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Pharmacy Compliance — India

The drug inspector doesn’t accept ‘I think it was somewhere in this register’

Schedule H1 register, NDPS compliance, cold chain logs, and batch-level expiry tracking. Every record timestamped, every transaction traceable, every audit answered in under 5 minutes.

5 min
Audit response time
100%
H1 compliance
0
Failed inspections reported

What happens when the drug inspector walks in

The Drug Inspector from CDSCO walks in at 2 PM on a Tuesday. No appointment. They want to see:

  1. Your Schedule H1 register for the last 6 months — every H1 drug sale with patient name, doctor name, prescription number, quantity, and date.
  2. Your NDPS register — separately maintained, separately audited, every narcotic and psychotropic substance accounted for.
  3. Cold chain records — temperature logs for your refrigerator, especially the vaccines.
  4. Batch-level traceability — pick any product on your shelf, trace it back to the supplier invoice.

You have the register. It’s behind the counter. Somewhere. The last 3 months are in the spiral notebook. The 3 months before that might be in the drawer. The cold chain log is... you’ll find it.

This inspection is going to take a while.

ShelfLifePro users answer the same inspection in under 5 minutes. Every record. One screen.

Six compliance capabilities built for Indian pharmacy regulation

Not a generic checklist bolted onto inventory software. Purpose-built registers, formats, and workflows for the regulations you actually face.

Digital Schedule H1 Register

Every H1 drug sale automatically logged: patient name, doctor name, quantity, batch number, date. No handwriting. No missing entries. Print for inspector or show on screen.

NDPS Compliance

Separate narcotic/psychotropic register per NDPS Act. Running balance, usage tracking, and discrepancy alerts. Inspector-ready format.

Cold Chain Monitoring

Temperature logs for every refrigerator. Configurable alerts (2-8°C vaccine range). Excursion documentation when limits are breached.

Batch-Level Traceability

Pick any product. See the full chain: supplier → invoice → batch number → stock entry → every sale. Under 30 seconds.

FSSAI Compliance

E-invoice format compliance, food supplement tracking, labeling requirements. FSSAI license number on every invoice.

Expiry & Return Windows

Track return deadlines by supplier. Auto-alert when return window is closing. Generate return documentation with batch details.

Temperature monitoring that stands up to inspection

Your vaccine refrigerator should maintain 2-8°C. Your insulin should be stored at 2-8°C. Your certain antibiotics at 15-25°C.

When the power went out for 45 minutes last Thursday, did you document it? Did you assess which products were affected? Did you follow the temperature excursion protocol?

ShelfLifePro logs temperatures continuously (with compatible sensors) or via manual twice-daily entries. When a limit is breached, you get an alert. The system documents the excursion, the duration, and which products were affected.

When the inspector asks about that power outage, you show them the log, the excursion report, and the disposition decision.

Continuous Logging

Compatible Bluetooth sensors log every 5 minutes. Manual option: staff enter temperatures twice daily. Either way, the record exists.

Excursion Alerts

Configurable thresholds per refrigerator. Breach detected? Alert goes out immediately. Not at the next morning check — now.

Disposition Documentation

Which products were affected. How long the excursion lasted. What action was taken. Inspector asks? You hand them the report.

Five reports that answer 90% of inspection questions

Every report available as PDF, Excel, or on-screen. Date range filters. Full audit trail.

01

H1 Register Report

Complete Schedule H1 register with patient name, doctor name, prescription number, quantity, batch, and date. Sorted chronologically. Print or display.

02

NDPS Register

Narcotic and psychotropic substance register per NDPS Act format. Running balance, receipt and issue records, discrepancy log.

03

Cold Chain Log

Temperature readings by refrigerator, date range, and product type. Excursion incidents highlighted with disposition decisions.

04

Batch Traceability Report

Full chain for any product: supplier invoice → batch number → stock entry → every sale transaction. Searchable by batch or product.

05

Expiry Summary

All products by expiry window: expired, expiring this week, this month, next 3 months. Value at risk for each window. Return window status per supplier.

Pharmacy compliance FAQs

The questions pharmacists ask before signing up (and the honest answers)

The next inspection is coming. Your registers should be ready before you are.

Start your free trial. Get your compliance reports running before the inspector arrives.

14-day free trialNo credit card requiredFree migration assistanceSchedule H1 compliant