Drug License

Drug License Registration

Overview

Access to drugs and medicines is vital to make sure that people of the nation have good health, proper drugs, and medical services are essential. But there can be a misuse of such goods if the access to medicines and drugs is not regulated.

Drugs and Cosmetic Act, 1940, and the practices outlined thereunder govern the manufacture and sale of drugs in India. Regulations and checks are imposed on drugs starting from the raw material stage during production, distribution, selling, and up to the time it is passed on to a patient or consumer by a pharmacist in a retail pharmacy, clinic, or hospital. The Drugs and Cosmetics Act, 1940, covered Unani and ayurvedic drugs also under its purview from the year 1960 Business entities may need multiple types of drug licenses based on their business. MeraLegal.Com will guide you through the process of acquiring a drug license in India.

Drug License Registration Application

The rules and regulations related to drug licenses are governed by the Food Safety and Drug Administration Department of each state that controls the rules and regulations about drug license. This very department is responsible for handling the application and granting of drug licences. There are various types of drug licenses. One has to know all before applying. Lists of these licenses are shown below:

Documents Requirement

Out of the licenses mentioned above, application in form no. 19 /19A /19B/19C would be required for starting a medical shop. Following documents would be needed along with the application in such a case:

• Photo ID proof of director/ proprietor/partner/Receipt of fee deposited online.
• Incorporation certificate or the constitution of the firm.
• Site plan and key plan of the place
• Official declaration in the form of an affidavit about non-conviction of proprietor/partner/director as well as the firm under the Drug & Cosmetics Act, 1940
• An affidavit from the registered pharmacist /experienced person

• For retail sale registered pharmacist

  • Qualification proof
  • Local pharmacy council registration
  • Letter of appointment

• For wholesale license experienced person

  • Qualification proof
  • Certificate of experience
  • Letter of appointment
• Address proof in the form of rent agreement or sale deed

• Storage

  The store premises must-have a refrigerator & air conditioner. Some drugs like vaccines, Insulin Injections, Sera, etc. are essential to be stored in the refrigerator as defined by their labeling specification.

• Technical Staff

  Wholesale – Presence of a registered pharmacist or a qualified person who is a graduate with 1-year experience of dealing in drugs is mandatory for wholesale selling drugs. The wholesale selling can also be monitored by a person who has passed S.S.L.C with 4 years experience of dealing in drugs, especially approved by the department of drug control for the purpose.

  Retail- Presence of registered pharmacist approved by the Drug License department is mandatory for the retail sale of drugs.

Infrastructure

• The premises are of an area of not less than 10 sq. meters for issuing of license in Form 20B or Form 21B or both; and
• The premises are of an area of not less than 15 square meters For issuing of license (i) In Form 20 or Form 21 or both, and (ii) In Form 20-B or Form 21-B or both

Further, the clear height of the business site should be in agreement with the National Building Code of India, 2005, as revised from time to time.

Multi-State Operation

If any business is operational in more than two states, a drug license has to be obtained in every state in which business is being conducted because a drug license is specific to the location. The application should be made, and a license should be issued for each such place if drugs are stocked or sold at more than one place, except in the case of migrant vendors.

After obtaining the license to the business, all such Licensees must make sure that all the provisions in the drug license are compiled at all times during the tenure of the business. The licensing authorities specify how the registers/records /Forms must be maintained as well as the authorities should be kept up to date about all the changes or modifications in the business activities

Going through the above section, if you have chosen to enter the business of sale of drugs, then connect with the MeraLegal.Com team who are trained and experienced to take on cases of new license registrations and renewal of the same.

Frequently Asked Questions ?