The Central Pharmaceuticals Standard Control Organisation (CDSCO) is an important part of India's healthcare system, functioning as the primary regulatory authority for pharmaceuticals and medical equipment. However, a recent investigation by the Parliamentary Standing Committee has raised concerns about operational inefficiencies, regulatory opacity, and the impact on India's desire to become a worldwide powerhouse for medical device manufacture.

CDSCO is responsible for authorising new pharmaceuticals, conducting clinical studies, controlling imports, and ensuring that drug regulations are enforced consistently. The Drugs and Cosmetics Act gave the power to make and distribute drugs to the states. The central authority, on the other hand, is in charge of licensing important medical products like vaccines, blood products, and high-risk medical equipment, as well as approving new drugs and conducting clinical studies. Despite this established framework, there are ongoing worries about regulatory delays and bureaucratic impediments that impede corporate operations.

A major topic of controversy is the classification and licensing of medical devices. India, which is now an affiliate member of the worldwide Medical Devices Regulatory Forum (IMDRF), uses a worldwide categorisation system for medical devices.

However, applicants and industry stakeholders claim considerable delays in obtaining import licenses, and CDSCO admits that it does not keep an organised database of processing timeframes. This lack of openness raises concerns about inconsistent decision-making, which creates uncertainty among manufacturers.

One of the most urgent issues raised by the Standing Committee is the irregular timing of licenses for identical medical devices.

The regulatory body explains this by emphasising the importance of thorough application reviews, but the lack of a standardised, publicly accessible tracking system adds to applicants' irritation. The opacity of the procedure, combined with several rounds of questioning from CDSCO, has given the perception of regulatory arbitrariness.

The committee also stated that India is at risk of losing its competitive advantage in medical device manufacturing due to lengthy regulatory procedures. Reports indicate that regulatory challenges have incentivised corporations to establish manufacturing plants in Vietnam and Malaysia, due to their perceived superior licencing frameworks. This trend threatens India's ambition of becoming a self-sufficient medical technology hub.

From a public health standpoint, CDSCO's strict regulatory approach is not without merit. Ensuring the safety and efficacy of medical devices is critical, especially as India deals with quality issues in healthcare. The recent increase of statutory licensing criteria to cover all medical devices aims to improve patient safety. However, critics contend that the policy's implementation has been hampered by unnecessary delays and inconsistent monitoring, disproportionately hurting smaller enterprises and startups with few resources to negotiate complex bureaucratic channels.

The CDSCO's goal in enacting these reforms is to find a balance between regulatory stringency and sector growth. The proposed digitisation approach, which includes automated notifications and real-time tracking, would increase openness while also instilling trust in manufacturers, particularly startups, by lowering regulatory barriers. AI-powered pre-screening could improve application processing by ensuring that only full submissions enter the approval pipeline, reducing unnecessary delays.

The single-query policy and conditional approvals for globally approved items would also get rid of unnecessary red tape, making the regulatory environment more predictable and effective. Together, these steps have the potential to change CDSCO from a perceived bottleneck to a facilitator of innovation, assisting India's ambitions to become a global leader in medical device production while maintaining the safety and efficacy of medical products.

Beyond procedural inefficiencies, a manpower shortage contributes to CDSCO's operational issues. The extension of regulatory oversight to include all types of medical devices has greatly expanded CDSCO's workload, but staffing levels have not kept up. The committee has recommended the government speed up recruiting, particularly for specialised positions, like drug inspectors and medical device controllers.

In addition, the idea of letting experts from other industries join CDSCO could help fill the skills gap and make regulations more business-friendly. A formal avenue for conversation and dispute resolution would be provided by the establishment of an Industry Advisory Board made up of manufacturers, healthcare providers, and regulatory specialists.

The Standing Committee's observations are not without merit—CDSCO's operations should be more efficient, transparent, and industry-friendly. However, regulatory organisations must maintain a delicate balance between expediting approvals and maintaining stringent safety standards. The notion of CDSCO as a 'license raj' arises from a combination of legitimate concerns and reasonable regulatory caution..

Industry leaders call for a balanced regulatory approach 

The Medical Technology Association of India (MTaI) has responded to the Parliamentary Standing Committee report by calling for a more nuanced assessment of the Central Drugs Standard Control Organisation (CDSCO). While acknowledging the committee's constructive recommendations, such as digitising the licensing system, reducing bureaucratic delays, and incorporating industry expertise, the MTAI emphasises the importance of recognising CDSCO's current challenges as well as the larger factors influencing India's medical device industry.

According to MTaI, CDSCO's centralised regulatory functions are driven by the organization's concentration of specialised expertise. They also point out that, while regulatory delays are a concern, companies that choose Vietnam or Malaysia for production are impacted by a variety of factors, including tax policy and commercial incentives that CDSCO cannot regulate. Furthermore, MTaI reiterates the committee's previous concerns about CDSCO understaffing, emphasising that the problem has worsened with the extension of the required licensing requirements for all medical devices.

Despite these hurdles, MTAI supports the idea of establishing a specialised support team to help applicants, particularly startups, navigate the regulatory minefield. A system like this, similar to a "chaperone service," could assist in simplifying communication and decreasing procedural inefficiencies.

While supporting regulatory reforms, MTAI emphasises the necessity of preserving high-quality and ethical standards. They argue for a regulatory system that strikes a balance between industry expansion and patient safety, ensuring that India's medical device sector remains globally competitive while maintaining high efficacy and innovation levels.

Reforming CDSCO's regulatory framework necessitates a balanced approach that takes into account both industry concerns and the agency's institutional constraints. While decentralisation may appear to be a solution to simplify approvals, it must be carefully calibrated to avoid differences in enforcement standards among states while also ensuring that expertise stays centralised when needed.

Furthermore, while regulatory delays have been suggested as reasons for firms to relocate to Vietnam or Malaysia, larger economic concerns, such as tax breaks, infrastructure, and labour prices, are also important. Addressing CDSCO's difficulties must therefore go beyond simply speeding approvals and instead focus on systemic changes such as workforce increase and capacity enhancement. The agency's rising workload, particularly since all medical devices are now subject to statutory licensing, needs targeted recruitment and training efforts to improve efficiency while maintaining safety and quality requirements. Reform initiatives should strive for a regulatory framework that promotes both public health protections and a competitive economic environment.

India is confronting a critical juncture in the regulation of medical devices. While CDSCO has made great progress, such as the launch of the MDOnline platform for paperless licensing, the system still needs significant modernisation to keep up with industry demand. A transparent, technology-driven, and efficiency-focused regulatory environment is essential for encouraging innovation while protecting public health.

By embracing new technologies like digital process tracking, AI-driven approvals, and industry collaboration, CDSCO could go from being seen as a barrier to growth, making India a world leader in making medical devices.