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Thu, Aug 13 2026
Raju Karn
If you are planning to manufacture, import, distribute, or market drugs, medical devices, cosmetics, or other regulated products in India, understanding the CDSCO License Cost is an important part of your compliance planning.
However, there is no single fee called the “CDSCO License Fee.” The amount depends on the type of product, licence, application form, number of products, manufacturing site, risk classification, and applicable regulatory rules. CDSCO's SUGAM portal provides different fee structures for different regulatory applications.
For example, the current CDSCO SUGAM fee information lists ₹1,000 for an import licence for one drug and ₹100 for each additional drug in the applicable category. For medical devices, fees can range from $1,000 to $3,000 or more for the overseas manufacturing site, depending on the device class, with additional product-level fees.
This guide explains the CDSCO License Cost in India in 2026, including drug import licences, medical device licences, cosmetics registration, manufacturing-related applications, clinical trials, documents, online application process, and additional expenses.
The Central Drugs Standard Control Organisation (CDSCO) is India's central drug regulatory authority under the Directorate General of Health Services, Ministry of Health & Family Welfare.
CDSCO performs functions under important legislation including the Drugs and Cosmetics Act, 1940; Drugs Rules, 1945; New Drugs and Clinical Trials Rules, 2019; Medical Devices Rules, 2017; and Cosmetics Rules, 2020.
Depending on the product and activity, businesses may need approval, registration, permission, or a licence from the applicable central or state licensing authority.
Therefore, when someone searches for “CDSCO License Cost,” the first question should be:
Which CDSCO approval or licence do you actually need?
The following table provides an overview of several important CDSCO government fees.
Note: Fees vary by regulatory category and applicable rules. The table should be used as a planning reference, not as a universal fee quotation. Always verify the applicable fee for the exact application before payment. CDSCO's current SUGAM manual lists these purpose-wise fees.
One of the most searched categories is the CDSCO Drug Import Licence.
For the applicable Form 8 import licence, the CDSCO SUGAM fee schedule specifies:
The same fee structure is listed for the applicable Schedule X import licence through Form 8A.
However, the government fee is only one part of the total import compliance cost. Businesses may also need to account for:
Businesses importing drugs may also need a Registration Certificate for the foreign manufacturing site and products.
The CDSCO SUGAM fee schedule currently lists:
USD 1,000 for one product, with additional product fees applicable under the relevant fee structure.
The CDSCO SUGAM manual specifically lists these fees under Import & Registration.
Therefore, the total cost can increase significantly when a company is registering several products from the same foreign manufacturing site.
Medical device fees work differently from drug fees.
Under the Medical Devices Rules, 2017, medical devices are classified according to risk into:
CDSCO confirms this risk-based classification framework on its medical-device portal.
The applicable fee therefore depends on the device class and whether you are importing or manufacturing the device.
For an import licence under MD-14, the current fee structure includes site-level and product-level components.
Broadly, the applicable fees include:
These fees are based on the fee schedule under the Medical Devices Rules, 2017.
The exact payable amount should be checked against the current applicable regulatory provisions and SUGAM payment requirements before submission.
For manufacturers of Class C and Class D medical devices, CDSCO handles the central licensing process.
CDSCO states that an application for manufacturing a Class C or Class D medical device is made through the online portal using Form MD-7, while a loan licence application uses Form MD-8. The resulting manufacturing licences are issued in MD-9/MD-10 as applicable.
The prescribed fee for Class C/D manufacturing includes:
The fee structure is specified in the Medical Devices Rules.
Businesses importing cosmetics into India also come under the CDSCO regulatory framework.
For cosmetic import registration, the current CDSCO fee information lists:
USD 250 per cosmetic category
The CDSCO's cosmetics FAQ also confirms the USD 250-per-category fee for the applicable registration application.
The total compliance expenditure can be higher depending on the number of categories, products, documentation, labelling requirements, foreign manufacturer documentation, and professional assistance.
Businesses conducting clinical trials or seeking certain new-drug permissions may also have to pay prescribed regulatory fees.
The current SUGAM fee schedule lists:
These amounts are listed in the current CDSCO SUGAM payment information.
Clinical trial compliance, however, involves substantially more than the government fee. Sponsors may also incur costs relating to clinical sites, investigators, ethics committees, testing, documentation, insurance, monitoring, and other regulatory requirements.
Your total CDSCO License Cost can vary because of several factors.
Drugs, medical devices, cosmetics, vaccines, biological products, and other regulated products have different regulatory pathways and fee structures.
Some CDSCO applications have a base fee for one product and an additional fee for each subsequent product.
For imported products, foreign manufacturing-site registration fees may apply separately from product fees.
For medical devices, the risk classification can significantly change the applicable government fee.
Import licences and domestic manufacturing licences use different forms, authorities, and fee structures.
Certain applications may require testing, inspections, audits, or expert evaluation. These costs are separate from the basic application fee.
Most applicable CDSCO applications are submitted through the SUGAM online portal. CDSCO's Citizen Charter identifies SUGAM as the online platform for several services, including import and registration processes.
First determine whether you require a drug import licence, registration certificate, medical device licence, cosmetics registration, manufacturing permission, clinical trial approval, or another CDSCO service.
The applicable form depends on the regulatory activity.
For example:
Collect the technical, manufacturing, product, company, and regulatory documents required for the specific application.
The applicant submits the applicable application through the CDSCO SUGAM system.
Upload the prescribed documents and product information in the required format.
Pay the applicable government fee through the prescribed online payment mechanism.
CDSCO reviews the application and supporting documents. Depending on the application, queries, inspections, testing, or additional information may be required.
If CDSCO raises deficiencies or requests clarification, the applicant must submit an appropriate response within the prescribed process.
Once the applicable regulatory requirements are satisfied, CDSCO issues the relevant approval, registration, or licence.
The documents vary according to the type of application, but may include:
The exact checklist should be checked against the applicable CDSCO application category.
Choosing the wrong regulatory pathway can lead to additional work, delays, or the need to submit a fresh application.
The statutory application fee does not necessarily represent the complete cost of compliance.
For several CDSCO applications, additional products attract additional fees.
Missing technical or regulatory documents can result in queries and delays.
A medical device's risk class directly affects its regulatory pathway and applicable fees.
CDSCO regularly updates regulations, notifications, circulars, and guidance. The CDSCO website currently lists multiple regulatory updates issued during 2026, so businesses should verify the latest requirements before applying.
CDSCO applications can involve technical documentation, regulatory forms, product classification, testing, foreign manufacturer documents, SUGAM submissions, and responses to regulatory queries.
A professional CDSCO consultant can assist with:
This can help businesses avoid preventable errors and better plan their overall compliance budget.
Planning to import, manufacture, or sell drugs, medical devices, cosmetics, or other CDSCO-regulated products in India? Our CDSCO experts provide end-to-end support—from identifying the correct licence and calculating applicable government fees to SUGAM portal filing, documentation, testing coordination, and regulatory query support.
📞 Call: +91 8796104190📧 Email: support@psrcompliance.com
There is no single CDSCO licence fee. The cost depends on the type of approval, product category, number of products, manufacturing site, device classification, and applicable regulatory rules.
For the applicable Form 8 import licence, the current SUGAM fee schedule lists ₹1,000 for one drug and ₹100 for each additional drug.
Medical device fees depend on whether the device is being imported or manufactured and its risk classification. For example, the import fee structure includes site and product-level fees, while Class C/D manufacturing has prescribed site and device fees.
The current CDSCO information lists USD 250 per cosmetic category for the applicable cosmetics import registration.
Yes. Many CDSCO applications are submitted online through the SUGAM portal.
For several regulatory applications, yes. The applicable fee structure may include a base/site fee plus additional product-level fees.
No. Testing, inspection, documentation, professional consultancy, translation, technical evaluation, and other compliance expenses may be additional.
The prescribed fee includes ₹50,000 for one manufacturing site and ₹1,000 for each distinct medical device under the applicable fee structure.
For the applicable registration framework, the SUGAM fee information lists USD 1,500 for each foreign manufacturing site and USD 1,000 for each product.
Because CDSCO regulates multiple product categories and activities. The applicable fee depends on the licence type, product, number of products, manufacturing site, risk classification, and regulatory pathway.
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