Drug License is a mandatory license for all entrepreneurs dealing in Drugs, Medicines and Cosmetics. Every entrepreneur engaged in activities such as manufacturing, wholesaling, stocking, importing and retailing any Drugs, Medicines or Cosmetic product need to obtain the license. Drug license includes Ayurvedic Medicines, Allopathic Medicines, and Homeopathy Medicines.

Drug license is issued by Central or State authorities as per the DRUG and COSMETIC ACT, 1940. Drug license is location based licensing and every entrepreneur needs to obtain license for all such locations, If an entrepreneur working in more than 1 state or working from more than 1 location need to obtain license for every such location or every such state.

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Advantages of Drug License

  1. Legal permission to run the business belongs to Drugs, Medicines and cosmetics
  2. Being a mandatory license it avoid penalties and fine imposed on dealing without license
  3. Ensures that the Drugs and cosmetics are manufactured as per the standards and norms which helps in building trust and market reputation
  4. Drug license helps in business expansion and provides new business opportunities like E-commerce or Supply in hospitals etc

Penalties for not obtaining Drug License:

Running a business without a drug license can be far outstretched and can have a bad impact on the business. Non-compliances result in the punishment and imprisonment of the person selling medicine without a Drug License.

As required under clause (c) of Section 18, If a person sale any medicine without Drug license and without complying with the Drug license process, he shall be punishable with-

  • Imprisonment for a period which shall not be less than 1 year, which may extend to 3 years, and in that case the period of limitation will come under Section 468 (2)(c) of Criminal Procedure Code and
  • Fine which shall not be less than Rs.5000/-

Factors to consider for Drug License

Working area: A minimum of 10 sq. meter area is required for retail counter of medicines and for retail cum wholesale counter a minimum of 15 sq. meter area is required.

Storage facility: A proper storage facility is required for drugs and medicines like cold and dry places, refrigerators, cold storage units or any other facility as required for safe and proper storage of medicines and drugs.

Adequate staff: A Retail pharmacy must have an experienced and technical staff with in-depth knowledge of the same. A qualified pharmacist is a must for obtaining a Drug License. However, in the case of Wholesale Drug License, the said staff must either be a graduate with minimum one-year experience or an undergraduate having four years’ experience.

Inspection: Drug license are issued after the inspection of premises by the Inspector having jurisdiction over the area. The inspector can visit the premises, can ask for documents and details submitted while applying for the license, can take measurement of the premises or can ask for any other details as he deems fit and required. The inspector can also interview the concerned person or applicant.

Documents required for Drug License:

  1. A duly signed application form which has already been filed.
  2. A copy of the Challan as a proof of depositing the prescribed fee.
  3. Identity proof in the form of PAN Card, Driving License, Voter ID, Passport, etc. in case the applicant is a proprietor/ partner/ director.
  4. If in case the applicant is a partnership firm, the copy of Partnership Deed.
  5. Constitution of Firm (MOA/AOA) and the Certificate of Incorporation in the case of a Private/Public/OPC.
  6. A copy of the Site Plan and key plan of the premises.
  7. Board Resolution for authorizing the company to obtain the license.
  8. Appointment letter of the person being authorized by the company.
  9. A copy of the Property paper (In the case of owned property).
  10. A copy of the Rent agreement or Lease Deed (In the case of rented property).

The following listed are the additional documents needed in the case of the Retail Sale

Registered Pharmacist:

  • Proof of Qualification, i.e., Certificate of Final degree or the Provisional Certificate along with mark sheets
  • Registration of the Pharmacy Council
  • A copy of the Bio-data and the Appointment Letter

The following listed are the additional documents needed in the case of the Wholesale License

  • Proof of Qualification, i.e., Certificate of Final degree or the Provisional Certificate along with mark sheets
  • A copy of the Bio-data and the Appointment Letter
  • A copy of the Experience Certificate of minimum one year
  • Surety from existing license holder

Currently the service is available in Rajasthan only.

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