The Indian Pharmaceutical industry contributes 2% of India’s economy and 8% to the total export merchandise. India ranked third for pharmaceutical production by volume and 14th by value according to the India Brand Equity Foundation, 2021. The industry is broadly classified into three categories namely manufacturing, marketing trading and distribution and the retail distribution. It is mandatory to follow the prescribed procedure under the statute for getting license to establish and run a new pharmaceutical unit in the country.

What is concluded in the definition of drug?

The word drug is defined in the Drug and Cosmetic Act, 1940 as:

  • all medicines for internal or external use of human beings or animals and all substances intended to be used for or in the diagnosis, treatment, mitigation or prevention of any disease or disorder in human beings or animals, including preparations applied on human body for the purpose of repelling insects like mosquitoes;
  • such substances (other than food) intended to affect the structure or any function of the human body or intended to be used for the destruction of 10[vermin] or insects which cause disease in human beings or animals, as may be specified from time to time by the Central Government by notification in the Official Gazette;
  • all substances intended for use as components of a drug including empty elatine capsules; and
  • such devices intended for internal or external use in the diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals, as may be specified from time to time by the Central Government by notification in the Official Gazette, after consultation with the Board;]

What is the primary requirement to obtain license to start drug marketing business?

The initial requirement for starting drug marketing business is to obtain license and for obtaining license some requirements has to be fulfilled.

  1. Pharmacist: The person applying for the retail license must be a qualified pharmacist as per Regulation 10 of Pharmacy Act, 1948. Whereas for obtaining wholesale license person must be graduated with 1 year experience in the required field or undergraduate with 4 year experience in the said field.
  2. Space: For every wholesale and retail licence the specified area of storage must be there i.e. 15 sq meters for the wholesale business and 10 sq meters in case of retail or medical shop.
  3. Storage: Proper storage facility must be there with the person applying for the licence as some drugs needs to be stored in the low temperature therefore fridge and A.C must be there.
  4. Technical Staff: The staff hired for the wholesale pharmacy must have qualification of a wholesale pharmacist.

What documents are required to obtain licence?

  1. The person who wants to obtain drug licence has to submit their ID proofs.
  2. Documents related to premises have to be submitted as copy of ownership document or rent agreement and NOC from the owner in case the property is rented.
  3. Site plan and key plan of the premises.
  4. The evidentiary document for cool storage space i.e. refrigerator and A.C.
  5. The proof of fee deposit by submitting copy of challan.
  6. A non conviction affidavit.
  7. Cover letter with name and designation of the applicant.
  8. The required proof for the qualification such as for retail sale qualification letter, registration of local pharmacy and the appointment letter is required and for wholesale licence qualification letter, experience letter and appointment letter is required.
  9. Declaration form in prescribed format

How to apply for drug sale licence?

The Drug Controlling Authority is responsible for issuing the drug licence in India. Drug sale licence is issued by the State Drugs Standard Control Organisation. The following procedure has to be followed for getting drug sale licence:

  • Filing of application: The applicant must file application on the website of the authority responsible for issuing drug sale license with the necessary details asked in the application form.
  • Documents upload: After applying for the license, the applicant has to upload updated documents mentioned above with the prescribed fee.
  • Visit by Drug inspector: After receiving the application the drug inspector will visit the premises for the verification of details mentioned in application form.
  • License: After the satisfaction of drug inspector that all the documents are original and the necessary requirement are fulfilled he will issue the drug license in favour of the applicant.

-Surbhi Singla

Associate at Aggarwals & Associates, S.A.S. Nagar, Mohali