How to Find a WHO GMP Certified Pharmaceutical Company in India

India's pharmaceutical industry, often dubbed the "Pharmacy of the World," plays a pivotal role in global healthcare. As the demand for high-quality medicines continues to rise, ensuring that pharmaceutical companies adhere to stringent manufacturing standards becomes paramount. One such benchmark is the World Health Organization's Good Manufacturing Practices (WHO GMP) certification. This guide delves into the importance of WHO GMP certification and provides actionable steps to identify certified pharmaceutical companies in India in 2025.

Understanding WHO GMP Certification

What is WHO GMP?

WHO GMP refers to the World Health Organization's guidelines that ensure pharmaceutical products are consistently produced and controlled according to quality standards. These practices cover all aspects of production, from raw materials to hygiene, equipment, and staff training.

Why is WHO GMP Certification Important?

• Quality Assurance: Ensures products are manufactured consistently with high quality.

• Global Acceptance: Facilitates international trade and acceptance of pharmaceutical products.

• Patient Safety: Minimizes risks involved in pharmaceutical production that cannot be eliminated through testing the final product.

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Steps to Identify WHO GMP Certified Pharmaceutical Companies in India

1. Consult Official Government Resources

   The Central Drugs Standard Control Organization (CDSCO) maintains an updated list of WHO GMP certified manufacturing units. Accessing their official website provides a reliable starting point for verification.

2. Review Company Documentation

   Legitimate pharmaceutical companies often display their certifications on their official websites. Look for:

   • WHO GMP certificates

   • Certificate of Pharmaceutical Product (CoPP)

   • ISO certifications

These documents attest to a company's compliance with international manufacturing standards.

3. Assess Manufacturing Facilities

   A WHO GMP-certified pharma company should have state-of-the-art manufacturing facilities. Key aspects to consider include

   • Cleanroom environments

   • Advanced machinery and equipment

   • Trained and qualified personnel

   • Robust quality control and assurance systems

4. Evaluate Product Portfolio

   Companies with a diverse and extensive product range often indicate robust manufacturing capabilities. Assess the variety of dosage forms they produce, such as tablets, capsules, injectables, and syrups.

5. Check for Regulatory Approvals

   Beyond WHO GMP, companies may also possess certifications from other regulatory bodies like:

   • US FDA (United States Food and Drug Administration)

   • EU GMP (European Union Good Manufacturing Practice)

   • TGA (Therapeutic Goods Administration, Australia)

Such approvals further validate a company's commitment to quality.

6. Seek Client Testimonials and Reviews

   Feedback from clients and partners can provide insights into a company's reliability, product quality, and adherence to delivery timelines.

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Notable WHO GMP Certified Pharmaceutical Companies in India (2025)

1. Vaxova Drugs

   Recognized for its commitment to healthcare excellence, Vaxova Drugs is WHO GMP-certified facilities and a robust R&D division. The company specializes in manufacturing a wide range of pharmaceutical formulations, including tablets, capsules, injections, syrups, and ointments.

2. Watran Pharmaceuticals

   With a focus on innovation, Watran offers a diverse portfolio of over 2,600 brands across various therapeutic segments. Their WHO GMP-certified facilities ensure the production of high-quality medicines and healthcare products.

3. Lincoln Pharmaceuticals

   Established in 1979, Lincoln Pharmaceuticals operates WHO GMP certified manufacturing facilities in Gujarat. The company produces a wide range of pharmaceutical formulations and has a significant presence in both domestic and international markets.

4. Akums Drugs and Pharmaceuticals

   As one of India's leading contract manufacturing pharmaceutical companies, Akums holds WHO GMP certifications and has multiple manufacturing units across the country. Their facilities are equipped to produce various dosage forms, ensuring compliance with global quality standards.

Recent Regulatory Developments in India

In December 2023, India's Union Ministry of Health and Family Welfare introduced revised Schedule M guidelines, enhancing Good Manufacturing Practices (GMP) for pharmaceutical manufacturers. These updates aim to improve manufacturing quality, safety, and regulatory compliance across the sector. Notably:

• Extended Compliance Deadlines: Small and medium-sized pharmaceutical companies with an annual turnover of less than INR 2.5 billion have been granted an extension until December 31, 2025, to comply with the revised standards.

• Enhanced Quality Standards: The revised guidelines encompass critical principles such as Pharmaceutical Quality System (PQS), Quality Risk Management (QRM), sanitation and hygiene, qualification and validation, complaints and adverse reactions, product recalls, and change control.

These regulatory changes underscore the Indian government's commitment to aligning its pharmaceutical manufacturing practices with international standards.

Conclusion

Identifying WHO GMP-certified pharmaceutical companies in India requires diligent research and verification. By consulting official resources, reviewing company documentation, assessing manufacturing facilities, and staying informed about regulatory developments, stakeholders can ensure they partner with companies that prioritize quality and compliance. As India's pharmaceutical landscape continues to evolve, adherence to WHO GMP standards remains a cornerstone of global trust and excellence in healthcare.