Inside India’s Clinical Trial Ecosystem: Insights from a Pharma Operations Leader

Interview with Clinical Research Consultant Krutikesh Age

Summary

Clinical trials are the foundation of modern medicine. Yet their biggest challenges are often not scientific; they are operational.

From patient recruitment and documentation to regulatory compliance and hospital coordination, execution complexity frequently slows research progress.

In this interview, Krutikesh Age, a Doctor of Pharmacy (PharmD) professional turned clinical research consultant, explains how execution-focused support systems help pharma companies, hospitals, and patients benefit from faster and more efficient research.

He shares insights on:

Key Takeaways

Founder Background

Interviewer:

Could you briefly share your background and what led you into clinical research consulting?

Krutikesh:

Although I initially wanted to become a medical doctor, my PharmD education kept me closely connected to hospitals and patient care environments. During my hospital training, I noticed that many doctors were interested in research but did not have the time to manage the operational complexity involved in clinical trials.

There is a common saying in clinical research:

“If it’s not documented, it never happened.”

Clinical trials require extensive documentation, reporting, coordination, and compliance management. Physicians are already overloaded with clinical duties, which creates a gap that specialized execution teams can fill.

My entry into this field happened during COVID when a pharma contact approached me for support on a clinical trial project. What started as freelance consulting gradually expanded into multiple projects, including oncology trials, which eventually led me to build a structured consulting practice.

Interviewer:

How did this evolve into a business?

Krutikesh:

The journey was very organic. Initially there was no formal company structure. Most projects came through referrals.

As projects increased, I started collaborating with peers and delegating execution tasks. After successfully completing early trials, we formally structured operations around 2020 and began building partnerships with hospitals and pharma organizations.

Clinical Trial Role

Interviewer:

What role do you play in the clinical trial ecosystem?

Krutikesh:

We are not drug manufacturers. We act as execution partners supporting trial operations.

Our work includes:

Clinical trials are not just medical exercises. They are highly operational processes that depend heavily on compliance and documentation accuracy.

Interviewer:

How do you see the broader impact of clinical trials?

Krutikesh:

Coming from a Tier-2 city background, I also saw the affordability dimension. Clinical trials sometimes provide patients access to advanced therapies they may not otherwise afford.

I see trials not only as research programs but also as access pathways to treatment.

There are two major trial categories:

Innovator trials
New drug development

Generic trials
Post-patent affordability drugs

Generic trials are particularly important in countries like India because they help bring lower-cost treatment alternatives to market.

Generic Drug Testing

Interviewer:

Do generic drugs also require trials?

Krutikesh:

Yes.

Even after patents expire, companies must prove:

A drug contains:

Innovator companies prove efficacy through full clinical trials. Generic manufacturers must prove equivalence.

Recent regulatory updates have allowed reduced testing for certain biologics, but I believe extensive safety testing remains important due to India’s population diversity.

Interviewer:

What exactly do generic companies need to prove through these trials?

Krutikesh:

The innovator drug company must initially prove that their drug works for a particular indication.

For example, Semaglutide known through brands like Ozempic was originally tested for diabetes. Later it was also tested and approved for weight loss.

When generic companies enter, they must prove:

This is called demonstrating equivalence. The generic drug must closely resemble the innovator drug in effectiveness and safety.

Interviewer:

Can you share an example of how this works in practice?

Krutikesh:

Yes. Taking the example of Semaglutide again, once the opportunity opened up, multiple pharmaceutical companies in India started working on similar molecules.

Companies like Sun Pharma and others have entered this space. This is quite common once a drug shows strong demand and goes off patent.

How Pharma Builds Adoption

Interviewer:

We have seen companies trying to connect with specialists and doctors when launching new drugs. Is that common?

Krutikesh:

Yes, that’s very common.

Pharmaceutical companies often work with specialists like diabetologists or oncologists depending on the drug category. They also try to build doctor networks across regions to improve adoption and awareness.

This ecosystem includes:

Generic Trial Regulations

Interviewer:

Have there been any recent regulatory changes affecting clinical trials for generics?

Krutikesh:

Yes.

Around August–September last year, some regulatory changes impacted biologic drugs.

Earlier, companies making generic versions of biologic drugs had to conduct large clinical trials similar to new drugs. Now, in some cases, regulators allow companies to prove similarity through lab tests and controlled comparisons instead of full trials.

The main focus now is to prove that the generic biologic is very similar to the original drug in terms of safety and effectiveness.

Interviewer:

Do you see any risks in reducing clinical trial requirements?

Krutikesh:

I see both advantages and concerns.

Advantage:

Drugs become cheaper faster because companies save on trial costs.

Concern:

India is extremely diverse genetically and environmentally. A drug that works well in one population may behave differently elsewhere.

Because of this diversity, broader testing can sometimes better identify safety risks.

That said, regulators likely considered these factors. I would be cautious about drawing strong conclusions without full regulatory context.

Why Side Effects Remain Central to Drug Testing

Interviewer:

Why do you emphasize side effects in clinical testing?

Krutikesh:

Because every drug is ultimately a balance between benefit and risk. The goal is not just to prove effectiveness, but also to minimize harm. A good drug achieves therapeutic outcomes with minimal adverse reactions. This is why sample diversity and monitoring are critical.

Current Scale of Operations

Interviewer:

What scale are you operating at today?

Krutikesh:

Currently we operate across:

Interviewer:

Are you also working with global pharmaceutical companies and CROs?

Krutikesh:

Yes.

We currently work with global pharmaceutical companies like Eli Lilly and Company. We are also in the process of signing with organizations like Amgen.

We also collaborate with CROs such as IQVIA and Parexel.

In India, we also work with pharma companies and hospitals as part of the research ecosystem.

Interviewer:

How does your value differ between pharma companies and hospitals?

Krutikesh:

For pharma companies:

We reduce operational burden by managing hospital execution.

Benefits:

For hospitals:

We act as research enablers.

Benefits:

Many hospitals claim research capability but lack operational infrastructure. Our role is converting potential into actual trials.

Government Hospitals in Trials

Interviewer:

Do government hospitals also show interest in clinical trials?

Krutikesh:

Yes. Nearly 80% of our collaborations involve government institutions and Tier-2 hospitals.

Interviewer:

Are government hospitals required in site selection?

Krutikesh:

Yes.

Some studies require approximately 50% participation from government institutions as a regulatory requirement to ensure diversity and accessibility.

Clinical Trials Revenue Model

Interviewer:

How do you monetize your services?

Krutikesh:

Revenue comes primarily from consulting and execution fees from pharma companies and CROs.

Depending on agreements:

Interviewer:

Since this is a services business, how do you price your work?

Krutikesh:

Pricing depends on:

We also determine pricing based on Fair Market Value (FMV) to ensure our services are aligned with industry standards and regulatory expectations.

Indian companies generally pay less than global sponsors.

Interviewer:

What kind of margins typically exist?

Krutikesh:

Margins are roughly 20–22%.

This is an execution-heavy business, so efficiency drives profitability.

Interviewer:

Is pricing phase-based or activity-based?

Krutikesh:

Pricing is usually visit-based. Each patient has defined visits. If visits are incomplete, those are not billed. This keeps pricing aligned with actual work.

Therapy Areas and Research Experience

Interviewer:

What therapeutic areas have you worked in?

Krutikesh:

Apart from oncology:

Being involved in early COVID research was particularly meaningful.

Interviewer:

Were you involved in any COVID-related clinical trials?

Krutikesh:

Yes.

I was part of an investigator team working on an antiviral drug trial. Being associated with that effort was a proud moment.

Authority Structure During Trials

Interviewer:

Who controls decisions during trials?

Krutikesh:

Doctors control:

Our team manages:

Interviewer:

How do you handle safety incidents?

Krutikesh:

We differentiate between:

Serious events must be reported within 24 hours to:

Our role is ensuring timelines are met.

Safety always comes first.

Interviewer:

What operational support do you provide in regulatory reporting?

Krutikesh:

We support reporting through systems like the Sugam portal.

Doctors may not have time to complete administrative processes, so we prepare documentation for their review and approval.

Interviewer:

Who is responsible if something goes wrong?

Krutikesh:

Responsibility is shared among:

Patients sign informed consent documents covering risks and alternatives.

Interviewer:

How do patients understand risks before participating?

Krutikesh:

Patients receive detailed informed consent documents of about 15–20 or more pages. If needed, legal representatives can help them understand. We ensure patients clearly understand risks and benefits before enrollment.

Interviewer:

Have you encountered high-risk cases?

Krutikesh:

Yes.

Especially in aggressive cancers like triple-negative breast cancer. Patients enrolling usually understand risks and the experimental nature of treatment.

Why Trials Require Multiple Locations

Interviewer:

Why are trials conducted across multiple hospitals?

Krutikesh:

Regulations require geographic diversity.

Trials typically include:

Some also require government hospitals.

Patient Adherence Responsibility

Interviewer:

Are you responsible for ensuring patients complete trials?

Krutikesh:

Yes.

Trial value depends on patient completion. Patient follow-ups are a critical responsibility.

About the Organization

Interviewer:

How large is your organization today?

Krutikesh:

We currently have about 18 operational employees. Some functions like HR, finance, and digital support are outsourced.

Interviewer:

Is this a profitable business?

Krutikesh:

We have been profitable from day one and mostly bootstrapped. We did take a loan for expansion but focus on sustainable growth.

Interviewer:

Are you exploring technology to improve margins?

Krutikesh:

Yes.

We have been exploring an AI/ML idea to reduce manual processes. Many hospitals still operate on paper systems, which slows recruitment. We want to build platforms to identify eligible patients faster.

Interviewer:

Are you a solo founder?

Krutikesh:

We technically have three co-founders, but only two of us are actively involved currently.

Patient Recruitment Bottlenecks

Interviewer:

What key problem does this platform aim to solve?

Krutikesh:

Patient recruitment.

Enrollment for innovative trials can take over a year. We want systems that match patients to trials faster.

Competition in Clinical Trial Execution

Interviewer:

How competitive is your industry?

Krutikesh:

Very competitive and quite cut-throat.

Most trials are concentrated in metros. Our focus on Tier-2 cities differentiates us. There are three to four large players with 20+ years of history. Our differentiation comes from underserved regions.

Winning Clinical Trial Business

Interviewer:

How do you sell your services?

Krutikesh:

Traditional sales teams don’t work well here. Clinical trials require scientific understanding.

If a pharma company asks technical questions and answers are weak, projects are lost. These deals can be worth ₹25–30 lakh or more.

Most of our business comes organically through trust and technical credibility.

Hiring Requirements

Interviewer:

What educational background do your employees need?

Krutikesh:

Most operations staff have Pharma and Biotech backgrounds. Domain knowledge is essential. In some regions like Kerala hiring is difficult because many pharmacists move abroad.

Regulatory Complexity as a Barrier

Interviewer:

Are regulations a major challenge?

Krutikesh:

Yes, regulations can slow things down a lot.

For example, it took us more than a year initially to get some major clinical trial sites ready to run studies because of regulatory approvals, institutional processes, and compliance requirements.

But now, because we understand the system better, we can start trials much faster.

Also, having a  healthcare background and good relationships with doctors helps build trust with pharma companies (sponsors), which makes it easier to get projects

Future of Clinical Trials in India

Interviewer:

What is your long-term vision?

Krutikesh:

India is expanding trial infrastructure under initiatives like the National Biopharma Mission. But infrastructure alone is not enough.

Public participation is critical. In the US, people voluntarily register for trials. India still lacks that culture. We need more awareness and responsible participation.

Measuring Clinical Trial Success

Interviewer:

What metrics define trial success?

Krutikesh:

There is no single answer.

Traditional definition: Drug reaches market.

Other definitions:

Example:

Minoxidil failed in hypertension but succeeded in hair treatment. Sometimes stopping trials early is also a success because it limits losses.

Future of Decentralized Trials

Interviewer:

Will trials move toward home-based models?

Krutikesh:

Initial visits must happen in hospitals due to consent.

Remote follow-ups are being explored but challenges exist:

Home models currently work better in geriatric care.

Why Clinical Research Awareness is Low

Interviewer:

Why don’t more people understand this industry?

Krutikesh:

It is a communication issue. People see pharmacies but not research ecosystems.

Clinical research gets less exposure compared to engineering. Awareness platforms are important.

Why Pharma Companies Have Low Public Visibility

Interviewer:

Why aren’t pharma companies more visible?

Krutikesh:

Regulations restrict drug promotion. Companies can promote themselves but not specific drugs. This keeps many industry players relatively unknown.

Vision for Impact

Interviewer:

What impact do you want to create?

Krutikesh:

I see my work as building bridges between:

My goal is helping treatments reach markets faster while improving patient access.

Interviewer:

Anything else you would like to add?

Krutikesh:

Clinical research is a challenging but meaningful field.

We welcome collaboration from:

Anyone interested in strengthening India’s research ecosystem.

Final Takeaway

Clinical research may appear scientific on the surface, but its biggest bottlenecks often lie in execution.

Professionals building operational infrastructure like Krutikesh Age are enabling the next generation of treatments by ensuring trials run efficiently, safely, and compliantly.

Sometimes innovation does not require new science.

Sometimes it simply requires better execution.

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