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Tackling the issue of sub-standard drugs, supporting small and medium-sized drug manufacturers, and aligning the medical device vertical are the priority areas for India’s apex drug regulator, the Drugs Controller General of India (DCGI), who has been granted an extension of his tenure on a contractual basis.

“DCGI Rajeev Singh Raghuvanshi has been given the mandate to work on weeding out quality issues along with upgrading standards at small manufacturing sites by giving support to MSME drug-makers and seamlessly adding medical devices vertical into CDSCO which is only known for handling drugs so far,” said a senior official requesting anonymity.

“The ministry is satisfied with his performance as he has been able to drastically improve the manufacturing quality of drugs via risk-based inspections. His zero-tolerance approach has created an environment of fear. Based on the same, renewed responsibilities have been given till the time we find the appropriate candidate.”

Despite some concerns, the appointments committee of the cabinet has approved the proposal of the department of health and family welfare for the re-employment of Raghuvanshi as drugs controller, Central Drugs Standard Control Organisation (CDSCO), on a contract basis for one year starting March 1.

He has been given the charge “…beyond his attaining the age of superannuation or till the appointment of the regular incumbent to the post, or until further orders, whichever is the earliest…”

The announcement specifically mentions that the decision has been taken “…by keeping the recruitment rules of the post in abeyance”.

Wipe out sub-standard drugs
India has been battling the issue of sub-standard or not-of-standard quality drugs (NSQs). Last year, in September, top pharmaceutical companies indicated that spurious drugs are to blame after the antacid Pan D, calcium supplement Shelcal, anti-diabetic drug Glimepiride, high blood pressure drug Telmisartan and many more biggest-selling medicines were flagged for failing quality tests in the monthly drug alert released by the country’s drug regulation watchdog CDSCO.

Pharma companies had approached CDSCO to change the pattern of alert announcements due to the high chances of spurious drug failures instead of original drugs. In fact, India’s largest lobby of domestic drug-makers, the Indian Pharmaceutical Alliance (IPA), said that the lobby will collaborate with the government to strengthen regulations against counterfeit products to protect public health and India’s global standing.

Falsified medicines are not only a domestic concern but also a global issue. In 2019, the ‘Special 301 Report’ released by the Office of the United States Trade Representative (USTR) blamed India for its growing problem of counterfeit medicines.

It said that almost 20 per cent of all pharmaceutical goods sold in the Indian market are counterfeit. Hence, the drug regulator needs to strengthen its monitoring mechanism to solve the issue of spurious drugs in India.

According to Sudarshan Jain, Secretary General of the Indian Pharmaceutical Alliance (IPA), three priority areas that DCGI must look into immediately include, “implementation of Schedule M and Move to PIC/S (Pharmaceutical Inspection Co-operation Scheme (PIC/S) standards, management of counterfeit drugs and regulatory simplifications with thrust on simplifying new product processes”.

Handholding MSME firms
Hit by risk-based inspections (RBI), micro, small and medium enterprises (MSMEs) are feeling the heat. The Union government has mandated the need to upgrade facilities to follow Schedule M, making manufacturing standards on par with WHO-Good Manufacturing Practices (GMP).

The move was aimed to retain the confidence of global health regulators in made-in-India medicines. However, these drug-makers have asked the government to extend hand-holding in the form of financial and technical support to improve quality standards.

“We need the government to help and guide us to upgrade our facilities. Also, they should understand that we are not earning in crores. So many of us won’t have the budget to upgrade our factories. We have requested the government not to treat us as criminals but as small businessmen who need help to make our factories on par with global standards,” said an officer of the MSME industry.

Overall, once the drug-makers are upgraded to follow global standards, India’s reputation in the global arena will be enhanced along with trust in Indian medicines, leading to a jump in exports of pharmaceutical products and creating a win-win situation for both the government and the drug-makers.

Syncing Medical Devices With Drugs
To bring regulatory uniformity in medical devices, the government is working to classify around 1,178 medical devices into four categories based on their risk approach.

Till now, medical devices were treated on par with drugs, which was unfair. However, the drug regulator is revising the existing list of medical devices and classifying them into four categories—interventional radiology, radiology therapy, oncology and a newly introduced category named class A non-sterile and non-measuring medical devices.

Presently, the medical device industry is already simmering with discontent and asking for a “predictable regulatory environment”.

“Industry cannot be invited to invest in a state of chaos, yesterday- today- tomorrow- every day a new confusion will not build confidence, so we need a predictable regulatory and policy environment where we are not challenged by arbitrary demands of NoCs (no-objection certificate) being sought or SLAs (state licensing authorities) insisting manufacturers to get written clarification from DCGI,” Rajiv Nath, forum Coordinator of Association of Indian Medical Device Industry (AIMED), said. News18

Medical debt is a struggle for millions of Americans, and recent moves from a federal government watchdog to help people tackle it are up in the air right now.

The Consumer Financial Protection Bureau (CFPB) issued new regulations at the start of the year, but the fate of the CFPB and its regulations are now uncertain.

“Your credit report is that report card that shows financial institutions, lenders, anyone that’s going to give you money. This is why it’s your report card to prove, ‘I’m good for it,’” said financial coach Maureen Paley.

Credit reports are critical to financing many aspects of American life, like owning a home, a car or starting a business. But for the millions of Americans with medical debt, reaching those goals could be harder.

“Medical debt has been getting in the way of folks getting approved for financing either completely or approved at reasonable terms,” said Paley.

In early January, in the final days of the Biden administration, the CFPB announced new regulations barring medical debt from credit reports, effective March 17, 2025.

The CFPB workforce was ordered to stop working by acting director Russ Vought in February after President Donald Trump took office.

Paley says there’s concern the new rule could be reversed.

“They could remove that order, which would again be a burden. We would bring the burden back to the consumers and the everyday consumers that incur this medical debt and have a hard time getting out of it,” said Paley. “And, it would benefit those organizations that benefit from people being in those debts.”

Paley says medical debt is the cause of 60% of bankruptcies. The new regulation could open doors to people struggling with it.

The change is estimated to raise credit scores by an average of 20 points or so.

“Twenty points can save you tens of thousands of dollars…A 20-point difference on your credit score could be the difference between you getting financing at an exorbitant high interest cost or one at a more moderate interest cost. It could also be the difference between you getting approved at all,” said Paley.

The CFPB website is back up and running after a brief shutdown last month coinciding with the stop-work order and the Consumer Complaint Database is still online, but there may be no one available to take those complaints or help.

Paley has advice for people managing medical debt.

“One thing I would suggest is call the entity that’s issuing the debt and understand, one, where the debt came from,” said Paley.

Get the details of the charge and call the provider for “charity care” to try and get the debt reduced. You can also ask them to negotiate the debt.

Keep in mind, the credit reports of Californians are safe from most medical debt thanks to a law signed last year by Gov. Gavin Newsom. ABC10

For years, MedTech firms around the globe (and certainly European companies) introduced their products in Europe, which requires obtaining a CE mark certifying compliance with relevant EU health and safety standards, prior to entering the US market. But more recently, especially with the EU’s implementation of the complex and burdensome Medical Device Regulation (MDR) requirements for obtaining a CE mark for MedTech products, Europe has started losing its status as the preferred MedTech product launchpad.

International companies have more recently been shifting operations to the US in preparation for launching their products in the region. About 89% of MedTech executives said they will prioritize US regulatory approval, according to a Boston Consulting Group (BCG) and UCLA Biodesign survey.1

As a result, the world’s largest MedTech market, accounting for roughly 40% of the global MedTech market, will now see MedTech companies entering much earlier in their life cycle. This transition necessitates that companies navigate US-specific regulatory, corporate, and intellectual property regimes at an earlier point in their life cycle than many of their past predecessors. We will explore each of these topics in a series of articles.

European Regulatory challenges drive MedTech firms to US
The introduction of MDR in 2021 is likely a key catalyst in driving more MedTech companies to seek device approvals in the US.

The MDR regulation increases the safety criteria required for medical device regulatory approval, in many cases including new clinical evidence. Devices with software components are subject to particularly rigorous requirements due to potential data privacy risks.

Companies are required to obtain a certificate confirming that they meet MDR safety requirements before marketing and selling their devices. As feared, the stringent rules have created bottlenecks and delays: more devices are now falling into higher classifications under the MDR, meaning increased data requirements and increased review from Notified Bodies, who are themselves adjusting to an increased volume of work on an increased number of devices under the MDR regime. This all impacts the timeline for certification.

According to a 2022 survey of MedTech Europe members, the time required for device certification roughly doubled after the MDR regulations took effect. More than 85% of previously certified devices had not received MDR certificates at the time of the survey.

According to a more recent 2024 MedTech Europe survey, uncertainty around certification timelines persists and costs significantly increased for clinical evaluation, post-market surveillance, and certification.

Established US Regulatory processes may Lure MedTech companies
MedTech companies pursuing approval for devices across a range of uses have been increasingly turning to the FDA for initial regulatory approvals. Many end up establishing and growing their operations in the US.

The preference for the US in part reflects a much more positive view of the US regulatory process compared with more than a decade ago.

For example, a Stanford University survey of MedTech companies published in 20102 showed only 16% of respondents had excellent or very good experiences with the FDA, compared with 75% in the EU . In comparison, the 2022 BCG/UCLA Biodesign survey indicated a dramatic change. About 62% of surveyed MedTech executives found the FDA approval process for standard medical technology predictable, while only 22% said the same for the EU.

These data suggest that the steps taken by the FDA designed to expedite the development and approval processes are paying off. The Breakthrough Devices Program, for instance, offers companies enhanced opportunities to gain clarity on regulatory expectations and potentially accelerate their entry into the market. Such measures have positioned the FDA as a more innovation-friendly regulator, particularly for companies developing cutting-edge technologies. Indeed, 79% of the BCG/UCLA Biodesign survey respondents agreed that the FDA has responded well to advances in MedTech innovation over the past decade, while only 13% disagreed.

The hard data underscores the FDA’s strides towards establishing pathways to get advanced technologies to market.

The strong market potential and smoother regulatory process will likely continue to draw MedTech companies into the US sooner than anticipated. As a result, many firms will face unfamiliar regulatory, corporate, and intellectual property issues and decisions. We will unpack these topics in more depth in our “MedTech Coming to America” series. JD Supra

The global clinical trial services market, valued at USD 60.76 billion in 2024, is forecasted to grow at a robust CAGR of 8.9%, reaching USD 66.59 billion in 2025 and an impressive USD 101.86 billion by 2030. Factors such as the growing focus on patient-centric clinical trials such as Decentralized Clinical trials (DCTs) and the increasing number of clinical trials for precision/personalized medicines are supporting the growth of this market. Moreover, the upcoming therapeutic drugs patent cliff is propelling major pharmaceutical companies to heavily invest in R&D and outsource their clinical trial service. Additionally, CROs offer service flexibility which enables sponsors to modify their outsourcing strategies and optimize costs by paying only for required resources and expertise. Additionally, the rise in pediatric clinical trials for various therapeutic drugs and increasing pressure from regulatory bodies to conduct diversified clinical trials offer growth opportunities for CROs offering these specialized services. However, challenges associated with the cybersecurity of patient data and sponsors’ intellectual properties, and patient retention during trials hinder the growth of the market to a certain extent.

By based on modality, the clinical trial services market is divided into small molecules, biologics, and medical devices. The large share of the small molecules clinical trial segment can be attributed to the established role of these drug modalities in drug development across various therapeutic areas. Small molecules have a high oral bioavailability, making them more convenient for patients compared to biologics. Additionally, pharmaceutical companies continue to invest in small molecule research due to their cost-effectiveness, stability, and ability to target intracellular pathways, maintaining their dominance in clinical trials.

By on therapy area, the clinical trial services market is segmented into oncology, neurology, infectious diseases, cardiovascular system (CVS) disorders, metabolic disorders/endocrinology, immunological disorders, respiratory disorders, psychiatry, dermatology, hematology, ophthalmology, gastrointestinal diseases, genitourinary & women’s health, and other therapeutic areas. The oncology segment accounted for the largest share of the clinical trial services market by therapy area in 2024. The large share of this segment is attributed to the increase in global cancer cases due to aging populations and lifestyle factors, supported by rising demand for new treatments. For this reason, pharmaceutical companies are increasingly investing and collaborating with CROs to develop advanced oncology drugs. This dominance is expected to continue throughout the forecast period as major players are developing new technologies for better oncology treatment.

By geography, the clinical trial services market is divided into six regions, North America, Europe, Asia Pacific, Latin America, Middle East, and Africa. In 2024, North America held the largest share of the clinical trial services market, followed by Europe. Aisa Pacific registered the highest CAGR growth within the clinical trial services market during the forecast period owing to its large patient population, high prevalence of chronic and infectious diseases, and increasing focus on developing biologics, biosimilars, and advanced therapies. Global pharmaceutical companies are increasingly relocating manufacturing and clinical research to the region to leverage cost benefits, regulatory advancements, and improved patient retention in trials. Additionally, government support and rising investments in clinical research have further accelerated the outsourcing of clinical trial activities to APAC. MarketsandMarkets