Drug License for Pharmacy Business

Services Offered :

  • Documentation & Consultancy.
  • Preparation of Application (File).
  • Filing of Application on your behalf.
  • End to End Follow Up with Department.
  • Assistance at the time of inspection.
  • Representation before competent authority.

BEST PRICE GUARANTEE

BUSINESS REGISTERED

NO HIDDEN CHARGES

YEARS OF EXPERIENCE

Checklist for Issue of Retail or Whole Sale Drug License

Area of Pharmacy

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.

Pharmacist or Technical Staff

The medicines need to be handled with by a specialist, and for that matter, there is a requirement of a qualified pharmacist or a graduate having experience of one year or an SSLC passed individual having two years experience in dealing with drugs.

Drug License for all types of Pharmacy Business in India

Drug license is a permission granted by the competent authority under drugs and cosmetic act 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, homoeopathic, ayurvedic or unani drugs. 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. Hence all the concerned must be alert and vigilant while dealing with drugs and cosmetics in India and must comply with the conditions of license and provisions of the Act or rules there of.

Documents Required for Issue Retail or Wholesale Drug License

  • Photo ID and address proof of Directors / Partners and an affidavit regarding non-conviction under the Act.
  • Ownership Proof or Rent agreement of the premises, and a No objection the owner of the premises.
  • Siteplan & Keyplan of the premises along with an affidavit that the premises is either commercial / mixed land use.
  • Appointment letter and qualification documents of Registered Pharmacist/Competent person employed.
  • An affidavit duly sworn before notary of the pharmacist / competent person regarding full time working & Bio-Data.
  • Challan evidencing payment of fee, Invoice of Refrigerator and Air Conditioner & Duly filled application Form.

We are providing our services for Drug License for the below states in India, as of now.However, in case of other state we do take up assignments on case to case basis

  • Delhi
  • Bihar
  • Chhattisgarh
  • Goa
  • Gujarat
  • Haryana
  • Maharashtra
  • Himachal Pradesh
  • Jammu & Kashmir
  • Jharkhand
  • Kerala
  • Pondicherry
  • Karnataka
  • Punjab
  • Rajasthan
  • Tamil Nadu
  • Uttaranchal
  • West Bengal

Important Points on Drug Licence in India

Prior Licensing

It is mandatory for drugs & cosmetics business to obtain a license as per the nature of business by applying with the controller of the drugs and cosmetics and that every drug & cosmetic business needs to comply with the conditions of the licence.

Type of License

Based on the requirement of the business, an applicant must apply for issue of specific drug license. There are various licenses, for example, Manufacturing, Wholesale Drug License, Retail Drug License, Import of drugs or cosmetics.

Location Based License

If drugs are sold or stocked for sale at more than one place, a separate license is needed in respect of each such place. Similarly, in case of manufacturer, a separate license is required to manufacture same or different drugs but at different location.

Commercial Premise Must

Licences 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.

License for Each State

In case a business is operating in more than two states, it has to obtain drug licence in every state in which business is being carried on. Drug licence is location specific, and hence within state application, all site must be included.

Import of Drugs or Cosmetics

Drugs and Cosmetic Act aims at ensuring safety, effectiveness and conformity of the drugs and cosmetics sold in India to the state quality standards. Drugs or cosmetics of schedule X can be imported into India only after obtaining a License.

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