How to obtain a Drug License Certificate in India?

Stepping into Pharmaceutical industry is quite challenging, specifically in a country like India that already accommodates about 5, 50,000 Drug stores. The market of Indian Retail Pharmacy has tremendously grown over the recent years on an average of 18% per annum. The increasing health deterioration cases have prompted the need for multiple Drug stores & Pharmacists in every nook and corner of our nation. If you also want to open a Drugstore, then you have to acquire permission from Government in the form of Drug License. This document will provide you comprehensive knowledge related to Drug License Certificate in India.

Importance of Drug License in India

Anyone who wishes to carry out the activities of trade, sale, manufacture, import or resale of Drugs in Pharmaceutical market must procure Drug License. It is mandatory to have a Drug License Certificate under Drugs & Cosmetics Act, 1940.  It is issued by Central Drug Standard Control Organization (CDSCO).

CDSCO regulates and approves new clinical trials and Drugs in India. The Authority also lays a set of standards for Drugs and ensures the quality of imported Drugs by coordinating with State Drugs Standard Control Organizations. Further, it aims to bring steadiness in the enforcement of Drugs and Cosmetics Act, 1940.

The Act safeguards the public health and any negligence of Drug retailer or manufacturer shall be considered as an offence. Drug License is indispensable to have for every type of cosmetics and Drugs business ranging from Homeopathic to Ayurvedic, Allopathic and even Unani Drugs.

Provisions to get a Drug License Certificate

Drugs and Cosmetic Act 1940 has laid the guidelines and rules which are required to be met by a Pharmaceutical applicant. Here are the conditions to comply with before and after attaining a Drug License:

• Any person with the intent of running a Drug business must have at least four years of knowledge and practical experience in Drug distribution.
• A Drug retailer needs to make an entry in the register each time of Drug supply.
• The Drug Licensee must not sell any Drug subsequent to its expiry.
• The Drugs can only be manufactured under the supervision of a Registered Pharmacist.
• Every Drug Licensee must keep a record of the Drugs sold through retailing or intended for sale.
• Drugs are prohibited from being sold by a minor (below 18 years).
• The Drug Licensee must not store any Drug at his/her premise that was meant for free sample distribution to a Medical Practitioner.
• A medicine to cure animals must be labeled with “Not for human use, for the treatment of animals only.”
• Schedule X and Schedule H Drugs categorized under the Drugs and Cosmetics Rules 1945 should only be supplied to the registered hospitals, dispensaries, nursing homes on a signed written order.
• A Registered Pharmacist must undertake a thorough inspection of medicines prescribed by a Registered Medical Practitioner before retail supply.
• In case, a Drug License has stored an expired Drug to claim a rebate from the Income Tax Department; then it shall not be regarded as an offence under the Drug and Cosmetic Act, 1940 until it was not intended for sale.

Who can apply for Drug License?

Nowadays everyone relies upon local Drugstores for trivial diseases, it is crucial to have certified professionals operating the entity. Therefore, Central Drug Standard Control Organization has listed stringent criteria to get Drug License Certificate:

• Drug Storage Facility– A Pharmacy or Drugstore must have a sound ventilation system, refrigerator and an air conditioner.
• Area of Pharmacy/Drugstore– The minimum carpet area of a Drugstore/pharmacy shop has to be 10 Sq. meters for retail or wholesale outlets. Moreover, in the case of a combined wholesale and retail Drugstore or Pharmacy, the prescribed area is 15 Sq. meters.
• Requirement of a competent person– An individual can only conduct a Drug business under the guidance of these persons:
  • A Registered Pharmacist/Chemist under State Pharmacy Council;
  • A graduate with at least one year of experience in Drug marketing & sales in a reputed Pharmacy;
  • A person who has passed S.S.L.C. and has four years of experience in Pharmacy marketing;
  • Any certified person from the department of Drug control is also eligible.

Checklist of documents

Affix the documents given below along with your Drug License Application Form:

• Incorporation Certificate of the Company
• ID proof of Proprietor, Partner or Director (as the case may be)
• Address proof of your office such as Rent Agreement or Sale Deed
• A valid Affidavit that confirms non-conviction of the Proprietor, Partner or Director of the Pharmacy under Drugs and Cosmetics Act, 1940
• Qualification proof, Experience Letter of the Pharmacist
• An Affidavit issued from a proficient person or Registered Pharmacist
• Memorandum of Association and Articles of Association
• Drugstore details such as invoices, air conditioner, refrigerator etc.
• Appointment Letter for the person who will carry out daily operations
• Receipt of the online fee deposited
• A self-attested copy of the Registered plant layout
• Key plan and site plan of premises

Online process for Drug License Registration

To acquire a Drug License Certificate, you need to follow the simple steps mentioned below:

• Visit the official portal of Food Safety and Drug Administration (fsdaup) [1] and select the online option of Registration for Drugs/Cosmetics.
• File the appropriate Registration Application Form and attach a scanned copy of all essential documents. Also, submit the fees prescribed by the Authority.
• Therefore, the Drug Inspector will pay a visit to your proposed Pharmacy shop or Drug store to validate the authenticity of the documents.
• Once the inspection is complete, the concerned State Drug License Authority will issue the Drug License to you.

The entire process of Drug License issuance usually takes a minimum 30 days if the applicant fulfills all the conditions and provides valid information.

Conclusion