💊 India Pharma Hub

Pharmaceuticals & Life Sciences

India is the world's 3rd largest pharmaceutical market by volume and the global pharmacy — supplying 20% of global generic medicines. Swiss pharma companies (Novartis, Roche, Lonza) are deeply embedded, with TEPA creating new duty advantages for specialty drugs and APIs.

Market Size 2025

USD 62.6B

₹5.26 Lakh Cr

CAGR 2025–30

12.3%

Specialty 18.7%

Global Rank

By volume

Generic Drug Supplier

20% of global supply

TEPA Duty Benefit

HS Ch. 30: E7 (0% by Yr 7)

Swiss Pharma Revenue

USD 700M+ (Novartis + Roche)

CDSCO New Drug Approvals

180+ per year

TEPA FTA Advantage

HS Chapter 30 (Pharmaceutical Products)

India's Concession to Switzerland

Most drugs: E7 staging — BCD reduced to 0% by Year 7

Biologics: E10 staging — 0% by Year 10

APIs (Ch. 29): E5 staging — 0% by Year 5

Current MFN Rates

Formulations: BCD 10–15%

Biologics: BCD 10%

APIs: BCD 7.5–10%

Nutraceuticals: BCD 30–100%

Pharma Sub-Sector Breakdown

💊

Generic Pharmaceuticals

Schedule H/H1

Off-patent small molecule drugs, oral solids, injectables, APIs

USD 22B

₹1.85 Lakh Cr

CAGR 2025–3011.4%

Import Dependency12%

Swiss Players

Novartis Generics (Sandoz), Mepha Pharma

India is the world's largest generic drug supplier — Swiss generics must compete on quality differentiation

View HS Ch. 30 tariffs →

🔬

Specialty & Patented Drugs

Schedule H1/New Drug

Oncology, immunology, rare diseases, biologics, targeted therapies

USD 8.5B

₹71,400 Cr

CAGR 2025–3014.2%

Import Dependency68%

Swiss Players

Novartis, Roche, Idorsia, Molecular Partners

Fastest growing segment. Novartis and Roche hold 15%+ of India's specialty pharma market

View HS Ch. 30 tariffs →

🧬

Biologics & Biosimilars

Biologics — New Drug

Monoclonal antibodies, biosimilars, vaccines, blood products

USD 4.2B

₹35,280 Cr

CAGR 2025–3018.7%

Import Dependency55%

Swiss Players

Roche (Herceptin, Avastin), Novartis (Cosentyx), Lonza (CDMO)

India's biosimilar market is 3rd largest globally. Lonza provides CDMO services to Indian manufacturers

View HS Ch. 30 tariffs →

⚗️

Active Pharmaceutical Ingredients (APIs)

API — Schedule M

Bulk drug substances, intermediates, specialty chemicals for pharma

USD 18B

₹1.51 Lakh Cr

CAGR 2025–309.8%

Import Dependency30%

Swiss Players

Lonza Group, Siegfried Holding, DOTTIKON ES

Swiss CDMO/API manufacturers (Lonza, Siegfried) have strong India partnerships for high-potency APIs

View HS Ch. 29 tariffs →

🧪

Pharmaceutical Diagnostics

Schedule H / Radiopharma

Contrast media, radiopharmaceuticals, in-vitro diagnostics reagents

USD 3.8B

₹31,920 Cr

CAGR 2025–3016.3%

Import Dependency70%

Swiss Players

Bracco Suisse, Roche Diagnostics, Guerbet Switzerland

Radiopharma growing 25%+ CAGR driven by AIIMS and Tata Memorial PET-CT expansion

View HS Ch. 30 tariffs →

🌿

Nutraceuticals & OTC

FSSAI / Schedule K

Vitamins, minerals, dietary supplements, OTC drugs, herbal formulations

USD 6.1B

₹51,240 Cr

CAGR 2025–3021.5%

Import Dependency22%

Swiss Players

DSM Nutritional Products (now dsm-firmenich), Galenica, Vifor Pharma

Post-COVID immunity supplement boom. India's nutraceutical market growing at 21.5% CAGR

View HS Ch. 21 tariffs →

CAGR vs Import Dependency by Sub-Sector

CAGR %

Import Dependency %

CDSCO Drug Registration Pathway

All imported pharmaceutical products require CDSCO registration under the Drugs & Cosmetics Act 1940 and New Drugs & Clinical Trials Rules 2019. Foreign manufacturers cannot apply directly — an Indian importer with a valid wholesale drug licence is mandatory.

Classify Drug & Determine Regulatory Pathway

1–2 weeks

Determine if the drug is a New Drug, Known Drug, or Biosimilar under Drugs & Cosmetics Act 1940 and New Drugs & Clinical Trials Rules 2019

New Drug: first-time approval in India — full dossier required

Known Drug: approved elsewhere (USFDA/EMA) — abbreviated pathway available

Biosimilar: separate biosimilar guidelines under CDSCO

OTC/Schedule K: simplified registration

Appoint Indian Manufacturer / Importer

2–4 weeks

Foreign manufacturers must partner with a licensed Indian importer holding Form 10/10A wholesale drug licence

Indian importer holds wholesale drug licence (Form 10/10A)

Importer responsible for regulatory submissions

Power of Attorney from foreign manufacturer required

Importer liable for post-market surveillance

Prepare Regulatory Dossier (CTD Format)

4–12 weeks

Compile Common Technical Document (CTD) dossier for SUGAM portal submission

Module 1: Administrative (India-specific labelling, patent declaration)

Module 2: Summaries (Quality, Non-clinical, Clinical)

Module 3: Quality (CMC — Chemistry, Manufacturing, Controls)

Module 4: Non-clinical study reports

Module 5: Clinical study reports (or waiver for known drugs)

Submit Application on SUGAM Portal

1 week

Online application via CDSCO SUGAM portal. Application fees vary by drug type.

New Drug (Form CT-04): ₹50,000 fee

Known Drug with foreign approval: ₹25,000 fee

Biosimilar: ₹1,00,000 fee

Nutraceutical (FSSAI route): separate portal

CDSCO Technical & Clinical Review

6–36 months

CDSCO Subject Expert Committee (SEC) reviews dossier. May request clinical bridging study in Indian patients.

Known drugs with USFDA/EMA approval: 6–12 months

New drugs without global approval: 18–36 months + Phase III India trial

Orphan drugs: expedited 6-month pathway

Biosimilars: 12–24 months with comparative studies

Receive Import Licence (Form 10-AB)

Perpetual validity

Import licence issued under Form 10-AB; valid perpetually with annual renewal fee

Annual renewal fee: ₹5,000–25,000

Post-market surveillance mandatory

Adverse Drug Reaction (ADR) reporting to CDSCO VigiBase

Pharmacovigilance Programme of India (PvPI) compliance

Swiss Pharma Companies in India

Novartis India

Basel, Switzerland

Specialty & Generics

India Presence

Mumbai HQ; 2,500+ employees; listed on BSE

Revenue

USD 350M+ India revenue

TEPA Relevance

TEPA member; EFTA-India FTA beneficiary for specialty drugs

Key products: Cosentyx, Entresto, Kisqali, Sandoz generics

Roche India

Basel, Switzerland

Oncology & Diagnostics

India Presence

Mumbai HQ; Herceptin, Avastin market leader

Revenue

USD 280M+ India revenue

TEPA Relevance

TEPA member; oncology biologics growing 20%+ CAGR

Key products: Herceptin, Avastin, Tecentriq, cobas diagnostics

Lonza Group

Basel, Switzerland

CDMO / API Manufacturing

India Presence

Hyderabad & Visakhapatnam partnerships

Revenue

USD 100M+ India CDMO revenue

TEPA Relevance

Swiss CDMO expertise for Indian pharma manufacturers

Key products: High-potency APIs, biologics CDMO, capsules

Siegfried Holding

Zofingen, Switzerland

API & CDMO

India Presence

API supply partnerships with Sun Pharma, Cipla

Revenue

USD 40M+ India API exports

TEPA Relevance

TEPA member; niche API supplier for complex molecules

Key products: Specialty APIs, controlled substances, intermediates

dsm-firmenich (Pharma)

Kaiseraugst, Switzerland

Vitamins & Nutraceuticals

India Presence

Mumbai office; Vitamin D3, Omega-3 market leader

Revenue

USD 60M+ India nutraceutical exports

TEPA Relevance

Nutraceutical APIs — FSSAI registered; growing supplement market

Key products: Vitamins A, C, D, E; Omega-3; Carotenoids; Probiotics

Idorsia Pharmaceuticals

Allschwil, Switzerland

CNS & Rare Diseases

India Presence

Market entry phase; insomnia drug Quviviq

Revenue

India market entry 2025

TEPA Relevance

TEPA member; rare disease pathway under CDSCO

Key products: Quviviq (daridorexant), clazosentan, aprocitentan

Key Hospital End-Buyers

Tata Memorial Centre

Mumbai · 700 beds

Focus: Oncology

Swiss Link

Roche, Novartis oncology drugs

AIIMS Delhi

New Delhi · 2,478 beds

Focus: All specialties

Swiss Link

Novartis, Roche, Lonza APIs

Apollo Hospitals

Pan-India · 10,000 beds

Focus: Multi-specialty

Swiss Link

Novartis, Roche, dsm-firmenich

Narayana Health

Bangalore · 6,000 beds

Focus: Cardiac, Oncology

Swiss Link

Roche Herceptin, Novartis Entresto

HCG Cancer Centres

Pan-India · 3,000 beds

Focus: Oncology

Swiss Link

Roche, Novartis, Intas (biosimilars)

Manipal Hospitals

Pan-India · 8,000 beds

Focus: Multi-specialty

Swiss Link

Novartis, Lonza CDMO

Indian Pharma Distributor Directory

Swiss pharma companies must partner with licensed Indian distributors holding Form 10/10A wholesale drug licences. These are the top distributors by segment relevance for Swiss products.

8 distributors

Medley Pharmaceuticals

Mumbai, Maharashtra

TEPA: HIGHTier 1

Specialty & branded generics distribution

SpecialtyBranded GenericsOTC

Turnover: USD 120M+

Clients: Apollo, Fortis, Wockhardt, Breach Candy

Top 10 Indian pharma distributor; 15,000+ retail pharmacy clients

[email protected]

Zydus Lifesciences (Distribution)

Ahmedabad, Gujarat

TEPA: HIGHTier 1

Generics, biosimilars, specialty drugs

GenericsBiosimilarsSpecialty

Turnover: USD 2.1B

Clients: Pan-India hospital network

Listed company; strong biosimilar portfolio; USFDA approved manufacturing

[email protected]

Emcure Pharmaceuticals

Pune, Maharashtra

TEPA: HIGHTier 1

Oncology, gynaecology, cardiology

OncologySpecialtyBranded Generics

Turnover: USD 800M+

Clients: Tata Memorial, AIIMS, Narayana Health

Strong oncology portfolio; partnership with Roche for trastuzumab distribution

[email protected]

Intas Pharmaceuticals

Ahmedabad, Gujarat

TEPA: HIGHTier 1

Biologics, oncology, critical care

BiologicsOncologyCritical Care

Turnover: USD 1.2B+

Clients: HCG Cancer Centres, Manipal, Aster

India's leading biosimilar manufacturer; Novartis biosimilar distribution partner

[email protected]

Alkem Laboratories

Mumbai, Maharashtra

TEPA: MEDIUMTier 1

Branded generics, nutraceuticals, OTC

Branded GenericsNutraceuticalsOTC

Turnover: USD 900M+

Clients: Retail pharmacy chains, hospital pharmacies

Top 5 Indian pharma company; strong rural distribution network across 600+ districts

[email protected]

Glenmark Pharmaceuticals

Mumbai, Maharashtra

TEPA: HIGHTier 1

Dermatology, respiratory, oncology

SpecialtyDermatologyRespiratory

Turnover: USD 1.5B+

Clients: Apollo, Max Healthcare, Medanta

Strong dermatology portfolio; Swiss partnership for specialty molecules

[email protected]

Torrent Pharmaceuticals

Ahmedabad, Gujarat

TEPA: MEDIUMTier 1

Cardiology, CNS, gastroenterology

CardiologyCNSGastro

Turnover: USD 1.1B+

Clients: Zydus Hospitals, Sterling Hospitals, CIMS

Strong cardiology focus; Idorsia CNS partnership potential

[email protected]

Hetero Drugs

Hyderabad, Telangana

TEPA: MEDIUMTier 1

ARVs, oncology, APIs

ARVOncologyAPI

Turnover: USD 800M+

Clients: Government hospitals, AIIMS, NIMS

World's largest ARV manufacturer; strong government tender business

[email protected]

Industry Events & Webinars

6 events

CPhI India 2026

November 26–28, 2026 Bombay Exhibition Centre, Mumbai

India's largest pharmaceutical ingredients, machinery & technology exhibition. 1,200+ exhibitors, 35,000+ visitors. Key platform for Swiss API and CDMO companies entering India.

Why Attend

Direct access to India's top 200 pharma manufacturers. Ideal for Swiss API suppliers and CDMO companies.

APICDMOFormulationsMachinery

35,000+Register

TEPA Partner

TEPA Swiss Pharma India Webinar

April 15, 2026 Online (Zoom)

TEPA-organised webinar on CDSCO drug registration pathways, TEPA FTA benefits for pharma (HS Chapter 30), and Swiss pharma company case studies in India.

Why Attend

Expert guidance on CDSCO pathways and TEPA FTA duty concessions for pharmaceutical products.

CDSCORegistrationFTA BenefitsSwiss Pharma

200+Register

India Pharma Summit 2026

March 5–6, 2026 Hyderabad International Convention Centre

India's premier pharma policy conference. Government ministers, CDSCO officials, and top pharma CEOs. Key for understanding India's pharma policy direction.

Why Attend

Direct access to CDSCO officials and Ministry of Chemicals policymakers. Essential for regulatory intelligence.

PolicyRegulationMarket AccessBiosimilars

3,000+Register

BioAsia 2026

February 24–26, 2026 HICC, Hyderabad

Asia's premier life sciences and biotech conference. 5,000+ delegates, 50+ countries. Hyderabad is India's pharma capital — home to Dr. Reddy's, Hetero, Aurobindo.

Why Attend

Hyderabad pharma cluster access. Ideal for Swiss biotech and biologics companies seeking Indian partnerships.

BiotechLife SciencesBiologicsInnovation

5,000+Register

TEPA Partner

TEPA Pharma Trade Mission to Hyderabad

September 2026 Hyderabad, India

TEPA-organised trade mission to Hyderabad's pharma cluster. Meetings with Dr. Reddy's, Hetero, Aurobindo, and CDSCO South Zone. B2B matchmaking with Indian API buyers.

Why Attend

Pre-arranged B2B meetings with India's top API manufacturers and CDMO partners in Hyderabad.

Trade MissionB2BAPIHyderabad Cluster

20–30 Swiss companiesRegister

PHARMEXCIL India Pharma Expo

January 2027 India Expo Mart, Greater Noida

Government-backed pharma export promotion exhibition. Direct access to Indian pharma exporters and government procurement officials.

Why Attend

Government procurement access. Ideal for Swiss companies seeking government hospital supply contracts.

ExportGovernmentGenericsAPIs

15,000+Register

TEPA Intelligence Tools