Who this roadmap is for
The nine steps below are written for a manufacturer of drugs or medical devices. Two other investor types follow a shorter path:
- An importer skips the plant steps (site, land, Schedule M design and manufacturing licences) but needs a CDSCO import licence, applied for in Form MD-14 and held through an authorised Indian agent appointed by the overseas maker under a power of attorney. Price control and the marketing code still apply from launch.
- A hospital operator needs no manufacturing licence, but state health and facility rules apply. Hospitals take up to 100% FDI on the automatic route.
Incorporation and general registrations are covered after the sector steps, and in the general set-up roadmap.
Nine steps from entry decision to commercial production
- Confirm the FDI route. Greenfield pharma and all device projects are 100% automatic. Brownfield pharma above 74%, or a land-border-country beneficial owner above 10% or with control, needs Government approval before closing. Who: Department of Pharmaceuticals; FIF portal.
- Map products to their regulatory path. Fix each product’s path: device risk class A to D, new drug or generic, price-controlled formulation under DPCO 2013, and any clinical data or test licences needed. Who: CDSCO; NPPA.
- Choose the state and site. Compare state packages and the central parks: bulk drug parks in Gujarat, Andhra Pradesh and Himachal Pradesh; device parks in Uttar Pradesh, Madhya Pradesh and Tamil Nadu. Who: state industry departments.
- File incentive applications early. Some state policies need the application before commercial operations; Uttar Pradesh also requires at least 80% of the capital investment to be made after the policy’s effective date. Who: state single-window portals.
- Secure land and state consents. Take the plot and obtain the state consents needed before construction. Device parks offer common infrastructure and testing facilities. Who: state agencies.
- Design to revised Schedule M. Build to revised Schedule M good manufacturing practice. RPTUAS (10% to 20% of upgrade investment, up to ₹2 crore) ran to FY2025-26; ₹250 crore is in Budget 2026-27. Who: state drug regulator; CDSCO.
- Obtain test and manufacturing licences. Drug test licences carry a 45-day statutory timeline since January 2026. Devices: Class A and B licences come from the state, Class C and D from CDSCO, with inspection due within 60 days. Who: CDSCO; State Licensing Authority.
- Settle pricing and marketing compliance. Check whether formulations fall under DPCO 2013 ceiling prices before launch, and align promotion with the Uniform Code for Pharmaceutical Marketing Practices 2024. Who: NPPA; Department of Pharmaceuticals.
- Apply for open central support. PLI places are allocated and the last PRIP call closed on 19 November 2025. Watch for new PRIP calls, the medical device sub-schemes and, once its guidelines are issued, Biopharma SHAKTI. Who: Department of Pharmaceuticals.
Sources: DPIIT FDI Policy 2020 and Press Note 2 (2026); CDSCO Medical Devices FAQs; Akashvani, 28 Jan 2026; DoP Annual Report 2025-26; UP IIEPP 2022; Invest India medical devices page (retrieved 1 Oct 2026).
Before claims are made
- File state incentive applications before commercial operations begin; Uttar Pradesh requires the application before commercial operations and at least 80% of the capital investment after the policy’s effective date.
- Confirm the scheme is still open: the pharma, bulk-drug and device PLIs have selected their beneficiaries, and only approved companies lodge PLI claims.
- Check RPTUAS status before planning an upgrade around it; its approved period ran to FY2025-26, though ₹250 crore is in Budget 2026-27.
- Wait for Biopharma SHAKTI operating guidelines before treating it as a source of funding; applications cannot open until they are issued.
- For park sites, confirm the park scheme’s status: bulk drug parks were extended to FY2026-27, and an extension of the device park scheme to March 2028 has been sought.
Scheme details and statuses are on central incentives and state incentives.
Entry vehicles
Most investors use a private limited subsidiary; offices serve narrow aims. A company or LLP is an Indian resident entity. Branch, liaison and project offices are extensions of the foreign parent, opened through an authorised dealer bank under RBI rules. The generic page is entry vehicles.
| Vehicle | What it may do | Approval needed | Suits |
|---|---|---|---|
| Wholly owned subsidiary (private limited company) | Any lawful business within its objects and the FDI policy. At least 2 shareholders (up to 200) and 2 directors, one meeting the 182-day residence test. | None on the automatic route without a land-border owner; else government route. Incorporated with the Registrar through SPICe+. | Operating businesses that want full control and limited liability. |
| Joint venture company | As a subsidiary, with an Indian partner; caps and conditions apply to the total foreign stake. | As for the sector. Land-border investors taking up to 49% in a fast-track sector, where resident Indians keep majority ownership and control, have a 60-day decision target. | Capped sectors, or where a partner brings licences, land or customers. |
| Limited liability partnership (LLP) | Business with partnership-style governance and limited liability; at least 2 designated partners, one resident. LLP agreement filed within 30 days. | Automatic route only in sectors fully open under the automatic route with no FDI-linked performance conditions. | Service businesses in fully open sectors. |
| Branch office | Activities RBI permits for branches, such as export and import, consultancy and research on behalf of the parent. | Authorised dealer bank; parent needs a sound financial track record. RBI approval in specified cases, such as defence or telecom. | Serving Indian clients directly without a subsidiary. |
| Liaison office | Represents the parent in India; may not carry on business. Valid generally for three years. | Authorised dealer bank, with the same track-record test and RBI referral cases as a branch. | Market study and relationship building before committing capital. |
| Project office | Executes a specific contract in India; valid for the tenure of the project. | Authorised dealer bank under RBI’s project office rules. | Contractors delivering a defined Indian project. |
| No entity yet: distributor or employer of record | Sell through an Indian distributor or importer; engage staff through a third-party employer of record. | None for the foreign company itself. | Testing demand; review tax and contract exposure first. |
Sources: Invest India, Doing Business in India 2025-26 and Legal and Regulatory Framework (Dec 2025); RBI Master Direction on branch, liaison and project offices; DPIIT SOP, 4 May 2026.
For this sector, the choice maps to the investor type. A manufacturer, hospital operator or capability centre normally needs a subsidiary or joint venture. A brownfield pharma joint venture above 74% foreign ownership goes to the Government route, with the five-year NLEM and R&D conditions on the FDI rules page. An overseas device maker testing the market can sell through an Indian importer or distributor, with the CDSCO import licence held through its authorised Indian agent.
Incorporation: ten steps for a foreign-owned company
The sequence for a private limited subsidiary in an automatic-route sector. Times are shown only where a rule fixes them; state registrations depend on location and activity. The generic page is incorporation.
- Prepare and apostille parent documents. Constitutional documents, board resolution and identity papers of foreign subscribers and directors are notarised and apostilled or legalised. Who: parent company; notary; apostille authority.
- Obtain digital signatures and DINs. A digital signature certificate for at least one proposed director. Director identification numbers are applied for within the SPICe+ form. Who: certifying authority; MCA (SPICe+).
- Reserve the company name. Check the name against existing companies and registered trademarks, then reserve it through RUN or within SPICe+. Who: MCA (RUN or SPICe+).
- File SPICe+ with the MoA, AoA and AGILE. One integrated filing covers incorporation, DINs, PAN and TAN. The linked AGILE form can also obtain GST, EPFO and ESIC registrations. Foreign subscribers attach a signed physical MoA and AoA. Who: MCA Central Registration Centre.
- Receive the certificate of incorporation. The Central Registration Centre scrutinises the documents and may ask for changes. The CIN, PAN and TAN are allotted on incorporation. Who: Registrar of Companies (CRC).
- Open a bank account and bring in capital. Receive share capital through an authorised dealer bank and allot shares within 60 days of receipt, priced at not less than fair value. Who: authorised dealer bank; board. Within 60 days.
- Report the share issue (FC-GPR). File Form FC-GPR for shares issued to the foreign parent that count as FDI. Who: RBI FIRMS portal. Within 30 days of issue.
- Declare commencement of business. Declare receipt of the subscription money and verify the registered office before starting business. Who: MCA. Within 180 days.
- Register for GST and obtain an IEC. If not done through AGILE, apply for GST; low-risk applicants can opt for automated registration within three working days. Importers and exporters also need an Importer-Exporter Code. Who: GST portal (3 working days); DGFT.
- First board meeting; staff registrations. Appoint the first auditor and open statutory registers. Obtain shops and establishments, professional tax, EPFO and ESIC registrations as applicable. Who: board; state labour department; EPFO; ESIC.
Sources: Invest India, Doing Business in India 2025-26; RBI FEMA 395 Regulations; RBI Master Direction, Jun 2026; Tribune/ANI and KPMG on GST registration (secondary).
What to check next
- Decide whether you are a manufacturer, importer or hospital operator; it sets which of the nine steps apply.
- Screen the ownership chain for land-border beneficial owners and, for a brownfield pharma deal, model the NLEM and R&D conditions before signing.
- Classify every product (device class, new drug or generic, DPCO status) before choosing a site, since it decides the licensing authority and timeline.
- File state incentive applications before commercial operations and time capital spend to the policy’s effective date.
- Put the FC-GPR (30 days), share allotment (60 days) and commencement (180 days) deadlines in the company calendar on day one.