Drugs license or Pharmacy license

The Drugs and Cosmetics Act, 1940 is an Act which regulates the import, manufacture and distribution of drugs in India. Main objectives of this ac is to make sure that drugs sold or manufactured in India are safe and conform to standards. This act was passed in 1940. Since then, act has gone several amendments. It is also known as Drugs and cosmetics act, 1940.

Drug License wholesale and retail

Drug license is issued foe both wholesale are retail sale purposes. Dug license or Pharmacy license is a mandatory requirement to distribute drugs anywhere in India. Drug license is issued to a competent person with knowledge of drugs and having minimum storage and distribution facility as per drugs and cosmetics act.

Conditions for sale of license

An applicant that is applying for a drug license need to fulfill following conditions-

As per drugs and cosmetics act, minimum area of 10 sqm and height of 2.75 m is required for retail as well wholesale of drugs,
Storage facilities like deep freezer and storage facility for general drugs should be available within premise.

Types of drug license in India

As per drugs and cosmetics act, there are following drugs license issued to dugs distributor or manufacturer

Manufacturing drug license
Sale drug license – Retail drug license, wholesale drug license and restricted drug license.
Import drug license
Loan drug license
Multi-drug license

Manufacturing Drug License

manufacturing drug license is issued to a business that manufactures drugs or medicinal items that includes allopathy and homeopathy medicines too.

Retail Drug License

As per drugs and cosmetics act, it is mandatory for every retailer who is selling medicinal items or drugs in India to obtain a retail drug license. Retail drug license is provided to small petty pharmacist who sell drugs to end customers.

Wholesale drug license

Wholesale drug license issued to a business and person who wants to sell drugs at wholesale level. A wholesaler sells drugs to a retailer in large quantities.

Restricted drug license

Restricted drug license is issued to those business or stores which sell drugs and medicines that doesn’t require any medical supervision. Restricted drug license holder can only issue list of restricted drugs items from his premise.

Import drug license

Import drug license is issue to business or person who are engaged in selling, manufacturing and distributing imported drugs in India.

Loan drug license

Loan drug license is issued to a person who doesn’t have any manufacturing facility of his own. He or she uses manufacturing facility of another business premise for his drug manufacturing.

Multi Drug License

Multi drug license is issued to those person or business who are operating two or more different states with same business name.

Prerequisites For Obtaining a License

Pharmacist or a competent individual – Presence of pharmacist is a mandatory requirement for retail drug business. While for wholesale drug business, a competent graduate having more than one year of experience in drugs is required. If he is not graduate then at least 4 years of related experience is required.
Space – For wholesale and retail business, a space of 15 sqm is required. While for other business, arear requirement is 10 sqm.
Storage facility – Storage facility is one of the most important criteria for obtaining a license. A decent storage facility along with cold storage and air conditioning is a must.

Drug license application forms

There are different application forms for different types of drug licenses as mentioned below –

Form 19 – Application for grant or renewal of a license to sell, stock, exhibit or offer for sale, or distribute drugs apart from those specified in Schedule X
Form 19A – Application form to sell or distribute drugs via dealers who doesn’t have services of a qualified individual.
For 19B – Application form to sell, distribute or stock homeopathic medicines
Form 19C – Application for grant or renewal to sell, distribute durgs mentioned in Schedule 10.
Form 24 – Application for grant or renewal for manufacturing sale of drugs which are not mentioned in Schedule C and Schedule 10.
Form 24A – Application for either the grant of a loan license or renewal of a loan license to manufacture for sale or distribution of drugs other than those specified in Schedule C, C (1) and X.
Form 24B – Application for grant or renewal of a license to repack for sale drugs excluded in schedule C and C1
Form 24C – Application for grant or renewal for sale or manufacturing of homeopathic medicines,