India’s pharmaceutical industry is poised for significant growth, with projections estimating its market value to reach $130 billion by 2030. The country has earned the title of the “pharmacy of the world,” largely due to its substantial production of generic drugs and vaccines. The industry boasts over 2,000 production units that meet World Health Organization Good Manufacturing Practices (WHO-GMP) standards, reflecting an increasing emphasis on quality in pharmaceutical manufacturing. As compliance with Good Manufacturing Practices (GMP) has become essential for companies, especially those aspiring to enter international markets, the intricacies of GMP adherence can present challenges. To address these complexities, specialized GMP services in India play a critical role by ensuring regulatory compliance, optimizing operational processes, mitigating risks, and enhancing overall efficiency for pharmaceutical companies navigating the global market landscape.

In this blog, we will provide an overview of the GMP services active in India, their involvement in compliance, industry-specific solutions, how to select the right provider, and the practical benefits. Whether you are a start-up scaling up or a well-established organization expanding your exports, understanding the GMP service landscape in India is vital for your growth in 2025 and beyond.

 Types of GMP Services: Building a Strong Foundation

GMP services cover a wide range of services that support pharmaceutical companies in their commitment to maintaining the highest quality standards from raw materials to final packaging. In India, these services are provided as comprehensive packages to address sector-specific challenges such as rapid scaling and the pressure to reduce costs. Here is a summary of the primary types of services available:

• GMP Audits and Inspections: These are third-party assessments to ensure compliance with local standards, specifically Schedule M (the GMP framework in India) or WHO-GMP. Audits will note non-conformance to regulatory standards related to processes, facilities, or documentation to avoid costly consequences if an investigation finds a shut-down occurred. For instance, Zenovel, specializes in delivering GMP audits for the pharmaceutical and biologics sectors, ensuring preparedness and readiness for regulatory inspection
• Staff training and capacity building: Practical  training on GMP principles, hygiene, and quality control for staff. As the workforce grows in India, Zenovel can help to prepare GMP training modules to facilitate a culture of compliance and reduce human error during
• Documentation and quality management systems (QMS): Create Standard Operating Procedures (SOPs), batch records, and risk assessments. This includes implementation of digital QMS to manage deviations and ensure traceability for audits.
• Validation and Qualification: At Zenovel, we have process validation, equipment qualification, and cleaning validation to demonstrate the systems to make safe products repeatedly. These aspects are essential to sterile manufacturing and biologics since it only takes a matter of time for a small lapse to lead to a recall.

Most of these services are bundled together to allow companies to supplement their in-house knowledge while giving them the opportunity to concentrate on their core R&D.

Regulatory Compliance Support: Navigate Indian and Global Standards

The Indian pharma industry is faced with the requirement to meet both regulations from Central Drugs Standard Control Organization (CDSCO) for the India market, and compliance with various international standards e.g. US FDA, EMA, and WHO-GMP, and failure to comply can lead, but is not limited to, export bans, or product recalls. We have witnessed recent MSME companies being forced to shut down due to GMP non-compliance issues.  Our GMP services can help level the playing field within expectations for providing expertise.

Consultants or Service provide are able to assist in aligning with Schedule M (for drugs) and Schedule M-III (for medical devices), while preparing for WHO inspections. For international exports Zenovel also offer services like mock audits, gap analyses, and other required GMP audits services on request.

In 2025 with tighter regulations coming into effect (eg: enhanced risk-based inspections), these service ensure compliance, reducing downtime, and accelerating entry to market. For instance, Zenovel Consultants provides end-to-end support for EU-GMP and US FDA alignment to support firms like generics to avoid trouble.

 Industry Specific Solutions: Customize For Your Niche

Generics need ease for high-volume efficiency while biologics need sterile process to precision. Indian GMP providers have tailored solutions for suitable fit. Generics and APIs: Focus on cost-effective audits and validation for high-throughput production. Top generic players benefit from services optimizing supply chains for Schedule M compliance.

• Biologics and Vaccines: Specialized validation for cleanrooms and biosafety for intensified fed-batch processes yielding >25 g/L titers. This needs EU-GMP tailored solutions for contract manufacturing in the spaces.
• Third-Party Manufacturing: Full QMS setup and training, as provided by WHO-GMP certified units required for contract firms.
• Medical Devices: In this section, in line with Schedule M-III is essential that involves risk management for implants and diagnostics.

These on request customized solutions assure sector-particular risks such as contamination in injectable can be actively managed while enhancing scalability

Choosing the Right Service Provider: A Complete Guide

With hundreds of consultants in India, selecting the right one is crucial. Look for providers with proven track records in your niche. Here’s how:

• Verify Credentials: Ensure ISO certifications, WHO/EMA audit experience, and client testimonials
• Assess Scope and Customization: Opt for firms offering end-to-end services that offer GMP audits for diverse clients
• Evaluate Cost vs. Value: Initial audits might cost ₹5-10 lakhs. Compare quotes from top players before making budget for audit
• Check References and Scalability: Review case studies (e.g., EU-GMP compliance for exporters) and ensure they can scale with your growth.
• Location and Accessibility: Providers in hubs like Mumbai, Hyderabad, or Ahmedabad offer on-site support.

Advantages of GMP Services

The role of investment in GMP services is not only about meeting a requirement but providing a sustainable strategic advantage. A few of the advantages are:

• Quality and Safety Assurance of Products: Manufacturers can implement strict validation protocols to reduce chances of contamination, and ensure the product’s consistency in efficacy; thus helping to gain trust with regulators and your end-users.
• Access to Global Market: WHO-GMP certification will allow your organization to enter into exports of manufacturers products, which will become critical as India’s pharma exports reach the market as India’s exports are projected to be $25 billion in 2024. WHO-GMP certification provides assurance of safety, increasing the acceptance of the product in the US, EU & abroad.
• Operational Management: On quality basics, GMP will allow the manufacturer to improve processes, increase efficiencies, and reduce waste and downtime, improving sales margin in a competitive market.
• Mitigate Risks and reduce costs: Prevailing proactivity during audits will reduce the chances of a recall or a facility closure, as GMP non-conformance led to facility closures of MSMEs. The long-term costs savings reduce liability exposure while enhancing competitiveness.
• Innovate & Sustainable Practices: GMP support modern standards, having green practices that align with India’s vision for pharma for 2047.

In essence, GMP experts in India transform compliance from a burden to a business accelerator.

As India’s pharmaceutical sector advances toward a projected value of $130 billion by 2030, investing in reliable GMP services will be essential for ensuring long-term compliance, innovation, and sustainable growth. Partnering with trusted GMP experts today can empower companies to achieve operational excellence and secure a competitive edge in the global market.