Different Types of CDSCO Registration in India

In India, the Central Drugs Standard Control Organisation (CDSCO) operates under the Ministry of Health and Family Welfare and serves as the national regulatory authority for pharmaceuticals, medical devices, and cosmetics. Its main role is to ensure that the products available in the Indian market are safe, effective, and of high quality. To achieve this objective, CDSCO mandates several types of registrations depending on the nature of the product or activity. These registrations are not only legal requirements but are also vital for consumer protection and public health safety.

In this article, we explore in detail the various types of CDSCO registration available in India, their importance, eligibility, and the procedures involved. Whether you are a manufacturer, importer, or exporter of pharmaceuticals, medical devices, or cosmetic products, understanding the scope of CDSCO registrations is essential.

Types of CDSCO Registration in India

1. Drug Manufacturing License

A Drug Manufacturing License is the foundational registration required by pharmaceutical companies in India. It is mandatory for any individual or entity intending to manufacture drugs for sale or distribution in the country. This license ensures that all manufacturing activities are in compliance with Schedule M of the Drugs and Cosmetics Act, 1940, which lays down detailed guidelines for quality control, infrastructure, hygiene, personnel qualifications, and operational protocols.

The Drug Manufacturing License is issued by the State Licensing Authority (SLA) but operates under the oversight and coordination of CDSCO, especially for manufacturing drugs listed under the central list.

There are different categories under this license, such as:

• Form 25 – For the manufacture of non-schedule drugs

• Form 28 – For the manufacture of schedule C and C1 drugs (biological products)

• Form 29 – For experimental or testing purposes

Obtaining a drug manufacturing license typically requires a detailed application, site inspection, submission of technical personnel details, quality assurance mechanisms, and proof of compliance with Good Manufacturing Practices (GMP).

2. Import License

An Import License issued by CDSCO is required when a company or an individual seeks to import drugs, cosmetics, or medical devices into the Indian market. The primary purpose of this license is to ensure that imported products meet Indian standards of safety and efficacy before they are allowed for commercial sale or distribution.

The license is governed under Rule 24 of the Drugs and Cosmetics Rules, 1945, and varies based on the type of product:

• Form 10 – For import of drugs (excluding Schedule X drugs)

• Form 10A – For import of drugs falling under Schedule X

• Form 11 – For import of small quantities of drugs for personal use, examination, or testing

Applicants must obtain a Registration Certificate (Form 41) for the foreign manufacturer and product before applying for an import license (Form 10). Moreover, documents such as Free Sale Certificates, GMP Certificates, and Undertakings from the manufacturer are also required.

The import license is vital for multinational pharmaceutical and device companies operating in India through collaborations, distributors, or subsidiaries.

3. Registration Certificate for Drugs

A Registration Certificate for Drugs (Form 41) is essential for foreign manufacturers who intend to register their products in India before they are eligible for import or marketing. This certificate verifies that the foreign drug or pharmaceutical product has been evaluated and approved for compliance with Indian standards.

Before a foreign drug can be marketed or sold in India, the manufacturer must designate an Authorized Indian Agent (AIA) to act on its behalf. The agent must apply to CDSCO with complete dossiers containing:

• Product composition and label

• Manufacturing process details

• Clinical trial reports (if applicable)

• Regulatory approvals from the country of origin

CDSCO follows a stringent review mechanism, often requiring bioequivalence studies, safety data, and pharmacological evidence. Upon satisfaction, the registration certificate is granted for five years or until the product’s license validity expires.

This registration is important  for ensuring that the products entering Indian territory are not counterfeit or substandard.

4. Medical Device Registration

Medical Device Registration is another key form of CDSCO registration, particularly important since India implemented a structured regulatory framework for medical devices under the Medical Device Rules, 2017. These rules categorize medical devices into four classes based on risk:

• Class A – Low risk (e.g., thermometer)

• Class B – Low-moderate risk (e.g., hypodermic needles)

• Class C – Moderate-high risk (e.g., infusion pumps)

• Class D – High risk (e.g., implantable pacemakers)

Depending on the classification, the registration process and CDSCO’s involvement vary. While Class A and B can be approved at the State Licensing Authority level, Classes C and D require approval directly from CDSCO.

The registration includes submitting:

• Device Master File (DMF)

• Plant Master File (PMF)

• ISO 13485 Certification

• Clinical investigation data

• Undertaking of compliance with BIS standards

The objective is to ensure that medical devices entering the Indian market are safe, reliable, and effective, minimizing risks to patients and healthcare providers.

5. Clinical Trial Approval

Before launching new drugs or medical devices in the Indian market, manufacturers must obtain Clinical Trial Approval from CDSCO. This is mandated under Schedule Y of the Drugs and Cosmetics Rules, 1945, which outlines the requirements for conducting clinical trials in a scientific and ethical manner.

A clinical trial approval is essential for evaluating:

• Safety

• Tolerability

• Pharmacokinetics

• Efficacy

Manufacturers or sponsors must submit an application using Form CT-04 to the Clinical Trials Division of CDSCO, along with the protocol, investigator brochure, and Institutional Ethics Committee (IEC) approvals. The trials are registered with Clinical Trials Registry – India (CTRI) and are monitored by the Subject Expert Committees (SEC) for compliance and integrity.

This registration is vital not just for new drug approvals but also for global clinical research organizations (CROs) conducting Phase I–IV trials in India.

6. Good Manufacturing Practice (GMP) Certification

GMP Certification, though indirectly administered by CDSCO, is a critical requirement for any pharmaceutical manufacturing company seeking credibility in the global or domestic market. While CDSCO does not issue the GMP Certificate directly, it lays down the Schedule M compliance norms, which are enforced by state licensing authorities under CDSCO supervision.

GMP ensures the consistent quality, safety, and efficacy of pharmaceutical products. It covers multiple aspects:

• Quality assurance systems

• Documentation and record-keeping

• Sanitation and hygiene

• Equipment validation and calibration

• Training of personnel

A GMP-certified manufacturer enjoys better market access, credibility in exports, and regulatory alignment with agencies like WHO, US FDA, or EMA. Exporting pharmaceutical companies often combine GMP certification with COPP (explained below) for enhanced international acceptance.

7. Certificate of Pharmaceutical Product (COPP)

A Certificate of Pharmaceutical Product (COPP) is issued by the licensing authority (under CDSCO guidance) to facilitate export of pharmaceutical products. It confirms that the product is registered and marketed in India and is manufactured in compliance with WHO-GMP norms.

The COPP is an essential document when a pharmaceutical company wants to export its drug to other countries under the WHO Certification Scheme. The certificate contains:

• Product details

• License number and validity

• GMP compliance confirmation

• Conditions of marketing approval

The COPP enhances the global trust in Indian pharmaceuticals and helps streamline the registration process in the importing country. To obtain this certificate, companies must ensure their product is duly registered in India and the facility is inspected for GMP compliance.

Conclusion

CDSCO registrations are an integral part of India’s regulatory landscape for healthcare products. From drug manufacturing and import licenses to clinical trial approvals and GMP certifications, each type of registration ensures that only quality-compliant and scientifically validated products are available in the market. Understanding the different types of CDSCO registrations not only helps businesses comply with Indian laws but also enhances their credibility, marketability, and export potential. As India continues to grow as a global hub for pharmaceuticals and medical devices, aligning with CDSCO’s regulatory framework is no longer just a requirement—it’s a strategic advantage.

For manufacturers, importers, researchers, and exporters, timely and accurate compliance with CDSCO guidelines is the key to successful operations and market expansion.

If you need any support in obtaining any of these CDSCO Registration, then you can book a consultation with experts through email info@ccoffice.in or Call/Whatsapp at +91 9988424211.

FAQs

Q1. What is CDSCO, and why is its registration required?

Ans. CDSCO (Central Drugs Standard Control Organisation) is India's national regulatory authority under the Ministry of Health and Family Welfare. Its registration ensures that drugs, medical devices, and cosmetics meet Indian safety, efficacy, and quality standards before being manufactured, imported, sold, or exported in India.

Q2. What is the difference between an Import License and a Registration Certificate for Drugs under CDSCO?

Ans. An Import License (Form 10/10A) allows Indian entities to import drugs or cosmetics. In contrast, a Registration Certificate (Form 41) is issued to foreign manufacturers for registering their products before applying for an import license. Both are mandatory steps for introducing foreign pharmaceutical products into India.

Q3. Is CDSCO Medical Device Registration mandatory for all medical devices?

Ans. Yes, medical device registration under CDSCO is mandatory for all notified medical devices as per the Medical Device Rules, 2017. Depending on the risk class (A to D), the device must be registered either at the state level or directly with CDSCO before it can be marketed in India.

Q4. What is the validity of a Drug Manufacturing License issued under CDSCO regulations?

Ans. The Drug Manufacturing License is generally valid for five years from the date of issue. However, manufacturers must comply with ongoing Good Manufacturing Practices (GMP), maintain infrastructure standards, and renew the license before expiration to continue operations without interruption.

Q5. Can a company conduct clinical trials in India without CDSCO approval?

Ans. No, clinical trials cannot be conducted in India without CDSCO’s approval. The sponsor or CRO must obtain clearance using Form CT-04 and get prior approval from the Ethics Committee and Clinical Trials Registry–India (CTRI) as mandated under Schedule Y of the Drugs and Cosmetics Rules.

Q6. What is the purpose of a Certificate of Pharmaceutical Product (COPP)?

Ans. A COPP is issued for exporting Indian-manufactured pharmaceutical products and confirms that the drug is approved, marketed, and manufactured as per WHO-GMP guidelines. It simplifies regulatory approvals in foreign countries that accept COPP under the WHO certification scheme.

Q7. Is GMP Certification issued by CDSCO or State Authorities?

Ans. GMP Certification is issued by the State Licensing Authorities, but the compliance requirements are governed by CDSCO under Schedule M of the Drugs and Cosmetics Rules. CDSCO may conduct inspections or audits to ensure adherence to national and international GMP norms.