applications.

Due to the intricate nature of the CDSCO registration process and stringent compliance standards, many businesses seek professional support to navigate the complexities efficiently. CertificationsBay offers specialized assistance for CDSCO registrations, helping clients prepare accurate documentation, submit applications correctly, and communicate effectively with regulatory authorities, ensuring timely approvals and regulatory adherence.

1. CDSCO Manufacturing License for Medical Devices in India

The Central Drugs Standard Control Organization (CDSCO) serves as India’s apex regulatory authority overseeing medical device registration and manufacturing licenses. If you intend to manufacture medical devices within India, obtaining a CDSCO Manufacturing License is mandatory under the Medical Devices Rules, 2017. This guide details the process, eligibility, documentation, and key steps to secure your manufacturing license.

Overview of CDSCO Medical Device Registration and Licensing

The CDSCO Manufacturing License falls under the Central Licensing Approval Authority (CLAA) scheme. While the State Licensing Authority issues the license, it requires CLAA’s approval, contingent on compliance with regulatory standards and medical device classifications.

For companies importing raw materials or components for final assembly in India, possessing a manufacturing license is essential. Conversely, if the entire medical device is manufactured abroad and imported as a finished product, an import license is required.

Step-by-Step Process to Register for CDSCO Manufacturing License

1. Determine the License Type: Based on the classification of your medical device (Class A, B, C, or D), identify the applicable license type.
2. Meet Eligibility Requirements: Ensure your manufacturing unit complies with Good Manufacturing Practices (GMP) and other CDSCO-mandated criteria.
3. Employ Qualified Technical Personnel: Your facility must have skilled professionals responsible for overseeing manufacturing quality and compliance.
4. Prepare and Submit Application: Complete the required forms (such as Form MD-3 for Class A & B, or Form MD-7 for Class C & D devices), upload necessary documents including site master file and manufacturing process details, and pay applicable fees.
5. Application Submission: Submit your application to the appropriate State Drug Control Department or CDSCO, depending on device class.

Phases of the CDSCO Medical Device Manufacturing License

• Phase I – Applicant Registration: Register on the CDSCO portal by providing valid documents such as company registration certificates and authorized person IDs. Upon submission, you will receive a preliminary approval via email, followed by a request for hard copy documents.
• Phase II – Manufacturing Test License Application: To manufacture devices in limited quantities for testing, demonstration, or training, apply online through Form MD-12, upload required documents, pay fees, and track application status.
• Phase III – Commercial Manufacturing License Application: For full-scale production, submit the appropriate application form online, upload supporting documentation, pay fees, and await approval or rejection notification from CDSCO.

Classification of Medical Devices

India classifies medical devices into four risk-based categories:

• Class A (Low Risk): Examples include bandages and stethoscopes.
• Class B (Low to Moderate Risk): Devices like syringes and blood pressure monitors.
• Class C (Moderate to High Risk): Includes orthopedic implants and catheters.
• Class D (High Risk): Devices such as pacemakers, ventilators, and heart-lung machines.

Documentation and Approval Process

• Device Classification: Accurately categorize your device risk class as per CDSCO guidelines.
• Prepare Technical Documentation: Compile detailed information including device specifications, safety data, manufacturing procedures, and quality control methods.
• Submit Application: Upload completed forms, documents, and pay fees via the CDSCO portal.
• Review and Inspection: CDSCO reviews submissions and may conduct on-site inspections of manufacturing facilities to verify compliance.
• License Issuance: Upon successful evaluation and inspection, CDSCO grants the manufacturing license.
• License Renewal: Manufacturing licenses typically remain valid for five years and must be renewed timely to avoid penalties.

Important CDSCO Forms for Medical Device Manufacturers

• Form MD-3: Application form for manufacturing Class A & B devices.
• Form MD-5: License issued post-approval for Class A & B devices.
• Form MD-7: Application form for manufacturing Class C & D devices.
• Form MD-9: License issued post-approval for Class C & D devices.

Applying on the CDSCO Portal

To apply online, follow these steps:

• Create a CDSCO portal account using a valid email.
• Log in and select the Medical Devices category under applications.
• Complete the appropriate application form with detailed company and product information.
• Upload all required documentation, including manufacturing plans and quality protocols.
• Pay application fees via the secure online gateway.
• Submit the application and monitor its status through the portal.
• Once approved, download your manufacturing license from the portal.

Advantages of Medical Device Parks in India

India’s emerging medical device parks offer modern infrastructure and supportive regulatory frameworks, making it easier for manufacturers to establish operations and scale production efficiently.

Obtaining a CDSCO Manufacturing License for Medical Devices is an essential step to ensure compliance and legal distribution in India. With meticulous preparation and adherence to regulatory requirements, manufacturers can secure their licenses with relative ease.

2. CDSCO Medical Device Import License in India

Importing medical devices into India requires strict adherence to regulatory guidelines set by the Central Drugs Standard Control Organization (CDSCO), the national regulatory authority under the Ministry of Health and Family Welfare. The CDSCO oversees the import licensing process, ensuring that all medical devices entering the Indian market comply with safety, quality, and performance standards.

Overview of CDSCO Medical Device Import License

Any medical device imported into India must meet the regulatory requirements established by CDSCO, which enforces quality control and collaborates closely with State Drug Control Authorities. The import license, often referred to as the MD-15 license, is mandatory for all categories of devices classified as Class A, B, C, or D based on risk.

The Indian medical device regulatory landscape has evolved significantly since the 2006 reforms, which introduced more rigorous import regulations. Failure to obtain or renew the appropriate import license within stipulated timelines can lead to suspension or cancellation of the license, impacting the ability to market devices in India.

Key Prerequisites for Applying for a CDSCO Import License

Before initiating the application, importers must gather detailed information about the medical device, including:

• Generic or Brand Name
• Intended Use and Application
• Material Composition
• Mode of Operation
• Risk-based Classification as per CDSCO guidelines

Stepwise Process for CDSCO Medical Device Import License Registration

Phase 1: Applicant Registration

Applicants, who may be authorized distributors or agents possessing valid licenses such as Form 20/21B (wholesale drug license) or Form 41/42 (registration certificates), must register on the CDSCO online portal. This requires:

• Submission of Form MD-14 to the Central Licensing Authority.
• Uploading required documentation and awaiting approval.
• Addressing any rejection notices by resubmitting corrected information.

Phase 2: Import License Application Submission

Once registered, applicants must submit a detailed application including:

• Device classification and product description.
• Intended use and operational details.
• Supporting regulatory documents such as:
  • European CE Certificate
  • Free Sale Certificate
  • ISO 13485 Certification
  • Plant Master File and Device Master File

Payment of applicable fees based on device classification is also completed during this phase, followed by the generation of an application reference number for tracking.

Phase 3: Application Review

The CDSCO carefully examines the submitted application and attached documents. If discrepancies or incomplete information are identified, applicants receive queries requiring prompt responses and document resubmissions to avoid processing delays.

Phase 4: License Granting

After satisfactory review and resolution of any queries, CDSCO issues the Medical Device Import License, valid for five years from the date of issuance. This license authorizes legal import, distribution, and sale of the medical device within India.

3. CDSCO Cosmetic Import License

The Indian cosmetics market is expanding rapidly, driven by growing consumer demand for diverse beauty and personal care products. To ensure that only safe, quality, and compliant cosmetics enter the Indian market, the Central Drugs Standard Control Organisation (CDSCO) mandates obtaining a Cosmetic Import License. This license is issued under the authority of the Ministry of Health & Family Welfare and regulated by Rule 21 of the Drugs and Cosmetics Rules, 1945. Holding this license allows businesses to legally import and sell cosmetics in India without regulatory hurdles.

Definition and Scope of Cosmetics under CDSCO

A cosmetic product, as defined by Indian regulations, includes any substance or article intended to be applied, sprayed, or introduced onto the human body to cleanse, beautify, alter appearance, or enhance attractiveness. This definition extends to components used within cosmetic products, which clarifies the range of items requiring import registration.

Role of CDSCO in Regulating Cosmetic Imports

The CDSCO plays a crucial role in enforcing the amended Cosmetic Rules, 2020 and oversees several regulatory functions such as:

• Evaluating and granting No Objection Certificates (NOCs) for imported cosmetics.
• Addressing complaints and public concerns related to cosmetic standards.
• Coordinating with the Bureau of Indian Standards (BIS) and other government agencies.
• Processing applications for cosmetic import registrations under the Drugs and Cosmetics Act, 1940.
• Handling public inquiries, court cases, and regulatory hearings involving cosmetics.

Eligible Applicants for CDSCO Cosmetic Import Registration

Under the current regulatory framework, the following categories are authorized to apply for the CDSCO Cosmetic Import License:

• Manufacturers: Foreign manufacturers can directly apply if they have a recognized presence in India.
• Authorized Agents: Agents formally appointed by manufacturers to act on their behalf during registration and import processes.
• Indian Subsidiaries: Indian subsidiaries of foreign manufacturers can apply for registration.
• Other Importers: Indian importers authorized to bring in cosmetics from foreign manufacturers.

Key Documents Required for CDSCO Cosmetic Import License

Applicants must prepare and submit a comprehensive set of documents including but not limited to:

• A formal Covering Letter indicating the application type (new registration, product endorsement, site addition, etc.).
• Part-1 of the Second Schedule containing manufacturer undertakings.
• Detailed List of Ingredients with percentages, ensuring compliance with limits on heavy metals such as lead and mercury.
• Product Labels showing critical information: product name, manufacturer, expiry, batch number, importer details, and ingredients.
• Specification and Testing Methods as per prescribed guidelines.
• Manufacturing Licenses issued by the regulatory authority of the country of origin.
• A Free Sale Certificate confirming the product’s lawful sale in its origin country.
• Declarations regarding Non-Animal Testing and Heavy Metal & Hexachlorophene Compliance.
• Correctly filled COS-1 Application Form.
• Fee payment proof via TR-6 Challan.

Stepwise Procedure to Obtain CDSCO Cosmetic Import License

Step 1: Cosmetic Product Classification
Identify the classification of the cosmetic product under CDSCO Gazette Notifications to understand applicable regulatory requirements.

Step 2: Appointment of Indian Authorized Agent
Foreign manufacturers must appoint a legally authorized Indian agent empowered through a Power of Attorney to manage registration and import activities.

Step 3: Application Submission
The applicant submits the online application through the CDSCO portal, ensuring all supporting documents and fees are included accurately.

Step 4: Application Review and License Issuance
The Drugs Controller General of India (DGCI) reviews the application, may raise queries for additional clarifications, and upon satisfaction, issues the Cosmetic Import License (Registration Certificate). This license enables lawful import and distribution of cosmetics across India.

4. CDSCO Cosmetic Manufacturing License in India

The booming cosmetic industry in India, fueled by widespread media and social media influence, has heightened the demand for cosmetic products. To legally manufacture and market these products, obtaining a CDSCO Cosmetic Manufacturing License is mandatory. This license ensures compliance with Indian safety and quality regulations, protecting consumers and legitimizing manufacturers.

Definition and Regulatory Framework for Cosmetics

As per Section 3 (aaa) of the Drugs & Cosmetics Act, 1940, a cosmetic includes any article intended to be applied, poured, sprayed, rubbed, or introduced into or onto the human body to cleanse, beautify, promote attractiveness, or alter appearance. This also covers components used in cosmetic formulations. The CDSCO regulates manufacturing licenses to ensure these products meet stringent regulatory standards.

Regulatory Authorities and Licensing

In India, the State Licensing Authorities (SLAs) appointed by state governments handle the issuance and renewal of cosmetic manufacturing licenses, enforcing compliance with the Drugs and Cosmetics Act, 1940, and associated rules. Meanwhile, the Central Licensing Authority (CLA) governs the import regulations for cosmetics.

Categories of Cosmetic Products Under CDSCO License

The CDSCO license covers a wide range of cosmetic products including:

• Deodorant soaps and toilet soaps
• Hair colorants, setting products, and hairdressing items such as lacquers and lotions
• Lipsticks, lip glosses, and other lip products
• Skin-whitening products, creams, lotions, gels, and emulsions
• Face masks, make-up powders, and powders for hygiene
• Deodorants, antiperspirants, and shaving products like creams and foams
• Sunbathing products, depilatories, and perfumes
• Mouth and teeth care products
• Alcoholic fragrance solutions and eau de Cologne

Schedule M-II Cosmetic Categories

The Drugs and Cosmetics Rules, 1945, further classify cosmetics under Schedule M-II into 11 categories, such as powders, creams, shampoos, nail polishes, hair dyes, aerosol products, toothpastes, and more.

Compliance Requirements for Manufacturing License

Before granting a license, the SLA conducts thorough inspections of the manufacturing facility, evaluating compliance with regulations. Key requirements include:

• Qualified Technical Staff:
  Personnel must be qualified with credentials such as registration under the Pharmacy Act, 1948, a diploma recognized by the Pharmacy Council of India, or equivalent qualifications accepted by the Licensing Authority.
• Labeling Regulations:
  Labels must transparently display ingredients, batch numbers (starting with “B” for batch and “M” for manufacturing batch), product names on both inner and outer packaging, and usage directions or warnings. For small containers, principal place and PIN code suffice. BIS may periodically audit product quality standards.

Essential Documents for CDSCO Cosmetic Manufacturing License

Applicants must prepare and submit comprehensive documentation including:

• Application in Form COS-5
• Specific Power of Attorney for authorized signatory
• List of directors, partners, or trustees with ROC or partnership deed copies
• Covering letter detailing the application purpose
• Appointment letter for competent technical staff (preferred)
• Detailed manufacturing process and flow charts
• Site master file and plant/machinery list
• Standard Operating Procedures (SOPs)
• Draft label copies
• Site layout plans and property ownership/lease documents
• List of technical staff with qualifications and experience
• Fee payment challan

Step-by-Step Process to Obtain the Manufacturing License

1. Application Filing:
   Submit Form COS-5 with all required details. Professional help is recommended to ensure accuracy.
2. Document Submission:
   Deliver the complete dossier to the concerned State Licensing Authority.
3. Authority Examination:
   The licensing authority reviews documents and conducts on-site inspections for compliance verification.
4. License Issuance:
   After successful evaluation, the license is granted in Form COS-8, authorizing legal manufacturing of cosmetics.

Validity and Renewal

The CDSCO Cosmetic Manufacturing License issued in Form COS-8 is valid indefinitely, provided the manufacturer pays the retention fees every five years. Failure to comply or pay fees may lead to suspension or cancellation by the State Licensing Authority.

5. CDSCO Medical Device Import License in India

Importing medical devices into India requires strict adherence to regulatory guidelines set by the Central Drugs Standard Control Organization (CDSCO), the national regulatory authority under the Ministry of Health and Family Welfare. The CDSCO oversees the import licensing process, ensuring that all medical devices entering the Indian market comply with safety, quality, and performance standards.

Overview of CDSCO Medical Device Import License

Any medical device imported into India must meet the regulatory requirements established by CDSCO, which enforces quality control and collaborates closely with State Drug Control Authorities. The import license, often referred to as the MD-15 license, is mandatory for all categories of devices classified as Class A, B, C, or D based on risk.

The Indian medical device regulatory landscape has evolved significantly since the 2006 reforms, which introduced more rigorous import regulations. Failure to obtain or renew the appropriate import license within stipulated timelines can lead to suspension or cancellation of the license, impacting the ability to market devices in India.

Key Prerequisites for Applying for a CDSCO Import License

Before initiating the application, importers must gather detailed information about the medical device, including:

• Generic or Brand Name
• Intended Use and Application
• Material Composition
• Mode of Operation
• Risk-based Classification as per CDSCO guidelines

Stepwise Process for CDSCO Medical Device Import License Registration

Phase 1: Applicant Registration

Applicants, who may be authorized distributors or agents possessing valid licenses such as Form 20/21B (wholesale drug license) or Form 41/42 (registration certificates), must register on the CDSCO online portal. This requires:

• Submission of Form MD-14 to the Central Licensing Authority.
• Uploading required documentation and awaiting approval.
• Addressing any rejection notices by resubmitting corrected information.

Phase 2: Import License Application Submission

Once registered, applicants must submit a detailed application including:

• Device classification and product description.
• Intended use and operational details.
• Supporting regulatory documents such as:
  • European CE Certificate
  • Free Sale Certificate
  • ISO 13485 Certification
  • Plant Master File and Device Master File

Payment of applicable fees based on device classification is also completed during this phase, followed by the generation of an application reference number for tracking.

Phase 3: Application Review

The CDSCO carefully examines the submitted application and attached documents. If discrepancies or incomplete information are identified, applicants receive queries requiring prompt responses and document resubmissions to avoid processing delays.

Phase 4: License Granting

After satisfactory review and resolution of any queries, CDSCO issues the Medical Device Import License, valid for five years from the date of issuance. This license authorizes legal import, distribution, and sale of the medical device within India.

6. CDSCO In Vitro Diagnostic Device (IVD) Manufacturing License in India

The manufacturing of In Vitro Diagnostic Devices (IVDs) in India is regulated under the Drugs and Cosmetics Act, 1940, and the associated Rules of 1945. In 2017, updated guidelines were introduced to ensure that manufacturing practices meet rigorous quality standards while safeguarding patient health. If you plan to manufacture IVD devices in India, obtaining a CDSCO IVD Device Manufacturing License is mandatory.

What Are In Vitro Diagnostic Devices (IVDs)?

IVDs comprise kits, reagents, instruments, and systems designed to collect, prepare, and analyze specimens from the human body. These devices help diagnose diseases, assess health conditions, and assist in treatment planning and preventive care.

Classification of IVD Devices as per Medical Device Rules, 2017

IVDs are categorized both by risk level and intended use, which determines licensing authority and compliance requirements:

• Risk-Based Classes:
  • Class A: Low Risk
  • Class B: Low to Moderate Risk
  • Class C: Moderate to High Risk
  • Class D: High Risk
• Classification Based on Intended Use:
  Examples include devices for diagnosing HIV, detecting Hepatitis B Virus (HBV), identifying Hepatitis C Virus (HCV), and blood grouping sera.

Regulatory Authorities for IVD Device Licensing

• State Licensing Authority (SLA):
  Responsible for issuing manufacturing licenses for Class A and Class B devices. Applications are submitted to the respective State Drugs Control Authority.
• Central Licensing Authority (CLA):
  Handles licenses for Class C and Class D devices, ensuring compliance with higher-risk device regulations.

Types of Licenses and Relevant Application Forms

Licenses are differentiated by device class and license type—manufacturing or loan licenses:

Mandatory Documents for CDSCO IVD Manufacturing License

Applicants must submit the following:

• Covering letter specifying application details
• Completed application form per device class
• Fee payment challan
• Company constitutional documents (e.g., Partnership Deed, Memorandum & Articles of Association)
• Details of directors or partners with identification
• Site ownership or rental agreement documents
• Declaration and appointment letters for manufacturing and analytical chemists, including their qualifications and experience certificates
• Registration certificate from District Industries Centre
• Consent letter from State Pollution Control Board
• Performance evaluation reports, if applicable
• Copy of test license (if any)
• Undertaking of compliance with Fifth Schedule requirements

Additional for Loan License Applicants (Form MD-4):

• Consent letter from principal manufacturer
• Wholesale license of the loan licensee
• Valid manufacturing license and product permissions of the principal manufacturer

Step-by-Step Process to Obtain the CDSCO IVD Manufacturing License

1. Application Submission:
   Submit the filled application form with all documents and fees to CDSCO or the concerned State Licensing Authority.
2. Application Scrutiny:
   Authorities review the application for completeness and regulatory adherence. Any discrepancies will require correction.
3. Site Audit by Authorized Body:
   The manufacturing facility undergoes a thorough inspection. Non-compliance issues must be resolved, and the compliance report submitted.
4. Audit Report Examination:
   The authority examines the audit report to ensure all standards are met.
5. Product Scrutiny:
   Detailed evaluation of the IVD products is conducted to confirm safety and regulatory compliance.
6. License Grant:
   After successful scrutiny and audit, the license is issued, permitting lawful manufacturing of IVD devices in India.

6. CDSCO In Vitro Diagnostic (IVD) Device Import License

Importing In Vitro Diagnostic (IVD) devices into India is a regulated process under the Medical Device Rules, 2017, overseen by the Central Drugs Standard Control Organization (CDSCO). A valid CDSCO IVD Import License is mandatory to legally bring IVD diagnostic kits, reagents, and instruments into the Indian market.

This comprehensive guide outlines the eligibility criteria, regulatory forms, documents required, and step-by-step application procedure for securing the license in compliance with CDSCO’s latest rules.

Who Can Apply for an IVD Import License?

Foreign manufacturers cannot apply directly for an IVD import license. They must appoint an authorized Indian agent, who will:

• Possess a manufacturing license or a wholesale license to sell/distribute medical devices in India.
• Act on behalf of the foreign manufacturer through a Power of Attorney.
• Submit the import application to CDSCO.

Note: The agent must be registered on the SUGAM Portal and comply with all regulatory mandates.

Required Forms for IVD Device Import

Applicable for all device classes: Class A (low risk), B (moderate risk), C, and D (high risk).

Step-by-Step Process to Get CDSCO IVD Import License

1. Product Evaluation

Ensure the IVD device complies with Medical Device Rules, 2017, and meets quality and safety standards.

2. Device Classification

Classify the product correctly (A, B, C, or D) based on risk. This classification determines the documentation and approval pathway.

3. Appoint Indian Authorized Agent

The agent must have:

• A valid wholesale or manufacturing license
• A notarized and apostilled Power of Attorney

4. Document Preparation

Compile technical and regulatory documents (see checklist below). All must be authenticated and signed by the authorized signatory.

5. Application Submission via SUGAM

The Indian agent:

• Creates a profile on the CDSCO SUGAM portal
• Fills Form MD-14 and uploads documents
• Pays government fees and submits the application online

6. Query Handling & Follow-Up

CDSCO may raise technical or legal queries. Timely resolution and accurate responses are essential to avoid delays.

7. Approval & Grant of License

After successful review, CDSCO issues Form MD-15, authorizing import and sale of the IVD product in India.

Document Checklist for IVD Import License

Here are the mandatory documents required for filing:

Company & Product Documents

• Cover Letter with product and application details
• Product Description Sheet
• Manufacturing Site Details
• Valid Power of Attorney (Notarized & Apostilled)

Quality & Compliance Documents

• ISO 13485 Certificate
• CE Design Certificate
• Good Manufacturing Practices (GMP) Certificate
• Declaration of Conformity

Sales & Legal Documents

• Free Sale Certificate (FSC) from GHTF countries
• TR-6 Challan (proof of CDSCO fee payment)
• Plant Registration / Business License
• Post-Market Surveillance Reports

Technical Documentation

• Device Master File (DMF)
• Site Master File (SMF)
• Batch Release Certificate
• Comprehensive Test Reports
• Audit Reports (internal & external)

Agent Credentials

• Agent’s Constitution Documents (LLP Agreement, COI)
• Valid Wholesale or Manufacturing License

Validity of CDSCO Import License (Form MD-15)

Once issued, the MD-15 import license remains valid indefinitely, subject to:

• Timely payment of retention fees every 5 years as per the Second Schedule of the Medical Device Rules, 2017
• Ongoing regulatory compliance

Non-payment or non-compliance may lead to suspension or cancellation by CDSCO.

Key Points to Remember

• Power of Attorney must follow CDSCO’s prescribed format and be legally notarized and apostilled.
• Device classification is the foundation for correct form selection and documentation.
• Each manufacturing site must be declared with full technical details.
• Document formatting for DMF and SMF must strictly follow CDSCO guidelines.

7. CDSCO Drug License in India

In India, any individual or business involved in the manufacture, distribution, or sale of drugs must obtain a valid Drug License, as mandated under the Drugs and Cosmetics Act, 1940. This license is issued by the Central Drugs Standard Control Organization (CDSCO) or the respective State Drug Control Authorities, depending on the nature of the license and business operations. The primary objective of the CDSCO Drug License is to ensure that the manufacture and trade of pharmaceuticals meet established safety, efficacy, and quality standards.

Why a CDSCO Drug License is Required

Drugs are integral to medical treatments and public health. As they are developed using chemically defined compositions to treat specific conditions, even minor deviations in their composition, dosage, or handling can result in serious health consequences. To mitigate such risks and protect consumer welfare, regulatory authorities strictly monitor every aspect of the pharmaceutical supply chain. A CDSCO Drug License ensures that entities engaged in manufacturing, importing, or selling pharmaceutical products operate in compliance with national health regulations.

Types of Drug Licenses Issued in India

The type of Drug License required depends on the nature of the applicant’s business. The key categories include:

1. Manufacturing Drug License

Issued to entities involved in the production of allopathic, ayurvedic, or other specified drugs. This license is granted by the State Licensing Authority (SLA) in whose jurisdiction the manufacturing unit is located.

2. Loan Drug License

Applicable for businesses that do not own a manufacturing facility but use a third-party licensed manufacturing unit to produce drugs under their brand name.

3. Import Drug License

Mandatory for companies importing drugs or pharmaceutical raw materials into India. This license is regulated by CDSCO.

4. Multi-Drug License

Required for organizations operating across multiple states, ensuring compliance at each operational location.

5. Sale Drug License

This license governs the wholesale or retail distribution of drugs and is further divided into two types:

• Wholesale Drug License: Required for entities selling drugs in bulk. Applicants must employ qualified personnel with a degree or diploma in pharmacy and at least one year of relevant experience.
• Retail Drug License: Applicable to pharmacies or retail drug stores selling directly to consumers. Issued by the State Pharmacy Council.

Essential Requirements for Obtaining a CDSCO Drug License

To qualify for a Drug License, applicants must meet several foundational criteria:

• Premises Area: A minimum of 10 square meters is required for either wholesale or retail operations. For businesses engaging in both, a minimum of 15 square meters is mandatory.
• Storage Facilities: The premises must be equipped with suitable storage conditions, including refrigeration for temperature-sensitive drugs.
• Qualified Personnel: Staff must include individuals with formal pharmacy education and professional registration, depending on the license type.
• Location-Based Licensing: A separate license must be obtained for each location where drugs are stocked or sold.
• Ongoing Compliance: Licensees are obligated to follow all terms and conditions. Any changes in business structure must be reported to the licensing authority.

Documentation Required for Drug License Application

The following documents are essential for a successful application:

• Duly filled and signed application form.
• Fee receipt or TR-6 Challan.
• Proof of identity of the applicant (e.g., PAN card, passport, voter ID).
• Partnership Deed or company incorporation documents (MOA, AOA, COI).
• Board Resolution authorizing the applicant to obtain the license (for companies).
• Appointment letter of authorized person responsible for drug handling.
• Details of qualified pharmacists (degrees, certificates, experience, registration).
• Affidavit of the pharmacist and employer.
• Layout plan of the premises and proof of ownership or lease.
• Utility bills or electricity connection as proof of functional infrastructure.

Procedure to Apply for a CDSCO Drug License

The process of acquiring a drug license involves the following steps:

Step 1: Online Registration

Applicants must register online on the CDSCO portal, selecting the appropriate license category.

Step 2: Unique Registration Number

Upon submission, the system generates a unique registration number used for further processing.

Step 3: Submission of Physical Documents

Applicants must submit hard copies of the supporting documents to the district-level Drug Licensing Authority within 15 days of online registration.

Step 4: Inspection and Verification

The authority may conduct an inspection of the premises to verify compliance with licensing standards.

Step 5: Grant of License

If all criteria are met, the license is issued by the CDSCO or the State Licensing Authority, enabling the applicant to legally operate in the pharmaceutical sector.

Conclusion

Obtaining a CDSCO Drug License is not only a legal requirement but also a critical step in ensuring the quality and safety of pharmaceuticals circulating in the Indian market. Whether you are involved in manufacturing, importing, or selling drugs, adhering to regulatory norms is essential to build trust and avoid legal penalties. For a seamless licensing process, businesses are encouraged to consult regulatory experts to ensure complete and accurate compliance with CDSCO norms.

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