Drug License

What are the Basic Requirements for Wholesale Drug License?

calendar03 Aug, 2022
timeReading Time: 3 Minutes
Requirements for Wholesale Drug License

If anyone wants to start a Pharma business in India, a Drug License is required. The CDSCO (Central Drugs Standard Control Organisation) issues Drug License in India. However, the Drug Control Organisation issues 2 types of Drug licenses in India: Retail Drug License and Wholesale Drug License. For an independent agent or distributor or company to be an authorised Indian agent for foreign or local manufacturing at the CDSCO, they must have a valid Wholesale Drug License. But before obtaining a Wholesale Drug License, one must know all the basic requirements for Wholesale Drug License. In this write-up, we will discuss the basic requirements for Wholesale Drug License.

Qualification to Obtain Wholesale Drug License

An individual who applies for Drug Licenses should possess one of the following qualifications:

  1. A minimum of one year of experience as a salesman in a registered Wholesale Drug Licensed firm after graduation;
  2. The pharmacist must be registered person under the Pharma Council;
  3. For non-graduates, the experience tenure has been capped at 4 years.

Requirements for Wholesale Drug License in India

Following are the requirements for Wholesale Drug License in India:

  1. Area: To start a Wholesale outlet, the minimum area required is 15 square meters.
  2. Storage Facility: Certain drugs such as vaccines, insulin injection, sera, etc., need to be stored refrigerated. So, it is compulsory that there must have an air conditioner and refrigerator on the premises.
  3. Technical Staff: The sale of the drug by wholesale shall be made either in the presence of registered pharmacists or in the presence of a competent person or individual who shall be a graduate SSLC with one year of experience in dealing with drugs or an individual who has passed SSLC with four years of experience in dealing in drugs, specially approved by the department of drug control.

Document Requirements for Wholesale Drug License in India

The required documents may vary state by state. However, the following is the list of document requirements for Wholesale Drug License in India:

  1. Application in Form-19 along with the declaration;
  2. Applicant’s qualification;
  3. Copy of Board Resolution;
  4. Key Plan & Site Plan;
  5. (No Objection Certificate) NOC[1] from the Property Owner, in case the premises are rented property;
  6. Copy of challan (Proof of payment of a fee);
  7. Identity proof of a Partner or Director or Proprietor;
  8. MOA (Memorandum of Association) and AOA (Article of Association) in the case of a company;
  9. Submit Partnership Deed in case of a Partnership and Submit LLP Agreement in case of an LLP;
  10. Affidavit stating that the Partner or Director or Proprietor has never been convicted;
  11. Affidavit from the competent person or pharmacist;
  12. A cover letter containing the name & designation of the applicant;
  13. Qualification certificate, experience certificate, and appointment letter of the pharmacists or the competent person;
  14. Proof of cold storage, refrigerator, air conditioner etc.

Note: After submission of all the document requirements for Wholesale Drug License as mentioned above, CDSCO ensures that inspections are held by a Pharmacy Inspector. Strict norms or rules have been formulated to maintain the display, storage, and sale of drugs.

Document Requirements for Wholesale Drug License Renewal

The registered person seeking the renewal of a Wholesale Drug License must have the following documents in place:

  1. Form-19 properly filled by the applicant;
  2. Copy of the receipt of the challan;
  3. Registration Certificate of the Pharmacist (not been in the expired state) issues by the pharmacy council;
  4. Copy of the latest certificate of renewal;
  5. Photo id such as Aadhar, PAN, Voter Id, etc.;
  6. Self-declaration of the applicant properly validated by the Notary Public, where the applicant is not serving as a registered pharmacist;
  7. In case of any change or addition, the revised site plan and layout plan of the proposed premises clearly show the shop size, furniture details, adjoining areas, and fixtures provided, building location, if any;
  8. In case of change in the premises, ownership proof or possession of the proposed premises, i.e., the latest copy of the allotment letter or Rent Agreement or Deed in case of allotted or rented accommodation.

Conclusion

Drugs are typical commodities and are widely used to cure human diseases; that’s the reason why the Government has introduced strict norms and regulations for its distribution, selling & manufacturing. So, those who seek a Wholesale Drug License must have aforesaid requirements for a Wholesale Drug License in place. Drug License is issued by the competent authority under the Drugs & Cosmetic Act, 1940 to carry out a business regarding drugs, medicines, or cosmetics.

Read our Article:6 Viable Benefits of Wholesale Drug License that worth Your Attention

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