In short: Before appointing a specialty distributor in India, a manufacturer should confirm the distributor holds the right wholesale drug licences, stores and moves product under Good Distribution Practice with a validated cold chain, keeps batch-wise records that support a recall, buys and sells only through licensed channels within the agreed territory, operates ethically, and can report stock and secondary sales in the manufacturer’s format.
Licences and the people behind them
In India a drug distributor needs wholesale licences issued by the state drug control authority — Form 20B for most drugs and Form 21B for products in Schedules C and C(1), which include biologicals and vaccines. Check that the licences cover every category you will supply, that they are current, and that the competent persons named on them are actually employed at the premises.
Storage and cold chain
Specialty portfolios are often temperature-sensitive, so the audit usually spends most of its time here:
- Written SOPs for receipt, storage, picking, dispatch and returns, and evidence they are followed.
- A temperature-mapped cold room and controlled-ambient store, with continuous monitoring, alarms and power backup.
- Calibration records for sensors and data loggers.
- Validated shippers for the routes and transit times the distributor actually uses.
Traceability and recalls
A distributor that records batch numbers on every purchase and sale can tell you, within hours, which customers received an affected batch. Ask to see a sample invoice and a batch-wise sales report, and read the recall procedure: who is responsible, how customers are contacted and how recalled stock is quarantined and reconciled.
Channel integrity
Protecting patients and your brand means knowing exactly where product comes from and where it goes:
- Purchases only from the manufacturer or its authorised channels.
- Every buyer’s drug licence verified before the first supply.
- Supply limited to the territory set out in your agreement.
- Patients supplied only against a valid prescription.
Ethics, safety reporting and visibility
Finally, check that the distributor has a written code of conduct consistent with the Uniform Code for Pharmaceutical Marketing Practices, a procedure for forwarding adverse events and complaints to your pharmacovigilance team, and the ability to send stock and secondary-sales statements — batch-wise, in your format — every month.
How RS Surgipharm prepares for your audit
We keep our licences, ISO 9001:2015 certificate, SOPs, temperature-mapping report and sample records ready to share, under NDA if you prefer, and welcome on-site or remote audits of our Ahmedabad warehouse and cold room. Our Quality page sets out how we answer each of the questions above.
This guide is general information for healthcare professionals, procurement teams and patients, not medical, legal or regulatory advice. Rules change; confirm with the relevant authority.