Just 5 of the 16 states and union territories that applied to be onboarded on the Central Drugs Standard Control Organisation (CDSCO) SUGAM Labs portal have actually completed the process. India’s drug regulator confirmed the gap in a fresh letter to all state and UT drug controllers, asking them to speed up registration and nominate a coordinating officer. The story was reported by Financial Express on 10 November 2026.
The numbers matter because SUGAM Labs is the plumbing under India’s entire drug-quality surveillance system. Until a state’s inspectors and testing laboratories sit on that platform, the sample journey that begins in a pharmacy in Patna, Guwahati or Kochi is still recorded partly on paper, partly in a state database, and partly not at all. Every Not of Standard Quality (NSQ) monthly list you read on this site is a downstream product of that plumbing.
This brief breaks down what SUGAM Labs is, who is blocking the rollout, what the latest NSQ counts show, and — for buyers and importers of Indian generics — how to read the difference between a delay in data plumbing and a deterioration in drug quality.
🔍 What SUGAM Labs Actually Does
SUGAM Labs is a web portal operated by CDSCO that automates the full workflow for testing medical products — drugs, vaccines, cosmetics and medical devices — against their quality specifications and traces testing status inside the laboratories. According to the Ministry of Health and Family Welfare, the portal has been in place since September 2023, built to integrate the drug testing labs of CDSCO onto one system. The platform itself was developed by the Centre for Development of Advanced Computing (C-DAC).
In practical terms the portal is designed to carry one sample through six states of being:
- Collection — a drugs inspector draws a sample from a manufacturer, wholesaler, retailer or pharmacy.
- Registration — the sample is logged with its details, batch and source on a common digital record rather than a local register.
- Referral — assignment to a notified laboratory, with the sampling authority and the lab seeing the same record.
- Testing — the laboratory’s progress and status are visible in the system instead of being tracked by correspondence.
- Result approval — the pass or fail outcome is recorded centrally and attributed to a specific batch and licence holder.
- Follow-up action — a failed result becomes a documented NSQ finding with a traceable trail for enforcement.
The intended beneficiaries are four: the central regulator, state drug authorities, drugs inspectors, and the testing laboratories themselves. The intended output is coordination — one of the persistent weaknesses of a system where manufacturing licences are issued by states but standards are set centrally.
SUGAM Labs should not be confused with the main SUGAM portal, which is the separate online system for applications — permission to manufacture, import or conduct clinical trials, plus formulation data. SUGAM Labs is the quality-testing layer; SUGAM is the licensing layer.
📉 The Onboarding Shortfall: 5 of 16
Financial Express reported that of the 16 states and union territories that sought onboarding, only 5 have completed the process. CDSCO’s letter states the regulator is still awaiting the details of officials and drug-testing labs from the 11 states and UTs yet to complete onboarding.
Two notes of caution are worth stating plainly, because this is exactly the kind of story where headlines outrun the data:
- 16 is the number that applied, not the number of states and UTs in India. India has 28 states and 8 union territories. The article does not establish how many of those have their own functioning drug-testing laboratories, nor whether all of them were expected to onboard at this stage. Do not read “5 of 16” as “5 of every state in India.”
- The article does not name the five compliant states or the eleven pending ones. That list would be the most useful data point for any exporter or buyer, and it is not yet public.
CDSCO’s September 2026 communication had already asked states and UTs to submit details of officials and drug-testing laboratories for onboarding. The 10 November letter is a follow-up enforcement step — an escalation of tone rather than a new programme. It also asks state drug controllers to nominate officials responsible for coordinating with CDSCO and for ensuring the portal’s workflows are adopted inside their own departments.
Why the coordination layer is the hard part
Onboarding a laboratory onto a portal sounds like an IT task. In practice it requires three things from a state: named officials with delegated authority, digitised laboratory workflows that can accept the portal’s data fields, and a decision about who signs off on results inside the system. A state that has the laboratory but not the delegated officer cannot complete onboarding. This is why the ministry’s own framing emphasises coordination — “strengthen coordination among drug regulatory authorities and testing laboratories by bringing them onto a common digital system” — rather than technology.
The stated operational payoff, per CDSCO, is automated monthly NSQ compilation. Today, NSQ counts are assembled from state returns; on a fully onboarded portal they would compile themselves. For anyone who tracks NSQ trends, that is the difference between a numbers exercise and an audit trail.
📊 What the Latest NSQ Counts Show
The same Financial Express report carries CDSCO’s NSQ sample counts for four months of 2026, and the trend is not flat:
- June 2026 — 159 NSQ samples
- July 2026 — 280 NSQ samples
- August 2026 — 220 NSQ samples
- September 2026 — 330 NSQ samples, the highest of the four months
State drug-testing laboratories reported 288 of the 330 September cases — roughly 87 percent. That single figure explains why state onboarding is the critical variable: the overwhelming majority of NSQ findings originate in state laboratories, so a portal that excludes them is a portal covering a minority of the evidence.
Context from the Ministry of Health and Family Welfare helps calibrate these monthly numbers. In a Rajya Sabha reply dated 24 March 2026, the ministry published state-wise testing totals: 1,16,323 samples tested in FY 2024-25, of which 3,104 were declared Not of Standard Quality and 245 spurious or adulterated. The prior years ran 96,713 tested in FY 2022-23 (3,053 NSQ, 424 spurious), 1,06,150 in FY 2023-24 (2,988 NSQ, 282 spurious) and 88,844 in FY 2021-22 (2,545 NSQ, 379 spurious).
Read those two datasets correctly and they say something reassuring rather than alarming. India now tests well over a lakh samples a year, and the NSQ rate sits in the region of 2.5 to 3 percent of samples tested — a rate that has been broadly stable for five years while testing volume rose by more than a third. Rising monthly NSQ counts in 2026 most likely reflect more sampling, not worsening quality. A month with 330 findings and a month with 159 findings are not automatically a quality signal unless you also know how many samples each month drew.
🧭 What This Means for Buyers of Indian Generic Medicines
For importers, distributors and procurement teams, the onboarding shortfall has three practical consequences — none of which is “Indian generics got worse.”
1. The NSQ record is real but uneven by geography
Because central and state laboratories feed the NSQ lists at different levels of digitisation, the thoroughness of a given state’s NSQ reporting is not uniform. A state with a fully onboarded laboratory and an active sampling programme will generate more recorded findings than a state with a thinner testing footprint — without necessarily having worse medicines. When you see a batch linked to a particular state or facility, treat the finding as a fact about that batch, and treat the absence of findings elsewhere as weak evidence at best.
2. Verify the batch, not the reputation
The discipline that actually protects you is unchanged: verify the specific batch you are buying. A supplier’s general reputation, or its state’s NSQ record, is not a substitute for batch-level documentation.
- Ask for the Certificate of Analysis for the exact batch, and check that the batch number matches the outer carton, the primary label and the CoA.
- Cross-check the batch date against the product’s shelf life and the shipping documents — mismatches usually indicate relabelling.
- Check the licence holder and manufacturing site on the product permission, not just the marketing company’s name.
- Where the product carries a QR code or barcode under the 2023 amendments to the Drugs Rules, 1945 for Schedule H2 brands and for active pharmaceutical ingredients, use it — those codes exist precisely for authentication and traceability.
- Confirm the manufacturer holds a current WHO-GMP certificate and that the certificate’s scope covers the dosage form you are ordering.
3. Prefer counterparties with auditable records
A supplier whose quality documentation is already digitised, internally traceable and consistent across shipments is a supplier whose records will migrate onto a regulatory portal without surprises. When a state completes SUGAM Labs onboarding, the difference between an exporter with clean batch records and one without will become visible faster than it is today. That is a competitive advantage for well-run Indian manufacturers, and a due-diligence shortcut for buyers.
For a list of verified and reliable pharmaceutical distributors, refer to the IMSDA’s verified member directory.
⏱️ What to Watch Next
- Which states complete onboarding — and whether CDSCO publishes the list. A named list would convert this from a coordination story into a usable procurement input.
- The October and November 2026 NSQ counts — if monthly findings keep climbing alongside onboarding, that indicates rising sampling intensity; if they fall while onboarding expands, that points to real improvement.
- The final version of the substandard-drug licence suspension rules — the draft notified in October 2026 would turn certain NSQ findings into immediate action against manufacturing licences. Faster automated NSQ compilation and faster enforcement are two halves of the same design.
- Whether the portal opens to buyers at all — currently it is a regulator-and-laboratory system. Any public-facing search by batch or product would be a genuine step change in transparency.
✅ The Bottom Line
India’s drug-quality surveillance is being rebuilt on a common digital platform, and the rebuild is roughly one-third complete at the state level by the count CDSCO itself is using — 5 completed onboardings against 16 applications. The NSQ numbers this system produces are rising in 2026, but the multi-year testing totals show a stable NSQ rate against a rising sampling volume, which is what a working surveillance system looks like.
For buyers, the practical instruction does not change: verify at batch level, demand CoAs that reconcile with packaging, check licence and WHO-GMP scope, and prefer suppliers whose records are already clean enough to survive sunlight. Regulatory digitisation does not replace due diligence — it just makes sloppy records more expensive to hide.
Sources: Financial Express, “Drug testing portal yet to gain traction; only 5 out of 16 states complete onboarding”, 10 November 2026 (onboarding figures, C-DAC attribution, CDSCO letter wording, June–September 2026 NSQ counts, 288-of-330 state laboratory share). Press Information Bureau, Ministry of Health and Family Welfare, “Steps taken to ensure drug quality and curb counterfeit medicines”, 24 March 2026, Release ID 2244523 (SUGAM Labs since September 2023, FY 2021-22 to FY 2024-25 testing and NSQ totals, Schedule H2 and API QR code amendments under the Drugs Rules, 1945).
For more information, contact IMSDA at contact@indiamedicine.org.