Drug License

Checklist and Requirement for Drug License

In India, to start any business in Drugs & Cosmetics requires License. The provisions of Drugs & Cosmetics Act, 1940^[1] deals with the Drug License and other rules regulation regarding Drugs and Cosmetic Business. The license is required based on the business transactions of a particular business.

Features of Drug License?

Drug License is issued to run a business in Drugs & Cosmetics. The license is normally based on the type of business transactions. A different license requires a different type of business.

• The license is mandatory for drugs & cosmetics business.
• Licenses for the sale of drugs can be granted in the commercial premises or other premises independent of residence.
• Every drug & cosmetic business needs to comply with the conditions of the license.
• A license shall be displayed at the prominent place of premises.

Classification of Drug License

Drug license is classified under different categories like Manufacturing Licence, Sale Licence, and Loan license.

Manufacturing Licence to manufacture allopathic/ Homeopathic medicines/ and cosmetics and also to repack Drugs can be granted only in the recognized Industrial areas.

Sale license is further classified as wholesale Licence, Retail Licence and Restricted (General Store) license depending on the manner in which sales are done.

Loan license is the license issued to the applicant who intends to avail the manufacturing facilities owned by another licensee.

Different Drug License for each Operation

The drug license is required for each business operation is carried. That is if business operation is in two or more states than a different license for each state is required.

The license is specific to the location. If drugs are sold or stocked for sale at more than one place, a different application shall be made, and the separate license shall be issued, in respect of each such place except migrant vendors.

Procedure to obtain Drug License

Following is the procedure to obtain Drug Licence in India–

• Since we know the license is classified based on the type of business entity. In accordance with the type of business, the application shall be prepared and the applicant shall be registered.
• On successful registration, the system will generate a unique Registration No. for the application which can be used for further processing.
• After submission of application, the following documents along with the application shall be submitted to the office of Drug Licensing Authority of a respected district within 15 days of registration.
• Application form duly filled and signed by the applicant.
• The Challan of depositing the requisite fees.
• Photo Identity proof of proprietor (In case of proprietorship firm)
• Copy of partnership deed and Photo identity proof of partner/partners responsible for day to day business (in case of Partnership firm)

In the case of Private/Public Limited Company:

• Copy of Memorandum & Articles of Association of the Company,
• Copy of Certificate of Incorporation,
• Copy of resolution of Board of Directors regarding authorization of applicant for the license and for the person responsible for day to day business from the premises for the license is being applied
• Copy of appointment letter of applicant and person responsible for day to day business

Documents related to Registered Pharmacist:

• Copy of Diploma Pharmacy
• Copy of Registration Certificate from Pharmacy Council
• Copy of renewal of Registration (if applicable)
• Copy of Appointment and Joining Letter
• 2 passport size photographs per applied license
• Original affidavit of Pharmacist
• Documents related to a Competent Person (For wholesale licenses):
• Copy of Educational qualification certificate(s) including High School Certificate
• Original certificate of experience in dealing with drugs from authorized persons
• 2 passport size photographs per applied license
• Plan of Premises of premises for which license is being applied
• Area requirement: License applied for wholesale of drugs or retail sale of drugs than a minimum area of 10 square meters is required and if the applicant applies for both wholesale as well as retail licenses on the same premises then a minimum area of 15 square meters is mandatory.
• Documentary proof of ownership of premises/rental basis of premises.
• Proof of electricity availability in the premises
• Proof of availability of special storage conditions (cold storage/refrigerator)
• On satisfaction of application, the authority shall issue License.
• Once the license is granted to the business, all such Licensee must ensure that all the condition in the drug license is compiled at all the time during the course of the business.

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The records, registers, Forms shall be maintained in the manner specified by the licensing authorities and authorities shall be kept informed of all the changes or modification in the business activities.

Read our article: Procedure for obtaining Drug License in India