A company or distributor bidding a medicine tender needs two sets of documents: its own, and the manufacturer’s. The purchaser evaluates both. This is the manufacturer’s set as tender schedules in India usually ask for it, with what each item is and who issues it.
1. Manufacturer’s authorisation form
A letter on the manufacturer’s letterhead, in the format printed in the tender document, authorising the bidder to quote the manufacturer’s products for that tender, signed and stamped by the manufacturer. Most tenders ask for it per tender and per product list, not a general letter. Ask the manufacturer for it as soon as the tender is published; it cannot be issued after the closing date.
2. Manufacturing licence
The licence to manufacture for sale issued by the state drug controller, Form 25 for general formulations and Form 28 for the categories it covers, with the product permissions attached. The purchaser checks that every quoted item is on the licence and that the licence is valid on the closing date and through the supply period.
3. WHO-GMP certificate
The site certificate issued by the state drug controller under the WHO Good Manufacturing Practice scheme, naming the sections it covers. Most state medical services corporations make it a condition of eligibility. Check that the sections on the certificate match the dosage forms in the schedule.
4. GMP under Revised Schedule M and GLP certificates
The GMP certificate under the Revised Schedule M of the Drugs Rules and, where the purchaser asks, the GLP certificate for the manufacturer’s quality control laboratory. Some schedules accept either; some ask for both.
5. Certificate of analysis
Issued by the manufacturer’s laboratory for every batch supplied, against the pharmacopoeial standard in the schedule. It travels with the consignment and is the document the consignee store checks first.
6. Stability data
Accelerated and long-term stability data from the manufacturer’s own studies, asked for by some purchasers to support the shelf life printed on the pack.
7. Capacity statement
A declaration of installed capacity for the sections quoted, sometimes on the purchaser’s format, sometimes as a letter. The purchaser uses it to judge whether the manufacturer can meet the delivery schedule alongside its other commitments.
8. Samples
Samples of each quoted product for the purchaser’s technical evaluation or laboratory testing, labelled as the schedule requires, submitted with the bid or on request.
9. Declarations in the tender’s format
Non-conviction, non-blacklisting, market standing and other declarations, in the wording the tender prints. The manufacturer issues those that relate to the plant; the bidder issues its own.
What the bidder provides itself
Wholesale drug licence (Form 20B and 21B), GST registration, PAN, the earnest money deposit, turnover and experience documents, and the price bid. These are the bidder’s and do not come from the manufacturer.
Timing
Ask the manufacturer for its document set and the authorisation form the day the tender is published. Check the closing date, the sections on the WHO-GMP certificate against the schedule, and the product permissions against the item list before you price the bid. A product not on the manufacturer’s licence needs an endorsement from the state drug controller first, which takes time the tender will not give you.
Vibcare Healthcare issues the manufacturer’s authorisation, the licence and certificate copies, certificates of analysis, stability data, a capacity statement and samples for bidders quoting its products. The document kit and a tender enquiry form are on the Institutional Supply page.
