National Good Laboratory Practice (GLP) Compliance Monitoring Authority {NGCMA}

National GLP Compliance Monitoring Authority (NGCMA) was established by the Department of Science & Technology (DST), Government of India, with the approval of the Union Cabinet on April 24,2002. India is full-member for Mutual Acceptance of Data (MAD) in the OECD's Working Group on GLP w.e.f March 3, 2011. As a consequence, the non-clinical health and safety studies/ data of such studies generated by Indian GLP laboratories is acceptable in 36 OECD member countries and 6 non-memberMAD adherent countries. This facilitates export of chemicals,drugs, pesticides etc. to these countriesincluding developed markets of USA, UK, Australia, Japan, European Union, etc.

The National GLP Programme functions through anApex Body, represented by Secretaries of concerned Ministries/ Departments with Secretary, DST being its Chairman. This Apex Body oversees that the National GLP Programme functions as per OECD Principles of GLP & OECD Council norms. The Apex Body is supported by Technical Committee on GLP, which is a recommending body of NGCMA on cases of GLP certification and various technical matters concerning GLP.

To meet the increasing demand of GLP compliance monitoring in the country, NGCMA has 17 trained GLP Inspectors from various Government laboratories, Universities & public funded institutions to evaluate the technical competence of the applicant test facility for its compliance to OECD Principles of GLP and OECD Test Guidelines.

GLP certification is voluntary in nature. The test facilities have to submitthe prescribed Application fee and apply in the prescribed application form of NGCMA. A pre-inspection of the laboratory is carried out by NGCMA, followed by a final inspection. The report of the final inspection is considered by Technical Committee on GLP,whose recommendationsare placed before Chairman, GLP Authority for a final decision on grant/ non-grant of GLP certification. GLP Certification is valid for a period of three years and the GLP Secretariat organizes surveillance inspection at 18 months from the date of certification and a re-certification inspection during third year for maintaining the certification.

Test Facilities, dealing with chemicalslisted in para above and conducting safety studies for submission to Regulatory Authorities, can apply to NGCMA for obtaining GLP Certification in one or more of the following areas of expertise:

  • Physical-chemical Testing
  • Toxicity Studies
  • Mutagenicity Studies
  • Environmental Toxicity Studies on Aquatic and Terrestrial Organisms
  • Studies on Behaviour in Water, Soil and Air, Bio-accumulation
  • Residue Studies
  • Studies on Effects on Mesocosms and Natural Ecosystems
  • Analytical and Clinical ChemistryTesting
  • Others (please specify)