FDA & CDSCO Quality Standards
DoseBox is fully compliant with the Central Drugs Standard Control Organization (CDSCO) guidelines, the Drugs and Cosmetics Act, 1940, and respective State FDA rules.
We strictly maintain wholesale distribution licenses, cold storage audits, and qualified pharmacist supervision to ensure patient safety and drug bioequivalence.
1. CDSCO & State FDA Regulatory Framework
In India, the manufacturing, sale, and distribution of drugs are governed by the **Drugs and Cosmetics Act, 1940** and the **Drugs and Cosmetics Rules, 1945**. DoseBox operates under strict compliance with this statutory framework, partnering exclusively with licensed wholesale distributors, clinical depots, and retail pharmacy entities who possess active retail and wholesale drug licenses under Forms 20, 21, 20B, and 21B.
2. Prescription Requirements for Scheduled Drugs
As required by national pharmaceutical laws, prescription-only medicines (classified under Schedule H, Schedule H1, and Schedule X of the Drugs and Cosmetics Rules) cannot be sold, dispensed, or distributed without a verified, valid prescription:
2.1 Schedule H & H1 Compliance
Schedule H and H1 medications represent prescription-only therapies (including most oncology, cardiovascular, and diabetes formulations). All orders for these products require a clear prescription upload. The prescription must explicitly show:
- The Registered Medical Practitioner (RMP)’s name, clinic details, and official state medical council registration number.
- The patient’s legal name, age, and date of issue (prescriptions older than 6 months for acute care or 12 months for chronic care require clinical re-validation).
- Clear dosage directions, strength (e.g. 50mg, 100mg), and drug composition.
2.2 Schedule X Restrictions
Schedule X comprises highly controlled psychotropic substances and narcotics. DoseBox strictly complies with Special Schedule X storage rules, requiring physical prescription copies and separate retention of prescriptions in physical form for a minimum of 2 years, subject to surprise inspections by state drug inspectors.
3. Cold-Chain & Good Storage Practices (GSDP)
Specialty medications, such as chemotherapy injections, biologicals, and immunology drugs, require strict temperature management to prevent denaturation. We adhere strictly to Good Storage and Distribution Practices (GSDP):
- Continuous Cold Chain (2°C - 8°C): Storage facilities are equipped with clinical-grade refrigeration systems and digital temperature monitors linked to alert systems.
- Validated Transit Logistics: Shipping is conducted using specialized thermal boxes and validated ice pack ratios, maintaining temperature ranges for up to 72 hours.
- Temperature Indicators: High-risk biological items are shipped with physical temperature indicator cards to verify to the customer that the cold chain remained unbroken.
4. Bioequivalence & Quality Assurance
DoseBox facilitates generic drug swaps to maximize patient savings. We guarantee that all substituted generic medicines are therapeutically bioequivalent to their branded counterparts:
- WHO-GMP Certification: We source generics exclusively from manufacturers possessing valid WHO-GMP (Good Manufacturing Practices) certifications.
- Equivalence Validation: Every generic alternative undergoes molecular validation by our clinical team to ensure the active pharmaceutical ingredient (API), dissolution rate, and bioavailability match the original branded drug.
5. Telemedicine Practice Guidelines Compliance
Our digital doctor consultation service conforms to the **Telemedicine Practice Guidelines** issued by the Ministry of Health and Family Welfare:
- Registered Practitioners: Only practitioners registered with the National Medical Commission (NMC) or State Medical Councils are permitted to consult on DoseBox.
- Restricted Drug Dispensation: Doctors consulting via the platform cannot prescribe Schedule X medicines or other habit-forming drugs during online sessions.
- Patient Consent: Initiating an online consultation serves as implied consent for sharing health symptoms, with explicit consent obtained before sharing prescription charts.
6. Auditing & Batch Traceability
To prevent counterfeit medications from entering our inventory, DoseBox maintains a complete trace log for every batch:
- Barcode Tracking: Every shipment received is logged with its batch number, expiry date, and manufacturer barcode.
- Drug Recall Protocols: In the event of a quality recall by State FDA or CDSCO, we can instantly trace and contact all patients who received medications from the affected batch.
