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When Pills Betray Trust

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Why India’s Drug Quality Crisis Demands a Mindset Reset?

A Familiar Headline, a Fading Sense of Shock:

It happened again.
According to The Economic Times (October 24, 2025), 112 drug samples failed quality tests in September — one even found spurious.

If that didn’t startle you, you’re not alone. These headlines have become as routine as morning tea. Public outrage brews for a moment, then cools before the next edition hits the stands.

But imagine if 112 aircraft failed safety checks in a single month — would anyone dare call that a “batch-specific issue”?
When it comes to medicines that enter human bodies and decide between sickness and survival, such excuses sound absurd. Yet, we’ve come to accept them.

That quiet acceptance is where the real danger begins.

When Data Lies, Patients Pay the Price:

As reported by The Economic Times on October 30, 2025, in a separate and alarming development — “Drug cos forging data for approval, mislabeling brands to be barred.”

If the first report showed what went wrong, this one revealed why - Forged data. Mislabeled brands. Corners cut in dossiers. It’s not just a lapse in manufacturing — it’s a collapse in ethics.

Let’s be honest: you can’t market “Make in India, Trust Globally” when the fine print whispers “Data Forged, Labels Fudged.” Somewhere between speed-to market and responsibility-to-patient, we’ve misplaced our moral compass.

And when that happens, it’s not just a regulatory failure — it’s a betrayal of trust.

Quality: Built In, Not Inspected In:

Each time such headlines appear, the reflex is predictable — emergency reviews, press statements, promises of stricter enforcement. All necessary. Yet, all reactive.

Because quality cannot be inspected in after production — it must be built in before it begins.
And that calls for something no checklist or audit can enforce: a fundamental change in mindset.

  • A corporate mindset that values patient safety above quarterly profits.
  • A regulatory mindset that prizes prevention over post-mortem.
  • A leadership mindset that refuses to normalize mediocrity when human lives are at stake.

This is not a question of capacity or compliance — it’s a question of conscience.

“You can’t inspect quality into a pill — it has to be built into the process, the mindset, the culture.”

From Blame Games to Shared Accountability:

Every time this issue resurfaces, the blame carousel spins:

  • Regulators point to resource gaps.
  • Companies point to complexity.
  • Everyone points to the system.

But systems don’t act — people do.

A regulator’s vigilance cannot replace a company’s integrity. Nor can corporate SOPs mask ethical indifference.

India’s recurring quality crises demand not louder warnings, but shared accountability — an honest partnership between regulators and industry that treats every tablet as a promise, not a product.

If we achieve that, the next set of headlines won’t read “112 Drug Samples Fail.” They’ll read: “India Sets New Global Benchmark in Drug Quality.”

A Dose of Humor — and a Hint of Hope:

Someone once quipped, “In India, we don’t recall drugs — we recall excuses.”
Clever. Painfully accurate.

But here’s the hopeful twist: India has achieved the impossible before.
We built vaccine networks the world now depends on.
We made medicines affordable to millions who once had none.
We can certainly lead in quality — if we decide to make integrity non-negotiable.

The prescription isn’t complicated:

  • Less denial, more diligence.
  • Fewer circulars, more conviction.
  • And a mindset that views every patient not as a market opportunity — but as a moral responsibility.

Because every failed sample isn’t just a number — it’s a risk to a trusting patient who believed the system would protect them.

It’s time it truly did.

“When data lies, patients pay the price.”
“Quality in pharma isn’t a regulatory requirement — it’s a moral one.”

Conclusion:

The Bottom Line

India has earned its title as the pharmacy of the world.
Now it must earn another — the pharmacy the world can trust.

That journey doesn’t begin with another inspection or circular.
It begins with a mirror — and a mindset.

— By: Tapan J. Ray

Author, commentator, and observer of life beyond the corporate corridors.

 

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.


Sources & References

  1. “112 drug samples fail quality tests in September 1 found spurious: Govt” — PTI / ET Manufacturing (The Economic Times), October 24, 2025.
  2. “Drug cos forging data for approval, mislabeling brands to be barred” — The Economic Times, October 30, 2025.
  3. Background: Business Standard reports on CDSCO alerts and enforcement updates, 2024–25.

 

Pills and Payments: India’s Unethical Drug Marketing Problem

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The recent exposé by The Economic Times, titled “Rx Name Unethical practitioners,” published on June 19, 2025, which brought to light allegations of a prominent global pharmaceutical company sponsoring extravagant foreign trips for doctors in violation of ethical codes, serves as an urgent reminder, yet again, of the persistent and deeply entrenched malpractices plaguing India’s pharmaceutical marketing landscape. While India proudly holds the title of “pharmacy of the world,” this distinction is increasingly overshadowed by unethical practices that jeopardize public health, distort prescribing patterns, and erode trust in the medical profession.

The Anatomy of Malpractice: A Systemic Issue:

The incident, highlighting the Department of Pharmaceuticals (DoP) apparently shielding names despite clear breaches, underscores a systemic failure in accountability. Unethical marketing manifests in various forms:

  • “Freebies” and Inducements: Offering gifts, money, travel, and hospitality directly influences prescribing behavior. This leads to unnecessary prescriptions, a preference for expensive branded drugs, and the over-medicalization of minor ailments.
  • Misleading Claims: Companies make unsubstantiated or false claims, misleading both professionals and the public, often with dangerous health impacts as highlighted by the Supreme Court.
  • Undue Influence in CME: Company-sponsored educational events often serve as thinly veiled marketing opportunities, subtly promoting specific products.
  • Lack of Transparency: The refusal to disclose names of doctors involved in unethical practices exemplifies pervasive opacity, shielding wrongdoers.

Why Self-Governance (UCPMP) Is Not Working and Malpractices Persist:

Despite the notification of the Uniform Code of Pharmaceutical Marketing Practices (UCPMP) 2024, malpractices continue to thrive. This is primarily because the UCPMP, even in its revised form, relies heavily on self-governance, which has proven ineffective.

Why Self-Governance Fails:

  1. Not a Full Law: While the UCPMP 2024 has moved from “voluntary” to “quasi-statutory,” it still isn’t a strong, legally binding law passed by Parliament. This means there are no direct legal punishments for violations. The DoP can only “recommend” action to other bodies or associations, lacking the power to impose immediate, significant fines or sanctions. Companies know this, which reduces their incentive to fully comply.
  2. Weak Punishments and Enforcement: The penalties under the UCPMP are often too light to deter large pharmaceutical companies, for whom the profits from unethical practices far outweigh a mere reprimand or expulsion from an industry association. Enforcement relies heavily on industry associations themselves (through Ethics Committees for Pharmaceutical Marketing Practices – ECPMPs). This creates a conflict of interest, as these associations are made up of the very companies they are supposed to regulate. There’s a natural tendency for these committees to be lenient or prioritize industry interests over stricter compliance.
  3. Lack of Proactive Investigation: Enforcement largely depends on complaints being filed. This means many unethical practices go unreported or unaddressed, especially when there’s an imbalance of power, making whistleblowing risky. The system isn’t designed for active investigation, but rather reactive response.
  4. Deep-Rooted Culture of Incentives: The Indian pharmaceutical market is highly competitive. Companies face immense pressure to push their products. The ingrained culture of offering incentives, even subtle ones, has become a “cost of doing business.” When competition is fierce, relying on competitors to self-regulate fairly is often wishful thinking.
  5. Loopholes and Vague Rules: Despite revisions, the code may still have gaps, or new, indirect ways companies promote drugs might not be clearly covered. For instance, the lack of mandatory public disclosure for payments made to doctors for research or advisory roles is a significant loophole that allows conflicts of interest to remain hidden.

In essence, self-governance simply isn’t strong enough to counter the massive financial incentives driving unethical marketing. It relies on goodwill and internal discipline in an industry where competitive pressures are intense, leading to a situation where the rules exist, but the teeth to enforce them are missing.

The Ripple Effect: Impact on Public Health and Trust:

These malpractices inflict significant harm: patients receive inappropriate or excessive treatments, leading to higher healthcare costs. Public trust in doctors and drug companies erodes, and market competition is distorted.

Moving Ahead: A Stronger Path to Ethical Marketing for Viksit Bharat:

Ensuring ethical pharmaceutical marketing practices is not just a matter of professional integrity; it is a fundamental pillar for achieving India’s cherished vision of Viksit Bharat by 2047. A developed nation thrives on a healthy, productive populace and a healthcare system rooted in trust and equity, free from commercial exploitation. The UCPMP 2024 is a vital starting point, but its success – and indeed, its contribution to this national ambition – hinges on taking critical next steps:

  1. Make UCPMP a Full Law: The code must become legally binding with clear, stringent punishments directly under a parliamentary act. This means no more personal benefits for healthcare professionals, strictly enforced by law.
  2. Stronger Oversight and Enforcement: Create an independent, empowered regulatory body with real power to investigate, impose significant penalties, and ensure timely resolution of complaints. Regular, proactive audits of marketing expenses, strong whistleblower protection, and, crucially, publicly naming companies and professionals found guilty are vital for accountability. Inspired by global best practices such as the US Physician Payments Sunshine Act, which mandates public disclosure of payments to healthcare providers, this level of transparency is critical. Better coordination between the DoP, National Medical Commission (NMC), Income Tax Department, and Competition Commission is also essential.
  3. Empower Doctors and Promote Ethics: Medical schools must focus more on ethical practice. The NMC and State Medical Councils must consistently act against doctors who break rules. Encouraging doctors to prescribe generic drugs and supporting independent medical education are key steps.
  4. Industry Must Adapt to Real Regulation: While industry associations can support compliance, the primary responsibility for enforcement must shift from self-regulation to an external, statutory body. Companies must be mandated to comply, not just encouraged.
  5. Educate the Public: Inform people about their rights, how marketing can influence prescriptions, and the importance of generic alternatives. Also, encourage reporting of misleading drug ads.

Conclusion:

The path to ethical pharmaceutical marketing in India is challenging but vital. It needs a united effort from the government, regulators, drug companies, doctors, and the public. The June 19, 2025, revelations, as brought forth by The Economic Times, serve as a critical turning point. By committing to transform the UCPMP into a fully statutory and robustly enforced framework through the vital steps outlined above, we can effectively turn the bitter pill of malpractices into the sweet success of ethical healthcare, laying a crucial groundwork for a healthier, more prosperous, and truly developed ‘Viksit Bharat’ by 2047.

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.

 

 

USFDA ‘Import Bans’: The Malady Calls For Strong Bitter Pills

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It is a matter of pride that Indian pharmaceutical industry is the second largest exporter of drugs and pharmaceuticals globally, generating revenue of around US$ 13 billion in 2012 with a growth of 30 percent (Source: Pharmexcil).

Though sounds awkward, it is a reality that India is a country where ‘export quality’ attracts a premium. Unintentionally though, with this attitude, we indirectly accept that Indian product quality for domestic consumption is not as good.

‘Export quality’ being questioned seriously:

Unfortunately today, increasing number of even ‘export quality’ drug manufacturing units in India are being seriously questioned by the regulators of mainly United States (US) and the United Kingdom (UK) on the current Good Manufacturing Practices (cGMP) being followed by these companies. In many instances their inspections are culminating into ‘Import Bans’ by the respective countries to ensure dug safety for the patients.

Are drugs for domestic consumption safe?

Despite intense local and global furore on this subject, Indian drug regulators at the Central Drugs Standard Control Organization (CDSCO), very strangely, do not seem to be much concerned on this critical issue, at least, not just yet. Our drug regulators seem to act only when they are specifically directed by the Supreme Court of the country.

A recent major incident is yet another example to vindicate the point. In this case, according to media reports of November 2013, the Drug Controller General of India (DCGI) has ordered the Indian pharma major Sun Pharmaceuticals to suspend clinical research activities at its Mumbai based bio-analytical laboratory, after discovering that the company does not have the requisite approval from the central government for operating the laboratory. The DCGI has decided not to accept future applications and will not process existing new drug filings that Sun Pharma has made from the Mumbai laboratory until the company gets an approval.

Considering the blatant violations of cGMP standards that are increasingly coming to the fore related to ‘export quality’ of drugs in India, after inspections by the foreign drug regulators, one perhaps would shudder to think, what could possibly be the level of conformance to cGMP for the drugs manufactured in India solely for the local patients.

This question comes up as the record of scrutiny on adherence to cGMP by the Indian drug regulators is rather lackadaisical. The fact that no such warnings, as are being issued by the foreign regulators, came from their local counterpart, reinforces this doubt.

USFDA ‘Import Bans’:

Be that as it may, in this article let me deliberate on this particular drug regulatory issue as is being raised by the USFDA and others.

It is important to note that in 2013 till date, USFDA issued ‘Import Alerts/Bans’ against 20 manufacturing facilities of the Indian pharmaceutical exporters, sowing seeds of serious doubts about the overall drug manufacturing standards in India.

The sequence of events post USFDA inspection: 

Let us now very briefly deliberate on the different steps that are usually followed by the USFDA before the outcomes of the inspections culminate into ‘Import Alerts’ or bans.

After inspections, depending on the nature of findings, following steps are usually taken by the USFDA:

  • Issue of ‘Form 483’
  • The ‘Warning letter’
  • ‘Import Alert’

Revisiting the steps: 

Let me now quickly re-visit each of the above action steps of the USFDA.

‘Form 483’: 

At the conclusion of any USFDA inspection, if the inspecting team observes any conditions that in their judgment may constitute violations of the Food, Drug and Cosmetic (FD&C) and other related Acts, a Form 483 is issued to the concerned company, notifying the firm management of objectionable conditions found during inspection.

Companies are encouraged to respond to the Form 483 in writing with their corrective action plan and then implement those corrective measures expeditiously. USFDA considers all these information appropriately and then determines what further action, if any, is appropriate to protect public health in their country.

The ‘Warning Letter’:

The ‘Warning Letter’ is a document usually originating from the Form 483 observations and results from multiple lacking responses to Form 483 requiring quick attention and action. It may be noted that higher-level USFDA agency officials and not the investigator issue the ‘Warning Letters’.

‘Import Alert/ Ban’:

‘Import Alerts’ are issued whenever USFDA determines that it already has sufficient evidence to conclude that concerned products appear to be adulterated, misbranded, or unapproved. As a result, USFDA automatically detains these products at the border, costing the related companies a lot of money. The concerned company’s manufacturing unit remains on the import alert till it complies with USFDA cGMP.

What happens normally?

Most of the USFDA plant inspections are restricted to issue of Form 483 observations and the concerned company’s taking appropriate measures accordingly. However, at times, ‘Warning Letters’ are issued,  which are also mostly addressed by companies to the regulator’s satisfaction.

Import Bans are avoidable: 

Considering the above steps, it is worth noting that there is a significant window of opportunity available to any manufacturing facility to conform to the USFDA requirements by taking appropriate steps, as necessary, unless otherwise the practices are basically fraudulent in nature.

The concern:

Currently, there is a great concern in the country due to increasing frequency of ‘Import Alerts’.  As per USFDA data, in 2013 to date, about 20 drug manufacturing facilities across India attracted ‘Import Alerts’ as against seven from China, two each from Australian, Canadian and Japanese units and one each from South African and German facilities.

The matter assumes greater significance, as India is the second-largest supplier of pharmaceuticals to the United States. In 2012, pharmaceutical exports from India to the US reportedly rose 32 percent to US$ 4.2 billion. Today, India accounts for about 40 percent of generic and Over-The-Counter (OTC) drugs and 10 percent of finished dosages used in the US.

Ranbaxy cases: ‘Lying’ and ‘fraud’ allegations: 

In September 2013, after the latest USFDA action on the Mohali manufacturing facility of Ranbaxy, all three plants in India of the company that are dedicated to the US market have been barred from shipping drugs to the United States. The magnitude of this import ban reportedly impacts more than 40 percent of the company’s sales. However, Ranbaxy has a total of eight production facilities across India.

This ‘Import Alert’ was prompted by the inspection findings of the USFDA that the Mohali factory of Ranbaxy had not met with the cGMP.

Other two plants of Ranbaxy’s located at Dewas and Paonta Sahib faced the same import alerts in 2008, and are still barred from making drug shipments to the US.

The import ban on he Mohali manufacturing facility of Ranbaxy comes after the company pleaded guilty in May 2013 to the felony (criminal) charges in the US related to drug safety and agreed to pay a record US$ 500 million in fines.

In addition, the company also faced federal criminal charges that it sold batches of drugs that were improperly manufactured, stored and tested. Ranbaxy also admitted to lying to the USFDA about how it tested drugs at the above two Indian manufacturing facilities.

Heavy consequential damages with delayed launch of generic Diovan:

The ‘Import Alert’ of the USFDA against Mohali plant of Ranbaxy, has resulted in delayed introduction of a cheaper generic version of Diovan, the blockbuster antihypertensive drug of Novartis AG, after it went off patent.

It is worth noting that Ranbaxy had the exclusive right to sell a generic version of Diovan from September 21, 2012. 

Gain of Novartis:

This delay will help Novartis AG to generate an extra one-year’s sales for Diovan. This is expected to be around US$ 1 billion, only in the US. This development prompted Novartis in July this year to raise its profit and sales forecasts accordingly.

Wockhardt cases: Non-compliance of cGMP

Following Ranbaxy saga, USFDA inspection of Chikalthana plant of Wockhardt in Maharashtra detected major quality violations. Second time this year USFDA noted 16 violations of cGMP in the company’s facility. Earlier, in July 2013, the Agency issued a ‘Warning Letter’ and ‘Import Alert’ banning the products manufactured at the company’s Waluj pharmaceutical production facility.

Moreover, in September 2013, Medicines and Healthcare Products Regulatory Agency (MHRA) had pulled the GMP certificate of the company’s unit based in Nani Daman, after an inspection conducted by the UK regulator showed poor manufacturing standards. 

Again, in October 2013, the MHRA withdrew its cGMP certificate for the Chikalthana plant of Wockhardt. This move would ban import of drugs into the UK, manufactured in this particular plant of the company.

However, MHRA has now decided to issue a restricted certificate, meaning Wockhardt will be able to supply only “critical” products from these facilities. This was reportedly done, as the UK health regulator wants to avert shortage of certain drugs essential for maintaining public health. The impact of the withdrawal of cGMP certificate on existing business of the company can only be ascertained once Wockhardt receives further communications from the MHRA.

Earlier in July 2013, MHRA had reportedly also imposed an import alert on the company’s plant at Waluj in Maharashtra and issued a precautionary recall for sixteen medicines made in this unit.

RPG Life Sciences cases: allegedly ‘Adulterated’ products: 

In June 2013, USFDA reportedly issued a ‘Warning Letter’ to RPG Life Sciences for serious violation of cGMP in their manufacturing plants located at Ankleshwar and Navi Mumbai.

USFDA investigators had mentioned that “These violations cause your Active Pharmaceutical Ingredients (APIs) and drug products to be adulterated …the methods used in, or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with cGMP.”

Strides Arcolab case: Non Compliance of cGMP

In September 2013, Strides Arcolab announced that its sterile injectable drug unit – Agila Specialties (now with Mylan) had received a warning letter from the USFDA after its inspection by the regulator in June 2013. However, Strides Arcolab management said, “the company was committed to work collaboratively and expeditiously with the USFDA to resolve concerns cited in the warning letter in the shortest possible time.”

USV case: allegation of ‘data fudging’: 

Recently, USFDA reportedly accused Mumbai-based drug major USV of fudging the data.

After an inspection of USV’s Mumbai laboratory in June 2013, the US drug regulator said the company’s “drug product test method validation data is falsified”. The USFDA has also reprimanded USV for not training its staff in cGMP.

Probable consequences: 

USFDA import bans and a similar measure by the UKMHRA would lead to the following consequences:

  • Significant revenue losses by the companies involved, till the concerned regulators accept their remedial actions related to cGMP.
  • Increasing global apprehensions about the quality of Indian drugs.
  • Possibility of other foreign drug regulators tightening their belts to be absolutely sure about cGMP followed by the Indian drug manufacturers, making drug exports from India more difficult.
  • Huge opportunity cost for not being able to take advantage from ‘first to launch’ generic versions of off patent blockbuster drugs, such as from Diovan of Novartis AG.
  • Indian patients, including doctors and hospitals, may also become apprehensive about the general quality of drugs made by Indian Pharma Industry, as has already happened in a smaller dimension in the past.
  • Opposition groups of Indian Pharma may use this opportunity to further their vested interests and try to marginalize the Indian drug exporters. 
  • MNCs operating in India could indirectly campaign on such drug quality issues to reap a rich harvest out of the prevailing situation.
  • Unfounded ‘foreign conspiracy theory’ may start gaining ground, prompting the Indian companies moaning much, rather than taking tangible remedial measures on the ground to effectively come out of this self created mess.

Conclusion: 

Repeated cGMP violations made by the Indian drug exporters, as enunciated by the USFDA, have now become a malady, as it were. This can be corrected, only if the reality is accepted without attempting for justifications and then swallowing strong bitter pills, sooner.

Thereafter, the domestic pharma industry, which has globally demonstrated its proven capability of manufacturing quality medicines at affordable prices for a large number of patients around the world and for a long time, will require to tighten belts for strict conformance to cGMP norms, as prescribed by the regulators. This will require great tenacity and unrelenting mindset of the Indian Pharma to tide over the crisis.

Any attempt to trivialize the situation, as indicated above, could meet with grave consequences, jeopardizing the thriving pharma exports business of India.

That said, any fraud or negligence in the drug quality standards, for whatever reasons or wherever these may take place, should be considered as fraud on patients and the perpetrators must be brought to justice forthwith by the DCGI, with exemplary punitive measures.

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.