PHARMA KNOWLEDGE

Did you know India was the first country to produce and approve biosimilar in 2000, years before the US and Europe established their formal regulatory frameworks?  While the UK established the world's first formal, dedicated regulatory pathway for biosimilars in 2003, India had already approved a recombinant Hepatitis B vaccine in 2000. This product successfully protected millions of people from disease and established the baseline for what has become a highly respected, multi-billion dollar global manufacturing powerhouse.

If you are wondering what a ‘Biosimilar product’ is we first need to know about ‘biologic drugs’.  Unlike conventional medicines that are made through chemical processes, biologics are produced using living cells and are often used to treat complex diseases such as cancer, diabetes, autoimmune disorders, and chronic kidney diseases. A biosimilar is a medicine that is highly similar to an existing biologic medicine that has already been approved and used successfully by patients.Once the patent of an original biologic expires, other manufacturers can develop biosimilars that offer the same safety, quality, and effectiveness at a lower cost. This is  transforming healthcare across the world by reducing treatment costs and increasing access to life-saving medicines. As a result, more patients can benefit from advanced therapies for chronic conditions and complex diseases. The growing acceptance of biosimilars by regulators and healthcare providers worldwide has further strengthened their role in modern medicine.

Presently India has emerged as one of the leading manufacturers of biosimilars globally.One of the biggest stepstone was the expiry of patents for several major biologic medicines after 2020 which created significant opportunities for Indian pharmaceutical and biotechnology companies to develop biosimilars for both domestic and international markets. Moreover positive factors like a skilled workforce, cost-effective manufacturing, and government initiatives, Indian companies have expanded their presence in this rapidly growing sector. India also ranks 2nd Globally for  the total number of people living with certain major chronic non-communicable diseases (NCDs, which leads to rising demand for affordable biologic treatments. The Indian pharmaceutical industry currently supplies more than 60% of the world’s vaccines and accounts for over 20% of global pharmaceutical exports by volume, highlighting its significant role in global healthcare.

The future of biosimilars in India looks highly promising. Between 2025 and 2032, around 39 high-value biologic medicines are expected to lose patent protection, creating fresh opportunities for biosimilar manufacturers. Several of these biologics generate billions of dollars in annual global sales, making them attractive targets for biosimilar development.  Indian companies are investing heavily in research and development, expanding manufacturing facilities, and building stronger global partnerships to capitalize on this opportunity. At the same time, government initiatives such as the Production Linked Incentive (PLI) Scheme and supportive biotechnology policies are encouraging investment in research, development, and large-scale manufacturing.

From pioneering one of the world’s earliest biosimilars to becoming a major global supplier of affordable biologic medicines, India has come a long way and is well positioned to become a leading global hub for high-quality biosimilars, contributing significantly to the future of healthcare worldwide.

In order for any medicine to be effective it must go through a complex manufacturing process that ensures product safety and quality. And this is where Good Manufacturing Practices play a critical role. Commonly known as Gmp, they are a system of guidelines designed to ensure that products across all industries are consistently manufactured according to established quality standards. For the pharmaceutical industry, it serves as the foundation for quality assurance, helping manufacturers produce medicines that are safe, effective, and of the required quality every time.

GMP works on a simple principle. Instead of relying solely on testing the final product, it incorporates quality checks and regulations into every stage of production. While product testing is an essential part, it alone cannot detect every issue that may have occurred during manufacturing. GMP aims to prevent these problems from occurring through strict controls throughout the production process..

Risk prevention is another major goal of GMP.  Pharmaceutical manufacturing involves multiple steps, beginning from sourcing raw materials to packaging finished products. At each stage, there is potential for contamination, cross-contamination, mix-ups, or human error. GMP establishes procedures and controls that help minimize these risks and ensure that products meet the required standards of safety and quality.

One of the major benefits following GMP is maintaining consistency . Patients and healthcare providers expect every batch of a medicine to perform the same way. GMP helps ensure that products manufactured today are identical in quality to those produced months or even years later. This consistency is essential for maintaining patient safety and ensuring confidence in healthcare products.

In a pharmaceutical manufacturing unit GMP measures include clean, well maintained and  regularly calibrated facilities and equipment to ensure reliable performance. Employees must receive appropriate training and follow strict hygiene practices to prevent contamination and errors. Comprehensive documentation is required at every stage of production, creating a clear record that supports traceability, accountability, and quality control. In addition, raw materials must be carefully sourced, tested, handled, and stored to ensure they meet established specifications before entering the manufacturing process.

The World Health Organization (WHO) GMP framework is the most recognized standard , which provides internationally accepted guidelines for pharmaceutical manufacturing and quality assurance. The European Union (EU) GMP standards are also regarded as some of the most stringent regulatory requirements globally, focusing on comprehensive quality systems, risk management, and product integrity throughout the manufacturing lifecycle. Similarly, United States GMP regulations, enforced by the U.S. Food and Drug Administration (FDA), establish strict requirements for facilities, processes, documentation, and quality control to ensure pharmaceutical products consistently meet safety and efficacy expectations. Compliance with these internationally recognized GMP standards reflects manufacturer’s commitment to quality, patient safety, and continuous improvement. As products meet the expectations of regulatory authorities worldwide it helps facilitate access to global markets.

GMP is widely referred to as 'cGMP', where c represents 'current'. This emphasizes that manufacturing practices must keep evolving with the development of technology and highlights the need for manufacturers to continuously update their processes and methods to meet evolving quality standards. This approach helps ensure that manufacturing practices keep pace with scientific advancements and regulatory expectations. In an industry where quality directly impacts human health, GMP remains one of the most important pillars of pharmaceutical manufacturing. It is much more than a regulatory requirement, it is a commitment to quality which helps ensure that every product reaching patients meets the highest standards of safety, efficacy, and reliability.