The founder of a pioneering medical device company leaned back in his chair, frustration evident in his voice as he recounted his experience. Since 1981, his team had dedicated themselves to developing innovative medical devices, resulting in over 140 patent applications with more than 40 patents granted — tangible evidence of their commitment to pushing healthcare boundaries.
For years, G Surgiwear Limited had invested between Rs 5-8 crore in developing resorbable metal implants, a potentially transformative technology for patients worldwide. After completing comprehensive animal studies, they approached the Central Drugs Standard Control Organisation (CDSCO) to secure a licence for clinical trials.
That's when they started to get sucked in by the bureaucratic quicksand.
"One 'knowledgeable' official simply instructed us to first take a test licence, conduct animal studies, and then come back," G D Agrawal explained. "He failed to grasp both the implications of his advice and the significance of our research."
In India, having a manufacturing facility is a precondition for a test licence. No other major country imposes such a restrictive condition.
The official didn't understand that conducting animal studies after receiving a test licence made no practical sense. These studies had already cost the manufacturer of surgical products about Rs 1 crore — an investment virtually impossible to duplicate for them at the time.
"We've been forced to suspend the entire project," the chairman and managing director concluded with a mixture of resignation and anger.
“Drugs need clinical trials — phase 1, phase 2, phase 3 — and a test licence. Medical devices need clinical investigation and evaluation of pivotal studies. Outside India, there is no concept of a test licence granted by the US FDA (United States Food and Drug Administration) or the European regulators,” says Rajiv Nath, forum coordinator for the Association of Indian Medical Device Industry (AiMeD).
"Whenever someone speaks enthusiastically about R&D (research and development) in India, I'm tempted to tell them to simply walk away. Innovation of this calibre seems virtually impossible in our regulatory landscape," Agrawal said.
His story is far from unique, as we’ll see later in this piece. It represents just one example of the impenetrable regulatory maze that “medtech” startups have had to deal with for decades in India.
Things have improved of late. But the pace of progress has lagged woefully behind the accelerated, soaring ambitions of India’s contemporary medtech players.
The Medtech Opportunity For India
India relies heavily on imports to meet its medical device needs — the import dependence is about 70 per cent, with imports expected to cross Rs 75,000 crore this year. Whatever medical devices are made in India tend to be primarily low-to-moderate-value, high-volume offerings, such as cardiac stents, surgical instruments, and consumables and disposables.
After the Covid-19 pandemic jolted the medical R&D community wide awake, domestic production of medical devices accelerated. But also, the government woke up — to the potential of the medical devices sector. Other emerging markets, like Thailand, Brazil, and China, were already posting handsome growth in their domestic medical devices sector — from a compound annual growth rate of nearly 6 per cent in Brazil to over 20 per cent in China.
The market size of this “sunrise sector” in India was about $11 billion (Rs 90,000 crore) in 2020, with a share of about 1.5 per cent in the global market. The government has since committed to turning India into a leading manufacturing hub of medical devices with a focus on innovation, aiming to raise the market size and share in the global market, respectively, to $50 billion by 2030 and 10-12 per cent in the next 25 years, as per the National Medical Devices Policy 2023.
Key initiatives in recent years have included the production-linked incentive (PLI) scheme for medical devices, introduced in 2020 with an outlay of Rs 3,420 crore for the period extending from financial year (FY) 2020-21 to FY 2027-28 and a goal of encouraging domestic manufacturing in select high-technology areas, and an infrastructure support scheme of Rs 100 crore each for the development of facilities in four medical device parks in Uttar Pradesh, Tamil Nadu, Madhya Pradesh, and Himachal Pradesh with a goal of reducing the production cost of medical devices.
Safe to say, the Indian government has certainly been tuned in to this potential Indian growth story.
However, the medtech sector is also getting severely held back in the country. Some factors are inherent to the industry — the huge demand for capital; the years of R&D needed to produce truly competitive products; the hope for more faith than usual from investors; the need for proper, thorough checks for safety, quality, and efficacy; continuous induction of new technologies; and regular training of medtech personnel.
But other factors hindering the sector from meeting its exceptional potential are not in any way natural, obvious, or unavoidable. The problems chiefly stem from the unnecessarily dark and dingy regulatory environment associated with medical devices in India.
Medtech Regulation
The Medical Device Rules, 2017, which fall under the Drugs and Cosmetics Act, 1940, dictate the regulation of medical devices in India. These rules cover clinical trials, manufacture, import, sale, and distribution.
The government body in charge of regulating the devices is the CDSCO, an organisation under the Directorate General of Health Services, Ministry of Health and Family Welfare, Government of India.
As per the regulatory regime, medical devices get classified according to their risk profile. There are four categories, Class A, Class B, Class C, and Class D, in the order of increasing risk of low, low-moderate, moderate-high, and high risk, respectively.
Depending on the classification of the device, either the central licensing authority or the state licensing authorities come into play. Whereas the state licensing authorities look into the manufacture for sale or distribution of Classes A and B medical devices, the central licensing authority — the Drugs Controller General of India (DCGI) — looks into the manufacture of medical devices in Classes C and D.
The central licensing authority is also responsible for classifying medical devices according to risk, in addition to licensing imports and clinical trials, approval of novel devices (those without a “predicate device”), registration of laboratories for testing or evaluation, and provision of test licences for all classes of devices.
The regulation proceeds phase-wise from voluntary registration to mandatory registration and then finally to licensing. The devices that make it to the market are then monitored for safety by the Materiovigilance Programme of India (MvPI), which keeps an eye out for any adverse events emerging from the use of the devices. The Indian Pharmacopoeia Commission (IPC) is the national coordinator for MvPI.
Startups that get that far are among the fortunate ones. For it’s quite the arduous journey for medical devices through the regulatory process. The CDSCO is the vital cog in the regulatory wheel. Unfortunately, it has often been under fire for its inability to provide safe and effective passage for medtech companies — especially startups — through the long, dark, and winding tunnel of medical device regulations.
Parliamentary Panel’s Stinging Criticism
The department-related standing committee on health and family welfare did not hold back in its criticism of the CDSCO recently, calling out “the perception” of the agency as “licence raj” and expressing “concerns” around “centralisation of authority” leading to “arbitrary/discretionary decision making.”
In a report presented in Rajya Sabha on 12 March, the committee said, “The CDSCO's current licensing process is plagued by delays, inconsistent timelines, and a lack of transparency” and, as a result, is “hindering the growth of the medical device industry.”
According to the committee, “Several medical devices manufacturers are scared to set up a unit in India due to delaying tactics of the CDSCO” and there was an exodus of manufacturing units to Vietnam and Malaysia “due to rigid process and inordinate delays” on account of the organisation.
“The frequent and delayed queries raised” by the CDSCO were also pointed out as “a major obstacle for applicants, particularly startups and entrepreneurs.”
The committee called for “streamlining and overhauling” of the “licensing system and preventing the deliberate delays by following a transparent process with minimum room for discretion/human inference.” This would result in “India becoming a hub of the medical devices’ manufacturing and alone generating an over one trillion dollar industry in medical devices.”
The recommended measures included regular training for CDSCO officials, implementation of a fully digitised, time-bound, and trackable licensing system, adoption of lateral entry of experts from the industry, and the establishment of an industry advisory board.
CDSCO under fire by parliamentary panel, experts
Swarajya spoke to various medtech players in India — startups, academics, and experts in the industry — to understand their struggles with medical device regulations in the country, including how it was to work with the CDSCO. What emerged is a ringside view of the situation.
Confusion, Delays, Incompetence
“What CDSCO is not doing is that they are not making the information accessible,” says Amitabha Bandyopadhyay, a professor at the Department of Biological Sciences and Bioengineering at the Indian Institute of Technology (IIT), Kanpur.
Illustrating the point with an example, he says, “Imagine you have developed a very good prototype for, say, a cardiac surgical device. Before you even do testing on a patient — forget manufacturing, just testing — you have to get a test licence from the CDSCO.” Getting this test licence itself is a “fairly complex” affair. “But just to get the classification, whether it is a Class A, B, C, D device, CDSCO takes anywhere between one month and three months.”
One to three months is too slow to simply assign a class for a medical device. Time weighs heavily on startups, who do the hard yards through an extended period of R&D, raise funds through different means — from loans taken from friends and family to capital raised from venture capitalists — and build and sustain a team, only to wait for months to just get their device classified, let alone receive a licence to test or manufacture the device.
In some cases, the classification of a medical device itself proves elusive. The founder and chief executive officer of a women-led company, based out of Pune, says, “To initiate the regulatory clearances process, the most significant challenge is the very first step — uncertainty surrounding the risk classification of medical devices and in vitro diagnostics (IVDs). This lack of clarity creates substantial obstacles in product development, affecting timelines and strategic planning.”
At a time of proliferating artificial intelligence (AI), Prof Bandyopadhyay wonders what prevents the adoption of technological applications for things like classifying a medical device. “Why is there not an interactive website where I log in, describe my device, and there is a questionnaire — today, with machine learning, you can do so much — where I describe my device further, and it automatically assigns a class.”
The search for a predicate device typically follows the classification of the device. A predicate device is a similar device that is already in the market.
According to the Pune-based entrepreneur advancing women's health, “There are no fixed standards in place. Even though predicates exist and, in theory, should provide a basis for the next device, there is no consistency in this rule either. This lack of uniformity further complicates the regulatory process.”
Even the predicate device can actually be figured out using machine learning. “You try asking a few questions to Grok. Grok will give you very elaborate answers. So I do not believe that if I write that this is the device I want to make, a platform like Grok will not be able to tell what the predicate for it is,” Prof Bandyopadhyay says.
Such a ‘smart’ and interactive website or platform designed for the purpose could even help with the next steps — what tests need to be carried out and in which test centres, along with any other helpful details, all documented in a downloadable report.
For at present, the reality is very different. “The published guidelines are incomplete, and often all the requirements for licensing become clearer after applying for it," says Chirag Agrawal, co-founder of medical device manufacturer Lenek Technologies. "There is almost no documentation for reference, which makes it difficult to understand the scope of the documentation necessary for the process,” he notes, adding that “it is also difficult to keep abreast of notices published by regulatory bodies, leading to a lack of preparation.”
“Have clear guidelines on the website, keep different tabs (for different verticals), have nice downloadable PDFs, have newsletters, update your website, give a contact number, attend calls, respond to emails,” the Pune-based entrepreneur advises.
“Even for getting that initial meeting with the regulator, there is no set process for it. We are calling personal cell phones and asking who we should be talking to,” the founder of a biotech company who did not want to be named says. “Then we send an email, and then the response comes to us via the back channel; it does not come in direct response to the email. Someone will call us and say, you should talk to this ma’am or that sir.”
This entrepreneur’s experience with the FDA was vastly different. There, he found a formal process in place, and, most importantly, followed, for innovators to reach out and receive written and in-person feedback on their plans for preclinical studies, manufacturing, and so on.
“With the FDA, you can ask them, and they will tell you, and once you have the document in hand, there are very strong guidelines, and they will follow what they have said,” he says.
The document prepared by him was thoroughly reviewed by experts, who offered helpful feedback and paved the way for progress through the regulatory process. “They had almost 40 reviewers read through that document, all of whom are qualified PhDs and medical doctors with deep experience in this area. And they gave us feedback within a couple of months,” he says.
Notably, this was for a plan presented prior to the clinical trial application. So the founder came away with greater clarity about what studies to conduct and what critical parameters to pay close attention to during manufacturing and quality-control process development closer to the start of his journey.
Such a process might have helped G Surgiwear and Agrawal, and their product might have been alive and kicking in the market today.
“Most of the time, after you've spoken to them (FDA regulators) and taken their feedback, they're more than happy to allow you to go forward. Unfortunately, in India, the regulator takes a very long time to approve even an initial trial for a novel drug. Sometimes it can take years,” the biotech founder says.
In the case of the Pune-based entrepreneur, due to unforeseen circumstances, a crucial trial had to be repeated because of a lack of clarity on the regulatory front, leading to a significant loss of both time and resources.
The initial study was completed just before the onset of the Covid-19 pandemic, which severely impacted further research as their access to hospitals was also limited, forcing this innovator to halt their work, endure financial losses, and wait until conditions improved to proceed with the necessary regulatory approvals.
“The challenges faced within the regulatory framework have been overwhelming,” she says, describing it as an intricate system that is difficult to navigate. The lack of clear pathways often leads to frustration, with individuals feeling trapped in a process that seems impossible to escape.
At the time of this writer’s conversation with her, a medtech innovator was in the process of booking flights to Delhi in an effort to resolve the classification issues surrounding her medical device. Frequent travel for regulatory discussions has become a significant financial burden, with airfare surprisingly turning out to be one of the highest expenses on the balance sheet.
A longtime regulatory affairs official who has worked for both Indian and multinational companies dealing with the CDSCO said he at times waited days sitting in the CDSCO lobby in Delhi to get just one perfunctory sign-off on an already-reviewed form from officials.
Folks from startups, with their limited resources, find it especially challenging to repeatedly attend regulatory meetings, where answers may not even be forthcoming. The process has proven difficult, frustrating, and, in recent times, rather demotivating for innovators.
Active assistance from the CDSCO would have helped, but the organisation is unanimously believed to be hard to reach and unresponsive. “It is difficult to reach out to people in regulatory bodies, leading to a lot of confusion. Helpline numbers are often not picked up,” says Agrawal of Lenek Technologies.
Improper Staffing
A lot of this trouble — more a feature than a bug of this process — is believed to be stemming from the fact that the CDSCO is not properly staffed to oversee the regulation of medical devices.
“The CDSCO used to regulate drugs and cosmetics, and all the people are from that background, who understand chemistry, biology well. It was decided that it will also dictate the regulation of medical devices, which are pure engineering products. As a result, they don't know what to do,” Prof Bandyopadhyay says.
“Basically, there is a lack of understanding within them (CDSCO) because they were all into pharma and drugs previously. Now they have come into devices. Now they are the ones who need the most training,” says Sathyendra M G, a former director of the Bureau of Indian Standards (BIS) who now helps Indian industry to conform with global standards.
“From IIT Kanpur and other institutes, we have recommended that they should recruit, for example, biomedical engineers. The process is on. But everything takes time,” he says.
“They probably have a very good workforce on the drugs and pharmaceuticals side, but on the medical devices side, I think the number of people who actually understand what exactly a medical device is, especially medical devices with electronics and software, is few. Drugs and software are like chalk and cheese,” says Harshit Rathore, co-founder of Noccarc, who, with the support of Prof Bandyopadhyay and entrepreneur and investor Srikant Sastri, developed a ventilator for deployment in intensive care units (ICUs) when India desperately needed it during the pandemic.
Rathore proposes getting experienced medical electronics professionals into the CDSCO. “And if, for example, they are not available, there are other sectors which are electronics-heavy and can be tapped. A lot of electronics are manufactured in India. Maybe within the CDSCO, there could be a different body which specialises in electronic products.”
“I don't know why the government is not creating a separate body or not mandating an independent vertical,” Prof Bandyopadhyay says. “To be honest,” says Sathyendra, “they should have created an independent body and started from scratch with the recruitment of proper qualified professionals in the relevant field. Maybe at the government level, they thought pharma and devices were all one. But they are not the same thing.”
According to a proposal led by IIT Kanpur — both Prof Bandyopadhyay and Sathyendra were part of the initiative alongside other experts — the CDSCO could be structured into three verticals — drugs and pharmaceuticals, in vitro diagnostics (IVDs), and medical devices — as each area requires specialised expertise. Recruitment could then be aligned with these distinct competencies.
This group also recommended elevating the position of the DCGI and addressing the dearth of accredited testing labs in India. They proposed that the government fund the National Institutes of Pharmaceutical Education and Research (NIPERs) and IITs to establish testing labs on campus that could handle the wide variety of medical devices out there.
“The parliamentary committee, NITI Aayog, and AiMeD have been recommending a separate medical devices regulator like the FSSAI (Food Safety and Standards Authority of India) or at least a separate division for medical devices manned by engineers and scientists and not by pharmacists with drug expertise viewing everything from their knowledge of drug rules, even though medical device rules are separately applicable now,” Nath says.
“It’s like seeking the Army to oversee naval training and competence when both defence forces require different skill sets and technologies. That’s why regulators from a drug background have a challenge to be empathetic to the diverse needs of medical devices,” he adds.
The biotech founder who chose to remain anonymous believes that the CDSCO must hire career officials who are scientists, and not just academics but, more importantly, industry professionals. Ideally, these officials would be coming off distinguished careers in R&D in academia and industry.
“In fact, if they do it now, they can go and get a bunch of ex-FDA Indian people because the FDA is doing layoffs,” he says.
It’s also essential, according to this founder, to have continuity within the organisation. Frequent transfers of personnel can affect a startup’s regulatory outcome because views on the device under consideration can change from one regulator to another.
“There is a lot of subjectivity involved,” says Agrawal of Lenek. “Some regulators are too strict, and some are lenient.”
“There needs to be subject matter experts in regulatory discussions,” says the women’s startup founder from Pune. “When addressing issues related to IVDs, it is crucial to speak with professionals who have sufficient knowledge in that domain. Engaging with someone primarily experienced in pharmaceuticals or drug development, for example, may lead to a lack of understanding, making it difficult to effectively communicate the test’s purpose, classification, and intended use for specific indications.”
From unclear processes to outdated standards, several issues to sort out
Outdated Standards
Besides personnel, the regulations and standards themselves are in need of a refresh. “Regulatory bodies are still using the old standards, which should be obsolete by now since technology has changed a lot,” says Agrawal from Lenek. “Due to this, compromises have to be made in the product to pass the regulatory stage.”
Often, startups are victims of outdated requirements. “They suddenly get to know they have to redesign something because it is not allowed. For example, with some devices on the body, you cannot charge the device when it is on the body. So then you have to make a module like in the old digital cameras, where you take out the battery and charge it on the outside,” Sathyendra explains.
Prof Bandyopadhyay, despite being a veteran medical innovator, is presently struggling with an outdated standard. “IIT Kanpur was asked to develop a handheld X-ray machine. It is absolutely critical because we want to eliminate tuberculosis. In the villages, you cannot do screening with laboratory-based X-ray. So you take a handheld X-ray machine there,” he says.
Despite some delays, Prof Bandyopadhyay was able to develop the machine in less than two years. However, they are now in a period of indefinite wait for certification. “Because for the Bureau of Indian Standards, an X-ray machine must be powered through a wall socket. That is the 1980s definition. They do not want to create a definition on a war footing for an X-ray machine that can have rechargeable batteries,” he says.
Startups might want to take a lesson here. “Ideally, a product like a medical device or a drug has to be developed after studying the regulatory standards. This generally does not happen in India, and that is one of the main reasons why most of the startups struggle,” Rathore says.
Trying to learn about and comply with the standards only after developing the product can be very time-consuming, as multiple iterations might be required, as well as multiple interactions with a government body, which are not known to be swift.
Problems Beyond CDSCO — Public Procurement
Medtech startups on occasion have been able to pass through the regulatory process largely unscathed. Rathore’s was one such case. “We had in our team a person who was looking at it end to end. So we were able to navigate it ourselves without a consultant. So our experience was okay.”
Interestingly, this ‘expert’ on Rathore’s team was just a self-taught batchmate at IIT Kanpur who had previously worked in the automotive industry.
The challenge, Rathore explains, is that due to the lack of clarity around the regulatory processes, medtech startups are often having to choose between reading and comprehending several hundred pages of murky rules and regulations and easing their journeys by onboarding consultants. “And these consultants are pretty expensive. For somebody to get them is not very easy,” he says.
Some consultants also operate as intermediaries, leveraging their connections within the system to facilitate regulatory processes in exchange for a fee. This practice raises concerns about transparency and fairness, as it suggests that access to regulatory approvals may sometimes depend on personal networks rather than standardised procedures.
Noccarc received help from the CDSCO the “couple of times” they needed it, likely also because they were operating without a consultant. “If we didn't understand anything or if we were not clear about what exactly to do, then the CDSCO people were there to pass on the information. They also didn't want us to get a consultant. Because consultants are just mediators who will charge you money for that information arbitrage,” Rathore says.
The Noccarc co-founder is also sympathetic to the CDSCO for its delays. “I think the reason why it (the licensing) got delayed a lot was because it was newly implemented, and that is why there was a big queue for CDSCO licences, and they took a lot of time.”
Before 2023, the regulation of medical devices was sparse. “Which means that you could make any product, for example, a ventilator, the way you like it and launch it in the market. And if there was somebody willing to pay for it, you could sell your ventilator,” he explains.
The better manufacturers picked up certifications like those from the International Organization for Standardization (ISO) before doing business. Noccarc themselves picked up the globally accepted ISO 13485 certification before the mandatory licensing.
Since October 2023, however, all medical devices have been thrust into the regulatory regime. Whether it is to manufacture or import a medical device, a company must first necessarily get a licence from the CDSCO.
Noccarc also picked up a BIS certification for their ventilator, making them the first company in India to get it. “We got that, and because of that, now we are able to also participate in government tenders,” Rathore says, adding that Noccarc has been able to supply over 300 ventilators to hospitals in the last couple of years, with orders received from the All Indian Institute of Medical Sciences (AIIMS) in Bathinda and Deoghar and from a couple of public sector undertakings (PSUs).
But that is where Noccarc’s struggles unexpectedly began. They found that they were being disadvantaged in government procurement.
Despite the official acceptance of Indian certifications for procurement, government bodies and hospitals in many states do not accept them. “Instead, they insist on foreign certifications such as the CE or US FDA. This goes against their own procurement manuals, which typically state that Indian certifications must be accepted if available, and foreign certifications should only be considered when the Indian ones are not,” Rathore says.
For example, in Uttar Pradesh, the state procurement manual clearly specifies that the BIS certification (ISI Mark) should be accepted. However, tenders floated by the Directorate General of Medical Education always mandate CE and FDA certifications, effectively excluding Indian companies and startups from participating.
“Today, to get a CE certification, the wait time is more than five years, and the out-of-pocket expense is more than Rs 5 crore. Who will fund it?” asks Prof Bandyopadhyay.
Perhaps an even bigger issue facing startups participating in government procurement is linked to China.
In 2020, after the clashes between Indian and Chinese troops in Ladakh, the Indian government decided to move away from Chinese products in public procurement due to concerns over national security and data vulnerabilities. “The Chinese companies then started setting up their Indian entities. And they started to make products in India and say that the products are manufactured in India. But the ultimate spirit of the order which the government had brought in was that we don't want Chinese technology in our government system,” Rathore says.
So the Union government posted a new order in 2023, excluding companies developing products in collaboration with Chinese companies from bidding in government tenders.
But Chinese companies found another workaround.
“They are tying up with Indian companies, supplying a product in four or five pieces — for example, a ventilator is broken down into the screen, left cover, right cover, bottom cover, main body — and selling it to Indian companies, who are declaring it in customs as spare parts. In India, those four or five pieces are tied up together, giving rise to the product again — just with a different label,” Rathore explains.
These Indian entities are picking up CDSCO manufacturing licences and participating in government tenders, claiming ‘Made in India’ products. “Ultimately, Chinese products are going into government procurement. You know what they do with their pricing. So products like ours have a very hard time competing with the products of these sorts of companies,” the Noccarc co-founder says, adding that the ‘Make in India’ and ‘Startup India’ benefits meant for Indian companies are in this way indirectly flowing to China.
What's Working, And What Else Might
Though far from substantive, nearly every startup Swarajya spoke to reported incremental improvements in the medtech regulatory process over the past couple of years.
MedTech Mitra, an initiative of the Indian Council of Medical Research (ICMR) in partnership with the CDSCO, in particular drew praise.
“The challenge of regulatory approval is being sorted out to a large extent by ICMR's MedTech Mitra,” Sathyendra says. “We have had this initiative for the last six, eight months. We meet twice every month, and a minimum of 10 to 14 startups come there with their problems.”
A CDSCO personnel also sits in on these meetings to advise startups on regulatory compliance.
“Fantastic platform. You go there with your issues, and people are really trying to solve them,” Prof Bandyopadhyay says.
“We are lucky to have collaborated with ICMR, as with their help we now understand the regulatory landscape for medical devices. Their MedTech Mitra initiative is a need of the hour for Indian startups venturing into the medtech space,” says Agrawal of Lenek Technologies.
That is not to say that MedTech Mitra is perfect, of course. In one founder’s experience, the experts with the MedTech Mitra and “the people that we speak to on the phone” were “not necessarily on the same page with a lot of things.”
Another founder was unconvinced by his interactions with MedTech Mitra. He came away feeling like it was all a formality. “People genuinely want Indian companies to become large companies globally, but that attitude wasn't there in the MedTech Mitra team,” he says, adding that people from the BIS or CDSCO were more open to hearing them out.
ICMR has also been helping ease the process of medical device certification for startups. “ICMR has already approved grant-in-aid in advance to several high-quality teaching hospitals. If you have a device to be tested, they have created many channels. You come through any one of those channels, and they will send it to these hospitals for clinical testing. So one of the most expensive and time-consuming steps of medical device certification is completely taken care of by ICMR and free of cost,” says Prof Bandyopadhyay.
Medtech startups would also benefit from not having to pay a fee for the manufacturing licence and from having the licence issued within 30 days, according to Prakash Rana, technical director at Prahas Healthcare and SUV Biologicals. Similarly, he calls for the removal of a fee to get a test licence for startups, with approvals granted within seven days. Recommendations from the parliamentary panel could also be considered.
The CDSCO could start an online learning campaign free of cost for medical device manufacturers, suggests Agrawal of Lenek. There could be lectures or reference materials for setting up a manufacturing facility as per CDSCO standards.
However, from a big-picture point of view, if India is seeking inspiration for effective medtech governance, it only needs to turn the clock back five years. “There is no debate that India overcame Covid with its own products, and we produced it within three to seven months. Why can't we do it again?” asks Prof Bandyopadhyay, recalling the popular American phrase, “If it ain’t broke, don’t fix it.”
The IIT Kanpur innovator urges the adoption of that same execution philosophy again. “What was the philosophy at that time? That we desperately need it, our life depends on it, and therefore let us remove all the red tape.”
“For the ventilator, there was no standard for testing,” recalls Prof Bandyopadhyay as he jogs his memory down Covid lane. “So what was done was that in Patel Bhawan in Delhi, a team of expert clinicians sat, and all the startups carried their ventilators along with oxygen cylinders and demonstrated on the spot that it works. And on the spot, they were given a certificate that you can sell it. That is the reason why it could go out in the market in three months, from start to finish. And the demand was very high, so they all sold a lot and made a business,” he says.
A transformed regulatory landscape — one that combines Covid-era urgency with proper technical expertise, clear guidelines, and procurement policies that genuinely favour domestic innovation — is essential for India's medtech growth.
Otherwise, the government's ambitious vision for a $50 billion sector will remain a vision, while innovative companies and life-saving technologies continue to languish in bureaucratic quicksand.
Karan Kamble writes on science and technology. He occasionally wears the hat of a video anchor for Swarajya's online video programmes.
