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How To Get Drug License in India

How To Get Drug License in India – Looking for steps to obtain a drug license in India? Want to know the procedure to get a drugs license in India? If you are a person dealing in pharma drugs, then you need to own a drug license in India. The trade and business of medicines and drugs are an important aspect of the government as it involves lives of the public. The rules and regulations related to the drugs are strict. This involves ownership of a drugs license. In this post, we will be telling you about the steps on how to get drug license in India.

How To Get Drug License in India

What is Drug License and Its Types

Every businessman in the pharma industry needs to have their own drug incense to carry out their day-to-day business work. The Drugs & Cosmetics Act of 1940 made it mandatory for the pharma people to own a drug license. The license gives you the permit to sale, resale, market, manufacture, trade, etc of drugs. You can apply for the following types of drug licenses:

  • A wholesale drug license for permitting wholesale distribution of drugs.
  • A retail drug license for retail owners like a chemist, stand-alone pharmacy etc.
  • Restricted license for Gen.Store.

The Central Drugs Standard Control Organization (CDSCO) is the regulatory body of pharmaceuticals drugs and medical devices of India. It is the head of Drugs Controller General India (DCGI). DCGI is responsible for granting the drug license to various pharma organizations. You can obtain the drug’s license from two authorities:

  1. Central Drug Standard Control Organization
  2. State Drug Standard Control Organization

The drug license form to be filled by you will differ like your need. If you want a license for marketing allopathic drugs or Homeopathic medicines both to have different forms. Ask the officer or look for the particular forms you have to fill. The drugs you are marketing are according to the Drugs and Cosmetic Act Schedule SC, C(1) and X.  So, confirm twice before filling the form.

Basic Requirements Of A Drug Marketing License in India

The provisions and guidelines under Drugs and Cosmetic Act 1940 and Rules 1945 will always prevail. The requirements are to be fulfilled by the candidate. When you submit the form, a drug inspector or officer will come to visit you for inspection. The original documents and requirements should be fulfilled or else your license would not get approved. Here are the requirements:

  • The size of the premises should be 10 Sq. Meter for retail and wholesale outlets. In case of combined wholesale and retail, you need to have 15 square meters. It is mandatory for all.
  • A refrigerator, air conditioner and good ventilation system for the premises.
  • There should be a presence of any of the one person:
  1. A Registered Pharmacist under State Pharmacy Council.
  2. A graduate with min 1-year experience in drugs sales and marketing with a reputed pharma company.
  3. A person having 4 years experience in pharma marketing and has passes S.S.L.C.
  4. A person approves by the department of drug control is also eligible.

Important Documents To Obtain A Drug License

After fulfilment of all the requirements, you need to have some important documents. The documents should be scanned and uploaded in 100 dpi & black and white (For online applicant). The copy has to be submitted along with the form. The original documents are needed to be with you at time of inspection. This is in case the inspector asks for the original one. Here is the list.

  • Application form
  • Rent Agreement/ Ownership papers of premises.
  • Blueprint of premises site plan and key plan.
  • Declaration form
  • Covering Letter
  • Fee challan
  • Copy of the documents like purchase bills (like a refrigerator, air conditioner etc), electricity bills.
  • Original copy of Incorporation Certificate, AOA and MOA.
  • Partnership Deed (If)
  • Affidavit and a copy of full-time employment appointment letter of the registered pharmacist or competent person (in accordance with Drugs and Cosmetics Act, 1940).
  • Property tax receipt.
  • Rs 2 stamps (4 will be required.

Conclusion:

Drug license in India can be obtained by two ways. You can go online, fill options and make an online payment. On the other hand, you can go to the local drug license office to get the form. The online system has been said to be better and fast. Many states are offering online filling of drug license at the click of the finger.

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