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The rules and regulations pertaining to drug license is governed by the Food Safety and Drug Administration Department of the concerned State Government. This department would be responsible for processing application for grant of drug license. Some of the different types of drug license application forms are:

Application Type Description

Form 14A – Application from a purchaser for test or analysis of a drug under Section 26 of the Drugs and Cosmetics Act, 1940

Form 19 – Application for grant or renewal of a licence to sell, stock, exhibit or offer for sale, or distribute drugs other than those specified in Schedule X

Form 19A – Application for grant or renewal of a restricted licence to sell, stock or exhibit or offer for sale, or distribute drugs by retail by dealers who do not engage the service of a qualified person

Form 19B – Application for licence to sell, stock or exhibit or offer for sale, or distribute Homoeopathic Medicines.

Form 19C – Application for grant or renewal of a [ licence to sell, stock, exhibit or offer for sale, or distribute] drugs specified in Schedule X

Form 24 – Application for the grant of or renewal of a licence to manufacture for sale or for distribution of drugs other than those specified in [Schedule C, C (1) and X]

Form 24A – Application for grant or renewal of a loan licence to manufacture for sale or for distribution of drugs other than those specified in Schedule C, C (1) and X

Form 24B – Application for grant or renewal of a licence to repack for sale or distribution of drugs, being drugs other than those specified in Schedule C and C (1) excluding those specified in Schedule X

Form 24C – Application for the grant or renewal of a licence to manufacture for sale [or for distribution] of Homoeopathic medicines or a licence to manufacture potentised preparations from back potencies by licensees holding licence in Form 20-C

Form 24F – Application for grant or renewal of a licence to manufacture for sale or for distribution of drugs specified in Schedule X and not specified in Schedule C and C(1).

Form 27 – Application for grant or renewal of a licence to manufacture for sale or for distribution of drugs specified in Schedule C and C (1) excluding those specified in part XB and Schedule X

Form 27A – Application for grant or renewal of a loan licence to manufacture for sale or for distribution of drugs specified in Schedule C and C (1) excluding those specified in part XB and Schedule X

Form 27B – Application for grant or renewal of a licence to manufacture for sale or for distribution of drugs specified in Schedules C, C (1) and X.

Form 27C – Application for grant/renewal of licence for the operation of a Blood Bank for processing of whole blood and/or preparation of blood components.

Form 27D – Application for grant or renewal of a licence to manufacture for sale or for distribution of Large Volume Parenterals/Sera and Vaccines excluding those specified in Schedule X

Form 27DA – Application for grant or renewal of a loan licence to manufacture for sale or for distribution of large volume parenterals /sera and vaccine/recombinant DNA (R-DNA) derived drugs excluding those specified under Schedule X

Form 27E – Application for grant /renewal* of licence to manufacture Blood products for sale or distribution

Form 27F – Application for grant or renewal of licence.

Form 30 – Application for licence to manufacture drugs for purpose of examination, test or analysis

Form 31 – Application for grant or renewal of a licence to manufacture cosmetics for sale or for distribution

Form 31A – Application for grant or renewal of a loan licence to manufacture cosmetics for sale [or for distribution]

Form 36 – Application for grant or renewal of approval for carrying out tests drugs/cosmetics or raw materials used in the manufacture thereof on behalf of licensees for manufacture for sale of drugs/ cosmetics.

Form 44 – Application for grant of permission to import or manufacture a New Drug or to undertake the clinical trial.

Form 3F – Form 3J – Application for grant of Recognition to Medical Institution.

Application for Blood Storage Centre

Of the above types of drug license, application in form no. 19 /19A /19B/19C would be required for setting up of a medical shop. In such cases, the following documents would be required along with the application:
1. Online fee deposit receipt.
2. Site plan and key plan of premises.
3. Constitution of a firm like incorporation certificate.
4. Photo ID proof of proprietor/partner/director
5. Affidavit regarding non-conviction of proprietor/partner/director as well as the firm under the Drugs & Cosmetics Act, 1940
6. The affidavit from the registered pharmacist /competent person
7. For retail sale registered pharmacist
– Proof of qualification
– Registration of local pharmacy council
– Appointment letter
8. For wholesale licence competent person
– Proof of qualification
– Experience certificate
– Appointment letter
9. Address proof (rent agreement/sale deed)

Infrastructure Requirement

To obtain drug license, the applicant has to provide an independent shop with adequate area for grant of retail / wholesale license as per details given below:

• For grant of licence in Form 20 or Form 21 or both, the premises are of an area of not less than 10 square meters;
• For grant of licence in Form 20-B or Form 21-B or both, the premises are of an area of not less than 10 square meters; and
• For grant of licence (i) In Form 20 or Form 21 or both, and (ii) In Form 20-B or Form 21-B or both the premises are of an area of not less than 15 square meters

Further, the clear height of the premises of the sale should be in accordance with the National Building Code of India, 2005 as amended from time to time.

Multi-State Operation

In case a business is operating in more than two states, it has to obtain a drug licence in every state in which business is being carried on. Drug licence is location-specific. If drugs are sold or stocked for sale at more than one place, the application should be made, and license should be issued, in respect of each such place except migrant vendors. Once the licence is granted to the business, all such Licensee must ensure that all the condition in the drug licence complied at all the time during the course of the business. All the records /registers /Forms must be maintained in the manner specified by the licensing authorities and authorities should be kept informed for all the changes or modification in the business activities.

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