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
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.
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.
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).
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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.
The following documents are required to apply for a Drug License in Maharashtra.
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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:
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.
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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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
Based on the requirement of the pharmaceutical business, an applicant must apply for issue of specific drug license. There are various licenses, for example,
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.
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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