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Looking for a trusted CDSCO consultant in Gurgaon? PSR Compliance offers expert guidance for obtaining CDSCO registration, ensuring compliance with all regulatory requirements. Our services include:
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The Drugs and Cosmetics Act, 1940 and the Drugs and Cosmetics Rules, 1945 govern the manufacture, sale, import, and distribution of drugs, medical devices, and cosmetics in India. Under these regulations, any product classified as a drug or medical device must be registered before it can be imported, manufactured, or sold in the country.
The Central Drugs Standard Control Organisation (CDSCO) is the national body responsible for granting this registration. As India's National Regulatory Authority, CDSCO's approval is mandatory before any drug clinical trial can proceed, and it sets and monitors quality standards for medicines, cosmetics, and medical devices nationwide.
Whether you're an importer, manufacturer, or authorized Indian representative of a foreign business, a single CDSCO registration - filed through the CDSCO SUGAM Portal — covers your regulatory obligations for market entry.
CDSCO is India's national regulatory authority for pharmaceuticals and medical devices, operating under the Directorate General of Health Services, Ministry of Health & Family Welfare. It primarily oversees new drug approvals and clinical trials, and it frames quality standards under the Drugs and Cosmetics Act, 1940, and its accompanying Rules of 1945.
CDSCO now also assesses all categories of medical devices — including implants and contraceptives — under an expanded regulatory mandate. For specialized categories such as blood products, IV fluids, vaccines, and sera, CDSCO works in coordination with State Drug Control Authorities to issue licenses.
Manufacturers, importers, and exporters involved in pharmaceuticals or cosmetics also typically conduct bioavailability (BA) and bioequivalence (BE) studies — data that feeds into the same CDSCO registration process.
CDSCO registration verifies that a drug, cosmetic, or medical device is safe and effective for public use. It gives products legal standing to be sold in India and builds consumer trust by confirming the product has cleared rigorous quality checks.
A CDSCO license offers tangible advantages to businesses in the pharmaceutical, medical device, and cosmetic industries:
CDSCO registration is the legal gateway to marketing and selling medicines, medical devices, and cosmetics in India.
Registration ensures adherence to India's pharmaceutical and healthcare laws, reducing the risk of penalties or legal disputes.
CDSCO enforces Good Manufacturing Practice (GMP) standards through regular audits and inspections, helping maintain consistent manufacturing quality.
CDSCO sets strict benchmarks for safety, efficacy, and quality — registration signals that your product and processes meet these defined criteria.
A CDSCO certificate acts as a regulatory seal of approval, reassuring consumers that the product has been tested for safety and efficacy.
For exporters, CDSCO registration — particularly the Certificate of Pharmaceutical Product (COPP) — is often a prerequisite for regulatory clearance in the destination country.
Filing through the CDSCO online SUGAM portal reduces paperwork, cuts administrative costs, and speeds up processing compared to manual submissions.
The online portal allows applicants to track application status in real time, staying informed on requirements and progress at every stage.
The CDSCO web portal is open for registration to the following applicants:
Note: Manufacturing units cannot register directly on the portal. A company must first establish login credentials for the production unit to gain access.
Although CDSCO registration is processed online, specific documents must be uploaded to complete the application:
CDSCO registration is completed entirely online through the SUGAM portal. Here's how the process works:
Processing time varies significantly by product category and risk classification. Here's an indicative timeline:
Note: Actual timelines depend on product complexity, dossier completeness, inspection requirements, and CDSCO query cycles. PSR Compliance's proactive follow-up process helps minimize avoidable delays.
The types of CDSCO drug license or certifications are mentioned below:
Required for businesses producing pharmaceuticals; confirms the production unit meets all applicable rules and specifications.
Granted after a comprehensive assessment of a product's safety, effectiveness, and formulation data. Essential for marketing and sales in India.
Required for manufacturers looking to import drugs, cosmetics, or medical devices into India, validating that imported goods meet CDSCO's quality standards.
Mandatory for organizations conducting clinical trials on new medications, ensuring studies follow ethical and scientific protocols that protect participant safety.
Issued to wholesalers and distributors, permitting them to store and distribute drugs and medical devices under required storage and documentation conditions.
Mandatory for pharmacies and retail outlets selling drugs or medical devices, covering both prescription and over-the-counter products.
Ensures medical devices meet safety and quality standards; requires details on device design, intended use, and manufacturing process.
Granted to manufacturing facilities that comply with production guidelines for medicines, denoting adherence to quality assurance controls.
Required for businesses manufacturing or importing skincare, makeup, and personal hygiene products, ensuring compliance with safety, quality, and labelling regulations.
Exported with pharmaceutical products, attesting to the product's approval for sale in the destination country.
Getting a CDSCO license is only the first milestone — ongoing compliance is equally important to avoid suspension or cancellation:
PSR Compliance offers ongoing post-registration support, so your license stays active and audit-ready year-round.
Renewing your CDSCO license on time is essential to avoid gaps in your ability to manufacture, import, or market products legally. Here's how it works:
A CDSCO registration certificate is valid for three years from the date of issuance, unless suspended or cancelled earlier. PSR Compliance tracks your renewal timeline and initiates the process well ahead of expiry.
Talk to a CDSCO Renewal Expert
Getting a CDSCO registration involves several interlinked procedures — even though the process is online, a minor error can cause significant time and financial loss. That's where professional guidance pays off.
Get expert assistance with CDSCO Registration 2026 requirements and SUGAM portal approval. Our compliance specialists handle the entire process—from product classification and documentation to final approval and post-registration audits—so your business stays fully compliant with CDSCO and state drug authority requirements.
📞 Call: 8796104190📧 Email: support@psrcompliance.com
Written by
Raju Karn
SEO Team Lead · PSR Compliance
Raju Karn has 5+ years of experience writing compliance content covering CPCB, CDSCO, BIS, EPR, FSSAI, WPS, PESO and various small and large business registrations, licenses and certifications across India.
The primary regulating agency for the Indian pharmaceutical and medical device industry is the Central Drugs Standard Control Organization (CDSCO). Medical device sales in India are under the jurisdiction of the State Food and Drug Administration (State FDA). Any medical device sold in India must have a wholesale drug license form MD 20 B/21 B or a registration certificate form MD 41/42.
Medical devices and IVDs are regulated by the Drug Controller General of India (DCGI) within the Central Drugs Standard Control Organization (CDSCO), a division of the Ministry of Health and Family Welfare.
Starting on October 1, 2022, items classified as class A and class B are required to get CDSCO certification; products classified as class C and class D will require certification starting on October 1, 2023. Products falling to Class A (measuring and sterile), Class B, Class C, and Class D require a CDSCO license.
The corresponding quantity of medicine that enters the intrinsic circulation and has the capacity to exert an active effect on the body is known as its bioavailability, or BA. On the other hand, BE, or bioequivalence refers to two medications whose purpose is to give equal amounts of the same medication.
A CDSCO registration certificate is valid for three years from the date of issuance, unless it is suspended or canceled earlier.
PSR Compliance is a trusted CDSCO consultant in Gurgaon, offering expert support for regulatory approvals, CDSCO registration, and compliance management.
Our team provides complete assistance in obtaining CDSCO licenses, ensuring full compliance with Indian drug and medical device regulations.
CDSCO Form MD-42 is required for the registration of medical devices in India. If you need CDSCO Form MD-42 guidance, PSR Compliance provides expert support in documentation, application filing, and compliance with regulatory requirements.
Book your free consultation with our specialists today.
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