The drug discovery oriented pharmaceutical companies who are looking for outsourcing regulatory toxicology testing may soon have a National Good Laboratory Practices (GLP) Compliance Monitoring Authority accredited laboratory in the government sector.

The Mohali based National Institute of Pharmaceutical Education and Research (NIPER) would become the first government institution in the country to have this approval, it is learnt.

According to sources, the GLP Authority has already inspected the NIPER's GLP compliant facility. The facility, once accredited would provide another trusted option for the pharmaceutical companies to carry out their acute and subchronic toxicity testing for regulatory submission.

Interestingly, there are only 7 GLP Monitoring Authority approved test facilities in the country. The discovery research facility of Dr Reddy's Laboratories at Hyderabad, Chennai based Orchid Chemicals and Pharmaceuticals, Mumbai based Gharda Chemicals Ltd, the Zydus Research Centre of Cadila Healthcare Ltd., Ahmedabad, Jai Research Foundation, Gujarat and International Institute of Biotechnology and Toxicology (IIBAT), Tamilnadu are the GLP complied labs according to the monitoring authority.

GLP Compliance Monitoring Authority, established by the Department of Science & Technology (DST), Government of India, enjoys the status of a provisional member of the OECD for GLP. India is an observer to the OECD's Working Group on GLP and also a member of the OECD Test Guidelines Programme. The Indian GLP is expected to be approved by all OECD member countries by next year when India attains the status of full membership of OECD.

With more companies coming forward to carry out new drug research, the requirement of regulatory toxicology testing is expected to grow several times in the coming years.