For Prelims: Materiovigilance, RTI Act, 2005 - Section 8(1)(d), Central Information Commission (CIC), Indian Pharmacopoeia Commission (IPC), Total SAEs (2020-2025), SAEs in 2025, Nodal Body for MvPI, Regulatory Body for Action
For Mains: Materiovigilance, Regulatory transparency, Patient safety, RTI Act exemptions
Source:
Indian Express
5 facts for one-day exams
SSC, railway, police and teaching exams ask direct questions like these.
- The IPC disclosed 9,373 Serious Adverse Events (SAEs) from medical devices from 2020 to 2025.
- SAEs jumped nearly three-fold from 808 in 2020 to 2,176 in 2025.
- The data was released after a CIC order under the RTI Act on September 10, 2026.
- The Materiovigilance Programme of India (MvPI) was launched in 2015 under the IPC.
- The IPC's online portal for reporting adverse events is the Adverse Drug Monitoring System (ADRMS).
Why in the news?
The Indian Pharmacopoeia Commission (IPC) has disclosed, for the first time, that 9,373 Serious Adverse Events (SAEs) from medical devices were logged since 2020, with a nearly three-fold rise from 808 to 2,176 in 2025. The data was released after a Central Information Commission (CIC) order under the RTI Act, highlighting transparency gaps in India's Materiovigilance Programme of India (MvPI).
Summary
- The IPC disclosed 9,373 Serious Adverse Events (SAEs) from medical devices from 2020 to 2025, with a jump from 808 to 2,176 in 2025.
- The data was accessed under the RTI Act following a CIC order that overruled IPC's objections citing commercial confidence under Section 8(1)(d).
- Only a tiny fraction of Medical Device Adverse Events (MDAEs) are forwarded to the CDSCO for action: 22 of 14,584 in FY 2024-25.
Highlights
3-fold SAE Jump
Serious Adverse Events from medical devices rose from 808 in 2020 to 2,176 in 2025, totalling 9,373 over six years.
RTI Disclosure
Data was released only after a CIC order, as IPC had withheld serious event figures citing commercial confidence under Section 8(1)(d) of the RTI Act.
Low Regulatory Action
Only 22 of 14,584 MDAEs in FY 2024-25 were forwarded to CDSCO, raising concerns about the effectiveness of the Materiovigilance Programme.
Background
The Materiovigilance Programme of India (MvPI) was launched in 2015 under the IPC to monitor adverse events related to medical devices. The IPC has 775 monitoring centres across India. Despite this network, the IPC had classified SAE data as restricted, only disclosing broad MDAE figures in its annual reports. This changed after an RTI appeal by The Indian Express led to a CIC order on September 10, 2026.
Key Analysis and Impact
The nearly three-fold rise in SAEs from 808 to 2,176 over six years indicates either a genuine increase in device-related harm or improved reporting. However, the extremely low number of cases forwarded to CDSCO (22 out of 14,584 MDAEs in 2024-25) suggests systemic under-reporting of serious events or a weak regulatory follow-up mechanism. The IPC's refusal to disclose brand and manufacturer details, citing commercial confidence, limits public accountability and patient safety oversight.
Way Forward
India needs a public, searchable database akin to the US MAUDE system, which provides granular details on device-related deaths and injuries. Strengthening the MvPI with mandatory reporting, faster regulatory action by CDSCO, and clearer guidelines on RTI disclosure exemptions for medical devices would enhance patient safety and transparency.
Background GK
Textbook concepts you need to understand this news
- Materiovigilance
- The systematic monitoring of adverse events associated with medical devices, analogous to pharmacovigilance for drugs.
- RTI Act, 2005 - Section 8(1)(d)
- Exempts from disclosure information that relates to commercial confidence, trade secrets, or intellectual property, the disclosure of which would harm the competitive position of a third party.
- Central Information Commission (CIC)
- A statutory body established under the RTI Act, 2005, that hears appeals against decisions of Central Public Information Officers.
- Indian Pharmacopoeia Commission (IPC)
- An autonomous body under the Ministry of Health and Family Welfare that sets official standards for drugs and pharmaceutical products in India.
Facts to remember
Tap a card to see the answer. Try to recall it first.
How exams will ask this
- Data: 9,373 SAEs from medical devices (2020-2025); 2,176 in 2025
- Nodal Body: Indian Pharmacopoeia Commission (IPC) under Ministry of Health and Family Welfare
- Legal Point: Section 8(1)(d) of the RTI Act, 2005
Don't make this mistake!
They may confuse Materiovigilance Programme of India (MvPI) with Pharmacovigilance Programme of India (PvPI) or swap the nodal body from IPC to CDSCO. Remember: IPC runs MvPI; CDSCO takes regulatory action on forwarded cases.
Write these in mains answers
- Materiovigilance, Regulatory transparency, Patient safety, RTI Act exemptions
Stuck? Get it in one tap
Medical devices like stents, ventilators, and syringes can sometimes cause serious harm to patients. The Indian Pharmacopoeia Commission (IPC) tracks these 'Serious Adverse Events' but had kept the numbers secret. After a newspaper filed an RTI appeal, the Central Information Commission ordered the IPC to release the data. The numbers show that serious events have nearly tripled from 808 in 2020 to 2,176 in 2025. However, very few of these cases are actually sent to the drug regulator for action, raising questions about patient safety.
- The IPC disclosed 9,373 Serious Adverse Events (SAEs) from medical devices from 2020 to 2025.
- SAEs jumped nearly three-fold from 808 in 2020 to 2,176 in 2025.
- The data was released after a CIC order under the RTI Act on September 10, 2026.
- The Materiovigilance Programme of India (MvPI) was launched in 2015 under the IPC.
- The IPC's online portal for reporting adverse events is the Adverse Drug Monitoring System (ADRMS).
- Governance: RTI Act and transparency
- Science and Technology: Medical devices and health technology
Related concepts: Materiovigilance, RTI Act, 2005 - Section 8(1)(d), Central Information Commission (CIC), Indian Pharmacopoeia Commission (IPC)
Practice questions
Pick an answer, then read the explanation.
- Q1Easy
Which body is responsible for implementing the Materiovigilance Programme of India (MvPI)?
Explanation: The IPC is the nodal body for MvPI, which monitors adverse events from medical devices. CDSCO takes regulatory action on forwarded cases but does not run the programme. NPPA handles drug pricing, and DTAB advises on technical matters.
- Q2Hard
Consider the following statements:
- 1.The IPC disclosed SAE data for medical devices only after a CIC order under the RTI Act.
- 2.All MDAEs reported to the IPC are automatically forwarded to the CDSCO for action.
- 3.The IPC has an online portal called Adverse Drug Monitoring System (ADRMS) for reporting adverse events.
Which of the statements given above is/are correct?
Explanation: Statement 1 is correct: the data was released after a CIC order on September 10. Statement 2 is incorrect: only a tiny fraction of MDAEs (22 out of 14,584 in 2024-25) are forwarded to CDSCO. Statement 3 is correct: the ADRMS portal is used for reporting adverse events related to medical devices.
- Q3Medium
What was the total number of Serious Adverse Events (SAEs) from medical devices logged by the IPC between 2020 and 2025?
Explanation: The IPC disclosed 9,373 SAEs for the period 2020-2025.
- Q4Medium
What is the primary objective of the Materiovigilance Programme of India (MvPI)?
Explanation: MvPI is specifically designed for monitoring adverse events from medical devices, similar to how pharmacovigilance tracks drug reactions. Pricing is handled by NPPA, import regulation by CDSCO, and drug certification by IPC's pharmacopoeia standards.
Frequently asked questions
1. What is the Materiovigilance Programme of India (MvPI)?
MvPI is a programme launched in 2015 under the Indian Pharmacopoeia Commission (IPC) to monitor and report adverse events related to medical devices.
2. How many Serious Adverse Events (SAEs) from medical devices were reported in India between 2020 and 2025?
A total of 9,373 SAEs were reported, with a nearly three-fold increase from 808 in 2020 to 2,176 in 2025.
3. Which section of the RTI Act was cited by the IPC to withhold device manufacturer details?
The IPC cited Section 8(1)(d) of the RTI Act, 2005, which exempts information related to commercial confidence and third-party information.
4. Which body takes regulatory action on adverse events forwarded by the IPC?
The Central Drugs Standard Control Organisation (CDSCO) takes necessary action on cases forwarded by the IPC.
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- Original6 November 2026 · Read story
