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Different Types of Drug Licenses in India

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A nation’s ability to get medicines and treatments is important to keeping its general health. To make sure that people don’t abuse or misuse these things, access to drugs and medicines must be managed. As a result, the Indian government has created strict laws and rules connected to the creation and sale of drugs. The 1940 Drugs and Cosmetics Act and the rules made under it include laws related to the production and sale of drugs.

From the moment a drug is used as a raw material throughout production, sale, and distribution until a chemist in a retail pharmacy, hospital, or clinic moves it to a patient or customer, control is kept over the substance. The Drugs and Cosmetics Act of 1940 was changed to cover Ayurvedic and Unani medicines in 1964. However, depending on their line of work, a certain company organisation can need a different kind of drug licence. This article examines the types of Drug Licenses in India.

What is a Drug License?

A drug license is an authorization provided by regulatory agencies, such as the Central Pharmaceuticals Standard Control Organization and the State Directorate of Drugs Control in India, enabling persons or enterprises to participate in activities connected to pharmaceuticals and cosmetics. It is required by law for any drugstore or business dealing with drugs.

Types of Drug License:

 A drug licence is the permission given by the Drug controller to deal in drugs. Categories of the Licence depend upon the type of business as follows.

1. Sales Drug Licence

  • Retail Sale Drug Licence:

The end customer is the one who buys drugs through retail sales. Drug stores can sell medications to places like hospitals, clinics, educational institutions, study groups, and more. The Drugs and Cosmetics Act states that individuals who sell drugs need to have a drug licence. A store pass is granted by the Drug Controller Authority of the concerned State. In case any person sells drugs without a Licence, he shall be punished with jail for a term of not less than one year, and it may extend up to 3 years with a fine up to Rs. 5000.

Note – If a store is interested in the drugs business in more than one state, then a different licence is needed for the different states.

  • Wholesale Drug Licence:

A trade pass is given to the company or distributor or an independent agent who can be an authorized agent for the local or foreign producer. Or we can say that the sales licence is given to the producer and approved Indian agent. A wholeSale Drug Licence is granted by the CDSCO for those who deal in mass selling of Drugs.

  • Restricted Licence for Drugs:

Under Form 20A and 21A, this pass is given to those individuals who want to sell drugs without the guidance of a responsible person.

2. Manufacturing Licence for Drug

A manufacturing licence is given to the manufacturer of Allopathic and Ayurvedic medicine and beauty products; a licence is granted by the manufacturer’s state government.

  • Test Licence – Form -29: This licence is given by the Zonal Office and State licensing body for the purpose of testing. Testing and analysis of drugs in small amounts are also given for the purchase of small quantities of drugs for evaluation, testing, and analysis of drugs.
  • Post successful clinical trial licence – Form -46, Licence allowed to manufacture for sale of medical products which are new in the market, and a clinical trial has not been done.
  • Notified medical products production licence – Form -28 Form – 27 This Licence is granted to the maker of disposable injectable syringes and needles, heart stents, catheters, IVD Devices for HIV, HCV, etc.

3. Loan Drug Licence

As per the Drug and Cosmetic Act, a loan drug license is a license that an authorised body may give to an applicant who doesn’t have their own system of manufacturing but wants to use the manufacturing facilities of a licensee.

4. Import Licence

Under Schedule 10, Drugs & Cosmetics can be brought to India only after getting a Licence. Not only are drugs recorded, but the production unit should also be registered for import reasons.

5. Multi-licence for Drug

This Licence is for those people who run their business in more than one state. Without a multidrug pass, you cannot sell drugs in more than one state.

What is the process for getting a Drug License in India?

  • Signing up on the Website: First, people need to check the website of their local state drug licensing body and register themselves by filling out the registration form. After that, the candidate has to fill in his information, company details, and contact details to create OTP.
  • Uploading documents: After finishing up the form, the candidate has to share documents.
  • Payment of Fees: After posting all the papers, the due fees of the form should be submitted and generate challan for further processing.
  • Securitization of Documents: After sending the form, the licence body will review the form, and the DCO (District Coordination Officer) of the district will check the organization and ensure that it meets all the requirements. After the proof and inspection of documents, the officer will forward the report to the SDCO of the zone for giving the License.
  • Issuing Drug License: The report of SDCO will be given to the respective State’s Drug License Authority, and, if the authority sees no error in the report, then it will issue a Drug License to that person. Generally, it takes 30 or more than 30 days for the issue of a Drug license in India, if the application meets all the requirements.

Key Requirements for Obtaining a Drug License

 The key requirements for getting a Drug License in India are as follows:

  • Premise Area: Any person who desires to set up a Medical Store or a Retail Pharmacy needs to have an area of more than 10 sq meters. A more short and clear way to write the text is: “For a Retail Cum Wholesale Drug Business, the minimum space requirement is 15 sq mtrs.”
  • Storage Facility: An individual must ensure that the location is equipped with proper storage facilities, such as a refrigerator and cold storage facility, to store drugs.
  • Technical and Storage Staff: A Retail Pharmacy Store must have an expert and technical team with full information regarding the same. Further, it is required for the Pharmacist to be qualified for getting a Drug License, However, it shall be noted that in the case of a Wholesale Drug License, the staff selected needs to be a graduate with 1-year experience or a student with 4 years experience.
  • Inspection of the Premises: Prior to the issue of a Drug License, a Drug Inspector, who has power, has the right to visit the location for inspection. Further, he shall have the power to check the information provided, measure the premises, and question the capable person.

Documents You Need to Apply for a License

 The papers necessary for getting a selling license are:

  • The following documents are necessary, depending on the kind of business organisation: an LLP deal for a Limited Liability Partnership (LLP); a partnership contract for a partnership; and a company’s constitution, memorandum of association, and articles of association.
  • ID evidence of partner/director/proprietor.
  • Papers connected to premises – Copy of ownership papers of property or rental agreement and No Objection Certificate from the owner of the leased premises, as the case may be.
  • Site plan of the property.
  • Copy of Board resolution authorising acquiring of a license.
  • Evidence of having enough space for storing items that require cooling, such as a freezer or a fridge.
  • A copy of the challan is used as evidence of the depositing fee.
  • A stamp statement about the lack of criminal records of the owner/partner/director and the company.
  • The affidavit from the registered pharmacist or competent person.
  • Cover letter with name and designation of an applicant
  • Applicant’s qualification certificate

For a pharmacist during a retail sale:

  • Proof of qualification
  • Registration of local pharmacy council
  • Appointment letter
  • For a pharmacist at a wholesale sale:
  • Proof of qualification
  • Experience certificate
  • Appointment letter

Conclusion

In conclusion, understanding the different types of drug licenses in India is important for companies in the pharmaceutical industry. Recapitulating key points, these licenses include Manufacturing, Wholesale, and Retail Drug Licenses, each having specific roles within the business. When filing for a drug license, critical aspects to consider include holding the necessary educational skills as per the Drugs and Cosmetics Act of 1940, ensuring ideal locations with appropriate cooling facilities, and having competent staff with relevant experience. Compliance with laws, proper paperwork filing, and attention to location-specific requirements are vital for a good drug license application process.

Sachin Jaiswal

Sachin Jaiswal B.A.(Hons)! Sachin Jaiswal has been writing material on his own for more than five years. He got his B.A.(Hons) in English from the well-known University of Delhi. His success in this job is due to the fact that he loves writing and making material that is interesting. He has worked with a lot of different clients in many different fields, always giving them high-quality content that their target audience will enjoy. Through his education and work experience, he is able to produce high-quality content that meets his clients' needs.