PHARMACOVIGILANCE PROGRAMME OF AYURVEDA, SIDDHA, UNANI AND HOMEOPATHY (ASU & H) DRUGS

PHARMACOVIGILANCE PROGRAMME OF AYURVEDA, SIDDHA, UNANI AND HOMEOPATHY (ASU & H) DRUGS

• Pharmacovigilance refers to the science and activities related to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems.

• For traditional medicine systems like Ayurveda, Siddha, Unani, and Homeopathy, pharmacovigilance plays a vital role in ensuring the safety and efficacy of classical and proprietary formulations.

• The Department of AYUSH launched the Pharmacovigilance Programme for ASU&H Drugs to strengthen patient safety and promote rational use of medicines in traditional systems.

SANSKRIT REFERENCE ON DRUG SAFETY

"न हि सर्वेषु कालेषु सर्वं सर्वत्र साधनम्।
स्वभावतो वा दोषेण कार्याण्यन्यथास्युरपि॥"
— Charaka Samhita, Sutrasthana 30/26
(Translation: Not all treatments are suitable at all times and places; due to inherent nature or defects, the intended action may sometimes fail.)

NEED FOR PHARMACOVIGILANCE IN ASU & H DRUGS

• Increased usage of traditional medicines globally.

• Self-medication practices are common.

• Adulteration, substitution, and contamination of drugs.

• Irrational combinations in proprietary formulations.

• Reported cases of drug-induced toxicity (e.g., heavy metal toxicity).

• Drug interactions with modern medicine in integrative treatment.

OBJECTIVES OF THE PROGRAMME

• To develop a systematic reporting system for adverse drug reactions (ADRs) of ASU&H drugs.

• To document and analyze data to ensure drug safety.

• To educate and create awareness among stakeholders (physicians, pharmacists, manufacturers, and patients).

• To recommend regulatory decisions based on ADR data.

• To promote rational use of ASU&H medicines.

STRUCTURE OF THE PHARMACOVIGILANCE PROGRAMME

• Launched by: Ministry of AYUSH, Government of India in 2008.

• National Coordinating Centre (NCC): All India Institute of Ayurveda (AIIA), New Delhi.

• Peripheral Pharmacovigilance Centres (PPvCs): Located in colleges, hospitals, and research institutions.

• Intermediary Pharmacovigilance Centres (IPvCs): Monitor and analyze data received from PPvCs.

• Data is uploaded to the central portal: www.ayushsuraksha.com

CATEGORIES OF PHARMACOVIGILANCE ACTIVITIES

• Adverse Drug Reaction Monitoring

  • Spontaneous reporting of suspected ADRs.

  • Causality assessment using WHO-UMC scale.

• Documentation of Classical Toxicity

  • Based on textual references (e.g., visha dravya, uparasa, nishiddha yogas).

• Monitoring Misbranded, Adulterated, Spurious Drugs

  • Enforcement under Drugs & Cosmetics Act 1940, Rule 158(B).

• Case documentation of heavy metal toxicity and adverse events associated with Rasa aushadhis.

• Public awareness programmes and training of stakeholders.

MODERN CONCEPTS AND TOXICOLOGY IN RASASHASTRA

• Heavy metals like Mercury (Parada), Arsenic (Haratala), Lead (Naga), etc., though processed (Shodhana & Marana), can cause toxicity if improperly handled.

• Studies show biotransformation and detoxification reduce toxicity post-Shodhana.

• Emphasis on analytical quality control using ICP-MS, AAS, HPLC, TLC, GC-MS.

• Good Manufacturing Practices (GMP) and Shelf-life standards are mandated.

• Monitoring herb-drug interactions in co-administered therapies.

KEY GUIDELINES AND REGULATIONS

• Drugs and Cosmetics Act, 1940 & Rules 1945: Rule 158(B) – Essential requirements for safety & efficacy of ASU drugs.

• Schedule T: GMP requirements for Ayurvedic drugs.

• Pharmacopoeial standards from API (Ayurvedic Pharmacopoeia of India) and UNANI Pharmacopoeia.

• Reporting tools: AYUSH Adverse Drug Reaction reporting form available on AYUSHSuraksha portal.

ROLE OF PHYSICIANS AND STUDENTS

• Encourage ADR reporting even if unsure of causality.

• Maintain patient records with clear documentation of ASU drug history.

• Understand indications, contraindications, drug interactions from classical and modern perspectives.

• Utilize classical references for rational formulation use and avoid pravritta yogas with known toxic potential.

"युक्तियोगं हि भैषज्यमग्निदोषानुसारतः।
नात्यर्थमोषधं कुर्यान्न ही स्याच्छान्तिकारणम्॥"
— Ashtanga Hridaya, Sutrasthana 1/14
(Translation: The medicines should be used judiciously in appropriate combinations according to the doshas and agni, excessive use is not beneficial.)

CHALLENGES IN IMPLEMENTATION

• Lack of awareness among practitioners and patients.

• Incomplete ADR reporting due to fear or ignorance.

• Inadequate analytical facilities in many institutions.

• Poor documentation and record-keeping practices.

• Traditional belief that Ayurveda drugs are always safe delays reporting.

STRATEGIES TO STRENGTHEN PHARMACOVIGILANCE IN ASU&H

• Inclusion of Pharmacovigilance training in BAMS curriculum.

• Regular CME programs, workshops, and awareness campaigns.

• Strong collaboration between regulators, academia, industry, and physicians.

• Use of mobile apps and digital portals for easy ADR reporting.

• Development of digital pharmacovigilance databases and research integration.