Slow Clinical Trials Are Keeping Indian Pharma a Supplier, Not an Innovator

Resources for this Article

Download PDF Print-ready A4 notes · Free

The Lift Line

Rigour does not require regulatory delay; predictability, speed and depth of scrutiny are compatible.

Why This Editorial Matters for Your Exam

Pharma questions are usually answered as an Aatmanirbharta and access question (GS3). The stronger answer engages the regulatory framework that decides whether Indian discoveries reach clinics in India at all, and the cross-country comparison with the US FDA, Australia and China.

GS Paper 3: Indian economy; science and technology; achievements of Indians in science and technology; issues relating to intellectual property rights.

Concept	Meaning	Why it is testable
First-in-human (FIH) trial	The first administration of a candidate drug to human volunteers	The entry-to-clinic step
CDSCO	Central Drugs Standard Control Organisation, India’s national regulator	The institutional question
Subject Expert Committee	Committee within CDSCO that reviews clinical trial applications	The bottleneck
ICH standards	International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use	The benchmark
Out-licensing	Sale of the rights to develop and market a drug candidate to another company	The commercial metric

Central Argument

Kiran Mazumdar-Shaw, executive chairperson of Biocon (a company the piece itself cites), and Soham Sankaran argue that India’s first-in-human clinical trial approvals take six months to a year or more, against a US FDA review period of 30 days. The delay pushes early clinical development of Indian-discovered molecules to Australia, the United States and Europe, and is a key bottleneck to India moving from supplier to innovator.

Supporting Details

Biocon launched BIOMAb EGFR in 2006 after completing trials entirely in India; that pathway is much harder to replicate today. China conducts over 1,000 FIH trials a year of novel medicines, against fewer than 50 in India; recorded 76 innovative drug approvals in 2025; out-licensing transactions with headline values above USD 130 billion, versus under USD 2 billion for Indian companies. AI and computational biology are compressing discovery timelines to months; the regulatory bottleneck erodes the advantage.

The Counter-View

The authors anticipate the safety objection themselves. India rightly tightened oversight after legitimate concerns over clinical trial practices, and in their words the issue is not whether trials should be regulated: they must be. Their answer is that rigour does not require delay, and that accountable, specialised expert review can improve the depth, predictability and speed of scrutiny together.

Beyond the column: read the case with its source in mind. One author leads Biocon, a company with a direct stake in faster trial approvals; that does not make the argument wrong, but a balanced Mains answer should test it against the patient-safety record that prompted the 2013 tightening.

Way Forward

• Empower accredited hospitals, medical colleges, universities and research institutions to establish CDSCO-registered expert committees on prescribed qualifications and governance.
• Follow ICH standards with time-bound scientific and ethical recommendations.
• Retain CDSCO statutory authority for final permission, system-wide standards, site audits, and the power to suspend trials on safety grounds.

📌 Data and Institutions Vault

Prelims-grade facts:

• CDSCO is India’s national drug regulator, headed by the Drugs Controller General of India (DCGI), under the Ministry of Health and Family Welfare.
• The New Drugs and Clinical Trials Rules, 2019 replaced earlier rules under Schedule Y of the Drugs and Cosmetics Rules, 1945.
• Subject Expert Committees (SECs) within CDSCO review clinical trial applications.
• US FDA clinical trial application review: 30 days.
• India FIH approval: six months to a year or more.
• China FIH trials per year (recent): over 1,000; India: fewer than 50.
• China innovative drug approvals 2025: 76.
• China out-licensing transactions (headline values) 2025: exceeding USD 130 billion; India: under USD 2 billion.
• BIOMAb EGFR (2006): India’s first indigenously developed novel biologic monoclonal antibody, by Biocon.
• ICH: International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use.

Prelims-grade traps:

• The CDSCO is under the Ministry of Health and Family Welfare, not the Ministry of Chemicals and Fertilizers.
• ICH is a body of regulators and pharma companies from major regulatory jurisdictions, not a UN body.

Mains, arguments and keywords:

• Regulatory decentralisation with accountability, not deregulation.
• Accredited institution model with CDSCO retaining statutory authority.
• ICH standards as the benchmark.
• AI and computational biology compressing discovery timelines.
• Keywords: FIH trial, CDSCO, DCGI, SEC, ICH, New Drugs and Clinical Trials Rules 2019, out-licensing.

Interview, be ready for:

• “What is a first-in-human trial?” The first administration of a candidate drug to human volunteers, following completion of preclinical studies.
• “Why did the 2013 Supreme Court intervention matter?” It led to stronger safeguards; the authors argue its interpretation has since added layers of review.
• “What does ‘decentralisation with accountability’ mean here?” Accredited institutions run expert committees on prescribed standards, with the CDSCO retaining final approval, system-wide standards and the power to suspend trials on safety grounds.

Source: Slow Clinical Trials Are Keeping Indian Pharma a Supplier, Not an Innovator — Ujiyari.com | Free UPSC & State PCS Editorial Analysis

Key Arguments at a Glance

Kiran Mazumdar-Shaw (executive chairperson of Biocon, a company the piece itself cites) and Soham Sankaran argue that first-in-human (FIH) trials in India take six months to a year or more against a US FDA norm of 30 days, and that the resulting shift of early clinical development to Australia, the United States and Europe is a key bottleneck to India moving from being a supplier of generic medicines to being an innovator of novel ones.

✓ Supporting

• In 2006, Biocon launched BIOMAb EGFR, India’s first indigenously developed novel biologic monoclonal antibody used for certain cancers, after completing clinical trials entirely in India.
• After 2013 Supreme Court intervention, oversight was rightly tightened; but the regulatory interpretation over the past decade has added procedural complexity and multiple layers of review.
• US FDA operates with a 30-day review period for clinical trial applications.
• Australia combines ethics-committee oversight with risk-based regulatory pathways for rapid initiation of many trials.
• India relies heavily on Subject Expert Committees (SECs) within the CDSCO framework, and a limited number of committees must review many applications, often requiring multiple meetings and repeated submissions.
• China conducts more than 1,000 FIH trials of novel medicines a year, against fewer than 50 in India.
• China recorded 76 innovative drug approvals in 2025; Chinese out-licensing transactions in that year had headline values exceeding USD 130 billion, versus under USD 2 billion for Indian companies.
• AI, computational biology and platform technologies are compressing drug-discovery timelines to months; the regulatory bottleneck erodes the advantage.

⚠ Counter

The authors themselves concede that clinical trials must be regulated: patient safety, scientific rigour and ethical standards are non-negotiable, and India rightly tightened oversight after legitimate concerns over trial practices. Beyond the column: a reader should also weigh that one of the authors heads a company that runs clinical trials, so the case for faster approvals comes from an interested party.

→ Way Forward

Decentralise and accelerate clinical trial approvals while maintaining rigorous oversight: empower accredited hospitals, medical colleges, universities and research institutions to establish CDSCO-registered expert committees with prescribed qualifications, following ICH standards, on time-bound scientific and ethical review, with CDSCO retaining statutory authority for final permission and system-wide oversight.