A preclinical lab facility in India has to satisfy two sets of rules at once. If it uses animals, it must be registered with CPCSEA and designed for their welfare, with its own air handling, barriers and sanitation. If its data will support drug approvals, it must meet OECD Good Laboratory Practice (GLP), which shapes everything from room separation to how raw data is archived. And because India now allows non-animal methods in drug testing, new facilities should leave room for those labs too.
Why does GLP certification matter so much?
Preclinical studies are the safety tests a drug or chemical goes through before it reaches people. Regulators only trust that data if it was produced under GLP, a quality system covering how studies are planned, run, recorded and stored.
India has been a full adherent to the OECD system for Mutual Acceptance of Data since March 2011. In practical terms, GLP studies done at certified Indian facilities are accepted in other member countries without being repeated. Certification in India comes from the National GLP Compliance Monitoring Authority (NGCMA) under the Department of Science and Technology. By 2022 it had certified 52 test facilities.
That acceptance is the commercial point of the whole exercise. A certified facility can sell studies to the world. An uncertified one is mostly selling to itself.
What does a GLP facility need physically?
GLP is mostly about systems, but it does make demands on the building. Activities have to be separated so they cannot interfere with each other. Test items need controlled receipt and storage. Raw data and specimens need secure, long-term archives. The quality assurance team has to work independently of the studies it checks.
| Area | Purpose | What to get right |
|---|---|---|
| Test item handling | Receiving, storing and preparing the substance under test | Controlled access, segregated storage, records |
| Vivarium (animal facility) | Housing animals during studies | Dedicated HVAC, pressure control, barrier zones |
| Quarantine | Holding new animals before they join studies | Physically separate, its own air |
| Procedure and dosing rooms | Dosing, sampling and observation | Near housing, easy to clean |
| Necropsy and histopathology | Examining tissues after studies | Strong extraction, chemical handling, drainage |
| Cage wash and sterilisation | Cleaning cages and equipment | Heavy steam and water load, heat and humidity control |
| Archives | Storing raw data, specimens and slides for years | Fire protection, controlled access, stable conditions |
| In vitro and NAMs labs | Cell-based and other non-animal methods | Standard biosafety lab design, cell culture suites |
What makes a vivarium different from a normal lab?
Air, mostly. A vivarium usually runs on 100% fresh air with high air change rates, so odours, allergens and pathogens do not move between rooms. Pressure is set so clean areas stay protected and dirty areas stay contained, often with a “clean corridor, dirty corridor” layout.
Then there is the daily grind. Cage washers use a lot of steam and water, bedding and feed need dry, pest-proof storage, and animal waste needs its own route out. None of it is glamorous. All of it decides whether studies run smoothly.
In India, any facility using animals must be registered with CPCSEA, the national committee overseeing animal experiments, and must run an Institutional Animal Ethics Committee to approve each study.
How are non-animal methods changing the design?
In 2023, India amended its New Drugs and Clinical Trials Rules to allow non-animal methods in drug testing. These include organoids, organs-on-chip and 3D bioprinted tissues. Animal studies will not disappear overnight, but the mix is shifting.
For anyone building today, that is a planning question. A facility built only around animal rooms may have space sitting idle in ten years. One with flexible lab space for cell-based and organ-on-chip work can move with the science.
What should you check before building or leasing?
- Can the building support dedicated, 100% fresh air HVAC for animal areas?
- Is there enough steam and water capacity for cage washing?
- Can clean and dirty flows be kept separate?
- Is there secure, fire-protected space for long-term archives?
- Can quarantine be physically separated?
- Is there flexible lab space for in vitro and non-animal methods?
- How will CPCSEA registration and GLP inspection timelines fit your launch?
How does a science campus help?
Vivariums are almost always built-to-suit, because the HVAC and services are so specific. Building on a campus that already runs power, utilities, waste handling and monitoring still takes a lot of risk out of the project.
NQF Hubs (NXT QST FWD) does not run preclinical studies. It provides the buildings that preclinical companies and in-house research teams operate in: built-to-suit facilities, build-outs with design and project management, GMP/GLP qualification support, and 24×7 campus operations, as set out on its Solutions page. See also our earlier piece on GMP/GLP qualification and our guide to lab build-out timelines.
Frequently asked questions
Who certifies GLP test facilities in India?
The National GLP Compliance Monitoring Authority (NGCMA), under the Department of Science and Technology. India has been a full adherent to the OECD Mutual Acceptance of Data system since 2011.
What approvals does an animal research facility need in India?
It must be registered with CPCSEA and run an Institutional Animal Ethics Committee to approve studies. GLP certification is separate and applies when data supports regulatory submissions.
Does India allow non-animal methods for drug testing?
Yes. A 2023 amendment to the New Drugs and Clinical Trials Rules allows non-animal methods such as organoids, organs-on-chip and 3D bioprinted tissues.
Why do vivariums use 100% fresh air?
Recirculated air can carry odours, allergens and pathogens between rooms. Single-pass fresh air with high air change rates protects both animals and study results.
Planning a preclinical or GLP facility? Talk to NQF Hubs about built-to-suit lab and vivarium space. Get in touch
6. External sources cited
- BioSpectrum India, “Govt pushes for capacity building to make India global leader in Good Laboratory Practice” (26 Jul 2022): https://www.biospectrumindia.com/news/22/21695/govt-pushes-for-capacity-building-to-make-india-global-leader-in-good-laboratory-practice.html
- Drishti IAS, “Removing Animals from Drug-Testing Process” (14 Aug 2023): https://www.drishtiias.com/daily-updates/daily-news-analysis/removing-animals-from-drug-testing-process
- DST, About NGCMA: https://dst.gov.in/about-ngcma