How to Open a Pharma Company in India: A US Outsourcing Perspective

Are you planning to expand your pharma business setup into India but unsure where to begin? India offers one of the fastest-growing pharmaceutical markets, with cost advantages and a strong pool of skilled professionals. In FY2023–24, India’s pharmaceutical exports reached nearly US$28 billion, with the United States alone accounting for about 31%. Outsourcing pharmaceutical operations to India can also cut costs by 60–75%, helping US firms reduce expenses in manufacturing, R&D, and support services.

This blog will guide you through how to open a pharma company in India, covering compliance requirements, registration, licensing, outsourcing opportunities, and how VJM Global supports US businesses throughout the process.

Before You Get Started

• Choosing the correct business structure and confirming the FDI route are the first steps that shape your long-term operations.
  
• Compliance in India requires continuous attention, from Schedule M manufacturing standards to tax filings and data protection obligations.
  
• Outsourcing functions such as bookkeeping, payroll, and audit support allows you to concentrate resources on product development and licensing.
  
• Appointing qualified pharmacists and technical staff at the start is mandatory, since most drug licenses require their names on record.
  
• Partnering with VJM Global gives you dual expertise in US and Indian regulations, reducing risk while supporting cost control.

Why Should US Companies Consider India for Pharma Business Expansion?

India has established itself as a vital node in the global pharmaceutical supply chain, especially for generics. It supplies about 20% of global generic medicines by volume and meets 40% of US demand for generics.

For you as a US pharma entrepreneur, India offers three major advantages:

• Access to a large, specialized talent pool
  Skilled professionals in regulatory affairs, formulation development, and quality assurance are widely available. For instance, if you’re preparing US FDA submissions, India has teams experienced in compiling dossiers (ANDA, DMF) that meet US compliance requirements.
  
• Lowering costs without sacrificing quality
  Outsourcing accounting, compliance monitoring, or secondary manufacturing activities to India can reduce expenses substantially. Many US firms already rely on Indian contract research organizations (CROs) for clinical trial management because the cost is a fraction of running the same trial domestically, yet it meets international GCP standards.
  
• Reliable infrastructure backed by compliance
  With nearly 500 FDA-approved facilities, India provides reassurance that production and testing environments match US expectations. This is why four out of every ten prescriptions dispensed in the US are supplied by Indian manufacturers; an example of how American healthcare already depends on Indian capacity.
  

Once you understand India’s advantages, the next step is knowing the precise process for setting up your pharma company.

Step-by-Step Guide on How to Open a Pharma Company in India from the US

Setting up a pharma company in India requires careful planning and adherence to regulatory norms. Each step involves distinct legal, financial, and operational tasks. The process becomes smoother when you know the sequence and the authorities involved.

Step 1: Choose The Right Business Structure For How To Open a Pharma Company In India

Your entity choice determines control, licensing pathway, tax treatment, and investor readiness. Most US founders use a Private Limited Company or a Wholly Owned Subsidiary for pharma. LLPs suit small services units but are rarely ideal for regulated manufacturing. Foreign “office” setups exist, but manufacturing typically requires a company incorporated in India.

Use this quick comparison before you file:

What you prepare before filing:

• Proposed company name, main objects covering pharmaceutical activities, and registered office proof.
  
• Director KYC, digital signatures, and capital structure that matches future funding plans.
  
• Draft Memorandum and Articles that explicitly cover manufacturing, import, and sale of drugs if relevant.
  

Outputs you should expect:

• Certificate of Incorporation, Corporate Identification Number, and automatic allotment of PAN and TAN.
  
• Board resolutions for opening bank accounts and appointing key managerial personnel.
  
• Foundational registers and minutes templates that will be required during inspections and audits.
  

Practical example you can follow:

If you plan tablet manufacturing plus contract development, opt for a Wholly Owned Subsidiary. Keep objects broad enough to cover APIs, formulations, import, sale, and R&D support. This avoids amendments when you add lines later.

Common pitfalls to avoid from day one:

• Choosing an LLP when you intend to raise equity or apply for multiple manufacturing licenses later.
  
• Narrow objects in the incorporation documents that do not cover APIs, FDFs, or import and wholesale activities.
  
• Skipping cap-table planning, which complicates later FDI filings and transfer pricing documentation.
  
• Selecting a name too close to an existing pharma brand, which invites objections and delays.

Step 2: Verify FDI Route And Set Ownership Plan

Before you bring money into India, confirm the Foreign Direct Investment (FDI) route your pharma venture falls under. The FDI framework determines whether you can invest automatically or if you need prior government approval. This step is critical, because ownership structure mistakes can delay or even invalidate your operations.

FDI rules for pharmaceuticals:

• Greenfield projects (new manufacturing facilities): Up to 100% foreign ownership is allowed under the automatic route. You don’t need government approval here.
  
• Brownfield projects (acquiring or investing in existing Indian pharma companies): Up to 74% foreign ownership is allowed automatically. Beyond 74%, you must obtain approval from the Government of India.
  
• Medical devices: Treated separately from drugs, they allow 100% FDI under the automatic route.
  

What you should prepare:

• Confirm whether your plan is greenfield or brownfield. For example, if you’re building a new plant in Hyderabad, it’s a greenfield case. If you are acquiring a stake in an existing Indian pharma company, it becomes brownfield.
  
• Align your proposed shareholding with these caps before you start incorporation paperwork. This avoids the need to restructure shares later.
  
• Set up a clear board and ownership plan that specifies nominee directors, profit repatriation policies, and internal reporting lines.
  

Compliance you must handle:

• All FDI inflows must be reported on the RBI’s FIRMS/SMF portal within strict deadlines (30 days for receipt of funds, 60 days for allotment of shares).
  
• Bank certificates, Foreign Inward Remittance Certificates (FIRCs), and valuation reports will form part of your compliance pack.
  

Pitfalls that trip up US founders:

• Issuing shares to the US parent before checking if you’re within the automatic or approval route.
  
• Missing the RBI reporting deadlines, which leads to compounding applications and extra legal costs.
  
• Structuring ownership without clarity on repatriation of dividends and transfer pricing, which can affect tax efficiency later.

Also Read: Foreign Direct Investment (FDI) Policy in Pharmaceuticals Sector

Step 3: Incorporate The Company

Once you’ve confirmed the FDI route and ownership plan, the next milestone is formally incorporating your pharma company in India. Incorporation gives you a legal identity, without which you cannot apply for licenses, open a bank account, or register for taxation.

Core process you must complete:

• Digital Signatures (DSC): Obtain DSCs for all directors to enable e-filing.
  
• Director Identification Number (DIN): Apply through the incorporation form for each proposed director.
  
• SPICe+ webform: File Part A for name reservation and Part B for incorporation on the Ministry of Corporate Affairs portal. This includes details of capital, registered office, and business objects (make sure you clearly mention “pharmaceutical manufacturing, import, and sale” if these are in scope).
  
• Linked filings: Use the same process to obtain PAN, TAN, and optionally EPFO/ESIC registrations.
  

Documents you’ll need ready:

• Identity and address proof of directors and shareholders.
  
• Proof of registered office (lease deed or utility bill).
  
• Draft Memorandum of Association (MOA) and Articles of Association (AOA) covering pharma activities.
  
• Consent forms from directors and declarations that they are not disqualified under the Companies Act.
  

What you receive at the end:

• Certificate of Incorporation with Corporate Identification Number (CIN).
  
• PAN and TAN, allotted automatically upon approval.
  
• Bank account authorization for the new company.
  

Practical example for US founders:
If your US parent company is the 100% shareholder, you will list it as the subscriber in the MOA. The parent will sign digitally through its authorized representative. This ensures a clear ownership trail and makes FDI reporting easier in the next stage.

Common pitfalls to avoid:

• Drafting MOA/AOA objects too narrowly (e.g., covering only manufacturing but not import, sale, or R&D). This forces amendments later.
  
• Submitting incomplete registered office proofs, which often trigger resubmission by MCA.
  
• Overlooking the requirement that at least one director must be a resident in India (staying at least 182 days in a financial year).

Step 4: Register Tax And Statutory IDs

After incorporation, your pharma company needs tax and statutory registrations to operate legally. These IDs are the backbone of your financial and regulatory activities in India. Without them, you cannot invoice customers, deduct taxes, or import and export goods.

Key registrations you must secure:

• Permanent Account Number (PAN): Serves as your company’s tax identity.
  
• Tax Deduction and Collection Account Number (TAN): Mandatory if you deduct tax at source (TDS) on salaries, contractor payments, or other specified expenses.
  
• Goods and Services Tax (GST) registration: Needed if you plan to supply goods or services. Pharma companies almost always require GST since they manufacture or distribute drugs.
  
• Importer Exporter Code (IEC): Required if you intend to import APIs or export formulations.
  

What the process involves:

• PAN and TAN are generally allotted automatically during incorporation through the SPICe+ form. Verify they are active once you receive the incorporation certificate.
  
• Apply for GST on the GST portal. You will need proof of business address, PAN, and details of directors.
  
• Apply for IEC on the Directorate General of Foreign Trade (DGFT) portal with basic company documents and bank details.
  

Compliance table for quick reference:

Example you can follow:
If your US company sets up an Indian subsidiary to manufacture generics, you’ll need PAN and TAN automatically at incorporation, GST to charge tax on sales, and IEC to import raw APIs from abroad.

Common pitfalls to avoid:

• Forgetting to activate GST early, which prevents you from issuing valid invoices.
  
• Not applying for IEC before your first shipment, leading to customs delays.
  
• Treating PAN and TAN as optional; both are mandatory even if you outsource accounting.

Step 5: Obtain Pharma Licenses You Need For How To Open Pharma a Company In India

Once your company is incorporated and registered for taxes, the next critical step is securing the licenses that allow you to legally manufacture, sell, or distribute pharmaceutical products. In India, licensing responsibilities are divided between the Central Drugs Standard Control Organization (CDSCO) at the national level and State Food and Drug Administrations (FDAs) at the state level.

Core licenses and approvals you will deal with:

• Manufacturing license:
  
  • Issued by the State FDA.
    
  • Apply using Form 25 for most drugs and Form 28 if you’re making sterile or parenteral products (Schedule C and C1 drugs such as injectables).
    
• Wholesale and retail licenses:
  
  • Form 20/21 for retail sales.
    
  • Form 20B/21B for wholesale distribution.
    
  • These are issued by the State FDA, typically requiring a registered pharmacist to be appointed.
    
• Central approvals (CDSCO/DCGI):
  
  • Needed for new drugs, biologics, vaccines, and certain high-risk categories.
    
  • All applications are filed through the SUGAM portal, which is CDSCO’s online licensing platform.
    

What to prepare in advance:

• Qualified technical staff: You must employ pharmacists or chemists with the required qualifications and register them as “competent technical staff” with the licensing authority.
  
• Site documentation: Plant layout, equipment details, and proof of compliance with Good Manufacturing Practices (GMP) as per Schedule M.
  
• Quality assurance documents: Standard Operating Procedures (SOPs), quality control measures, and record-keeping systems.
  
  

Example you can follow:
If you want to start by manufacturing generic oral tablets in Gujarat, you will need a Form 25 manufacturing license from the state FDA. You will also need to prove you have qualified technical staff and submit a plant layout showing compliance with Schedule M requirements.

Common pitfalls to avoid:

• Applying for the wrong form (e.g., Form 25 instead of Form 28) based on the type of drugs you plan to manufacture.
  
• Not hiring or documenting competent technical staff, which is a standard reason for application rejection.
  
• Submitting incomplete plant or quality documentation, which slows down the approval process significantly.

Step 6: Secure Import Permissions For APIs And Finished Drugs

If your pharma business plan in India includes importing active pharmaceutical ingredients (APIs), raw materials, or even finished formulations from outside India, you must obtain specific import authorizations. These are handled centrally by the Central Drugs Standard Control Organization (CDSCO). Without these, your consignments will be held at customs and you risk regulatory penalties.

Core import licenses you must know:

• Form 10: Standard import license for drugs not listed under restricted categories.
  
• Form 10A: Import license specifically for drugs in Schedule X (narcotics and psychotropic substances).
  
• Form 41 (Registration Certificate): Issued for the overseas manufacturer and its premises. It confirms that the foreign site and products meet Indian regulatory standards.
  
• BA/BE study materials: Require special permissions if you’re importing small batches for bioavailability/bioequivalence trials.
  

Steps you need to take:

• Register the foreign manufacturing site and the specific products with CDSCO through the SUGAM portal before applying for Form 10 or 10A.
  
• Submit complete dossiers, including GMP certificates from the country of origin, testing protocols, and stability data.
  
• Appoint an authorized Indian agent or subsidiary who will be legally responsible for import and distribution.
  

Example you can follow:
If you plan to import APIs for antibiotic tablets from a US facility, the US site must first receive a Form 41 registration certificate. Only then can your Indian subsidiary apply for a Form 10 import license covering those specific APIs.

Common pitfalls to avoid:

• Attempting to import without first registering the manufacturer under Form 41. Customs will not clear such shipments.
  
• Overlooking storage requirements (e.g., cold chain for biologics) in your wholesale license, which can lead to license suspension.
  
• Not appointing an Indian agent with proper authorization. This is mandatory for overseas manufacturers without an Indian subsidiary.

Step 7: Obtain Clinical Trial And New Drug Permissions (If Applicable)

If your business plan includes introducing a new drug to the Indian market or conducting clinical trials, you must secure approvals under the New Drugs and Clinical Trials Rules, 2019 (NDCTR). These rules govern everything from trial site registration to ethics committee approvals and ensure compliance with both Indian and international standards.

Situations where this applies to you:

• Launching a new chemical entity or a biologic not yet approved in India.
  
• Conducting bioavailability/bioequivalence (BA/BE) studies for generic versions.
  
• Introducing fixed-dose combinations (FDCs) that have not been previously approved.
  

Core permissions and registrations you’ll need:

• Clinical trial application submitted to the Central Licensing Authority (through CDSCO).
  
• Ethics Committee registration with CDSCO for any trial site you use.
  
• Trial site approval, ensuring the hospital or facility meets infrastructure and personnel standards.
  
• BA/BE study approvals, if you are testing generics against reference drugs.
  

What you must prepare:

• Complete dossier including preclinical and clinical data, manufacturing details, and investigator’s brochure.
  
• Approval letters from ethics committees and agreements with trial investigators.
  
• Compliance with Good Clinical Practice (GCP) guidelines, with SOPs covering monitoring and reporting.
  

Example you can follow:
If you plan to run a bioequivalence study for a generic cardiovascular drug in India, you will need trial site approval, ethics committee registration, and a CDSCO clearance for the BA/BE protocol. Without this, the data you generate will not be valid for market authorization.

Common pitfalls to avoid:

• Starting a trial without securing Central Licensing Authority approval, which makes the entire study invalid.
  
• Using an ethics committee that is not registered with CDSCO, which risks trial suspension.
  
• Skipping site inspections; CDSCO often audits trial centers for GCP compliance.

Step 8: Prepare Your Plant With GMP Compliance And Environmental Clearances

If you plan to manufacture in India, your facility must meet Good Manufacturing Practices (GMP) under Schedule M of the Drugs and Cosmetics Rules. Alongside this, you must also obtain environmental permissions from the state authorities before beginning operations.

What GMP compliance requires you to establish:

• Infrastructure standards: Segregated areas for production, quality control labs, storage, and packaging. Each must be designed to prevent cross-contamination.
  
• Documentation and SOPs: Batch manufacturing records, quality assurance protocols, and change control procedures that inspectors can audit at any time.
  
• Quality systems: In-process quality checks, stability testing facilities, and validation of equipment and processes.
  

Environmental permissions you cannot skip:

• Consent to Establish (CTE): Issued by the State Pollution Control Board before you install machinery or start construction.
  
• Consent to Operate (CTO): Required before production begins, confirming your plant meets standards under the Water and Air Acts.
  
• Hazardous waste authorization: If your plant handles solvents, chemicals, or byproducts requiring special disposal.
  

Example you can follow:
A US company setting up a greenfield plant in Hyderabad must obtain CTE first, then submit proof of plant layout, emissions controls, and waste management systems. After installation, they must secure CTO before launching any commercial batches. In parallel, the plant design must follow Schedule M to pass inspections by the State FDA.

Common pitfalls to avoid:

• Purchasing or installing equipment before receiving Consent to Establish, which can result in stop-work orders.
  
• Ignoring solvent recovery and hazardous waste systems; these are often flagged during inspections.
  
• Preparing GMP SOPs only on paper but not aligning them with day-to-day practices, which leads to non-compliance observations.

Step 9: Build Local Capability And Operational Controls

Once your facility is licensed and compliant, you need to demonstrate that your company has the right people and systems to manage pharmaceutical operations. Regulators focus heavily on whether you have qualified staff and robust internal controls to maintain quality and compliance.

Core staffing requirements you must meet:

• Pharmacists and technical staff: You must appoint “competent technical staff” with pharmacy or chemistry qualifications, as mandated by the Drugs and Cosmetics Rules. Their names and qualifications are recorded on your license.
  
• Quality assurance (QA) and quality control (QC) leads: Required to oversee batch records, deviations, stability studies, and product recalls.
  
• Regulatory compliance officer: Handles filings with CDSCO, State FDA, and ensures records are inspection-ready.
  
  

Operational systems you should implement:

• Standard Operating Procedures (SOPs): Cover all activities from cleaning validation to batch release with version control and staff training records.
  
• Documentation and record keeping: Maintain batch manufacturing records, deviation logs, and corrective/preventive action (CAPA) reports.
  
• Supplier and contract manufacturer oversight: Conduct audits and qualify vendors, ensuring raw materials and outsourced work meet GMP standards.
  
  

Example you can follow:
A US subsidiary producing generic oncology drugs in India typically employs a registered pharmacist as technical head, a QC manager for lab operations, and a QA head for release processes. This team maintains SOPs, oversees training, and ensures inspection readiness for both Indian authorities and US FDA audits.

Common pitfalls to avoid:

• Hiring unqualified technical staff, which can result in license suspension during inspections.
  
• Treating SOPs as paperwork rather than implementing them in daily operations, which inspectors quickly detect.
  
• Ignoring vendor qualification; if an unverified supplier delivers substandard raw materials, you are held accountable.

Step 10: Finance, Cross-Border Reporting, And Ongoing Filings

After you begin operations, your compliance burden shifts heavily toward financial and regulatory reporting. Since your company involves foreign direct investment (FDI), regulators closely track cross-border inflows, shareholding, and ongoing tax filings.

FDI and RBI reporting obligations:

• Foreign Inward Remittance Certificates (FIRCs): Collect these from your bank each time funds arrive from your US parent.
  
• FC-GPR filing: Report share allotments on the RBI’s FIRMS/SMF portal within 30 days of allotment.
  
• Annual FLA return: Disclose foreign liabilities and assets each year to the RBI.
  

Tax and statutory filings you must stay on top of:

• Corporate Income Tax: File annual returns with audited financial statements. Transfer pricing documentation is essential if you transact with your US parent.
  
• GST filings: Monthly or quarterly returns for sales and purchases, plus annual reconciliation.
  
• TDS compliance: Deduct tax at source on salaries, contractor payments, and vendor invoices, then file quarterly TDS returns.
  
  

Internal controls you should implement:

• Maintain an audit trail of all invoices, cross-border contracts, and intercompany agreements.
  
• Use accounting systems integrated with GST and TDS modules to avoid errors.
  
• Schedule internal audits before statutory audits to catch discrepancies early.
  

Example you can follow:
If your Indian subsidiary receives $1 million in FDI to set up a manufacturing plant, you must file FC-GPR within 30 days of issuing shares to the US parent. Later, when selling drugs domestically, GST invoices must be filed monthly. If you also provide contract research services to the parent, a transfer pricing report must be filed with your income tax return.

Common pitfalls to avoid:

• Missing the 30- or 60-day RBI deadlines for FDI reporting, which forces you into a compounding application with penalties.
  
• Recording intercompany transactions without proper benchmarking, which leads to transfer pricing disputes.
  
• Failing to reconcile GST input credits with vendor invoices, resulting in disallowance of credits during audits.

Step 11: Set Up Distribution And Secondary Operations For How To Open a Pharma Company In India

Once your manufacturing or import operations are ready, the final step is to establish your distribution and secondary sales channels. This ensures your products reach hospitals, pharmacies, and wholesalers legally and under strict compliance.

Licenses you must secure:

• Wholesale license (Forms 20B and 21B): Required if you distribute to hospitals, clinics, or smaller retailers.
  
• Retail license (Forms 20 and 21): Needed if you plan to sell directly to consumers through pharmacies.
  
• Storage approvals: Cold chain facilities for biologics or vaccines must be inspected and approved by the State FDA.
  

How you structure operations:

• Warehousing: Either build your own facility or contract with an approved logistics provider. Warehouses must meet storage, security, and hygiene conditions prescribed by State FDA.
  
• Contract distribution: You may appoint third-party distributors, but your licenses and agreements must clearly define roles and accountability.
  
• Technology support: Inventory and batch-tracking systems are essential to maintain audit trails and enable product recalls if required.
  

Example you can follow:
If you are importing finished generics for US clients and distributing within India, your subsidiary will need a wholesale license (20B/21B). You can operate through a compliant warehouse in Mumbai and appoint a distributor with refrigerated trucks to handle vaccines.

Common pitfalls to avoid:

• Using unlicensed third-party warehouses, which invalidates your wholesale license.
  
• Not maintaining cold chain integrity for temperature-sensitive drugs, leading to regulatory action.
  
• Failing to maintain proper sales records and invoices, which inspectors verify during audits.

Also Read: How To Start A Biotech Company In India From The US

Following the setup steps, you must focus on compliance areas that directly impact your operations and regulatory approvals.

Key Compliance Considerations For US Pharma Entrepreneurs

When you expand into India’s pharmaceutical market, your long-term success depends on meeting strict compliance requirements. Authorities expect you to protect sensitive data, meet manufacturing and testing standards, and follow both domestic and international regulations.

1. Data protection and confidentiality

• If you handle patient data during clinical trials or BA/BE studies, you must comply with India’s Information Technology Act and rules on sensitive personal data.
  
• Contracts with Contract Research Organizations (CROs) or third-party vendors should include non-disclosure agreements and confidentiality clauses.
  
• For US companies, it’s best practice to align with HIPAA or GDPR standards, since global regulators often cross-check trial records.
  

2. Product testing requirements

• Every batch manufactured must undergo stability testing and in-process quality control before release.
  
• Drugs imported into India require testing at government-approved laboratories before market release.
  
• You should establish a Quality Assurance (QA) unit responsible for batch release documentation, deviation logs, and corrective action/preventive action (CAPA) records.
  

3. Import and export rules

• APIs or finished drugs cannot be imported without a valid Form 10 or Form 10A license, plus a Form 41 registration certificate for the overseas manufacturer.
  
• Exporters must obtain an Import Export Code (IEC) and comply with customs reporting, especially for restricted drugs under Schedule X.
  
• Shipping documentation must demonstrate compliance with cold chain and hazardous material handling requirements.
  

4. Clinical trial approvals

• Trials involving new drugs or BA/BE studies require permission from the Central Licensing Authority (CDSCO) under the New Drugs and Clinical Trials Rules, 2019.
  
• Each trial site must be approved and linked to a registered Ethics Committee.
  
• US sponsors often appoint an Indian subsidiary or CRO to manage filings and ensure compliance with both Indian GCP and US FDA standards.
  

5. Manufacturing standards under Schedule M

• Your plant must comply with Schedule M of the Drugs and Cosmetics Rules, which sets Good Manufacturing Practices (GMP) for facilities, equipment, documentation, and quality systems.
  
• Inspectors expect to see validated processes, qualified personnel, and complete SOPs.
  
• Non-compliance with Schedule M can lead to suspension of your manufacturing license, and repeated violations may affect your ability to export to the US
  

Quick-scan table of core compliance areas:

Also Read: Business Setup in India: Essential Steps for Entrepreneurs

Meeting these compliance demands can be challenging, which is where VJM Global provides expert guidance and ongoing support.

How VJM Global Supports US Businesses Opening Pharma Companies in India

Setting up a pharma company in India requires more than just licensing and plant approvals. You also need reliable partners who can manage incorporation, compliance, and ongoing financial operations. This is where VJM Global plays a pivotal role for US entrepreneurs.

Specialized support you gain with VJM Global:

• Company setup and registration: Assistance with entity incorporation, drafting charter documents, and securing statutory IDs like PAN, TAN, and GST.
  
• FEMA and RBI compliance: Timely reporting of FDI inflows, FC-GPR filings, and ongoing foreign exchange compliance to avoid penalties.
  
• GST and tax compliance: Registration, monthly returns, and reconciliation, ensuring smooth operations in line with Indian regulations.
  
• Accounting outsourcing: End-to-end bookkeeping, financial reporting, and payroll handled by teams trained in both US GAAP and Indian standards.
  
• Audit support: Preparation of audit schedules, reconciliations, and control testing, reducing workload during statutory or internal audits.
  

Why this matters to you as a US entrepreneur:

• You maintain long-term compliance without having to build large in-house finance or compliance teams in India.
  
• By outsourcing accounting and regulatory tasks, you save 40–50% of administrative costs, which you can redirect toward R&D, manufacturing upgrades, or clinical trials.
  
• You gain the confidence of knowing that your Indian operations meet both US and Indian regulatory expectations, which reassures auditors and investors.
  

If you are exploring how to open a pharma company in India, VJM Global provides the expertise to handle the company setup, outsourcing, and compliance side of your business so you can focus on growth.

Conclusion

Expanding into India’s pharmaceutical sector gives you access to a growing market, cost savings, and a skilled workforce. Success depends on choosing the right structure, securing licenses, and staying fully compliant with regulatory and financial requirements. With the right support, the process becomes manageable and cost-efficient.

Are you ready to set up your pharma company in India with the right compliance and cost support? VJM Global helps US entrepreneurs handle company registration, FEMA/RBI reporting, GST, accounting outsourcing, and audit support, ensuring your operations remain compliant while reducing overhead. Partner with VJM Global today to start your expansion journey confidently.

Are you ready to expand your pharma business into India with confidence and compliance? VJM Global’s dual expertise in U.S. GAAP and Indian regulations helps businesses cut up to 50% of administrative costs. Schedule a call with VJM Global today and take the first step toward your compliant and cost-efficient setup.

FAQs

‍

Q: What is the minimum investment needed to open a pharma company in India?

‍ A: The required investment varies by scale. A small formulation unit can start under $200,000, while large plants need multi-million budgets.

Q: Can I start operations in India without building my own manufacturing facility?

‍ A: Yes. You can use contract manufacturing organizations with FDA-approved plants, allowing quick market entry without high capital expenses.

Q: How can I ensure imported APIs meet Indian quality standards?

‍ A: Imported APIs must be registered with CDSCO. Testing at government-approved labs is mandatory before they are released into the market.

Q: Do I need a local partner to handle compliance filings?

‍ A: Not necessarily. A wholly owned subsidiary can manage compliance, but many US companies outsource filings to trusted Indian firms.

Q: How quickly can I begin selling after incorporation and licensing?

‍ A: Incorporation may take 2–3 weeks. Licensing, import permissions, and GST registration often extend the timeline to 6–12 months.

Q: Can VJM Global manage both US and Indian accounting requirements simultaneously?

‍ A: Yes. VJM Global teams are trained in US GAAP and Indian standards, ensuring unified reporting and consistent compliance across jurisdictions.

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