Drug License- Wholesale & Retail Trade
Drug License for Wholesale and Retail Trade is a legal requirement for any business involved in the wholesale or retail sale of drugs and medicines in India. It is issued by the State Drugs Control Department or the Central Drugs Standard Control Organization (CDSCO) and is required to ensure that the sale of drugs is done in compliance with the regulatory requirements.
The Drug License for Wholesale and Retail Trade can be of two types:
- Wholesale Drug License: This license is required for businesses engaged in the wholesale trade of drugs and medicines. The license is issued to the wholesale distributor, and it permits the sale of drugs in bulk to retailers, hospitals, and other institutions.
- Retail Drug License: This license is required for businesses involved in the retail sale of drugs and medicines to the general public. The license is issued to the retailer, and it permits the sale of drugs to individual consumers.
The following are the eligibility criteria and documents required to obtain a Drug License for Wholesale and Retail Trade:
Eligibility criteria for Wholesale Drug License:
- The applicant must be a registered firm or company.
- The applicant must have a minimum of one year of experience in the drug trade.
- The applicant must have a minimum of 1200 square feet of storage space.
- The applicant must have a qualified and registered pharmacist.
- The applicant must have a valid Goods and Services Tax (GST) registration.
Eligibility criteria for Retail Drug License:
- The applicant must be a registered firm or company.
- The applicant must have a qualified and registered pharmacist.
- The applicant must have a minimum of 10 square meters of retail space.
- The applicant must have a valid Goods and Services Tax (GST) registration.
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Document Required for Drug License- Wholesale & Retail Trade.
The following are the list of documents required to obtain a Drug License for Wholesale and Retail Trade:
- Application form
- Proof of ownership or lease of premises
- Proof of constitution of the firm or company (partnership deed or memorandum of association)
- Affidavit of the authorized signatory
- Declaration by the authorized signatory
- List of drugs to be stocked
- Details of technical staff
- Educational qualification and experience certificate of the registered pharmacist
- Proof of the appointment of the registered pharmacist
- Challan of the paid fee
- Copy of PAN card
- Copy of Aadhaar card
- Copy of Goods and Services Tax (GST) registration
- Layout plan of the premises
- Affidavit regarding storage space
- Affidavit regarding transportation arrangements
- Agreement with suppliers
- Permission letter from the owner of the premises (in case of leased premises)
The above documents are required for both Wholesale Drug License and Retail Drug License. However, the eligibility criteria and the specific documents required may vary depending on the state and the type of license applied for.
Registration Process of Wholesale & Retail Drug license
The registration process for Wholesale and Retail Drug License in India is similar and involves the following steps:
- Application: The first step is to obtain the application form for Wholesale or Retail Drug License from the State Drugs Control Department or the Central Drugs Standard Control Organization (CDSCO) website.
- Submission of Documents: The next step is to submit the duly filled application form along with the required documents to the respective State Drugs Control Department.
- Inspection: The State Drugs Control Department will conduct an inspection of the premises to ensure that the applicant is complying with the requirements of the Drugs and Cosmetics Act, 1940 and the rules framed thereunder.
- Approval: If the inspection is successful, the State Drugs Control Department will issue the Wholesale or Retail Drug License to the applicant. The license will be valid for a period of five years.
Compliance to do after Obtaining Wholesale & Retail Drug License
After obtaining a Retail Drug License, the following compliance requirements need to be fulfilled:
- Display of License: The license should be prominently displayed in the premises.
- Maintenance of Records: The licensee should maintain records of all drugs purchased and sold, along with their batch numbers, expiry dates, and other relevant details.
- Appointment of Pharmacist: A registered pharmacist should be appointed and should be present in the premises during working hours.
- Storage and Handling of Drugs: The drugs should be stored and handled as per the requirements of the Drugs and Cosmetics Act, 1940 and the rules framed thereunder.
- Sale of Prescription Drugs: Prescription drugs should be sold only on the prescription of a registered medical practitioner.
- Reporting of Adverse Reactions: Adverse reactions to drugs sold should be reported to the concerned authority.
- Renewal of License: The license should be renewed before its expiry date.
After obtaining a Wholesale Drug License, the following compliance requirements need to be fulfilled:
- Display of License: The license should be prominently displayed in the premises.
- Maintenance of Records: The licensee should maintain records of all drugs purchased and sold, along with their batch numbers, expiry dates, and other relevant details.
- Appointment of Registered Pharmacist: A registered pharmacist should be appointed and should be present in the premises during working hours.
- Storage and Handling of Drugs: The drugs should be stored and handled as per the requirements of the Drugs and Cosmetics Act, 1940 and the rules framed thereunder.
- Sale of Drugs: Drugs should be sold only to a person holding a valid license for sale or distribution of drugs.
- Sale of Prescription Drugs: Prescription drugs should be sold only on the prescription of a registered medical practitioner.
- Reporting of Adverse Reactions: Adverse reactions to drugs sold should be reported to the concerned authority.
- Renewal of License: The license should be renewed before its expiry date.
It is important to note that failure to comply with these requirements may lead to the cancellation or suspension of the Wholesale Drug License. Therefore, it is advisable to ensure that all the compliance requirements are met in a timely and effective manner.
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