2025-09-02

The Central Drugs Standard Control Organisation (CDSCO) has issued its first formal guidelines on Subject Expert Committees (SECs) for drug, biologic, and medical device approvals. This move—aligned with WHO recommendations—seeks to fix longstanding issues of ad-hoc processes, unclear eligibility, and inconsistent decisions that slowed approvals and weakened trust.

For businesses, this could mean faster, more predictable approvals and a transparent, evidence-driven compliance regime. But it also raises the bar—requiring robust data integrity, scientific rigour, and regulatory preparedness.

We spoke with Rishi Agrawal, Co-Founder and CEO of TeamLease RegTech, to gain insights into how these changes will impact pharmaceutical and medical device companies.

Q. How will formalising SEC processes impact approval timelines and predictability for pharma and medical device companies?

The earlier process involved multiple bodies, primarily the Drugs Controller General of India (DCGI) office, but lacked a formalised structure for SECs. Membership was ad-hoc, eligibility criteria were unclear, and panel compositions varied case by case. The formalisation of appointing SECs aims to fix problems of unclear and inconsistent approvals that may have previously slowed down drug and device launches. It looks like a step in the right direction, addressing practices that did not contribute to effective and efficient cycles of drug and devices approval.  

These guidelines aim to establish a clear framework for SECs, introducing clear timelines, such as finalising recommendations within seven working days of a meeting and completing clinical trial or manufacturing approvals within 90 working days. They also introduce expedited review pathways for critical therapies, including drugs for serious conditions or public health emergencies, and allow clinical trial waivers for products approved in major regulatory jurisdictions, significantly reducing time to market. Additionally, requirements such as concise pre-submission briefing materials and post-approval surveillance may enhance efficiency and clarity. While these changes promise faster approvals and a more reliable regulatory environment, companies must adapt to new procedural demands and maintain strict adherence to Good Manufacturing Practices in order to fully capitalise on these improvements.

Q. What compliance challenges will arise from stricter eligibility, disclosure, and documentation requirements?

The stricter eligibility, disclosure, and documentation requirements outlined in the CDSCO’s July 2025 SEC guidelines present notable compliance challenges for pharmaceutical and medical device companies in India. The mandate for SEC members to have a minimum of 10 publications with a 2:1 citation ratio ensures high-quality expertise but may limit expert availability, potentially delaying reviews, especially for niche therapies. This reflects that the industry falls short of experts and the capacity to publish citation-based papers. Enhanced disclosure norms, aligned with WHO’s 2023 recommendations, require detailed conflict-of-interest declarations and comprehensive submission data. It may increase the administrative burden, particularly for smaller firms lacking regulatory expertise. Stringent administrative documentation demands, such as concise 20-25 slide pre-submission materials due five days before meetings and ongoing post-approval surveillance, challenge companies to produce high-quality, timely submissions, with smaller firms facing resource constraints. Inconsistent enforcement across SECs could create uncertainty, while balancing faster timelines (e.g., 90-day approvals) with an array of requirements, risking delays if submissions are inadequate. These challenges may raise operational costs and require a steep learning curve, especially for smaller innovators and entrepreneurs, though they aim to enhance transparency and global alignment. Companies can sieve these challenges through regulatory training, technology adoption, and early SEC engagement, while the Indian Drugs Manufacturers Association (IDMA) emphasises the need for support mechanisms to ease compliance for smaller players.

Q. Can structured SECs reduce India’s exposure to low-quality or counterfeit drugs and devices?

India is referred to as the ‘pharmacy of the world’. The country caters to the medical needs of its own while also serving global markets. Currently, India fulfills over 60 percent of the vaccine needs and 40 percent of the generic drugs in the United States, alongside 25 percent of the UK’s generic drug requirements. With around 3,000 companies and over 10,563 industrial units, India boasts the largest number of manufacturing sites approved by the US FDA outside of the United States.

However, India’s exposure to low-quality and counterfeit drugs and devices has been a menace for years. The formalisation of SECs cannot alone solve these long-standing issues. Ideally, 10,000 samples should be tested yearly, but only 3000 are being tested now. According to the Malshekar committee recommendation, there should be one drug inspector for every 50 manufacturing units and one per 200 distribution retailers. Less than half of Maharashtra's 200 sanctioned posts for drug inspectors within the state’s leading drug regulatory authority are functional. The CDSCO is short on drug inspectors as well. A parliamentary panel report from December 2023 indicates that around 300 out of 504 sanctioned posts for drug inspectors at CDSCO were vacant at that time. The situation is grave at the state level as well. For example, Maharashtra still faces a significant shortage of inspectors along with Kerala, Punjab, and Assam. The numbers are so dire that the number of inspectors falls under two-digit numbers for a state with five-digit establishments to be inspected.

The regulatory capacity across the country remains stressed. There is a need to create capacity on the operational level to support the directions of the SECs. Risk-based, timely inspections with a greater scope of action on non-compliance are paramount to develop an effective regulatory framework that prohibits the production and circulation of subpar medical drugs and devices.

Q. Will mandatory justifications for decisions (e.g., trial waivers) improve industry trust in the regulator?

The mandatory requirement for SECs to provide justifications for decisions, such as clinical trial waivers, under India’s CDSCO guidelines released in July 2025, is expected to significantly boost industry trust in the regulator. By mandating clear, science-based rationales, the guidelines enhance transparency, addressing past industry frustrations with opaque decision-making and fostering confidence through traceable, evidence-based outcomes. This requirement ensures consistency and predictability by aligning decisions with standardised benchmarks, reducing variability and reassuring companies, as noted by the Indian Drugs Manufacturers Association, which praised the guidelines for tackling inconsistent verdicts. Clinical trials are a product of long-drawn, expensive processes that are closely managed and controlled. Trial waivers are necessary for expediting drug discovery cycles, doubling efficiency, and cutting down on compliance costs and documentation requirements. It may enhance India’s capacity to produce lower-cost drugs and devices.

Aligning with global standards, as recommended by the WHO’s 2023 review, further builds trust, particularly for multinational firms familiar with transparent regulatory frameworks. Additionally, documented justifications promote accountability, supported by credible experts with robust research credentials, mitigating perceptions of bias. The guidelines also encourage SECs to offer constructive feedback, fostering a collaborative environment that strengthens regulator-industry ties. However, consistent implementation is crucial to avoid vague justifications, and smaller firms may need support to navigate detailed rationales. Overall, these measures create a more trustworthy and predictable regulatory landscape, supporting India’s pharmaceutical and medical device industries.

Q. How should companies strengthen their regulatory submissions to meet higher expectations for transparency and scientific merit?

To strengthen regulatory submissions in line with the new SEC guidelines for medical drug and device approval, companies should implement practices that promote both transparency and scientific merit. Modern requirements call for well-structured briefing documents that clearly present the scientific rationale, methodologies, and data supporting the drug or device, while also emphasising ethical standards. Firms must present their clinical trial outcomes, bioequivalence studies, and risk-benefit analyses using statistical methodologies, ensuring that all information is transparent and easily verifiable. The documents should be concise and focused, usually in a standardised format for submission ahead of review sessions to facilitate timely and effective evaluation by regulators. Companies should use smart document and data management solutions that will help in better decision-making through organised, secure, and easily retrievable data.

If companies seek clinical trial waivers, these requests must be backed by thorough scientific and regulatory justifications, referencing applicable global precedents or highlighting urgent unmet medical needs, such as treatments for orphan diseases or pandemic response drugs. Ethical conduct is paramount; submissions should highlight the use of Good Clinical Practice (GCP), the informed consent process, and ongoing safety monitoring protocols. Aligning the supporting evidence and approval pathways with established international standards, such as those used by regulatory bodies in the developed world, will help demonstrate global credibility and facilitate expedited reviews or conditional approvals when applicable.

Early and active engagement with regulatory authorities is encouraged, treating them as partners in the development process. Companies should also strengthen their capability and processes for post-market surveillance and compliance systems, including pharmacovigilance and timely adverse event reporting, to reinforce their commitment to patient safety and ongoing regulatory updates. Meticulous documentation and integration of these approaches will support firms to accelerate regulatory approvals and build lasting trust with stakeholders in the sector.