The government’s recent notification on categories of medical devices including an entire range of implantable devices as drugs, to ensure the supply of safe devices, and monitoring the introduction, has perturbed the medical devices community. Informing that the government’s intentions are good, yet these could have some far reaching impact. Experts in the medical devices segment also argue that the decision is half-baked and has left them questioning the approach taken.
The Union Health Ministry recently notified that eight more categories of medical devices including the entire range of implantable devices will be known as drugs — MRI equipment, PET, bone marrow separators, dialysis machines, CT scan and defibrillators — which is set to come into effect from April 2020.
Elucidating the background of how medical devices are regulated in India, Sumit Goel, Partner, Healthcare Advisory, KPMG in India, informed that till 2017, there were very limited regulations and in a bid to regulate the medical devices, the Government of India in February 2017 notified the new Medical Device Rules 2017, by exercise of powers conferred by the Drugs and Cosmetics Act.
For the medical devices to be regulated under the Medical Device Rules 2017, a medical device has to be notified under the said Act as ‘drugs’ by the Central Drugs Standard Control Organization (CDSCO). Initially, only 15 categories of medical devices were notified under the said Act and hence, covered under the Medical Device Rules.
Hence, classifying these medical devices as drugs is more of a legal technicality rather than an attempt by the government to regulate these devices along the line of drugs. However, different set of rules apply to medical devices under the Medical Device Rules-2017.
Goel further emphasised that it was a positive step by the government to ensure that devices available in the market will meet certain quality standards. These devices play an important role in diagnosis, treatment, mitigation or prevention of diseases or disorder in patients and a sub-standard quality can adversely impact patient safety.
Talking about the move, Pavan Choudary, Chairman, Medical Technology Association of India (MTaI), said, “A device is an electro-mechanical unit. Drugs are chemical or biological entities. The beginning made in 2005 to regulate drugs as devices, in our view, was a mistake. However, a lot has been done in the last few years to correct this mistake. And, we feel that the government is finding its path again.”
Experts inform that the medical devices segment is a vital cogwheel of the healthcare sector and it has a unique functionality. They contend that these devices cannot be treated the same as a drug. They raise questions on the new notification.
Can devices be categorised as drugs?
Experts question how can a regulatory mechanism for drugs ‘also’ be the yardstick for the safety and efficacy of medical devices?
Usage of drugs and equipment is completely different, informed Dr Tejinder Kataria, Chairperson, Radiation Oncology, Cancer Institute Medanta, The Medicity. She added that medical devices and pharmaceuticals vary in their development, evolution, manufacturing, method of delivery, and impact on patients. “You cannot have both under the same banner. This will not help patients but risk their lives even more,” she said.
Informing that when we call a medical device a drug, the approval on its use and regulation becomes complicated. Mohammad Ameel, Senior Consultant, Healthcare Technologies, WHO CC for Priority Medical Devices & Health Technology Policy, National Health Systems Resource Centre, Ministry of Health & Family Welfare, Government of India, said, “Let’s not forget that India imports a major share of its medical devices. We use regulations on these devices as per international standards, or as instructed. They cannot be under the same roof.”
Asserting that it is a challenge, Himanshu Baid, Chairman CII Medical Technology Division and Managing Director, Polymedicure, said, “Regulation of medical devices along the lines of drugs under Drugs and Cosmetic Act with desired intervention will help address various challenges as the act does not provide requisite provisions to control and monitor all the medical devices.”
Highlighting that the medical devices and drugs are two core elements of health treatment, yet the two are different in application and function, Choudary, said, “The two sectors cannot be treated as one. CDSCO recognised this distinctiveness of medical devices and has come with Medical Device Rules 2017, specifically for this sector. These regulations will surely help in the development of quality management systems in the country because these regulations lay custom-made regulatory foundation for medical devices which was required.”
Stating that regulating medical devices is a knowledge-and experience-intensive work, Choudary also mentioned, “Keeping the historical development of medical devices regulation in mind, CDSCO has the maximum expertise in this area because since 2005, it is the organisation which has been regulating medical devices. To try to duplicate this expertise in any other body would be a herculean task and will lead to duplication. In reality, MTaI is against the idea of a separate agency for standards. The point which is made that we need to have another agency for India-specific standards also has to be carefully considered. The essential principle guidelines, which the CDSCO implements and makes sure the industry follows, are standards which finally confirm whether the product is safe and effective for patients.”
Demanding a separate regulatory act for devices, Dr BB Chanana, Head of Department Interventional Cardiologist, Maharaja Agrasen Super Specialty Hospital, said, “As a healthcare community, we were expecting a separate regulatory act for devices. We need a scientific approach to regulatory issues, particularly for devices which are engineering-driven products and not chemical entities like drugs. You cannot ensure patient safety by putting drugs and devices under the same regulations? The notice lacks clarity. Is an implantable device the same as a medicine?”
Taking the manufacturer perspective, Baid opined that including high-end medical devices and all implantables under Medical Device Rules 2017 has and will ensure access to quality medical device for all stake holders.
“The latest notification in February 6, 2019 technically includes majority of Class III medical devices which are under implantable category and high-end medical devices encompass major portion of Class II/III medical devices. Manufacturers need to get multi-ministerial approvals in initial stage, followed by commitment to maintain the equipment’s running as per specification over a decade which involves import of several parts/replacement of critical portion of equipment. All this requires import of parts post-sales and required to be serviced at users premises. These high-end medical devices undergo stringent evaluation, thereby undergoing minor to major changes depending on the market response post release, hence requires regulatory approvals . All these challenges will be difficult to handle under current provisions of Medical Device Rules. It is advisable that regulators should consider to bring desired changes in Act for medical devices to control and monitor all the medical devices under regulations. Also, there is an urgent need to review requirements of high-end medical devices with respect to maintenance, testing, stock and sale. It may be appropriate that regulators provide separate provisions under Medical Device Rules 2017 to address separate needs of said products,” he stated.
Informing that medical devices are nowadays a pervasive part of contemporary medical care, Dr Gaurav Laroia, General Manager, Roche Diabetes Care India said, “At Roche we believe that MDR 2017 rules will help in bringing up the QMS standards across the board. With the escalating use of medical devices, stringent regulatory standards are necessary to certify that the devices are safe, well studied and have minimum adverse reactions.”
“It is the prerogative of the government to safeguard the interests of patients and the country. The public also expects that medical devices are of the highest safety standards. Regulations that are in the best interest of patients will only help the industry. Risk Based Classification Systems, QMS requirements, Concept of Notified body assessments etc. will all support the quality objective,”he added.
He further added, “Quality assurance programmes need to be familiar with frequent problems with medical devices and how to approach them.”
Explaining the government’s stand, a Union Health Ministry official said, “Many medical devices are not yet regulated and are available in the market without any certification or regulatory control. Till now 23 medical devices are regulated and nearly 5000 more devices needs regulation. We have picked up the Singapore model after systems in the US, Canada, Australia and Japan were also examined at a high-level meeting with officials from health ministry, CDSCO and associations, representatives from industry. Our concern is patient safety, medical device can have serious adverse events so we are bringing in adequate regulatory interventions as far as medical device regulatory system is concerned.”
Reinstating that as a manufacturer, regulations are always welcome, as it provides a basic structure for development to market access Baid said, “CDSCO’s recent proposal to bring in simple regulations to include all medical devices by simple regulatory process similar to models followed by few major Asian countries like Singapore is a welcome step. At the outset bringing Class III Medical devices under regulation will definitely provide requisite check and balance for manufacturers, users and end beneficiary patients. There is an urgent need for more approved test houses to support during design development.”
“Industry is waiting for proposed road map by CDSCO for regulating all the medical devices which will provide innovators , manufacturers clarity on upcoming regulations under existing Medical Device Rules next three to five years. Current provision needs a notification for regulating medical device,” he added. The medical devices fraternity also informs that the biggest relief which the industry requires to function efficiently is to get rid of the multiple controlling bodies. Today, the Indian medical devices industry is controlled by CDSCO, Atomic energy Regulatory board (AERB), Department of Telecommuni-cations (DoT), State Food and Drug Administration (FDAs) and Bureau of Indian Standards (BIS), among others.
Call for a single window regulatory exercise
The medical devices industry is controlled in various aspects by ten bodies. This leads to interdepartmental delays, duplication and sometimes even turf issues. The Medical Device Rules is the first coherent and comprehensive move from the government which is tailor made for medical devices.
“We hope that this regulatory exercise will be taken to its logical conclusion, and there would hopefully be just one regulator for the medical devices sector. MTaI believes that a single-window regulatory regime for medical devices will enable the industry to serve the patients better and keep this sector attractive for all serious players irrespective of their domiciliary origins. Wider consultation on all matters plaguing the healthcare sector will highlight the necessity of having a single window where all the compliance requirements converge,” Choudary added. Reiterating on the positive step taken by the government, Goel informs that the regulated medical devices play an important role in diagnosis, treatment, mitigation or prevention of diseases or disorder in patients and a sub-standard quality can adversely impact patient safety. For example, digital thermometers being regulated, will ensure only quality products which provide correct readings are available in the market. Wrong readings can result in adverse impact on a patient.
Informing that there will be significant impact on domestic and international market post implementation of regulation and future action of bringing all medical devices under MDR 2017, industry doyens say that 70-75 per cent products available in market will get impacted in terms of availability, quality to healthcare providers and end beneficiary.
“The increase in prices of stents indicates that NPPA is mindful of the operational pressures in the medical device industry. We continue to be hopeful that in the interest of Indian patients and quality of Indian healthcare, the Government will bring in a policy to differentially price the innovative generations of medical devices. We are also engaged with the NPPA to find a way to offset the exchange value depreciation and thus mitigate the economic threats in the system to the medical device industry,” Choudary said.
Pointing out that robust implementation of these regulations would ensure that quality and patient safety stay in the foreground, Choudhary added that stressing on quality would eventually improve the reimbursement levels for devices and give a share of this pie to the quality supplier too. Internationally, the reputation of Made in India products would go up.
“Sanitising the sector was important. We must not over-regulate and sterilise it,” he concludes. Demanding patients’ protection, stronger regulation and price capping to make devices and quality treatment accessible, the Association of Indian Medical Device Industry (AiMED) has recommended political parties to include concerns regarding medical devices in their manifestos.
“The key points of their recommendations demand regulation of all medical devices under a patients’ safety medical devices law, protect consumers from exploitatively high pricing in medical devices through rational price controls, to encourage employment and Make in India, ensuring public procurement of quality medical devices at affordable price, shift from L1 (lowest cost) to Q1 (best quality at reasonable price) so best price and best quality can be factored for public procurement in public health institutions,” AiMED proposal for election manifesto read. Meanwhile, public health advocates inform that the new regulations will increase transparency. Still with one year for implementation, we need to wait and watch on the on the outcomes of the new regulations and its impact on the medical device manufacturers and device companies functioning in India.