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When a “Visiting Gynaecologist” Isn’t One: Delhi Consumer Commission on Medical Negligence, Vicarious Liability, Misrepresentation & Proximate Cause (Samreen v. Dr. Kuljit Kaur Gill & Anr.)

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A recent order of the Delhi District Consumer Disputes Redressal Commission (Central) in Samreen v. Dr. Kuljit Kaur Gill & Anr. (Consumer Complaint No. DC/77/CC/148/2023) is a textbook consumer-law medical negligence decision; because it ties together four issues that often decide outcomes in real litigation: (i) medical negligence in a high-risk obstetric setting, (ii) vicarious liability of a nursing home for a “visiting doctor”, (iii) professional misrepresentation of qualifications, and (iv) proximate cause between delay and irreversible harm (infertility).

The Commission ultimately held both the doctor and the nursing home liable, and awarded ₹20,00,000 compensation (with interest), while giving the nursing home liberty to recover from the doctor in accordance with law.

The factual spine: timeline + missed red flags

The complainant tested positive for pregnancy and visited a nursing home/clinic where the treating doctor repeatedly addressed abdominal pain and bleeding with symptomatic medicines and reassurances, but without timely diagnostic work-up (notably ultrasound/testing) across multiple visits. When pain became unbearable, she was taken elsewhere; tests revealed a dead embryo, she was shifted to hospital, and emergency surgery was performed—one fallopian tube was removed, and she was informed this led to permanent loss of reproductive capacity. samreen-vs-dr-kuljit-kaur gynaec medical neligence

What made the case sharper was the “context”: the complainant had a high-risk obstetric history, making timely investigation even more crucial, as the Commission noted while analysing the duty of care.

1) Medical Negligence: breach of duty in a high-risk pregnancy is judged more strictly

(A) The core legal frame: duty → breach → damage

Consumer fora typically evaluate medical negligence through the familiar structure:

  1. Duty of care (doctor–patient relationship)
  2. Breach (acts/omissions below reasonable standard)
  3. Causation & damage (harm flowing from the breach)

Here, the Commission treated the case as classic omission-based negligence: repeated symptoms + high-risk context demanded investigation, monitoring, and diagnosis before continuing treatment. The order specifically discusses the doctor’s failure to properly investigate and record a diagnosis across visits, and the resulting substandard care.

(B) Why obstetrics changes the “standard”

Obstetric care is not evaluated in a vacuum—time sensitivity is the whole point. The Commission’s reasoning makes an implicit but powerful point: when warning signs (pain + bleeding) persist, and risk factors exist, the acceptable range of “watchful waiting” narrows sharply. In this case, the Commission read the conduct as “casual” treatment where caution and monitoring were mandatory.

(C) Bolam is not a shelter for illogical omissions

Even where a doctor invokes clinical judgment, consumer fora increasingly test it on logic and defensibility (often described through the Bolam/Bolitho lens). The Commission’s analysis treats a prolonged failure to investigate in the face of repeated red flags as not logically defensible, therefore not protected merely because “some doctor could have done it”.

2) Misrepresentation: projecting a qualification you don’t legally hold can itself be actionable negligence

One of the most important parts of this order is that the Commission treats misrepresentation of medical qualifications not as a “side issue”, but as part of the negligence matrix.

The Commission noted that the doctor was qualified as MBBS, yet used “M.S./M.D.” style suffix/representation and projected herself as a specialist gynaecologist without the requisite recognised qualification—amounting to professional misrepresentation.

Why this matters legally

Misrepresentation of qualification strengthens a complainant’s case in three ways:

  1. Standard of care rises: If you hold yourself out as a specialist, you are judged closer to a specialist’s standard.
  2. Consent becomes tainted: The patient’s choice of provider is influenced by the representation.
  3. Negligence per se logic: Courts/fora have repeatedly treated practice without requisite qualification as inherently negligent because it violates professional norms and patient trust.

Practice pointer for clinics: If your letterhead, signage, prescriptions, or online listings show a qualification, it must be recognised and legally usable in India. Don’t let marketing outrun compliance.

3) Vicarious Liability: the nursing home cannot escape by calling the doctor “visiting”

A recurring defence in consumer litigation is: “She was only a visiting consultant; hospital isn’t liable.” The Commission rejected that logic and held the nursing home vicariously liable for the doctor’s acts/omissions—especially because the institution failed to verify qualifications and ensure proper supervision/standards of care.

The consumer-law rationale (why this is consistent)

From a patient’s perspective, the “service” is offered under the clinic/hospital’s umbrella. The institution:

  • attracts patient trust via its name/reputation,
  • provides infrastructure,
  • controls who is permitted to treat inside the facility,
  • and is expected to ensure competent staff and systems.

So, the Commission’s reasoning aligns with a consistent line of principle: hospitals/nursing homes must answer for negligence of doctors engaged by them—even if the internal contract calls them “consultants” or “visiting”.

Compliance takeaway for nursing homes: Credential verification is not optional paperwork; it is risk control. If you can’t prove due diligence on credentials, you practically invite vicarious liability.

4) Proximate Cause: the “delay → emergency surgery → infertility” chain was treated as direct and foreseeable

Causation is where many medical negligence cases collapse. Here, the Commission clearly framed delayed diagnosis as the proximate cause of the emergency surgical intervention and the resulting irreversible harm.

The order connects the dots: repeated omission to investigate and rule out serious pregnancy complications led to a deterioration requiring emergency surgery, resulting in removal of the fallopian tube and consequent loss of reproductive capacity. In other words, the harm was not a remote possibility; it was a foreseeable consequence of ignoring the red flags. samreen-vs-dr-kuljit-kaur gynaec medical neligence

Why this proximate-cause finding is powerful

Because it answers the classic defence: “Complications can happen anyway.”

Yes, complications can happen—but proximate cause asks: Did the breach materially contribute to the harm in a legally significant way? The Commission’s answer was effectively: the delay converted a treatable/containable situation into an emergency with permanent consequences.

Litigation takeaway: The strongest causation proof is often a timeline + medical records + what should have been done at the earlier visit. This case shows how delay itself becomes the causative engine.

Compensation and outcome: consumer fora treat reproductive harm as serious, not symbolic

After fixing negligence and institutional liability, the Commission awarded ₹20 lakh as compensation (covering medical expenses, mental agony, etc.) and permitted the nursing home to recover from the doctor as per law. The complaint against the government department was dismissed for lack of deficiency material against it.

Delhi High Court Highlights Importance of Typography in Pharma Branding and Trademark Disputes

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Delhi High Court’s interim restraint in Sun Pharma v Dr Reddy’s is a sharp reminder that in IP law, typography can matter as much as vocabulary.

In late December 2025, the Delhi High Court stepped into a dispute that sits right at the intersection of pharma branding and consumer-facing skincare: Sun Pharmaceutical Industries Ltd. alleges that Dr Reddy’s VENUSIA sunscreen labels placed the word “SUN” so prominently that it stopped being a mere description and began functioning like a badge of origin—i.e., a trademark. The Court, at the interim stage, agreed prima facie and directed Dr Reddy’s to maintain status quo and not undertake further manufacturing under the impugned labels until the next hearing.

This isn’t just another “two big companies fighting” story. For anyone building brands in the OTC / dermacosmetic / cosmeceutical space, it reads like a practical lesson in how courts evaluate “descriptive use” defences: not in theory, but as the consumer sees the label on the shelf.

What the Court did (and what it did not do)

This was an interim order—the Court is not delivering final findings on infringement or passing off. It made a prima facie assessment and granted temporary restraint to preserve the market situation until further hearing. That distinction matters because interim orders often become the real commercial battleground in fast-moving consumer health categories like sunscreens.

The central legal question: “descriptive use” vs “trademark use”

Words like sun, care, shield, aqua, derma, etc., are common in skincare. The Trade Marks Act, 1999 allows bona fide descriptive use (commonly invoked under Section 30(2)(a))—but that protection is not a free pass.

The Court’s interim reasoning (as reported) is essentially this:
You may be permitted to use a descriptive term—yet the moment your packaging makes that term look like a brand identifier, you risk stepping into infringement/passing off territory.

This is where label mechanics become legal evidence:

  • font size and weight
  • colour contrast
  • placement and repetition
  • whether the descriptive function is already served elsewhere (e.g., “sunscreen gel” clearly printed)
  • whether the house brand is visually eclipsed

The Court’s reported view was that the usage appeared to function as a trademark and not as mere description, leading to interim restraint and status quo direction.

A doctrinal anchor: you can’t split the defence into “parts”

A particularly interesting legal hook (useful for law students and practitioners alike) is the Court’s reliance on the Zydus Wellness Products Ltd. v Cipla Health Ltd. line of reasoning: the benefit of Section 30(2)(a) is not available to only a part of the mark—it helps only where the impugned mark as a whole is used descriptively.

Why does this matter in practice? Because packaging disputes often involve a defendant saying:

“We used that word descriptively.”
But courts examine whether the word is being used in a way that dominates the consumer’s impression and works as a source identifier. If yes, the descriptive defence weakens—especially when the overall label presentation suggests branding.

Commercial Courts Act angle: why pre-institution mediation didn’t block the suit

For IP litigators (and students tracking procedure), the order also reflects the post-Patil Automation era reality: Section 12A pre-institution mediation is mandatory unless the suit contemplates urgent interim relief. The Supreme Court in Yamini Manohar v T.K.D. Keerthi clarifies that urgency is assessed from pleadings and reliefs sought; such suits shouldn’t be dismissed merely for not exhausting mediation if urgent interim relief is sought.

This matters because brand disputes often require immediate court protection—labels are printed, stocks are distributed, and consumer impressions form quickly.

Why this case is especially relevant to pharma + dermacosmetics

1) The “pharma halo effect” in consumer health branding

In India, the boundary between pharmaceutical goodwill and OTC skincare trust is porous. A strong pharma house mark can create consumer assumptions of quality and safety even in non-prescription skincare. So when a disputed element resembles a known house identifier, the risk is not just confusion—it’s borrowed credibility.

2) Sunscreen is a high-frequency product with low-involvement purchase behaviour

Most sunscreen purchases aren’t made like prescription drug choices. Consumers rely on quick visual cues: bold words, large fonts, familiar marks. That makes “initial impression” analysis extremely important in this category—exactly the kind of reasoning courts tend to emphasize in label disputes.

3) For in-house teams: marketing choices become litigation exhibits

In label disputes, your brand team’s creative decisions become courtroom facts. A judge may not need consumer surveys if the label itself creates a strong prima facie impression.

What brand owners and regulatory teams should take away

If you work in product development, branding, regulatory, or in-house legal, here’s the practical checklist this order indirectly teaches:

A) If you must use a descriptive word, design it like a description—not a mark

  • keep it smaller than the house mark
  • keep it in the same style family as other descriptive text
  • avoid colour contrast that makes it the “hero” element
  • don’t repeat it in a way that looks like a brand series

B) Don’t let the descriptive word overshadow the true brand

If the consumer’s eye lands first on the disputed word and only later on your actual brand, you have a problem—even if the word is “common”.

C) Document your intent early

Internal records showing that the word was chosen for descriptive need (and designed accordingly) can become valuable in court. “We’ll modify later” is rarely a comfortable posture if the label is already in commerce.

D) Watch for “family marks” and cross-category expansion

Companies often extend marks across categories (drug → OTC → skincare). Courts are sensitive to the possibility of association where the plaintiff plausibly operates in or near the defendant’s product space.

A law-student’s closing thought: trademark law is increasingly “visual”

We often study trademark law through statutory language—Sections 29 and 30, infringement and defences. But modern consumer markets are won (and litigated) in the visual grammar of packaging.

This interim order signals a simple proposition that every pharma-linked consumer brand should internalize:

If your label makes a descriptive word look like a trademark, courts may treat it like a trademark—even before trial.

The matter is sub judice and will evolve. But as an early snapshot of judicial instinct in packaging disputes, it is already instructive—for lawyers, brand teams, and the growing ecosystem of dermacosmetic innovation.

Reference

The Rise and Retreat of India’s “Mandatory App State”: A Legal Analysis of the Sanchar Saathi Pre-Installation Mandate and Its Rapid Rollback

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I. Introduction: A Day-Long Policy Experiment with Constitutional Stakes

On 28 November 2025, the Department of Telecommunications (DoT), invoking powers under the Telecommunications (Telecom Cyber Security) Rules, 2024, issued a sweeping direction requiring mandatory pre-installation of the Government’s Sanchar Saathi app on all mobile phones manufactured or imported into India.

Within 24 hours of severe public backlash—privacy concerns, industry resistance (including Apple’s reported refusal), constitutional objections, and political criticism—the Government withdrew the mandate, clarifying that Sanchar Saathi would remain voluntary.

This short-lived order has, however, left behind profound constitutional questions:

  • Can the executive compel software installation on every personal device through delegated legislation?
  • Where is the outer limit of State power over digital ecosystems?
  • Does mandatory cybersecurity-driven software risk creating tools of surveillance?
  • Are subordinate rules being stretched beyond legislative intent?
  • What does this mean for future health-tech, pharma-regulatory, and digital governance apps?

This commentary examines the mandate—and its reversal—through India’s current legal architecture, judicial precedents, and constitutional doctrine.

II. Legal Basis Claimed by the Government: Rule 8 and Rule 5 of the Cyber Security Rules

The withdrawn direction relies on:

1. Rule 8(3), 8(4) and 8(8) of the Telecom Cyber Security Rules, 2024

  • Rule 8(3): prohibits tampering with telecom identifiers (e.g., IMEI).
  • Rule 8(4): allows the Centre to issue directions to manufacturers/importers to assist in preventing IMEI tampering.
  • Rule 8(8): obligates compliance with such directions.

2. Rule 5

Empowers the Government to establish security mechanisms to prevent acts that may endanger telecom cybersecurity.

But the key question:

Do these rules contemplate—explicitly or implicitly—the power to require compulsory pre-loading of a government application on every mobile device sold in India?

The answer, in constitutional terms: highly doubtful.

Delegated legislation must remain within the boundaries of the parent Act. The Telecommunications Act, 2023 nowhere authorises the State to mandate installation of government-controlled software on personal devices.

The Government relied on broad phrasing, but broadness cannot substitute for specific legislative mandate, particularly where fundamental rights are implicated.

III. Ultra Vires Concerns: When Delegated Legislation Overreaches

Indian constitutional jurisprudence is clear:

1. Subordinate legislation cannot extend or enlarge the scope of the parent Act.

Refer:

  • Bimal Chandra Banerjee v. State of M.P. (1970) – Rules cannot widen statutory scope.
  • General Officer Commanding-in-Chief v. Dr. Subhash Chandra Yadav (1988) – Delegated legislation must remain within “four corners” of parent Act.

Applying this doctrine:

A rule meant to prevent IMEI tampering cannot be used to justify embedding government software in every citizen’s device, because such a mandate is not “necessary” for fulfilling the statutory purpose.

Thus, the order arguably suffered from excessive delegation and colourable exercise of power.

IV. Constitutional Scrutiny — The Puttaswamy Privacy Doctrine

The Puttaswamy (2017) nine-judge bench decision created the Four-Fold Proportionality Test for all State actions impinging privacy:

  1. Legality — must have a valid law
  2. Legitimate Aim — cyber-fraud prevention is valid
  3. Rational Nexus — linking IMEI fraud to Sanchar Saathi is arguable
  4. Necessity & Least Restrictive Means — this is where the direction collapses

Why it fails necessity:

  • Fraud and IMEI-cloning prevention can be addressed by network-side solutions, CEIR back-end strengthening, audits, and voluntary app usage.
  • No empirical basis was shown that mandatory pre-installation enhances protection beyond voluntary adoption.
  • No Privacy Impact Assessment was published.
  • Less intrusive alternatives exist.

Therefore, the mandate cannot survive Puttaswamy scrutiny.

V. Device Autonomy and Digital Freedom Under Articles 19 & 21

India’s Constitution, though written in 1950, has evolved to protect digital personhood.

1. Article 19(1)(a): Informational autonomy

Compulsory presence of a government app interferes with one’s right to control the informational environment of one’s device.

2. Article 19(1)(g): Business autonomy of manufacturers

Manufacturers (Apple, Google, OEMs) design ecosystems with security and privacy philosophies. Mandated apps violate platform integrity.

3. Article 21: Liberty, dignity and digital privacy

Courts have repeatedly held that personal liberty includes autonomy over one’s personal electronic devices.

Cases reinforcing this include:

  • PUCL v. Union of India (1996) – surveillance requires strict legality.
  • Anuradha Bhasin v. Union of India (2020) – digital access and freedom integral to liberty.
  • K.S. Puttaswamy (Aadhaar-II) (2018) – State cannot intrude into devices without statutory safeguards.

A government app pre-loaded on every phone—especially one dealing with identifiers (IMEI)—touches the most sensitive element of digital autonomy.

VI. Consent and the DPDP Act, 2023: A Silent Conflict

India’s Digital Personal Data Protection Act, 2023 (DPDP Act) requires:

  • Free, informed, specific consent for personal data processing
  • Purpose limitation and data minimisation
  • User control over data

A pre-installed app creates structural coercion.
Even if the user “can uninstall”, the default setting is State-mandated presence—which contradicts the spirit of free consent.

Mandatory installation may be justified only by:

  • Section 7 legitimate use (for State functions),
    but only if backed by a clear, specific, narrowly-tailored law—not merely a direction under cyber rules.

The Government’s withdrawal implicitly acknowledges that DPDP compliance was questionable.

VII. The Surveillance Risk Argument: Why Concerns Were Not Paranoia

Digital rights groups had labelled the mandate a “backdoor to surveillance”.

This fear is grounded in:

  • Sanchar Saathi’s access to IMEI—one of the strongest device-tracking identifiers.
  • Future updates could expand functionality without user awareness.
  • India does not have a comprehensive surveillance oversight law (unlike EU/UK).
  • Past examples such as:
    • Aarogya Setu (opacity around source code & data flows)
    • FACIAL RECOGNITION used by law enforcement without parliamentary debate
    • Delhi Police’s AI-enabled profiling systems

Even if the current version of the app does nothing sinister, constitutional law examines potential misuse, not only present conduct (see PUCL).

VIII. Comparative Jurisprudence — How Democracies Handle Mandatory Apps

1. EU (GDPR, ePrivacy Directive)

Mandatory installation of State software without explicit legislation would be unlawful.

2. US

The Supreme Court in Riley v. California (2014) emphasised deep privacy interests in smartphones; compulsory app installation would require Congressional authorization.

3. German Federal Constitutional Court

Extremely sensitive about “state trojans” and any software embedded by the State in personal devices.

India’s withdrawn order was an outlier in democracies, reinforcing why the rollback was necessary.

IX. The Positive Angle — The Government’s Immediate Rollback Is Constitutionally Significant

The speed of withdrawal shows:

  • Public accountability works
  • The executive recognized the proportionality issue
  • India’s digital policy environment is maturing
  • Civil society, privacy advocates, and courts have shaped constitutional expectations

This is reminiscent of:

  • The rollback of the IT Rules 2011 Intermediary Guidelines draft,
  • The modification of Aarogya Setu usage mandates,
  • Government rescinding certain facial-recognition mandates in airports after public pressure.

X. Broader Implications for Future “Regulatory Apps” in Health, Pharma & Medicine

Our focus is particularly on health sector.

Once the government uses delegated legislation to mandate apps for cybersecurity, similar logic could be applied to:

  • e-prescription apps
  • Pharmacovigilance apps
  • Digital health monitoring apps
  • NDPS enforcement tools
  • Telemedicine compliance apps

The Sanchar Saathi episode acts as a precedent in principle—even without a judgment:

The State cannot compel installation of regulatory apps on personal devices without explicit legislation, strong safeguards, and demonstrable necessity.

This is crucial for future health-tech governance.

**XI. Conclusion:

India Must Resist the Temptation of “App-Driven Governance” Without Constitutional Guardrails**

The Sanchar Saathi mandate was a constitutional misadventure, but its rollback was a constitutional triumph.

It marks a reaffirmation of:

  • Privacy as a fundamental right
  • Device autonomy as part of personal liberty
  • Limits on delegated legislation
  • A maturing digital constitutionalism in India

As India expands into national digital infrastructures—Digital Health Mission, DPDP Act implementation, AI regulation, telecom reform—it must avoid shortcuts like compulsory apps.

The path forward is clear:

  • If the State wants a nation-wide security tool, it must enact a specific law,
  • justify its necessity,
  • conduct privacy-impact assessments,
  • build technological safeguards, and
  • uphold autonomy.

Our smartphones belong to us, not to the State.
The Constitution demands nothing less.

Cannabis, Ganja and Bhang in India: What the Kerala High Court Has Now Made Crystal Clear

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1. Why there is so much confusion about cannabis law in India

Socially and culturally, cannabis has been part of India for centuries. At the same time, the Narcotic Drugs and Psychotropic Substances Act, 1985 (NDPS Act) is one of the strictest anti-drug laws in the world.

This creates three very common doubts:

  1. If bhang is openly sold, how is cannabis “banned”?
  2. Is it really illegal to grow just a few plants at home, even in pots on the terrace?
  3. Do small, non-flowering plants count as “ganja” or “cannabis plants” under NDPS?

A recent judgment of the Kerala High Court in Jatin v. State of Kerala, 2025:KER:83177 (Crl. M.C. No. 8469 of 2025) directly answers these questions and settles several grey areas in favour of a strict interpretation against cultivation.

This post brings together the statutory scheme and the latest case law to explain the current legal status of cannabis in India, especially after Jatin.

2. Statutory framework: how the NDPS Act classifies cannabis

2.1 Key definitions – Section 2 NDPS Act

Under Section 2(iii), “cannabis (hemp)” is defined to cover three things:

  1. Charas – separated resin from the cannabis plant, including hashish oil.
  2. Ganja – only the flowering or fruiting tops of the cannabis plant, excluding seeds and leaves when not accompanied by the tops.
  3. Any mixture of the above forms or any drink prepared from them.

Separately, Section 2(iv) defines “cannabis plant” as any plant of the genus Cannabis. There is no requirement in this definition that the plant must have flowers or fruits.

This distinction – between “ganja” (flowering tops) and the broader category “cannabis plant” – becomes crucial in Jatin.

2.2 Core prohibitions – Section 8 NDPS Act

Section 8(b) NDPS lays down a clear prohibition:

No person shall cultivate the opium poppy or any cannabis plant…

So even before we look at quantities and punishment, the act of cultivation itself is banned, unless permitted for specific purposes.

2.3 Punishments – Section 20 NDPS Act

Section 20 prescribes penalties for two broad situations:

  1. Section 20(a) – cultivates any cannabis plant
    • Punishment: rigorous imprisonment up to 10 years + fine up to ₹1 lakh.
  2. Section 20(b) – deals with cannabis (charas/ganja) by producing, manufacturing, possessing, selling, purchasing, transporting, etc.
    • Small quantity (e.g. up to 1 kg ganja, 100 g charas): up to 1 year or ₹10,000 fine or both.
    • Intermediate quantity: up to 10 years + ₹1 lakh fine.
    • Commercial quantity (e.g. 20 kg ganja, 1 kg charas or more): 10–20 years RI + fine between ₹1–2 lakh (or more with reasons).

So, cultivation of cannabis plants is treated as a serious standalone offence, irrespective of commercial quantity.

3. Why bhang is legal but cannabis cultivation is not

3.1 The “leaves and seeds” gap

The NDPS Act does not ban every part of the cannabis plant. Under Section 2(iii)(b), seeds and leaves are excluded from the definition of “ganja” when they are not accompanied by the flowering tops.

Bhang is typically prepared from the leaves (and sometimes seeds) of the cannabis plant, not from the resin or flowering tops. As a result:

  • Bhang is not treated as “cannabis (hemp)” under the NDPS definition, and therefore NDPS does not directly criminalise bhang.

However, this does not mean bhang is completely free from regulation.

3.2 States’ power to regulate bhang

The SCC Times and Vajiram articles both note that states have power to regulate or even prohibit the use of cannabis leaves and seeds under their excise laws.

  • Uttar Pradesh and Rajasthan license authorised bhang shops.
  • Some states, such as Assam, have prohibited bhang through state laws.

So, bhang is “legal” only in the limited sense that NDPS does not list leaves and seeds as “cannabis (hemp)”. Whether you can buy or sell it in a particular state depends on that state’s excise framework.

3.3 The crucial distinction

Putting it simply:

  • Bhang (leaves-only preparations) – outside NDPS definition of cannabis, but subject to state control.
  • Ganja (flowering/fruiting tops) and charas (resin) – fully under NDPS criminal prohibition.
  • Cannabis plant (any plant of genus Cannabis) – cultivation of the plant itself is banned under Section 8(b), even if it has no flowers yet.

This last point is what Jatin v. State of Kerala makes absolutely clear.

4. The Jatin case: facts and issues before the Kerala High Court

4.1 The factual background

In Jatin v. State of Kerala, the excise authorities received information that the petitioner was cultivating cannabis on the terrace of a rented house in Thiruvananthapuram.

  • They seized five cannabis plants in pots (two about 59 cm and three between 29–46 cm) from the terrace.
  • They also recovered about 5 grams of ganja seeds and dried branches from the petitioner’s bedroom.

A case was registered for offences under Section 8(c) read with Sections 20(a)(i) and 20(b)(ii)(A) NDPS Act, and the matter went before the Additional Sessions Court, Thiruvananthapuram.

Jatin filed a Criminal Miscellaneous Case before the Kerala High Court seeking to quash the proceedings, invoking the High Court’s inherent power (now Section 528 BNSS, corresponding to Section 482 CrPC).

4.2 Arguments by the accused

The petitioner raised three key legal points:

  1. Plants without flowering tops are not “cannabis plants”
    • He argued that to qualify as a “cannabis plant” under Section 2(iv), the plant must have flowering or fruiting tops, otherwise Section 20(a)(i) is not attracted.
  2. Cultivation in pots is not “cultivation” under Section 20(a)(i)
    • According to him, “cultivates” in Section 20(a)(i) implied only cultivation in earth/soil (i.e. agricultural-type cultivation), not growing in pots on a terrace.
  3. Seeds and leaves alone cannot be treated as ‘ganja’
    • The 5 grams seized were only seeds and leaves, so Section 20(b)(ii)(A) was not attracted as “ganja” requires flowering tops.

He also disputed that he was actually residing in the premises where the plants and contraband were found, relying on a rental agreement.

4.3 Stand of the State

The State argued that:

  • The complaint and seizure clearly showed conscious possession and cultivation of cannabis plants.
  • Whether the petitioner was actually residing in the premises or whether the seized material qualified as “ganja” were questions of fact, to be decided at trial, not at the quashing stage.

5. What the Kerala High Court actually held in Jatin

The judgment systematically answers each of the petitioner’s contentions. This is the most important part for your blog.

5.1 “Cannabis plant” ≠ “ganja”; flowers are not required for cultivation offence

The Court carefully compared the definitions in Section 2(iii)(b) and Section 2(iv) NDPS Act:

  • “Ganja” is specifically the flowering or fruiting tops of the cannabis plant (excluding seeds and leaves when not accompanied by tops).
  • “Cannabis plant” is any plant of the genus Cannabis, without any reference to flowers.

From this, the Court held:

  • The statute clearly treats “cannabis plant” and “ganja” as two distinct concepts.
  • A plant does not need to bear flowering or fruiting tops to be a “cannabis plant”.
  • Therefore, the argument that plants without flowers cannot attract Section 20(a)(i) (cultivation of cannabis plant) is without merit.

In other words, for a cultivation offence under Section 20(a)(i), the prosecution does not need to prove that the plant has matured into “ganja”. Merely raising a plant of the genus Cannabis is enough, if done in contravention of the Act.

The Court also referred to an earlier Division Bench decision in Kunju v. State of Kerala, which recognised that cultivation could be for producing various intoxicating preparations from the cannabis plant – not just ganja – and that cultivation of cannabis is also punishable under the Abkari Act.

5.2 Cultivation includes growing cannabis in pots

The NDPS Act does not define “cultivate”. So the Court turned to standard legal dictionaries – Law Lexicon and Stroud’s Judicial Dictionary – which describe “cultivate” as including activities like planting, tilling, raising or growing plants, and even specifically refer to growing cannabis in pots in a bedroom window as “cultivation” under UK law.

Relying on these meanings, the Kerala High Court held that:

  • The expression “cultivate any cannabis plant” in Sections 8(b) and 20(a) covers any act of planting, raising, growing, farming or gardening a cannabis plant with the necessary mens rea.
  • The statute does not distinguish between planting in the earth and growing in pots.
  • The essence of the offence is the conscious act of planting and nurturing a cannabis plant in violation of the Act, not the medium (soil vs pot) or place (farm vs terrace vs balcony).

Thus, the slogan emerging from Jatin is effectively:

“Growing cannabis is a crime whether in soil or in pots.”

5.3 Separate offences: cultivation vs possession

The Court also emphasised that:

  • Section 8(b) explicitly prohibits cultivation of any cannabis plant, and
  • Section 20 creates separate punishments for:
    • (a) cultivating cannabis plant; and
    • (b) possessing/trafficking cannabis (ganja/charas, etc.).

Therefore, even if there is some debate about whether seeds and leaves amount to “ganja”, the cultivation of the plant itself is an independent offence. The Court thus rejected the attempt to collapse “cultivation” into “production of ganja”.

5.4 Quashing under Section 528 BNSS / Section 482 CrPC: limited scope

On the procedural side, the Court relied on classic precedents like State of Haryana v. Bhajan Lal and later Supreme Court decisions on the limits of inherent powers to quash criminal proceedings.

The principles it reaffirmed:

  • The High Court cannot conduct a “mini-trial” at the quashing stage.
  • The test is simply: if the allegations in the complaint are taken at face value, do they disclose the ingredients of the offence?
  • Disputed questions such as:
    • whether the accused was actually residing in the premises, or
    • whether the seized material is indeed ganja,
      are matters for trial, not for a Section 528 BNSS / 482 CrPC petition.

Since the complaint alleged that:

  • the petitioner was present when the plants and contraband were seized, and
  • five well-grown cannabis plants and some ganja seeds/dried branches were recovered from premises tied to him,

the Court held that there was clearly a prima facie case. It therefore refused to quash the proceedings and dismissed the Crl. M.C.

6. How earlier case law fits in

The judgment in Jatin also discusses and distinguishes several earlier decisions that had been cited by the defence, including:

  • Alakh Ram v. State of U.P. (2004) 1 SCC 766 – where the Supreme Court found lack of proof of possession of the premises.
  • Narendran Purakunnel v. State of Kerala (2022 KHC 4777) – where the Kerala High Court held there was no material to show that the accused was the real occupier of the premises.
  • K.K. Rejji (Karnataka HC) and Killo Subbarao (AP HC) – which deal primarily with interpreting “ganja” and when leaves/branches alone can amount to ganja.

The Kerala High Court clarifies that:

  • These cases turn mainly on facts (no clear proof of possession) or on “ganja”/quantity issues, and
  • They do not alter the basic statutory position that any plant of the genus Cannabis is a “cannabis plant” and that cultivating such a plant is independently punishable.

Thus, Jatin consolidates earlier jurisprudence while sharpening the statutory interpretation.

7. Practical legal takeaways on cannabis status in India

Putting the statute, commentary, and Jatin together, the current legal position can be summarised as follows:

  1. Growing any cannabis plant is illegal (without licence)
    • Even a few plants in pots on your terrace or balcony fall under “cultivation of cannabis plant” and are punishable under Section 20(a)(i) NDPS.
    • The plant need not have flowers; it is enough that it is a plant of the genus Cannabis.
  2. Bhang is not the same as ganja or charas
    • NDPS criminalises resin and flowering tops, not leaves and seeds alone.
    • That is why bhang (leaf-based preparation) can be allowed by states under their own laws.
  3. Legality of bhang is state-specific
    • Some states license bhang shops; others restrict or prohibit it. Before dealing in bhang commercially, one must examine the relevant state excise laws and notifications.
  4. For possession cases, “ganja” still requires flowering tops
    • Courts have previously held that leaves and stems alone are not “ganja”, which is consistent with the statutory definition.
    • In Jatin, the Court leaves this aspect to be decided at trial on evidence, but it separates that question from the cultivation offence.
  5. High Courts will rarely quash NDPS cultivation cases at the threshold
    • If the complaint, on its face, shows that the accused was consciously growing cannabis plants, courts are reluctant to use Section 528 BNSS / 482 CrPC to quash proceedings.
  6. Narrow exceptions exist under Section 14 NDPS
    • The Central or State Government can permit cannabis cultivation for industrial fibre, seeds, or medical research. States like Uttarakhand, UP, Himachal Pradesh and MP have permitted industrial hemp under this window, and institutions like CSIR have licences for medical research.
    Outside these licensed frameworks, personal cultivation remains illegal.

8. Conclusion: Clear statutory text, stricter judicial reading

The NDPS Act already gave a strict framework. What Kerala High Court’s 2025 judgment in Jatin v. State of Kerala does is:

  • Reaffirm that “cannabis plant” is a broad category – any plant of the genus Cannabis, irrespective of stage of growth.
  • Confirm that cultivation is medium-neutral – it does not matter if the plant is in a pot, backyard, farm or terrace.
  • Separate cultivation offences from ganja possession offences, making it harder for accused persons to rely on technical arguments about flowering tops at the quashing stage.

For lawyers, policy researchers and law students, Jatin is now a leading authority on:

(a) the meaning of “cannabis plant” in Section 2(iv);
(b) the scope of “cultivate” in Sections 8(b) and 20(a); and
(c) the approach to be taken when considering quashing of NDPS cultivation cases under Section 528 BNSS / 482 CrPC.

In short, Indian law is very clear and very strict:

  • Bhang (leaves/seeds) may be sold only under state licence,
  • but any cultivation of a cannabis plant – even one sapling in a flower pot – is an NDPS offence.

Jatin v. State of Kerala cements this position and is now a vital reference for future position on the matter.

Further Readings:

Supreme Court Flags Generic-Only Prescriptions and Pharma Freebies: What the Dolo-650 Case Reveals

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Introduction

A recent hearing before the Supreme Court of India in W.P.(C) No. 323/2021 (FMRAI v. Union of India) has brought renewed focus on two systemic issues in India’s pharmaceutical ecosystem:

  1. Inducement-driven brand prescriptions, and
  2. Poor enforcement of generic-only prescription norms.[1]

These proceedings indicate that stronger statutory reforms may soon reshape the pharma–doctor regulatory framework.

The Case at a Glance

The Federation of Medical & Sales Representatives Associations of India (FMRAI) has challenged the continued reliance on voluntary marketing codes and sought mandatory statutory regulation.

Key issues include:

1. Alleged large-scale freebies to doctors

Media reports presented in court allege that the manufacturer of Dolo-650 (Micro Labs) distributed inducements worth nearly ₹1,000 crore to boost prescriptions.[1][5]

2. No binding law on pharma-company marketing practices

While doctors are bound by the Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002, pharmaceutical companies are not subject to an equivalent statutory framework governing their interactions with medical practitioners.[2]

3. Supreme Court’s emphasis on generic-only prescriptions

The Court remarked that prescribing drugs solely by generic name “would make a huge difference,” questioning why such norms are not enforced nationwide.[1]

What the Court Observed

1. Rajasthan already requires generic-only prescriptions

The Court noted that Rajasthan mandates doctors to prescribe only generics and asked why similar directions should not be extended to all states.[1]

2. Voluntary UCPMP 2024 remains inadequate

The Court observed that the Uniform Code for Pharmaceutical Marketing Practices, 2024 (UCPMP 2024), although improved, lacks statutory backing, independent adjudication, and enforceable penalties—leaving patients vulnerable to unethical marketing.[1][6]

Why This Matters

Consumer & Public Health Impact

Brand-driven prescribing influenced by inducements results in:

  • Higher out-of-pocket expenditure,
  • Irrational drug use, and
  • Increased risks from unnecessary or irrational drug combinations.[5]

Regulatory & Legal Implications

Doctors are prohibited from accepting gifts and must prescribe generics under the MCI/NMC Ethical Regulations, but there is no statutory bar on pharmaceutical companies offering inducements—a regulatory asymmetry identified by the Court.[2]

A statutory regime could introduce:

  • Penalties,
  • Transparency obligations, and
  • A level playing field between ethical and non-ethical companies.

Relation to Other Key Judgments & Codes

Apex Laboratories Pvt. Ltd. v. DCIT (2022)

The Supreme Court held that pharma freebies are “prohibited by law” because they induce doctors to violate ethics.
Such expenditure cannot be claimed as business deductions under Section 37(1) of the Income Tax Act.[3]

This principle reinforces that commercial incentives undermining medical ethics will not receive legal recognition.

UCPMP 2024

Although more structured than its predecessor, UCPMP 2024 is still non-statutory.
Analyses show that without legal force, it lacks deterrent value and remains dependent on self-regulation by industry associations.[6]

What Might Follow

Possible reforms suggested by the Court’s observations include:

  1. Nationwide generic-only prescription mandate
  2. Statutory controls on pharma marketing practices
  3. Mandatory public disclosures of pharma-physician transfers
  4. A national portal for complaints and enforcement records

Such changes would align India with global transparency models such as the U.S. Sunshine Act.

Conclusion

The FMRAI case may become a turning point for India’s healthcare regulation.
Generic-only prescriptions would strengthen rational drug use, while statutory restrictions on pharmaceutical marketing are essential to dismantle the entrenched system of inducement-driven prescriptions.

The Supreme Court’s message is unequivocal:
Voluntary compliance is insufficient. Binding legal frameworks are required to protect patients and ensure ethical medical practice.

References

[1] Verdictum – “SC Questions Promotion of Branded Medicines, Asks Centre to Consider Generic-Only Prescriptions”

[2] Supreme Court Observer – “Distribution of Freebies to Doctors to Increase the Sale of Drugs”

[3] Apex Laboratories Pvt. Ltd. v. DCIT – Supreme Court Judgment

[4] Department of Pharmaceuticals – UCPMP 2024

[5] Mint – “Dolo 650 Freebies Case: Why Is SC Asking the Centre to Act?”

[6] Trilegal – Analysis of UCPMP 2024

Evolving Regime of Information Technology & Cyber Law: Insights from Dr. Mahendra Limaye’s Webinar at BASL Nagpur

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Introduction

On November 8, 2025, Dr. Babasaheb Ambedkar School of Law (BASL), Nagpur, under Rashtrasant Tukadoji Maharaj Nagpur University (RTMNU), hosted a webinar on “Evolving Regime of Information Technology & Cyber Law” featuring Dr. Mahendra Limaye, Advocate and techno-law specialist. The session was organized under the guidance of Smt. Rutunja Bhelave and Shri. Ankit A. Shripatwar, Program Coordinators, BASL.

The webinar aimed to introduce law students to the growing importance of cyber law in a digital society increasingly dependent on technology and data.

Key Highlights from the Session

  1. Understanding the IT Act, 2000
    Dr. Limaye traced the origin of India’s Information Technology Act, 2000 — one of the earliest legislations based on the UNCITRAL Model Law on E-Commerce. Initially enacted to support e-commerce and online communication, it has evolved to cover cybercrimes, digital signatures, and data protection.

  2. Core Definitions and Concepts
    He emphasized key terms under Section 2, including computer, computer network, computer system, and intermediary, explaining their crucial role in understanding liabilities under cyber law.

  3. Digital Signatures and Hash Functions (Sections 3–42)
    Explaining encryption and decryption using public–private key mechanisms, he compared it to a bank locker system, helping students visualize how digital signatures authenticate and secure electronic communication.

  4. Civil and Criminal Liabilities (Sections 43 & 66)
    The webinar clarified how Section 43 deals with civil wrongs like unauthorized access, data theft, or introducing viruses, while Section 66 criminalizes the same acts when done dishonestly or fraudulently.

  5. Repeal of Section 66A
    Dr. Limaye discussed the landmark Shreya Singhal v. Union of India case, which struck down Section 66A as unconstitutional for violating free speech.

  6. Adjudicating Authorities and Jurisdiction (Section 46)
    Civil disputes under the IT Act are adjudicated by designated IT Secretaries of each State, not regular civil courts. Appeals lie before TDSAT, then High Courts, and finally the Supreme Court.

  7. Emerging Relevance of the Digital Personal Data Protection Act, 2023
    With the repeal of Section 43A, the new Data Protection Act introduces a comprehensive legal framework for safeguarding personal data and user consent — a vital area for future legal professionals.

  8. Cyber Crimes & Offenses (Sections 65–67F)
    He explained cybercrimes such as source code tampering, identity theft, cyber terrorism, and online obscenity, citing the severity of punishments ranging from 3 years to life imprisonment.

  9. Advice for Law Students
    Dr. Limaye urged students to treat cyber law as an emerging and high-demand field, combining legal knowledge with technological awareness. He advised building early familiarity with current judgments, NCRB data, and RBI’s Zero Liability Circular for digital frauds.

Conclusion

The session concluded with an interactive Q&A, where Dr. Limaye answered questions on digital signatures, data privacy, and cybercrime reporting through helpline 1930. His practical insights bridged the gap between statutory law and real-world application, inspiring students to explore techno-law as a professional path.

About the sepaker

Adv. (Dr.) Mahendra Limaye is a techno-legal cyber law expert (Ph.D.) and FDPPI-certified data privacy professional. He heads the Cyber Awareness Organisation, advises government and private bodies on IT Act, DPDP 2023, GDPR/CCPA compliance, and appears before Adjudicating Officers, district courts, and High Courts in cyber and IPR matters.

When Life Itself Becomes a Lawsuit: Thalidomide and the Birth of Modern Medical Liability

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The Human Question Behind the Legal One

Few legal questions are as haunting as those born from medicine’s mistakes.
When a drug meant to ease pregnancy causes deformities in the unborn, law must answer the unthinkable:

  • Can a child sue for being born injured?
  • Can parents claim for the pain of a birth they would have avoided?
  • Who should bear the burden — the doctor, the company, or no one at all?

The Thalidomide disaster of the late 1950s and early 1960s forced courts around the world to confront these very questions, giving rise to doctrines that still define pharmaceutical and medical negligence law today.

1. Parental Injury: When the Mother Suffers as a Patient

In principle:
A parental injury claim arises when a parent—most often the mother—suffers direct physical or mental harm because of a drug or medical negligence. The injury is personal: it might involve miscarriage, illness, emotional trauma, or other physiological effects of a harmful medicine.

In the Thalidomide context:
While the children bore visible deformities, many mothers endured lasting injuries—some physical, others psychological. They had taken the drug in good faith, believing it to be safe. Their legal standing was clear: they were patients wronged by negligence, capable of suing manufacturers and prescribers for failure to test, failure to warn, and breach of duty of care.

But when they sued not for themselves but for their children, the boundaries of law began to blur—ushering in the next two doctrines.

2. Wrongful Birth: The Parents’ Claim for an Avoidable Life

In principle:
A “wrongful birth” claim belongs to the parents, not the child. It argues that, had the parents been properly informed of the risks or given correct medical advice, they would have avoided conception or terminated the pregnancy. The injury here is the deprivation of choice, not the child’s existence itself.

Damages may include the emotional distress of raising a disabled child or the extraordinary costs of medical care.

In the Thalidomide context:
Mothers argued they would never have taken Thalidomide—or would have discontinued it—had they known its dangers. Some courts sympathized, treating this as a breach of the manufacturer’s and physician’s duty to warn.

However, others hesitated. The emotional and moral complexity of saying a child’s birth was “wrongful” unsettled traditional legal thinking. Yet Thalidomide made the concept unavoidable: the right to informed choice became the foundation of modern medical-consent law.

Today, many jurisdictions (including the UK and India) recognize wrongful birth as a valid parental claim in limited circumstances—especially when negligence deprived the mother of a lawful opportunity to avoid an afflicted birth.

3. Wrongful Life: When the Child Sues for Existing

Thalidomide-induced limb deformity (Phocomelia).
Source: Store medisinske leksikon, CC BY-SA 4.0.

In principle:
A “wrongful life” claim goes one step further—and most courts stop there. Here, it is the child who sues, arguing that they should not have been born at all. The claim contends that non-existence would have been preferable to a life burdened by severe disability.

The conceptual problem is immediate: how can law compare life with suffering to the absence of life? Courts have struggled to quantify damages for existence itself.

In the Thalidomide context:
Several victims’ families attempted this argument, especially in the United Kingdom and Australia. Courts uniformly rejected it. In the landmark McKay v Essex Area Health Authority (1982), the English Court of Appeal held that life, however impaired, cannot constitute a legal injury.

Thalidomide thus drew a clear line between compassion and logic: society could compensate for disability, but it could not say that existence was a wrong.

This doctrine’s rejection preserved the sanctity of life while acknowledging the moral responsibility to support those born injured.

4. The Learned Intermediary Doctrine: The Doctor Between the Drug and the Patient

In principle:
Under this doctrine, the manufacturer’s duty to warn runs to the physician, not directly to the patient. The doctor, being “learned,” acts as the intermediary who interprets risks and decides whether to prescribe.

If adequate information is given to doctors, the company is generally not liable for failure to warn patients directly.

In the Thalidomide context:
This defense collapsed. The manufacturer, Grünenthal, had not conducted proper teratogenic studies or supplied full data to doctors. The warnings were absent, vague, or misleading. Hence, the intermediary could not have been “learned” in any real sense.

The Thalidomide tragedy proved that the duty to test is inseparable from the duty to warn.
A doctor can only act as a gatekeeper if the manufacturer holds the keys of knowledge.

This realization reshaped global pharmaceutical law. Today, every label, data sheet, and package insert bears the imprint of that failure.

5. The Doctrines Converge: A New Era of Accountability

Together, these doctrines form a continuum:

  • Parental injury protects the parent’s body.
  • Wrongful birth protects the parent’s informed choice.
  • Wrongful life tests the boundaries of existence itself.
  • Learned intermediary defines who must know the truth first.

Conclusion

Thalidomide forced law to map these contours with empathy and logic.
It turned grief into jurisprudence and tragedy into reform.
From it emerged the modern expectation that manufacturers must know before doctors prescribe, and doctors must inform before patients decide.

Thalidomide is more than a pharmaceutical tragedy — it is a mirror held up to the conscience of modern law. It taught us that when life itself becomes the subject of litigation, every judgment must balance empathy with logic. The doctrines of Parental Injury, Wrongful Birth, Wrongful Life, and the Learned Intermediary emerged not from academic debate but from the cries of families betrayed by science and silence alike.

Through them, law found language to express both compassion and restraint: that parents deserve the truth, children deserve care, and manufacturers must never confuse innovation with immunity. Every warning label, informed-consent form, and patient leaflet we see today is, in a way, a quiet apology written by history.

Thalidomide reshaped not only the regulation of drugs — it redefined the relationship between human vulnerability and institutional responsibility.

Glossary of Core Doctrines (as Illustrated by Thalidomide)

Term General Meaning Application in Thalidomide Cases
Parental Injury Direct physical or emotional harm suffered by a parent due to a drug or medical negligence. Mothers who took Thalidomide suffered both physiological and psychological injuries; they were recognized as patients wronged by negligence.
Wrongful Birth Parents’ claim that negligence deprived them of the chance to avoid conceiving or continuing a pregnancy that resulted in a disabled child. Parents argued that proper testing or warnings would have prevented exposure during pregnancy; modern consent laws evolved from this reasoning.
Wrongful Life A child’s claim that being born with disability is itself a legal injury. Rejected by most courts (e.g., McKay v Essex AHA, 1982); law cannot compare life with non-existence. Thalidomide reinforced this boundary.
Learned Intermediary Doctrine Principle that drug manufacturers discharge their duty to warn by informing prescribing physicians. Collapsed in Thalidomide cases because the manufacturers failed to test or warn adequately; no “learned” intermediary truly existed.

 

When Cough Syrups Turn Deadly: India’s Child Health Crisis & The Legal Reckoning

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Disclaimer : Following article is based on publicly available news reports, regulatory advisories, and official statements. It is intended solely for informational and educational purposes. The author makes no independent allegations regarding the accuracy of third-party reports. Readers are advised to refer to official investigation findings and legal documents for authoritative information.

A Spoonful That Should Heal, Not Harm

Imagine this: A worried parent gives their coughing child a spoonful of over-the-counter or prescription syrup, expecting relief.
But what if that spoon becomes a silent killer?

Over the past few weeks, several states in India have been rocked by tragic child deaths linked to contaminated cough syrups. What began as isolated reports has now snowballed into nationwide criminal investigations, regulatory crackdowns, and intense legal scrutiny.

This issue isn’t just for pharma insiders. It affects every parent, pharmacist, doctor, regulator, and lawyer. Let’s break it down clearly.

What Happened: The Recent Incidents

  • In Madhya Pradesh, at least 17 child deaths have been linked to a cough syrup named Coldrif, allegedly manufactured by Sresan Pharma. [1]
  • Laboratory tests reportedly found Diethylene Glycol (abbreviated as DEG) contamination at levels nearly 500 times higher than permissible. DEG is a known nephrotoxic and neurotoxic chemical, responsible for historic mass poisonings globally.[2]
  • Police have registered manslaughter cases against company officials. Regulatory teams have launched nationwide inspections.[3]
  • In Rajasthan, after two child deaths, the health department issued new paediatric cough protocol guidelines, warning that most syrups offer “minimal benefit and significant risk” for children.[4]
  • The state has now banned dextromethorphan (DXM) for children under 4 and discouraged Fixed Drug Combinations (FDCs) contianing it. There is also an notification issued against the use of Chlorpheniramine + Phenylephrine syrups in children below age of 2 years.

These are not isolated incidents — they echo the Gambia (2022) and Uzbekistan (2022–23) tragedies where contaminated syrups exported from India led to dozens of child deaths abroad. Arguably hurting India’s reputation as “Pharmacy to the World”.

The Legal Earthquake Beneath the Surface

Behind every regulatory press release is a set of legal provisions that are now in sharp focus. Here’s how this plays out legally:

1. Drugs & Cosmetics Act, 1940 & Rules

  • Beyond limit DEG contamination makes a product “adulterated / not of standard quality”.
  • Regulatory authorities can suspend or cancel licences, recall products, and prosecute companies.
  • Firms are legally required to test every batch of raw material and finished product any lapses here can attract serious penalties.

2. Indian Penal Code (IPC)

  • Police have filed manslaughter (culpable homicide not amounting to murder) cases against manufacturers.
  • Sections 275 & 276 (adulterated drugs causing harm) may also be invoked.

3. Civil / Product Liability

  • Victims’ families can file negligence or wrongful death claims.
  • Courts may lean toward strict liability, especially since DEG’s dangers are well known and preventable.
  • Plaintiffs can demand batch Certificate of Analysis (COA), excipient COAs, stability data, recall records, audit reports, etc.

4. Constitutional Remedies

  • PILs or writ petitions (Art. 226) can demand transparency, wider recalls, or court-monitored investigations.
  • A key emerging question is: Why isn’t domestic testing as stringent as export testing?
    (India requires govt lab CoA for exported syrups — but not consistently for batches for domestic trade.)

Paediatric Concerns That Go Beyond FDCs

Even apart from toxic batches, several paediatric risks are coming under the legal and medical scanner:

Concern Why It Matters What’s Changing
DEG / EG contamination Causes acute kidney failure and death in children Wider raw-material testing & surprise inspections
Ineffective decongestants (e.g., phenylephrine) Weak scientific evidence US FDA has flagged; Indian Subject Expert Committee (SEC) reviewing
Codeine / DXM misuse Respiratory depression, sedation in children Rajasthan bans DXM under 4; global bodies warn against codeine in less than 12 years age children
Irrational multi-drug syrups Increased Adverse Drug Reaction (ADR) risk, poor benefit to risk ratio New protocols discourage FDCs
OTC misuse Parents self-medicating without guidance Phtsicians and Pharmacists associations have urged to practice caution

How does it affect, what to expect and possible precautions (for parents) and defences (for pharma prefessionals):

Pharma Professionals

  • Strengthen raw material testing, supplier audits, and GMP documentation.
  • Review your paediatric FDC portfolio; irrational combinations can be identified and banned in near future.

Lawyers

  • These cases combine criminal law, product liability, administrative law, and constitutional remedies.
  • Potential for PILs, consumer complaints, negligence suits, and corporate liability litigation is rising.

Parents

  • Avoid OTC cough syrups for young children unless prescribed.
  • Check age restrictions and avoid adult syrups for kids.
  • Report adverse effects to local FDAs or CDSCO portals.

From Tragedy to Accountability

The recent cough syrup deaths are a stark reminder that drug safety cannot be taken for granted. What should have been routine paediatric medicines have exposed serious regulatory and accountability gaps. For manufacturers, compliance failures can now invite not just regulatory action but the possibility of strict liability, while for legal professionals, these cases illustrate how public health and law intersect. Strengthening testing, enforcing transparent regulation, and ensuring accountability at every level is essential to prevent such tragedies from repeating.

References:

[1] MP, Death toll Rises to 17; Times of India

[2] Police launch manslaughter probe into India’s cough syrup deaths; Reuters

[3] India flags testing lapses at pharma firms after cough syrups deaths; Reuters

[4] Cough medicines have minimal proven benefit, significant risk: Health Departments new protocol; Times of India