"Government Launches 7th National Formulary, Approves Biovigilance Programme"
Pharmacovigilance
science of detecting, assessing and preventing adverse effects of medicines after use.
Materiovigilance
safety monitoring of adverse events linked to medical devices.
India's drug-safety regulatory framework rests on the Drugs and Cosmetics Act, 1940 and is implemented through the Central Drugs Standard Control Organisation (CDSCO) under the Ministry of Health and Family Welfare. The Indian Pharmacopoeia Commission (IPC), an autonomous institution under the same Ministry, publishes the Indian Pharmacopoeia (IP), the official book of drug-quality standards used for regulatory approval and manufacturing in India. IPC also functions as the National Coordination Centre for the Pharmacovigilance Programme of India (PvPI), the national system for detecting, assessing and preventing adverse effects of medicines after they reach patients.
Pharmacovigilance in India has grown steadily since PvPI's launch, expanding into a nationwide network of ADR reporting centres across public and private hospitals and medical colleges. Alongside PvPI, IPC coordinates the Materiovigilance Programme of India (MvPI), which tracks adverse events linked to medical devices rather than medicines. Both feed into India's contribution to the World Health Organization's global drug-safety database, part of the WHO Programme for International Drug Monitoring.
The National Formulary of India (NFI) is a periodically revised guidance document that turns scientific evidence on medicines into practical prescribing advice for doctors and pharmacists. Unlike the National List of Essential Medicines (NLEM), which decides which medicines should be available and affordable, the NFI focuses on how these medicines should be used correctly, covering dosage, precautions and rational combinations. Its 7th edition continues this role and is also available online for easier access.
PvPI's core mechanism is spontaneous reporting. Healthcare professionals, and increasingly patients, report suspected adverse drug reactions through hospitals, helplines or mobile applications. …
Match the following vigilance programmes with the area they monitor:
List I (Programme)
A.Pharmacovigilance Programme of India
B.Materiovigilance Programme of India
C.Biovigilance Programme of India
List II (Monitored Area)
1.Medical devices
2.Organ and tissue transplantation
3.Medicines
Select the correct answer using the code given below:
Consider the following statements regarding drug-safety monitoring in India:
1.The Pharmacovigilance Programme of India (PvPI) is coordinated by the National Coordination Centre at the Indian Pharmacopoeia Commission (IPC).
2.The Indian Pharmacopoeia Commission functions under the Ministry of Health and Family Welfare.
Which of the statements given above is/are correct?
With reference to global drug-safety monitoring, consider the following statements:
1.The WHO Programme for International Drug Monitoring maintains a global database of adverse drug reaction reports contributed by member countries.
2.India's contribution ranking to this database has improved significantly over the past decade.
Which of the statements given above is/are correct?
The National Formulary of India (NFI) differs from the National List of Essential Medicines (NLEM) in that:
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