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:

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.