Auditor asks: Is the distributor licensed for every product category it handles?
We hold wholesale drug licences in Form 20B and Form 21B from the Food & Drugs Control Administration, Gujarat, covering biologicals and vaccines as well as other drugs, and our quality system is certified to ISO 9001:2015.
How we do it
- Wholesale drug licences (Form 20B and 21B) displayed at the premises and renewed on time
- Qualified, registered competent persons named on the licences
- ISO 9001:2015 certified quality management system
- GST, MSME (Udyam) and company registrations current
Documents you can request
Auditor asks: Are products stored in suitable, controlled conditions under written procedures?
Our 5,000 sq ft Ahmedabad warehouse runs to written SOPs, with separate temperature-controlled areas and stock issued first-expiry, first-out.
How we do it
- Written SOPs for receipt, storage, picking, dispatch and returns
- Separate cold room (+2 °C to +8 °C) and cool room (+15 °C to +25 °C)
- First-expiry, first-out stock rotation
- Separate holding area for returned, damaged or near-expiry stock
- Licensed, insured premises with 24-hour fire and security monitoring
Documents you can request
Auditor asks: Can the distributor prove refrigerated products stayed in range, in storage and in transit?
The cold room is temperature-mapped and logged around the clock with mobile alerts and power backup, and every refrigerated consignment ships in a validated shipper with a data logger.
How we do it
- Temperature-mapped cold room with known warm and cold spots
- Cloud monitoring with computer and mobile alerts, 24 hours a day
- 24-hour power backup to hold temperature through outages
- Validated insulated shippers and conditioned coolant chosen for the transit time
- Data logger in every refrigerated consignment; record shared with the receiver
Documents you can request
Auditor asks: Where does stock come from, and can every pack be traced to the customer who received it?
We buy only from manufacturers and their authorised channels, and keep batch-wise purchase and sales records, so every pack can be traced from receipt to the customer who received it.
How we do it
- Purchases only from manufacturers or their authorised distributors
- Batch, expiry and packaging checked against the invoice on receipt
- Every sales invoice carries batch number and expiry
- Batch-wise purchase and sales records kept as the Drugs Rules require
Documents you can request
Auditor asks: How quickly can the distributor act on a recall, and how are complaints handled?
Because sales are recorded batch by batch, we can identify every customer who received an affected batch and act on a manufacturer’s recall instruction straight away.
How we do it
- Written recall procedure with named responsibilities
- Customer list for any batch available from our records on request
- Recalled and returned stock quarantined and reconciled with the manufacturer
- Product complaints recorded and passed to the manufacturer
Documents you can request
Auditor asks: Will adverse events and quality complaints reach the manufacturer?
Any adverse event or product-quality complaint we hear about is forwarded to the manufacturer’s pharmacovigilance or quality team promptly, in the format they ask for.
How we do it
- Adverse-event and complaint forwarding procedure
- Staff briefed on recognising and reporting adverse events
- Manufacturer contact details for safety reporting kept current
Documents you can request
Auditor asks: Does the distributor operate ethically, without inducements to prescribers?
We follow a written code of conduct: no gifts or inducements to healthcare professionals, consistent with the Uniform Code for Pharmaceutical Marketing Practices, and no off-label promotion.
How we do it
- Written code of conduct for all staff
- No gifts, payments or inducements to healthcare professionals
- No promotion of prescription medicines to the public
- Transparent invoicing; no cash-only or unbilled sales
Documents you can request
Auditor asks: Who does the distributor sell to, and does it stay within the agreed territory?
We supply only licensed buyers — hospitals, institutions, chemists and distributors — and patients against a valid prescription, within the territories agreed with each manufacturer.
How we do it
- Buyer’s drug licence and GST verified before the first supply
- Supply within the territories agreed with each manufacturer
- Prescription required for supply to patients
Documents you can request
Auditor asks: What visibility will the manufacturer get on stock and sales?
Manufacturers receive regular stock and secondary-sales statements, batch-wise and in their own format where they have one, plus early notice of near-expiry stock.
How we do it
- Monthly stock and secondary-sales statements
- Batch-wise and customer-wise detail on request
- Near-expiry and slow-moving stock flagged early
- A named account contact for each manufacturer
Documents you can request