After achieving the status of full adherence to Good Laboratory Practices (GLP) certified by the Organisation of Economic Co-operation and Development (OECD), the Department of Science and Technology (DST) is now mulling on bringing in legislation on GLP mainly to harmonize the standards and procedures in different sectors including pharmaceutical and biotechnology.
In the run-up to gather the inputs from the industry and other stakeholders, an interactive meet was held here recently with a view to prepare a roadmap for harmonising the GLP with regulatory systems. “The attempt is to earn credibility on the international front and pave way for a legislation on GLP in association the regulatory bodies, industry, concerned ministries and departments,” an official in the DST said, on the sidelines of the interactive meeting.
The National GLP-Compliance Monitoring Authority (NGCMA), set up by DST with the approval of the Union cabinet, will take further initiatives to coordinate with other stakeholders and experts to frame a draft legislation which would seek to ensure high quality and reliable test data related to the safety of chemicals in the country. It will also take efforts to harmonise the GLP policies in all sectors including pharmaceuticals, biotechnology and chemicals, he said.
India has officially joined the 34-member OECD which includes some of the world’s most advanced countries such as the US, the UK, Canada, Australia, Sweden,Switzerland, Denmark, Hungary and Korea to get the status of full adherence to GLP certification recently. With this certificate India has become the third key emerging economy, after South Africa and Singapore, to join the OECD system for mutual acceptance of data in the assessment of chemicals, ensuring that the results of non-clinical chemical safety tests done here will be accepted in all other member countries. Earlier, manufacturers wanting to export pharmaceuticals and agro products had to get the tests done overseas.
Industry had been eagerly awaiting this international recognition. Technical barriers to trade will be eliminated with this. Companies will be able to save the cost of getting their test data generated in GLP-compliant facilities outside the country. Indian test facilities will also save the expense of hosting multiple foreign inspection teams.
Addressing the meet, Secretary of DST, Dr T Ramasami said, “This work is a giant leap forward in the field of quality compliance and best practices.” Dr VM Katoch, secretary, department of health research, said, “We have to be active partners in thinking and building our own standards.” According to chairman of GLP Technical Committee and head of the department of pharmacology at the All India Institute of Medical Sciences (AIIMS), Professor YK Gupta, “This is a historic moment not only for DST but for the entire country since it is after nine long years of effort that India has got this recognition.”