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.
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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?

Expertise

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

Partner

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Anish Jaipuriar

Anish Jaipuriar

Partner

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Ankit Bhasin

Ankit Bhasin

Partner

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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

Roma and her team at Burgeon Law blend business practicalities within legal boundaries and create implementable outcomes. They keep a professional, yet thorough and balanced approach while negotiating with an Investor. Their availability and ability to think on their feet sets them apart from other firms. They are always mindful of the kind of assistance required by businesses at different stages, which makes their advice bespoke and highly customized. Working with them was an evolving exercise and we look forward to more future projects together.
Ashish KashyapFounder - INDMoney
I have worked with Roma and her team over 100 different transactions over the last decade. Burgeon Law with a team of maestros who understands the requirements of both startups and investors. They have a blend of Legal and Technology with deep knowledge of the tech ecosystem and have experience of managing transactions of different sizes and complexities.
Rajesh SawhneyFounder & CEO - GSF Accelerator
Biryani By Kilo has immensely benefited from our association with Burgeon Law. Other than great legal advice, Roma and her team with their sensitivity and understanding of legal challenges of our industry assisted as a great partner in the growth of Biryani by Kilo. Best wishes for great success to them.
Vishal Jindal Founder -Biryani By Kilo
Roma is able to look at the issues both at macro as well as micro level; and has always been able to come up with implementable strategies. Her understanding of tech space is deep and nuanced, which is reflected in the strategic inputs she provides. We have the confidence of reaching out to her because she is dependable and has a robust team to provide end-to-end support. They are our go-to support system and we found their assistance during the fund-raising process absolutely trustworthy, proactive and forward moving with a remarkable turnaround.
Radhika GhaiFounder - Kindlife, Ex Co-Founder - Shopclues
AngelList India’s experience with Burgeon Law has been nothing short of spectacular. The way they’ve handled our fast-paced deal-making and took over our entire legal process including entrepreneurial approach towards transactions, tracking, negotiation, immediate feedback loops, and diligent turnarounds. I’d recommend them to anyone who wants in on our secret to quick closures.
Utsav SomaniPartner - AngelList India
The team at Burgeon Law works with an outcome-oriented approach, which helps them plan the course of action and strategy from the very beginning. Especially for start-ups, they understand their specific issues extremely well. Once we started working with them, they have advocated and protected our interests - both from the perspective of a startup organization as well as in individual capacity of the founders. We have been satisfied with the way they have negotiated effectively with investors and at the same time recommended solutions and workarounds to make sure the process keeps moving forward. They are super quick which is much needed for any startup or investor.
Sachin BhatiaFounder - BulBul, Ex Co-Founder - MakeMyTrip
Throughout our transactions, Burgeon Law provided practical solutions rooted in sound law that also made complete commercial sense and acted as a catalyst to the transaction. The firm also has an undisputed penchant for delivering on consistently efficacious timelines, again saving considerable amounts of cost on the transaction. I can see that it taps into its reservoir of experience working with a large volume of growth stage start-ups. They are able to anticipate the life cycle of issues that will arise, and act to be one step ahead always.
Samir SoodFounder - Venture Highway
Roma has been doing spectacular work to build a strong legal ecosystem and culture for the startups and funds across multiple jurisdictions. Her team at Burgeon Law has contributed to the evolution of the startup sector and have earned a formidable reputation for being preferred service providers for market-leading venture capital & growth equity investors, as well as pioneering founders and companies.
Rishab Malik, Venture PartnerJungle Ventures, Ex-Co-founder - Droom.in
Roma with her team is one of the finest law firms for Startups and Investors in the country. I have had the pleasure of working with them! They bring in-depth understanding of the tech/start-up ecosystem market and advise with a focus to get the deal done. They are extremely responsive, flexible and have the mindset of a start-up entrepreneur. I highly recommend Roma and the team for start-ups and funds at all stages!
Ashish TanejaPartner - growX Ventures
Roma and her team at Burgeon Law have advised Lumikai on several transactions over the course of the last 18 months. As transaction lawyers, they are able to maintain a fine balance in providing pragmatic commercial advice alongside sharing sound legal judgment, which is so valuable. We have always been impressed with their methodical, high-quality work product, personalized attention, and prompt turn-arounds especially in time-sensitive matters.
Salone SehgalFounding General Partner - Lumikai Fund
Deal Making is complex and time consuming. Having a partner like Burgeon Law by your side makes the entire process streamlined and hassle-free, including legally structuring deals, negotiating legal nuances within contracts, and supporting with full range of documentation. Since 2015, Burgeon Law has been a true partner to Powerhouse.
Sri PedduManaging Director - Powerhouse Ventures
Burgeon Law with an exceptional team have always been very responsive and make sure to keep the balance of Investors and Founders need and demand.
Manu Rikhye Partner - Merak Ventures
The Burgeon team has a deep understanding of the nuances of startups. They solve problems with a practical mindset, something that is still missing in the current ecosystem. We’ve had a great experience working with them across multiple transactions.
Nandan VenkatachalamPrincipal - Axilor Ventures
Kae has been delighted to have Burgeon Law as its transaction advisor. Very professional approach and highly responsive team. They provide end-to-end advice and support on any transaction. With their practical approach, many deal-breaker situations are sorted out easily.
Madhura SardarLegal Head - Kae Capital
Over the years, we have worked with Burgeon Law for various transactions, corporate commercial requirements, and strategic legal advisory. We are a high-growth company always working with aggressive deadlines and the Burgeon team has always made sure to complete the project as per our timelines even if it required them to align with multiple stakeholders to make it happen. We are always pleased with the quick & strategic support and feedback we get from them to safeguard our long-term interests in our company. Rusk and the team will definitely be working with the same team for our next fundraiser, hopefully very soon!
Mayank Yadav CEO - Rusk Media
Working with Burgeon Law was an excellent months-long lesson "101 on how to invest in India". Burgeon Law not only guided us through legal issues, but also helped us navigate problems we didn't know existed
Sasa VucinicManaging Partner and CoFounder, North Base Media Fund
Roma is one of the best corporate lawyers that I have ever worked with. Not only is she a legal eagle but she is a master business negotiator often pacifying both sides to reach a suitable understanding. Backed by a super team, her firm provides reliable and efficient services.
Ashish ChandFounding Partner - Nueva Capital
Extremely happy with the Burgeon Law Team. They have been diligent with the paperwork and making sure all the compliances/ Statutory requirements are fulfilled. This makes it easy for us as a Company.The team was very prompt during our Transaction Process and while the drafting of the contracts. We did not have to follow up and the Burgeon team provided everything on time.They have been very clear with their drafting skills which made it simple and uncomplicated throughout the process.
Sangmesh JattiCFO - Heads Up For Tails
I have worked with Ketan in Srei Equipment Finance Limited on a range of legal challenges related to our business of equipment leasing and receivables purchase. Ketan had an exceptional ability to balance between retaining our legal advantages and providing a solution for practical business and commercial deadlocks. I look forward to working with him again.
Vineet Pasari Founder and CEO at Assetz Finanz
I have known Ketan to be a proactive solution oriented counsel who is known for his ability to offer balanced advice in a deal which makes him a preferred counsel not only for his clients but also amongst other parties in the deal. His ability to foresee the risk parameters and to provide for a mitigation mechanism is definitely praiseworthy.
Varun KhandelwalDirector at Buller Capital Pvt Ltd
Ketan is one of the most efficient and thorough corporate legal counsel who would provide an expert and articulate advice across a plethora of business situations.
Sourav DaspatnaikChief Executive Officer, Swach Environment Private Limited
I have no hesitation in recommending Ketan Mukhija. The legal support Ketan has provided to Vikram Solar has been excellent. Ketan works extremely hard, is responsive to all requests no matter the deadline, and is very detailed and thorough in his approach. He not only gives constructive and expert legal opinion, but also grasps the business implications of his counsel and as such his work is particularly significant in ensuring best value for VSL in contract negotiations and other legal matters. Ketan has been a pleasure to work with and I look forward to continuing the partnership with VSL.
Anil LadhaHead - Corporate Finance, Vikram Solar Limited
Ketan is an astute corporate lawyer. He has a deep understanding of corporate law and data privacy law. He is also a start-up enthusiast and actively involved in the ecosystem. He is also always up for pro bono service to NGO, entrepreneurship bodies, or any other social causes. I wish him all the best!
Wasim KhanCo Founder, Zotalabs
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FAQs

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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