Drug Licensing

For any Individual/Corporate/Partnership Firms etc , it is mandatory to obtain a valid Drug Licence from concerned State Authorities (Drugs Control Department). The provisions for this has been made in Drugs and Cosmetic Act 1940 and Rules 1945 applicable in India.

DRUG DEFINITION

Drugs and Cosmetics Act,1940 defines “drug” to include all medicines and devices for the use of human beings or animals internally or externally, and all substances planned to be used for or in the diagnosis, mitigation, treatment, or prevention of any disorder or disease in animals or human beings, including preparations applied on the human body for the purpose of repelling insects like mosquitoes; it also includes all substances that can be used for the destruction of insects and all components of a drug – like empty gelatin capsules. The definition was amended in 1964, to include Ayurvedic and Unani Drugs.

TYPES OF DRUG LICENSE

• Manufacturing License– License issued to a business that manufactures drugs inclusive of allopathic/homoeopathy medicines.
• Sale License – License issued for the sale of drugs. It has the following bifurcations: – Wholesale Drug License – Retail Drug License
• Loan License – License issued to a business that does not own the manufacturing unit but uses the manufacturing facilities of another licensee.
• Import License – License issued for the import of drugs.
• Multi-Drug License – License issued to businesses that own pharmacies in multiple states with the same name.

Prerequisites For Obtaining a License

• Pharmacist/ Competent Individual: The pharmacist must be qualified in the case of a retail business. In the case of a wholesale business, the individual must be a graduate with 1-year experience or an undergraduate with 4 years experience.
• Space Requirement: The other important requirement is space, that is the area of the pharmacy/unit. For both wholesale and retail licenses the area of the pharmacy/unit should be 15 square meters. In the case of a retail and medical shop, it should be 10 square meters. The clear height of the sales premises shall be as per the guidelines laid down under the National Building Code of India, 2005.
• Storage Facility: The other important requirement is storage facility since some drugs require to be stored in low temperatures, refrigerators and air conditioners are a must.
• Technical Staff: The retail pharmacy staff must be experienced with in-depth knowledge. The staff of the wholesale pharmacy must be a graduate with a minimum of 1-year experience or an undergraduate having four years of experience.

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Documents requirement for Drug License in India

- The firm’s constitution (MOA & AOA for Company and Partnership Deed for Firm/LLP
- Property Paper ( Registry Deed/Lease Deed/POA in case of owned Property)
- ID proof of Directors/Partners/Proprietor
- Copy of Rent agreement ( in case of rented premises)
- The key plan and the site plan of the premises ( Blue Print).
- One Invoice copy of Refrigerator/Air conditioner purchased for use
- Board Resolution, List of Directors, Certificate of Incorporation ( in case of company)
- Covering Letter stating purpose of the Application
- For Retail & Wholesale license - Affidavit from the Regd. pharmacist/competent person
- For Manufacturing - List of Technical Staff and their proof of Education Qualification, Experience Certificate, Biodata, Appointment Letter, three photographs.
- For Manufacturing - Affidavit from employer and or Technical Staff for full time working with the firm
- In case of Retail License:- Registered Pharmacist’s degree certificate, Registration certificate with State Pharmacy Council and Appointment Letter and Bio-data.
- In case of Wholesale License:- Competent person’s degree certificate, Experience Certificate in medicine job and Appointment Letter and Bio-data.
- For manufacturer - Affidavit of Non Conviction, List of Equipment and Machineries for manufacturing and List of Equipment Provided for Testing

Application for a Drug License

The following are the steps to be taken for obtaining the drug license:

• The applicant must apply online for the license as per the line of business, for which he/she must have a valid email id and contact number.
• The next step is to keep all the documents updated.
• Next is to upload the documents and the form along with the applicable fees.
• Upon completion of the online process, an inspector will visit the site and verify the validity of documents.
• If all the above steps have been duly complied with, the authority will issue the drug license.