CENTRAL SECTOR SCHEME AND CENTRES OF PHARMACOVIGILANCE OF ASU & H DRUGS

CENTRAL SECTOR SCHEME AND CENTRES OF PHARMACOVIGILANCE OF ASU & H DRUGS

• The Central Sector Scheme (CSS) and Pharmacovigilance Programme for Ayurveda, Siddha, Unani, and Homoeopathy (ASU & H) drugs are crucial regulatory and quality control measures under the Ministry of AYUSH, Government of India.

• These initiatives aim to ensure the safety, efficacy, and rational use of traditional medicines.

• The focus is on standardization, monitoring of adverse drug reactions (ADRs), and strengthening institutional mechanisms.

CENTRAL SECTOR SCHEME (CSS) FOR DEVELOPMENT OF AYUSH DRUGS

• Launched by the Ministry of AYUSH, Government of India.

• Focuses on regulatory development, quality assurance, and pharmacovigilance of ASU & H drugs.

• Objectives:

  • To ensure the safety and efficacy of ASU & H drugs.

  • To strengthen the drug testing laboratories and State Drug Licensing Authorities (SDLAs).

  • To promote good manufacturing practices (GMP) among ASU & H drug manufacturers.

  • To support documentation and scientific validation of classical formulations.

  • To provide financial assistance for the establishment of Pharmacovigilance Centres.

KEY COMPONENTS OF CSS FOR DRUG DEVELOPMENT

• Support for Pharmacovigilance Centres.

• Upgradation of State Pharmacies and Drug Testing Laboratories.

• Awareness Programs and Workshops.

• Surveillance and Quality Assurance Measures.

• Incentivizing GMP Certification.

PHARMACOVIGILANCE PROGRAMME OF ASU & H DRUGS

• Launched in 2008 and revised in 2017 under the Central Sector Scheme.

• Objective: Detection, assessment, understanding, and prevention of adverse effects or any other possible drug-related problems.

• Structured into a three-tier system:

  • National Pharmacovigilance Co-ordination Centre (NPvCC)

  • Intermediary Pharmacovigilance Centres (IPvCs)

  • Peripheral Pharmacovigilance Centres (PPvCs)

NATIONAL PHARMACOVIGILANCE CO-ORDINATION CENTRE (NPvCC)

• Currently functioning at All India Institute of Ayurveda (AIIA), New Delhi.

• Responsibilities:

  • Overall coordination of the pharmacovigilance programme.

  • Data compilation and submission to the Ministry of AYUSH.

  • Training and capacity building.

INTERMEDIARY PHARMACOVIGILANCE CENTRES (IPvCs)

• Located in research councils, national institutes, and universities.

• Roles include supervision of peripheral centres, training, ADR assessment, and data forwarding.

• Examples:

  • National Institute of Ayurveda (NIA), Jaipur

  • Institute for Post Graduate Teaching and Research in Ayurveda (IPGT&RA), Jamnagar

PERIPHERAL PHARMACOVIGILANCE CENTRES (PPvCs)

• Established in teaching hospitals and colleges across India.

• Responsibilities:

  • Reporting ADRs from ASU & H drug use.

  • Educating healthcare professionals on reporting mechanisms.

  • Ensuring data flow to IPvCs.

REPORTING PROCESS

• Adverse Drug Reaction (ADR) reporting through:

  • Suspect Adverse Drug Reaction Reporting Form.

  • Mobile application and online portals (PvPI/AYUSH).

• Collected data is scientifically analyzed and used for regulatory decisions.

MODERN ASPECTS FROM MODERN RASASHASTRA & BHAISHAJYA KALPANA

• Pharmacovigilance is a mandatory part of pharmacological studies.

• Emphasis on post-marketing surveillance (PMS) of Ayurvedic medicines.

• Focus on phytochemical analysis, heavy metal content, and toxicity studies.

• Role of clinical trials and ethical committees in evaluating classical formulations.

• Use of analytical instruments (HPLC, GC-MS, AAS) to detect contamination or adulteration.

• Rasaushadhis (herbo-mineral preparations) undergo extensive safety profiling.

• Integration with modern pharmacology to develop evidence-based AYUSH drugs.

IMPORTANT CLASSICAL REFERENCES RELATED TO DRUG SAFETY AND TOXICITY

• चरकसंहिता (Charka Samhita), Kalpa Sthana
  "दोषाः सर्वेऽपि द्रव्याणां, संशोधनविशेषतः।"
  (Caraka Kalpa Sthana 1/3)
  All substances have inherent faults; purification techniques are necessary for safe use.

• सुश्रुतसंहिता (Sushruta Samhita), Sutra Sthana
  "येन यथा यदाभ्यस्तं तदेव तस्य लभ्यते।"
  (Sushruta Sutra Sthana 1/22)
  Whatever drug is used in the right manner and dose gives the desired effect.

• अष्टाङ्गहृदय (Ashtanga Hridaya), Kalpa Sthana
  "विशुद्धं हि रसं शक्तं रोगाणां नाशनं परम्।"
  (Ashtanga Hridaya Kalpa Sthana 1/8)
  Properly purified rasa (metal/mineral) is potent and capable of curing diseases.

• काश्यपसंहिता (Kashyapa Samhita), Khilastana
  "औषधं हि यथाविद्यं हितं भवति देहिनाम्।"
  Only well-understood and correctly used medicines are beneficial to the body.

SIGNIFICANCE OF PHARMACOVIGILANCE IN AYUSH

• Builds public trust in traditional medicine systems.

• Minimizes adverse events and therapeutic failure.

• Promotes scientific validation of formulations.

• Strengthens international acceptance and trade.

• Encourages responsible manufacturing and prescribing practices.

• Aids in pharmaco-epidemiological studies and database creation.

CHALLENGES AND SCOPE FOR IMPROVEMENT

• Underreporting of ADRs.

• Lack of awareness among practitioners and patients.

• Insufficient integration of pharmacovigilance in the UG/PG curriculum.

• Need for wider implementation of Standard Operating Procedures (SOPs).

• Training in documentation and vigilance reporting protocols.

• Expansion of public-private partnerships and technological tools for real-time monitoring.