The investigation has also revealed a range of alleged irregularities. It claimed that doctors from top hospitals in the country were given freebies to sell products to patients who didn't need them.
Governments of a dozen countries including many in Asia don’t regulate medical devices and have instead placed their trust in European authorities or in the US FDA, a new investigation by International Consortium of International Journalists (ICIJ) and a team of more than 250 reporters and data specialists from 58 news organisations in 36 countries has found. The Indian Express, which was a part of the investigation, reported that in India, breasts implants are being done in basement Operating Theatres in DDA flats while the country’s premier medical institution, AIIMs, has ‘an ever-swelling crowd of patients with botched-up device surgeries’.
According to The Indian Express, the number of cases of a medical device implant going wrong in a patient have increased from 40 in 2014 to 556 in 2018. These include about a dozen deaths after stents were implanted. An analysis of the reports maintained by the Indian Pharmacopoeia Commission (IPC) – an autonomous institution under the Health Ministry – revealed that Abbott, the world’s leading manufacturer for drug-eluting stents, is linked to 290 of the 556 adverse events for 2018; followed by Cook Medical (18 adverse reports) and Terumo Europe (14 adverse reports), The Indian Express report said.
Another giant, Johnson & Johnson features in 19 reports related to orthopaedic implants, and Bayer AG in 36 reports, mostly for its IUD named Merina. While smaller cities like Nagpur, Jaipur, Rohtak, Kota, Thrissur, Dehradun etc are filing adverse event reports in batches, the metropolitan cities remain ignorant about them.
Not a single event was reported from AIIMS in 2018 – which has emerged as the last hope for victims of botched hip implant surgeries in India.
CS Yadav, one of India’s top orthopaedic surgeons, told The Indian Express that AIIMS conducts over 1,500 hip and knee replacement surgeries out of which 20 per cent are revision surgeries. “An implant lasts for at least 10 years. But due to surgical errors, many patients have to undergo revision surgery within months… 80 per cent of these surgeries are because of surgical errors, mostly to correct faulty hip implants,” he said.
The investigation has also revealed a range of alleged irregularities. It claimed that doctors from top hospitals in the country were given freebies to sell products to patients who didn’t need them. It said that money running into crores was spent on conferences and seminars to push these products.
Medtronic – world’s largest cardiac devices company spent Rs 50 crore in four years on freebies as “product giveaways” as an internal audit by the company revealed that its distributors aggressively marketed devices, many of them “forging documents” on promotion and conferences, reported The Indian Express. On conferences and seminars, the company spent Rs 36 crore in 2013, Rs 43 crore in 2014, Rs 48 crore in 2015, Rs 49 crore in 2016 and Rs 26 crore in 2017, as per the report.
What patients need to check
Before going ahead with the implant, the patients need to check if the doctor has an authorised licence to conduct the procedure. They should make sure that the device that is being implanted has received approval from the regulator for commercial use.
They should also know about the long-term and short-term risks of the implantation. The patients need to check where they should report if they experience an adverse reaction caused by the implant. Lastly, they should ask the doctor to submit all documents including model number, batch number of all components of the device implanted in the body.
Regulatory framework governing medical devices in India
In India, medical devices are regulated as ‘drugs’ via the Drugs and Cosmetics Act, 1940, and that newly introduced Medical Device Rules, 2017, which came into effect on January 1, 2018. A medical device is indentified as any “instrument, apparatus, appliance, software, material, or other article” that is to be used, whether alone or in combination, for “diagnostic or therapeutic purposes” by India’s regulator Central Drugs Standard Control Organisation (CDSCO). It has divided these devices into 23 categories including syringes, needles, perfusion sets, in vitro devices for HIV treatment, catheters, intra-ocular lenses, cannulas, bone cements, heart valves, orthopaedic implants, coronary stents, IUDs and condoms.
As per the new rules, the devices are classified into three categories based on the amount of risk: Class A (low risk), Class B (low moderate risk), Class C (moderate high risk) and Class D (high risk). While Class C or Class D devices require prior official inspection, it is not required for Class A devices. Classz B devices require prior audit by a third party but do not require official inspection.
The prices of medical devices are monitored by the National Pharmaceutical Pricing Authority of India (NNPA). It has listed four devices as drugs – cardiac stents, drug eluting stents, condoms and intra-uterine devices – ceiling prices of which have been fixed. NPPA ensures that prices of other devices are not increased by more than 10% during the preceding 12-month period.