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DRUG LICENSE

DRUG LICENSE

We support wholesale and retail license

Drug License is permission from the government to deal with drugs. There are two kinds of license, the retail license and wholesale license of for drug distribution or sale in India. This license is issued subject to certain conditions attached to premises and the competent person who shall be dealing with drugs.

24,999.00

Drug License

Drug license is a permission granted by the competent authority under Drugs and Cosmetic Act, 1940 to carry out a business concerning drugs/medicines or cosmetics. In other words, no person can start or continue a business dealing with drugs or cosmetics in India, unless an appropriate license is obtained for the conduct of such activity. Under the purview of Drugs and Cosmetics Act, 1940 all types of drugs or cosmetics business is covered including allopathic, homeopathic, ayurvedic or unani drugs. To maintain the quality of drugs and cosmetics is the responsibility of all persons dealing with it. If any person consuming or using a drug or cosmetic suffers any harm from the negligence on the part of the manufacturer or seller the same is an offence, which is triable as an offence of grievous hurt under IPC.

Checklist for Issue of Retail or Whole Sale Drug License

  • Competent Person/ Pharmacist: The medicines need to be handled with by a specialist, and for that matter, there is a requirement of a qualified pharmacist in case of retail drug license and in case of wholesale a graduate with 1 years experience or undergraduate having four years experience is must
  • Area of Pharmacy Shop: For opening a pharmacy business, the carpet area of the pharmacy must be a minimum of 10 square meters, and in case the application is for both retail and wholesale pharmacy the minimum area prescribed in 15 square meters. The premises must be adequately ventilated.
  • Storage Facility of Drugs: Medicines need to be stored at a clean, ventilated and cool storage facility, since some drugs, in particular, the vaccines need to be stored in a low-temperature freezing zone. Hence, facility of a refrigerator and air conditioner is essential for grant of a drug license in India.
  • Inspection by Drug Inspector: Before the grant of a drug license, the drug inspector having jurisdiction of the area visits the premises where drug license is required and verify the particulars furnished with the application and if required take measurement of the premises and also interview the competent person.

Documents Required

In General

The right documents will save you from any kind of rejections, the documents to be submitted is the most important step in obtaining the drug License it includes preparation of key plan and site plan and various affidavits and declaration pursuant to the applicable rules and regulation of the law.

The following documents would be required along with the application

  1. Receipt of the Online fee deposit.
  2. Site plan and key plan of premises as required in the respective state as per applicable rules.
  3. Incorporation proof like incorporation certificate.
  4. ID proof of proprietor/partner/director as the case may be.
  5. A valid affidavit stating about the non-conviction of proprietor/partner/director/ the firm under the Drugs & Cosmetics Act, 1940.
  6. An affidavit from the competent person or registered pharmacist.
  7. In case of retail sale registered pharmacist
    1. Proof of qualification of the pharmacist
    2. Registration under the local pharmacy council
    3. Appointment letter in this regard
  1. For wholesale license competent person
    1. Proof of qualification of such competent person
    2. Experience certificate of the person dealing into it
    3. Appointment letter of such competent person
  1. Address proof either the rent agreement/sale deed

FAQ

Is it necessary to obtain drug license prior to commencement of the drug business?

Yes, before you start any business dealing in drugs, whether it is Allopathic Drugs, Ayurvedic Medicine, Homeopathy or Unani, to manufacture, distribute or sell the drugs It is mandatory to obtain a license as per the nature of business by applying to the controller of the drugs and cosmetics

Is it true that for grant of a drug license my shop must be located at a commercial premises?

Licenses for the sale of drugs can be granted only at premises which is commercial premises or other premises independent of residence, also known as mixed land use. For this purpose state drug office issues guidance which may be referred to.

What are different types of Licenses Issued for the Pharmaceutical Business?

Based on the requirement of the pharmaceutical business, an applicant must apply for issue of specific drug license. There are various licenses, for example,

  1. Drug Manufacturing License
  2. Wholesale Drug License,
  3. Retail Drug License,
  4. Import of Drugs or Cosmetics
  5. Import of Medical Equipment
  6. Export of Medicines etc.
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