Drug License

In the pharmaceutical sector, the acquisition of a drug license is an important aspect for companies that manufacture, distribute, and sell drugs. A drug license is a legal permit that the government issues to ensure observance of various regulations and standards meant to protect the public's health.

This drug license is an official document from the Central Drugs Standard Control Organization (CDSCO) or respective State Drug Standard Control Authorities (SDSCAs) permitting the manufacturing, sale, and distribution of drugs and pharmaceuticals. These are supposed to be released for use by people who meet quality standards and thus pose no harm to consumers.

Who can apply for a Drug License?

In India, the following parties can apply for a drug license:

• Manufacturers: Any individual or company looking to manufacture drugs and pharmaceuticals must seek a manufacturing license. This is to adhere to safety and quality standards.
• Wholesalers: Companies that sell drugs wholesale must apply for a wholesale license. This is to allow them to purchase drugs from manufacturers and sell them to retailers or healthcare providers.
• Retailers: Pharmacies and drug stores selling drugs directly to customers require a retail license. They must also adhere to rules in terms of storage, labeling, and dispensation.
• Importers: To import drugs into India, import licenses are required. All such imported drugs will be approved concerning Indian quality.
• Clinical Trial Sponsors: Clinical license applicants are organizations or individuals conducting clinical trials on new drugs. The clinical license ensures that the trials are conducted ethically and safely.

Each of the categories has its regulatory requirements and documentation, ensuring public health and safety.

There are more than ten different types of drug licenses. However, a business unit may require a separate permit based on its requirements. Some major types of drug licenses are as follows-

Manufacturing License

The manufacturing license is for a firm that is into the manufacturing of allopathic homoeopathic drugs.

Sale License

The sale license has two subcategories depending on the activity the firm is indulged in.

• Drug Wholesale License: If the applicant's firm is a drug wholesaler, he must register under the wholesale category.
• Drug Retail License: If the applicant is willing to sell the drugs through a retail shop, dispensary, and hospital. Then he must get himself registered under the Drug Sale license application only.

Loan License

When the applicant uses the resources of a previously registered manufacturer, like the machinery, staff and equipment, then he needs to get the Loan License to manufacture drugs as per the Drugs and Cosmetic Act.

Import License

Suppose the applicant is willing to import drugs from any foreign nation in India. In that case, they must apply for an import license with CDSCO to obtain the necessary permits to sell them in India.

FDA License

An FDA license is a permit that a company needs to get before selling food, drugs, cosmetics, or medical products in the USA. The FDA is a government agency that was set up in 1906 to protect consumers. They make sure that these products are safe for people to use. So, if a company wants to sell any of these products in the USA, they have to get an FDA license first. It's like getting approval from the government to show that the products are safe and can be sold to the public.

• The applicant must have at least fifteen square meters of space for the wholesale license, while the space requirement for the retail license is ten square meters.
• The applicant must also submit a layout plan, and the National Building Code of India guidelines must be followed.
• A registered pharmacist in wholesale and retail firms must have in-depth operation knowledge.
• The pharmacist must possess a license from the pharmacist council of India and have a valid registration date.
• The Drug License is not granted to a premise built on a DDA-allotted land.
• The proper storage facilities should be there. If the drugs must be placed at a low temperature, refrigeration arrangements must be available.

You need the following documents to obtain a drug license registration from the State Drug Licencing Authority. Some states may prescribe a slightly different list, but the basic structure of the checklist will be the same-

• Drug License Fees Receipts
• Application Form No. 19, as per the applicability
• Site Plan and Key Plan of the Premises
• Memorandum and Articles of Association
• Copy of Passed Resolution
• Partnership Deed
• Trust Deed
• Photo ID Proof of the Responsible Firm
• Non-Conviction Certificate
• Affidavit Regarding Compliances (if any)
• Registered Pharmacist Affidavit
• Proof of Qualification
• Pharmacy Council Registration
• Experience Certificate
• Appointment Letter of Competent Person
• Proof of Land Ownership or Possession

The Drug License certificate is provided to the applicant after going through the following steps-

Registration on Drug Licensing Portal

• You first need to register on the Drug Licensing Portal of your state.
• Every state has a separate Drug Licensing Authority which manages a Drug Licensing Portal online for Drug License Registration.
• If you already have the credentials, you can directly log in to the portal to apply for the Drug License Certificate.
• A central Drug Licensing Authority maintains a separate licensing portal for some specific cases and interstate matters.

Application Filing

• Once logged in, you must enter the pharmacist's and competent people's details.
• Then enter the parties regarding the Pharmacist Council Registration along with the name.
• After this, you can file the application using the appropriate form according to your application type.
• Form 19, Form 19A, Form 19B or Form 19C are available to apply for the Drug License Registration certificate according to your requirement.
• After filling in the requisite details, double-check the facts as you cannot edit them later and finally submit the Drug License Application Form Online.

Inspection Process

• After successfully submitting the Drug License Application Form, the Drug Licensing Authority (DLA) schedules the inspection of your premises.
• At the scheduled date, Drug Inspector visits the premises to register for the Drug License.
• The Drug Inspector (DI) verifies the location requirements for the issue of a Drug License.
• The Drug Inspector also verifies the original documents of the applicant.
• After completing the inspection, he submits the report to the Drug Licensing Authority.

Grant of Drug License

• Drug Licensing Authority goes through the submitted report of the Drug Inspector. It checks whether the applicant complies with the Drug Rules or not.
• If the report is in support of the applicant. Based on the report of the Drug Inspector, the appropriate authority grants a drug licence to the applicant.

The Drug License fees may differ for different states. For offline mode, you must deposit drug license fees in the government treasury. At the same time, you can also pay it online through various methods available in your state. The table below provides standard drug license fees for the issue of the Drug License-

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