How to Specify a Generic Medicine Order: A Practical Guide for International Buyers

One of the most common sources of friction in pharmaceutical procurement from India is imprecise order specification. A vague inquiry ("we need paracetamol tablets") generates a vague response and wastes time on both sides. A well-specified inquiry — one that defines the molecule, strength, dosage form, pack size, quality standard, shelf life, and labelling requirement — gets you an accurate quotation and a reliable supply arrangement.

This guide walks through how to specify a generic medicine order correctly.

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1. Use the INN (International Non-Proprietary Name)

Always specify the International Non-Proprietary Name — the molecule's official generic name as defined by the WHO. Do not specify by brand name unless you are specifically sourcing a branded generic (in which case also state the brand name and manufacturer).

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2. Strength

State the exact active ingredient strength per unit dose.

Where a fixed-dose combination (FDC) is required, list all active ingredients and their strengths: - Amoxicillin 500mg + Clavulanic Acid 125mg tablets

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3. Dosage Form

Be specific about the physical form: - Tablets, film-coated tablets, dispersible tablets, extended-release tablets - Capsules, hard gelatin capsules, soft gelatin capsules - Oral suspension (and if so, reconstituted or ready-to-use) - Injection (ampoule, vial, pre-filled syringe — and volume/concentration) - Cream, ointment, gel (with percentage strength) - Eye drops, ear drops, nasal drops (with concentration and preservative status)

The dosage form affects manufacturing complexity, packaging, storage, and price — do not leave it ambiguous.

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4. Pack Size

State the required pack configuration: - Number of units per primary pack (e.g., 10 tablets per blister strip, 10 strips per box) - Volume per bottle (for liquids, syrups, suspensions) - Ampoule/vial volume and quantity per carton

Also indicate whether you need consumer-pack sizes or bulk/hospital packs — these often have different price points and labelling requirements.

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5. Pharmacopoeia / Quality Standard

Specify which pharmacopoeia standard applies: - IP (Indian Pharmacopoeia) — acceptable for most markets - BP (British Pharmacopoeia) — often required for UK, Commonwealth markets - USP (United States Pharmacopeia) — for US market supply - In-house (manufacturer's validated specification) — acceptable in some markets

If your importing country's regulatory authority has a preference, state it.

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6. Minimum Remaining Shelf Life at Time of Dispatch

This is one of the most important and most frequently overlooked specifications. State what minimum remaining shelf life you require on the date of dispatch from India:

- Example: "Minimum 24 months remaining shelf life on dispatch" (for a product with a 36-month total shelf life)

Failing to specify this leads to disputes when short-dated stock arrives. The industry norm varies by market — check your country's import regulations and your own commercial requirements.

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7. Labelling Language and Requirements

If you need labelling in a language other than English, state this upfront. Re-labelling in the destination country may also be an option — clarify who is responsible for this in the purchase order.

State any mandatory label elements required by your country's regulation (e.g., local language product name, local distributor details, country-specific warnings).

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8. GMP Standard Required

State the GMP certification you require from the manufacturer: - WHO-GMP - EU-GMP - US FDA-approved facility - Or: "Schedule M compliant — for local market only"

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Sample Specification Format

When sending an inquiry to Bharat Medex (or any Indian pharma trader), use a structured format:

``` Product: Metformin Hydrochloride Extended-Release Tablets INN: Metformin Hydrochloride Strength: 500mg Form: Film-coated extended-release tablet Pack size: 10 tablets per blister x 10 blisters per box Pharmacopoeia: BP Quantity: 100,000 boxes Min shelf life: 24 months on dispatch Labelling: English; local distributor name to be added (we will re-label) GMP required: WHO-GMP Incoterm: CIF [Destination Port] ```

This level of specificity eliminates ambiguity and lets your supplier respond with a precise quotation and realistic lead time.

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