Maharashtra Drug License Registration- Fees, Online Process and Validity

Updated on July 06, 2024 06:09:39 PM

A drug license is mandatory for selling and manufacturing any kind of pharmaceutical product in Maharashtra. You could get into serious trouble with the authorities if you don't have one. You must apply for a drug license before opening a pharmacy or Cosmetic store. The requirement of a drug license isn't just limited to a medical store or a pharma store. You need a drug license to manufacture medicines, import medicines and cosmetics from other countries, import medical devices, and export medicines from India.

Drug and Cosmetic Act 1940 and 1945 made it mandatory for everyone involved in manufacturing, distributing, and selling drugs to obtain a drug license. The Act is intended to increase safety and reduce the number of adverse events associated with medications. It will require pharmaceutical companies to provide detailed information about their products, including ingredients, dosage instructions, and warnings about possible side effects or interactions with other drugs or foods.

This law is important because it protects consumers from unsafe medications and helps ensure that doctors have all the information they need to prescribe.

Drug License Certificate Sample

  • Form-20B
  • Form-21B
Drug License Certificate Sample
Drug License Certificate Sample

Who issues the License to start a Drug Store in Maharashtra?

Maharashtra's Drug Control Department issues drug licenses in Maharashtra. It is a regulatory department that controls the production of medicines and cosmetics and their sales. Maharashtra State has been split into two Divisions to enforce various drug laws. Two Zones make up each Division, which is led by a Drugs Controller.

  • One Division is made up of the North-West Zones, and
  • The other Division is made up of the South-East Zones.

Until January 1986, the Drugs Control Organization was an underlying office under the directorate of health services. After that, The Drugs Control Organization was transformed into a separate Department with the Drugs Controller serving as the Department Head.

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Types of Drug Licenses

There are many types of licenses for drugs. They include a manufacturing license, sales license, and loan License. The type of License you need depends on what kind of activity you want to do with your drugs. A sales license is needed if you want to sell your drugs in any way. A loan license is needed if you want to let people use your drugs by borrowing them (for example, from a hospital). And a manufacturing license is needed if you want to make your own drugs or have someone else make them for you (for example, at a factory or pharmacy).

  1. Manufacturing Drug License: A manufacturing license is needed to make the drugs in the first place. A manufacturing license allows both manufacturing and distribution of drugs at large scales; however, its cost is higher than that of other licenses because it requires more stringent regulatory standards than other licenses do.
  2. Wholesale Drug License: A wholesale drug license is a sales license that allows you to distribute medicines and cosmetics at a wholesale price.
  3. Retail Drug License: A retail License is required to open and run a medical shop/ pharmacy store.
Types of Drug License
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Drug License Fees in Maharashtra

The drug License fee in Maharashtra is ₹39,999 for a wholesale drug license, ₹49,999 for a retail drug license(Medical store/ pharmacy shop), and ₹99,999 for a manufacturing drug license. It takes around 45-60 days for approval. The above cost includes document preparation, online application, and assistance in the inspection by the authority.

Type of Drug License Total Fees
Wholesale Drug license Rs. 39,999/-
Retail Drug license Rs. 49,999/-
Manufacturer license Rs. 99,999/-

Note: The aforementioned Fees are exclusive of GST.

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Documents required for Drug License registration in Maharashtra

The following documents are required to apply for a Drug License in Maharashtra.

  • The firm's constitution (MOA & AOA for Company and Partnership Deed for Firm/LLP)
  • For Retail & Wholesale license - Affidavit from the Regd. pharmacist/competent person
  • Property Paper ( Registry Deed/Lease Deed/POA in case of owned Property)
  • Board Resolution, List of Directors, Certificate of Incorporation ( in case of company)
  • The key plan and the site plan of the premises ( Blue Print).
  • One Invoice copy of Refrigerator/Air conditioner purchased for use
  • Copy of Rent agreement ( in case of rented premises)
  • Covering Letter stating purpose of the Application
  • ID proof of Directors/Partners/Proprietor
  • For Manufacturing - Affidavit from employer and or Technical Staff for full time working with the firm
  • For Manufacturing - List of Technical Staff and their proof of Education Qualification, Experience Certificate, Biodata, Appointment Letter, three photographs.
  • Incase of Retail License:- Registered Pharmacist's degree certificate, Registration certificate with State Pharmacy Council and Appointment Letter and Bio-data.
  • Incase of Wholesale License:- Competent person's degree certificate, Experience Certificate in medicine job and Appointment Letter and Bio-data.
  • For manufacturer - Affidavit of Non Conviction, List of Equipment and Machineries for manufacturing and List of Equipment Provided for Testing
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How to apply for a Drug license in Maharashtra?

How to apply for drug license

To open a medical shop or a cosmetic store in Maharashtra, you need a Drug License from the Maharashtra drugs department. The process for obtaining this License is lengthy and expensive. We recommend finding an experienced lawyer who specializes in this area of law if you want to get your business off the ground as quickly and easily as possible.

The online registration process for Drug license application in Maharashtra is carried out in the following steps:

  1. Login ID and password: Applicants can get a Login ID and password by giving a request letter in person with the details of the firm.
  2. Online application for drug license: All the information must be filled in correctly and precisely to avoid rejection.
  3. Uploading required documents: Scanned documents should be uploaded using the ID and password.
  4. Physical inspection by the authority: The documents provided by the applicant will be checked by the inspection authority, and they may also ask for some additional documents as per the requirement.
  5. Approval of drug license: You will receive a confirmation SMS about the grant of your drug license. After that, you will receive the drug license with a valid e-signature and official seal.
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Drug license Validity and Renewal

A drug license is valid for five years unless the drug department suspends and cancels it by going into the relevant drug controlling website, inputting the drug license number, filling out the renewal application, and submitting the document along with the fee for the issuance of the renewal of the drug license.

It must be renewed before the expiration date. A new drug license will be issued by the drugs controller when you apply for your Drug license renewal.

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Get Drug License for Medical Shop in Maharashtra with Professional Utilities

A drug license is necessary to start a pharmacy business. You can get in touch with Professional Utilities directly for any kind of medical store/drug license, whether you're a retailer, distributor, or manufacturer of pharmaceuticals and cosmetics in India or abroad. Professional Utilities guarantees a smooth process of license registration with the help of its team of professionals skilled in Medical licenses. For drug manufacturers looking to open a testing facility and secure a license in India, we provide a full range of services.

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Frequently Asked Questions (FAQs)

Is it necessary to obtain drug license prior to commencement of the drug business?

Yes, before you start any business dealing in drugs, whether it is Allopathic Drugs, Ayurvedic Medicine, Homeopathy or Unani, to manufacture, distribute or sell the drugs It is mandatory to obtain a license as per the nature of business by applying to the controller of the drugs and cosmetics

What are different types of Licenses Issued for the Pharmaceutical Business?

Based on the requirement of the pharmaceutical business, an applicant must apply for issue of specific drug license. There are various licenses, for example,

  1. Drug Manufacturing License,
  2. Wholesale Drug License,
  3. Retail Drug License,
  4. Import of Drugs or Cosmetics,
  5. Import of Medical Equipment,
  6. Export of Medicines etc.
Is it true that for grant of a drug license my shop must be located at a commercial premises?

Licenses for the sale of drugs can be granted only at premises which is commercial premises or other premises independent of residence, also known as mixed land use. For this purpose state drug office issues guidance which may be referred to.

How to import Drugs or Cosmetics?

Drugs and Cosmetic Act aims at ensuring safety, effectiveness and conformity of the drugs and cosmetics sold in India to the state quality standards. Drugs or cosmetics of schedule X can be imported into India only after obtaining a License


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