FDI In Pharmaceuticals Sectors— Procedures, Fees And Documents Required

Updated on May 06, 2025 02:36:56 PM

To liberal the economy from threatened diseases, malnutritioned nations, and bodily dysfunctions, the pharmaceutical sector in India cares to build a global community with the intervention of healthy antidote drugs and early vaccines.

Although the changing lifestyle, disorganized schedule and chronic diseases wrap up the life under anxiety mode, and followed by charging the negative opportunity costs, exceeding government spending particularly on health sectors, it is so obvious to lay a quality enhancement on the pharmaceuticals sector.

The pharmaceuticals sector in India offers lucrative offers and quality enhanced compositions in medicines. Many people around the world demand for generic medicines from India due to cheap and relative affordability in medications, vaccines and drugs. The number of plants which are earmarked for drugs is adhered to GMP (Good Manufacturing Practices) standards set up by WHO and USFDA.

As India is known for being the best vaccine producer in the world such as measles vaccines, DPT and BCG, it is a thriving sector which is constantly conquering and occupying its supremacy in the modern medicine age. It is because of the low overhead cost of selling with the same quality which is affordable at a good luxurious cost.

India had occupied about 20% of the global supply volume in the global medicine market. India is home to over 3,000 pharmaceutical businesses, with a robust network of over 10,500 production facilities and a highly qualified talent pool. It also boasts the biggest number of US-FDA compliant pharma plants outside the USA. The total exports of medical goods and services has reached over US$ 25.3 Bn in FY 2022-2023.

This sector contributes over 3.3% in the total FDI inflows, one of the major contributions of the pharmaceutical sector alone. The sum total of schemes outlet provided by the government of India has crossed the anticipated investment of worth US$ 21.58 Bn between April 2000 to September 2023.

The major government initiatives have been taken to promote the Indian Pharmaceutical revolution worldwide which includes— Ayushman Bharat Digital Mission (ABDM), Scheme for Development Of Pharma Industry, Strengthening Of Pharmaceutical Industry (SPI) and PLI scheme for bulk drugs and pharmaceuticals manufacturings.

To join this exciting journey along with the pharmaceutical sector, applicants are required to register under the Foreign Investment Facilitation Portal (FIFP). The procedure can be puzzling for any newcomer applicant since it incorporates several terms and conditions without rendering direct access to portals that can generate approvals for FDI.

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Objectives Of FDI In Pharmaceuticals Sectors

The objectives of FDI in pharmaceuticals sectors are as follows:

  • To boost inward medical tourism within geographical boundaries to generate forex revenues
  • To enhance technological expertise in the medical sector by transferring professional expertise to local medical experts.
  • To improve healthcare products access to poor section of society
  • To improve quality in medical infrastructure in both domestic as well as international level.
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Components Permitted Under FDI In Pharmaceuticals Sectors

100% FDI is allowed in pharmaceuticals sector under automatic route for Green field pharmaceuticals

While 100% FDI is allowed in the pharmaceutical sector in brownfield projects. Where 74% is allowed under automatic route and beyond 74% required government route.

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Documents Required For FDI In Pharmaceuticals Sector

Many documents are required for FDI in pharmaceuticals sector which are as follows:

  • List of names, addresses, and identification proof of all foreign collaborators of the investor company/entity
  • From both investor/investee entities- Certification of Incorporation and MoA
  • Copy of joint venture agreement/ shareholders agreement/technology
  • Copy of downstream intimation
  • Copy of relevant past FIPB/SIA/RBI joint with the current proposal
  • Copy of Downstream Intimation
  • An affidavit to ensure all documents are relevant
  • Valuation certification approved by a certified chartered accountant
  • CS Certificate
  • Declaration by the Authorized Representative of the Indian Company/LLP
  • Pre and post-shareholding pattern in the Indian company
  • Copy of the order of the High Court on the scheme of merger/ demerger/ amalgamation (if applicable)
  • RBI approval on the amount of refund concerning the amount of the issue (if applicable)
  • Valuation certificate
  • Approval letter (if non-compliant with the guidelines – if applicable)
  • Relevant RBI approvals for an issue of equity shares against funds payable to the foreign investor
  • FIRC/ Debit statement
  • Know Your Customer (KYC)
Documents Required For FDI In Pharmaceuticals Sector
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Procedure Of FDI Approval (Government)

Following are the procedures which required at the time of FDI in the pharmaceuticals sector:

Step 1: FILLING APPLICATION FORM ONLINE

Applicants must fill out the online application form along with the relevant documents for making out the proposal for Foreign Direct Investment

Step 2: SENDING APPLICATION TO POTENTIAL AUTHORITY

Filing the proposal for FDI online within two working days, DIPP then will address the concerned administrative ministry to transfer the proposal of applicants electronically

Step 3: SUBMIT REQUISITE PHYSICAL DOCUMENTS

Collect all the requisite documents for continuing the process of the investment proposal. In case documents may be found incorrect, applicants will be held responsible in case of any deviation found.

Step 4: PROCESSING AND APPROVAL

The DIPP along with potential authorities will process the application internally and recognize various ministries for adding several comments such as the Ministry of Home Affairs, Reserve Bank of India, Ministry of External Affairs, Ministry Of Finances, etc.

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What Are The Conditions For Procedure Of FDI Approval?

There are conditions tapping for the procedure of FDI approval which must be understood by investors.

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Key Advantages For Investors In India

The key advantages for investors in pharmaceuticals sector under FDI is as follows:

  1. Cost efficiency - India is currently the greatest supplier of medicines in the world with cheap costs of production (30-35% lower than US and Europe), cost efficient R&D (87% less than developed markets) cost and better quality, Indian medicines are preferred worldwide and therefore called ‘Pharmacy Of The World’. India is the largest supplier of cheap vaccines in the world with an efficient output in medications.
  2. Economic drivers - Tata Memorial Centre of India and Vietnam National Cancer Hospital entered into an agreement on December 21, 2020, to foster partnership in the fields of training and scientific research, health care services, and cancer patient diagnosis and treatment. The market size of the Indian Pharma Industry is expected to reach US$ 130 billion by 2030.
  3. Increasing investment - Between April 2000 and September 2023, the drugs and pharmaceuticals industry received a total of US$ 21.46 58 billion in foreign direct investment (FDI) equity inflow. This represents around 3.3% of all FDI inflows received across all sectors. In the US and EU, Indian pharmaceutical businesses hold a sizable portion of the pharmaceuticals market. India has the most FDA-approved plants outside the United States.
  4. Policy Support - To improve sustainability, productivity and quality in small-medium healthcare enterprises in the country, the Ministry’s scheme ‘Strengthening Of Pharmaceutical Industry’ outlines a total finance of US$ 60.9 Mn. Moreover, the government of India has set a target to cross over 10,500 centers of Pradhan Mantri Bhartiya Jan Aushadhi Yojana by 2025. The product which is being derived from this scheme includes–240 surgical instruments and 1,450 drugs.
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Benefits Of FDI In Pharmaceuticals Sector

Following are the benefits which are derived from pharmacy sector under FDI:

  1. Healthcare diversification options - Establish the restorative approach towards pharmaceuticals units in building the better formulation of manifolds of Indian medications therapies, practices, and products.
  2. Skill development and shaping capacity - FDI in the healthcare sector instills the elevation of skills by ensuring pharmacy training and development research. This stimulates attention in pharmaceuticals professionals sectors and research in the natural medications sector.
  3. Promoting global expansion - The marketing of traditional Indian approaches in the healthcare sector can promote product competition across global rivalry and create multiple phenomena for economic growth and employment opportunities for both local people and foreign investors.
  4. Advent of technology - The strengthened healthcare education can generate knowledge within the human force, and the possibility of venting up innovation along with technology footprints can also be adopted in order to boost the effectiveness of medical products and practices.
  5. Modernization and infrastructural development - Accessing high-quality medical products can directly affect the modernization input and shape infrastructural development in the country's quality control measures, healthcare institutions, and manufacturing segments.
Documents Required For FDI In Pharmaceuticals Sector
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Conclusions

FDI in the pharmaceutical sector in India is the going up sector worldwide offering a diverse range of products at lower cost rates. The medical facility and services have evolved continuously in India by not only benefiting the economy to generate higher employment and revenue creation but also serve new offerings to add lifespan in human lives to achieve more dreams true.

For making one’s lifespan long, and to reduce ineffective productivity in the economy, the nation should achieve its first and foremost milestone in the health of the citizen. There are various other schemes, reforms and initiatives which continuously monitor to enhance the performance of the medical startup revolution in India.

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Attention Investors

Several other factors to consider for investors while investing in medical industries are listed below:

  • Before involving huge investments, applicants must be prerequisites to check the kind of companies the government allows them to invest in. Because investment in the stock market is volatile and may not recover your loss, leading to unwriggled investment which will not recover at the time of redemption of company loss.
  • Additionally, before application applicants need to inspect and ensure that all the requisite documents are submitted online without discovering any omissions and incorrect information within the documents. FDI is largely inspired to bring investors forth along with certain advantages that benefit sectors.
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What Are The Eligibility Requirements For FDI In India?

Investors must also need to check eligibility criteria for buying investment in India in sectoral companies.

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Frequently Asked Questions

Is pharma sector good for investment?

Yes, the Pharma sector is good for investment as it offers lucrative forms of incentives to boost quality drugs evolution in the economy. It offers antibiotics, anti-inflammatory drugs, vaccines, painkillers, sanitary napkins, and dermatologist products.

What is Generic Medicine?

The generic medicine is the type of category which doesn’t belong to any brand and thus is an unbranded product. The benefits derived from generic medicine in terms of quality is as same as branded medicines. However, the only difference is the price which is lower than branded products.

What is Pradhan Mantri Bhartiya Janaushadhi Pariyojana?

Pradhan Mantri Bhartiya Janaushadhi Priyojana (PMBJP) is the initiative launched by the government of India to provide cheap medicines requirements among people, especially if they belong to poor segments of society so that the affordability can be improved among poor people.

How much pharma contribute to GDP?

According to the latest data estimation released by DPIIT, it contributed over 1.72% in GDP share and potential to generate revenue around US$42 Bn within the nation’s boundary.

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