Drug License

Access to drugs and medicines are essential for ensuring good health of a Nation. However, the access to drugs and medicines must be restricted to ensure that such goods are not misused or abused by individuals. Hence, the government has laid down stringent law and regulations for manufacturing and distribution of drugs and medicines in India. Regulation governing manufacture and sale of drugs are given in Drugs and Cosmetics Act, 1940 and rules framed thereunder. Control is exercised over drugs from the raw material stage during manufacture, sale, distribution and upto the time it is passed on to a patient or consumer by a Pharmacist in retail pharmacy, hospital or a dispensary. In 1964, Ayurvedic and Unani drugs were also included under the Drugs and Cosmetics Act, 1940. However, a particular business entity may require different types of drug licence based on their business. In this article, we look at the procedure for obtaining drug license in India.

Drug License Application

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	Download
Form 14A	Application from a purchaser for test or analysis of a drug under Section 26 of the Drugs and Cosmetics Act, 1940	Download Now
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	Download Now
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	Download Now
Form 19B	Application for licence to sell, stock or exhibit or offer for sale, or distribute Homoeopathic Medicines.	Download Now
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	Download Now
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]	Download Now
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	Download Now
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	Download Now
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	Download Now
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).	Download Now
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	Download Now
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	Download Now
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.	Download Now
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.	Download Now
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	Download Now
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	Download Now
Form 27E	Application for grant /renewal* of licence to manufacture Blood products for sale or distribution	Download Now
Form 27F	Application for grant or renewal of licence.	Download Now
Form 30	Application for licence to manufacture drugs for purpose of examination, test or analysis	Download Now
Form 31	Application for grant or renewal of a licence to manufacture cosmetics for sale or for distribution	Download Now
Form 31A	Application for grant or renewal of a loan licence to manufacture cosmetics for sale [or for distribution]	Download Now
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.	Download Now
Form 44	Application for grant of permission to import or manufacture a New Drug or to undertake clinical trial.	Download Now
Form 3F	Form 3J – Application for grant of Recognition to Medical Institution.	Download Now
	Application for Blood Storage Centre	Download Now

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 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 Drugs & Cosmetics Act, 1940
6. Affidavit from the registered pharmacist /competent person
7. For retail sale registered pharmacist
   1. Proof of qualification
   2. Registration of local pharmacy council
   3. Appointment letter
8. For wholesale licence competent person
   1. Proof of qualification
   2. Experience certificate
   3. 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 sales premises 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 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, 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 are 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.