Pharmacovigilance Guidance Document for Marketing Authorization Holders of Pharmaceutical Products (Version: 2.0)
In India, Pharmacovigilance is governed by a dual framework: the New Drugs and Clinical Trial (NDCT) Rules, 2019 for clinical trials and the Pharmacovigilance Programme of India (PvPI) for post-marketing surveillance.
1. Clinical Safety (During Clinical Trials)
Requirements under the NDCT Rules, 2019 (which superseded Schedule Y) focus on trial participant safety:
-
SAE Reporting Timelines: Investigators must report any Serious Adverse Event (SAE) to the CDSCO, the Sponsor, and the Ethics Committee (EC) within 24 hours of occurrence.
-
Formal Reporting: The Sponsor must submit a detailed report on the SAE to the CDSCO within 14 days.
-
Medical Care & Compensation: Sponsors are legally mandated to provide free medical management and financial compensation for trial-related injuries or deaths. Compensation is calculated using specific formulas defined in the NDCT Rules.
-
Ethics Committee Oversight: Continuous monitoring by a registered EC is mandatory. The EC must review SAEs and provide recommendations on causality and compensation to the Central Licensing Authority.
-
Annual Status Reports: Sponsors must submit an annual report to the CDSCO summarizing the safety and progress of the trial.
2. Post-Marketing Pharmacovigilance
Once a drug is approved, the Pharmacovigilance Guidance Document for Marketing Authorization Holders (MAHs) (Version 2.0, 2024) dictates compliance:
-
Pharmacovigilance System Master File (PvMF): Every MAH must maintain a PvMF describing their Pharmacovigilance system. It must be located in India.
-
Pharmacovigilance Officer In-charge (PvOI): Companies must appoint a PvOI (Medical Officer or Pharmacist) based in India to oversee safety operations.
-
Periodic Safety Update Reports (PSURs):
-
For the first two years after approval: Submit every 6 months.
-
For the subsequent two years: Submit annually.
-
Submission must be made via the SUGAM portal within 30 days of the data lock point.
-
Expedited Reporting: All serious unexpected adverse reactions must be reported to the National Coordination Centre (NCC-PvPI) within 15 days.
-
Risk Management Plan (RMP): Required for new drugs to outline how safety risks will be monitored and mitigated in the real-world population.
Summary of Key Bodies
| Entity |
Role |
| CDSCO |
The central regulatory authority that enforces the Drugs and Cosmetics Act/Rules. |
| NCC-PvPI |
Located at the Indian Pharmacopoeia Commission (IPC); serves as the national hub for ADR data collection. |
| ADR Monitoring Centres (AMCs) |
Over 250 centers (mostly medical colleges) that collect and forward safety data to the NCC. |
Human Vaccines’ Safety Guidelines in India Version 2.
Toll-Free Number for Reporting
Helpline Number Managed by NCC PvPI to provide assistance in ADRs reporting for the HCPs and general public:
1800 180 3024 (All Working Days 9:00 AM to 5:30 PM IST)
Adverse Event reporting form for patients in Hindi & other Vernacular Languages
AYURVEDA, SIDDHA, UNANI and HOMOEOPATHY (AYUSH) - Pharmacovigilance
Please send the completed form to:
The centre from where the form is received
or to
The Coordinator,
National Pharmacovigilance Centre
All India Institute of Ayurveda,
Sarita Vihar,
New Delhi - 110 076
E-Mail: pharmacovigilanceayush@gmail.com
The ADR Probability Scale - AYUSH
Pharmacovigilance Guidance Document for Marketing Authorization Holders of Pharmaceutical Products (Version: 2.0)
In India, Pharmacovigilance is governed by a dual framework: the New Drugs and Clinical Trial (NDCT) Rules, 2019 for clinical trials and the Pharmacovigilance Programme of India (PvPI) for post-marketing surveillance.
1. Clinical Safety (During Clinical Trials)
Requirements under the NDCT Rules, 2019 (which superseded Schedule Y) focus on trial participant safety:
-
SAE Reporting Timelines: Investigators must report any Serious Adverse Event (SAE) to the CDSCO, the Sponsor, and the Ethics Committee (EC) within 24 hours of occurrence.
-
Formal Reporting: The Sponsor must submit a detailed report on the SAE to the CDSCO within 14 days.
-
Medical Care & Compensation: Sponsors are legally mandated to provide free medical management and financial compensation for trial-related injuries or deaths. Compensation is calculated using specific formulas defined in the NDCT Rules.
-
Ethics Committee Oversight: Continuous monitoring by a registered EC is mandatory. The EC must review SAEs and provide recommendations on causality and compensation to the Central Licensing Authority.
-
Annual Status Reports: Sponsors must submit an annual report to the CDSCO summarizing the safety and progress of the trial.
2. Post-Marketing Pharmacovigilance
Once a drug is approved, the Pharmacovigilance Guidance Document for Marketing Authorization Holders (MAHs) (Version 2.0, 2024) dictates compliance:
-
Pharmacovigilance System Master File (PvMF): Every MAH must maintain a PvMF describing their Pharmacovigilance system. It must be located in India.
-
Pharmacovigilance Officer In-charge (PvOI): Companies must appoint a PvOI (Medical Officer or Pharmacist) based in India to oversee safety operations.
-
Periodic Safety Update Reports (PSURs):
-
For the first two years after approval: Submit every 6 months.
-
For the subsequent two years: Submit annually.
-
Submission must be made via the SUGAM portal within 30 days of the data lock point.
-
Expedited Reporting: All serious unexpected adverse reactions must be reported to the National Coordination Centre (NCC-PvPI) within 15 days.
-
Risk Management Plan (RMP): Required for new drugs to outline how safety risks will be monitored and mitigated in the real-world population.
Summary of Key Bodies
| Entity |
Role |
| CDSCO |
The central regulatory authority that enforces the Drugs and Cosmetics Act/Rules. |
| NCC-PvPI |
Located at the Indian Pharmacopoeia Commission (IPC); serves as the national hub for ADR data collection. |
| ADR Monitoring Centres (AMCs) |
Over 250 centers (mostly medical colleges) that collect and forward safety data to the NCC. |
Human Vaccines’ Safety Guidelines in India Version 2.
Toll-Free Number for Reporting
Helpline Number Managed by NCC PvPI to provide assistance in ADRs reporting for the HCPs and general public:
1800 180 3024 (All Working Days 9:00 AM to 5:30 PM IST)
Adverse Event reporting form for patients in Hindi & other Vernacular Languages
AYURVEDA, SIDDHA, UNANI and HOMOEOPATHY (AYUSH) - Pharmacovigilance
Please send the completed form to:
The centre from where the form is received
or to
The Coordinator,
National Pharmacovigilance Centre
All India Institute of Ayurveda,
Sarita Vihar,
New Delhi - 110 076
E-Mail: pharmacovigilanceayush@gmail.com
The ADR Probability Scale - AYUSH
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