Introduction
India’s pharmaceutical industry is a global leader, known for producing high-quality, affordable medicines. One of the key certifications that enhance credibility and global acceptance is the World Health Organization-Good Manufacturing Practices (WHO-GMP) certification. This certification ensures that pharmaceutical products are manufactured and controlled according to international quality standards.
If you are looking for WHO-GMP certified pharma companies in India, this blog provides a detailed guide on their significance, benefits, and a list of top companies with this certification.
What is WHO-GMP Certification?
WHO-GMP (Good Manufacturing Practices) is a system that ensures pharmaceutical products are consistently produced and controlled according to quality standards. It covers aspects such as hygiene, manufacturing processes, documentation, and quality assurance.
Importance of WHO-GMP Certification
- Ensures Quality Assurance – WHO-GMP compliance guarantees that medicines meet international safety and efficacy standards.
- Facilitates Global Market Access – WHO-GMP certified pharma companies can export to multiple countries.
- Enhances Business Reputation – Companies with this certification are trusted by doctors, healthcare organizations, and regulatory bodies.
- Prevents Contamination & Errors – Ensures that drugs are produced in controlled environments, reducing the risk of contamination.
- Regulatory Compliance – Helps companies meet strict national and international regulations, avoiding penalties and bans.
WHO-GMP Certified Pharma Companies in India
Below is a list of some of the top WHO-GMP certified pharma companies in India:
1. Sun Pharmaceutical Industries Ltd.
- Location: Mumbai, Maharashtra
- Specialization: Generic medicines, oncology drugs, dermatology
- Exports: Over 100 countries
2. Cipla Ltd.
- Location: Mumbai, Maharashtra
- Specialization: Respiratory, cardiovascular, anti-infectives, and oncology
- Global Reach: Strong presence in Africa, the USA, and Europe
3. Aurobindo Pharma Ltd.
- Location: Hyderabad, Telangana
- Specialization: Antibiotics, cardiovascular, CNS drugs
- WHO-GMP Certified Facilities: Yes, across multiple plants
4. Cadila Pharmaceuticals Ltd.
- Location: Ahmedabad, Gujarat
- Specialization: Biotechnology, oncology, vaccines
- Global Presence: 90+ countries
5. Intas Pharmaceuticals Ltd.
- Location: Ahmedabad, Gujarat
- Specialization: Neurology, nephrology, cardiology, rheumatology
- Regulatory Approvals: WHO-GMP, USFDA, MHRA (UK)
6. Dr. Reddy’s Laboratories Ltd.
- Location: Hyderabad, Telangana
- Specialization: Generic drugs, biosimilars, active pharmaceutical ingredients (APIs)
- Market Presence: Strong presence in the US, Europe, and emerging markets
7. Lupin Pharmaceuticals Ltd.
- Location: Mumbai, Maharashtra
- Specialization: Tuberculosis, cardiovascular, anti-diabetic, and respiratory drugs
- Certifications: WHO-GMP, USFDA, EMA
8. Glenmark Pharmaceuticals Ltd.
- Location: Mumbai, Maharashtra
- Specialization: Dermatology, respiratory, oncology
- Manufacturing Standards: WHO-GMP, USFDA, EU GMP
9. Alkem Laboratories Ltd.
- Location: Mumbai, Maharashtra
- Specialization: Anti-infectives, gastroenterology, pain management
- Export Reach: Over 50 countries
10. Biocon Ltd.
- Location: Bengaluru, Karnataka
- Specialization: Biosimilars, oncology, immunology
- WHO-GMP Approved: Yes, multiple facilities
How to Identify WHO-GMP Certified Pharma Companies?
To check if a pharmaceutical company is WHO-GMP certified, follow these steps:
- Visit the CDSCO Website (cdsco.gov.in) – The Central Drugs Standard Control Organization maintains a list of certified companies.
- Company Website & Certifications Section – Most reputable pharmaceutical companies display their certifications.
- Check WHO’s Official Database – The WHO website may have a list of globally recognized GMP-certified manufacturers.
- Request Certification Proof – If dealing with a supplier, always ask for a WHO-GMP certificate before making business decisions.
WHO-GMP Certification Process for Indian Pharma Companies
- Application Submission – Companies apply through the State Drug Control Authority or CDSCO.
- Facility Inspection – WHO and local regulatory bodies inspect manufacturing facilities.
- Compliance Check – Evaluation of hygiene, quality control, storage conditions, and documentation.
- Approval & Certification – Once all requirements are met, the company receives WHO-GMP certification.
- Regular Audits – Certified companies must undergo periodic inspections to maintain compliance.
Challenges Faced by Pharma Companies in Getting WHO-GMP Certification
- Strict Quality Control Requirements – Requires advanced infrastructure and skilled personnel.
- Lengthy Approval Process – It may take 6 to 12 months to complete the certification process.
- High Costs – Setting up a WHO-GMP compliant manufacturing unit can cost crores of rupees.
- Frequent Audits – Regular inspections mean companies must maintain compliance at all times.
Future of WHO-GMP Certified Pharma Companies in India
The demand for WHO-GMP certified pharmaceuticals is expected to grow due to:
- Increased Global Exports – More countries are recognizing India’s GMP-compliant pharma companies.
- Rising Healthcare Awareness – Patients prefer medicines from companies with international quality standards.
- Government Initiatives – The Indian government is encouraging pharma companies to obtain WHO-GMP certification for global competitiveness.
Conclusion
WHO-GMP certification is essential for pharmaceutical manufacturers to ensure product quality, enter global markets, and gain consumer trust. India has a strong base of WHO-GMP certified companies, contributing significantly to the global pharmaceutical supply chain. If you are looking to partner with or invest in WHO-GMP certified pharma companies in India, this guide provides the necessary insights to make an informed decision.
For businesses seeking third-party pharmaceutical manufacturing or PCD pharma franchise opportunities, collaborating with WHO-GMP certified companies ensures high-quality, compliant products that meet global standards.