What are the Documents required for a Drug License?

The government of India has made stringent Drug License laws to regulate the production, storage, and sale of drugs and medicines in the market. 

The main end-to-end regulatory framework legislation dealing with drug license laws is the ‘Drugs and Cosmetic Act, 1940’. It aims to stop the manufacturing and sale of counterfeit drugs, misuse, illegal hoarding, and the distribution of medicines. In 1964, the Ayurvedic and Unani medicines were given a place in this act for proper regulation.   

Importance of Documents

By and large, documents play a critical role in obtaining a Drug License in Rajasthan. The government wants to ensure that only good-quality drugs reach the pharmaceutical shops and are not abused by anyone. Therefore, your pharmacy business documents should be updated to show compliance.

What is a ‘Drug’ according to Section (b) of the Drugs and Cosmetic Act, 1940?

Table of Content

1. Introduction 
2. Importance of Documents
3. Types of Drug License 
4. General Documents required for a Drug License
5. Specific Documents for Retail Drug License
6. Specific Documents for Wholesale Drug License
7. Specific Documents for Manufacturing Drug License
8. Documents for Drug License Renewal
9. Role of Drug Establishment Database
10. Process of Application
11. Pre-requisites for Obtaining the Drug License in Rajasthan
12. Conclusion

Types of Drug License

The application for drug license for manufacturing should be submitted to the Central Drugs Standards Control Organization (CDSCO) of India. The application for drug sales should be submitted to the respective State Drug Standards Control Organization (SDSCO). 

Before you consider getting your drug license number, we will discuss the types of licenses to see which drug establishment license will suit your business. 

Drug Manufacturing License :-

Drug Wholesale License :-

Drug Retail License :-

Drug Loan License:-

Drug Import License :-

Multi-Drug License :-

General Documents required for a Drug License 

• ID Proof of Proprietor/Owner – Documents like Passport, Aadhaar Card, Voter ID, and Driving License.
• Address Proof of Business Premises – Rental document, Property ownership document, Electricity Bill. 
• Photograph of Applicant – Furthermore, submit 5 passport size photographs of the applicant. 
• Education Qualification Proof – It included copies of certificates of degree/diploma in Pharmaceutical sciences. These copies should be self attested.
• Company Incorporation Documents – Article of Association, Memorandum of Association, Partnership Deed, and LLP Agreement in case of LLP.
• Affidavit stating Non-Conviction of the Owner/Proprietor/Director as well as the firm under Drugs and Cosmetic Act, 1940. 
• Building Premises Detail – The Structural plan of the site/business premises. Additionally, it should show the storage area for drugs.
•  Cover Letter – A cover letter stating the Name and Designation of the applicant.
•  Application Form – Correctly filled Application Form for the type of License the applicant seeks.
• Affidavit from the registered pharmacist/Competent person.
• Copy of Board Resolution – It stated the permission by the Firm’s Board to obtain a drug license.  
• Copy of Challan – A copy of a Challan of rupees 3000 as a proof of fees deposition.
• Copy of Electricity Bill – Electricity bill of the business premises.
• Refrigerator Purchase Bill copy – A copy of refrigerator bill is essential.
• Air-Conditioner Purchase Bill – Additionally, this bill is also required.
• List of Drugs – If you want to obtain Wholesale Drug License then you have to submit a list of drugs your business seeks to deal in. 
• GST Registration Number (if required)  

Specific Documents required for a Retail Drug License 

Whenever you start the ‘application for drug license’ process, these additional documents should be submitted alongside the general documents stated above. And so, these documents are mentioned below-

• Copy of Diploma in Pharmacy.

• A Registration Certificate from the Pharmacy Council.

• Appointment Letter.
• Experience Letter (if any)

Specific Documents required for a Wholesale Drug License 

People get confused regarding how to get a wholesale drug license in Rajasthan. In short, besides the general documents, we will mention that these specific documents are required to get your drug license number.

• Copy of Diploma in Pharmacy

• Form 19

• Letter of Purpose for obtaining the drug License

• Copy of Receipt of Property Tax

• Appointment Letter
• Experience Letter (if any)

Specific Documents required for a Manufacturing Drug License 

Lastly, for obtaining a drug manufacturing license in India you need to submit these following documents alongside the general documents mentioned above. 

• Documents of Agreements between the manufacturer and the loan licensee
• Valid Drug Manufacturing License of the manufacturer

Specific Documents required for a Drug License Renewal

The drug license renewal is an essential aspect of the pharmaceutical business. In-fact, it is one of the most critical things to remember as a business owner in India. While applying for renewal, you have to submit the following documents –

• Last Renewal Certificate.

• Coloured Copy of Unique Pharmacist Registration Certificate.

• Current Passport-size photo of the applicant.

• Identification Proof – Aadhar Card, Driving License, Voter ID, or Passport.

• Appointment Letter.
• Evidence proof of Last Name change (if any)

Role of Drug Establishment Database 

The Central Drugs Standards Control Organization (CDSCO) under the Union Health and Family Welfare Ministry has made an effort to constitute a 7-member panel for creating a digital Drug National Database of pharmaceutical manufacturers and the drugs and cosmetics they manufacture. The role of the Drug Establishment License Database is given below-

Process of Application for Drug License

In this section, we will explain the question, ‘How to get a drug license?’ We will discuss the step-by-step process of obtaining a drug license in Rajasthan. 

1. Visiting the Official Website – The applicant should visit the official website of the concerned licensing authority. This depends on the type of license they are applying for. These authorities are – SDSCO, CDSCO, and Ayush. To apply for a Wholesale Drug License, you must visit the concerned State website.

1. Application Form Filing – In order to obtain a license, the applicant must carefully complete all the points of the application. The application for a drug license is a serious document, and it should be filled out without any mistakes.

1. Uploading Required Documents—After completing the form, the applicant must upload all the required documents online. Keep your records updated accordingly. 

1. Online Payment of Fees—As an applicant, you pay the fees according to the rules. There are different fees for each type of drug license.

1. Inspection by Authorities/Officer – After submitting your application form, an Inspector will arrive at your business premises to verify documents and facts (mentioned in the application). 

1. Issuance of Drug License – Lastly, after the verification is done by the Inspector, the Drug Controller will approve and issue your Drug License. You will be allotted a drug license number for future business use. 

Pre-requisites in obtaining Drug License in Rajasthan 

1. Qualification of the Applicant – Qualification of the Applicant – The applicant should hold a diploma/degree in pharmaceutical science to obtain Retail Drug License in Rajasthan. For a Wholesale Drug License, the applicant should be a graduate with 1 year of experience or an undergraduate with 4 years of training. 

1. Premises Requirement – For obtaining any drug establishment license, a prescribed size of business premises is required. 

• For a Retail Drug License in Rajasthan – The medical shop should be 10 square meters.
• For Wholesale Drug License in Rajasthan – The building premises should be 15 square meters. 
• Storage Area – The area for drugs storage should be of low temperature with an air-conditioner and a refrigerator. 
• Trained Staff – Always hire a well-qualified and trained staff for your drug store or drug wholesale business. 

Conclusion 

The government is primarily concerned about the health and well-being of citizens, and providing medicines and essential drugs is crucial. For this, the government has required Pharmaceutical businesses to follow the strict guidelines of the FDA and CDSCO. 

Whether you want to obtain a retail, wholesale or manufacturing drug license, you must follow all CDSCO, FDA, and the Ayush Ministry rules and regulations. We have provided a detailed list of documents for each type of drug license, making it easier for you to apply for the same. We have even provided the documents required for drug license renewal in Rajasthan. 

If you own a drug business, we advise you to stay updated with current government rules for the Pharmaceutical Industry and keep your documents updated.

For any queries regarding how to get a drug license in India contact our Legal Window’s expert team.  

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