The following documents are required to obtain a wholesale drug license in India to start a wholesale pharma distribution business:
1. Filled Form 19. This form is available on the website of the Drug Controller General of India (DCGI).
2. Challan fees i.e., 3000/-Rs. The challan fee can be paid online or offline.
3. Affidavit of proprietor on stamp paper of 20 Rs. This affidavit must be signed by the proprietor of the business.
4. Educational certificate copies of proprietor (Self attested) This includes the educational certificates of the proprietor, such as a diploma or degree in pharmacy.
5. Self-attested copies of Identity proof of proprietor (Domicile/Driving License/ Voter Id Card) This includes the identity proof of the proprietor, such as a passport, driving license, or voter ID card.
6. Affidavit of Regd. pharmacist/competent person. This affidavit must be signed by the registered pharmacist or competent person who will be responsible for the day-to-day operations of the wholesale pharma distribution business.
7. Educational certificate copies of Regd. pharmacist/competent person (Self attested) This includes the educational certificates of the registered pharmacist or competent person, such as a diploma or degree in pharmacy.
8. Self-attested copies of Identity proof of Regd. pharmacist/competent person (Domicile/Driving License/ Voter Id Card) This includes the identity proof of the registered pharmacist or competent person, such as a passport, driving license, or voter ID card.
9. Blueprint of Plan layout of proposed area /premises. This blueprint must show the layout of the proposed wholesale pharma distribution business premises.
10. Copy of Refrigerator bill. This bill is proof that the wholesale pharma distribution business has a refrigerator for storing drugs.
11. Rent agreement (50 Rs.) This rent agreement is proof that the wholesale pharma distribution business has a rented premises.
12. Ownership document of the premises including the copy of tax receipt of proposed area / premises. This document is proof that the wholesale pharma distribution business owns the premises.
13. Covering letter. This letter should state the purpose of the application for a wholesale drug license.
The documents must be submitted to the Drug Controller General of India (DCGI) or the licensing authority in the state where the wholesale pharma distribution business will be located. The application process can take several weeks or months, so it is important to submit the application well in advance of the start date of the business.
In addition to the documents listed above, the wholesale pharma distribution business must also meet certain premises and storage requirements. The premises must be clean, well-ventilated, and free of pests. The storage area must be cool and dry, and it must be equipped with a refrigerator for storing drugs that require refrigeration.
The wholesale pharma distribution business must also comply with all applicable laws and regulations governing the sale and distribution of drugs in India. These laws and regulations can vary from state to state, so it is important to consult with an attorney or other legal advisor to ensure that the business is in compliance with all applicable laws and regulations.
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