Updated on September 16, 2025 01:18:50 PM
The Central Drugs Standard Control Organisation along with state regulators are responsible for granting licenses for Specialized Categories of Critical Drugs such as blood and blood products, I.V fluids, Vaccine and Sera. Drugs Import License is required to Import Drugs into India by following government regulations.
CDSCO is the National Regulatory Authority (NRA) of India. In India, import, manufacturing, sale and distribution of drugs is regulated under Drugs & Cosmetics Act 1940 and Rules 1945.
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A Wholesale Drug License is required by the wholesalers who deals with Drug activities as in sale of drugs or pharmaceuticals. A Wholesale Drug License is granted by the Individual State Licensing Authority.
A Duly Notarized and Valid Copy of the Wholesale license for sale or distribution of drugs must be submitted under Drugs and Cosmetics Rules, 1945 in the form 20B and 21B for obtaining the CDSCO Wholesale License.
“Legal Obligation refers to a person’s Legal Duty to do something”.
Legal Obligation under CDSCO Wholesale Drug License refers to the applicant that must meet the specific criteria and standards which are set and fixed by the Central Drugs and Standard Control Organisation.
Following steps can be noted to understand the procedure;
You need to visit the official website of CDSCO, then you have to apply on the registration portal which is “SUGAM”. Click on the ‘SIGN UP HERE’ option to apply for the registration.
Fill up the space with your required details. Fill the ‘Applicant Registration Form’ providing the necessary personal and organizational details.
Complete the application process by submitting the required documents for the verification process for authorizing the Drug Import License.
A Confirmation link will be sent to the registered email Id to verify the registration. To activate your account on the SUGAM portal, you need to click on the confirmation link.
Once the Confirmation link is clicked, the application for registration will be sent to the concerned authority, to the CDSCO officials for approval of the license.
After completing the whole procedure, your documents will undergo a verification process to see any secrecy. If the officer gets satisfied with the whole document procedure then the License for Drug Import will be authorized to you.
After submitting the required documents, CDSCO ensures that the premises investigations are held by the officers. Under the Drugs and Cosmetics Act, 1940, Strict regulations are made by the authority to maintain the storage, display & sale of drugs.
Important documents required in the process are as follows:
Obtaining a Wholesale Drugs License under CDSCO have various benefits that can be seen as follows;
In India import, manufacturing, sale and distribution of drugs is regulated under Drugs & Cosmetics Act and Rules, 1940 and 1945. Within the CDSCO, the Drug Controller General of India (DCGI) regulated pharmaceuticals and its positioning with the Ministry of Health and Family Welfare. India, being the largest pharmaceutical market in the world, it is mandatory to require a Wholesale Drug license by the individuals who deals with drug activities.
You can acquire CDSCO Wholesale Drug License with Professional Utilities at ₹99,999/- + additional fee for the government applications.
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Frequently Asked Questions
A Wholesale Drug License is required by the wholesalers who deals with Drug activities as in sale of drugs or pharmaceuticals
The Validity time period of a Wholesale Drug license is two-five years.
The Drug Controller General of India regulates pharmaceuticals and medical devices and its positioning with the Ministry of Health & Family Welfare.
You can start the registration process on the official website of CDSCO at SUGAM Portal
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