How New Drugs Get Approved in India: Step-by-Step Process

Medically Reviewed By

Mr. Jitendra K Das M.Pharma • Pharmacology Jitendra K Das is a qualified pharmacist (M.Pharma-Pharmacology) with 9+ years of experience in hospital pharmacy and occupational healthcare. Currently working as Cluster Head in a leading Healthcare sector, he specializes in medication management, patient safety, and clinical support services.

This article has been medically reviewed for accuracy, clinical relevance, and evidence-based medical information.

Last medically reviewed: September 5, 2026

Introduction

How New Drugs Get Approved in India is a question that sits at the intersection of pharmaceutical science, clinical research, regulatory affairs, public health, and patient safety.

A medicine cannot simply move from a laboratory into a pharmacy because it appears promising. Before a new drug can be routinely marketed, regulators need evidence that it has an acceptable balance of quality, safety and efficacy for its proposed use. That evidence is built progressively through laboratory research, non-clinical studies, clinical trials, manufacturing controls, regulatory review and post-marketing safety monitoring.

In India, the regulatory framework is primarily governed by the Drugs and Cosmetics Act, 1940, the Drugs Rules, 1945, and the New Drugs and Clinical Trials Rules, 2019 (NDCTR 2019), together with applicable guidance, notifications and standards. CDSCO maintains the current NDCTR framework and related regulatory notifications.

At the central level, the Central Drugs Standard Control Organization (CDSCO) performs major regulatory functions, including review of new drugs and clinical-trial applications. The Drugs Controller General (India), commonly called the DCGI, is closely associated with the central regulatory system. State Drug Control Authorities also have important responsibilities, particularly around manufacturing and distribution licensing.

Understanding the new drug approval process in India is valuable not only for pharmaceutical companies and regulatory affairs professionals, but also for pharmacists, doctors, researchers, clinical research professionals and students. It explains why a medicine may take years to reach patients, why some applications receive additional questions, and why regulatory approval does not end the responsibility for monitoring safety.

Important terminology: “DCGI approval” is commonly used in industry and general discussion, but the legal framework uses terms such as Central Licensing Authority (CLA) and specific permissions/forms under the NDCTR 2019. The exact pathway depends on the type of product and regulatory application.

Understanding Drug Approval in India

What Is Drug Approval?

Drug approval is the regulatory process through which a competent authority evaluates evidence submitted by a sponsor or applicant and determines whether a medicinal product may be investigated, manufactured, imported, marketed or otherwise used for the proposed purpose.

The regulator is essentially asking:

• Is the product consistently manufactured to the required quality?
• Does the product work for the proposed indication?
• Are its benefits greater than its known and reasonably foreseeable risks?
• Is the proposed dose appropriate?
• Are the manufacturing facilities and processes adequately controlled?
• Are labeling and prescribing information appropriate?
• Can the product be safely monitored after it reaches patients?

Approval is therefore not simply a certificate that a drug is “safe.” Rather, it is a regulatory decision based on the available evidence and the proposed conditions of use.

Why Drug Approval Is Necessary

A promising molecule can have unexpected toxicity, interactions, contamination, inconsistent manufacturing or limited therapeutic benefit.

For example, a compound may show excellent activity in a laboratory experiment but fail during human trials because:

1. the human dose required is too high;
2. the drug is poorly absorbed;
3. toxicity limits its use;
4. the treatment does not improve clinically meaningful outcomes;
5. the manufacturing process cannot consistently produce acceptable-quality batches.

Drug regulation attempts to identify these problems before widespread exposure.

Objectives of Drug Regulation

The Indian regulatory system broadly seeks to protect public health while facilitating access to useful medicines.

Its major objectives include:

• Safety: minimizing unacceptable risks.
• Efficacy: establishing that the medicine provides the claimed therapeutic benefit.
• Quality: ensuring consistent identity, strength, purity and performance.
• Manufacturing control: ensuring products are manufactured under appropriate standards.
• Ethical research: protecting clinical-trial participants.
• Accurate information: ensuring appropriate labeling and prescribing information.
• Post-marketing surveillance: identifying safety signals that may only become visible after broader use.

Patient Safety Comes First

A regulatory approval is not the end of the evidence-generation process.

Clinical trials involve selected populations and controlled conditions. After commercialization, medicines may be used by much larger and more diverse populations, including older adults, children, patients with multiple diseases, and people taking several medicines simultaneously.

This is why pharmacovigilance remains essential after approval.

Overview of India’s Drug Regulatory System

India has a multi-layered regulatory structure rather than a single organization performing every regulatory function.

Regulatory body	Main role
CDSCO	Central regulatory functions for drugs, new drugs, clinical trials, imports and specified products
DCGI	Drugs Controller General (India); senior central regulatory role within CDSCO
Ministry of Health & Family Welfare	Central government ministry under which CDSCO operates
State Drug Control Authorities	Licensing and enforcement functions within states, including manufacturing and sale/distribution activities
Indian Pharmacopoeia Commission (IPC)	Pharmacopoeial standards and national pharmacovigilance coordination through PvPI
Institutional Ethics Committees	Ethical oversight of clinical research involving human participants

Central Drugs Standard Control Organization (CDSCO)

CDSCO is India’s central drug regulatory organization under the Directorate General of Health Services, Ministry of Health and Family Welfare.

Its new-drug functions include review of applications involving new drugs and clinical trials. CDSCO’s current regulatory pages identify separate functions for investigational new drugs, new drugs and subsequent new drugs.

Applications are processed through regulatory systems such as the SUGAM portal, depending on the application type.

Drugs Controller General of India (DCGI)

The DCGI is the senior central drug regulatory authority commonly referred to when discussing “DCGI approval.”

For practical purposes, professionals should understand that the legally relevant regulatory permissions arise through the applicable central licensing framework and prescribed forms under the law rather than treating “DCGI approval” as a single generic certificate.

Ministry of Health & Family Welfare

The Ministry provides the broader governmental and policy framework for India’s central health regulation. CDSCO operates under the Directorate General of Health Services within this ministry.

State Drug Control Authorities

Drug regulation in India also involves State Licensing Authorities.

For example, after central permission for a new drug is obtained where required, manufacturing and other state-level licensing requirements may still need to be fulfilled before commercial operations can proceed.

This distinction is important:

Central new-drug permission ≠ complete permission to manufacture, sell and distribute in every circumstance.

The exact licensing pathway depends on the product, activity, manufacturing arrangement and applicable rules.

Indian Pharmacopoeia Commission

The Indian Pharmacopoeia Commission (IPC) contributes to medicine quality through publication and maintenance of Indian Pharmacopoeia standards and operates the National Coordinating Centre for the Pharmacovigilance Programme of India (PvPI).

IPC describes the Indian Pharmacopoeia as the official book of standards for drugs included within its scope, covering characteristics such as identity, purity and strength.

Legal Framework Governing Drug Approval in India

Drugs and Cosmetics Act, 1940

The Drugs and Cosmetics Act, 1940 provides the foundational legislative framework governing drugs and cosmetics in India.

It establishes powers and regulatory provisions concerning manufacture, import, distribution and other activities involving drugs.

Drugs Rules, 1945

The Drugs Rules, 1945 provide detailed regulatory requirements under the Act.

CDSCO currently publishes the Rules and amendments, including an updated compilation dated 1 July 2024 on its official website.

New Drugs and Clinical Trials Rules, 2019

The New Drugs and Clinical Trials Rules, 2019 significantly modernized India’s framework for new drugs, clinical trials, bioavailability/bioequivalence studies and related regulatory processes.

The rules were notified as G.S.R. 227(E) on 19 March 2019 and have subsequently been amended. CDSCO’s current NDCTR page lists amendments and notifications, demonstrating that professionals should always verify the latest version rather than relying solely on the original 2019 text.

Good Clinical Practice (GCP)

GCP provides ethical and scientific principles for conducting clinical research involving human participants.

It covers areas such as:

• participant protection;
• informed consent;
• protocol compliance;
• investigator responsibilities;
• safety reporting;
• data integrity;
• documentation;
• quality assurance.

Good Manufacturing Practice (GMP)

GMP helps ensure that medicines are consistently manufactured and controlled according to appropriate quality standards.

In practical terms, GMP addresses facilities, equipment, personnel, sanitation, documentation, production controls, quality control, validation and related systems.

Schedule Y: Historical Perspective

Schedule Y was historically a major reference point for clinical trials and new-drug approval requirements under the Drugs and Cosmetics Rules.

However, professionals studying the current Indian drug approval process should not treat Schedule Y as the primary current legal framework for new-drug and clinical-trial applications. The NDCTR 2019 framework replaced and reorganized many of these provisions.

Older regulatory documents may still mention Schedule Y, particularly historical guidance. CDSCO’s legacy new-drug materials demonstrate this transition.

How New Drugs Get Approved in India: Step-by-Step Process

A simplified development pathway looks like this:

Discovery → Lead Optimization → Preclinical Research → Clinical-Trial Application → Ethics Review → Phase I → Phase II → Phase III → Marketing Application → Regulatory Review → Manufacturing/Import Licensing → Commercial Launch → Pharmacovigilance

The actual pathway can vary substantially depending on whether the product is an innovative chemical entity, biological product, vaccine, generic, biosimilar, fixed-dose combination, phytopharmaceutical, orphan drug or another regulated category.

Step 1: Drug Discovery

The first stage begins long before CDSCO receives an application.

Target Identification

Researchers identify a biological target believed to be involved in a disease.

The target could be:

• an enzyme;
• receptor;
• ion channel;
• transporter;
• signaling pathway;
• genetic target;
• microbial protein.

Molecule Discovery

Researchers then search for compounds capable of interacting with the target.

Approaches may include:

• high-throughput screening;
• structure-based drug design;
• computational modeling;
• medicinal chemistry;
• biotechnology.

Lead Optimization

A promising molecule is called a lead compound.

Scientists modify it to improve:

• potency;
• selectivity;
• absorption;
• stability;
• pharmacokinetics;
• safety;
• formulation properties.

At this stage, many compounds are eliminated.

Step 2: Preclinical Studies

Before exposing humans to a new investigational product, researchers generate non-clinical evidence.

Preclinical development may include:

Pharmacology

Researchers investigate what the drug does to biological systems.

Questions include:

• Does it produce the desired pharmacological effect?
• At what concentration?
• What unintended pharmacological effects occur?

Pharmacokinetics

Pharmacokinetics describes what the body does to the drug.

The classic framework is:

ADME = Absorption + Distribution + Metabolism + Excretion

This information helps researchers understand exposure and dosing.

Toxicology

Toxicology evaluates potential harmful effects.

Studies may address:

• acute toxicity;
• repeated-dose toxicity;
• genotoxicity;
• reproductive and developmental toxicity;
• safety pharmacology;
• local tolerance;
• other product-specific requirements.

Animal Studies

Depending on the product and development stage, appropriately designed animal studies may contribute to the assessment of safety and pharmacology.

The objective is not simply to “prove the drug is safe in animals.” Instead, the data help characterize risks and establish whether human exposure can be ethically justified.

Step 3: Application to CDSCO for Clinical-Trial Permission

Once sufficient preclinical and pharmaceutical information is available, the sponsor can move toward human clinical research.

In India, the regulatory application for permission to conduct a clinical trial of a new drug or investigational new drug is made in Form CT-04, accompanied by the required documents and applicable fee under the NDCTR framework. CDSCO’s current FAQ confirms that clinical-trial permission is granted through the central licensing framework and that permission is issued in Form CT-06.

CDSCO’s Investigational New Drug Division also states that IND-related applications are submitted through the online SUGAM system.

Typical Submission Package

Depending on the product and pathway, the regulatory package may include:

• investigator’s brochure;
• clinical-trial protocol;
• informed-consent documents;
• pharmaceutical/CMC information;
• non-clinical data;
• pharmacology data;
• toxicology data;
• previous human experience;
• manufacturing information;
• stability information;
• safety information;
• proposed study sites and investigators;
• ethics documentation;
• statistical considerations.

Step 4: Ethics Committee Approval

Regulatory permission alone does not remove the need for ethical oversight.

An Institutional Ethics Committee (IEC) reviews the proposed research from the perspective of participant rights, safety, welfare and ethical acceptability.

Informed Consent

Participants must receive understandable information about:

• the study;
• potential benefits;
• foreseeable risks;
• alternatives;
• procedures;
• confidentiality;
• voluntary participation;
• withdrawal rights.

CDSCO’s clinical-trial FAQ confirms that the informed-consent form and patient information sheet must be approved by the ethics committee and submitted to the central licensing authority as applicable.

Why Ethics Review Matters

A scientifically interesting clinical trial can still be ethically unacceptable.

For example, exposing participants to unnecessary risk when a scientifically adequate safer design is available would raise serious ethical concerns.

Step 5: Clinical Trials in India

Clinical development progressively evaluates safety, dose, efficacy and longer-term risks.

Phase I

Phase I is generally the first stage of human exposure.

Objectives

• assess initial safety;
• characterize tolerability;
• evaluate pharmacokinetics;
• explore pharmacodynamics;
• identify dose-related effects;
• support selection of doses for subsequent studies.

Participants are often healthy volunteers, although patients may be used when the medicine is expected to have substantial toxicity or in diseases such as cancer.

The precise design depends on the drug.

Phase II

Phase II generally involves patients with the target disease.

Main Objectives

• obtain preliminary evidence of efficacy;
• further characterize safety;
• explore dose-response;
• refine the dosing regimen;
• identify appropriate endpoints.

Phase II is often where researchers determine whether the promising biological effect observed earlier translates into a meaningful therapeutic effect.

Phase III

Phase III provides larger-scale evidence.

Major Objectives

• confirm efficacy;
• compare treatment with placebo, standard therapy or another appropriate comparator;
• characterize safety in a larger population;
• evaluate clinically important endpoints;
• provide pivotal evidence for marketing authorization.

The exact size and design depend on the disease, treatment and regulatory pathway.

Phase IV

Phase IV occurs after marketing authorization and is part of the broader post-approval evidence-generation environment.

It can include:

• post-marketing studies;
• additional safety studies;
• effectiveness research;
• long-term safety monitoring;
• pharmacovigilance;
• real-world evidence.

Clinical Trial Phase Comparison

Phase	Typical purpose	Main population	Key questions
Phase I	Initial human safety and PK	Often healthy volunteers or selected patients	Is the drug tolerated? What dose/exposure is appropriate?
Phase II	Preliminary efficacy and dose finding	Patients	Does it appear to work, and at what dose?
Phase III	Confirmatory evidence	Larger patient population	Does it provide clinically meaningful benefit and what are the risks?
Phase IV	Post-approval evidence	Real-world population	What happens during broader and longer-term use?

The familiar Phase I–IV model is broadly consistent with international clinical-development concepts, although specific Indian regulatory requirements depend on the product and applicable rules.

New Drug Application and Marketing Authorization Submission

The term NDA (New Drug Application) is widely used internationally and in Indian industry practice, but professionals should recognize that Indian regulatory submissions are made through specific forms and pathways under the NDCTR 2019 rather than one universal “NDA form.”

For example, CDSCO identifies Form CT-21 for applications to manufacture a new drug for sale or distribution, while Form CT-18 is used for certain applications to import a new drug for sale or distribution.

Documents Required for Regulatory Review

The exact requirements vary, but a comprehensive submission generally addresses:

Evidence area	What regulators assess
Administrative information	Applicant, product, authorization and regulatory details
Quality/CMC	Identity, composition, specifications, manufacturing process, controls and stability
Non-clinical	Pharmacology and toxicology
Clinical	Safety, efficacy, dose and benefit-risk evidence
Manufacturing	Facilities, processes and quality systems
Labeling	Indications, dosage, warnings, contraindications and other information
Safety	Adverse events and risk characterization
Statistical analysis	Validity and interpretation of clinical evidence

CDSCO’s current FAQ and NDCTR framework provide specific requirements depending on the new-drug category and application.

Regulatory Review by CDSCO and the Central Licensing Authority

Once submitted, the application undergoes scientific and regulatory evaluation.

1. Administrative and Technical Screening

The submission may be checked for:

• completeness;
• required forms;
• fees;
• supporting documents;
• consistency;
• appropriate data presentation.

2. Quality Review

Reviewers evaluate pharmaceutical and manufacturing information.

Important areas include:

• drug substance;
• drug product;
• specifications;
• impurities;
• analytical methods;
• manufacturing process;
• process controls;
• validation;
• stability;
• container-closure system.

3. Non-Clinical Review

Regulators examine whether the pharmacology and toxicology package adequately supports the proposed clinical use.

4. Clinical Review

Clinical reviewers examine:

• trial design;
• patient population;
• endpoints;
• statistical analysis;
• efficacy;
• adverse events;
• dose-response;
• subgroup information;
• benefit-risk balance.

5. Subject Expert Committee Review

CDSCO uses expert committees for scientific deliberation on relevant applications.

The committee may recommend:

• approval;
• approval with conditions;
• additional data;
• additional studies;
• protocol modifications;
• rejection;
• other regulatory action.

CDSCO’s new-drug division describes deliberation of proposals through Subject Expert Committees and handling of safety information, PSURs and other post-approval information.

6. Queries and Clarifications

A regulatory review is often interactive.

The regulator may ask the applicant to clarify:

• unexplained adverse events;
• missing data;
• statistical analyses;
• manufacturing deviations;
• stability results;
• proposed indications;
• dosage;
• labeling;
• risk-management measures.

The sponsor responds with additional information.

7. Inspection

Depending on the product and application, regulatory inspection may examine clinical sites, manufacturing facilities, laboratories or other relevant systems.

Manufacturing License and Commercial Launch

Regulatory permission to market a new drug does not mean the company can ignore manufacturing and licensing requirements.

Commercialization may involve:

• manufacturing authorization;
• import permissions where applicable;
• site compliance;
• quality-control systems;
• packaging;
• labeling;
• storage;
• batch release;
• distribution controls.

CDSCO identifies specific forms and pathways for import and manufacture of new drugs, including Form CT-18 and CT-21 for specified activities.

Labeling and Packaging

The approved product information must appropriately communicate:

• generic/approved name;
• strength;
• dosage form;
• route;
• indications;
• dosage and administration;
• contraindications;
• warnings;
• precautions;
• adverse reactions;
• storage conditions;
• other legally required information.

The commercial product must match the approved specifications and conditions.

Pharmacovigilance After Drug Approval

A medicine continues to be evaluated after launch.

Adverse Drug Reaction Reporting

Healthcare professionals and patients can report suspected adverse reactions.

The Pharmacovigilance Programme of India (PvPI) collects, collates and analyzes medicine-related adverse-event information through its network of ADR Monitoring Centres.

IPC states that healthcare professionals including doctors, pharmacists and nurses, as well as consumers, can report suspected ADRs.

Periodic Safety Update Reports

Marketing authorization holders may have continuing obligations to submit periodic safety information for applicable new drugs.

CDSCO continues to publish regulatory notices concerning PSUR submission, including recent clarification regarding delayed marketing after approval.

Risk Management

For medicines with important identified or potential risks, regulatory risk-management measures may include:

• additional monitoring;
• safety studies;
• restricted prescribing;
• warnings;
• contraindications;
• educational programs;
• additional post-marketing data.

Product Recalls

If a product presents a significant quality or safety concern, regulatory and company actions can include:

• investigation;
• batch quarantine;
• market withdrawal;
• recall;
• safety communication;
• labeling modification;
• restriction or suspension.

Timeline for Drug Approval in India

There is no single universal drug approval timeline in India.

The total development journey can take many years because discovery, preclinical research, clinical trials and manufacturing development occur over different periods.

The regulatory-review portion itself depends on:

• application type;
• completeness of submission;
• product complexity;
• quality of evidence;
• regulatory queries;
• committee review;
• inspections;
• clinical-trial requirements;
• applicant response time;
• product-specific regulations.

Therefore, websites claiming that every new drug receives approval in one fixed number of days should be treated cautiously.

CDSCO has published targeted internal timelines for processing applications, but these should not be confused with a guaranteed total development timeline.

Suggested Timeline Infographic

Discovery → Preclinical → Regulatory Clinical-Trial Permission → Phase I → Phase II → Phase III → Marketing Application → Regulatory Review → Manufacturing/Import Licensing → Launch → Pharmacovigilance

Fast-Track and Emergency Drug Approvals

Special regulatory pathways can become important when there is:

• serious disease;
• unmet medical need;
• rare disease;
• public-health emergency;
• pandemic;
• significant therapeutic innovation.

The NDCTR framework allows certain requirements to be relaxed, abbreviated, omitted or deferred in specified circumstances, subject to applicable regulatory provisions. CDSCO’s FAQ specifically discusses situations involving serious/life-threatening diseases and rare diseases.

Emergency Approval During COVID-19

COVID-19 demonstrated how regulatory systems can operate under extraordinary public-health pressure.

For example, CDSCO granted restricted emergency-use permissions for remdesivir and favipiravir in 2020, with specific restrictions and conditions. CDSCO stated that remdesivir was initially approved for import and marketing in June 2020, followed by permissions for indigenous manufacturers, while favipiravir was approved for manufacture and marketing in June 2020.

Importantly, emergency authorization is not synonymous with an ordinary unrestricted marketing pathway. Conditions, restrictions, informed consent or additional evidence requirements may apply depending on the authorization.

Generic Drug Approval Process in India

Generic medicines follow a different development logic from an entirely new chemical entity.

How Generic Approval Differs

A generic manufacturer generally does not need to repeat the entire original discovery and development program of the innovator.

Instead, the regulatory evidence may focus on:

• pharmaceutical quality;
• manufacturing;
• equivalence;
• bioavailability/bioequivalence where required;
• stability;
• applicable regulatory requirements.

Bioequivalence

Bioequivalence studies compare the rate and extent of absorption of a test product with an appropriate reference product.

The objective is to determine whether the products are sufficiently comparable for the intended regulatory purpose.

However, the exact evidence requirements vary according to the product.

Biosimilars and Biological Products

Biological medicines are more complex than many conventional small-molecule medicines.

A biosimilar is not simply a “generic biologic.” Biological products are produced using living systems and may have complex molecular structures.

India has specific regulatory guidance for similar biologics.

CDSCO publishes the Guidelines on Similar Biologics: Regulatory Requirements for Marketing Authorization in India, originally issued in 2016.

Evidence may include:

• analytical characterization;
• quality comparability;
• non-clinical evidence;
• pharmacokinetic/pharmacodynamic studies;
• immunogenicity;
• clinical evidence where required;
• manufacturing controls.

The regulatory burden depends on the product and the extent to which similarity can be demonstrated.

Generic vs New Drug Approval

Feature	New/Innovative Drug	Generic Drug
Discovery program	Usually extensive	Usually not repeated
New molecule	Yes, typically	No
Full non-clinical program	Generally required for innovative development	Usually not repeated in the same way
Clinical efficacy package	Extensive	Usually relies on established reference-drug knowledge plus required equivalence evidence
Bioequivalence	Product/pathway dependent	Commonly important
Manufacturing controls	Required	Required
Post-marketing surveillance	Required	Required
Regulatory review	Extensive benefit-risk assessment	Focused on quality/equivalence and applicable requirements

Challenges in Drug Approval

Clinical Trial Delays

Recruitment can be difficult for rare diseases, oncology or specialized indications.

Regulatory Compliance

A technically strong product can face delays if:

• forms are incomplete;
• documents conflict;
• data are poorly organized;
• responses to regulatory queries are inadequate.

Ethical Challenges

Recruitment must balance scientific objectives with participant rights and safety.

Documentation Problems

Regulatory submissions require extraordinary attention to document control.

A discrepancy between a protocol, investigator brochure, statistical plan and clinical report can trigger questions.

Manufacturing Inspections

A promising clinical product cannot be successfully commercialized if its manufacturing process cannot consistently produce the approved quality.

Global Harmonization

Multinational companies may need to satisfy multiple regulators with different legal requirements.

India increasingly participates in international regulatory harmonization, but ICH alignment does not mean that Indian and foreign regulatory requirements are identical.

India’s Drug Approval Process Compared With Other Countries

Feature	India	USA	European Union	UK	Japan
Main regulator	CDSCO/central licensing system	FDA	EMA + European Commission/national systems depending on route	MHRA	PMDA/MHLW
Clinical development	Product/pathway specific	IND framework	EU clinical-trial framework	UK clinical-trial/medicines framework	PMDA/MHLW framework
Marketing application	Indian regulatory forms/pathways	NDA/BLA etc.	Marketing Authorisation Application	Marketing Authorisation	New drug application
Scientific review	CDSCO and expert mechanisms	FDA review teams	CHMP/other committees	MHRA	PMDA/MHLW
Post-market safety	Pharmacovigilance/PSUR and regulatory monitoring	FDA safety surveillance	EU pharmacovigilance system	MHRA pharmacovigilance	PMDA/MHLW
Centralized pathway	India has central regulatory functions	National	Centralized procedure for eligible products	National UK system	National

The comparison is simplified because each jurisdiction has multiple pathways.

For example, the EU centralized procedure involves a single application and scientific assessment through EMA, followed by a legally binding European Commission decision.

In the United States, FDA describes a development pathway involving discovery, preclinical research, clinical research, FDA review and post-market safety monitoring.

In the UK, medicine applications are submitted through the MHRA system and require a marketing authorization for human medicines.

Role of Regulatory Affairs Professionals

Regulatory affairs professionals connect scientific development with regulatory requirements.

Regulatory Strategy

They determine:

• which pathway applies;
• what evidence is required;
• which countries will be targeted;
• what regulatory interactions should occur;
• how development should be sequenced.

Submission Preparation

They coordinate information from:

• clinical teams;
• toxicology;
• pharmacology;
• CMC;
• manufacturing;
• quality assurance;
• statistics;
• pharmacovigilance;
• medical writing.

Compliance Management

Regulatory professionals monitor:

• regulations;
• notifications;
• guidelines;
• commitments;
• submissions;
• approvals;
• post-approval changes.

Labeling Review

They help ensure that approved claims and safety information are accurately reflected in product information.

Lifecycle Management

Regulatory affairs does not end at approval.

Professionals manage:

• variations;
• additional indications;
• new strengths;
• dosage-form changes;
• manufacturing changes;
• labeling updates;
• safety-related regulatory actions.

Communication With Authorities

Effective regulatory communication requires concise, evidence-based answers rather than promotional arguments.

Role of Hospital Pharmacists in Drug Regulation

Hospital pharmacists are important participants in the final stage of the medicine lifecycle.

Their responsibilities can include:

Medication Safety

Pharmacists identify:

• adverse reactions;
• medication errors;
• interactions;
• inappropriate dosing;
• contraindications;
• product-quality concerns.

Pharmacovigilance

Hospital pharmacists can contribute suspected ADR reports to pharmacovigilance systems.

PvPI explicitly recognizes pharmacists among healthcare professionals who can report suspected ADRs.

Patient Education

When a newly approved medicine enters clinical practice, pharmacists can explain:

• dosage;
• administration;
• storage;
• precautions;
• common adverse effects;
• important warning signs.

Monitoring Newly Approved Medicines

New medicines may have limited real-world exposure compared with older products.

Hospital pharmacists can therefore help detect unusual safety patterns early.

Real-World Case Studies

Case Study 1: From Laboratory Concept to New Medicine

Background

Imagine a company identifies a novel molecular target for a serious disease and develops a selective small-molecule inhibitor.

Regulatory Process

The company conducts:

1. discovery research;
2. lead optimization;
3. pharmacology studies;
4. toxicology studies;
5. pharmaceutical development;
6. clinical-trial application;
7. Phase I;
8. Phase II;
9. Phase III;
10. marketing application.

Challenge

The first clinical formulation has variable absorption, requiring formulation optimization before late-stage development.

Outcome

The improved formulation produces more predictable exposure and supports a better-defined dosing regimen.

Key Lesson

Drug approval is a development process, not a single regulatory event.

Case Study 2: Clinical Trial Success

Background

A hypothetical oncology medicine demonstrates strong activity in early studies.

Regulatory Process

Phase I establishes a tolerable dose. Phase II provides preliminary evidence of antitumor activity. Phase III compares the treatment with the appropriate standard of care.

Challenge

The sponsor must demonstrate not merely statistical significance but clinically meaningful benefit while carefully characterizing adverse events.

Outcome

The overall benefit-risk profile supports a marketing application.

Key Lesson

A successful regulatory submission depends on the totality of evidence, not on one positive clinical trial.

Case Study 3: Regulatory Delay Caused by Incomplete Evidence

Background

A hypothetical manufacturer submits an application for a new indication.

Regulatory Process

During review, regulators identify inconsistencies between:

• the proposed indication;
• clinical endpoints;
• statistical analyses;
• safety summaries.

Challenge

The applicant must provide clarification and potentially additional analyses.

Outcome

The review takes longer than originally anticipated.

Key Lesson

Submission quality directly affects regulatory efficiency.

A technically strong medicine can still experience delays when its regulatory dossier is incomplete or inconsistent.

Case Study 4: Emergency Approval During COVID-19

Background

COVID-19 created an urgent need for potential treatments.

Regulatory Process

In June 2020, CDSCO granted restricted emergency-use permission for remdesivir for severe COVID-19, and subsequently permitted Indian manufacturers to manufacture and market the formulation under specified conditions. Favipiravir was also approved for restricted emergency use for mild-to-moderate COVID-19.

Challenge

Evidence had to be evaluated while the public-health emergency was ongoing.

Outcome

Restricted emergency-use pathways enabled access while imposing conditions such as specialist prescribing and informed-consent requirements described in CDSCO communications.

Key Lesson

Emergency regulatory pathways can accelerate access, but acceleration does not eliminate the need for evidence, risk controls and continued monitoring.

Case Study 5: Post-Marketing Safety Monitoring

Background

A newly marketed medicine is used by thousands of patients.

A rare adverse event that was not detected during clinical trials begins appearing in spontaneous reports.

Regulatory Process

Reports are collected and assessed through pharmacovigilance systems.

A potential safety signal may trigger:

• additional analysis;
• signal evaluation;
• regulatory communication;
• label modification;
• risk-minimization measures;
• additional studies;
• restriction or withdrawal where justified.

Outcome

The regulatory system can respond to new evidence even after approval.

Key Lesson

Approval is the beginning of real-world safety surveillance, not the end.

PvPI encourages reporting of suspected adverse reactions, including known and unknown, serious and non-serious events.

Future of Drug Approval in India

The regulatory environment is becoming increasingly digital and data-driven.

Artificial Intelligence

AI may support:

• pharmacovigilance signal detection;
• document review;
• clinical-trial analytics;
• patient recruitment;
• quality-control analytics;
• regulatory intelligence.

However, AI-generated conclusions still require appropriate human oversight and validation.

Digital Regulatory Submissions

Electronic submissions can improve:

• document traceability;
• review efficiency;
• version control;
• lifecycle management.

Electronic Common Technical Document

The Common Technical Document (CTD) provides a harmonized structure for presenting quality, safety and efficacy information.

ICH describes the CTD as five modules, with Module 1 being region-specific and Modules 2–5 forming the common scientific structure.

The electronic CTD, or eCTD, supports electronic lifecycle management of regulatory submissions. ICH’s current eCTD work includes version 4.0 implementation materials.

Real-World Evidence

Electronic health records, registries and claims databases can provide information about how medicines perform in routine clinical practice.

Personalized Medicine

Future approvals may increasingly involve:

• biomarkers;
• companion diagnostics;
• genomic information;
• precision dosing;
• targeted therapies.

Digital Clinical Trials

Technology can enable:

• remote assessments;
• electronic consent;
• wearable monitoring;
• digital endpoints;
• decentralized trial components.

These technologies create opportunities but also introduce regulatory questions around data quality, cybersecurity, privacy and validation.

Key Regulatory Terms Glossary

Term	Beginner-friendly meaning
CDSCO	India’s central drug regulatory organization
DCGI	Drugs Controller General (India)
CLA	Central Licensing Authority under the applicable regulatory framework
NDCTR 2019	New Drugs and Clinical Trials Rules, 2019
IND	Investigational New Drug; in India, the term is used for specified unapproved investigational products
NDA	Common international/industry term for a new-drug marketing application
CT-04	Application form for permission to conduct a clinical trial
CT-06	Permission for conduct of a clinical trial
CT-18	Application associated with import of specified new drugs for sale/distribution
CT-21	Application associated with manufacture of specified new drugs for sale/distribution
GCP	Good Clinical Practice
GMP	Good Manufacturing Practice
IEC	Institutional Ethics Committee
ADR	Adverse Drug Reaction
PSUR	Periodic Safety Update Report
PvPI	Pharmacovigilance Programme of India
BA/BE	Bioavailability/Bioequivalence
CMC	Chemistry, Manufacturing and Controls
CTD	Common Technical Document
eCTD	Electronic Common Technical Document
MAH	Marketing Authorization Holder
RWE	Real-World Evidence
SEC	Subject Expert Committee

Frequently Asked Questions

Conclusion

The new drug approval process in India is designed to create a balance between pharmaceutical innovation and patient protection.

From the first laboratory experiment to preclinical safety testing, clinical trials, regulatory review, manufacturing authorization and post-marketing pharmacovigilance, every stage contributes a different piece of evidence.

The process is deliberately demanding because a medicine may ultimately be administered to thousands or millions of people. Regulators therefore need confidence not only that a drug can work, but also that its quality is reproducible, its risks are understood as far as reasonably possible, its manufacturing process is controlled and its use can be monitored after launch.

For healthcare professionals, understanding this pathway also changes how newly approved medicines should be viewed. Approval is not the same as absolute safety, and a newly approved medicine remains part of an evolving evidence base.

India’s regulatory environment is also becoming increasingly digital, scientifically sophisticated and internationally connected. Electronic submissions, real-world evidence, advanced biologics, personalized medicine, artificial intelligence and digital clinical trials are likely to reshape regulatory affairs over the coming years.

Ultimately, the goal of pharmaceutical regulation is not to prevent innovation. It is to make innovation responsible, evidence-based and patient-centered.

A successful medicine is therefore more than a molecule that reaches the market. It is a product whose quality, safety, efficacy and benefit-risk profile have been rigorously evaluated—and whose safety continues to be watched throughout its lifecycle.

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