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"Stay Legal, Stay Safe: Register Your Drug License Today!” To start a business in pharmaceutical industry including Ayurvedic & Unani Drugs, one must have to get a drug license to operate legally. As per Drugs Act, 1940, Drug license is mandatory throughout India. A particular license is needed on the type of business requirement. Obtain your Drug License from RegisterKaro hassle free.

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A quick overview on Drug License

In terms of volume, the Indian pharmaceutical market is third, while in terms of significance, it ranks fourteenth. It makes up about 20% of the global pharmaceutical industry's volume and 1.5% of its value. The Indian pharmaceutical industry has enormous potential, which presents opportunities for entrepreneurs and start-ups looking to enter or grow in the pharmaceutical sector. In India, registering for a drug license is a need for any pharmaceutical company that deals with pharmaceuticals, prescriptions, or cosmetics. In order to lawfully operate in the pharmaceutical sector, which includes Ayurvedic and Unani medications, one needs to obtain a drug license.

Drug License

A quick overview on Drug License

Basic pre-requisites for a drug license

The relevant state authorities (Drugs Control Department) must issue a legitimate drug license to any individual, corporation, partnership firm, etc. The provisions for this has been made in Drugs and Cosmetic Act, 1940 and Rules 1945 applicable in India. The following are some fundamental pre-requisites:

1 : Minimum space for the shop or office.

2 : Granted in a non-residential setting, such as a business space.

3 : Must adhere to the requirements of the licensing body.

4 : Refrigerator or air conditioner on the property.

5 : The Department of Drug Control-approved technical personnel profile needs to be on display at the business's location.

Basic pre-requisites for a drug license

Who may submit a drug license application?

Who may submit a drug license application?

Let's say you want to distribute pharmaceuticals or open a medical supply business and need a drug license. If so, you have to meet the educational requirements outlined in the 1940 Drugs and Cosmetic Act. A pharmacy degree is required of both competent individuals and pharmacists. The qualified individual needs to have prior drug distribution expertise. The pharmacist must maintain their registration with the Pharmacist Council at the same time. Since the Drug License Application will be submitted, they should have proof.

Types of Drug License Registration

There are numerous kinds of licensing for drugs. However, depending on its needs, a business unit can need a different permit. Here are some common categories of drug licenses:

1 : Manufacturing License: This license is intended for a company that produces allopathic and homeopathic medications.

2 : Sale License: Depending on the firm's operations, the sale license falls into one of two subcategories:

License for Drug Wholesale: The applicant must register under the wholesale category if his company deals in drugs.

Drug Retail License: In the event that the candidate agrees to sell the medications through pharmacies, retail stores, and medical facilities. Next, he needs to register himself using the drug sale license application exclusively.

3 : Loan License: In accordance with the Drugs and Cosmetic Act, the applicant must get a loan license in order to manufacture drugs if he plans to use staff, machinery, or other resources belonging to a previously registered manufacturer.

4 : Import License: Let's say the applicant wants to bring medications into India from any other country. If so, in order to acquire the required licenses to sell them in India, they would need to apply for an import license with CDSCO.

5 : Food and Drug Administration (FDA) License: Before a business may sell food, medications, cosmetics, or medical supplies in the United States, it must obtain an FDA license. They ensure that using these goods is safe for consumers. So, if a company wants to sell any of these products in the USA, they have to get an FDA license first.

Types of Drug License Registration

Documents requirement for Drug License in India

Documents requirement for Drug License in India

1 : The partnership deed, or memorandum and articles of association (MOA & AOA for companies) of the firm.

2 : For Retail and Wholesale Licenses: Affidavit of a licensed pharmacist or other qualified individual.

3 : Property Document (POA in the event of owned property, lease agreement, or registry deed).

4 : Certificate of Incorporation, List of Directors, and Board Resolution (if applicable to a company)

5 : The property's primary plan and site plan (blue print)

6 : A copy of the rent agreement (if the property is rented)

7 : One invoice copy of the refrigerator or air conditioner that was purchased for use.

8 : Cover letter outlining the application's purpose

9 : Identification proof for directors, partners, and proprietors

10 : For Manufacturing: Employer's affidavit and Technical staff’s evidence of education, experience, certificate of experience, bio-data, appointment letter, and photographs.

11 : In the event that a retail license is required: a degree from a registered pharmacist, a registration certificate from the state pharmacy council, an appointment letter, and biographical information

12 : In the event of a wholesale license: a certificate of competency in medicine, a letter of appointment, a bio-data file, and a certificate of experience.

13 : Affidavit of Non-Conviction, inventory of manufacturing tools, and inventory of testing tools are required for manufacture.

Drug License Registration process in India

You may follow the step by step process for registering your company in United kingdom:

Step 1: Get Your User ID and Password

The applicant must provide their personal information in person together with a request letter to obtain their User ID and Password.

Step2: Fill out the online application

Before sending the application, please double-check that all the fields are filled out accurately for the relevant application listed below. Should your application be rejected due to incomplete information, you will forfeit the previously paid fees.

Step 3: submit Documents

After scanning each document at 100 DPI in black and white, submit it to the designated location with the aforementioned ID and password. If more particular documentation is needed, the licensing authority may request it.

Step 4: Physical Inspection

Present the inspector with all original documentation at the time of the inspection. Any more documentation related to your application that the inspector may request from you.

Step 5: Approval/Rejection

You will be notified by SMS if your application is approved or denied. For new licenses and license renewals, print the approval or rejection from the "Print License" option. Within three days, click "MISC approvals" for additional approvals. Licenses and approvals bearing the official seal and current e-registration will be sent to you.

Step 6: Change in constitution

Changing the proprietor or partner will be interpreted as a "change in constitution," requiring the applicant to apply for a new license.

Step 7: Separate password for pharmacists

Registered pharmacists are also required to update their details by obtaining separate password.

Fees for drug license registration

The drug license fees may differ from state to state. 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-

Type of Drug LicenseFees (In Rupees)
Wholesale License Fees3000
Retail License Fees3000
Restricted License Fees1000
Schedule-X Drugs (Wholesale Fee)500
Schedule-X Drugs (Retail Fee)500

How RegisterKaro helps you in getting Drug License?

RegisterKaro has been one step solution for getting Drug License, because of the varied ranges of benefits such as:

Group of Experts : RegisterKaro holds a large group of experts from all over the world having specialization in getting Drug License. Our team of experts make sure that you work is taken care of in the most effective possible manner.

Cost-effective : RegisterKaro Drug License registration are of premium quality at the most efficient rate, which suits the client’s pocket, making sure that quality service is not the only thing which client gets on our platform.

Client-oriented approach : Our team of experts is well trained and equipped with a client-oriented approach, keeping in mind that the process must be client-centric, focusing on meeting all the requirements of their business and, therefore, satisfying their needs.

Trust builders : RegisterKaro builds the trust among its clients and because of only this trust we have built a good network in worldwide marketplace.

How RegisterKaro helps you in getting Drug License?

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What is a drug license?

A drug license gives you the ability to operate a drug, medicine, or cosmetic business in accordance with the Drugs and Cosmetic Act. Such a license is granted by the Central or State Drug Standard Control Organization in accordance with the Drugs and Cosmetics Act of 1940.

Who needs a drug license in India?

All manufacturers as defined by the Drugs and Cosmetics Act 1940 that deal with ayurvedic, allopathic, cosmetics, pharmaceuticals, etc.

What are the qualifications for obtaining a drug license?

With a focus on clinical pharmacology or microbiology, a graduate degree in pharmacy, pharmaceutical sciences, or medicine from an Indian institution founded by law is required. Additionally, two years of experience in the production, testing, regulation, or design of medical devices are required.

How long is a drug license valid for?

The cost of a license to manufacture pharmaceuticals is now set at Rs 6,000 for a duration of five years. A fee of Rs 1,500 will also be applied for the examination of the premises before a license is granted or renewed.

Who controls drugs in India?

The National Regulatory Authority (NRA) of India is the Central Drugs Standard Control Organization (CDSCO), which is housed inside the Directorate General of Health Services, Ministry of Health & Family Welfare.

What is Form 21B for drug license?

Permission to sell and distribute medications listed in Schedule C & C (1) of the medications & Cosmetics Act and Rules is granted to wholesalers via Form 21B.