With the voluntary scheme of giving Good Laboratory Practices (GLP) certificates to the companies picking up slowly, the Department of Science and Technology,(DST) is planning to bring in a legislation mainly to harmonize the standards and procedures in different sectors including pharmaceuticals and biotechnology.
The Department has held a couple of interactive meetings with the industry and other stakeholders to gather inputs for the legislation that will put in a regulatory mechanism, but still the process is in the initial stages only, sources said.
“The attempt is to earn credibility on the international front and pave way for a legislation on GLP in association with the regulatory bodies, industry, concerned ministries and departments,” an official in the DST said.
The efforts were launched after India getting the status of full adherence to Good Laboratory Practices (GLP) certified by the Organisation of Economic Co-operation and Development (OECD) in March, 2011.
However, this could not be translated well on the ground as the voluntary accreditation scheme by the National GLP-Compliance Monitoring Authority (NGCMA) is still not picking up as desired. This year so far, only four labs got the certification, taking the total number of the accredited labs to 22 during the last one decade of its operation, sources said.
Bioneeds Laboratories, Bengaluru, UPASI Tea Research Foundation, Valparai, in Coimbatore of Tamil Nadu, Syngenta Biosciences Pvt. Ltd., Goa, and Sun Pharma Advanced Research Company Ltd., Vadodara got the certification this year.
The NGCMA was tasked to develop guidelines and draft the legislation, in collaboration with the stakeholders and experts. The legislation was being planned 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.
India has officially joined the 34-member OECD 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. 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.