Look closely at a medicine strip and you will find two names: manufactured by and marketed by. The second is why your medicine is expensive; the first decides its quality. That quality is judged by Good Manufacturing Practices, or GMP. There are two versions in play; GMP and WHO GMP. To understand how this works, I spoke to a manufacturer, a former CDSCO member, and a regulatory expert. They chose to remain anonymous. What emerged was a picture of loopholes in the system, but also a roadmap for how you can be sure the medicine you take meets quality standards. Read on to uncover this mystery and to know how to ensure the medicine you consume is truly quality.
Table of Contents
What is GMP Certification?
At its simplest, GMP stands for Good Manufacturing Practices and is the government’s seal that a pharmaceutical manufacturer meets the baseline criteria for producing quality medicines. In India, these standards sit under Schedule M. The intent behind drafting and regularly updating them is clear: to cut down on the flood of Not of Standard Quality (NSQ) medicines in the market. Every licensed manufacturer in India holds GMP certification.
What are the Qualification Criteria for GMP Certificate?
Every pharma unit in India proudly displays its GMP certificate. But behind that one-page certificate sits a long, grinding process.
“It starts with a three-member inspection team, one from the Central Drugs Standard Control Organization (CDSCO), one from the zonal drug inspector’s office, and one from the state drug inspector’s office. They walk into the factory, checklist in hand. Only if the facility clears their combined scrutiny does the GMP stamp arrive. It doesn’t come easy” – former CDSCO official.
What does the team look for? Compliance on 29 separate criteria. Miss a few, and certification isn’t happening. At its core, GMP is about discipline. Licensed staff must oversee every manufacturing step. Raw materials and batches need to be labeled clearly, and at every stage. Standard operating procedures (SOPs) are written to prevent the smallest of errors: mix-ups, contamination, or even an air-handling failure.
Drugs that are sensitive? They get produced in isolated areas. Packaging lines? They have to be spotless, inspected, and cleared before production starts. Everything from air, people, machines, to drugs everything has to stay in its lane. That is what the 29 criteria boil down to. A framework designed to leave no room for improvisation. If you want to read guidelines in detail then click here to read more.
After qualifying for the certificate how can one apply and this takes us to next part…
How to Get GMP Certification in India?
Getting GMP certification is a detailed but simple process. First, understand the GMP requirements set by CDSCO. Then audit your facility to spot gaps in cleanliness, production, or training. Train employees so everyone follows GMP rules, and put strong quality control in place to test products at every stage. Once ready, apply to CDSCO for inspection. If your facility and records pass the audit, you will receive the GMP certificate. After certification, regular audits keep you compliant.
You might think these guidelines are enough to guarantee medicine safety. They are not. There is another layer, stricter and more demanding. WHO-GMP. The answer to the difference between WHO-GMP and GMP lies in the next section. That is where the contrast becomes visible, and where the rules that separate the two start to matter.
What is the difference between GMP and WHO GMP certification?
GMP is the entry ticket for manufacturing medicines in India. WHO-GMP is the permit for selling them abroad. Here’s the interesting part. A company making drugs for the Indian market only needs to comply with GMP. But if the same company wants to export, it must secure an additional certification: WHO-GMP.
So what separates the two?
A former CDSCO official explained it clearly: “GMP is the lowest qualification requirement for making medicines in India. WHO-GMP is a level higher and it’s non-negotiable if you want to export.”
That raised a more immediate question. Who can apply for WHO-GMP in the first place?
“Earlier, only manufacturers with a turnover of 250 crore could apply for WHO-GMP. Today, everybody can. Big players, with turnover above 250 crore, can apply within six months. Smaller firms, below that mark, get a window of twelve months,” said a manufacturer.
The larger puzzle was why medicine makers operate under two sets of rules in the first place. As I dug deeper into the differences between GMP and WHO-GMP, the picture became sharper. Nine criteria separate them. But the real story lies in how those criteria shape the quality of what reaches you.
On paper, India’s GMP (Schedule M) seems stricter with 29 prescription-like criteria, annual audits, plus special rules for dosage forms, facilities, and even niche categories. Meanwhile, WHO-GMP outlines nine basic criteria along with detailed chapters on GMP guidelines for different categories of medicines. To understand this let’s take example of letrozole 2.5mg a medicine approved and manufactured for breast cancer, the same strength when proposed for PCOS would require separate regulatory documentation, and approval, as indication-specific authorization is necessary despite identical dosage strength.
WHO-GMP audits are conducted once every two years, and the certification serves as a global export baseline. But here is where it gets twisty: a former CDSCO member quietly told me that India’s GMP, despite its more granular structure, actually reflects a lower overall standard. “In India, if caught, one can pay a bribe and easily get away with it, it’s that simple.” – Medicine Manufacturer
How to Verify my Medicine has been Manufactured by a GMP Certified Manufacturer ?
When you pick up a strip of medicine, the first thing you see are the brand name, expiry date, and dosage instructions. But the real question is how can one determine whether that tablet is safe is hidden behind an opaque wall: who manufactured it, and under what standard?
A drug regulatory expert told me bluntly that If the package shows off every certificate in the world but does not mention the manufacturer, that’s fishy.
And yet, even if the name is there, you may still be in the dark. Because verifying whether a manufacturer is actually GMP-certified and more importantly, whether their facilities are updated to the latest GMP guidelines it is harder than it looks.
In December 2023, the Ministry of Health and Family Welfare updated Schedule M, effectively rewriting the rulebook for pharmaceutical manufacturing. The new checklist goes beyond the basics. Below is the criteria that has been updated in schedule M:
Quality risk management: documenting and mitigating risks to protect patients.
Pharmaceutical quality system: making quality the shared responsibility of management, staff, suppliers, and distributors.
Computerized storage systems: mandating secure, trackable data logs with backup and access control.
Product quality reviews: annual audits of raw materials, processes, and finished drugs to identify gaps.
When these criteria were updated, a dark truth came out. Of the 11,000 pharmaceutical facilities in India, only about 2,000 complied with the updated Schedule M as of early 2024. Does that mean the remaining 9,000 are pumping out fake medicines? Not necessarily. As explained by drug regulatory expert “most of these non-compliant plants fall under MSMEs or the Make in India umbrella. Sometimes, “non-compliant” simply means one or two documents missing.”
But here is the catch: even if you wanted to verify a facility, there is no easy way. WHO-GMP certifications are supposed to be public. Yet when I checked the WHO-GMP 2024 list, not a single manufacturer from Baddi, Himachal Pradesh, India’s largest pharmaceutical hub was mentioned.
An industry insider gave me the unvarnished truth:
“It’s almost impossible to know who’s WHO-GMP certified in Baddi. The data is never released. And the drug inspector system there is riddled with corruption.”
A manufacturer added another layer. “State regulatory rules are weak. Getting DCGI approval for manufacturing is difficult. Because of this, manufacturers around Roorkee are producing combinations that are not even approved. The loophole is regulation itself.”
These gaps in regulatory compliance show up clearly in the NSQ reports of the CDSCO. Time after time, the reports mention states that have failed to submit medicines for testing. So the consumer is always left guessing. You can squint at the packaging, search half-updated certification lists, or take the word of your local pharmacist. None of that guarantees you are holding a medicine made in a facility that actually meets current GMP standards.
“Many companies are now making medicines on loan licences, even when the products are marketed by big firms. On paper, if a drug is flagged as NSQ, both the manufacturer and the marketer are liable. But the system is so weak that the marketer shifts all the blame to the manufacturer, finds another plant, and keeps the brand alive.” – medicine manufacturer
That brings us back to the only question that matters: where can you buy medicines that are truly GMP-compliant?
Right now, there is no simple answer. India has the rules. It even updated them. But until transparency improves, the gap between policy and pill will remain uncomfortably wide.
SayaCare: The Trusted online Pharmacy for Tested Generic Medicines
It is nearly impossible for an ordinary person to verify whether the medicine in their hand is genuine or is the kind that actually works or just another dud in the system.
Four years ago, while working at a Jan Aushadhi store in Dharamshala, Himachal, Dhruv saw this problem up close. Patients complained about the ineffectiveness of the medicine. Upon researching Dhruv found loopholes in India’s medicine supply chain which was visible everywhere: outdated certifications, opaque manufacturer data, and regulators who looked the other way. That’s when Dhruv, along with co-founder Dr. Shivangi, decided to flip the script. Instead of trusting certificates on paper, they built SayaCare to test medicines according to the standards laid out in the Indian Pharmacopoeia, the actual scientific benchmark for quality. The process is designed to cut out the guesswork. After SayaCare procures medicines from manufacturers, every batch is sent directly to an NABL-accredited laboratory. Only once the medicines clear testing are they delivered to customers’ doorsteps at discounts of up to 80%. It is a small but radical shift: in a market where transparency is the rarest ingredient, SayaCare tries to make trust the first thing you get when you open the package.
India may be the world’s largest medicine manufacturing hub, but when the government tightened GMP rules, only 2,000 out of 11,000 facilities complied. The rest continued business as usual. For patients, there is no clear way to verify medicine quality. Even the comfort of a big brand name doesn’t guarantee safety outsourcing blurs that line. That is the gap SayaCare was built to close. Founded seven years ago with transparency at its core, it tests every single batch against the standards set in the Indian Pharmacopoeia before it reaches a customer’s doorstep. The price tag is up to 80% lower, but the bigger promise is something rarer: certainty in a market built on doubt.
Mahak Phartyal completed her bachelor's in pharmacy from Veer Madho Singh Bhandari Uttarakhand Technical University. She previously worked as a Medical Writer at Meril Life Sciences, where she wrote numerous scientific abstracts for conferences such as India Live 2024 and the European Society of Cardiology (ESC). During her college years, she developed a keen research interest and published an article titled “Preliminary Phytochemical Screening, Physicochemical and Fluorescence Analysis of Nyctanthes arbor-tristis and Syzygium cumini Leaves.”
Mahak Phartyal completed her bachelor’s in pharmacy from Veer Madho Singh Bhandari Uttarakhand Technical University. She previously worked as a Medical Writer at Meril Life Sciences, where she wrote numerous scientific abstracts for conferences such as India Live 2024 and the European Society of Cardiology (ESC). During her college years, she developed a keen research interest and published an article titled “Preliminary Phytochemical Screening, Physicochemical and Fluorescence Analysis of Nyctanthes arbor-tristis and Syzygium cumini Leaves.”
