The establishment and maintenance of a drug store require strict adherence to legal and regulatory frameworks. These regulations ensure the safe storage, handling, and distribution of pharmaceutical products, protecting public health and maintaining the integrity of the supply chain.
1. Licensing Requirements
Retail Drug Store:
Drug License: Issued under the Drugs and Cosmetics Act, 1940 and the Drugs and Cosmetics Rules, 1945 in India.
Two primary types of licenses:
Form 20: For the sale of non-restricted drugs.
Form 21: For the sale of restricted drugs (prescription drugs).
Pharmacist Registration: The store must employ a registered pharmacist, holding a valid license from the State Pharmacy Council.
Wholesale Drug Store:
Wholesale License:
- Issued under the Drugs and Cosmetics Act for bulk distribution.
- Includes provisions for storing specific drugs like narcotics or biologicals.
Special Licenses: Required for selling Schedule X drugs (e.g., psychotropics) or narcotics.
2. Premises and Infrastructure
Size of the Premises: The minimum floor area is typically specified by law (e.g., 10 square meters for retail stores, 15 square meters for combined retail and wholesale operations).
Location: Should be in a hygienic area, away from contaminating influences like garbage dumps or polluted surroundings.
Design:
- Sufficient lighting, ventilation, and water supply must be provided.
- Separate areas for prescription medicines, over-the-counter (OTC) products, and narcotics.
3. Storage Requirements
Temperature Control: Facilities like air conditioning or refrigeration for temperature-sensitive products (e.g., vaccines and insulin).
Segregation: Separate storage for prescription drugs, Schedule H, Schedule X drugs, and OTC medications.
Stock Maintenance: Expired or damaged drugs must be segregated and disposed of as per regulatory guidelines.
4. Staffing
Qualified Personnel:
- Retail stores must have a registered pharmacist available during operational hours.
- Wholesale stores should have qualified personnel trained in handling and storage procedures.
Training: Employees must be aware of regulatory compliance, drug storage standards, and customer interaction protocols.
5. Record-Keeping
Purchase and Sale Records: Maintain detailed logs of all transactions, including the source, batch numbers, and expiry dates of drugs.
Prescription Maintenance: Prescription records must be retained for specific durations (usually 2 years or as per local laws).
Inspection Records: The store must maintain inspection reports and be ready for audits by regulatory authorities.
6. Regulatory Compliance
Periodic Inspection: Drug stores are subject to inspections by the Drug Controller or other authorities to ensure compliance.
Renewal of Licenses: Licenses must be renewed periodically, as specified by regulatory guidelines.
Adherence to Schedules: Compliance with drug schedules (e.g., Schedule H, H1, X) for labeling, sale, and prescription requirements.
7. Waste Disposal
Expired and Damaged Drugs: Follow standard operating procedures for the disposal of drugs to prevent environmental contamination.
Biohazard Materials: If applicable, biohazard materials must be disposed of as per biomedical waste management regulations.
8. Display and Advertisement
Restrictions on Display: Drugs requiring prescriptions (e.g., Schedule H drugs) cannot be openly displayed.
Prohibition of Misleading Ads: Advertising for prescription drugs is generally prohibited to prevent misuse.
9. Provisions for Controlled Substances
Narcotics and Psychotropic Substances:
- Additional licenses are required for storage and sale.
- Strict record-keeping for transactions involving such drugs is mandatory.
Conclusion
Complying with legal requirements for the establishment and maintenance of a drug store ensures the safety, efficacy, and integrity of pharmaceutical services. Adherence to licensing norms, infrastructure standards, storage guidelines, and regulatory frameworks is essential for ethical and responsible pharmacy practice. These regulations are designed to protect public health while ensuring that drug stores operate efficiently and legally.
