Drug License

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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.

Drug License Registration

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:

Application Type Description
Form 14A Application made by the purchaser for test or analysis of a drug under Section 26 of the Drugs and Cosmetics Act, 1940
Form 19 Application for renewal or grant of a license to stock, sell, exhibit or offer for sale, or distribute drugs other than those mentioned in Schedule X
Form 19A Application for renewal or grant of a classified license to stock, sell or exhibit or offer for sale, or give out drugs by retailers and dealers who do not take in the service of a qualified person
Form 19B Application for license to stock, sell or exhibit or offer for sale, or deal in Homoeopathic Medicines.
Form 19C Application for renewal or grant of a license to stock, sell, exhibit or offer for sale, or distribute drugs mentioned in Schedule X
Form 24 Application for the renewal or grant of a license to manufacture for sale or distribution of drugs other than those mentioned in [Schedule C, C (1) and X]
Form 24A Application for renewal or grant of a loan license to manufacture for sale or distribution of drugs other than those mentioned in Schedule C, C (1) and X
Form 24B Application for renewal or grant of a license to repack for sale or distribution of drugs, being drugs other than those mentioned in Schedule C and C (1) not including those specified in Schedule X
Form 24C Application for the renewal or grant of a license to manufacture for sale or distribution of Homoeopathic medicines or a license to manufacture potentized preparations from back potencies by licensees holding a licence in Form 20-C
Form 24F Application for renewal or grant of a license to manufacture for sale or distribution of drugs mentioned in Schedule X and not mentioned in Schedule C and C(1).
Form 27 Application for renewal or grant of a license to manufacture for sale or distribution of drugs mentioned in Schedule C and C (1) excluding those mentioned in part XB and Schedule X
Form 27A Application for renewal or grant of a loan license to manufacture for sale or distribution of drugs mentioned in Schedule C and C (1) excluding those mentioned in part XB and Schedule X
Form 27B Application for renewal or grant of a license to manufacture for sale or for distribution of drugs mentioned in Schedules C, C (1) and X.
Form 27C Application for renewal or grant of license for the process of a Blood Bank for processing of whole blood and/or preparation of blood components.
Form 27D Application for renewal or grant of a license to manufacture for sale or for allocation of Large Volume Parenterals/Sera and Vaccines other than those specified in Schedule X
Form 27DA Application for renewal or grant of a loan license to manufacture for sale or for distribution of large volume parenterals/sera and vaccine/recombinant DNA (R-DNA) derived drugs other than those mentioned under Schedule X
Form 27E Application for grant /renewal* of licence to manufacture Blood products for sale or distribution
Form 27F Application for renewal or grant of license.
Form 30 Application for license to manufacture drugs with the intent of examination, test or analysis
Form 31 Application for renewal or grant of a license to manufacture cosmetics for sale or for distribution
Form 31A Application for renewal or grant of a loan license to manufacture cosmetics for distribution or sale
Form 36 Application for renewal or grant of approval for carrying out drugs/cosmetics tests or raw materials used in the manufacture thereof on behalf of licensees for manufacture for sale of drugs/ cosmetics.
Form 44 Application for getting permission to import or manufacture a New Drug or to carry out clinical trial.
Form 3F  Form 3J – Application for grant of Recognition to Medical Institution.
Application for Blood Storage Centre

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 ?

The shop or premises being considered by the applicant should have an enough area of not less than 10 sqr.mtrs. The premise should be equipped with enough storage facilities for preserving the properties of drugs. The applicant must be a certified pharmacist with the Pharmacy Council.

The premises or shop being considered by the applicant should have an ample area of not less than 10 sqr.mtrs. The person in charge must be a graduate with 1-year experience of dealing in drugs is mandatory for the sale of drugs by wholesale. The wholesale sale can also be supervised by a person who has completed S.S.L.C with 4 years of experience of dealing with drugs, especially approved by the department of drug control for the purpose.

The area of premises or shop should be not less than 15 sqr. mtrs.

A written complaint can be given to the Drugs Control Department, Govt. of N.C.T. of Delhi, at F-17, Karkardooma, Shahdara, Delhi-32. Details regarding the complainant and nature of complaint must be mentioned.

Drugs & Cosmetics Act, 1940 & rules there under have all the provisions regarding drug license. You can get in touch with MeraLegal to get a one on one understanding of the same.