India becomes fully compliant on Good Laboratory Practices (GLP)
Aug. 26, 2011
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.
Announcing this here on Tuesday at an interactive session jointly organized by the Confederation of Indian Industry (CII) and the Department of Science and Technology (DST) , Mr Pawan Kumar Bansal, Minister of Parliamentary Affairs, Science & Technology and Earth Sciences, said, “This development demonstrates the confidence of the OECD council in India’s compliance monitoring system and the transparent procedures and processes for monitoring and complaint redressal present here.”
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.
Speaking on the occasion, Secretary , 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 services, 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.” It was in 2002 that National GLP-Compliance Monitoring Authority (NGCMA) was set up by DST with the approval of the Union cabinet.
Explaining the significance of this compliance for industry, Dr Vyas M. Shingateri, Vice-President-Drug Safety Evaluation at Ranbaxy Laboratories said now companies will be able to do all studies in-house and at a much lesser cost than what they used to incur earlier.
Most drug and pre-clinical trials are at present done in the US and Europe. A company wanting to develop a single molecule has to undertake at least 10 studies. Big players work on 15-20 molecules simultaneously and companies have to incur huge travel costs, in addition to other costs, to get them tested. With the new status from OECD, all such costs of companies will be saved.
Dr DM Wakankar, Vice-Chairman of Chemical Export Promotion Council (Chemexcil) said, “So far India did not have any legislation which required data to be submitted by companies wanting to export chemicals. Under REACH—the regulation on registration, evaluation, authorisation and restriction of chemicals which came into force globally in 2008, all companies wanting to export chemicals exceeding 1000 tonne in quantity had to be REACH compliant by 2010.” So far 22 Indian companies have registered 35 substances in European laboratories at a cost of Rs 12 crore. Out of this Rs 8 crore alone is the cost of data testing and verification.
With OECD recognition on full GLP compliance in hand India is planning to set up similar registration authorities so that those wanting to export chemicals will not have to go outside the country for this purpose.
In the past five years pharmaceutical products, pesticides and industrial chemicals, veterinary drugs, medical equipment, food and feed additives have witnessed a substantial growth in exports. Adherence to global quality standards will mean scope for significant improvement in these.
GLP-compliance certification is voluntary in nature. Test facilities or laboratories have to apply in the prescribed application form. At present there are 18 GLP-certified facilities in India out of which six are in pharmaceutical and agrochemical companies while 11 are contract research organizations and one is a government laboratory—housed at the National Institute of Pharmaceutical Education and Research in Mohali.
After the application for GLP certification is received, a pre-inspection of the laboratory is carried out by the GLP inspectors, followed by a final inspection. 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. This year NGCMA has received 10 new applications from different parts of the country.
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