Building BusinessServices

Section 14

Pharmaceutical formulations (tablets, capsules, injectables)

India’s exports: 24,630.12 US$ million · 2025-26 (provisional)

HS codes
1
top markets
5

How to start

  1. Get an Import Export Code (IEC) from DGFT online; it is free and linked to your PAN.
  2. Register with PHARMEXCIL and get your RCMC (Registration-cum-Membership Certificate) through the DGFT e-RCMC system.
  3. Many MSMEs start by loan-licensing or contract-manufacturing for an exporter, then file their own dossiers in less regulated markets.
  4. Plan dossier and registration costs per country before you choose markets; registration takes time.

Top buyer countries

  1. United States8,198.51 US$ million · 2025-26
  2. United Kingdom754.68 US$ million · 2025-26
  3. South Africa678.08 US$ million · 2025-26
  4. France617.07 US$ million · 2025-26
  5. Brazil530.15 US$ million · 2025-26

Certificates and registrations

  • Drug manufacturing licence from the State Drugs Controller, with revised Schedule M (GMP) compliance
  • WHO-GMP certificate and Certificate of Pharmaceutical Product (COPP) through CDSCO
  • Product registration in each importing country (US FDA, EU, African and Latin American regulators)

Watch out for

  • A failed inspection or contamination case can bar a plant from a market.
  • Export of some drugs needs a CDSCO no-objection certificate; check before shipping.
Sources (3)
  1. TradeStat, Department of Commerce — Export: Principal Commodity-wise, April–March 2026 (provisional), US$ million — row "H8, DRUG FORMULATIONS, BIOLOGICALS"
  2. TradeStat (Export Import Data Bank), Department of Commerce — Commodity-wise all countries export, HS 3004, 2025-26, US$ million · 2025-26
  3. HBP Appendix 2T — List of EPCs / Commodity Boards (DGFT), via research/export-import.json · 2023