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Category: Pharma Industry Insights

Third party manufacturing, PCD franchise, regulation and quality standards explained.

  • Six Mistakes to Avoid When Choosing a Pharma Manufacturer

    Six Mistakes to Avoid When Choosing a Pharma Manufacturer

    Choosing a manufacturing partner is the most consequential decision a new pharma brand makes. The wrong choice shows up months later as late deliveries, rejected batches or a licence problem. These are the mistakes we see most often.

    1. Choosing on price alone

    The lowest quotation often hides the cost elsewhere: thinner blisters, slower turnaround or no stability data. Compare the full offer, including packaging quality, testing and lead time.

    2. Not verifying certifications

    Ask for the current WHO GMP certificate and licence numbers, and check them with the issuing authority. A photocopy on a website is not verification.

    3. Skipping the plant visit

    A two hour visit tells you more than a hundred emails. Look at housekeeping, the quality control lab, and how staff answer questions.

    4. Vague agreements

    Specifications, MOQ, lead time, artwork responsibility, complaint handling and confidentiality should all be in writing. If it is not in the agreement, it is not agreed.

    5. Ignoring capacity

    A manufacturer at full capacity will deprioritise a small new brand when a large customer calls. Ask about current utilisation and how they schedule.

    6. No plan for growth

    Your first order is small; your tenth should not be. Choose a partner whose range and capacity can grow with you so you are not switching manufacturers, and re validating products, in year two.

    The short version

    Verify, visit, write it down, and pick a partner rather than a supplier.

  • How to Start Your Own Pharma Brand With a Third Party Manufacturer

    How to Start Your Own Pharma Brand With a Third Party Manufacturer

    Building a pharmaceutical plant costs years and crores. Third party manufacturing lets you skip that: you own the brand, the formulation choice and the market, and a licensed manufacturer makes the product for you. Here is how the process works in practice.

    Step 1: Decide what you will sell

    Start with a focused list. Ten well chosen products in a therapeutic area you understand will outsell a scattered catalogue of fifty. Look at what doctors in your territory prescribe most, and where supply is unreliable.

    Step 2: Get your licences in order

    You will need a drug licence (wholesale or marketing), GST registration and a trademark for your brand name. Apply for the trademark early. Name clashes are the most common reason launches slip.

    Step 3: Choose a manufacturer

    Shortlist manufacturers that hold current WHO GMP certification, make the dosage forms you need and can quote a minimum order quantity you can afford. Visit the plant if you can. Ask for references from existing brand partners.

    Step 4: Agree the paperwork

    A third party manufacturing agreement should cover the product list, specifications, pricing, MOQ, lead time, packaging artwork approval, quality complaints and confidentiality. You will also sign a Loan Licence or Third Party Manufacturing application with the licensing authority, listing the manufacturer as the production site.

    Step 5: Artwork and first batch

    Send your logo and brand guidelines. The manufacturer prepares label and carton artwork that meets regulatory text requirements. Approve it carefully, because reprints are expensive. The first batch is usually ready in four to six weeks after artwork approval.

    Step 6: Launch and repeat

    Plan your first order so that you can reorder before stock runs out. Lead time for repeat batches is shorter, but never zero. Track which products move and refine the list after the first quarter.

    Typical costs

    A starter range from a manufacturer with reasonable minimums can be launched for a few lakh rupees including licences, trademark and first stock. The exact figure depends on the products and the pack sizes, so get a written quotation.

  • What GMP, WHO GMP and GLP Actually Mean for the Medicine in Your Hand

    What GMP, WHO GMP and GLP Actually Mean for the Medicine in Your Hand

    Every serious pharmaceutical manufacturer lists a row of certifications on its website. To a patient or a new brand owner they can look like alphabet soup. Here is what each one guarantees, and what it does not.

    GMP: Good Manufacturing Practice

    GMP is a set of rules for how a factory must be designed, cleaned, staffed and documented so that every batch is made the same way. It covers the building, the air handling, the water, the equipment, the training of staff and the paperwork that proves all of it happened. In India, GMP requirements are set out in Schedule M of the Drugs and Cosmetics Rules and enforced by state licensing authorities.

    WHO GMP

    WHO GMP is the World Health Organization’s version of the same principles, used as the international benchmark. A WHO GMP certificate is issued after inspection and is often required for exporting medicines. It signals that the plant meets a standard recognised well beyond its home country.

    GLP: Good Laboratory Practice

    GLP applies to the testing side. A GLP laboratory has calibrated instruments, validated test methods, trained analysts and records that let an auditor reconstruct exactly how a result was obtained. When a manufacturer says a batch “passed analysis”, GLP is what makes that statement trustworthy.

    What the certificates do not tell you

    • They do not rank one manufacturer above another. They are pass or fail.
    • They do not cover the marketing claims on the pack. Those are regulated separately.
    • They expire and must be renewed after re inspection, so ask for a current copy.

    How to use this as a buyer

    If you are choosing a third party manufacturer, ask for the current GMP or WHO GMP certificate and the licence number, then verify them with the issuing authority. A manufacturer who hesitates to share them is telling you something.