What is GMP Certification?
Good Manufacturing Practice (GMP) is a system of regulations that ensures pharmaceutical products are consistently produced and controlled according to quality standards. In India, GMP certification is issued by the Central Drugs Standard Control Organisation (CDSCO) and state drug authorities under Schedule M of the Drugs and Cosmetics Act.
For B2B pharma buyers sourcing through platforms like Medrizehealthcare, GMP certification is the most important quality indicator to verify before placing any bulk order.
Types of GMP Certifications in India
1. Schedule M (Indian GMP)
The minimum requirement for any Indian pharmaceutical manufacturer. Revised in 2023, Schedule M now includes stricter requirements for documentation, equipment qualification, and process validation.
2. WHO-GMP
Required for export to most countries. WHO-GMP certified manufacturers follow international standards and are audited more rigorously. On Medrizehealthcare, WHO-GMP certified suppliers carry a verified badge.
3. EU-GMP
The highest standard, required for European market exports. EU-GMP certified Indian plants are audited by European regulatory authorities and command premium pricing.
4. US FDA Approved
Required for the US market. India has the largest number of US FDA approved plants outside the US — over 600 facilities.
Why GMP Certification Matters for B2B Buyers
- Product Safety: GMP ensures no contamination, correct dosage, and proper labelling
- Legal Compliance: Buying from non-GMP facilities can lead to drug licence cancellation
- Recall Protection: GMP manufacturers have documented batch records — essential if a recall occurs
- Export Eligibility: Your products can only be exported if sourced from appropriately certified manufacturers
- Insurance Coverage: Many pharma insurance policies require suppliers to be GMP certified
How to Verify GMP Certification
- Ask the manufacturer for their GMP certificate with validity dates
- Cross-check on the CDSCO portal (cdscoonline.gov.in)
- For WHO-GMP, verify on the WHO Prequalification database
- Use Medrizehealthcare's verified supplier filter — all listed suppliers have undergone document verification
Red Flags to Watch For
Be cautious of suppliers who provide expired GMP certificates, certificates without CDSCO registration numbers, or who refuse to share manufacturing facility details. Always request a facility audit for orders above ₹10 lakhs.
Source from Verified GMP Manufacturers on Medrizehealthcare
Every supplier on Medrizehealthcare undergoes document verification including GMP certificate validation. Post your enquiry today and connect with quality-assured pharma manufacturers across India.