Have you ever taken medication, only for the condition worsen? What did the doctor conclude? He/she probably upped the dosage or changed the medicine, and then things probably got better. It could have been that the disease was too powerful, or it could have been that medicine was fake.

The WHO (World Health Organization) estimates that 1/10 medications are fake, due to which 1/10 times that a person is treated – the expected effect doesn’t occur. World-wide statistics hide the large disparity that occurs off countries – some places like Sub-Saharan Africa – a whopping 43% of antibiotics are expected to be fake. Whether you recover from an infection is coin-flip, except one gambles with ones health. With such a proliferation of fake medicine in other countries – the question comes to what percentage of Indian Medicine is fake? The question is harder than it seems, because it depends on who is answering it.

Table of Contents

Sources of Truth:

WHO (World Health Organization) is a body of the United Nations. It is essentially a global organization which has no power to either enforce policies or get data. It is reliant on its member nations.

CDSCO (Central Drugs Standard Control Organization) the central drug regulatory body of India. It is falls under the purview of the Ministry of Health and is essentially liable to whichever government is in power and particularly whichever party controls the ministry. It has only regulatory power, and limited execution due to health being a state subject.

State FDAs (Food and Drug Regulatory Authority) the executing authority of India. These bodies are controlled by state governments, and respective parties – and ensure compliance of state and national laws.

ASSOCHAM (Associated Chambers of Commerce & Industry of India) is India’s oldest industrial chamber – it released a paper called: Counterfeit Medicines: Booming Business.

ASPA (Authentication Solution Providers Association) is India’s association of organizations that authenticate goods and services. They have released a report called the State of Counterfeiting 2002, wherein the third chapter concerns Pharmaceuticals.

Fake/Substandard/Spurious Drugs as percentage of Total Medication by Organization:

Organization	Sub-Heading	Estimate
WHO		10%
CDSCO	Government Sources	~10%
CDSCO	Private Sources	~3
ASSOCHAM¹		25%
ASPA	Distributors Survey	10%-20%
ASPA	Consumer Perception Survey	20%

Fake drug percentage reports

The variety in the answers is telling; estimates range from as low as 3% for private sources to 25%. Furthermore, the distributor surveys only tell what distributors think is spurious; i.e., fake.

Strengths and Weaknesses

WHO: The WHO estimate is one drawn from 30,000 feet. This is based on the Global Surveillance and Monitoring System wherein member states voluntarily submit information to the WHO for data analysis.²

There are reports that come in; but merely comparing what is in Indian news, and what is in the system – it becomes clear that India submits very little if any information. In 2024, there are 5 incidents; whereas I could Google *Fake Medicine India* right now or go to various state FDA sites (the more functional ones like Gujarat and Kerala) and come across countless articles highlighting cases of malfeasance.

Other countries incidents like Egypt, Argentina, and many more – seem to be in the same state. I doubt sending this information is in priority for the nationalist-insular regimes that seem to be in vogue.

From this Piddly of information, the WHO has estimated 1 in 10 drugs is spurious. This estimate seems far-fetched, although if they would release their analysis and data; I would love to see what statistical model they employed.

WHO’s Estimates are Questionable!

ASSOCHAM: The industry body’s paper has been cited in so many sources like Business Standard and India Today. However, I can’t seem to find a copy of the actual paper.

This is despite all of their files being open access on the web.
No literally: https://www.assocham.org/uploads/files/, you can look at every file they have uploaded to their site here. Additionally, the timings of the article upload are questionable. Some sources say it is from 2004, others 2017, others still 2020.

I went through the way back machine and checked their website every year since it has been recorded. I cannot find one mention of it. It is possible I missed it; I could build a bot that could check each recorded webpage for the supposed title – but honestly if it’s this hard to find – is it even valuable? Or worse, has it been buried? Moment, I feel like I want to practice my Selenium³, I’ll post an update.

At this point; I do not know if this paper exists, ever existed, or is just a media article that is cited with absolutely no basis. It could be like the Ancient Nalanda University (a lost bastion of knowledge) or it could be like the Saraswati River (mythological bastion of prosperity) – who knows? I sure don’t.

ASSOCHAM: WHERE IS THE PAPER?

CDSCO: The government conducted a survey from 2014-2016 taking 15 therapeutic categories, and 224 different drug molecules. It collected 47,954 samples, attempted a three-stage randomized trial across 654 districts. All samples were tested, and that analysis was presented.⁴

Let’s pay attention to the design:

WHERE

A list of sources was presented, but the surveyor was unaware of which source led to which location.

Location was visited – if it wasn’t open, then the nearest source was 5 kilometres away.

If more than one source was available; then the choice was left to representative of Civil Society.

2. What

The 224 molecules were compared against what was available.

All available molecules had all their formulations listed.

Their *Brands*.

Then a *mathematically* random drug was chosen.

3. HOW

Tested in a Laboratory

Visually Inspected for defects

Results:

Lots of break downs of sources (Retail, Govt, Ports) (Corporations, Villages, Metros, Municipals, Taluk HQ)

Assigned source drawing was only 60%.

Perfectly 3.0% of retail samples failed, while 10.2% of government samples failed.

Only 13 samples were found to be spurious – meaning 0.03%.

According to the CDCSO, roughly 5% of India’s medicine is bad, very little is fake. The bad number is bad, but better than the WHO estimate.

Time for My Opinion:

What is the number one cause of low-quality drugs in India?

Ineffective Regulatory Apparatus.

Being in the industry; I can say that honest drug regulators are an exception. Just google *Drug Inspector Bribe* right now, or even *CDSCO Bribe* right now, and you will find article, after article of various cases. It’s like fake medicine cases in India. If the executing hand of this survey is left in the hands of corrupt officials – how much do you think will be utilized for the advantage of the corrupt official.

The official could do malfeasance is the following manner:

Location not found – when it does exist.

Location closed – when it is not.

Formulation not found – when it does.

Formulation not in enough quantity – when it is.

Mathematically calculating before entering into the sheet to pre-choose the sample.

This exchange may have occurred:

This is a list, please say if you have this medicine.*
*Okay*
*Metformin!*
*No (This is a lie)*

If they were caught;

*Sir, please don’t do this sample; please don’t inspect us; please don’t……*
*Here is a small sum for your consideration*

Representatives of the Pharmacy Council of India & Civil Society were present to stop such malfeasance.
Which members of Civil Society? Was the Thakur Foundation present⁵? ⁶
Pharmacy Council of India – the same Pharmacy Council where members are arrested for corruption? Google *Pharmacy Council of India Corruption* right now.

Instead of money going directly to only the inspector – it should be split so many can eat.
Afterall, he/she is probably already used to making money for his entire hierarchy.

Lets throw off my Sarkari trauma and assume somehow everything went swimmingly:

Let us assume that a corrupt bureaucracy didn’t distort the noble intentions of this survey with malfeasance.

In this world, where roads are made wonderfully every time, the survey was properly gathered.
It was then compiled into this wonderful report and released by the Ministry of Health.

This data, of which I can only see the results – paints a better then expected picture of the pharmaceutical sector. Our medicine is substandard, either in dissolution or assay. Barely any adulteration or spuriousness.

The government has frequently tried to tame the pharmaceutical industry. Since 1976, a proper drug recall law has been stuck in debate in parliament.⁷ It tries many things; it fails frequently. The truth is, the pharmaceutical industry is a gem of India. The amount and variety of individuals who schmooze across the world to sell Indian drugs made by Indians is astounding. This Industry is a cornerstone; perhaps not as glamorous as IT or Bollywood; but it has a larger impact globally than nearly every other major industry.

If India’s pharmaceutical reputation went down the drain due to its own government – the government would be self-defeating. If I was in charge (and I cannot be, cause I’m American); it’d be quite the moral dilemma. Release open information and destroy your own industry, or pretend things are rosier than they are.

I’d like to say, I’d have the ethics of Dinesh Thakur; but the more pragmatic solution would be to internally tell everyone the real situation and externally present a rosy situation. Destitution for an important contributing Industry for some bad apples seems like a bad trade. But then, I also know if I share this information internally directly – it’ll leak to the outside world like pipes in most houses 30 years or older.

I’d tell everyone that everything’s fine, and then increase vigilance like a hawk. First though, I’d have to acknowledge that my bureaucracy is corrupt & inept – and reform the whole system to promote a culture of excellence.

This is all to say; that I believe the government has an incentive to lie.

I AM NO-NATIONAL

Do be aware; I don’t particularly support or dislike any party in India.
I supported Democrats in the last few elections in America, although at this point, I’m fairly despondent on the way the party has turned – abandoning its working-class roots for identity politics.

In India; I come from a BJP supporting family. My grandfather was the cultural convenor of the BJP and was Prime Minister Modi senior. He set up Modi’s office when he first came to Delhi.⁸ Regardless; I am fairly unaligned politically as I am not a citizen of this country. I believe in universal, small, and efficient government.

So why am I doing this? Well, SayaCare’s goal is to empower citizens. If your mayor is telling your town there isn’t a group of bandits whose notorious leader had taken his arms; the safe thing is actually learning there is bandit camp so you can prepare yourself and protect your families.⁹

CDSCO Results: Better than Expected – Government Corruption, Deception, or Both?

ASPA: The Authentication providers have gone to great lengths to prove that they provide a useful service. SayaCare, with it authenticating quality by testing each batch, would also like to think its service is useful. After all, what is the point of testing if everything is okay?

Unluckily for society, the Authentication providers conducted surveys with distributors, retailers, manufacturers, and consumers. If we believe it; it shows what people perceive.¹⁰

According to this report¹¹

Manufacturers and Retailers estimate 0.1-3% of medicine is counterfeited.

Distributors estimate 10-20% is counterfeit.

Consumers expect around 20%.

Counterfeiting perception would depend on your visibility into the supply chain.

Manufacturers: Manufacturers actually have very limited visibility into the supply chain. They produce medicine, they try to stick to quality guidelines, and they try to find companies to market their products. The only time they are ever aware; is if someone counterfeits to heavily their product in the market.

If I got 10 Lakh consistently from a district, and then one month I get 5 Lakh, but the retailers report that sales are just as strong – I know something is wrong. Beyond that, I have no idea. If someone counterfeits a little bit all over, if the retailers bind together to counterfeit, if the retailers report a drop in sales – I won’t get any picture that something is going wrong.

Most consumers who get the counterfeit products will either misinterpret the lack of effect to disease, not report it, or report it to someone who doesn’t report up.

Retailers: Most retailers purchase from just one or two distributors. Being so far down the supply chain, they don’t have any access to the manufacturer or even large stockists. They just give an order according to what doctors nearby prescribe, and it arrives on their doorstep – nothing more, nothing less.

Distributors: Distributors are what we would call the middlemen. SayaCare could be called a distributor. We have visibility into both the top and bottom of the supply chain. We purchase from manufacturers, marketing companies, aggregators, and even other distributors. We sell to so many different retailers (although in SayaCare’s case: customers). There is so much room for things to go wrong. I shudder to think what would occur had we not tested.

We middle-men, have the largest view, and are what a majority of medicine travel through to reach the consumer. If Distributors think that 10-20% of medicine is just spurious– I’d hate to see what they think is substandard/adulterated.

Consumers:

Consumers usually have no visibility or knowledge about the supply chain. SayaCare is trying to change that, but it’ll take some time. This is where I would be very interested in knowing how ASPA conducted its survey. Did the consumers they interview know what counterfeit medicine is?

Most people who visit our website have no idea.

The interesting thing is around 20% of people said they have experienced counterfeit medicine. Since the knowledge level of people is so uncertain, I do not know what to make of it. Most counterfeit medicine goes undetected because most people assume the disease was just too bad. How did these consumers know it was counterfeit. Again, do they know what counterfeit is?

ASPA: Supply Chain Visibility Determines Perception. Middle-Men think it’s Bad!

Conclusion

If you read all this. Congrats; that’s over 2,500 words. Now here’s 28 more.
Indian Medicine Quality is as Bad as The Authority You Trust Thinks It Is.
How Much Do You Trust That Authority?
How Bad Do You Think It Is?

This report has been cited by multiple reputable news bodies, but the copy of the report cannot be found.
https://www.who.int/teams/regulation-prequalification/incidents-and-SF/full-list-of-who-medical-product-alerts
The paper has been removed.
https://mohfw.gov.in/?q=documents/reports/drugs-survey-report
No, its impossible. Dinesh Thakur is a foreign agent meant to dismantle India’s pharmaceutical industry. He would bias the results. In case you cannot tell, I am being sarcastic.
There is a secondary issue, that I haven’t presented due to it paling in significance to this one. Inherent, unchangeable Design Flaw (illicit sale of pharmaceutical sources would not be present in the original source sheet presented to drug inspectors.)
Yes, India does not have proper drug recall.
He loves telling me how Modi wanted a map of the world behind his desk. He recently met Modi when receiving his Padma Sri, and asked: “Did you have the same global ambitions all those decades ago when you made me put a world map?” Modi Ji could only laugh.
Sholay!
I’d really like to see this survey data. This body doesn’t have close to the resources of the government, but I’m impressed they did as much as they did.
https://www.aspaglobal.com/pre_upload/nation/Pharmaceutical.pdf