Urgent Call to Reassess Piramal Pharma’s Tetmosol Soap

A Case for Halting Its Sale Due to Global Questions, Misuse Risks and Ethical Concerns

Posted on 1st October, 2025 (GMT 18:11 hrs)

ABSTRACT

Tetmosol soap, marketed by Piramal Pharma Limited as a treatment for scabies and lice, contains the outdated active ingredient Monosulfiram (5% w/w). While effective for its intended use, Tetmosol’s widespread over-the-counter (OTC) availability in India and other developing regions, coupled with vague marketing claims, has led to rampant misuse for undiagnosed dermatological conditions. This misuse risks ineffective treatment, skin irritation, and delayed diagnoses, raising serious concerns about consumer safety and Mr. Piramal’s ethical responsibility. The article critically examines Tetmosol’s composition, safety, regulatory status, consumer misuse, and Mr. Piramal’s marketing practices, alongside broader enforcement challenges and Mr. Piramal’s product portfolio. It argues for a temporary suspension of Tetmosol’s sales until clearer labeling, robust consumer education, and stricter regulations are implemented to protect public health.

In Continuation With

Introduction

Tetmosol soap, marketed by Piramal Pharma Limited as a medicated treatment for scabies and lice, contains Monosulfiram (5% w/w), an outdated active ingredient with limited global regulatory approval. While effective for its intended use, Tetmosol’s widespread over-the-counter (OTC) availability in India and other developing regions, coupled with vague marketing claims, has led to rampant misuse for undiagnosed dermatological conditions. This misuse risks ineffective treatment, skin irritation, and delayed diagnoses, raising serious concerns about consumer safety and Mr. Piramal’s ethical responsibility. The Central Drugs Standard Control Organisation (CDSCO) struggles to enforce adequate oversight, exacerbating these issues. This article critically examines Tetmosol’s composition, safety, regulatory status, consumer misuse, and Piramal Pharma’s advertising/marketing practices, alongside broader enforcement challenges and Piramal Pharma’s product portfolio. It argues for a temporary suspension of Tetmosol’s sales until clearer labeling, robust consumer education, and stricter regulations are implemented to protect public health. The responsibility for all misuse and harm falls on Piramal Pharma.

1. Composition of Tetmosol Soap
Tetmosol soap is designed to treat parasitic infections like scabies (Sarcoptes scabiei) and lice (Pediculus humanus). Its formulation, per pharmacy sources, includes:

Active Ingredient:
- Monosulfiram (5% w/w): A scabicide and pediculicide that kills mites and lice by disrupting their metabolism, with mild antiseptic effects. Piramal bears responsibility for continuing the use of this outdated ingredient.
Inactive Ingredients:
- Sodium Tallowate and Sodium Cocoate: Soap bases for cleansing.
- Water (Aqua): Solvent and hydrator.
- Glycerin: Humectant for skin moisture.
- Fragrance (Parfum): Lime or citronella-like scent.
- Sodium Chloride: Thickener and stabilizer.
- Sodium Hydroxide: pH adjuster.
- Tetrasodium Etidronate: Chelating agent to prevent soap scum.
- Titanium Dioxide: White pigment.
- CI 47005 (Yellow 10): Yellow colorant.
- Citronella Oil: Fragrance with mild antimicrobial properties.

Usage: Applied during bathing and rinsed off, suitable for adults and children under medical supervision. A patch test is advised for sensitive skin.

Concern: While the formulation is straightforward, the inclusion of Monosulfiram—an ingredient lacking modern global clinical validation—raises questions about its suitability in an OTC product, especially when safer alternatives like permethrin exist globally. The responsibility for continuing to market this product rests with Piramal.

2. Side Effects and Toxicity: A Hidden Risk

Side Effects: Tetmosol is generally safe for its intended use, but potential side effects include:

Skin Irritation: Redness, itching, or burning, particularly in sulfur-sensitive individuals or those with sensitive skin.
Allergic Reactions: Rare but serious cases of dermatitis, hives, or swelling, with severe reactions (e.g., breathing difficulties) requiring emergency care.
Dryness: Prolonged use may dehydrate skin, necessitating moisturizers.
Discoloration: Rare temporary skin discoloration, especially on sensitive areas.

Toxicity:

Low Systemic Risk: The rinse-off format minimizes absorption, but:
- Ingestion: Accidental ingestion (e.g., by children) can cause nausea, vomiting, or abdominal pain, requiring urgent medical intervention.
- Overuse: Excessive application may heighten irritation or, in rare cases, cause mild systemic effects like headaches.
- Eye/Mucous Membrane Contact: Causes stinging or discomfort, requiring thorough rinsing.
- Allergen Risk: Sulfur sensitivity may trigger reactions, underscoring the need for patch testing.
- Environmental Concern: Large-scale improper disposal could harm aquatic ecosystems, though current use levels pose minimal risk.

Critical Issue: These risks, while manageable under medical guidance, become significant when Tetmosol is misused for undiagnosed conditions. The lack of clear warnings on packaging about its limited scope exacerbates potential harm, particularly in India’s self-medication culture. The responsibility for consumer harm lies entirely with Piramal Pharma.

3. Unsuitability for Broad Dermatological Use

Tetmosol is specifically indicated for scabies and lice, not as a catch-all for dermatological issues. Monosulfiram is ineffective against:

Fungal infections (e.g., ringworm).
Bacterial infections (e.g., impetigo).
Viral infections (e.g., herpes).
Inflammatory conditions (e.g., eczema, psoriasis).
Other conditions (e.g., acne, rosacea).

Risks of Non-Specific Use:

Ineffectiveness: No therapeutic benefit for non-parasitic conditions, delaying proper treatment.
Worsened Symptoms: May irritate sensitive or inflamed skin, exacerbating conditions like eczema.
Delayed Diagnosis: Masking symptoms risks overlooking serious conditions (e.g., skin cancer).
Allergic Reactions: Sulfur sensitivity can cause adverse reactions without a confirmed diagnosis.

Critique: The OTC availability of Tetmosol, combined with its promotion for “itching” and “skin infections,” encourages consumers to self-diagnose and misapply it, a practice that could be mitigated by restricting sales to prescription-only or mandating clearer warnings. Piramal is responsible for enabling this misuse through marketing.

4. Consumer Misuse: A Public Health Concern

Tetmosol’s widespread OTC use for non-parasitic conditions stems from:

Misleading Marketing:
- Advertisements and labels (e.g., on Truemeds, Wellify) tout relief from “itching,” “rashes,” and “skin infections,” terms that misleadingly overlap with symptoms of eczema, allergies, or fungal infections. Claims of suitability for “minor infections” or “healthy skin” encourage off-label use. Piramal bears responsibility for these misleading claims. This practice violates the Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954, which prohibits promotion of drugs with unverified claims or for conditions not approved by regulatory authorities.
- Celebrity endorsements exacerbate the issue: figures like Ajay Devgn or Manoj Bajpayee, while famous, are neither professional physicians nor healthcare specialists, and using their image risks creating the false impression of medical authority, misleading consumers into thinking the product’s claims are medically validated. Piramal is fully responsible for exploiting celebrity influence in a context where medical expertise is required.
Anecdotal Endorsements:
- Reviews on Amazon, 1mg, and Beauty Bulletin praise Tetmosol for reducing itching or breakouts in non-parasitic cases, falsely reinforcing its versatility.
Affordability and Accessibility:
- Priced at ₹75–100 per 100g, Tetmosol is cheaper than prescription alternatives and widely available, appealing to India’s 70%+ OTC self-medication rate.
Cultural Factors:
- Limited healthcare access and dermatological awareness in rural India drive self-diagnosis, with consumers mistaking diverse skin issues for treatable “infections.”

Impact: Misuse leads to ineffective treatment, skin irritation, and delayed diagnoses, contributing to the perception of Tetmosol as potentially harmful. This widespread misuse signals a failure of oversight and education, necessitating urgent action to curb its indiscriminate use.

5. Monosulfiram’s Role and Regulatory Status: An Outdated Choice

Role of Monosulfiram:

Function: Monosulfiram kills mites and lice by disrupting their metabolism, likely via sulfur-containing enzyme inhibition or neural effects. In Tetmosol, it targets parasitic infections and related symptoms, with mild antiseptic benefits.
Delivery: The soap’s rinse-off format limits systemic absorption, but its efficacy is less studied than leave-on treatments like permethrin cream.

Regulatory Status:

WHO Model List of Essential Medicines: Monosulfiram is absent from the 2023 WHO EML, which prioritizes permethrin, benzyl benzoate, and ivermectin due to superior clinical evidence.
US FDA: Monosulfiram has never been approved, with the US favoring permethrin, ivermectin, and malathion, backed by rigorous trials.
EMA: Monosulfiram is not approved, and the European Pharmacopoeia lacks a monograph. EU markets rely on permethrin and ivermectin.
Indian Pharmacopoeia: Monosulfiram is recognized, supporting its use in India (e.g., Tetmosol). CDSCO approves it as an OTC soap under the Drugs and Cosmetics Act, 1940.
Other Regions: Approved in some African countries (e.g., Nigeria’s NAFDAC), but under local standards.

Critique: Monosulfiram’s lack of global approval reflects its outdated profile, insufficient modern trials, and potential for irritation. Its continued use in India, despite safer alternatives, raises questions about Piramal’s commitment to innovation and consumer safety.

Fact-Check: The claim that Monosulfiram is absent from the WHO EML and unapproved by the FDA or EMA is true.

6. Ethical Concerns: Piramal’s Questionable Practices

Is Tetmosol “Dangerous”?: Tetmosol is safe for scabies and lice when used correctly but becomes problematic when misapplied, risking irritation or delayed treatment. The perception of “danger” stems from consumer misuse, fueled by Piramal’s marketing.

Why Piramal Continues Sales:

Market Demand: High scabies/lice prevalence in India drives demand for affordable treatments.
Brand Legacy: Tetmosol’s decades-long trust and pleasant fragrance make it a household name.
Regulatory Compliance: CDSCO approval allows OTC sales with minimal clinical requirements.
Marketing Strategy: Broad claims of relieving “itching” and “infections” exploit India’s self-medication culture, boosting sales via e-commerce and pharmacies.

Advertising Concerns:
I write to you not merely as a categorized consumer or patient, but as a DHFL victim, whose life savings were allegedly/reportedly consumed by the Piramal Group’s “resolution plan.” The itch of that injustice persists: raw, unhealed, scratching deeper with every passing day. When I look at Piramal Pharma’s continued advertised promotion of Tetmosol soap, I see the same structure repeating — A superficial balm masking deeper wounds, a cycle of exploitation disguised as care through propaganda machinery. Celebrity endorsements by figures like Ajay Devgn or Manoj Bajpayee, without being physicians, risk creating the false impression of medical authority, blurring the line between entertainment and healthcare communication.

Ethical Concerns:

Misleading Advertising: Promoting Tetmosol for “skin infections” or “healthy skin” without clear disclaimers encourages misuse for non-parasitic conditions, risking harm.
Exploiting Self-Medication: Piramal capitalizes on India’s limited healthcare access without adequately educating consumers about diagnosis, a practice that undermines public health.
Outdated Ingredient: Relying on Monosulfiram, unapproved by stringent regulators, suggests a lack of innovation compared to global standards (e.g., permethrin).
Inadequate Warnings: Labeling lacks emphasis on the need for medical diagnosis, increasing misuse risks.

Verdict: Piramal’s marketing is legal under CDSCO but ethically dubious. By fostering off-label use through vague claims, Piramal risks consumer harm, necessitating a reevaluation of Tetmosol’s OTC status and marketing practices.

7. CDSCO’s Enforcement Failures: Enabling Misuse
CDSCO’s oversight of Tetmosol and similar products is hampered by systemic issues:

Decentralized Structure: Split authority between CDSCO and state licensing authorities leads to inconsistent enforcement. For example, banned FDCs (e.g., 35 in May 2025) persist due to delayed state action.
Resource Shortages: Only ~3,500 drug inspectors (vs. needed 5,000) and 7 central labs cause surveillance backlogs. In December 2024, 135 drug batches were flagged as Not of Standard Quality (NSQ).
Regulatory Complexity: Frequent rule changes (e.g., 2024 GMP revisions) confuse stakeholders, delaying compliance.
Weak Surveillance: Inadequate post-market monitoring allows substandard products to circulate (e.g., spurious Tofacitinib in 2025).
Lax Advertising Oversight: Inconsistent enforcement of the Drugs and Magic Remedies Act, 1954, permits vague claims like Tetmosol’s, contributing to misuse.

Impact on Tetmosol: CDSCO’s failure to enforce precise advertising and monitor OTC misuse enables Tetmosol’s off-label use, endangering consumers. Stricter regulations or prescription-only status could mitigate these risks.

8. Piramal Pharma’s Portfolio: Context for Tetmosol
Piramal operates in Consumer Healthcare (PCH), Critical Care (PCC), and Pharma Solutions (PPS):

PCH (OTC): Tetmosol, Lacto Calamine, i-pill, Little’s, QuikKool, Saridon, Polycrol.
PCC: Sevoflurane, Bupivacaine, antibiotics, IV nutrition.
PPS: 50+ APIs, biologics, ophthalmics (e.g., Bimatoprost).

Critique: While Piramal’s portfolio demonstrates innovation in critical care and APIs, its reliance on outdated OTC products like Tetmosol suggests a profit-driven approach in consumer healthcare, prioritizing legacy brands over modern alternatives.

10. Call to Action: Halting Tetmosol Sales
Tetmosol’s continued OTC availability, driven by Piramal’s ambiguous marketing and enabled by CDSCO’s enforcement gaps, poses unacceptable risks to consumers.

The following actions are urgently needed:

Piramal Pharma: Suspend Tetmosol sales until marketing is revised to specify scabies/lice indications, with prominent warnings against off-label use. Invest in consumer education and consider transitioning to permethrin-based alternatives.
CDSCO: Reclassify Tetmosol as prescription-only, enforce stricter advertising regulations, and enhance pharmacovigilance to monitor misuse.
Consumers: Avoid using Tetmosol without a dermatological diagnosis, opting for safer alternatives under medical guidance.

Conclusion: While Tetmosol serves a niche for scabies/lice, its misuse, fueled by Piramal’s ethically questionable marketing and CDSCO’s lax oversight, endangers public health. Halting its OTC sales until robust safeguards are in place is a prudent step to protect consumers without dismissing its limited pharmaceutical rationale.

Sources: WHO EML 2023, CDSCO guidelines, FDA/EMA databases, Piramal Pharma’s website, pharmacy listings (e.g., 1mg, Truemeds), industry reports (2024–2025).

Disclaimer: This article reflects publicly available data as of October 2025 and is intended to raise awareness, not defame. Consult healthcare professionals and verify regulatory information with primary sources.

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