The standard establishes a structured Indian Standard framework for organizations operating or establishing pharmacovigilance centres associated with ASU&H systems. It provides a common reference for service delivery, operational controls, documentation and quality practices relevant to pharmacovigilance activities.

What is IS 19792 : 2026?

IS 19792 : 2026 is an Indian Standard defining service requirements for pharmacovigilance centres associated with Ayurveda, Siddha, Sowa-Rigpa, Unani and Homoeopathy systems.

The standard provides organizations with a structured reference for establishing and operating pharmacovigilance services in a consistent and controlled manner.

What is Pharmacovigilance?

Pharmacovigilance generally relates to activities concerned with identifying, evaluating, understanding and managing safety information associated with medicinal products.

Within ASU&H systems, a structured pharmacovigilance centre can support systematic collection and evaluation of safety-related information and help strengthen service quality and documentation.

Systems Covered Under IS 19792

IS 19792 : 2026 applies to pharmacovigilance centres working with the following systems:

• Ayurveda

• Siddha

• Sowa-Rigpa

• Unani

• Homoeopathy

Purpose of IS 19792

The purpose of the standard is to provide a common service-quality framework for organizations involved in pharmacovigilance activities relating to ASU&H systems.

Standardized service requirements can help establish consistent operating practices, defined responsibilities, appropriate documentation and systematic management of pharmacovigilance activities.

Importance of Service Standardization

Pharmacovigilance activities involve structured handling of safety-related information. A dedicated service standard helps organizations develop consistent processes and provides a common benchmark for evaluating the quality of pharmacovigilance-centre operations.

The standard may also support internal quality systems, service audits, organizational assessment and improvement of pharmacovigilance processes.

Who Uses IS 19792?

• Pharmacovigilance centres: To establish and maintain structured service practices for ASU&H pharmacovigilance activities.

• Ayurveda, Siddha, Sowa-Rigpa, Unani and Homoeopathy institutions: To reference standardized service requirements when operating pharmacovigilance activities.

• Healthcare and research organizations: To support structured collection and evaluation of safety-related information.

• Quality and compliance teams: To assess service processes against an established Indian Standard.

• Auditors and assessors: To use the standard as a technical reference when reviewing pharmacovigilance-centre service systems.

Is BIS Certification Required Under IS 19792?

IS 19792 : 2026 is a service-requirements standard and not a product specification. Therefore, it should not be presented as a conventional ISI Mark product certification standard.

Organizations may use the standard as a reference for developing, evaluating and improving their pharmacovigilance-centre service systems. Any certification or conformity-assessment route should be evaluated separately based on the applicable BIS scheme and regulatory requirements.

Benefits of Implementing IS 19792

• Provides a standardized framework for ASU&H pharmacovigilance-centre services.

• Supports consistent operational and quality-control practices.

• Helps define responsibilities and structured service processes.

• Supports internal assessment and continuous improvement.

• Provides a common technical reference for organizations, auditors and stakeholders.

Frequently asked questions (FAQ)

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