THE GIST of Editorial for UPSC Exams : 30 JULY 2019 (Patients and victims (Indian Express))

Patients and victims (Indian Express)

Mains Paper 2: Health
Prelims level : MoHFW
Mains level : Steps taken by government towards faulty hip implants

Context

• Last year, a series of reports in this paper revealed the traumatic experiences of Indian patients who had received faulty hip implants manufactured by the pharma major, Johnson and Johnson.
• Another investigation by this paper, last week, has revealed that Johnson and Johnson paid hefty compensations to US patients who had received the defective implants.

The report highlights

• In India, however, the company has challenged government orders to compensate 4,700 patients who had undergone hip replacement surgeries.
• The reports also highlight that the story is more than that of corporate negligence.
• That Johnson and Johnson continues to brazen it out in India has much to do with the regulatory deficit in the country.
• The investigations pertain to implants manufactured under two brand names, ASR and Pinnacle.
• Both products are not in the market currently.
• Johnson and Johnson recalled ASR from the global market in 2010, while Pinnacle was withdrawn in 2013.
• But recalling a medical device is not like recalling a consumer product. Defective implants can cause crippling pain even death.
• Patients who receive such implants need regular monitoring.
• In several countries, registries track the health of such patients.

Slow reaction process from the government

• In India, in contrast, regulators were slow to react. Maharashtra’s FDA red-flagged ASR a few months after Johnson and Johnson withdrew the product from the global market.
• But it took another year for the Central Drugs Standard Control Organisation to ban the import of ASR.
• Another year went by before the drug regulator issued an advisory to orthopaedic surgeons asking them to not implant ASR.
• These delays are significant because last year, Johnson and Johnson told a Union Ministry of Health and Family Welfare (MoHFW) expert committee that it cannot trace as many as 3,600 patients who underwent surgeries involving the faulty implant.
• That India did not have a joint registry when these surgeries happened has compounded the problem.
• The want of a registry has also come in the way of ascertaining the damage caused by Pinnacle.
• Johnson and Johnson claims that it has no adverse reports of the device in the country.
• However, reports in this paper have highlighted the trauma of at least seven patients with Pinnacle implants.
• In 2017, the MoHFW issued the Medical Devices Rules.

Way forward

• However, the country’s base legislation on implants continues to be the Drugs and Cosmetics Act, 1940, which does not have the scope to cover most modern devices, including hip implants.
• The Indian orthopaedic device market is valued at over 450 million dollars and is expected to grow by 30 per cent per year till 2025.
• The investigations into faulty hip implants bring out the urgent need for a law to regulate medical devices.

  Online Coaching for UPSC PRE Exam

  General Studies Pre. Cum Mains Study Materials

Prelims Questions:

Q.1) With reference to the malnutrition, consider the following statements:
1. As per National Family Health Survey (NFHS) - 4 (2015-16), 52.1% children under 5 years age are underweight.
2. The overall child mortality rate as per NFHS- 4 is 9.4 which is declined from 18.4 as per previous NFHS- 3.

Which of the statements given above is/are correct?
A. 1 only
B. 2 only
C. Both
D. None

Answer: C
Mains Questions:
Q.1) What are the key investigations into faulty hip implants highlighted the urgent need for a law to regulate medical devices? Comment.