The Unseen Terror: Fake Drugs Claim More Lives Than Terrorism in India

In May 2025, the Union Health Ministry acknowledged in a response to the Lok Sabha that over 7,500 drug samples failed quality tests across India in the previous year, with spurious drugs reported from nearly every major state. The admission, buried in a routine reply, drew sharp criticism from public health experts who warned that the government was normalizing a crisis of mass scale.

This stark admission reveals more than a quality control failure — it points to a chronic, systemic threat that continues to escape urgent national reckoning. Why, then, do deaths of innocent Indians caused by fake or spurious drugs fail to trigger the same outrage, media scrutiny, and policy response as terrorist attacks — such as the one that recently shook the nation?

Terrorism, rightly, provokes collective anger, fear, and decisive action. It disrupts lives, societies, and the national psyche. But when another threat kills even more people every year, acts silently, and feeds off weak institutions — it too warrants being treated as a public emergency.

This comparison is not meant to diminish the horror of terrorism. Rather, it is to confront the staggering neglect of a parallel, preventable crisis. Fake drugs — spurious, substandard, or deliberately mislabeled medicines — kill more Indians annually than terrorism has in decades, yet the political and public response remains muted, fragmented, and disturbingly indifferent.


Fake Drugs: India’s Hidden Epidemic

India is often celebrated as the “pharmacy of the world,” supplying affordable generics globally. But that very scale makes it vulnerable to the systemic menace of fake drugs. According to a 2022 government survey, around 4.5% of drug samples tested in India were substandard, and 0.3% were spurious. While these numbers may seem small, they translate into millions of doses affecting patient outcomes.

Independent estimates, including those from the WHO, suggest that up to 10% of medicines in India’s supply chain may be fake or substandard. That figure increases dramatically in rural areas and among unregulated or informal sellers.

In 2022 and 2023, India-made cough syrups linked to the deaths of over 100 children in Gambia and Uzbekistan exposed the cracks in India’s drug quality surveillance. But such tragedies aren’t just export scandals — similar failures occur domestically, often undocumented and buried in private grief.


Terrorism vs. Fake Drugs: A Deadly Disparity

Let’s look at the numbers:

  • Terrorism-related deaths in India (2023): Less than 100, according to the South Asia Terrorism Portal.
  • Estimated deaths due to fake drugs (India, annually): 200,000–250,000, based on WHO extrapolations and Indian health sector data.

In other words, fake drugs kill as many Indians in one year as terrorism has in over two decades.

Yet, compare the national response:

  • We have a Ministry of Home Affairs-led anti-terror infrastructure, counter-terrorism forces, and international collaborations.
  • In contrast, India’s drug regulation is fragmented, underfunded, and chronically understaffed — with one drug inspector for every 200+ pharma units in some states.

Fake Drugs as a Public Health and Security Threat

Fake drugs don’t just cause death. They:

  • Undermine treatment of tuberculosis, malaria, HIV, and non-communicable diseases.
  • Fuel antibiotic resistance, now one of India’s top health threats.
  • Shatter public trust in doctors, hospitals, and medicines.
  • Waste public health budgets on ineffective procurement and recalls.

Their proliferation is enabled by:

  • Weak state-level enforcement
  • Political protection of unscrupulous manufacturers
  • Unregulated online drug sales
  • A vast informal medical economy, especially in Tier II–IV cities and rural India

Regulatory Paralysis: A Broken System?

Despite repeated alerts from the WHO, Parliamentary Committees, and even the judiciary, India’s drug regulatory ecosystem remains broken.

Key challenges:

  • CDSCO has jurisdiction only over a few functions; state drug controllers handle licensing and inspections.
  • Punishment for producing fake drugs is weak — most cases drag for years and end with acquittals or token fines.
  • A 2021 Parliamentary report found that even quality testing labs were under-equipped, with backlogs of over a year.

What India Must Do — Immediately

This is not an issue of awareness but of political will and systemic reform. India must:

  1. Strengthen and effectively implement the New Drugs, Medical Devices and Cosmetics Bill with strong enforcement provisions.
  2. Deploy a national track-and-trace system across the pharma supply chain, from factory to pharmacy.
  3. Invest in independent drug-testing labs in every state and digitize their data for public transparency.
  4. Shut down informal and unlicensed drug retailers through coordinated action by health, law enforcement, and revenue departments.
  5. Launch a public awareness campaign akin to anti-tobacco or anti-dowry campaigns, warning of the risks of fake medicines.

Conclusion: 

India has built a global reputation on pharmaceutical strength — but that strength is only as credible as the quality of every tablet sold, domestically and abroad.

Fake drugs may not detonate like a bomb, but their effects are just as lethal. It’s time India recognized this silent terror for what it is: a mass-scale threat to life, public health, and national reputation.

Let’s not wait for more headlines, more funerals, and more international embarrassments. Let’s fight fake drugs with the urgency we reserve for terrorism.

By: Tapan J. Ray

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.


‘Havoc’ and its ‘Aftermath’: Clinical Trials in India

Just as the New Year dawned, on January 3, 2013, in an embarrassing indictment to the Government, the bench of honorable justices R.M Lodha and A.R Dave of the Supreme Court reportedly observed that uncontrolled Clinical Trials (CT) are creating ‘havoc’ to human life causing even deaths to patients.

In an interim order, the bench directed to the Government that CTs can be conducted only under the supervision of the Health Secretary of India. Holding the Government responsible, the bench further observed, “You (Government) have to protect health of citizens of the country. It is your obligation. Deaths must be arrested and illegal trials must be stayed,”

Responding to this damning stricture by the Supreme Court, the Government has now reportedly decided that appropriate rules laying down guidelines for pharma companies and other organizations engaging in drug trials in India would be notified within January 2013. It is envisaged that thereafter, the government will also amend the Drugs and Cosmetics Act of India making any violation of prescribed rules and guidelines a punishable offense under the law.

It is worth mentioning that these guidelines have been reportedly worked out after due consideration of around 300 comments received from the stakeholders on the draft proposal circulated by the Ministry of Health in July 2011, couple of rounds of discussion with the members of the Civil Society, expert groups and against reported ‘stiff opposition from the drug companies’.

Better late than never:

In conformance to the well known saying – “better late than never”, it appears that after reportedly around 2,242 deaths related to CT and under immense pressure from the civil society and the Supreme Court, the Government has now left with no options but to bring US$ 500 million CT segment of the country, which is expected to cross US$ 1 Billion by 2016, under stringent regulations.

Experts believe that the growth of the CT segment in India is driven mainly by the overseas players for easy availability of a large patient population with varying disease pattern and demographic profile at a very low cost, as compared to many other countries across the world.

Clinical trial related deaths in India:

As per the Ministry of Health following are the details of deaths related to CTs registered in India from 2008 to August 2012:

Year Total no of deaths CT related deaths  Compensation paid to:
2012 (up to August) 272 12 NA
2011 438 16 16
2010 668 22 22
2009 737 NA NA
2008 288 NA NA

It is estimated that over the last four years, on an average, 10 persons have died every week in India related to CT.

However, looking at the above reported numbers it appears that financial compensation was paid for all registered death related cases however meager such amounts may be.

A huge ruckus:

The subject of CT in India has created a huge ruckus, mainly for wide spread alleged malpractices, abuse and misuse of fragile CT regulations of the country by some players in this field. The issue is not just of GCP or other CT related standards but more of ethical mind-set and reported rampant exploitation of uninformed patients, especially in case of trial related injuries or even death.

The Bulletin of the World Health Organization (WHO) in an article titled, “Clinical trials in India: ethical concerns” reported as follows:

“Drug companies are drawn to India for several reasons, including a technically competent workforce, patient availability, low costs and a friendly drug-control system. While good news for India’s economy, the booming clinical trial industry is raising concerns because of a lack of regulation of private trials and the uneven application of requirements for informed consent and proper ethics review.”

 Inadequate auditing:

It is unfortunate that focus on ‘Clinical Trial Registry’ and even ‘Auditing of Clinical Trials’ has been grossly lacking in India, which are considered so important not only in maintaining credibility of the studies, but also to demonstrate their scientific integrity and ethical values.

Unfortunately, there seems to be many loose knots in the current CT policy, practices, rules and guidelines. All these require to be adequately tightened by the Government to make the system efficient and transparent in the national endeavor of establishing India as a preferred destination for global CT without compromising safety and the health interest of the volunteers.

 Indian Parliament intervened:

On May 8, 2012, the department related ‘Parliamentary Standing Committee (PSC)’ on Health and Family Welfare presented its 59th Report on the functioning of the Indian Drug Regulator – the Central Drugs Standard Control Organization (CDSCO) in both the houses of the Parliament.

The PSC in its report made the following critical findings, besides many others:

  •  A total of 31 new drugs were approved in the period January 2008 to October 2010 without conducting clinical trials on Indian patients.
  • Thirteen drugs scrutinized by the panel are not sold in the United States, Canada, Britain, European Union and Australia, as instructed by their respective regulatory authorities.
  • Sufficient evidence is available on record to conclude that there is collusive nexus between drug manufacturers, some functionaries of CDSCO and some medical experts.
  • Due to the sensitive nature of CTs in which foreign companies are involved in a big way and a wide spectrum of ethical issues and legal angles, different aspects of CTs need a thorough and in-depth review.

 Jolted drug regulator initiates action: 

In response to the high-pitched conundrum and media glare, The Ministry of Health and Family Welfare of the Government of India issued a draft notification on 17th July 2012 seeking stakeholders’ views on:

  • Permission to conduct CT
  • Compensation of the CT victims

The draft notification also says that the licensing authority, only after being satisfied with the adequacy of the data submitted by the applicant in support of proposed clinical trial, shall issue permission to conduct CT, subject to compliance of specified stringent conditions.

However, some experts do apprehend that such stringent system may give rise to significant escalation in the costs of CT for the pharmaceutical players.

Similarly, to assess right compensation for clinical trial related injuries or deaths, following parameters were mooted in the document:

  • Age of the deceased
  • Income of the deceased
  • Seriousness and severity of the disease the subject was suffering at the time of his/her participation into the trial.
  • Percentage of permanent disability

Further, unlike current practices, the government is expected to set up independent registered Ethics Committees under medical institutions for effective and smooth conduct of CTs in India.

Poor patient compensation:

Absolutely unacceptable level of compensation, by any standard, paid by the concerned companies for the lives lost during CTs are mainly attributed to the lackadaisical attitude of the drug regulators to frame rules and laws for patient compensation for such cases in India.

Information reportedly gathered through the ‘Right To Information (RTI) Act’ reveals that one pharmaceutical company paid just Rs. 50,000 each to the families of two patients who died during CT of its cancer drug. Another Ahmedabad-based Clinical Research Organization (CRO) paid a compensation of exactly the same amount to another patient for a CT related death.

The report points out that in 2011 out of 438 CT related deaths in India only 16 families of such patients received any compensation, the quantum of which varied from Rs. 50,000 to Rs. L 3.0  with one exception being of Rs. L 5.

In 2012 till August, 272 more CT related deaths have already been reported.

Higher patient compensation expected:

It has been alleged that currently the pharmaceutical companies are “getting away with arbitrary payments” sometimes as meager as Rs. 50,000, as stated above, in case of loss of life during CT, as there are no set norms for calculating compensation to those patients.

It is expected that the new rules will help putting in place a transparent formula for providing a respectable compensation for CT related serious adverse events like deaths, along with a prescribed provision for minimum compensation amount to such patients.

Increasing public scrutiny:

Over the last few years, CTs in India are increasingly coming under intense public and media scrutiny. As a result, both the concerned pharmaceutical companies as well as the CROs are facing the wrath of various stakeholders including the Supreme Court.

Following are the reported numbers of registered CTs in India from 2009 to 2011:

Year Total Number
2009 181
2010 313
2011 513

Although the total number of CTs registered in India from 2007 to 2011, as per available records, was around 1875, the number of new trials registered in the country had reportedly sharply declined in 2011 over 2010, mainly due to time-consuming regulatory approvals and increasing public scrutiny on alleged unethical practices.

According to www.clinicaltrials.gov – the website of the U.S Government, out of 118,804 human trials conducted in 178 countries, less than 2,000 or 2%, are carried out in India as compared to 9,352 or 8% in China.

It appears, all concerned players now seem to be either willingly or grudgingly waiting for the CT regulatory system to function the way it should. 

Conclusion:

Although the Ministry of Health has already started taking some positive measures, as stated above, there is an urgent need for the players in this field to reassure the Civil Society, in general, and the Government in particular about the high ethical standards that the pharmaceutical companies and CROs would comply with and continuously practice, while conducting clinical research in India.

We all understand, CTs are the core of research-based pharmaceutical industry. No new drug can come into the market without CTs, which involve both potential benefits and risks to the participants. All CTs are conducted with the primary aim of bringing to patients new medicines with a favorable benefit–risk ratio.

Global CTs being relatively new to India, no wonder, there are several misconceptions on the subject. The companies conducting clinical research need to proactively publicize their commitment to protecting the rights, safety and the well being of the trial participants.

That said, the bottom line is, without any selfish interest or pressure to the Government in any form, from within the country or outside, all concerned must ensure that CTs of all types must strictly adhere to the prescribed norms and well laid down procedures of India, as soon as these are put in place.

By: Tapan J. Ray

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion and also do not contribute to any other blog or website with the same article that I post in this website. Any such act of reproducing my articles, which I write in my personal capacity, in other blogs or websites by anyone is unauthorized and prohibited.