Drug License Registration

What is Drug License Registration?

A drug license is required to start a pharmacy business in India. The permission to hold a drug license is given under the Drugs and Cosmetic Act 1940. The drug license is mandatory to carry out business concerning drugs and cosmetics. In other words, no person can start a business dealing with drugs and medicines unless the appropriate license is obtained for the conduct of such activity.
Under the Drugs and Cosmetic Act 1940, all types of drugs and cosmetics are covered including allopathic and homeopathic. This act was further amended in parliament to include Ayurvedic and Unani drugs.

Basic features of drugs license-:
  • Drugs license is mandatory for pharmacy dealing running in the state and union territories like Delhi and Panduchery.
  • In case a business is operating in more than two states, it has to obtain a drug license in every state in which business is being carried on. Drug license is location-specific.
  • Drugs license is granted in commercial premise or any other premise which is not residential
Requirements for drug license registration-:

The drug license is granted after certain requirements are completed by the firm. To obtain the license following condition are must-

  • Qualified/specialist pharmacist-The license holder should be a qualified person. The person should be graduate with one year of experience and an undergraduate. This is the first requirement to get the pharma license. The person handling the pharmacy shop should be knowledgeable about the medication and drugs to handle the business.
  • Area of your shop-The area of your pharma-shop also decides your chances to get a pharma license. The area of pharmacy must be 10 square meters for retail and wholesale outlets. In the case of combined wholesale and retail, the area should be 15 square meters.
  • Storage facility of drug-The storage facility of the pharma store should be clean and ventilated place. Medicines need to be stored in a clean and well-ventilated place. The store needs to have a refrigerator since some drugs in particular vaccines need to be stored in the low-temperature freezing zone. Hence, the storage facility should be of high quality to get a license.
  • Staff of the store-Apart from this the staff of your store also is another condition before getting a license. An inspection officer visits your store for verification. This officer checks the required condition regarding drug licenses and gives approval.

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Types of Drug License in India

  • Retail license: These are the general pharmacy chemist store primarily involved in the sale of medicines and cosmetics in India. Retail license is for the business who have limited stock of drugs and medicines. This license is issued by Licensing Authorities to retailers who are doing business in pharmaceuticals, stand-alone pharmacists, etc. The applicant should be a registered pharmacist under the State Pharmacy Council.
  • Wholesale license: The whole license in India is issued by (Central Drugs Standard Control Organisation) to wholesalers of pharmacy. This license is required for the large scale pharmaceutical business and involved in the import & export of drugs.

Documents required for Drug License Registration

  • Identity proof of the applicant
  • Application form in prescribed format
  • Covering letter with the intent of application signed with the name designation of application
  • Site plan of the premises to set-up a pharmacy.
  • Challan of fee
  • Copy of documents like purchase bills like [refrigerator, air-conditioner, etc.] electricity bills.
  • Declaration form in the format prescribed
  • Address proof ( Telephone/electricity bills)
  • Rent agreement of the premises, if rented
  • Proof of the constitution of the business [incorporation certificate, MOA/COA, partnership deed]
  • Affidavit of nonconviction of proprietor, partners, directors under Drug and Cosmetic Act 1940.
  • Affidavit of registered pharmacist or competent person working full time
  • Appointment letter by registered pharmacist