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Drug Licence

Drug Licence

6500

Drug License

Every establishment dealing with Drugs is required to get a Drug License from the concerned state government authority.

Procedure for obtaining License:

With the introduction of form INC29, establishing a company is much easier and less time consuming.

FAQs

Who is required to obtain drug license?

Every person or entity dealing with Medicines, Drugs and related products is required to mandatorily obtain Drug License for their organization.

What is the minimum area required to obtain drug license?

A minimum area of 10 square meters is required to start a medical shop or pharmacy or wholesale outlet. In case, the pharmacy business combines retail and wholesale, a minimum of 15 square meters is required.

What are the requirements as to the storage facilities which are to be made available in the premises?

The establishment should have Refrigerator and Air Conditioner in the premises, to store few drugs which are to be specifically stored in cool conditions.

In how many days does the authority grant drug license?

Drug License is usually granted in 15 days.

What are the documents that are required for grant of license for sale of drugs?

Following is the list of documents that any state government would normally ask for.

  • Application forms.
  • Challan of fee deposited.
  • Declaration form.
  • Key plan (Blue print)
  • Site plan (Blue print)
  • Basis of possession of the premises.
  • Proof of ownership of the premises, if rented.
  • Proof of constitution of the firm (Certified copy)
  • Affidavit of non-conviction of Proprietor/Partners/Directors under Drugs & Cosmetics Act, 1940.
  • Certified copy of Regn. Certificate of Delhi Pharmacy Council/Experience Certificate of the Registered Pharmacist/Competent person and qualification certificates.
  • Bio-data form.
  • Affidavit of Registered Pharmacist/Competent person regarding fulltime working with the firm duly attested by Notary.
  • Appointment letter of Registered Pharmacist/Competent person in charge, if employed person.

What are the other requirements for an establishment to obtain drug license?

Apart from the above mentioned requirements, entities should ensure that The sale of drug by wholesale shall be made either in the presence of registered pharmacist or in the presence of a competent person who shall be a graduate with 1 yr experience in dealing in drugs or a person who has passed S.S.L.C with 4y ears experience in dealing in drugs, specially approved by the department of drug control for the purpose and the sale of drug by retail must be made in the presence of registered pharmacist approved by the department, Registered pharmacist is required throughout the working hours.

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