If you manufacture pharmaceuticals in India and want to export beyond the US and EU, WHO-GMP certification is not optional. It is the baseline requirement for selling into most of Africa, the Middle East, Southeast Asia, and CIS countries. Over 130 countries participate in the WHO Certification Scheme, and more than 100 have directly incorporated WHO GMP guidelines into their national pharmaceutical law. Without a Certificate of Pharmaceutical Product (COPP) backed by WHO-GMP status, your products simply will not clear customs in these markets.
India's pharma exports hit $30.47 billion in FY2024-25. The country supplies roughly 20% of global generic medicines by volume and nearly 40% of all US generic imports. A huge share of that export volume -- particularly to regulated markets in Africa and Asia -- depends on WHO-GMP certified facilities. Right now, India has somewhere north of 2,000 WHO-GMP certified manufacturing units, according to CDSCO records. That sounds like a lot. It is not, when you consider there are 10,500+ manufacturing units in the country.
A Quick History (Because the Standards Keep Moving)
WHO first published its GMP guidelines in 1968. The current foundational text is TRS 986 Annex 2, published in 2014. For sterile products, the goalposts moved again in 2022 with TRS 1044, which tightened requirements around contamination control strategy and environmental monitoring -- bringing WHO standards much closer to the EU GMP Annex 1 revisions that shook up the sterile manufacturing world.
If you are manufacturing injectables, ophthalmic preparations, or any sterile dosage form, the 2022 update is the one that matters. Older facilities designed around pre-2022 cleanroom classifications and gowning protocols may need significant upgrades to pass a current WHO inspection. This is not hypothetical. Inspectors are actively citing against the TRS 1044 requirements now.
Where Are India's WHO-GMP Certified Units?
The distribution is heavily skewed toward a few states. Gujarat dominates by a wide margin. Maharashtra, Himachal Pradesh, Karnataka, and Tamil Nadu follow, but the drop-off is steep.
| State | Estimated WHO-GMP Certified Units | Notes |
|---|---|---|
| Gujarat | 684 - 1,077 | Ahmedabad and Vadodara clusters lead. ~33% of India's drug manufacturing capacity. |
| Maharashtra | 229+ | Mumbai, Pune, Nashik corridors. Strong in formulations and APIs. |
| Himachal Pradesh | 202 - 260 | The Baddi-Barotiwala-Nalagarh belt. Tax incentives drove rapid growth here. |
| Karnataka | ~98 | Bangalore-based biotech and pharma firms. |
| Tamil Nadu | 51 - 74 | Chennai cluster. Growing but smaller base. |
The range in numbers (for example, Gujarat at 684 to 1,077) reflects the difference between CDSCO's published list and industry estimates that include units with certificates in renewal. CDSCO's public PDF of WHO-GMP certified units is not updated in real-time, so there is always some lag. If you need to verify a specific manufacturer's current WHO-GMP status, the CDSCO online portal is your best bet -- or you can search our directory for verified manufacturers.
The Certification Process: Step by Step
Here is what actually happens when you apply for WHO-GMP certification and a COPP in India. The process has been tightened considerably in the last two years, especially with the mandatory move to digital applications.
Step 1: Application Submission
As of August 15, 2025, all WHO-GMP and COPP applications must be submitted through the ONDLS (Online National Drugs Licensing System) portal. Physical applications are no longer accepted. CDSCO initially set the cutoff for July 15, 2025, then pushed it to August 15, with the DCGI explicitly stating no further extensions would be granted.
The ONDLS portal was developed by CDAC (Centre for Development of Advanced Computing) and offers real-time tracking, document management, and automated status alerts. In practice, the portal has had teething issues -- slow load times, document upload failures, and confusing navigation -- so budget extra time for your first submission. If you run into technical problems, CDAC support can be reached at ondlssupport-noida@cdac.in.
Step 2: Joint Inspection
Once CDSCO accepts your application, a joint inspection is scheduled. This involves inspectors from both CDSCO (central) and your State FDA. The inspection covers your entire quality management system: facility design, equipment qualification, process validation, documentation systems, quality control laboratories, stability programs, CAPA processes, and personnel training.
The inspection is not a formality. Inspectors will pull batch records, review audit trails, interview your QC analysts, and walk your production floor. If you have been operating under a state manufacturing license alone and have never faced a rigorous GMP audit, the WHO-GMP inspection will be a step change in scrutiny.
Step 3: CAPA and Follow-up
Almost nobody passes on the first go without observations. The inspection team issues a list of deficiencies. You submit a Corrective and Preventive Action (CAPA) plan. Minor issues can be resolved with documented evidence. Major observations -- especially around data integrity or contamination control -- may trigger a re-inspection.
Step 4: Certificate Issuance
Once CDSCO is satisfied with your CAPA responses, the WHO-GMP certificate is issued along with your COPP. The COPP validity is 3 years (this was extended from 2 years in 2018, a welcome change that reduced the administrative burden on manufacturers who were spending half their time in a perpetual renewal cycle).
Timeline and Costs
Be realistic about how long this takes.
| Stage | Typical Duration |
|---|---|
| Application preparation and submission | 2 - 4 weeks |
| CDSCO processing and inspection scheduling | 2 - 3 months |
| Inspection + CAPA closure | 1 - 2 months |
| Certificate issuance | 2 - 4 weeks |
| Total | 3 - 6 months |
That timeline assumes your facility is already in reasonable shape. If you need significant upgrades to HVAC, water systems, or lab equipment, add 6-12 months of pre-application work.
As for costs, the government fees are modest: Rs 1,000 per COPP copy and Rs 500 per product listed on the certificate. The real expense is everything else. Facility upgrades, equipment qualification, validation studies, consultant fees, training programs, and documentation system overhauls can run anywhere from $10,000 for a small oral solid dose facility that is mostly compliant, to well over $100,000 for a sterile manufacturing site that needs a complete contamination control strategy buildout. The indirect costs dwarf the regulatory fees by orders of magnitude.
WHO-GMP vs. Revised Schedule M: How They Compare Now
The revised Schedule M notification (December 28, 2023) was India's most significant GMP regulatory update in decades. The explicit goal was to align domestic GMP standards with WHO guidelines. Before this revision, there were real gaps -- Schedule M did not adequately cover data integrity, pharmaceutical quality systems, or risk-based approaches to validation.
The alignment is now much tighter, but they are not identical.
| Area | WHO GMP (TRS 986 Annex 2) | Revised Schedule M (2023) |
|---|---|---|
| Pharmaceutical Quality System | Comprehensive PQS requirement with management review | Now requires PQS; previously weak on this |
| Data Integrity | ALCOA+ principles required | Now explicitly includes data integrity requirements |
| Risk Management | ICH Q9-based risk management throughout | Risk-based approach now incorporated |
| Qualification & Validation | Detailed requirements, process validation lifecycle approach | Aligned with WHO; lifecycle approach included |
| Sterile Products | TRS 1044 (2022) -- stringent contamination control strategy | Updated, but less prescriptive than TRS 1044 |
| Water Systems | Specific pharmacopoeial standards | Aligned with WHO water system requirements |
| Stability Studies | ICH-aligned, ongoing and accelerated | Now requires ongoing stability programs |
In practice, if your facility is fully compliant with the revised Schedule M, you are about 80-85% of the way to passing a WHO-GMP inspection. The remaining gaps tend to be in the details: documentation depth, audit trail expectations, and the specificity of your contamination control strategy for sterile products.
The MSME Compliance Problem
Large manufacturers (annual turnover above Rs 250 crore) had a compliance deadline of June 2024 for the revised Schedule M. Most of them were already at or near WHO-GMP standards anyway, so this was manageable.
The MSME segment is a different story. Small and medium pharma companies were given until December 31, 2025, after a one-year extension from the original deadline. They were required to submit an upgrade plan (Form A) by May 2025.
The numbers are sobering. Of approximately 8,500 MSME pharma manufacturing units in India, only about 25-26% currently comply with the revised Schedule M norms, based on industry estimates. That means roughly 6,300 units are non-compliant. Many of these are small operations making basic formulations for the domestic market, and the capital investment required to upgrade -- proper HVAC with differential pressure monitoring, electronic batch records, qualified water systems, validated cleaning procedures -- is beyond what many of them can absorb.
The health ministry has signaled it is unlikely to grant another extension. If that holds, a significant number of MSME units could face license suspension or be forced to consolidate, contract-manufacture, or close. This is both a risk and an opportunity. If you are looking for a contract manufacturer that already meets WHO-GMP standards, the supply of qualified partners will tighten as non-compliant units drop out. Request quotes from verified manufacturers before the December deadline reshuffles the market.
Why Audits Fail: The Top Reasons
After reviewing CDSCO inspection outcomes and FDA warning letters to Indian facilities, a consistent pattern emerges. The same problems come up again and again.
Data integrity is the number one reason for audit failures. It is not close. This covers everything from analysts not logging into HPLC systems under their own credentials, to deleted or overwritten electronic records, to the outright fabrication of test results.
The Mylan Laboratories (Viatris) case from 2024 is instructive. During an FDA inspection at their Pithampur facility in Madhya Pradesh (June 2024), investigators found that analysts were documenting test results for analyses they had not physically conducted. The analysts were not even present at the facility during the recorded testing times. WHO subsequently conducted a for-cause inspection in March 2025 and found a "significant remediation action plan" was needed to address data integrity, packaging material testing backlogs, and stability sample issues. The products remained prequalified, but with enhanced quality checks -- a polite way of saying the facility was on thin ice.
The other common failure areas:
- Documentation gaps: Incomplete batch records, missing deviation reports, SOPs that have not been updated in years. Inspectors compare what your SOP says to what your operators actually do. The gap is often embarrassing.
- Cross-contamination controls: Especially in multi-product facilities. Inadequate dedicated equipment, poor campaign sequencing, no cleaning validation for product changeovers.
- Training deficiencies: Training records that are just attendance sheets. No assessment of competency. Operators who cannot explain the "why" behind what they do.
- CAPA systems that exist on paper only: CAPAs opened but never investigated to root cause. Corrective actions that are just "retrain the operator" every single time. No trend analysis of recurring deviations.
Horror Stories You Can Learn From
Indian pharma has had some spectacular audit failures in recent years. These are not obscure cases -- they made international headlines and resulted in import alerts, product shortages, and billions in lost market value.
Intas Pharmaceuticals, Ahmedabad (2023): During an FDA inspection at their Sanand facility in late 2022, investigators found a QC analyst had poured acetic acid into a trash bin to destroy analytical balance slips and KF titration curves. Another analyst admitted to not reporting all test results and discarding balance printouts. Plastic bags full of torn production records were found stashed under a stairwell and loaded onto a truck parked outside. The FDA's warning letter, issued July 2023, called it a "cascade of failures." The facility was placed on Import Alert, meaning US customs could detain any shipment without inspection. Intas was a major supplier of generic cancer drugs. The import ban contributed to chemotherapy drug shortages in the US.
Kilitch Healthcare, Navi Mumbai (2024): FDA inspectors found that microbiology lab staff routinely fabricated environmental monitoring results. Samples were never collected, but results were recorded. Batch records from March 2023 were being filled in for the first time during the October 2023 inspection -- six months after supposed manufacturing. The company was placed on Import Alert 66-40 and voluntarily recalled 27 eye drop products from retailers including CVS, Rite Aid, and Target.
Granules India, Hyderabad (2025): The February 2025 FDA warning letter was almost cinematic. At least 15 plastic waste bags full of torn CGMP records -- including analytical balance printouts and testing worksheets -- were found in the facility. Bird droppings and feathers were discovered near air handling units, with birds entering through gaps in exterior walls. Granules installed netting, but the FDA noted the netting still allowed insects to access the AHU area. The response was deemed inadequate because the company failed to conduct a root cause analysis or assess similar vulnerabilities across the facility.
Every one of these cases started with a culture problem. Not a technical deficiency. Not a lack of equipment. A culture where cutting corners was tolerated, where quality was someone else's department, and where the response to a problem was to hide it rather than fix it.
Which Export Markets Require WHO-GMP?
The short answer: most markets outside the US, EU, UK, Japan, Canada, Australia, and Switzerland (which have their own stringent regulatory frameworks). For everything else, WHO-GMP and a COPP is typically the minimum entry requirement.
| Region | WHO-GMP / COPP Requirement |
|---|---|
| Sub-Saharan Africa | Required in virtually all countries. Many also require WHO Prequalification for specific products (HIV, TB, malaria). |
| Middle East & North Africa | Required. GCC countries (Saudi Arabia, UAE, etc.) accept WHO-GMP as part of their registration dossier. |
| Southeast Asia | Required in most ASEAN member states for imported pharmaceuticals. |
| South Asia | Sri Lanka, Bangladesh, Nepal, Myanmar -- all require COPP backed by WHO-GMP. |
| CIS Countries | Russia, Ukraine, Kazakhstan, Uzbekistan -- WHO-GMP accepted as part of the registration pathway. |
| Latin America | Varies. Some countries accept WHO-GMP, others require PIC/S or local audits. Brazil (ANVISA) has its own inspection program. |
For India-based manufacturers, the African and Middle Eastern markets are where WHO-GMP certification delivers the most immediate commercial value. These are large, growing markets with limited domestic manufacturing capacity and strong demand for affordable generics.
Practical Advice for Getting Through the Process
First, do a gap analysis before you apply. Hire a consultant who has actually worked on WHO-GMP audits -- not someone who just sells gap analysis templates. Walk your facility with fresh eyes and compare it against TRS 986 Annex 2, section by section. If you manufacture sterile products, add TRS 1044 to the checklist.
Second, fix your data integrity posture before anything else. If your HPLC and dissolution systems do not have proper audit trails enabled, if your analysts share login credentials, if your electronic data is not backed up with restricted access -- these are the things that will sink your inspection. Data integrity findings are the hardest to remediate because they imply a systemic cultural problem, not just a technical one.
Third, do not underestimate documentation. Your SOPs need to reflect what actually happens on the shop floor. If your SOP says one thing and your operator does another, the inspector will find out. They always do. They ask operators to explain their process, then check it against the documented procedure. Mismatches are red flags.
Fourth, invest in your people. Training is not a one-day PowerPoint session. Your QC analysts need to understand ALCOA+ principles. Your production operators need to understand why they record what they record. Your QA team needs to be empowered to stop production when something is wrong, without fear of management pushback.
Fifth, use the ONDLS portal early. Do not wait until your application is ready to figure out the system. Create your account, explore the interface, understand the document requirements and formats. Technical issues with the portal should not be the reason your timeline slips.
The Bottom Line
WHO-GMP certification is the price of entry for exporting to most of the world's pharmaceutical markets. The process is straightforward but demanding. The Indian regulatory framework -- especially after the revised Schedule M -- is now closer to WHO standards than it has ever been. That is good news if you are starting from a Schedule M compliant baseline. It is less good news if you are one of the 6,000+ MSME units that are not there yet.
The facilities that succeed are the ones where quality is embedded in operations, not layered on top as an afterthought. The Intas, Kilitch, and Granules cases show what happens when it is not. Those are extreme examples, but the underlying problems -- data integrity lapses, documentation gaps, inadequate training -- exist on a spectrum, and even mild versions can derail your WHO-GMP inspection.
If you are looking for a manufacturing partner with current WHO-GMP certification, you can search our directory of verified manufacturers filtered by certification type, dosage form, and state. If you need help comparing options, request quotes and we will connect you with qualified facilities.