By Pulse Pharma Mfg Co.2 min read
In this article
If you want a manufacturer to make medicines for your brand, you will be asked for some documents before production begins. The exact list depends on your product and your state, so confirm it with your manufacturer. This guide covers what most brand owners and marketers need.
Why the manufacturer asks for documents
Medicines in India are regulated by the Drugs and Cosmetics Act and Rules. A manufacturer must know who will buy and sell the product, that you are allowed to hold and sell medicines, and that the product and its label meet the rules. The paperwork protects both sides.
Documents about your business
- Business registration: proof of your firm, such as a proprietorship, partnership, LLP or company registration, with the address.
- GST registration: needed to buy and sell goods and to issue invoices.
- PAN card: of the firm or the proprietor.
- Identity and address proof: of the owner or partners.
- Bank details: a cancelled cheque or bank statement.
A drug licence for selling
To buy medicines and sell them to chemists or hospitals, you generally need a wholesale drug licence for your premises. Without it, a manufacturer cannot supply you in the usual way. If you plan to sell only to retail customers, ask which licence applies in your case.
Your brand
- Brand name: check that it does not clash with an existing medicine brand before you print anything.
- Trademark: consider registering your brand name. Ask the manufacturer whether they need your trademark details or application number.
- Artwork: the design of your label, carton and leaflet.
Documents about the product
- Composition and strength: exactly what each tablet, millilitre or vial must contain.
- Permission to make the product: most common medicines and combinations are already permitted, but some fixed-dose combinations need approval from the regulator. Check yours before you place an order.
- Specification and packing details: pack size, packing material and shelf life.
Labels must follow the rules
A medicine label must carry the details the rules require, including the manufacturer's name and licence number, batch number, manufacturing and expiry dates, and the price. Your manufacturer should review your artwork against these rules before printing.
Documents the manufacturer gives you
Expect an approved sample, a quotation and an order confirmation. For each batch, ask for the quality-control results and the batch details that go on your label.
Not sure which documents apply to you? Send your product and your business details and we will tell you what we need.
Next steps
Use the brief-writing guide to prepare your product details. Then read how third-party manufacturing works at Pulse Pharma or ask us for a quote. Note: this article is general guidance, not legal advice. Check current rules with your state drug authority or a regulatory consultant.
Want a product made for your brand?
Tell us what you need. It takes under a minute.