Proper drug storage is essential for ensuring that medicines remain safe, effective, and fit for use. Whether you own a medical shop or plan to start one, it’s important to understand the regulations and licenses needed to store drugs correctly. This blog covers everything you need to know about drug storage regulations and explains the roles of different drug licenses, such as manufacturing drug licenses, retail drug licenses, and wholesale drug licenses.
Why Is Proper Drug Storage Important?
Drugs are sensitive to environmental conditions such as temperature, humidity, and light. Improper storage can lead to:
Loss of potency, making the drugs less effective.
Chemical degradation, which can turn the medicine harmful.
Increased risk of contamination.
Medical shops must comply with strict regulations to ensure drug safety and maintain public trust.
Key Drug Storage Regulations for Medical Shops
Temperature Control
Most drugs should be stored between 20°C to 25°C.
Certain medicines, like vaccines and insulin, require refrigeration at 2°C to 8°C.
Medical shops must have thermometers and refrigerators to monitor and maintain the required temperature range.
Proper Shelving
Drugs should be stored on clean shelves, away from direct sunlight and moisture.
Expired medicines must be separated from active stock to prevent accidental dispensing.
Ventilation
The storage area must have proper ventilation to avoid excessive heat or humidity.
Avoid keeping drugs in damp or confined spaces.
Security Measures
Narcotics and controlled substances require additional security, such as locked cabinets.
The premises must be safe from theft or unauthorized access.
Labeling and Organization
All medicines must be clearly labeled with their batch number, expiry date, and storage instructions.
Separate storage for over-the-counter (OTC) drugs and prescription medicines.
Handling Expired or Damaged Drugs
Expired drugs should not be sold. These must be disposed of as per local regulatory guidelines.
Maintain records of returned or destroyed drugs.
Understanding Drug Licenses for Medical Shops
A drug license is mandatory for any business involved in the manufacture, storage, distribution, or sale of medicines. The type of license you need depends on the nature of your business:
Required for businesses involved in manufacturing medicines, whether allopathic, Ayurvedic, or homeopathic.
Issued by the State Drug Control Department.
Premises must comply with Good Manufacturing Practices (GMP).
Key requirements:
Adequate space for manufacturing and storage.
Skilled technical staff, including pharmacists and chemists.
Proper waste disposal systems.
Required for medical shops that sell drugs directly to customers.
Only granted to registered pharmacists or individuals under the supervision of a pharmacist.
Conditions:
Medicines must be stored according to prescribed standards.
Maintain records of all prescription drugs sold.
