Sloan’s “Promise”: Heritage Brand or Hazard in a Bottle?

Posted on 1st October, 2025 (GMT 18:38 hrs)

ABSTRACT

This representation critically examines Sloan’s Liniment/Balm (Piramal Pharma), exposing concerns about its irrational Fixed Dose Combination of counter-irritants (methyl salicylate, menthol, camphor, turpentine oil, eucalyptus oil, capsaicin), absent from global pharmacopeias (USP, Ph. Eur., WHO EML) and unsupported by clinical evidence in arthritis. Risks such as systemic salicylate poisoning, camphor neurotoxicity, turpentine irritation, and capsicum hypersensitivity are compounded by misleading claims of “lasting arthritis relief,” which distract from proper treatment and may delay evidence-based care. Regulatory loopholes in India (Drugs & Cosmetics Act, 1940; Drugs and Magic Remedies Act, 1954) enable this obsolete heritage brand to persist despite international withdrawal. Sloan’s thus embodies an ethical paradox: irritants sold as therapy, financial wounds masked as cure—mirroring the DHFL victims’ plight. The representation urges Piramal Pharma to halt deceptive claims, disclose safety data, and validate efficacy, while calling on CDSCO, WHO, FDA, and EMA to review authorization, issue advisories, and protect patients from irrational formulations.

“लाभनम् श्रेयः आरोग्यम्” 

“Among all profits, cure is the highest good.” (Mahābhārata, Vana Parva)

To:

Mr. Ajay Piramal,
Piramal Pharma Limited

Subject: Comprehensive Representation on Sloan’s Liniment/Balm – Regulatory, Pharmacological, and Ethical Concerns

Dear Sir/Madam,

This communication, investigated and compiled by a suffering DHFL victim, serves as both a letter of concern to Piramal Pharma Limited and a regulatory representation copied to national and international health authorities. Below is the complete representation, with annexures and references, submitted in good faith for urgent regulatory, pharmacological, and ethical review.

I. Subject

Regulatory, Pharmacological, and Ethical Review of Sloan’s Liniment/Balm marketed by Piramal Pharma Limited – Concerns regarding its safety, rationality, legality of combinations, absence from international pharmacopeia, misleading advertising practices, and inappropriate positioning for arthritic pain management.

For me, Sloan’s is not merely a topical liniment but a symbol of the DHFL victims’ plight: a mix of irritants disguised as relief, much like a financial “resolution” cloaked as justice.

II. Product Details (Revised with Verification Note)

• Product Names: Sloan’s Liniment Oil and Sloan’s Balm
• Formulation Type: Topical Analgesic / Counter-Irritant (Available as both an Oil/Liniment and a Balm)
• Manufacturer/Marketer: Piramal Pharma Limited

Key Active Ingredients (Varies by Product and Market):

a)   Core Counter-Irritants (Common to both Oil and Balm):

1.    Methyl Salicylate (10-30%) (sourced from Oil of Wintergreen/Gaultheria or synthetic)

2.    Menthol (1-16%) (sourced from Pudina/Mint or synthetic)

3.    Camphor (3-11%) (sourced from Karpoora Tailam or synthetic)

4.    Capsaicin / Capsicum Extract (0.025-0.25%) (provides the deep heat action)

5.    Eucalyptus Oil (sourced from Nilgiri Tailam or synthetic)

b)  Other Noteworthy Ingredients:

1.    Turpentine Oil (Prominent in some Liniment formulations; considered obsolete in modern pharmacopeias and removed from European Pharmacopoeia 10.0, 2019 edition)

2.    Gandha Biroja Tailam (Indian Wintergreen Oil, common in the Balm)

3.    Devadaru Tailam (Common in the Balm)

Disclaimer / Verification Note:
The above ingredient ranges are collated from publicly available international product labels (including U.S. DailyMed, Indian retail listings, and e-commerce portals). Piramal Pharma has not publicly disclosed batch-specific compositions or Safety Data Sheets (SDS). Verification through official CDSCO product filings and manufacturer-issued SDS is requested.

Just as Sloan’s blends irritants under the guise of relief, the DHFL resolution blended legality with exploitation, restructuring with injustice, creating a concoction as harmful to victims as turpentine is to the skin.

III. Legal and Regulatory Concerns

Globally, topical liniments with multiple counter-irritants raise concerns about rationality and safety.¹ Fixed Dose Combinations (FDCs) lacking pharmacological synergy are discouraged by WHO and national regulators.

Under the Drugs & Cosmetics Act, 1940, Rule 122E, marketed medicines must justify their combinations’ rationality.² Sloan’s appears to be an irrational FDC, providing symptomatic distraction via counter-irritation rather than evidence-based relief.

The specific formulation of Sloan’s requires verification against FDA OTC External Analgesic monographs (21 CFR 348)³ and EMA guidelines,⁴ as it appears to persist primarily in less-regulated markets like India without clear international pharmacopeial recognition.

Like irrational FDCs, the DHFL resolution was a toxic mix of judicial opacity, regulatory silence, and corporate greed.

IV. Scientific & Pharmacological Concerns

• Methyl Salicylate (10-30%): Absorbed through skin; linked to systemic poisoning, including acidosis, particularly dangerous in children.⁵
• Camphor (3-11%): Neurotoxic; associated with seizures, especially in children; banned in pediatric OTC products by Health Canada.⁶
• Turpentine Oil: Considered obsolete in modern formulations; irritant; toxic if ingested or inhaled; removed from European Pharmacopoeia 10.0.⁷
• Capsicum Oleoresin (0.025-0.25%): Causes burning with limited evidence of therapeutic benefit beyond temporary counter-irritation.⁸

Sloan’s primarily delivers a burning sensation rather than meaningful pain relief, operating on counter-irritation principles that distract rather than treat underlying pathology.

For a DHFL victim, methyl salicylate + camphor = financial loss + silencing; turpentine = corrosive regulatory failures; capsicum = the humiliation of being told our pain is “relieved.”

V. Arthritic Pain Relief: Critical Analysis of Claims vs. Evidence

Clinical Context and Misleading Positioning

Piramal Pharma positions Sloan’s for “joint pain” and “arthritis pain relief,” conflating symptomatic distraction with genuine arthritis management.

1. Pain Relief (What Sloan’s Claims to Provide):

• Short-term analgesia through counter-irritation (burning, cooling sensations)
• Transient masking of pain perception without addressing inflammation or joint pathology
• No modification of underlying arthritis disease processes

2. Pain Management (What Arthritis Patients Actually Need):

• Pharmacological: Topical NSAIDs, oral NSAIDs/acetaminophen, adjuvant therapies
• Non-pharmacological: Exercise therapy, weight management, physical therapy, heat/cold application
• Disease-modifying measures: DMARDs/biologics for inflammatory arthritis
• Monitoring, dose titration, and long-term safety considerations

3. Evidence Gap for Multi-Ingredient Counter-Irritants

• Capsaicin alone: Some evidence supports benefit in osteoarthritis with regular use, but initial burning limits adherence
• Methyl salicylate/menthol/camphor combinations: Limited high-quality, product-specific clinical trial data in arthritis populations
• Sloan’s specific formulation: No published randomized controlled trials demonstrating efficacy in arthritis

4. Safety Concerns in Chronic Arthritis Use

• Repeated application over large areas increases systemic salicylate exposure
• Local adverse effects (burning, dermatitis, blistering) limit utility in long-term arthritis care
• Elderly arthritis patients at higher risk for systemic toxicity

5. Inappropriate Marketing Claims
Claims such as “lasting relief from joint pain” and positioning as arthritis treatment lack clinical validation and mislead patients.

For DHFL victims, this mirrors how “resolution” schemes provided theatrical relief while underlying injustices remained unaddressed.

VI. Side Effects and Public Health Risks

• Severe skin irritation and chemical blistering
• Systemic salicylate poisoning (particularly in children and elderly)
• Camphor-related seizures and neurotoxicity
• Turpentine-induced dermatitis and respiratory effects
• Capsicum hypersensitivity and contact dermatitis
• Delayed arthritis care: Patients may rely on ineffective counter-irritation instead of seeking appropriate medical evaluation

Public health advisories in Western nations, including FDA and Health Canada, caution against such multi-ingredient formulations, particularly for pediatric use and chronic conditions.⁹

If Sloan’s can blister skin, the DHFL resolution blisters lives.

VII. Absence in International Pharmacopeia and Modern Guidelines

• Not listed in WHO Essential Medicines List (2019 edition)¹⁰
• Absent from U.S. Pharmacopeia (USP) and European Pharmacopoeia (Ph. Eur.) for this specific formulation
• Not recommended in major arthritis guidelines:
  • American College of Rheumatology Guidelines for Osteoarthritis
  • European League Against Rheumatism (EULAR) recommendations
  • Osteoarthritis Research Society International (OARSI) guidelines
• Persists due to brand nostalgia and less stringent regulatory oversight in select markets

As Sloan’s lacks a place in modern international pharmacopeia and arthritis care guidelines, the DHFL “resolution” lacks legitimacy in democratic justice.

VIII. Ethical & Advertising Issues

Piramal Pharma promotes Sloan’s with advertized endorsements and unsubstantiated claims, raising ethical concerns:

• Advertisements lend false legitimacy to a seemingly outdated product formulation
• Vulnerable arthritis patients are misled by exaggerated claims of relief
• Such promotions may contravene the Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954¹¹

Promotional Claims by Piramal Pharma (as advertised online):

• “A heritage pain relief brand helping kill pain since 1901”
• “Provides quick action and lasting relief from joint pain, neck pain, shoulder pain, low back pain, sprain and muscular aches”
• “Contains Capsaicin which gives it a unique heat action”
• “Contains powerful analgesic & pain relieving ingredients – Methyl Salicylate, Menthol & Eucalyptus Oil”
• “Easy to apply and faster penetration makes Sloan’s Liniment Oil an ideal solution for effective pain relief”
  (Source: Piramal Pharma retail portal, Wellify.in)

Critique of “Arthritis Pain Management” and “Heritage” Positioning:

1.    Scientific Ambiguity: Straddles modern pharmacology and traditional appeal without rigorous validation

2.    Misleading Arthritis Claims: Reduces “joint pain management” to sensory distraction, conflating temporary discomfort with genuine therapy

3.    Marketing Overstatement: Claims of “quick action and lasting relief” for joint pain risk overstatement given absence from arthritis treatment guidelines

When advertisements mask Sloan’s risks with glamour, the state-corporate collusion masks the DHFL resolution with crony rhetoric.

IX. Appeal for Relief (Regulatory Action Requested)

Piramal Pharma Limited is hereby urged to:

1.    Voluntarily suspend marketing of Sloan’s Liniment/Balm until pharmacological rationality is established through clinical evidence

2.    Cease advertised endorsements unless clinical validation supporting efficacy claims is published

3.    Publicly disclose adverse event reports and internal safety assessments for Sloan’s formulations

4.    Remove or substantiate arthritis-related claims with product-specific clinical trials in arthritis populations

5.    Provide clear labeling distinguishing between temporary sensory relief and comprehensive arthritis management

To Regulators: Should Mr. Piramal fail to comply, we respectfully request CDSCO, WHO, FDA, EMA, and other authorities to:
6. Conduct an independent review of Sloan’s safety and efficacy profile, particularly for arthritis claims
7. Issue public health advisories or suspend marketing authorizations if irrationality and disproportionate risks are confirmed
8. Evaluate arthritis-related advertising claims for compliance with evidence-based medicine standards

X. Concluding Statement

Sloan’s Liniment belongs more to a museum of corporate nostalgia than to modern evidence-based medicine. Its persistence in arthritis marketing reflects heritage branding, not scientific validation.

The positioning of Sloan’s for “joint pain” and “arthritis relief” particularly concerns the DHFL victims, as it may delay patients from seeking appropriate medical evaluation and evidence-based treatments. Counter-irritant distraction is not arthritis management.

For a DHFL victim experiencing the chronic pain of financial loss, Sloan’s serves as a perfect metaphor: a burning sensation that distracts momentarily from one’s pain arising out of financial abuse but heals nothing. The product’s marketing mirrors the DHFL “resolution”—theatrical relief masking systemic failure.

That such products thrive under Piramal Pharma’s rhetoric of a purported “goodness from within” reveals the paradox: turpentine irritation packaged as therapy, financial vivisection packaged as resolution, sensory distraction packaged as arthritis care.

The DHFL victims demand not Sloan’s-style relief—burning distraction from deeper wounds—but genuine therapeutic validation and transparent, evidence-based healthcare.

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XI. Annexures

Annexure I – Ingredient Table (Comparative Pharmacological Profile)

Ingredient	Pharmacology	Risks	International Status	Arthritis Evidence	DHFL Allegory
Methyl Salicylate (10-30%)	Counter-irritant, systemically absorbed	Toxicity, acidosis	Restricted in high doses (FDA, EMA)	No specific arthritis RCTs	Financial erosion
Camphor (3-11%)	Topical analgesic, CNS stimulant	Seizures, neurotoxicity	Banned in pediatric OTC (Health Canada)	No arthritis guidelines recommendation	Psychological trauma
Turpentine Oil	Counter-irritant, obsolete	Dermatitis, systemic toxicity	Obsolete (Ph. Eur. 10.0, 2019)	Not recommended for arthritis	Regulatory corrosion
Capsicum Oleoresin (0.025-0.25%)	Irritant, causes hyperaemia	Burning, hypersensitivity	Limited evidence (EMA, 2016)	Some OA evidence for pure capsaicin	Humiliation

Annexure II – Regulatory Precedents

• CDSCO’s Kokate Committee (2016) recommended banning irrational FDCs (Gazette S.O. 705(E), 2016)²
• Delhi High Court (2017) upheld rationality requirements in FDCs (Pfizer Ltd. v. Union of India, (2017) 249 DLT 46)
• Sloan’s lacks recognition in U.S. FDA OTC monographs and EMA assessment reports for external analgesics
• Arthritis Guidelines: Major international arthritis organizations do not recommend multi-ingredient counter-irritant formulations

Annexure III – Pharmacological Literature (Excerpts)

1.    Pain Management vs. Pain Relief (Arthritis-Specific)

o   WHO and IASP distinguish between pain relief (symptom reduction) and pain management (comprehensive care addressing underlying pathology)

o   Evidence-based arthritis management includes topical NSAIDs, structured exercise, weight management, disease-modifying therapies—not counter-irritant distraction

2.    Sloan’s and Counter-Irritation in Arthritis Context

o   Counter-irritants produce localized sensations that distract from deeper joint pain without addressing inflammation, synovitis, or cartilage degeneration

o   Modern rheumatology emphasizes treatments that modify disease processes, not merely mask symptoms

3.    Evidence Standards for Arthritis Claims

o   OARSI and ACR require clinical trial evidence for therapeutic claims

o   Multi-ingredient counter-irritant formulations like Sloan’s lack product-specific validation in arthritis populations

4.    Safety in Chronic Arthritis Use

o   Repeated application increases systemic exposure risks

o   Elderly arthritis patients are particularly vulnerable to salicylate toxicity

o   Local adverse effects may worsen in inflamed arthritic joints

5.    Appropriate Arthritis Positioning

o   If used at all, should be positioned as optional adjunct for mild symptoms, not primary therapy

o   Clear communication needed about limitations and when to seek medical evaluation

6.    Note (DHFL Victims’ Perspective)

o   Just as Sloan’s provides burning distraction while arthritis progresses untreated, the DHFL resolution provided procedural theater while financial wounds remained unhealed

o   Both represent “management” without genuine healing—corporate solutions that prioritize appearance over substance

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Self-Reflexive Note on DHFL Context

As the author of this representation and a DHFL victim, I recognize the broader context in which this letter is submitted. Mr. Piramal’s alleged role in the DHFL takeover—presented publicly as a “resolution” while acquiring distressed assets for only a rupee—seemingly reflects the same pattern critiqued above: interventions framed as relief or assistance while alleged systemic harms remain unaddressed. This underscores the ethical imperative that corporate actions, whether in healthcare products or financial resolutions, must be guided by transparency, accountability, and genuine redress rather than appearance or branding alone.

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References

Legal/Regulatory (Bluebook style):

1.    Drugs and Cosmetics Act, No. 23 of 1940, § 26A, Acts of Parliament, 1940 (India).

2.    Drugs and Magic Remedies (Objectionable Advertisements) Act, No. 21 of 1954, Acts of Parliament, 1954 (India).

3.    21 CFR 348 – External Analgesic Drug Products for Over-the-Counter Human Use, Code of Federal Regulations (2023).

4.    Gazette of India, S.O. 705(E), Mar. 10, 2016 (Central Drugs Standard Control Organization, Ministry of Health & Family Welfare).

5.    Pfizer Ltd. v. Union of India, (2017) 249 DLT 46 (Delhi High Court).

6.    Central Drugs Standard Control Organization, Prof. Kokate Committee Report on Irrational Fixed Dose Combinations (2016).

Pharmacological/Medical (APA style):

• Anderson, B. J., & Merry, A. F. (2011). Methyl salicylate poisoning: Life-threatening systemic absorption following topical use. Pediatric Anesthesia, 21(9), 977–981. https://doi.org/10.1111/j.1460-9592.2011.03621.x
• Brunton, L. L., Hilal-Dandan, R., & Knollmann, B. C. (Eds.). (2018). Goodman & Gilman’s: The Pharmacological Basis of Therapeutics (13th ed.). McGraw-Hill.
• Centers for Disease Control and Prevention. (2004). Camphor toxicity: New Jersey, 2003. Morbidity and Mortality Weekly Report, 53(24), 543–545.
• European Medicines Agency. (2016). Assessment report on Capsicum annuum L., fructus (EMA/HMPC/199069/2015). EMA.
• Hochberg, M. C., et al. (2012). American College of Rheumatology 2012 recommendations for the use of nonpharmacologic and pharmacologic therapies in osteoarthritis of the hand, hip, and knee. Arthritis Care & Research, 64(4), 465-474.
• International Association for the Study of Pain. (2020). IASP Terminology and Global Pain Management Recommendations.
• McAlindon, T. E., et al. (2014). OARSI guidelines for the non-surgical management of knee osteoarthritis. Osteoarthritis and Cartilage, 22(3), 363-388.
• World Health Organization. (2012). Guidelines on the Pharmacological Treatment of Persisting Pain in Adults. WHO.
• World Health Organization. (2019). WHO Model List of Essential Medicines (21st List). WHO.

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Sincerely,

Debaprasad Bandyopadhyay

COPY TO:

• Shri A.H. Laddhad, Prothonotary and Senior Master, Bombay High Court (With reference to Case No. S/42/2025)
• Secretary, Ministry of Health and Family Welfare (MoHFW)
• Drugs Controller General of India (DCGI / CDSCO)
• Chairperson, Food Safety and Standards Authority of India (FSSAI)
• Secretary, Indian Council of Medical Research (ICMR)
• Director General, Directorate General of Health Services (DGHS)
• Secretary, Ministry of Agriculture and Farmers’ Welfare
• Secretary, Ministry of Environment, Forest and Climate Change (MoEFCC)
• Chairman, Central Pollution Control Board (CPCB)
• National Green Tribunal (NGT)
• Chairperson, Securities and Exchange Board of India (SEBI)
• Governor, Reserve Bank of India (RBI)
• Secretary, Ministry of Corporate Affairs (MCA)
• President, All India Drug Action Network (AIDAN)
• Director, Public Health Foundation of India (PHFI)
• President, Indian Medical Association (IMA)
• Secretary, Indian Pharmacological Society (IPS)
• Director-General, World Health Organization (WHO) / WHO Essential Medicines Division
• Executive Director, United Nations Environment Programme (UNEP)
• UN Special Rapporteur on Toxics and Human Rights
• Director, International Agency for Research on Cancer (IARC)
• Executive Director, Medicines Transparency Alliance (MeTA)
• Chairperson, Advertising Standards Council of India (ASCI)
• Prasar Bharati (Chairman, CEO, Member-Finance)
• U.S. Food and Drug Administration (FDA)
• European Medicines Agency (EMA)