Setting Up a Pharma Business in India

Setting up a pharmaceutical business in India is an exciting venture, given the country’s booming pharmaceutical market and global prominence in generic drug production. Our expertise lies in facilitating pharma manufacturing units and guiding them through the legal intricacies, ensuring compliance and success.

  • Our team advising on starting a pharmaceutical company in India, includes specialists in intellectual property, regulatory compliance and commercial law.
  • Our firm has extensive experience in guiding clients through the complex procedures of setting up your pharma manufacturing unit in India. We handle all aspects of regulatory compliance, from obtaining necessary licenses to ensuring adherence to Good Manufacturing Practices (GMP).
  • We can facilitate connections with potential investors for business growth and collaboration in the manufacturing sector.
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Procedure for Setting Up a Pharma Business in India

Company Registration

Register your company under the appropriate legal entity, such as a private limited company or LLP.

Licenses and Permits

Obtain necessary licenses from the Drug Department, including manufacturing licenses and GMP certification. Ensure compliance with the Factory Acts regulation and the Current Good Manufacturing Practice regulations.

GST Registration

Apply for a GST identification number for tax purposes.

Trademark Registration

Register trademarks with the Trademarks Registry under the Trademarks Act, 1999. Safeguard the brand name and logo from unauthorized use or infringement.

Manufacturing Unit Setup

Setting up a pharma manufacturing unit in India requires careful consideration of zoning regulations and environmental norms.Acquiring necessary approvals and compliance with the State Food and Drug Administration (FDA) and Good Manufacturing Practices (GMP) standards, as prescribed by the Drugs and Cosmetics Act, 1940 and Rules, 1945, is important to ensure the quality and safety of pharmaceutical products.

Production and Quality Control

Set up your production line and implement stringent quality control measures to comply with FDA and CDSCO standards. Whether you choose to manufacture independently or through third-party contracts, ensure your products meet all bioequivalent and clinical trial requirements.

Obtain an Import-Export License

For businesses involved in importing or exporting pharmaceutical products, obtaining an Import-Export license from the Directorate General of Foreign Trade (DGFT) is necessary. This license facilitates compliance with international trade regulations and enables lawful trading activities across borders.

Adherence to Clinical Trial Regulations

If conducting clinical trials for pharmaceutical products, adherence to regulations laid down by the CDSCO under the New Drugs and Clinical Trials Rules, 2019, is essential.

Compliance with Packaging and Labeling Regulations

Compliance with packaging and labelling regulations specified under the Drugs and Cosmetics Act, 1940 and Rules, 1945, is crucial for ensuring product safety and consumer information.

Compliance with Labour Laws

Comply with relevant labour laws which include registration under the Employee State Insurance Act (ESI), Provident Fund Organization (EPFO) and compliance with the Minimum Wages Act, among others.

Documents Required for Starting a Pharma Business

  • Certificate of Incorporation
  • Memorandum of Association (MOA) and Articles of Association (AOA)
  • PAN Card of the company
  • Identity and address proofs of directors and shareholders
  • Application forms for manufacturing licenses and GMP certification
  • Proof of premises (lease agreement or ownership deed)
  • Layout plan of the manufacturing unit
  • List of equipment and machinery installed
  • Details of technical staff, including qualifications and experience
  • No Objection Certificate (NOC) from the Pollution Control Board
  • Consent to Establish (CTE) from the respective State Pollution Control Board
  • GST registration form
  • PAN Card of the company
  • Identity and address proofs of directors
  • Proof of business address (electricity bill, rent agreement, etc.)
  • Trademark application form
  • Logo and brand name to be trademarked
  • Proof of identity and address of the applicant
  • Proof of business registration
  • Standard Operating Procedures (SOPs) for manufacturing and quality control
  • Batch manufacturing records
  • Stability study reports
  • Bioequivalence study reports (for generic drugs)
  • Clinical trial approvals and reports (for new drugs)
  • Agreements with suppliers and distributors
  • Insurance policies for the manufacturing unit and employees
  • Environmental clearance certificates
  • Safety and health compliance certificates

Why Choose Us?


Benefit from our deep understanding and extensive experience in navigating the complex landscape of pharmaceutical regulations in India. 

Proven Track Record

With a history of helping to set up a pharma manufacturing unit in India, we bring a wealth of experience and a proven track record of success to every client engagement.

Client-Centric Approach

We prioritize clear communication and responsive service to empower you to make informed decisions and achieve your business objectives effectively.

Our Team

Abhisshek Singlla

Abhisshek Singlla


Anish Jaipuriar

Anish Jaipuriar


Ankit Bhasin

Ankit Bhasin


Work Highlights

Expansion of a Leading Tech Company into the Indian Market

We facilitated the seamless incorporation of multiple pharmaceutical startups, providing end-to-end legal support to navigate company registration, compliance requirements, and regulatory approvals, enabling them to enter the market with confidence.

Joint Venture between a Global Pharmaceutical Giant and an Indian Biotech Firm

We provided strategic legal counsel to established pharmaceutical companies seeking to expand their operations in India. Advised on regulatory compliance, licensing, and acquisition strategies, enabling them to capitalize on growth opportunities and enhance market presence.

Resolution of a Cross-Border Dispute for an International E-commerce Player

We negotiated favourable licensing and distribution agreements on behalf of our clients, ensuring compliance with intellectual property laws, regulatory requirements, and commercial objectives. Secured advantageous terms and mitigated legal risks to optimize business outcomes.

Client Testimonials


Choosing Burgeon Law for setting up a pharmaceutical business in India offers a distinct advantage due to our specialized expertise and comprehensive legal support tailored to the unique needs of the industry. We are committed to delivering efficient and timely legal services, streamlining the setup process, and minimizing delays to facilitate swift market entry.
Starting a pharmaceutical business in India requires adherence to various legal requirements to ensure regulatory compliance and operational legality. These include registering the company under the Companies Act, 2013, obtaining a drug license from the CDSCO or State Drugs Control Authority, and setting up a manufacturing unit in compliance with Good Manufacturing Practices (GMP) standards. Additionally, product registration with the CDSCO, trademark registration, and intellectual property protection are essential steps. Import-export licenses, tax registration, and compliance with employment, labour, and environmental laws are also mandatory.
We offer comprehensive assistance to set up a pharma manufacturing unit in India and its registration process. Beginning with an initial consultation, we tailor our services to align with your specific requirements and business objectives. Our support includes guiding you through the selection of the most suitable legal structure, such as a Private Limited Company or Limited Liability Partnership (LLP), considering factors like ownership, liability, and tax implications. We handle the preparation and compilation of all necessary documentation ensuring accuracy and compliance with regulatory requirements. Our team manages the entire application submission process, from company incorporation to obtaining essential licenses and permits.

We provide comprehensive assistance in securing intellectual property (IP) for your pharmaceutical business in India. Our services cover patent registration for formulations and processes, trademark registration for brand protection, copyright protection for creative works, and trade secret protection for confidential information. In case of infringement, we offer legal representation and support. Additionally, we assist in managing your IP portfolio for optimal protection and value maximization. 

We provide continuous support to pharmaceutical businesses with their ongoing legal and compliance needs, ensuring adherence to regulatory requirements and mitigating legal risks. Our services include monitoring regulatory updates and providing timely alerts on changes in pharmaceutical laws and industry trends. We conduct regular compliance audits and assessments to identify areas of non-compliance or risk, offering recommendations for corrective actions. 

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Get in touch with our Legal advisors and get your doubts and legal troubles solved in a most effective way at an affordable price.

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