Toxicity Testing: GLP Test facility

CSIR-Indian Institute of Toxicology Research (CSIR­IITR), a constituent laboratory of the Council of Scientific & Industrial Research, received certificate of GLP compliance in June 2014 for toxicity and mutagenicity studies. The scope has been enhanced to include environmental toxicity studies on aquatic & terrestrial organisms and analytical and clinical chemistry testing. It is the first laboratory of the CSIR family to receive this international accreditation. The GLP certificate is a testament of high quality research by way of thorough SOP­dnven practices by competent well-trained personnel and systematic documentation. The GLP laboratories at CSIR­IITR are designed as per Organization for Economic Co­operation and Development (OECD) guidelines, which make the integrity and quality of the laboratory data adequate for regulatory submissions across the globe.

Good Laboratory Practice (GLP) is an internationally accepted quality system concerned with the organizational processes and the conditions under which pre-clinical health and the environmental safety studies are planned, performed, monitored, recorded, reported and archived. The National and international regulatory authorities/ agencies require safety assessment data of all new products prior to their launch into the market. GLP is a system, which has been evolved by the OECD and is used for achieving such safety goals.

Our GLP facility leverages in silica, in vivo and in vitro models to enable safety of suitable products in pharma, biotech and life science sectors. Our experienced team with vast knowledge in the domain of toxicology, and advanced technologies at the GLP Test Facility is committed to realize its mission towards serving global needs in the area of toxicology and biosafety. This facility has the distinction of being the only government laboratory with GLP accreditation for ecotoxicology studies.

India has a full adherence member status of OECD's Working Group on GLP. Hence, the toxicity/bio-safety data generated for chemicals/formulations, pesticides, pharmaceuticals, cosmetics, feed and food additives; from the GLP Test Facility will be accepted as such by the regulatory authorities in more than 90 countries including 34 OECD member countries and all other associated non-member countries.


GLP Certified Studies:

The following studies are conducted under certificate of GLP compliance for various sponsors to meet the regulatory requirements:

  • Acute oral toxicity
  • Acute dermal toxicity
  • Sub-acute oral toxicity (14 or 28 days)
  • Sub-acute dermal toxicity (14 or 28 days)
  • Sub-chronic oral toxicity (90 days)
  • Sub-chronic dermal toxicity (90 days)
  • Chronic oral toxicity (180 days)
  • Micronucleus assay (in vitro and in vivo)
  • Chromosomal aberration test (in vitro and in vivo)
  • Primary skin irritation test
  • Skin sensitization test
  • Environmental toxicity studies on aquatic & terrestrial organisms (Earthworm and Fish)

Types of Chemicals/Materials for Toxicity Studies:

  • Industrial chemicals
  • Agrochemicals
  • Pesticides
  • New chemical entities (NCE)
  • Pharmaceuticals (Small molecules, Biosimilars, Biotherapeutics, Vaccines and Recombinant DNA products etc)
  • Cosmetics
  • Feed and Food additives
  • Nanomaterials
  • Medical devices
  • Biomedical implants
  • Veterinary drugs
  • Nutraceuticals
  • AYUSH products

Test Systems for the Studies:

  • Rat (Wistar)
  • Mouse (Swiss albino; CD-1; SKH-1; C57BL/6; BALB/C)
  • Rabbit (New Zealand White)
  • Guinea Pig (Hartley)
  • Aquatic and terrestrial organisms
  • Cell lines (Y79, CHO)

Studies under GLP Compliant Conditions:

  • Acute inhalation toxicity test
  • Mucous membrane irritation test
  • General reproductive performance screening test
  • Teratogenicity test
  • One generation reproductive toxicity
  • Two generation reproductive toxicity
  • Two year carcinogenicity study
  • Ecotoxicity studies in Daphnia

For information please contact:

The Director
CSIR-Indian Institute of Toxicology Research
Vishvigyan Bhavan
31, Mahatma Gandhi Marg
Lucknow - 226 001
Uttar Pradesh, India.
Email: director[at]iitr.res.in
Phone:+91-522-2628228,2621856
Test Facility Management
CSIR-Indian Institute of Toxicology Research
Gheru Campus
Sarojini Nagar Industrial Area
Lucknow - 226 008
Uttar Pradesh, India.
Email: tfm.glp[at]iitr.res.in
Phone:+91-522-2476091
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