Drug License Registration

What is Drug License?

Ensuring fair and universal access to medical drugs for all is one the most important priority and responsibility of any government. This is why all  governments strictly monitor and manage the right to manufacture and sell drugs. The Drugs and Cosmetics Act, 1940, regulates the end-to-end process of drug manufacture and sales in India. Drug license is issued by the drug controlling authority under the Drugs and Cosmetics Act, 1940.

Drugs: Meaning and Definition
According to Section 3(b) of the Drugs and Cosmetics Act, the term "drug" covers medicines, devices and substances used for diagnosis, treatment, or prevention of any disease in human beings as well as in animals. The definition of drug also includes Ayurvedic and Unani Drugs as well. Mosquito repellents, insect killers used for human use also come under definitions of drugs.

What is Drug License Registration Purpose?

As usage of drugs impacts life and death of individuals and careers of medical professionals depends on it, the manufacture, sale and purchase of medicines should be strictly regulated to prevent fraud, misuse, hoarding and stop production of low quality or counterfeit drugs. All persons involved in trade of drugs, cosmetics, traditional medicines and medical equipment like pharmacists, wholesalers, retailers, manufacturers and importers must obtain a mandatory drug license from competent authority before indulging in any kind of trade. 

This license grants permission to engage in businesses related to drugs and cosmetics, ensuring responsibility. No person or firm can be involved in drug trade without a valid license. In addition to a drug license, a Trade license and a Shop and Establishment Registration is also required to start trade in drugs. 

Apart from manufacturing and trade, The Drugs and Cosmetics Act, 1940 and the Drugs and Cosmetics Rules, 1945, also allow the government to check the quality of drugs sold in India. The government controls drugs right from the starting, from the raw material stage to manufacturing, sale, distribution till it's sold on prescription to a patient by a pharmacist in a retail pharmacy, or prescribed and used in hospitals in case of admission or emergency. The government also controls the import and export of medicines, sales to a minor person , sale and consumption of scheduled H & X drugs, etc. 

What is Drug License Registration Regulations?

The Drugs and Cosmetics Act, 1940, and the Drugs and Cosmetics Rules, 1945, enable the government to regulate and monitor drug quality from raw material to consumer sale.

What are the Types of Drug License Registration?

Various types of drug licenses are granted in India, depending on the nature of the drug business. These include:

• Manufacturing License: Drug manufacturing license is issued to manufacturers of drugs and firms willing to start manufacturing of drugs including allopathic/homeopathic medicines.
• Wholesale License: Person or firm willing to act or work as a drug wholesaler must obtain a wholesale license. Wholesale means the sale of the drug stock to a retailer who further sells it to the consumer. 
• Retail License: A retail license is issued to persons interested in the retail sale of drugs. A retail sale means the sale of drugs or cosmetics to the end consumer. After obtaining a retail license, a licensee can sell drugs and cosmetics to a  government dispensary, individuals, charitable trusts and hospitals, educational institutes, etc. Retailers include medical store owners, pharmacists and cosmetics sellers, stand-alone pharmacists and Ayurvedic, Siddha or Unani medicine sellers.
• Import License: Import License is issued to firms and dealers involved in import of raw materials and products for the manufacturing of drugs or is engaged in the business of importing drugs in India.
• Multi-Drug License: It is issued to firms or pharmacies operating in multiple states. 
• Loan Drug License: This license is issued to a business that does not have a manufacturing unit of their own but uses the infrastructure  facilities of another manufacturer to manufacture drugs for itself. 

What is Drug License Registration Controlling Authority?

Different regulatory bodies issue different drug licenses. These include:

• Central Drugs Standard Control Organisation (CDSCO): It is entrusted with issuing licenses for the new drugs and also for clinical trials of drugs. It also keeps control over the quality of the drugs imported in India. 
• State Drugs Standard Control Organisation (SDSCO): It is responsible for issuing licenses for the manufacture, distribution and sales of drugs which are to be regulated by the state authorities.
• State Drug Controlling Authority: It issues licenses for establishing blood banks and its products and components like Vaccines, Sera, etc. (with prior approval from Central Licensing Authority) 
• Ayush Department: Department of Ayush is responsible for issuing licenses for ayurvedic, Unani, Siddha, homeopathy and herbal products for medicinal and cosmetic uses. 

What is Drug License Registration Eligibility?

A person should be well versed with knowledge of medicines and drugs of all kinds before he or she is granted a license. Eligibility of obtaining drug license include:

• For Retail License: For getting a retail license a person must have a degree in B. Pharma or D.Pharma along with registration in State Pharmacy Council. 
• For Wholesale License: For getting a wholesale license a person must have a degree in B. Pharma or D.Pharma along with registration in State Pharmacy Council, or he/she must be a graduate with one year of experience in handling drugs or an undergraduate having four years of experience in handling drugs and medicines.

What is Drug License Registration Prerequisites?

Just like any other license, there are certain prerequisites involved with obtaining a drug license also. Prerequisites for obtaining a drug license include requirements for space, storage facilities and technical staff with relevant expertise. Details of prerequisites is given below:

• Space Requirement: The space requirement refers to the area of the pharmacy unit. For both retail and wholesale premises the area of the pharmacy/unit should be 15 square meters. For a retail and medical shop, it should be 10 square meters. The height of the sales unit must be according to the guidelines given in the National Building Code of India, 2005.
• Storage Facility: The other important requirement is having storage facilities in premises especially refrigerators, air conditioners and freezers since some drugs require to be stored in low temperatures like vaccines and life saving drugs. Other drugs too require to be kept in low temperatures. 
• Requirement of Technical Staff: The staff working at retail pharmacy stores must be qualified and experienced with in-depth knowledge of drugs, their components and reactions. They must be able to read prescriptions and must provide accurate medicine. In case of prescription drugs, they must not be sold without prescription. The staff of the wholesale pharmacy must also be a graduate with 1-year minimum experience or an undergraduate having minimum four years of experience.

What is Drug License Registration Process?

Now one can apply online for getting drug license in the following manner:

• First of all visit the website of Respective Drug Controlling Authority
• Now proceed with filing an Application and submit all details online. 
• Now proceed with submitting all the required documents
• After document submission, proceed with submission of prescribed fees.
• After your application is successfully submitted online a Drug inspector shall visit your premises for verification for all details provided in online registration. 
• If the drug inspector is satisfied with details provided and premises inspection he shall grant the drug license after inspection and verification.

What Documents are Required for Drug License?

Details of documents required for obtaining a drug license include the following:
In case of manufacturing unit:

• Constitution of the company
•  Memorandum of Association (MOA)
• Articles of Association (AOA)
• Partnership deed/LLP Registration agreement 
• ID proof of Directors/Partners

Documents of Premises:

• Copy of ownership documents of property
• Rent agreement and NOC from the owner in case the premises is rented 
• Site plan
• Copy of Board resolution giving permission to obtain a license.
• Proof of storage space and facilities like cold storage, refrigerator, etc.
• Copy of challan as proof of fees deposited
•  Affidavit from the pharmacist
• Declaration form in a prescribed format
• Qualification certificates of applicant

For Retail Unit:

• Proof of qualification of Pharmacist
• Registration with concerned pharmacy council
• Appointment letter at retail unit

For Wholesale Unit:

• Proof of qualification
• Experience certificate
• Appointment letter

Important Forms in Drug License

• Form 8: Application for license to import drugs except those specified in Schedule X
• Form 8A: Application for license for importing drugs specified in Schedule X of the Rules
• Form 9: Form for Undertaking accompanying an application for import license
• Form 12: Licence to import drugs for purpose of test, analysis or examination 
• Form 12A: Application for issuing license to import small quantities of drugs for personal use
• Form 12AA: License to import small quantity of new drugs by a government hospital or autonomous medical institution for the treatment of patients
• Form 19: Application for license to sell, stock, exhibit or offer for sale, or distribute drugs apart from those mentioned in Schedule X
• Form 19A: Application for grant or renewal of a license to stock, sell,  exhibit or offer for sale or distribute drugs in retail via dealers who do not take services of a registered pharmacist
• Form 19B: Application for license to stock, sell, exhibit, offer for sale or distribute Homeopathic Medicines
• Form 24C: Application for the grant or renewal of a license to manufacture for sale/distribution of Homeopathic medicines or a license to manufacture potentised preparations from back potencies by licensees holding a license in Form 20 C
• Form 24D: Application for the grant or renewal of a license to manufacture for sale of Siddha, Ayurvedic or Unani drugs
• Form 27C: Application for grant/renewal of license for operating a Blood Bank for processing of whole blood and/or preparation of blood components
• Form 27E: Application for grant/renewal of license to manufacture blood products for sale/distribution
• Form 30: Application to grant license to manufacture drugs for purposes of examination, test or analysis
• Form 40: Application for issue of license to import drugs into India
• Form 44: Application for permission to import/manufacture a new drug or to undertake clinical trial

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