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How to Apply for Drug Distribution License in India

How to Apply for Drug Distribution License in India

One of the world’s biggest markets for drugs is belongs to India. Both pharmacies and wholesale medication dealers are widely available in India. The availability of pharmaceuticals and medicines is essential for ensuring the public health, and the Indian government supervises their distribution to prevent abuse or misuse on the part of any person. Drug manufacturing and sales must be done with caution, and the government has established tight guidelines for issuing licenses for these activities. Therefore, a Drug Distribution License must be obtained in India in compliance with the guidelines of the 1940 Drugs and Cosmetics Act. In this article, we will discuss how to apply for Drug Distribution License in India.

What is Drug as per Drug and Cosmetics Act 1940?

According to Section 3(b) of the Drugs and Cosmetics Act of 1940, a “drug” is any medication or device intended for use on humans or animals either externally or internally, as well as any substance intended for use in the treatment, mitigation, diagnosis, or prevention of any disease or disorder in humans or animals, including preparations applied to the body to ward off insects like mosquitoes. The term was further expanded to include Ayurvedic and Unani medicines in 1964. 

The regulatory organization for drug registration in India is comprised of the Central Drugs Standard Control Organization (CDSCO) and State Drug Standard Control Organization (SDSCO), which also have the authority to grant licenses for drug distribution. The Drugs Controller General of India’s top representative is the CDSCO (DCGI). Every maker of cosmetic products must guarantee that they abide by the registration criteria and all other relevant conditions outlined in the Drugs and Cosmetics Rule of 1945[1].

The Process of obtaining Drug Distribution License in India 

The steps involved in obtaining a Drug Distribution License are as follows-

Document Filing 

The individual or entity must make sure that he has the list of papers that is given below. The former must make sure that he complies with all documents given below, although this list is not exhaustive in nature- 

  • Covering letter outlining the goal of the application.
  • Two applications were submitted using form 19.
  • Form of declaration.
  • Charge Challan (Rs.3000).
  • The layout of the commercial space
  • The lease agreement or ownership records for the commercial property, whether the store or office is rented.
  • Tax bill on real estate.
  • Certificate of Incorporation/MoA/AoA (If the business entity is a Company or LLP).
  • Deed of partnership (If the entity is a partnership).
  • Board decision (if the entity is a private limited company).
  • The directors’ list (if the entity is a private limited company).
  • Affidavit (of the proprietor, if applicable).
  • Affidavit (of the concerned pharmacist).
  • Educational certificate (of the proprietor, if applicable).
  • Biodata (of the concerned pharmacist or Competent person).
  • ID Verification (of the proprietor, if applicable).
  • Degree transcript (of the concerned pharmacist or Competent person).
  • Position letter (if applicable).
  • Receipt for the refrigerator’s invoice
  • Photographs (of the concerned pharmacist).
  • Photographs (of the proprietor, if applicable).

Application Submission

The online Drug Distribution License application must be completed. The applicant must upload scanned copies of the essential documents when completing the application. The application is accepted after the necessary fees have been paid.

Drug Inspector Inspection

A drug inspector examines the paperwork in person after the Drug Distribution Licene application is submitted. He visits the store in person to make sure it complies with all applicable regulations. Following verification, he provides the go-ahead.

Acceptance and Gran

The Drug Distribution License application is approved by the Drug Licensing Authority and the Drug Distribution License is given following the verification of the papers and fulfilment of the requirements. But this license called Drug Distribution License needs to be renewed. Renewal of Drug Distribution License is mandatory. 

Requirements for Drug Distribution License

Following are the requisites and pre-requisites of the Drug Distribution License- 

  • The business location must be at least 15 square meters in size.
  • It has to have a fridge. (This is done to preserve medications safely and guard against harm.)
  • A licensed pharmacist or a qualified individual with relevant experience in the wholesale drug licensing business may personally supervise the application for a license. Only those with a pharmacy degree are eligible to receive a wholesale medication license in several areas across the nation.
  • The individual in question must have completed their education and have at least one year of experience dealing in narcotics or
  • The individual in question must have completed SSLC and have 4 years of drug trafficking experience.
  • Once the drug license has been obtained, it should be prominently posted on the property for future inspection.
  • GST registration number, or Goods and Services Tax number. (This can be omitted)
  • The warehouse or business location must be secured and sterile. Areas with open ends or roofs are ineligible.
  • The appropriate furniture, such as storage racks, must be present in the space.

Conclusion

Drugs are essential and necessary goods. The government maintains a tight application process because of its importance. This guarantees that the Drug Distribution License holders follow the rules. These clauses in turn make sure that a qualified individual is running the business. Additionally, they make sure with the help of Drug Distribution License that drugs do not endanger people’s lives. The application process for Drug Distribution License is drawn out and necessitates the submission of numerous documents. Contact us at Registration Arena if you need any help with the Drug Distribution License procedure. Our help make the process easier by filing the documents for you and taking care of any hassle that you might encounter reach us directly at Bizadvisors.io for Drug Distribution License.

Read our article:Benefits of Obtaining a Drug Shop License in India

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