• 13 September 2011
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India to have GLP-compliant labs

The Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers, Government of India, is in the process of selecting a consultant to assess the existing facilities complying with the good laboratory practices (GLP) vis-à-vis requirement of pharma industry and drawing up schemes for upgrading the existing testing facilities to make them GLP compliant. Similarly, the Department of Science and Technology has put in place enabling mechanisms to encourage test facilities in both government and private sector to come up to the standards of GLP, including sensitizing programmes, training programmes for test facilities, and quality assurance personnel.

While providing information in this regard in Parliament on August, 1, 2011, the Minister of State for Science and Technology and Earth Sciences, Mr Ashwani Kumar, said, “The idea behind the move is to inculcate a GLP environment in the country and encourage test facilities to apply for a GLP Certification from the National GLP Compliance Monitoring Authority, Government of India.”

India achieved full adherent status on good laboratory practices (GLP), certified by the Organization of Economic Co-operation and Development (OECD), on March 3, 2011. This has come after the government accepted the invitation of OECD Council to become full adherent to OECD Council Act related to mutual acceptance of data in assessment of chemicals and to join that part of chemicals programme related to mutual acceptance of data, with all of the rights and obligations of OECD member countries.

ABLE-AG supports glyphosate products
After a few anti-biotech crop groups put forth their views on harmful effects of glyphosate, the Association of Biotech Led Enterprises-Agriculture Group (ABLE-AG) has termed these claims as unsubstantiated and unscientific to mislead people and policy makers. ABLE argued that glyphosate products, first introduced in 1974, are registered in more than 130 countries and approved by regulators for weed control in over 100 crops.

The ABLE-AG issued a press statement saying these groups were ideologically opposed to biotechnology and often utilized unvalidated claims to further their agenda, while ignoring the overwhelming weight of scientific evidence that underscores the safety and performance of these products.

In support of its argument, ABLE-AG said the comprehensive, robust data set, establishing the safety of the product was available on glyphosate, the active ingredient in round-up herbicide. The association also sought to dispel rumors that Glyphosate was a carcinogen. The chronic toxicity and oncogenic potential of glyphosate have been evaluated by a number of regulatory agencies and by international scientific organizations, says the statement, adding that each of these groups concluded that glyphosate was not carcinogenic. “This conclusion is based on long-term studies in which mice and rats were fed extremely high doses of glyphosate everyday for two years. The US EPA has placed glyphosate in category E (evidence of non-carcinogenicity for humans), the most favorable carcinogenicity category possible,” says the statement issued by ABLE-AG.

ICMR seeks to commercialize technologies
The Indian Council of Medical Research, New Delhi, is looking for companies interested in commercializing two unique technologies aimed at diagnosis and prevention of various diseases.

The first patented technology that is ready for commercialization is a kit for the detection of the urinary oxalate for semi-quantitative analysis by disposable strips. The measurement of oxalate in urine and plasma is very important for the diagnosis and medical management of innumerable disease conditions such as primary and secondary hyperoxaluria, idiopathic, steatorrhoea, ileal disease, ethylene glycol poisoning, E-ferrol toxicity syndrome, among others.

These disposable biostrips can be used by a person without the help of a laboratory and skilled person to differentiate a normal urine sample from a hyperoxaluria sample. The salient features are that it takes very less time and shows no loss of activity even after its storage at four degree centigrade for three months. Also, an alternative diagnostic technique based on reverse transcription (RT-PCR) to detect infective (L3) stage larvae (Wuchereria bancrofti) in vector mosquito (Culex quinquefasciatus) has been developed by Vector Control Research Center, Puducherry. This technique, which is not cumbersome, does not require live mosquito sample, and is amenable for large-scale screening of mosquito vectors, unlike the conventional technique.

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