India aims to get OECD member status by 2007
India is striving to attain the status of full membership of OECD in the near future so that the Indian industries can have their test facilities certified for GLP compliance, which would then be acceptable in all OECD countries. This would facilitate export of chemicals and drugs to these countries. India can become an OECD member probably by 2007, according to R Saha, head, National GLP Compliance Monitoring Programme.
Foreseeing the consequences of the proposed EU legislation, 'REACH' (Registration, Evaluation and Authorisation of Chemicals), the Central Government has intensified efforts to achieve a 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.
"Indian pharmaceutical companies are now looking at global competitiveness, which can be achieved through good laboratory practices (GLP). Once GLP is in place, Europe will be keen to work with Indian CROs. India should have good testing facilities to enable OECD member status," Dr Prakash V Diwan, deputy director and head of pharmacology division of Indian Institute of Chemical Technology said.
The National GLP Compliance Monitoring Authority was established by the Department of Science & Technology (DST), Government of India, with the approval of the Union Cabinet on April 24, 2002. Presently, 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 National GLP Programme functions through an apex body, which comprised secretaries of concerned ministries, departments, director-general, CSIR and the Drugs Controller General of India as its members with secretary of DST as its chairman. This apex body is responsible to ensure that the National GLP Programme functions as per OECD norms and principles.
The apex body is supported by a technical committee on GLP, national coordination committee for OECD test guidelines programme and legislation committee to enact a national legislation on GLP. The authority has trained over 40 experts in the country as GLP inspectors.
January 26, 2006