Regulations, Compliance & AI Ethics

All drug dispensing must be supervised by a registered pharmacist (B.Pharm / M.Pharm / D.Pharm / Pharm.D) as required under Rule 65 of Drugs & Cosmetics Rules, 1945.

AIPharmaPulse enforces Schedule H and H1 prescription requirements at POS — a valid prescription number must be entered before the sale can be completed.

Schedule X (narcotic/psychotropic) drugs maintain a mandatory dispensing register with full patient details, as required by the Narcotic Drugs & Psychotropic Substances Act, 1985.

Cold chain products (vaccines, biologicals, insulin) tracked separately with temperature monitoring log compliance per Schedule M guidelines.

Batch number and expiry date are mandatory fields for all pharmaceutical inventory entries — cannot be bypassed.

AIPharmaPulse is a pharmacy management SOFTWARE — it is a business management tool, not a medical device for diagnostic or treatment purposes.

The AI drug interaction checker is a clinical decision-support tool only. All dispensing decisions remain the sole responsibility of the licensed pharmacist.

We are actively pursuing registration as a Software as a Medical Device (SaMD) per CDSCO MDR 2017 guidelines for clinical AI features.

The platform does not support import, manufacture, or wholesale distribution of drugs — it is designed exclusively for retail dispensing management.

A valid State Pharmacy Council registration of the supervising pharmacist is required to use the platform for dispensing operations.

The Drug Licence number (Form 20 / Form 21 / Form 20B / Form 21B as applicable) is captured at registration and displayed on all generated invoices.

If a pharmacy's drug licence is detected as expired in the system, Schedule H/X drug billing is automatically restricted.

AIPharmaPulse does not enable or support unlicensed drug sales under any circumstances.

Schedule X drug quantities are enforced at POS — dispensing limits per prescription per patient per month.

Mandatory digital register maintained: prescription number, patient name and address, prescribing doctor's registration number, quantity dispensed, date, and pharmacist's digital signature.

Online sale or home delivery of NDPS-classified substances is not permitted through the platform.

Compliance reports for State Drug Inspectors available in the Compliance → Narcotic Register module.

Prices of scheduled essential medicines (National List of Essential Medicines) are capped by the NPPA (National Pharmaceutical Pricing Authority) — AIPharmaPulse prevents billing above the government-notified MRP.

Generic substitution feature shows bioequivalent alternatives per DPCO guidelines — pharmacist must inform patients of generic options.

MRP validation occurs at both purchase (GRN) and billing (POS) stages.

GST rates applied automatically based on HSN code: 0% (essential life-saving medicines per Schedule I), 5% (most prescription drugs), 12% (certain formulations and medical equipment), 18% (vitamins, supplements, some devices).

e-Invoice mandatory for turnover above ₹5 crore (current threshold). Threshold reduces to ₹1 crore from April 2025. AIPharmaPulse integrates with IRP (Invoice Registration Portal) for real-time IRN generation.

GSTR-1 (outward supplies) and GSTR-3B (summary return) auto-preparation is built into the platform. GST input credit on purchases is automatically calculated at GRN stage.

Composition scheme pharmacies (small retailers under ₹1.5 crore turnover) are also supported with simplified billing.

B2B invoices auto-registered with NIC's IRP for IRN + digitally signed QR code — printed on invoice automatically.

e-Way Bill generated automatically for consignments above ₹50,000 inter-state. Intra-state thresholds vary by state — system checks applicable threshold based on your registered state.

Cancellation of e-Invoices within 24 hours per GST rules — after 24 hours, amendment invoice (credit/debit note) required.

Complete audit trail of all transactions, modifications, voids, and deletions — including the user who made the change, timestamp (IST), and reason.

Books of accounts maintained digitally as per Section 44AA, Income Tax Act, 1961 — exportable in standard formats.

Tally-compatible XML export for seamless accounting integration.

AIPharmaPulse is a Data Fiduciary — we are legally responsible for lawful, fair, and transparent processing of personal data.

Patient health data (prescriptions, medical history, purchase records) constitutes Sensitive Personal Data — processed only for specified pharmacy purposes with informed consent.

Data Principals (patients) have rights to: Access their data, Correct inaccurate data, Erase data (right to be forgotten), and Nominate a person to exercise their data rights.

We appoint a Data Protection Officer (DPO) per DPDPA requirements — reach the DPO team at info@aipharmapulse.com (same inbox as general privacy and compliance).

Breach notification to CERT-In within 6 hours of discovery (as per CERT-In 2022 directions) and to affected Data Principals within 72 hours.

ALL data stored exclusively on AWS Mumbai (ap-south-1) region — India only. Data never leaves Indian territory.

No cross-border data transfers. AI model inference uses anonymised, aggregated patterns only — no patient-identifiable data sent abroad.

Prescription images stored in encrypted AWS S3 buckets (India region) with AES-256 encryption at rest.

No personal data sold to, shared with, or licensed to any third party — ever.

Patients can optionally link their ABHA (Ayushman Bharat Health Account) ID to their pharmacy profile.

Health records shared with ABDM Health Information Exchange (HIE) only with explicit, granular patient consent — consent artefact generated and stored.

PHR (Personal Health Records) linked to ABHA number as per NHA Health Data Management Policy.

Consent can be revoked by the patient at any time — data sharing with HIE is immediately suspended.

All electronic records maintained per Section 43A (Reasonable Security Practices) requirements.

Platform follows OWASP Top 10 security standards, quarterly penetration testing, and HTTPS everywhere with HSTS headers.

Session management: 8-hour session timeout, device fingerprinting, IP-based anomaly detection.

The AI Pharmacist Copilot is powered by Claude (Anthropic) via secure, encrypted API calls.

All queries are anonymised before sending to Claude — no patient names, ABHA numbers, prescription numbers, or any personally identifiable information is included in API calls.

Claude's responses are informational only — pharmacists must verify using authoritative sources (Drug Index, CIMS India, WHO Model Formulary, BNF).

We comply with Anthropic's usage policies and update our AI governance as Indian AI regulations evolve.

AIPharmaPulse adheres to NITI Aayog's "Responsible AI for All" (2021) framework — inclusivity, safety, diversity, and public interest.

We are inclusive: supporting 12+ Indian languages, accessible on low-bandwidth connections (2G/3G compatible PWA), and affordable pricing for small independent pharmacies.

We promote SDG Goal 3 (Good Health & Well-being) through accessible pharmacy automation for rural and semi-urban India.

Annual AI impact assessment published publicly. Current AI systems undergo bias testing for age, gender, language, and regional drug usage patterns.

The Ministry of Health & Family Welfare has proposed Draft Rules for Online Sale of Drugs (2018 draft; revised 2022 draft under review).

AIPharmaPulse currently supports in-store dispensing and pickup notification operations only — we do NOT support home delivery of prescription medicines.

Our delivery module handles same-day pickup notifications and logistics coordination for existing in-store prescriptions — this falls within current legal boundaries.

We will update our platform immediately upon enactment of final rules and obtain required additional licences (expected to include: online pharmacy licence from CDSCO, mandatory pharmacist-patient video consultation for Rx medicines, cold chain requirements for temperature-sensitive items).

Prescriptions issued via telemedicine (Telemedicine Practice Guidelines, 2020 — MoHFW) are accepted by AIPharmaPulse when accompanied by the digital prescription with doctor's registered number.

Schedule H drugs cannot be dispensed on teleconsultation prescriptions for first-time prescriptions (as per 2020 guidelines). Refills may be dispensed with existing documented prescription history.