Centre brings modern medical screening and consent norms to Siddha therapies

While the state's apex standards body views this uniform code as a critical step toward consumer safety, the new mandates have triggered a divide among traditional practitioners over adopting rigid, allopathic-style reporting rules.

The BIS has issued detailed codes of practice for the two Siddha therapies, introducing requirements for patient assessment, treatment documentation, monitoring and follow-up. The new norms, exclusively reviewed by Mint, seek to transform these traditionally practitioner-driven therapies into structured interventions with documented protocols for treatment administration and post-procedure care.

The move is significant as Siddha is a rapidly growing segment within the broader AYUSH (Ayurveda, Yoga & Naturopathy, Unani, Siddha, and Homeopathy) sector and is projected to reach $36.62 billion by 2031, according to the India Brand Equity Foundation (IBEF), an organisation supported by the commerce ministry. Industry observers said the move could help bring greater consistency in treatment delivery, training and quality assurance across Siddha institutions. The overall AYUSH sector itself is seeing rapid growth and increasing integration with mainstream healthcare services, experts said.

Rajiv Mehra, general secretary of the Federation of Associations in Indian Tourism and Hospitality (FAITH), said the new standards could boost confidence among wellness tourists seeking traditional treatments.

"This will enhance confidence among wellness travellers who visit southern states, particularly Tamil Nadu, for Siddha therapies. The absence of standardised protocols and regulatory oversight was proving to be a deterrent for some visitors. The introduction of screening protocols and informed consent processes will help improve transparency, strengthen patient safety and enhance the credibility of Siddha-based wellness services," Mehra said.

Until now, Siddha therapies have largely been administered based on institutional practices and physician judgement. The new BIS standards introduce a uniform framework covering patient assessment, informed consent, treatment records, infrastructure requirements and adverse-event reporting, bringing greater standardization to the delivery of these therapies.

As per the BIS documents, Siddha treatment centres will now be required to screen patients before administering therapy. Practitioners will be required to evaluate vital signs, medical history, existing illnesses, medication use, allergies and overall patient suitability before treatment.

In the case of Pugai therapy, patients must be free from fever and respiratory distress and maintain oxygen saturation levels of at least 98% before being exposed to medicated smoke. BIS has also standardised four methods of administration: nasal inhalation, oral inhalation, whole-room fumigation and localised fumigation for specific body parts.

For Poṭi Timirtal, practitioners must screen patients for skin disorders, varicose veins, fever, menstruation and pregnancy, as the therapy is considered unsuitable in such situations.

The standards also make written informed consent compulsory before treatment. Patients must be informed about the purpose of the therapy, expected benefits, possible risks, adverse effects, post-treatment care requirements and alternative treatment options. Separate consent formats have been prescribed, requiring both the patient and physician to acknowledge that the procedure, benefits and risks have been adequately explained before therapy is administered.

Additionally, the standards prescribe minimum infrastructure and safety requirements. Treatment rooms must display standard operating procedures, maintain hygiene protocols and keep emergency and safety equipment readily available. Therapists must use protective gear such as masks, gloves, head caps and aprons, while treatment centres must document and report complications ranging from dizziness and fainting to allergic reactions and respiratory distress.

“Protocols modelled on modern medicine are not necessarily wrong, but they should be adopted only to the extent required for traditional therapies, whose risk profile is generally different from that of chemical-based or invasive treatments," said Dr Rakesh Kotwal, medical officer (Ayurveda) of Kishtwar district in the Jammu & Kashmir government.

Countering this view, Dr Anand Vishal, professor at the department of medicine, Atal Bihari Vajpayee Institute of Medical Sciences and Dr Ram Manohar Lohia Hospital, New Delhi, said patient safety measures should apply across systems of medicine.

"The issue is not whether a medicine is natural or lab-produced. Any treatment given to a patient should follow basic safety protocols. Screening patients for underlying conditions, obtaining informed consent and maintaining records are standard healthcare practices across the world. Such measures improve accountability and patient safety,” Vishal said.