In a landmark development aimed at keeping pace with rapid innovation in modern therapies, India's apex drug regulator—the Central Drugs Standard Control Organisation (CDSCO)—plans to include experts from the private sector and international domain in its expert review committees. This reform marks a significant departure from the country’s traditional reliance on government-affiliated experts for reviewing new drug applications.

Why the Change is Crucial

Dr Rajeev Singh Raghuvanshi, the Drug Controller General of India (DCGI), described this strategic shift as a "very important milestone" during his address at the first Annual CAR-T Cell Therapy Summit held in Mumbai. The CDSCO, under his leadership, aims to strengthen its regulatory efficiency and accelerate approvals for cutting-edge treatments.

Historically, only government-appointed experts were eligible to serve on CDSCO’s subject expert committees due to conflict-of-interest concerns and institutional norms. However, Dr Raghuvanshi acknowledged that this approach had limitations, especially in evaluating novel and complex therapies like Cell and Gene Therapies (CGT).

“We are now moving beyond the government setup. The Ministry has agreed that we can bring in experts from non-government systems,” said the DCGI.

Bringing in Expertise from Outside

The new plan allows the CDSCO to tap into experienced professionals from private industries, academia, and even international institutions, particularly retired scientists and researchers who have been instrumental in developing and approving such advanced therapies.

“We don’t find many people who understand this domain within the government system. To solve that problem, we are expanding our horizon,” Dr Raghuvanshi said.

The reform will initially focus on the Cell and Gene Therapy space, which is undergoing rapid growth and innovation worldwide, and will later be extended to all relevant therapeutic areas.

Pilot Focus: Cell and Gene Therapy (CGT)

According to the DCGI, this pilot project in CGT is just the beginning. The goal is to integrate private and foreign experts across all Subject Expert Committees (SECs) within a year wherever necessary.

CAR-T therapies—among the most advanced forms of CGT—have already made an entry into the Indian market. The CDSCO has approved two CAR-T therapies developed by ImmunoAct and Immuneel, and nine others are currently undergoing clinical trials. There are 59 active applications in this domain.

“The review process for CGT will now be separate from traditional therapies. We’re reducing review layers and cutting internal timelines to 15 days,” Raghuvanshi added.

Accelerated Reviews and Digital Integration

To facilitate quicker and smoother operations, the CGT application process will soon be made online, with the rollout expected by the end of April 2025. This digital transformation aims to eliminate bureaucratic bottlenecks and enable transparency.

Further, the regulator is working on new CGT guidelines, co-developed with inputs from industry stakeholders. These comprehensive guidelines are likely to be released by June 2025, setting a clear pathway for drug developers and biotech startups.

From Regulation-Heavy to Execution-Heavy

A key aspect of this overhaul is CDSCO’s shift in regulatory philosophy. Dr Raghuvanshi noted that the organisation is now focused on being “lighter in regulation and heavier on execution”.

This new motto translates into reducing procedural delays. As part of this transition, up to 50% of T licences and export No Objection Certificates (NOCs) could be eliminated—freeing up crucial resources that can be redirected toward evaluating advanced treatments.

Wider Impact on India’s Biotech Ecosystem

This reform comes at a time when India is emerging as a major player in biopharmaceutical innovation, especially in personalised medicine and next-gen therapies like gene editing, RNA therapies, and immuno-oncology.

By incorporating top-tier talent from beyond government institutions, India can now aim to match global regulatory standards and provide a predictable, science-driven pathway for emerging technologies.

Experts believe this move will boost foreign investment, encourage startups in biotech, and improve patient access to lifesaving therapies.

What It Means for Stakeholders

For Pharmaceutical Companies:

• Faster approvals and clearer guidance for CGT products.

• A predictable regulatory environment enhances R&D investment confidence.

For Healthcare Startups:

• Opportunities to engage directly with expert regulators.

• A streamlined application process that reduces go-to-market time.

For Patients:

• Quicker access to advanced treatments like CAR-T and gene therapies.

• More innovation and better treatment options in the near future.

Conclusion

The CDSCO’s decision to bring in non-governmental and international experts is a transformational step in India’s healthcare regulatory landscape. With the growing complexity of therapies and the rise of personalised medicine, it’s crucial for regulators to be as innovative and adaptive as the industry itself.

This proactive reform, backed by digital integration and policy revamp, not only reflects India’s commitment to scientific excellence but also its ambition to become a global hub for modern therapeutics.

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