How to Start a Pharmaceutical Company in India?

Starting a pharmaceutical company in India involves selecting a business structure, obtaining necessary licenses like Drug Manufacturing or Wholesale License, registering with authorities such as CDSCO and GST, and setting up manufacturing or distribution units. It's essential to meet legal, quality, and regulatory standards laid out by the Drug Control Department to ensure safe and compliant operations.

This guide clarifies how to start a Pharmaceutical Company at each stage, from choosing the right company structure to secure a drug license, meeting GMP requirements, and building a quality-verified brand, so you can move confidently from planning to production.

Pharma Company Registration in India

India's pharmaceutical sector entered a golden phase in 2025, emerging as a global leader in generics and vaccines. Valued at around US $55 billion today, it is projected to more than double to $120–130 billion by 2030, with further expansion on the horizon. The government’s recent policies have significantly accelerated growth. 100% FDI is now permitted in greenfield pharmaceutical and medical device projects, with up to 74% allowed in brownfield ventures.

To foster domestic manufacturing, India launched a Rs.15,000 crore PLI scheme in 2021 aimed at high-value drug production, particularly cancer and diabetes therapies. Further support includes incentives worth Rs.6,940 crore for APIs and Rs.3,420 crore for medical devices. This is making India a more self-reliant and export-ready pharma hub.

With these robust incentives, streamlined policy reforms, and a favorable investment climate, 2025 offers an unparalleled opportunity to establish a successful pharmaceutical company in India.

Choosing the Right Business Structure

Choosing the right business structure is crucial for pharma startups in India, affecting liability, compliance, and funding:

• A Private Limited Company offers limited liability, perpetual succession, and investor appeal, which makes it ideal for entrepreneurs seeking growth, equity, and scale.
• A Limited Liability Partnership combines limited liability with flexible management and lower compliance. It’s well-suited for small teams or professionals building service-oriented businesses.
• A One Person Company offers similar legal protection as a company but works well for solo founders testing an idea, though they may need to convert to Pvt Ltd if they grow beyond Rs.2 crore turnover or Rs.50 lakh capital.
• Public Companies can tap into capital markets, ideal for large-scale pharma operations needing massive investment, though they come with rigorous compliance.
• An Indian Subsidiary suits foreign firms entering India, which offers a regulated framework and local compliance setup.

These structures offer distinct advantages depending on your team size, investment needs, and long-term goals under Indian law.

Eligibility and Key Requirements

In India, setting up a pharmaceutical company comes with clear legal and professional standards to ensure credibility and compliance. Every company type must have a minimum number of directors, one for an OPC, two for Pvt Ltd or LLP, and three for a public company, and at least one director must be an Indian citizen, even if others are foreign nationals. Each director is required to obtain a Director Identification Number and a Digital Signature Certificate, which are essential for filing official documents online.

The company must also have a registered office in India, backed by valid proof such as a rental agreement, NOC from the landlord, or ownership documents. On the expertise front, at least one director must be a qualified pharmacist registered with a State Pharmacy Council or have a year of industry experience. This ensures your leadership is equipped with practical pharma knowledge. Meeting these standards not only aligns with regulatory requirements but also strengthens your company’s foundation and reputation right from the start.

How to Start a Pharmaceutical Company in India?

Step 1: Name Approval using SPICe+ Part A

Start by logging into the MCA portal and filing SPICe+ Part A, also called the RUN service, with up to two name choices. A fee of Rs.1,000 applies. Once approved, the name is reserved for 20 days.

Step 2: Obtain DSC & DIN for Directors

Each proposed director must obtain a Digital Signature Certificate and a Director Identification Number. These are mandatory for electronically signing and submitting the incorporation documents.

Step 3: Prepare Company Documents

Draft the Memorandum (MoA) and Articles of Association (AoA), which define your company’s objectives and governance structure. If forming an LLP, prepare the LLP Agreement instead.

Step 4: File SPICe+ Part B with Required Docs & Fees

Once the name is approved, fill out SPICe+ Part B. This captures details like capital structure, director info, registered office address, and stamp duty. Attach supporting documents such as MoA, AoA, ID proofs, NOC for office, and attach your DSC. Pay filing fees based on capital, and include linked services like PAN, TAN, EPFO, ESIC, and optional GST.

Step 5: Receive Certificate of Incorporation

After successful submission and verification, the Registrar of Companies will issue the Certificate of Incorporation, officially confirming your company under the Companies Act.

This all-in-one SPICe+ process lets you reserve your company’s name, incorporate, obtain regulatory registrations, and open a bank account all in one go. It streamlines paperwork and speeds up your pharma startup launch in India.

Licenses & Post-Incorporation Registrations

After incorporation, your pharma venture needs several compulsory registrations to operate legally and thrive:

• Drug Licenses (Drugs & Cosmetics Act, 1940)

To manufacture, distribute, sell, import, or loan APIs or formulations, you must obtain appropriate drug licenses regulated by the CDSCO or State authorities. Categories include manufacturing, wholesale, retail, loan license, and import license, depending on your business model.

• GST Registration

Mandatory if your annual turnover exceeds Rs.40 lakh for goods or Rs.20 lakh for services, or if you undertake interstate sales. GST registration supports legal sales and enables input tax credit.

• FSSAI License

Necessary if you produce or market nutraceuticals or food supplements alongside pharmaceutical products, ensuring compliance with food safety norms.

• Trademark & Patent Registration

Not legally required, but strongly advisable to protect your brand, logo, and formulation IP. A trademark guards your brand identity, while a patent prevents replication of your proprietary formulas.

These registrations ensure your pharmaceutical venture in India is compliant, professionally credible, and protected across branding, production, and distribution.

Infrastructure & Quality Standards for Manufacturing

For manufacturing in India, robust infrastructure and strict quality systems are essential.

You must follow the Drugs & Cosmetics Rules, including revised Schedule M standards that align with WHO GMP requirements. This covers everything from plant design and equipment validation to hygiene practices and self-inspection protocols. The Indian government has extended the deadline for small and medium manufacturers to comply with these upgraded standards to December 2025.

Setting up your facility also means obtaining environmental and factory clearances under PCB and EIA norms, especially for API units classified as ‘Red’ under CPCB rules.

Internally, strong quality systems are non-negotiable. This includes well-equipped labs, documented Standard Operating Procedures, rigorous equipment validation, and implementation of GMP practices in daily operations.

Together, these standards ensure your pharmaceutical manufacturing meets global benchmarks and keeps your operations compliant, safe, and trusted.

Market Entry & Business Model Options

India's booming pharmaceutical sector in 2025 offers diverse pathways to enter the market, each tailored to your investment level, scale, and strategic goals:

• Contract Manufacturing / Loan License

Ideal for low-investment startups, this model lets you partner with an existing WHO GMP / FDA-certified facility to produce your products under your brand. It is also known as CDMO/CRAMS, a booming sector in India valued at approximately US $25.8 billion in 2025, growing at a fast 14.7% CAGR.

• PCD Franchise or Branded Generics

A popular route for pharma entrepreneurs, you collaborate with a manufacturer to distribute products under your brand. This model requires less capital, supports localized marketing, and offers flexibility in product and region choice.

• Export-Oriented Model

For companies aiming to serve regulated markets like the US or Europe, you must ensure FDA, EMA, or WHO GMP approvals. India's strengths are cost-effective production and skilled labor, equipping firms to thrive globally.

Choosing the right path depends on your resources, expertise, and ambitions. From contract manufacturing to global exports, each model offers strong growth potential and adaptability under India’s robust regulatory ecosystem.

Strategic Benefits in 2025

• India’s strong R&D and production ecosystem forms a compelling base for pharma growth. With over 10,500 manufacturing units, 650 US FDA-certified, the largest outside the U.S., and a leading role in generic drugs and vaccines, India is uniquely positioned to scale advanced pharmaceutical products.
• Export demand continues to surge, driven by global healthcare needs post-COVID and escalating demand in major markets like the U.S., U.K., and Africa. Pharma exports are broadly expected to grow 10–15% this year.
• The government’s PLI Scheme supports high-tech drug production and API self-reliance. With Rs.6,940 crore focused on critical APIs and Rs.15,000 crore on advanced drugs, which includes cancer and biosimilars, this incentive package spurs domestic manufacturing and boosts global competitiveness.

These strategic advantages, from a robust infrastructure to favorable export demand and bold government support, make 2025 an optimal time to start or scale a pharmaceutical venture in India.

Conclusion

In this article, you have learnt how to start a Pharmaceutical Company in India. India’s pharmaceutical ecosystem in 2025 is uniquely primed for growth, with strong government incentives like 100% FDI, lucrative PLI schemes, and an export-driven market. now is the ideal moment to launch your pharma vision. From selecting the right business structure and completing SPICe+ registration to securing essential licences and adhering to GMP norms, each step sets the stage for long-term success.

At Online Legal India, we simplify this journey. Our expert team supports you end-to-end from company registration to GST registration, FSSAI license filing, and post-launch filings. We offer seamless, 100% online assistance to ensure your pharmaceutical venture is compliant, credible, and ready for rapid growth under Indian law. Visit Online Legal India today.