Drug License

Introduction

Drug license is a permission granted by the authority under the Drugs and Cosmetic Act in order to carry out a business of drugs/medicines or cosmetics. The Drug license is issued by the State Drugs Standard Control Organization or the Central Drug Standard Control Organization.

The drugs are used in the medicines, in a medically defined ratio to cure our health. Drugs come in use on a need basis, to ensure our well being. However such medicines are manufactured with very restricted and correct amount of the drugs and it does not harm the body.

Basic Requirement for obtaining Drug License

The following are minimum requirements for obtaining drug license or starting a pharmacy in India:

  1. Area: The minimum area of 10 square meter is required to start a medical shop or pharmacy or wholesale outlet. In case, the pharmacy business combines retail and wholesale, a minimum of 15 square meter is required.
  2. Storage Facility: The store must have refrigerator & air conditioner in the premises. According to the labeling specifications certain drugs like vaccines, Sera, Insulin Injections etc., are required to be stored in the refrigerator.
  3. Technical Staff:
  • Wholesale – The sale of drug by wholesale shall be made either in the presence of registered pharmacist or in the presence of a competent person who shall be a graduate with 1 yr experience in dealing in drugs or a person who has passed S.S.L.C with 4y ears experience in dealing in drugs, specially approved by the department of drug control for the purpose.
  • Retail – The sale of drug by retail must be made in the presence of registered pharmacist approved by the department, Registered pharmacist is required throughout the working hours.

Required Documents for obtaining Drug License

The documents required for starting a pharmacy business varies from state to state. However, the following documents required for obtaining drug license in India.

  • Application form in the prescribed format
  • Covering Letter with the intent of the application signed with name and designation of the applicant
  • Challan of fee deposited for obtaining drug license
  • Declaration form in the format prescribed
  • Key plan(Blue print) for the premises
  • Site plan (Blue print) for the premises
  • Basis of possession of the premises
  • Proof of ownership of the premises, if rented
  • Proof of constitution of the business (Incorporation Certificate / MOA / AOA / Partnership Deed)
  • Affidavit of non conviction of proprietor / partners/ directors under Drugs and Cosmetics Act, 1940
  • Affidavit of registered pharmacist or competent person working full time
  • Appointment letter of registered pharmacist/competent person, if employed person.

FAQs

Qus: 1, What is drug Licence?

Ans: Drug License is permission from the government to deal with drugs. There are two kinds of license, the retail license and wholesale license of for drug distribution or sale in India. This license is issued subject to certain conditions attached to premises and the competent person who shall be dealing with drugs.

Qus: 2, What is Form 20b & 21b?

Ans:  Wholesale License

Wholesalers often purchase large quantities directly from the manufacturer or importer. Wholesale Drug licence is issued in Form 20B and Form 21B, for issuance of these licenses application have to be filled as per drug and cosmetic act 1940 and rules 1945.

Qus: 3, What is a wholesale drug distributor?

Ans: Wholesale drug distributors are a link between manufacturers and pharmacists. Their role is to ensure prescription medications are delivered safely and efficiently every day to thousands of health care practitioners and pharmacies nationwide.

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