IndiaFilings / Learn / Tripura Drug License
Tripura Drug License - Application Procedure - IndiaFilings Last updated: December 17th, 2019 4:56 PM

Tripura Drug License

Tripura drug license is a document of permission for carrying out businesses related to drugs, medicines and cosmetics. The government of Tripura issues drug license to regulate the manufacture, storage, distribution and sales of drugs. Tripura drug license is issued under the Drug and Cosmetics Act, 1940 to a person dealing with drugs. As per this act, it is mandatory to obtain a Tripura drug license before the launching a drug business. In this article, we look at the procedure for obtaining Tripura drug license in detail. Know more about How to start a pharmacy business

Drugs and Cosmetics Act

Tripura drug license is a crucial document according to the Drugs and Cosmetics Act, 1940. This act moderates the manufacture, distribution import and sale of drugs and cosmetics, which includes allopathic drugs, homoeopathic medicines, and even the Ayurvedic, Siddha or Unani drugs.

Importance of Tripura Drug license

Some of the significance of Tripura drug license is explained in detail below:
  • The Tripura drug license permits market, manufacture sale, resale, trade of drug and cosmetics.
  • Without a Tripura drug license, no person can do pharmacy business or even start to associate with any dealings in Tripura.
  • For protecting good health of India through adequately accessing the medicines and drugs, the Drugs and Cosmetics act made it mandatory for obtaining a drug license
  • Tripura drug license also ensure that the drug and drugs are not misused or abused by any individuals in Tripura
  • Dealing with drugs/medicines a without a drug license is a cognizable offence. Every trader in the pharmacy industry needs to have their drug incense to carry out their day-to-day business work.
  • Tripura drug license contains the rule and regulation for the person who is dealing with drugs business
Note: It is the responsibility of all individual dealing with drugs and cosmetics to maintain its quality. If any person consuming a drug or medicine suffers any harm from the negligence on the part of the seller or manufacturer of the medicine, the same is an offence, which is an offence of grievous hurt under IPC. Hence holding Tripura drug license is necessary.

Who needs Tripura Drug License?

Tripura drug license is crucial for dealing with the following type of business. Any proprietorship, partnership firm, limited liability company, company or business firm located In Tripura and is physically distributing the medicine in the state is required to hold a drug license:
  • Business with any cosmetics intended to be sprinkled, rubbed, poured or introduced into the human body or for beautifying, cleansing, promoting attractiveness, or altering the appearance of a human, must obtain Tripura Drug license.
  • It is vital to get a drug license to deal with the drug which is used for internal or external in human beings
  • Manufacturing and distribution drugs or cosmetics applied to the human body to repel insects like mosquitoes also need Tripura drug license.
  • Business with drugs used for the destruction or insects which cause diseases in human beings must get a drug license.
  • Tripura drug license also mandatory for dealing with empty gelatin capsule.
  • To manufacture, store and distribute the drugs used for diagnosis, mitigation, treatment or prevention of disease or disorder in humans or animal, need Tripura drug license
Click here to know more about the Medicine and drugs allowed for import without a licence

Basic Requirement for Obtaining Tripura Drug License

According to the provision of Drug and cosmetics act, to get a Tripura drug license the below-described requirements to be met by the trader.

Area Recruitment

The minimum area required for setting up a medical shop or pharmacy is ten square meter. In case of the store business combination with the wholesale and retail of drugs then the minimum area of fifteen square meters is required. License for the sale of drugs can be issued in the commercial premises or other premises independent of residence.

Storage Facility

It is crucial to have an air conditioner and refrigerator on the premises because some medicines such as insulin injections, vaccines are needed to be stored in the refrigerator.

Technical Staff

Sale of drugs should be carried in the presence of a registered Pharmacist approved by the Tripura Government who is required throughout the working hours in the retail shop. The wholesale of drugs can be made either by a registered pharmacist or any competent authority who graduate and having experience in drugs or in the presence of an of person who has passed SSLC having experience of four years in drugs/medicines business, specially approved by Health and Family Welfare Department.

Classification of Tripura Drug License

Based on the requirement of the pharma business, Tripura Drug License can be classified in the following categories:
  • Sale License
  • Manufacturing License

Sale License

Sale license is issued to persons or agencies engaged in the sale of drugs or medicines in Tripura. The sale drug license is further classified into the following two types.
  • Retail License: It is granted to run and sell drugs or drug products in Tripura.
  • Wholesales License: It is provided to a person or agency engaged in wholesale of medicine or drugs

Manufacturing License

Manufacturing license is granted to a person or agencies involved in the manufacturing of drugs, medicines and cosmetics. The government of Tripura also issued Manufacturing loan license.

Licensing Authority

The health and family welfare department, Government of Tripura issues manufacturing drug license as per the provisions of drug and cosmetics act. State Drugs Control Directorate issues the license for sale of drugs and cosmetics. The prescribed authority for issuing Tripura drug license is Drugs Controller.

Time Frame

Tripura drug license will be issued within 45 days from the date of application.

Validity Details

The Tripura drug license granted to carry out business related to the drug is valid for five years from the date of issue. After expiry, the license can be renewed.

Documents Required

Documents required for Obtaining Tripura Drug license is as follows:

Documents for New Manufacturing Drug License

  • Applications in the prescribed form
  • Approved plan copy
  • Wholesale license copy
  • Challan of rupees as prescribed to be paid under the correct head of account
  • Draft labels
  • Method of analysis
  • Flow sheet
  • Manufacturing process
  • Standard operating procedures
  • List of products
  • Stability data