Paediatrician served legal notice by pharma firms over ORS remarks, doctors flag threat to public health advocacy

Hyderabad: A Hyderabad-based paediatrician who had raised concerns over the marketing of oral rehydration products has been served a legal notice by pharmaceutical companies, alleging that her social media statements about their products are misleading and defamatory.

The development has drawn reactions from medical associations, which have expressed concern over the notice and stated that doctors should be able to raise evidence-based public health issues. The matter comes in the backdrop of recent regulatory action restricting the use of the term ORS on product labels unless they meet prescribed standards.

Legal notice to Paediatrician:

The Hyderabad-based paediatrician, Dr Sivaranjani Santosh, who advocates for public health concerns over sugar-laden products marketed alongside Oral Rehydration Solutions (ORS), which later led to a key regulatory shift in ORS labelling, has now been issued a legal notice by pharma majors.

After this prolonged battle, Dr Santosh is now facing legal trouble. The pharma companies have accused her of making false, misleading, disparaging, and defamatory remarks on social media about their products.

Medical Dialogues had reported that after the doctor's multiple pleas, Food Safety and Standards Authority of India (FSSAI) has issued an order prohibiting the use of the term 'ORS' (Oral Rehydration Salts) on beverage labels unless the formulation strictly adheres to the World Health Organization (WHO) recommended standards.

However, in the recent legal notice issued on March 16, two major pharma companies accused Dr Santosh of making slanderous remarks on social media about ORSL (Oral Rehydration Salt and Liquid) and its rebranded variant, ERZL.

The companies said in their legal notice that they are following the rules under the Food Safety and Standards Act, 2006, and that their claims are backed by government approvals and scientific evidence.

They also referred to ongoing legal proceedings in the Delhi High Court, where the judge observed that the products are “not adulterated or unsafe for use” and that the issue is mainly about branding.

The notice further stated that distributors have been told to return or relabel old stock as per FSSAI guidelines. The companies denied claims that older ORSL products are still being sold or that ERZL is being promoted as a replacement for ORS.

They have also asked the doctor to stop using their trademarks without permission, remove any posts they consider defamatory, and avoid making any negative statements about them or their products.

"Your claim of ORSL and ERZL being similar are absolutely baseless. In compliance of the FSSAl orders and directions, our clients have transitioned to a new brand ERZL which does not contain any reference of ORS. In fact, both the marks ORSL and ERZL cannot be said to be similar by any stretch of imagination. Clearly, as a doctor it is not your expertise to understand the regulatory framework as well as scientific risk assessment which is a specialized subject and therefore, making such false and derogatory remarks including alleged similarity of marks etc. against our clients and their products is clearly unwarranted and needs to be deprecated," the notice read.

The notice further added, "It is pertinent to mention that the Hon'ble Delhi High Court has categorically held that the product is not adulterated or unsafe for use. Additionally, since our clients have already re-branded the erstwhile ORSL brand to distinct ERZL brand, your reference of our client's and also product as Fake ORS amounts to trade libel."

In response to the allegations and the notice, the doctor taking the matter on social media platform 'X' (formerly Twiiter) posted, "How dare you send me a notice that I am maligning the names of ORSL and ERZL for my own commercial benefits and for increasing the number of followers for my page, and that you will drag me to the court."

She added, "My stance is predated and vindicated by the FSSAI order of October 14th and 15th. Delhi High Court clearly refused to give a stay. Saying ERZL is the new form of ORSL is a clear violation of the ban order and is misleading those people who still believe ORSL is ORS. Your notice is being processed by our lawyers and they will deal with it."

Support from the Medical Community

Coming in support of the doctor, the Federation of All India Medical Association (FAIMA) strongly condemned the notice and any attempt to intimidate or silence a medical professional for raising evidence-based concerns in the interest of patient safety and public health.

The association said that a practising paediatrician, highlighting the potential for caregiver confusion arising from the sale and branding of products alongside ORS in pharmacies, is not only within her professional competence but also a reflection of her ethical duty.

"Such commentary falls well within the ambit of fair comment and the constitutional right to freedom of speech, particularly when it pertains to matters of significant public health importance. It is deeply concerning that a clinician’s expertise in safeguarding child health is being questioned in matters that directly affect pediatric care. Medical professionals have both the authority and responsibility to raise concerns about products that may be misconstrued as therapeutic agents, especially in vulnerable populations such as children," FAIMA stated.

FAIMA also notes that regulatory developments, including actions by the Food Safety and Standards Authority of India (FSSAI), have already acknowledged concerns regarding misleading branding practices. This, according to the association, underscores that the issues raised were neither baseless nor malicious, but aligned with legitimate regulatory scrutiny.

Further, referencing globally recognised scientific guidelines, including those of the World Health Organisation (WHO), FAIMA said it is a standard and accepted practice in evidence-based medicine. Scientific discourse thrives on continuous evaluation and debate, and cannot be curtailed through legal pressure.

"The demands reportedly made in the legal notice, including removal of content and restrictions on future commentary, raise serious concerns regarding prior restraint on free speech, which has consistently been viewed with caution under Indian constitutional jurisprudence. FAIMA views such legal action as a form of corporate intimidation that risks creating a chilling effect on healthcare professionals who speak in the interest of patient welfare. Public health advocacy must not be equated with defamation, nor should it be suppressed through threats of litigation," mentioned the press note.

Following this, the association strongly condemn the issuance of the legal notice to Dr Sivaranjani Santosh and extends full support to her in her commitment to patient safety and ethical medical practice. It also called upon the concerned companies to immediately withdraw the legal notice and urged regulatory authorities to ensure strict oversight of product labelling, marketing, and placement in healthcare settings.

It further asserted the right and duty of doctors to raise evidence-based public health concerns without fear and appealed to the medical fraternity to remain united in defending scientific integrity and public health advocacy.

Similarly, Telangana Junior Doctors Association (T-JUDA) also opposed the legal notice against the paediatrician. "The Telangana Junior Doctors Association (T-JUDA) expresses its strongest condemnation of the legal notice issued to paediatrician Dr Santosh by Johnson & Johnson Health Equity and Kenvue companies for raising legitimate, evidence-based public health concerns. Dr Santosh has responsibly highlighted the issue of high-sugar beverages being marketed in a manner that may mislead the public as Oral Rehydration Solutions (ORS). Her concerns are rooted purely in safeguarding child health and promoting rational medical practice. T-JUDA views this legal action as unwarranted and deeply concerning. It appears to be an attempt to intimidate a medical professional who is fulfilling her ethical duty toward patient safety and public health," the press note mentioned.

T-JUDA firmly stated that public health advocacy is not defamation, scientific concerns must be addressed with transparency and evidence and not legal intimidation and that doctors must be free to speak in the interest of patient welfare without fear

The association reiterated that no doctor should be threatened for protecting patients. Furthermore, if the legal notice is not withdrawn promptly, T-JUDA, in coordination with other medical associations, will consider a united and appropriate course of action against such actions that undermine public health advocacy.

Meanwhile, Telangana Senior Resident Doctors Association (T-SRDA) also extended their support to the pediatrician and strongly condemned the legal notice agaisnt the doctor.

"T-SRDA stands in complete solidarity with Dr Sivaranjani Santosh and all healthcare professionals committed to patient safety and ethical medical practice," the press note stated.

Also read- Only WHO-Compliant Formulas Can Use ORS Tag: FSSAI Cracks Down on Misleading Beverage Labels