What is the first thing to check before choosing any pharma company?
Rather than getting impressed by their product list, lucrative prices, or flashy factory images, certification should be your top priority.
Any pharma manufacturing company in India can make tall claims. But if the paperwork doesn’t back it up, you’re taking a risk with your business. Worse, you’re taking a risk with patients. After all, the pharma manufacturers are as good as the quality of their medicine. Certificates like WHO-GMP ensure that the products are made in a safe environment with all international manufacturing guidelines in place.
It matters which certifications matter and why while working with any pharma manufacturing company.
Why Certifications Matter for a Pharma Manufacturing Company in India
Certifications aren’t just logos or signs on a website. Each one tells you something specific. How clean is the facility? How does it test raw materials? How does it record each batch? How does it handle complaints?
Skip this check, and you might end up with a manufacturer who cuts corners on hygiene. Or one who swaps ingredients without telling you.
The manufacturer’s certifications become your certifications too. Your brand is being manufactured by them. That’s worth getting right. Having all certifications is a hallmark of the best pharma manufacturing company in India.
Certifications of a Pharma Manufacturing Company in India
1. WHO-GMP
WHO-GMP stands for Good Manufacturing Practice, set out by the World Health Organisation. It covers the layout of the unit. It covers staff hygiene, equipment checks, and paperwork for every batch made.
If a pharma manufacturing company lacks this important certificate, they haven’t met the basic industry standard. This isn’t just for export-focused firms. It’s the standard every serious domestic manufacturer works to as well.
2. ISO Certification
ISO 9001 dictates quality management. It is granted after checking the company’s ability to enhance safety, reduce operational errors, and ensure GMP compliance.
Many facilities also hold ISO 14001 for environmental management. Both show a company has systems in place to catch errors early. It’s less about the finished product and more about the process behind it. Same inputs, same checks, same output, batch after batch.
3. DCGI Approval and Drug Licence
The Drugs Controller General of India handles drug approvals at the national level. State authorities issue the licence a facility needs to operate. Ask to see the actual licence copy. It’s usually from 25 or 28, depending on the product. Don’t just take someone’s word for it. A genuine pharmaceutical manufacturing company will hand this over without any hesitation.
4. GLP: Good Laboratory Practice
GLP certification covers the testing labs inside the facility. It confirms that raw material testing and stability studies follow a set process.
5. Schedule M Compliance
Schedule M covers the manufacturing and quality control rules under Indian drug law. The Revised Schedule M has raised the bar further. It covers air systems, water quality, and computer-based records. A manufacturer still working to the old rules is already behind.
6. FSSAI Licence, Where It Applies
Some companies also make nutraceuticals, health supplements, or food-grade products. For these, an FSSAI licence matters alongside the usual pharma certifications. It shows the same care extends across the whole product range.
How to Verify a Pharma Manufacturing Company in India Actually Holds These Certificates
Don’t just trust the logos on a homepage. Ask for certificate numbers. Cross-check them where public records allow it. A credible pharma manufacturing company in India will share scanned copies of its WHO-GMP, ISO, and drug licence documents on request. Hesitation or unclear answers are a warning sign.
It’s also worth asking when the facility was last audited. Certificates expire, or get renewed with new conditions attached. A certificate from three years ago tells you less than one confirmed in the latest audit.
Smayan Healthcare: A Manufacturer That Ticks the Boxes
We at Smayan Healthcare have all the necessary certifications required to run a pharma business in India. We run GMP- and WHO-certified units. We also hold ISO certification, and our products carry FSSAI and DCGI approval. That’s the full set most partners look for.
Smayan makes soft gelatin capsules, injectables, liquids, and ointments. For brand owners, that gives a paperwork trail making due diligence easy, not stressful. Rest assured, you have chosen a quality and reliable pharma manufacturing partner when you work with us.
Getting This Right From the Start
Certificates like WHO-GMP, DCGI, GLP, Schedule M and ISO are some of the important certifications to look for while choosing a drug manufacturer.
They’re the difference between a manufacturer you can build a brand on and one that leaves you exposed when something goes wrong.
Ask for documents. Verify them. Walk away from anyone who won’t show you the paperwork. A genuine Pharma Manufacturing Company has nothing to hide.
Frequently Asked Questions (FAQs)
Q1. What is the most important certification for a Pharma Manufacturing Company in India?
The first one is WHO-GMP. It covers the core standards of manufacture, hygiene, equipment and paperwork that everything else builds upon.
Q2. Is ISO certification mandatory for pharma manufacturers?
Not by law. But most established pharmaceutical manufacturing company operations hold it anyway. It shows partners and clients that quality systems are in place.
Q3. How to verify the manufacturer’s certificate’s authenticity?
Ask for certificate numbers and scanned copies. Cross-check them against the relevant state or central drug authority, where records are public.
Q4. What is the difference between GMP and WHO-GMP?
GMP is a general manufacturing standard. WHO-GMP is the international standard, benchmarked against World Health Organisation guidelines. It is more valuable for export and franchise deals.
Q5. Does every pharma product require an FSSAI licence?
No. FSSAI applies to nutraceuticals, health supplements and food-grade products. Regular pharmaceutical formulations come under drug licensing.
Q6. Why is Schedule M compliance more relevant now?
The Revised Schedule M raised the bar on air handling, water systems and record-keeping.
Q7. Can a manufacturer without WHO-GMP still make quality medicines?
It’s possible. But you’re relying on trust rather than a verified standard. For franchise and brand partnerships, that’s a risk most experienced players won’t take.
Contact Details
Company Name: Smayan Healthcare
Phone: +91 7696763030
Mail Us:Archit@smayanhealthcare.com
Address: SCO 50-51, Second Floor, Sector 9-D, Chandigarh, 160009