Frequently asked questions

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Retail sale drugs :

Drugs sold directly to consumers are referred to as "retail sales." Once the seller has a license, they can offer the medication at retail prices. Pharmacies, dispensaries, research facilities, and private customers are all possible destinations for drug retailers. Retail sale drug licenses are issued by the SDCA (state drug controller authority). Retailers who sell drugs or cosmetics without a retailer’s license are committing an offence. The accused will face a minimum of one year in prison and a maximum of three years in prison, as well as a fine of Rs. 5,000/-.Retailers who have business in more than one state require a separate license for each state.

Wholesaler license :

A wholesale drug license is required for the drug's wholesaler. Third-party manufacturing is an option for wholesalers. Third-party manufacturing must be done by a licensed manufacturer (company, distributor, wholesaler, etc.). Before manufacturing medicine under the brand name, the authorized Indian representative is required to obtain a brand affidavit. The manufacturer's (marketed by) and wholesaler's names will appear on the product package. The manufacturer must obtain approval before producing those drugs. The wholesaler license is issued by the CDSCO (Central Drug Standard Control Organization).

Manufacturing license for drugs:

Manufacturers who do not own land but manufacture drugs under their brand name on a rental property require a loan drug license under the 1940 Drug and Cosmetic Act. All producers and manufacturers of ayurvedic, allopathic, cosmetic, and medication products must get a manufacturing drug license. That is granted by the concerned state government. Manufacturing licenses are classified into three types:
• test license for manufacturing
• Post-successful clinical trial manufacturing license
• Notified by the license of a medical device manufacturer

Loan drug license:

According to the Drug and Cosmetic Act of 1940, this license is a grant to a manufacturer who doesn’t own land and manufactures the drug under their brand name on the rental property and therefore requires a loan drug license.

Import License :

To import drugs, the manufacturing company must be registered. Any dealer importing materials for the production of drugs or operating a drug import enterprise must receive a license from the Central Drug Control Organization

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Prerequisites For Obtaining A License

• Pharmacist/Competent staff - The pharmacist must be registered with the State Pharmacy Council and possess a B.Pharm. or D.Pharm. degree to work in retail. They must hold a B.Pharm. or D.Pharm. degree and be registered with the State Pharmacy Council to conduct wholesale business. They must be either a graduate with one year of drug dealing experience or an undergrad with four years of experience in that domain.

• Space Requirement - The pharmacy area or unit is an important requirement. The area of the pharmacy or unit should be 15 square meters in the case of a wholesale license, and for retail and medical shops, it should be 10 square meters. The guidelines are laid down under the National Building Code of India, 2005.

• Storage facility - To keep medications, a person must make sure the location has the appropriate storage space with lower temperatures, such as a refrigerator or cold storage facility.

• Inspection - Before issuing a drug license, an authorized drug inspector may visit the site for an inspection. They also have the power to verify the facts given, measure the area, and contact a qualified individual or pharmacist.

Overview

The foremost step in starting a pharmaceutical business is obtaining a drug license. No pharmaceutical business would run its operation without a license. The government of India regulates the import, manufacture, sale, and distribution of drugs in India. The primary objective of the government under the Drugs and Cosmetics Act of 1940 is to ensure that the drugs and cosmetics sold in India are safe, effective, and in line with a prescribed quality standard. Negligence by manufacturers or retailers is a punishable offence. As a result, it is essential to adhere to the license condition. However, an amendment in 1964 broadened the definition of drugs. Earlier, the drug defined in Provision 3(b) included allopathy and homoeopathy under the 1940 Drugs and Cosmetics Act. In 1964, the act was amended, and the definition of a drug changed to include Ayurvedic and Unani medicines. However, depending on their business, a specific business entity may require a different type of drug license. A drug license is regulated by the drug-controlling authority of India, which function under the ministry of health. It includes allopathic, homoeopathic, and veterinary medicines, as well as medical instruments. The Ayush drug control cell is a division of the central drug standard control organization (CDSCO), which is overseen by the ministry of Ayush - Ayurveda, Unani, and Siddha, herbal products for medicinal and cosmetic use.

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Documents required for obtaining a Drug License

• Application Form
• A copy of the Challan
• PAN Card, Driving License, Passport, Voter ID, etc. as ID proof
• In the case of a Partnership Firm, a copy of the Partnership Deed
• Memorandum of Association
• Articles of Association
• Certificate of Incorporation
• A copy of the Site Plan for the premises
• A copy of the Key Plan of the premises
• A CTC of the BR (Board Resolution) for authorizing the company to obtain the license
• Appointment Letter for the person being authorized by the company
• A copy of the Sale Deed or Property papers (In the case of an owned property)
• A copy of the Lease Deed or Rent Agreement (In the case of rented property)
• Proof of Storage Availability, such as the Cold Storage and Refrigerator, in the form of Invoices
• Affidavit concerning the compliance of MPD 2021

Additional Documents

In the case of Retail Sale, the additional documents required are as follows:

• Proof of Qualification (Certificate of Final Degree or Provisional Certificate, together with the Marksheet)
• Registration from the State Pharmacy Council
• A copy of the Bio-data
• A copy of the Appointment Letter
• 5 Photographs of both the proprietor and pharmacist

In the case of a Wholesale License, the additional documents required are as follows

• Proof of Qualification (Certificate of Final Degree or Provisional Certificate, together with the Marksheet)
• A copy of the Bio-data
• A copy of the Appointment Letter
• A copy of an Experience Certificate for at least 1 year

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Different forms of drug license

•Form 19 This form is used for the grant of renewal of a (License to sell, stock, exhibit or offer for sale, or distribute) drugs apart from those specified in Schedule X..

•Form 19 A Application for renewing or granting a restricted (license to stock, sell, exhibit or offer for sale, or distribute) drugs by retail through dealers who do not engage the services of a qualified person..

•Form 19 B Form 19B This form is used for grant or renewal of a (License to sell, stock, offer for service or exhibit, or distribute) Homoeopathic Medicines..

•Form 19 C Application for renewal/grant of a (license to sell, stock, exhibit or offer for sale, or distribute) drugs specified in Schedule X.

•Form 20 Application for License to sell, stock or exhibit for sale or distribute Drugs by Retail other than the specified under Schedules C, C (1).

•Form 20 A Form 20A Application for restricted (License to sell stock or exhibit or offer for sale, or distribute) drugs by retailers other than those specified under Schedules C, C (1), and X for dealers who do not engage the services of a registered pharmacist.

•Form 20 B Application for (License to sell, stock or exhibit, or offer for sale or distribute) by Wholesale, drugs other than those specified in 2[Schedules C, C (1), and X].

•Form 20 C Application for (License to stock, sell or exhibit or offer for sale, or distribute) Homoeopathic medicines by retailers.

•Form 20 D Application for (License to stock, sell or exhibit, or offer for sale or distribute) Homoeopathic medicines by wholesale.

•Form 20 E Application for certificate of renewal of 2(License to sell, stock or exhibit or offer for sale, or distribute) Homeopathic medicines.

•Form 20 F Application for License to stock, sell or exhibit for sale or distribute retail drugs specified in Schedule X.

•Form 20 G Application for 2(License to stock, sell or exhibit or offer for sale, or distribute) by wholesale drugs specified under Schedule X.

•Form 24 This form is for the grant of a license to manufacture for sale or distribution of drugs other than those specified in Schedule C, C (1) and X.

•Form 24 A Form 24A This application is for either the grant of a loan license to manufacture for sale or distribution of drugs other than those specified in Schedule C, C (1) and X.

•Form 24 B This form is for the grant of a license to repack for the sale or distribution of drugs other than those specified in Schedule C and C (1) 2[ excluding those specified in Schedule X.]

•Form 24 C Form 24C This is for the grant of a license to manufacture for sale( or for distribution of Homoeopathic medicines or a license to manufacture) potentised preparations from back potencies by licensees holding a license in Form 20-C.

•Form 24 D Application for the grant/renewal of a license to manufacture for sale of Ayurvedic, Siddha or Unani Drugs.

•Form 24 E Application for the renewal or grant of a Loan License to manufacture for sale of Ayurvedic (including Siddha) or Unani Drugs.

•Form 24 F This form is for the grant/renewal of a (license to manufacture for the sale or distribution) of drugs specified in Schedule X and not specified in Schedule C and C (1).

•Form 27 This is for renewal or grant of a (license to manufacture for sale or distribution) of drugs specified in Schedule C and C (1), [excluding those specified in Schedule X and Part XB.]