Pharmaceutical Plant Setup

In India, the pharmaceutical industry is one of the fastest growing sectors and is known for producing affordable generic drugs. Setting up a pharmaceutical plant in India is an important undertaking that contributes to the growth of the healthcare sector and the economy. The growing demand for pharmaceutical products, especially in the export market, has made it an attractive option for investors and entrepreneurs. India is recognized as the “pharmacy of the world” due to its strong pharmaceutical manufacturing capabilities. 

A pharmaceutical plant is a facility designed to manufacture pharmaceutical products, including drugs, vaccines, and other healthcare items. The plant must be equipped with production areas, equipment, quality control laboratories, storage and packaging units that were designed to meet regulatory standards for safety, efficiency, and product quality. The plant must meet the regulatory guidelines laid down by the Drug Controller General of India (DCGI) and follow good manufacturing practices (GMP). The primary functions of a pharmaceutical plant include raw material procurement, processing, packaging, quality control, and distribution. These facilities can range from small plants to large operations.

Who Can Start a Pharmaceutical Product Plant in India?

In India, anyone with the necessary qualifications, financial resources, and business acumen can start a pharmaceutical plant. This includes entrepreneurs, established businesses in other sectors, and people with a background in pharmaceuticals. However, specific expertise in chemistry, biology, or pharmacology is beneficial when planting. Additionally, individuals or organizations interested in setting up a pharmaceutical manufacturing plant should have a clear understanding of the technical, regulatory, and operational aspects of the industry. Knowledge of essential machinery, quality control procedures, and manufacturing protocols is required.

Setting up a pharmaceutical plant in India offers several benefits, both from a business and healthcare perspective:

• High demand for pharmaceuticals: India’s pharmaceutical market is the largest in the world. There is a continuous demand for generic drugs, which presents a significant opportunity for plant owners.
• Export opportunities: India is a major exporter of pharmaceuticals products, especially generics. The establishment of a pharmaceutical plant can help in entering the global market.
• Government support: The Government of India provides incentives and subsidies for setting up pharmaceutical plants, including tax benefits and funding options for specific projects.
• Technological advancements: With a growing focus on innovation in healthcare, pharmaceutical plants offer the opportunity to integrate advanced technologies, improving manufacturing processes and product quality.
• Favorable business environment: India’s pharmaceutical industry has favorable policies, making it an attractive destination for investment in the pharmaceutical manufacturing sector.

The machinery and equipment used in pharmaceutical plants are essential for the production of high-quality pharmaceuticals. The specific types of machinery depend on the type of pharmaceutical product being manufactured, but some common pieces of equipment used in pharmaceutical plants include:

• Mixers and blenders: These are used to mix ingredients to make tablets, capsules, or powders. Proper mixing ensures the consistency of the final product.
• Granulators: Used to make granulates from powdered materials, granulators help ensure uniformity of dosage of tablets and capsules.
• Filling Machines: These machines used in the production of liquid pharmaceuticals are responsible for filling bottles, vials, or syringes with liquid pharmaceuticals.
• Packaging machines: Packaging machines are used to package finished products, ensuring their safety, integrity, and compliance with industry standards.
• Autoclaves: These are used for sterilization in the pharmaceutical plant, to ensure that equipment and products are free from microbial contamination.
• Sterile filling equipment: For injectable and sterile drugs, special filling equipment is used to maintain aseptic conditions.
• Quality control equipment: Instruments such as spectrophotometers, chromatographs, and microscopes are used to check and analyze raw materials and final products.
• Labelling machines: These machines ensure proper labelling of pharmaceutical products with compliance with regulatory standards.

To set up a pharmaceutical plant in India, certain eligibility criteria must be met. Some key metrics include:

• Legal structure: The entity should be a registered company, partnership or sole proprietorship under Indian law. Foreign companies can also set up plants, but they have to follow foreign direct investment (FDI) guidelines.
• Technical expertise: The plant must be managed by qualified professionals, such as pharmacists, chemists, and engineers, who have experience in the pharmaceutical manufacturing sector.
• Financial capacity: Setting up a pharmaceutical plant requires a large investment and the entrepreneur or company must have the financial resources to cover the cost of infrastructure, machinery, and operational expenses.
• Compliance with regulations: The plant must comply with regulatory standards such as GMP and the Drug and Cosmetic Act, which ensure the safety and quality of drugs.
• Location: The plant should be located in an area that meets the environmental and safety standards set by the regulatory authorities.

Some documents and licenses are required to set up a pharmaceutical plant in India:

• Land Ownership or Lease Agreement
• Environmental Clearance Certificate
• NOC (No Objection Certificate) from the Pollution Control Board
• Factory License
• Fire NOC
• Hazardous Waste Management Certificate
• Labour Registration Certificate
• GST Registration

The process of setting up a pharmaceutical plant involves several steps:

• Plan and feasibility study: Conduct a comprehensive feasibility study to assess the market demand, cost and potential returns from the pharmaceutical plant. This includes analyzing financial, technical, and operational aspects to ensure long-term profitability.
• Securing land and infrastructure: Find an appropriate location for the plant by considering factors such as proximity to suppliers, transportation facilities, and labour availability. Ensure the site meets regulatory requirements and has the necessary infrastructure for construction, utilities, and waste management.
• Obtaining licenses and clearances: Obtain necessary legal permits, including pharmaceutical manufacturing licenses, environmental clearances, and fire safety clearances. This step ensures that the plant complies with local regulations and international standards for manufacturing and safety.
• Installation of machinery and equipment: Purchase and install all necessary machinery for the production, testing, and packaging of pharmaceutical products. This includes formulation, mixing, compression, quality control, and packaging equipment to meet regulatory and quality standards.
• Hiring and training employees: Recruit skilled employees for various tasks such as production, quality control, maintenance, and packaging. Provide comprehensive training on manufacturing processes, quality assurance, safety protocols, and compliance with Good Manufacturing Practices (GMP) to ensure product quality and regulatory compliance.

The cost of setting up a pharmaceutical plant in India depends on several key factors. Plant size is an important consideration, as larger facilities require larger investments in infrastructure and machinery. Location also plays an important role, with urban areas generally more expensive for land and construction than rural areas. The type of machinery and equipment needed varies depending on the scale of production and the level of automation, which further affects the cost. Labour costs, including hiring skilled workers, also contribute to overall expenses. In addition, obtaining the necessary licenses and meeting regulatory compliance standards increases the financial burden. All of these elements combine to create a diverse range of costs, making setting up a pharmaceutical plant a complex and expensive undertaking.

Corpseed is a top consulting firm, offering comprehensive assistance in setting up plants, and guiding businesses through the necessary processes. With years of expertise, we provide comprehensive, end-to-end support, guiding businesses through every stage of setting up and operating a pharmaceutical manufacturing unit. Our team ensures a seamless and efficient process from start to finish with a strong focus on quality and compliance.

• Land analysis and acquisition: Choosing the right location for a pharmaceutical plant is very important. Corpseed helps identify optimal land based on proximity to suppliers, utilities, transportation, and compliance with local laws and regulations, ensuring operational efficiency.
• Regulatory approvals and licenses: Pharmaceutical plants require several regulatory approvals. We assist in obtaining all necessary licenses and approvals from regulatory bodies, including GMP certification, to ensure the plant meets stringent industry standards.
• Financing and subsidies: Setting up a pharmaceutical plant can be capital-intensive. Corpseed helps secure the loans, grants and government subsidies available for industrial projects, ensuring businesses have access to the best financial terms to support their investments.
• Machinery selection: Choosing the right machinery is crucial for high-quality production. We provide expert guidance on cost-effective, durable and specialized equipment suitable for pharmaceutical manufacturing.
• Raw materials sourcing: Ensuring a steady supply of quality raw materials is key to uninterrupted production. We help establish reliable sourcing channels for active pharmaceutical ingredients (APIs) and excipients.
• Utility installation and labour: Corpseed supports businesses in installing utilities such as water, electricity and waste management systems and helps hire the skilled labour needed for plant operations.
• End-to-end services: From site selection to regulatory compliance, financing, machinery installation, raw material sourcing, and labour management, we provide end-to-end solutions for pharmaceutical plant setup.