Looking to start a drug business in India with the blessing of the central government? You need to obtain a drug license. In this article, we will outline the numerous documents required to obtain a drug license in India.
The process of drug licensing is tedious, especially in light of the pandemic. The strict regulating requirements set for issuing a drug license indicate the gravity of the hassle involved in obtaining one. The Drugs and Cosmetics Act of 1940 is the primary regulatory framework that governs the whole drug licensing lifecycle. It is also critical to understand that a drug license is location-specific.
According to Section 3(b) of the aforementioned Act, a drug is defined as the following:
| “all medicines for internal or external use of human beings or animals and all substances intends to be for or in the diagnosis, treatment, mitigation or prevention of any disease or disorder in human beings or animals, including preparations applied on the human body for the purpose of repelling insects like mosquitoes.” |
A drug license is issued in the following categories:
- Drug manufacturing license
- Loan License
| Explanation – A ‘loan license’ means a licence which a licensing authority may issue to an applicant who does not have his own arrangements for manufacture but who intends to avail himself of the manufacturing facilities owned by a licensee in Form 32. |
- Multi drug license
- Drug sales license
This can take the following sub-forms:
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Requirements for Obtaining a Drug License
There are several prerequisites which must be fulfilled by those people who want to get a drug license. Given the low success rate of drug license grants, particularly for those applicants seeking retail sales licenses, it is critical to ensure that all requirements are satisfied.
The following are the three major requirements:
- Availability of requisite space: This requirement is with regards to the area of the pharmacy or place of sale in case of a wholesale unit.
- In case of either a wholesale or retail operation, the area of the premises has to be at least 10 square meters.
- In case both the wholesale and retail operations are being conducted by a unit, the area of the premises has to be at least 15 square meters.
- The premise has to be adequately ventilated.
- The height of the premises being used for drug sales has to be in line with the National Building Code of India, 2005.
- Adequate storage facility for drugs: Certain medications must be stored at low temperatures in order to remain effective. Insulin doses, vaccines, and various sera are examples of these. As a result, cooled storage facilities such as refrigerators and air conditioners are mandated before applying for a license.
- Trained and qualified staff:Having competent personnel on board is compulsory before applying for a license.
The outline of this requirement is as follows:
- For a wholesale operation, sales can be made under the supervision of a registered pharmacist. A graduate with an experience of at least 1 year in dealing with drugs is sufficient in lieu of a pharmacist. If either is unavailable, an individual with SSLC qualification and experience of four years in dealing with drug needs can be substituted. This, however, should be approved by the department of drug control.
- For a retail operation, stores need to undertake sales in the presence of a registered pharmacist only. This qualified individual has to be present throughout the working hours of a store.
Once the above requirements can be met, one can begin the process of applying for a drug license.
Documents Required for a Drug License
The basic requirements for applying for a drug license include the availability of suitable premises, cooling facilities, and competent personnel. A completed Form 19 is the primary document required. This form requests approval for a license to sell, stock, exhibit, or offer for sale or distribution of drugs. However, these drugs must not be those listed in Schedule X. Dealers who intend to sell drugs in a retail setting without the assistance of a qualified individual must fill Form 19A. Form 19B is required for those who want to stock, sell, or distribute homeopathic medicines. Meanwhile, those wishing to sell Schedule X drugs must fill Form 19C.
Along with this, the following documents must also be submitted with the application:
- A challan of ₹ 3,000
- Affidavit of the proprietor on ₹ 20 stamp paper
- Self-attested copies of education certificate and identity proof of proprietor
- Affidavit of a registered pharmacist or competent person
- Self-attested copies of education certificate and identity proof of registered pharmacist or competent person
- Experience certificate of a competent person
- Blueprint of a plan layout of proposed premises
- Electricity bill of proposed premises
- Copy of refrigerator bill
- Either rent agreement or ownership document of the premises
- Covering letter
- 5 photos each of the proprietor, and either the registered pharmacist or the competent person.
To know more about how to obtain a drug license in India, get help from an expert at Vakilsearch.
