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The Drugs Control Department regulates the manufacture and sales of drugs and Cosmetics. The Government has laid down various drug laws under which the State Drug Controller deals with the licensing of both manufacturing and sale premises of drugs & cosmetics. Under the Drugs and Cosmetic Act, 1940, the competent authority is authorized to grant Drug license to carry out drugs/medicines or cosmetics relevant businesses. As per the act, the license covers all kinds of drug or cosmetic businesses such as homoeopathic, allopathic excluding the ayurvedic and unani medicines.
TYPES OF DRUG LICENSE ISSUED
Retail drug license
It is Issued to Persons/agencies involved in Standalone/ chemist pharmacy shops
Wholesale drug license
It is issued to Persons/agencies involved in wholesale distribution of drugs
Types of Licences issued by the Department for sale of Drugs:
FORM 20: For the sale of Allopathic drugs
FORM 20-A: For the sale of Restricted Allopathic drugs
FORM-20-B For wholesale of Allopathic drugs
Form 20-C – For the sale of Homoeopathic medicines by retail
Form 21-For Sale of Allopathic drugs specified in Sch C & C (1).
Form 21-B-For wholesale of Allopathic drugs specified in Sch C &C(1).
To Obtain Drugs Licence for manufacturing of drugs
• Application Form
• Online payment : Fees of Lic. Rs. 6000/- + Inspection Fees Rs. 1500/-
• Declaration Form
• Proof of Constitution of Firm in case of Partnership / Pvt. Ltd./ Ltd. /Trust.
• Copy of Resolution passed by Board of Directors.
• Key Plan and Site Plan in Blue Print / Ammonia Print.
• Proof of Possession: A) Rented : Rent Receipt & Rent Agreement. (Notary Attested)
B) Self Occupied.
• Proof of Ownership : Copy of Regd. GPA / Sale Deed / Property Tax Receipt
• Affidavit of Non Conviction as per format given in Guide Line Booklet.
• List of Equipment and Machineries Provided for Manufacturing.
• List of Equipment Provided for Testing.
• List of Technical Staff for manufacturing along with their Self Certified photocopies w.r.t. Certificates of Education Qualification, Experience Certificate, Biodata on Proforma, Appointment Letter, three photographs.
• List of Technical Staff for testing along with their Self Certified photocopies w.r.t. Certificates of Education Qualification, Experience Certificate, Biodata on proforma, Appointment Letter, three photographs.
• Affidavit from employer and or Technical Staff for full time working with the firm as per format given in Guide Line Booklet.
• List of Formulations to be permitted alongwith product information separately for each drug and affidavit about owner / user of the trade name applied for.
• Consent of Approved Testing Laboratory for Sophisticated Testing.
• Kindly refer “Drugs and Cosmetics Act, 1940 and Rules made there under
CHECKLIST/PRE-REQUISITES FOR DRUG LICENSE
Certain preplanning is required to be done before setting up the business pertaining to the Drugs and for obtaining the grant of drug license
FOR COMPETENT PERSON / PHARMACIST
1. The medicines need to be handled by a specialist.
2. A qualified pharmacist in case of retail drug license is a must.
3. In case of wholesale, a graduate with 1 years experience or undergraduate having four years experience is a must.
FOR AREA OF PHARMACY SHOP
1. The carpet area of the pharmacy must be a minimum of 10 square meters,
2. When you have applied for both retail and wholesale pharmacy the minimum area should be 15 square meters.
3. The premises are required to be adequately ventilated.
FOR STORAGE FACILITY OF DRUGS
1. Medicines need to be stored at a clean, ventilated and cool storage facility.
2. When in certain drugs cases and certain vaccines need to be stored in a low-temperature freezing zone or as required, it must be stored that way.
3. A refrigerator and air conditioner by default are essential for grant of a drug license in India.