Legal Obligation under CDSCO for obtaining a Wholesale Drug License - Meaning, Process, Documentation

Updated on April 17, 2024 11:38:24 AM

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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What is a Wholesale Drug License?

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.

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What is Legal Obligation under CDSCO for Obtaining 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.

  • A Wholesale Drug applicant must meet the requirements set by the Central Drugs Standard Control Organisation following the 1999 Act of Drugs and Cosmetics.
  • A prescribed area is decided and fixed for the applicant which intends to do business with Cosmetics and Drugs.
  • If there is supervision of a Certified Pharmacist or Competent Person, only then the license will be granted.
  • The main highlight of CDSCO’s education requirement is that the applicant of Wholesale Drug License must be a Certified Pharmacist and should have at least one year of experience in Drug selling.
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Procedure to acquire Wholesale Drug License under CDSCO

Following steps can be noted to understand the procedure;

Step 1: CDSCO registration Portal

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.

Step 2: Filling up the details

Fill up the space with your required details. Fill the ‘Applicant Registration Form’ providing the necessary personal and organizational details.

Step 3: Submitting the documents

Complete the application process by submitting the required documents for the verification process for authorizing the Drug Import License.

Step 4: Call for Confirmation

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.

Step 5: Approval from the Authority

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.

Step 6:Issuance 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.

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Documents required in the CDSCO Wholesale Drug License process

Important documents required in the process are as follows:

  • Covering Letter
  • Duly filled application pertaining to wholesale drug license in Form 19
  • TR6 Challan
  • A Floor Plan (Detailed drawing of the premises precisely indicating the perimeter and area in a standard format)
  • Proof of the ownership of the Premises
  • Affidavit indicating the non-indulgence of the applicant with the criminal activities under the drug and cosmetic act, 1940
  • Appointment letter of the applicant appointed as a full-time registered pharmacist
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Benefits obtained after acquiring CDSCO Wholesale Drugs License

Obtaining a Wholesale Drugs License under CDSCO have various benefits that can be seen as follows;

  • Improving a Company’s Reputation: Holding a CDSCO Wholesale license serves as proof of completing the government policy and working under all the terms and conditions, which improves the reputation of the Company in the domain.
  • Safeguard the Public Health: The vision and mission of Central Drugs Standard Control Organisation is to protect, promote, safeguard, and enhance public health by assuring the safety, efficacy, and quality of drugs to be consumed by the masses.
  • Indian Market Access: India has the largest Pharmaceuticals and medical device market in the world. CDSCO registration allows the manufacturers, importers, and pharmacists to sell their products to the consumers in the Indian Market.
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Conclusion

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

What is a CDSCO Wholesale Drug License?

A Wholesale Drug License is required by the wholesalers who deals with Drug activities as in sale of drugs or pharmaceuticals

What is the Validity of a Wholesale Drug License?

The Validity time period of a Wholesale Drug license is two-five years.

What is DCGI?

The Drug Controller General of India regulates pharmaceuticals and medical devices and its positioning with the Ministry of Health & Family Welfare.

Where to apply for CDSCO registration?

You can start the registration process on the official website of CDSCO at SUGAM Portal

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