How Indian CDMOs Comply with USFDA, EU-GMP, and WHO-GMP Standards

Introduction: The Shifting Landscape of Global Pharma Outsourcing

The world drug market is in a significant change. With the reduction in innovation periods and the rise in regulatory complexity, the Contract Development and Manufacturing Organizations (CDMOs) are becoming more popular in the global pharma as a way to speed up drug development and commercialization.

Frost and Sullivan, as well as Evaluate Pharma estimate that the total amount of outsourcing in pharma R&D and manufacturing will reach more than 250 billion dollars by 2030 due to the increasing demand of affordable, high, and compliant drug production.

In this ever-changing environment, India has become a strategic CDMO powerhouse, which provides the combination of low cost, compliance with regulations, and high-technology. Indian CDMOs are assisting MNCs in pharma markets to launch innovative products into the global markets at a faster and more efficient rate due to the quality infrastructure, talent, and internationally accepted facilities.

Knowing the CDMO Services and their place in the Pharma Value Chain

A CDMO (Contract Development and Manufacturing Organization) offers services on the whole pharmaceutical process - drug discovery, drug formulation and production of clinical trial material to large-scale commercial production.

In the past, most companies used CMOs (Contract Manufacturing Organisation) as the sole source of production. Things have however evolved; the current model of integrated CDMO is in a position to cover the lifecycle of products - not just manufacturing, but also R&D, regulatory documentation, and quality control.

In the case of global pharma companies, the CDMOs present three main benefits:

• Speed to market: Quickening the development cycles with targeted expertise.
• Scalability: Smooth movement between small-scale and production (commercial scale).
• Flexibility: Customized engagement models to streamline the costs and to control the risks.

The Indian Emergence as an International CDMO

The transformation of India into a complete CDMO destination has been impressive considering that it was the pharmacy of this world in terms of generics. Historically as a source of low-cost generic drugs and APIs, India has now evolved into full service CDMO capacity in regard to complex formulations, biologics and specialty products.

Good Regulatory compliance and International Certifications

Another characteristic of the major Indian CDMOs is that they have been found to be very strict in meeting the international regulatory standards.

Most of the Indian facilities pass the major international accreditation agencies, including:

• United States Food and Drug Administration (USFDA)
• EMA (European Medicines Agency)
• MHRA (Medicines and Healthcare products Regulatory Agency (UK))
• Australia Therapeutic Goods Administration (TGA)
• WHO-GMP (Good manufacture practices by World Health Organization)

The certifications are used to provide data integrity, product integrity and patient safety.

Indian CDMOs are subject to regular international inspections and traceability and validation of Indian CDMOs are in form of electronic documentation systems (21 CFR Part 11 compliant).

Example:

Other companies such as Syngene International, Jubilant Biosys and Dr. Reddy Custom Pharma Services have also entered into long term partnerships with Big Pharma players such as Pfizer, Novartis and GSK proving that India is also reliable in controlled markets.

Global Quality Infrastructure and technology

Indian CDMO are fast applying modern technologies and infrastructure:

• Biologics and Biosimilars: Modules of producing monoclonal antibodies, recombinant proteins, and gene therapies.
• Advanced Formulations: Injectable, inhalers and controlled release formulations capabilities.
• Digital Manufacturing: AI, process analytical technology (PAT), and IoT-based monitoring of quality control.

Strong Academic knowledge and Experienced Human Resource

• India possesses one of the biggest stocks of drug scientists and biotechnologists, approximated to be over 300,000.
• Good educational-industrial associations (with universities such as NIPER, IITs, and BITS Pilani) guarantee a constant flow of skilled labour in R&D and regulatory processes.
• This allows Indian CDMOs to deal with complicated chemistry and new drug delivery systems (NDDS) and therapeutics that are based on biotech effectively.

Major reasons Why Global Pharma Companies choose India to take CDMO Services

1. Affordability and Quality Excellence

Indian CDMOs have up to 40-60 percent cheaper cost of R&D and production than that of the US and European plants without quality compromise.

This advantage arises from:

• Reduced operations and labour costs.
• Effective exploitation of a large skilled science workforce.
• Economy of scale in bulk production of API.

Consequently, international drug companies are able to realize a quicker product development cycle as well as release periods on far less budget.

2. Within a supply chain, speed, scalability, and resilience are essential components and the primary focus of this paper

• The Indian CDMOs are renowned due to the high turnaround time and the capability to manufacture at high rate of growth.
• India demonstrated the resilience of its supply chains during the COVID-19 pandemic, with many global facilities being closed, where CDMOs guaranteed oil supplies without disruptions to its API and vaccines.
• Powerful logistics channels and strategic sourcing of APIs also enable assured massive distribution on a global level.

3. End-to-End Capabilities and Flexibility of Partnerships.

Indian CDMOs have full flexibility of engagement models:

• Fee-for-Service (FFS) of certain phases such as formulation or tests.
• Development-based milestone-based partnerships.
• End to end lifecycle management strategic alliances - pre-clinical R&D to commercial production.

Example:

Gland Pharma (India) has collaborated with multinational firms in sterile injections.

Biocon Biologics has partnered with Mylan in the production of biosimilars, which operates in regulated circumstances of the market.

4. Policy Support

The schemes of the Production Linked Incentive (PLI) Scheme, Make in India, and Atmanirbhar Bharat, introduced by the government, have further enhanced the ecosystem of the CDMO in India, which is the promotion of investment in R&D, innovation, and regulatory compliance.

5. The role of India in Globe Pharma Supply Chain

India is the source of more than 20% of generic medicines and 60% of total vaccine demand in the world.

• It does have over 600 USFDA-approved manufacturing facilities, the largest outside the USA.
• According to IBEF (India Brand Equity Foundation), the pharmaceutical export value in India reached more than 200 countries with the value exceeding 25 billion in FY2024.

Key Pharma Clusters:

• Hyderabad: Target APIs and biologics.
• Ahmedabad: Has units of formulation as well as export.
• Bengaluru: Contract development and R&D centre.
• Pune: New specialty pharma production hub.

Pitfalls and the Way Forward

Although developed, the CDMO sector in India has the following challenges:

• Reliance on imported raw materials (particularly of China) on some of its major intermediates.
• Desire to be more forceful in the IP to encourage innovation across the world.
• Logistics and cold-chain management infrastructure bottlenecks.
• Response of Government and Industry.
• Diversification in API parks to end import dependence.
• Improved Patent and IP frameworks by the National IPR Policy.
• Green manufacturing and sustainable supply chain incentive.

Future Trends

• Increasing interest in biologics and biosimilars CDMOs.
• Implementation of the continuous manufacturing and digital twins to streamline the processes.
• More co-operation in gene therapy and cell-based therapies.
• Specialist Knowledge and Idea Leadership.

"Indian CDMOs have changed into cost-driven vendors to quality-driven innovation partners. India is an inseparable component of the global pharma ecosystem as their capability to provide global-scale solutions with strict regulatory standards."

-- Kiran Mazumdar-Shaw Executive NP, Biocon Group.

As per McKinsey India Pharma 2030 Report, the Indian CDMO market is projected to be 25-30 billion by 2030, with the help of exports, innovation and manufacturing biologics abilities.

Conclusion- of the Strategic Edge of India in the Global CDMO Landscape

The fact that India is now being transformed into a low-cost manufacturing base, and strategically according to CDMO innovation partner highlights its increasing significance in the global pharma supply chain.

India is not only matching the standards of the world, but even exceeding them, with its combination of cost effectiveness, compliance superiority and scientific rigor and technological prowess.

With the world constantly in search of agile, compliant and scalable partners in the development of drugs, India is a reliable global CDMO destination.