Key Information

Who Issues the License to Start a Drug Store in Maharashtra?

Types of Drug Licenses

Drug License Fees in Maharashtra

Documents Required for Drug License Registration in Maharashtra

How to Apply for a Drug License in Maharashtra?

Drug License Validity and Renewal

Get a Drug License for a Medical Shop in Maharashtra with BizMantra

Frequently Asked Questions

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Who Issues the License to Start a Drug Store in Maharashtra?

The Maharashtra Drug Control Department is responsible for issuing drug licenses, overseeing the production and sale of medicines and cosmetics. Maharashtra is divided into two divisions for enforcing drug laws, each led by a Drugs Controller:

North-West Zones

South-East Zones

Since January 1986, the Drugs Control Organization has operated as a separate department, headed by the Drugs Controller.

Types of Drug Licenses

BizMantra assists with obtaining various types of drug licenses based on your business needs:

 

Manufacturing Drug License: Required for producing drugs, covering both manufacturing and distribution on a large scale with stringent regulatory standards.

 

Wholesale Drug License: Allows distribution of medicines and cosmetics at wholesale prices.

 

Retail Drug License: Required to operate a medical shop or pharmacy.

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Drug License Fees in Maharashtra
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The drug license fees in Maharashtra are as follows:

 

Wholesale Drug License : ₹59,999/-

 

Retail Drug License (Medical Store/Pharmacy Shop): ₹79,999/-

 

Manufacturing Drug License: ₹1,09,999/-

 

Approval typically takes 30-60 days, covering document preparation, online application, and assistance with inspection by authorities.

Documents Required for Drug License Registration in Maharashtra

To apply for a drug license in Maharashtra, the following documents are required:

 

Firm’s constitution (MOA & AOA for Companies, Partnership Deed for Firms/LLP)

 

Affidavit from the registered pharmacist/competent person (for Retail & Wholesale licenses)

 

Property documents (Registry Deed/Lease Deed/POA for owned property)

 

Board Resolution, List of Directors, Certificate of Incorporation (for companies)

 

Key plan and site plan of the premises (Blueprint)

 

Invoice copy of refrigerator/air conditioner purchased for use

 

Copy of the rent agreement (for rented premises)

 

Covering letter stating the purpose of the application

 

ID proof of Directors/Partners/Proprietor

 

Affidavit from employer and/or technical staff for full-time employment (for Manufacturing)

 

List of technical staff and their proof of qualification, experience certificate, biodata, appointment letter, and three photographs (for Manufacturing)

 

Registered pharmacist's degree certificate, registration certificate with the State Pharmacy Council, appointment letter, and biodata (for Retail License)

 

Competent person's degree certificate, experience certificate in the medicine field, appointment letter, and biodata (for Wholesale License)

 

Affidavit of non-conviction, list of equipment and machinery for manufacturing, and list of equipment provided for testing (for Manufacturers)

Why Choose BizMantra for Your Drug License Needs?
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At BizMantra, we understand that navigating the complexities of drug licensing can be overwhelming. Our goal is to simplify the process for you, ensuring a smooth and efficient experience. Here’s why BizMantra is the preferred choice for businesses across Maharashtra:

 
Expert Guidance and Support: Our team is well-versed with the intricacies of the Drugs and Cosmetics Act and stays updated on all regulatory changes. We provide expert guidance throughout the entire process, from document preparation to final approval, ensuring compliance and avoiding any legal complications.
 
Comprehensive Services: Whether you are a manufacturer, wholesaler, or retailer, we offer tailored services to meet your specific licensing needs. We handle everything from registration and inspection to renewal and compliance, so you can focus on growing your business.
 
Transparency and Integrity: We believe in complete transparency in our services and pricing. With BizMantra, you can rest assured that there are no hidden charges. We provide a clear breakdown of the costs involved and keep you informed at every stage of the application process.
 
Personalized Consultation: Every business is unique, and so are its licensing requirements. Our personalized consultation helps identify the right type of license for your business, whether it’s for a medical store, pharmaceutical manufacturing unit, or wholesale distribution.
 
Speed and Efficiency: Time is of the essence, especially when you’re launching a new business. We streamline the application process, ensuring your license is approved within the shortest possible time frame. Our established relationships with regulatory authorities allow us to expedite your application and minimize delays.
 
End-to-End Solutions: From initial consultation and documentation to liaising with regulatory authorities and final approval, we offer end-to-end solutions. If your business requires additional certifications or clearances, such as Good Manufacturing Practice (GMP) or import/export licenses, BizMantra can assist with those as well.
How to Apply for a Drug License in Maharashtra
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BizMantra simplifies the drug license application process with expert guidance. Follow these steps:

 
Login ID and Password: Obtain a Login ID and password by submitting a request letter in person with your firm’s details.
 
Online Application for Drug License: Fill out the online form accurately to avoid rejection.
 
Upload Required Documents: Use your Login ID to upload scanned documents.
 
Physical Inspection by the Authority: The authority will review your submission and may request additional documentation.
 
Approval of Drug License: You will receive a confirmation SMS, followed by the issuance of your drug license with an official seal.

Drug License Validity and Renewal

A drug license is valid for five years unless suspended or canceled. Renewal can be initiated by visiting the relevant drug control website, entering your drug license number, and submitting the necessary documents along with the renewal fee.

Get Your Drug License for a Medical Shop in Maharashtra with BizMantra

BizMantra is your trusted partner for all medical store or drug license needs. Whether you are a retailer, distributor, or manufacturer of pharmaceuticals and cosmetics in India or abroad, our team of professionals ensures a seamless license registration process.

FAQ
1.Is it necessary to obtain a drug license before starting a drug business?

Answer: Yes, it is mandatory to obtain the appropriate license before starting any business dealing with drugs or cosmetics.

2.Can I get a drug license for my business premises located in a residential area?

Answer: Licenses are granted only for commercial premises or mixed-use premises, not for residential areas.

3.Do I need separate drug licenses for branches of my pharmaceutical business in different states?

Answer: Yes, each business location must have its own drug license, whether within the same state or in different states.

4.What are the consequences of operating without a drug license in Maharashtra?

Answer: Operating without a drug license can lead to severe legal consequences, including fines, closure of your business, and potential criminal charges against the business owners.

5.What are the consequences of operating without a drug license in Maharashtra?

Answer: The approval process typically takes 45-60 days, depending on the completeness of your application and the efficiency of the inspection process.