Table of Contents
Why in NEWS?
- The International Consortium of International Journalists (ICIJ) recently published the ‘Implants Files investigation’ on medical devices Indian medical devices
- industry is in serious need of examination.
Concerns highlighted?
- “Medical device adverse events” has gone up from 40 in 2014 to more than 550 in 2018
- Deaths after the installation of a stent
- . The question of devices that have been recalled elsewhere.
- Medical device manufacturers are not following up on their responsibility to track down the recipients of medical devices that have been withdrawn.
- They also do not pay the compensation that is consequent upon such withdrawals.
Drawbacks in India?
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- The global withdrawals are not being followed through in India.
- Not even a public list maintained by the regulator of devices that have been recalled from the global or Indian markets.
- In this case, the Central Drugs Standard Control Organisation (CDSCO) has the responsibility.
- The data maintained by the Indian Pharmacopoeia Commission, or IPC, is also worryingly incomplete. In India a device such as a pacemaker cost less in the market and much more when implanted in a hospital. No specific rules or a law that allows the government to direct a medical device company to give compensation to a victim after the device has been found faulty.
Way forward
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- Engineering and medicine.
- It involves the creation of machines that are then used to support life within the human body.
- Careful regulation but also the highest ethical standards.
- The government to reinvigorate both the IPC and the CDSCO, and to give them more resources and a clearer mandate
- . Here are proposals that the government might include a special clause under the Medical Device Rules to include compensation for patients.
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- But the patient can always approach a consumer court to seek damages from the device company.
- Emergence of faulty hip implants from Johnson & Johnson, the Ministry of Health and Family Welfare is working on a formula for compensation.
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