Even as the deadline for mandatory implementation of Good Laboratory Practices (GLP) norms is nearing, the pharmaceutical industry by and large has taken little note of the national GLP programme in existence for over eight years now.

Only 16 companies, mainly the big players and a couple of government institutes have so far taken the GLP-compliance certification from the National GLP-compliance Monitoring Authority under the Department of Science and Technology (DST) as it has been functioning on a voluntary mode.

And interestingly, only one company came for this certification this year as all the certifications were done in last four years. As many as nine of them got certifications during the year of 2007. The last one to secure the accreditation as Indian Institute of Toxicology, Pune in April this year.

Those who got the accreditation included International Institute of Biotechnology and Toxicology, GLP Laboratory at Gharda Chemicals Ltd at Thane, discovery research facility at Dr Reddy’s Laboratories, Jai Research Foundation, Orchid Research Laboratories, Advinus Therapeutics Pvt Ltd, Zydus Research Centre of Cadila Healthcare, Intox Private Ltd of Pune, Laboratory Animal Research Services of Reliance Life Sciences, Torrent Research Centre of Torrent Pharmaceuticals, GLT test facility of Ranbaxy Research Laboratories, Gurgaon, SGS India Pvt Ltd, the National Toxicology Centre of NIPER at Mohali, GLP facility of Himalaya Drug Company, and Toxicology Centre of Shriram Institute of Industrial Research.

The Ministry of Health and Family Welfare is all set to make Good Laboratory Practices (GLP) under the Schedule L-1 mandatory for the pharmaceutical manufacturers in the country from November 1, 2010. But the lack of awareness about the GLP authority has prevented many to take the government assistance for accreditation, sources said.

India being a member of Organization for Economic Co-operation and Development (OECD) set up the GLP Compliance Monitoring Authority in 2002 under the DST so that data generated by these test facilities is acceptable in the countries of OECD. India, at present, enjoys the status of a Provisional Member of the OECD for the purpose of GLP, and this membership will end in April, 2012.

The National GLP Programme functions through an Apex Body, which has Secretaries of concerned Ministries/Departments, Director-General, CSIR and the Drugs Controller General of India as its members with Secretary-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 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 33 experts in the country as GLP inspectors. GLP-compliance Certification is valid for a period of three years and the GLP Secretariat organizes annual surveillance and a re-assessment during third year for maintaining the certification.