The need for trained good laboratory practices (GLP) inspectors will increase as the Central government has intensified its efforts to achieve Mutual Acceptance Data (MAD) status with the Organisation for Economic Cooperation and Development (OECD) for the GLP certification given by India's National GLP Compliance Monitoring Authority, keeping in mind the proposed EU legislation, REACH.

Recognising the importance of training inspectors in GLP, the Central government has trained 33 inspectors both from the government and industry two years ago in Jaipur. With Indian pharma companies aiming at drug discovery programmes and new chemical entity business in EU markets requiring GLP certification to export their drugs, Central government is keen to train more inspectors starting from September 2005. The GLP inspectors mainly from the government labs will be trained by the Centre, according to informed sources.

As of now, five companies have received GLP certification from Indian GLP authorities. More companies are trying to get GLP certification soon. Till now, pharma companies such as Ranbaxy and Torrent have been getting accreditations with individual EU countries.

Dr Prakash V Diwan, deputy director of Indian Institute of Chemical technology and head of Pharmacology division, said, GLP certification may be made mandatory in India soon. Initially, Indian authorities will carry out inspections, later joint inspections can be conducted by both Indian GLP authorities and OECD authorities and finally India can become a member of OECD.

India is a non-member country but has the status of OECD guideline and is monitored by National Compliance Monitoring Authority of India under the Department of Science and Technology.

India has been trying to get OECD status for the last few years, representations have been made, parliamentary decision has been sought for an ordinance on GLP and has already been approved by the Cabinet.

Chemical and drug toxicology has registered its importance in research and management around the world. Global understanding regarding the management of toxic and hazardous substance is reaching uniformity. The regulatory authorities of each country are looking for a common platform with respect to acceptance of data. Several countries have introduced GLP to establish the quality and integrity of data, which is a must for global competition, Dr Diwan added.

Indian pharma companies started realizing the significance of GLP and certification once they have started looking at export markets. Countries such as Germany, Netherlands and UK has been the frontrunners in issuing GLP certification.

The GLP certification procedure may take anywhere between three to nine months. GLP is slowly gaining significance in the analytical procedures too, Dr Diwan added.