1. Absence of Central Regulatory Authority

India currently lacks a regulatory framework exclusively governing Hyperbaric Oxygen Therapy (HBOT). However, several centers adopt guidelines including UHMS, BSAC, and EUBA, aligning them with local healthcare practices.

2. Clinical Governance through NABH

• The National Accreditation Board for Hospitals & Healthcare Providers (NABH) provides accreditation pathways for Hyperbaric Units under allied healthcare services.
• NABH-certified facilities follow established protocols for patient safety, chamber operations, documentation, and infection prevention measures.
• Accreditation enhances quality standards and facilitates insurance processes and collaborations.

3. Chamber Safety and Medical Device Standards

• Hyperbaric chambers should comply with applicable BIS requirements and commonly follow ASME/PVHO, CE, or FDA standards.
• Electrical systems, fire protection, and pressure safety must align with healthcare infrastructure regulations.
• Relevant authorities including CDSCO, AERB, or local agencies may oversee biomedical waste management and fire safety compliance.

4. Professional Training and Guidelines

• A HBOT training program is yet to be established, although institutions such as AFMC Pune follow UHMS-based protocols.
• IHDMA promotes adherence to standards for expertise, technical training, and professional credentialing.

5. Insurance and Billing Considerations

• HBOT insurance coverage remains variable across India.
• NABH accreditation and documentation of approved indications can improve claim acceptance.
• Use of HBOT for non-approved or experimental applications may involve regulatory concerns and is discouraged.

6. Need for National Standards

IHDMA continues to advocate for a policy, registry, and training framework for HBOT in India. This initiative requires collaboration among MoHFW, NABH, IHDMA, and organizations to promote safety, ethical practices, and consistency in quality implementation.