GLP laps in india

As we start moving towards a bigger and better world, the need for all of us to be well is becoming even more crucial. As a result of this, throughout the world, regulatory systems are becoming more stringent. The need to provide people with better standards has become the name of the game. As the old saying goes “prevention is better than cure.” The need for stringent standards that help saves lives has become the norm nowadays. A number of countries require manufacturers of industrial chemicals, pharmaceuticals, veterinary drugs, pesticides, cosmetic products, food products, feed additives, etc., to establish thorough data that informs that the use of these products do not pose any hazards to human health and the environment. Non-hazardous nature needs to be established through studies and data, which will be examined by the regulatory authorities of the concerned countries. Good Laboratory Practice (GLP) is a system, which has been evolved by Organization for Economic Co-operation and Development (OECD) that is used for achieving the above goals. It was primarily seen as a European and Northern American trend only up until recently, where the trend was bucked and GLP laboratories in India were setup. Good Laboratory Practice (GLP) embodies a set of principles that provides a framework within which laboratory studies are planned, performed, monitored, recorded, reported and archived. These studies are undertaken to generate data by which the hazards and risks to users, consumers and third parties, including the environment, can be assessed for pharmaceuticals (only preclinical studies), agrochemicals, cosmetics, food additives, feed additives and contaminants, novel foods, biocides, detergents etc. GLP helps assure regulatory authorities that the data submitted are a true reflection of the results obtained during the study and can therefore be relied upon when making risk/safety assessments. In the experimental (non-clinical) research arena, the phrase good laboratory practice or GLP specifically refers to a quality system of management controls for research laboratories and organizations to try to ensure the uniformity, consistency, reliability, reproducibility, quality, and integrity of chemical (including pharmaceuticals) non-clinical safety tests; from physical and chemical properties to chronic toxicity tests. Many might wonder why there ever came a reason for GLP come into existence, given that things have been going on just fine. The fact of the matter is, although regulations have been in place, it had become very easy for the power houses to buy off the guy in charge and superficially conduct studies and give results on the basis of that. The consequences of which, are well documented but not well known the world over. The GLP system clears any lingering doubts that anyone might have had. It was created for measurable quality controls and has evolved by member countries of the Organization for Economic Cooperation and Development (OECD) out of concern that organizational processes and conditions of non-clinical health and environmental studies have to be planned, performed, monitored, recorded, reported and archived in a universally acceptable way; so that, it could be followed the world over instead of the pre existing system which was not very successful in achieving universal acclaim. GLP laboratories in India were only a dream not too far in the past. It only became a reality once India became a provisional member of the OECD’s working group on GLP in 2003 under the guidance and oversight of the India’s National Good Laboratory Practice Compliance Monitoring Authority (NGCMA). It is the foremost authority in the country in this regard. It holds the responsibility of conducting GLP inspections, grants compliance, monitors test facilities and continues training based on OECD recommendations. As a result, there are a lot of GLP laboratories in India. For those, who are skeptical and are probably wondering about the credibility of NGCMA, here is the comprehensive answer for you that will no doubt clear any lingering doubts. NGCMA is now being evaluated as a full member of OECD’s GLP compliance, which means that data from Indian test facilities certified by NGCMA will be accepted by the 33 OECD countries that have “fully adherent status.” This means that NGCMA is globally recognized for its ability to adhere to the stringent regulations that are in place. Consequently, data generated by Indian test facilities will be valid in all OECD countries for review and consideration for registration or licensing of products. Thus, NGCMA has become pivotal in the emergence of India’s GLP capacity. Historically, the quality of India’s GLP data has been doubted by some OECD countries. The moves made by NGCMA and India’s status as fully adherent should put all these concerns to rest. Furthermore, as a result of the GLP laboratories in India, Indian agrochemical companies and foreign companies now have another option for their data generation. They stand to benefit by gaining faster access to markets for specific active substances. There are about 18 certified GLP laboratories in India, many of them created for the evaluation of pharmaceuticals. But in the last five years, a new entity has overseen the development of their pesticide analysis and recording, encouraging GLP laboratories in India to expand their capacity to encompass agrochemicals. Today, at least 12 are certified to generate data on agrochemicals under REACH-adherent specifications. Some of the facilities have limited capabilities, such as toxicity studies, gene mutation studies, and physical and chemical testing. A few offer environmental impact assessments and residue testing as well. As competition for access to research intensifies, GLP laboratories in India have ensured that the ones with long term plans succeed in their goals eventually, even when the ones that aim at immediate success, achieve their short term goals.

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