Chennai: India’s regulator, unlike in other countries, does not actively hold data on faulty and recalled devices, a report has stated. Patients are led to take up revision surgeries to counter operations done with poor quality devices, it says.
The Central Drug Standards Control Organization (CDSCO) is India’s main regulatory body for pharmaceuticals and medical devices. The Drug Controller General of India (DCGI) is the key official within the CDSCO.
The report was revealed by the International Consortium Of Investigative Journalists (ICIJ) and reported in 36 countries. The ICIJ has previously reported major business scandals like the Panama and Paradise Papers.
It stated that, in the Indian medical device industry that is estimated to be worth $5.2 billion and fourth largest in Asia, the rigour of reporting faults in medical devices in India is low.
In comparison with the US which had more than 26,700 product recalls and Canada that had over 8,300, India had not been disclosing the information up until 2014. Since then, there have been only 14 cases of recalls, according to the global investigation.
Implant targets
Conducted by a major media house, the report includes a 2013 internal document from Medtronic, which partnered with 88 hospitals, giving them a quota on doing ’20-50 implants’ per month.
The major medical device company told these hospitals that if they made this target, they would enjoy an ‘estimated’ 7.5 per cent increase in revenue for doctors and 10 per cent from ‘financing and tiered services’, the report said.
It must be noted that the Maharashtra FDA indicted Medtronic in 2014 for pricing their pacemaker devices ‘exorbitantly high’.
As per the report, records of medical device adverse events from the Indian Pharmacopoeia Commission stated that from 40 cases reported in 2014, the figure swelled to 556 in 2018.
There have been 903 similar events in the span of four years since the Commission began reporting these in 2014. Of the total 903, 325 cases were linked to coronary stents and 145 to orthopaedic implants.
Abbott, Cook Medical, Johnson and Johnson and Bayer AG have featured poorly in these reports, it stated. A bill for regulating the medical devices industry was first drafted 12 years back which has found no action being taken upon it