New Delhi: There has been a constant churning within the medical technology sector since last few years. The demands for the industry’s unique identification and separation from pharma category grew more louder and were finally granted by the government with creation of guidelines for the sector. The new rules that came into existence after innumerable meetings, if not completely in line with industry expectations, were certainly an indicator of fresh beginnings.
During 2018, the allegations over inflated prices of various types of stents by the activists flew thick and fast. Acting on the same, the National Pharmaceutical Pricing Authority initiated the action by fixing the prices of medical technology products especially the coronary stents, followed even by warnings/raiding hospitals still selling them at higher prices to patients. The union government, meanwhile, highlighted this as a major action.
The latest turmoil happened when the Johnson and Johnson was accused of faulty implants. The report by Central Drugs Standard Control Organisation (CDSCO) submitted in February, 2018 too found the gross malpractices. The key findings of the committee included that over 3,600 patients with the faulty implants remain untraceable, and that at least four patients with the implants have died.
In this tumultuous backdrop, the International Consortium of Investigative Journalists (ICIJ) in collaboration with publications in 36 countries recently conducted investigations into the various aspects of medical implants. In India too, it was conducted by the national newspaper, Indian Express. The results that were published on 26th November were shocking. The series of reports under hashtag #implantfiles not only implicated the medical technology industry but also the hospitals, doctors, and distributors. These have revealed a number of serious problems, including companies lobbying and bribing doctors, and patients being duped into unnecessary operations. Some glaring loopholes in the regulatory framework that governs the medical devices industry have also been exposed.
As per the figures quoted in the report, the number of cases of a medical device implant going wrong in a patient have increased from 40 in 2014 to 556 in 2018. This certainly doesn’t seem to be normal by any chance.
The investigation further showed that there were numerous cases of botched up breast implant surgeries that were conducted illegally or without any proper medical guidelines. It pointed towards the faulty Johnson & Johnson hip implants that affected approximately 4,000 people with no clarity over tracing and compensation of patients. The matter is now sub-judice under the Supreme Court of India.
The reactions from activists as expected were of jubilant nature. They felt vindicated by the investigation since as per them, they have been talking about this repeatedly. At the same time while domestic industry welcomed it, the global associations rubbished the allegations.
Domestic industry calls it a tip of the iceberg
In his reaction, Mr Rajiv Nath, Forum Coordinator of Association of Indian Medical Device Industry (AiMeD) was more vocal. “It was a big shocker. Even though we were expecting bad news but when I went through the story, even I was shocked by what has been happening internationally and also in India.”
“This year the government did introduce a separate medical device rulebook but it is still under the existing drug act which is a misfit,” Nath said, adding that two years back we were promised that a separate act will be coming out but we have not seen any consultation with stakeholders on the draft that was created by the ministry of health.
Only 23 out of over 5000 categories of devices are regulated and that also incorrectly as a Drug. Government needs to regulate all kinds of devices at one go with a defined transition period. If Govt is reluctant that it’s going to harm industry especially MSME and manufacturing may suffer then Govt needs to consider a phased in calibrated approach of initially incentivizing Voluntary QA ICMED certification by QCI to enable capacity building of MSME and then in next phase pass Quality Control order under BIS Act to make certain provisions in the Medical Devices Rules mandatory for all medical devices manufacturers and imports .
“As ICMED is voluntary it needs to be incentivized by giving preference in public health care procurement instead of seeking USFDA & CE Regulatory approvals which are beyond reach of a start up or most entrepreneurs,” mentioned Mr Rajiv Nath.
Mr Rajiv Nath had few hard hitting questions: “Ayushman Bharat will take care of the needy 1/3 of Indian population with nil or near nil income. What about the middle class? For them to afford healthcare at reasonable costs we need regulations of Healthcare & Medical Devices and caps on Trade Markups and a strong ethical marketing watchdog.”
“Does India need a calibrated approach to regulations to clean up the market and address the problem of over 1000-2000% mark up being charged on medical devices?,” he asked.
You are making a mountain out of a molehill, says global association
In its reaction, The Advanced Medical Technology Association (AdvaMed) that represents the global medical devices companies, called the ICIJ investigation as biased against the industry.
“These stories paint a very one-sided view of an industry which has always been committed to providing safe medical devices that help save and improve people’s lives. Patient safety has always been, and always will be, the #1 priority of the medical device industry. We recognize why we developed these technologies in the first place: to address the critical, debilitating, and often life-threatening needs of patients who are desperate for solutions,” said the AdvaMed statement.
“We should never discount any patient’s experience. But by magnifying the stories of only a few individuals, we overlook the overwhelmingly positive experiences of millions of others.” –ADVAMED
It added further: “While these stories have a uniformly negative tone, they do bring to light certain gaps that exist in the healthcare system prevalent in a country like India. In addition to the conversations AdvaMed has been building on the need to fill these gaps, the recent articles further present an opportunity to take the conversation ahead, for the sake of patient well-being.”
“We should never discount any patient’s experience. But by magnifying the stories of only a few individuals, we overlook the overwhelmingly positive experiences of millions of others. We take seriously all reports of patient impact, and though the medical community can never completely eliminate risk, we always strive to improve our technologies and care delivery.
What could lay in store during 2019
India’s medical device industry is estimated to be worth $5.2 billion – the fourth largest in Asia. The market at retail and institutional level is estimated to be over INR 10,000 crore. With such opportunities, both domestic and global companies are looking at expanding their share. Playing devil’s advocate, the regulators under government have to make sure that the business interests should be equally balanced with the accountability. This could mean more price regulations, strict quality assessment and equal opportunities for all.
There are many factors that are in the play. The domestic industry is full of ambitions and has been complaining about the lack of enough favorable measures to promote the indigenous companies. The global companies are finding it difficult to cede their space, fearing the decrease in revenue. The price regulations have been accepted by this section of industry as a bitter pill. So, the underlying tension remains at the fag end of the year too.
However, given the growth potential of medical technology sector, the future presents unlimited opportunities for both the sections of the industry. The opening of 270 acre Andhra Pradesh Medical Technology Zone (AMTZ) which is a collaborative special economic zone, has certainly laid a path for the domestic industry for quality manufacturing of medical devices. At the same time, it also provides an open chance for global companies to think local and start looking for more manufacturing opportunities in India.
With elections round the corner, it will be worthwhile to see whether it becomes an election issue and what government has for the sector? The most likely scenarios are that either few extreme regulatory steps could be in the offing or there would be none at all.
Whether there will be any major government policies on anvil before the elections or not, one thing is sure, that the coming times will lead to more accountability within the industry.
*Note: This article is a first one in the series ‘Rewind 2018’ that would include analysis on important happenings during the year 2018 within Indian bioscience sector.