Key factors to keep in mind while getting approval for wholesale drug license registration
- A wholesale drug license is required for manufacturing, distribution, sale, or storage of drugs.
- The Drugs and Cosmetics Act, 1940 outlines the requirements to obtain a manufacturing license in India.
- The wholesale drug license has a lifetime validity and the entire licensing procedure takes 1 month to complete.
Introduction
The primary concern of the Government is to ensure that every person has equal and fair access to drugs and medicines with affordable prices. The primary step in beginning drug production is securing a drug license from the relevant authorities.
The country’s pharmaceutical distribution and sales are regulated by the CDSCO. To ensure safety of drugs being sold in the market, the CDSCO has multiple licenses in place. A wholesale drug license is a must for any importer or manufacturer who wishes to sell any drugs in the Indian market.
Drug controlling authority
The Drugs and Cosmetic Act, 1940 assigns the duty of issuing various drug permits to different drug controlling authorities. The following are the drug licencing and governing authorities:
| Licensing Authority | Role |
| State Drugs Standard Control Organisation (SDSCO) | Grants licenses for the manufacture, distribution, and sale of pharmaceuticals under state regulation. |
| Central Drugs Standard Control Organisation (CDSCO) | Responsible for authorizing and distributing licenses for newly created pharmaceuticals and drug clinical studies. Additionally, it collaborates with the SDSCO and oversees the standard of the imported medications. |
| State Drug Controlling Authority with approval by the Central License Approving Authority | Grants licenses for the development of blood banks and the sale of associated supplies, including vaccines and sera. |
| Department of AYUSH | Responsible for issuing permits for ayurveda, unani, siddha, homeopathic, and herbal items for use in cosmetic and medicinal procedures. |
Need for wholesale drug license
A wholesale drug license is required for manufacturing, distribution, sale, or storage of drugs. The license serves as proof that you are a legitimate individual operating a legitimate pharmaceutical manufacturing or distribution business.
The Drugs and Cosmetics Act, 1940 and the Drugs and Cosmetics Rules, 1945, help the government regulate and monitor the quality of drugs sold in India. Indian law prohibits the production of pharmaceuticals without registration.
Prerequisites for obtaining drug license
The manufacturer or company should meet the following criteria to obtain a wholesale drug license:
| Prerequisite | Criteria |
| Qualification | The individual must possess a degree or diploma from a reputable university or institution, as well as a minimum of one year working with drugs, or they may hold an SSLC degree and have four years’ worth of such experience. |
| Space Requirement | The area of the pharmacy should be at least 15 square meters |
| Storage Facility | The premises should have an air conditioner for pharmaceuticals and a refrigerator for products since some drugs need to be stored at a low temperature |
| Technical Staff | A registered state pharmacist with experience and authorized degree who will supervise the business can apply for the wholesale drug license |
Process of obtaining wholesale drug license
The entire licensing procedure takes 1 month to complete. The wholesale drug license application must be completed online. Within 5 days, the licensing body will send the application to the drug inspector, and if everything is in order, the application will be approved.
The drug inspector will accept or decline the application within 10 days. The license will take 15 days to print, and the authorized employees must do so 3 days after the approval and hang it on the wholesale property.
Documents required for wholesale drug license
The main documents required for issuing a wholesale drug license include:
- Form No. 19
- Challan fees – Rs. 3000/-
- Affidavit of proprietor on stamp paper of 20 Rs.
- Educational certificate copies of proprietor (Self-attested)
- Self-attested copies of Identity proof of proprietor (Domicile/ Driving license/ Voter ID card)
- Affidavit of Regd. Pharmacist
- Educational certificate copies of Regd. Pharmacist (Self attested)
- Self-attested copies of Identity proof of Regd. Pharmacist (Domicile/ Driving license/ Voter ID card)
- Blueprint of Plan layout of proposed area/ premises
- Electricity bill of proposed area/ premises
- Rent agreement (50 Rs. Stamp paper)
- Ownership document of the premises including the copy of tax receipt of proposed area/ premises.
- Covering letter
- Photo 5-5 each of Regd. Pharmacist and proprietor
All documents submitted should be in PDF format.
Validity of wholesale drug license
The wholesale drug license has a lifetime validity unless it is terminated by the drug inspector due to any reason. However, a renewal fee must be submitted every five years to retain the license.
Conclusion
The main goal of any government is to guarantee that everyone has equitable access to pharmaceuticals and quality medical care. The wholesale drug license governs the nation’s pharmaceutical sales and distribution. The prerequisites for obtaining a manufacturing license in India are outlined in the Drugs and Cosmetics Act, 1940. The application process is entirely online and very convenient. Unless terminated by the drug inspector for a particular reason, the wholesale drug license has a lifetime validity.
CliniExperts is one of the leading regulatory consultancy agencies in India with expertise in obtaining licenses and approvals from the Central Drugs Standard Control Organisation (CDSCO). For a wholesale drug license, CliniExperts provides strategic planning services so that you may establish your pharmaceutical company and distribute drugs at the distributor level.
References
- GOVERNMENT OF INDIA MINISTRY OF HEALTH AND FAMILY WELFARE (Department of Health) THE DRUGS AND COSMETICS ACT AND RULES THE DRUGS AND COSMETICS ACT, 1940 (23 OF 1940) THE DRUGS AND COSMETICS RULES, 1945 [Internet] [cited 01 Aug, 2023]
Available from: https://cdsco.gov.in/opencms/export/sites/CDSCO_WEB/Pdf-documents/acts_rules/2016DrugsandCosmeticsAct1940Rules1945.pdf - How To Get Wholesale Drug Licenses In India? -CliniExperts [Internet]. 2022 [cited 01 Aug, 2023]
Available from: https://cliniexperts.com/how-to-get-wholesale-drug-licenses-in-india/
Saurangi is a food regulatory expert with 8 years of experience. She shares her knowledge and insights on regulatory updates, food trends, best practices, and news. Follow her for expert insights and practical advice on all things for food regulatory
Saurangi Shah
CliniExperts Services Pvt. Ltd.
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