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TIME UP FOR BRITISH-ERA DRUG REGULATIONS AS GOVT GOES FOR FRESH RELOOK
India will soon overhaul its 76-year old Drugs and Cosmetics Act 1940 and bring in a new , modern legislation to regulate production and consumption pharmaceuticals and other related products .
As a precursor to this , the government is bringing in a separate legislation to regulate a wide range of Medical Devices first and based on its success and acceptance by industry and other stakeholders , the drugs regulation Act will follow , said Mr K L Sharma , joint secretary , Ministry of Health and Family Welfare in Government of India , while delivering a Key Note address at the 10thAnnual US India BioPharma and Healthcare Summit 2016 at Cambridge , Massachusetts , organized by the USA-India Chamber of Commerce .
Mr Sharma said these decisions were taken by the Union Cabinet headed by Prime Minister , Mr Narendra Modi , while discussing the amendments proposed to the omnibus 1940 Drugs Act to make it more contemporary . The Cabinet asked for scrapping of the British-era Act and bring in separate legislations to regulate various areas covered by the Act . The Drugs and Cosmetics Act 1940 was last amended in 2003 with more guidelines . The Modi government wants a total fresh look to this Act .
The government has started an ambitious exercise in August 2015 to equip the drug regulatory set up in India ’ s 36 states and union territories and the central government set up by equipment modernization , hiring of hundreds of regulatory experts , multiple training programmes for existing staff with help from regulators from US and Europe and overall skill upgradation of human resources in the system , Mr Sharma said .
LUPIN RECALLS OVER 54K VIALS FROM US
Lupin Pharmaceuticals Inc , a US subsidiary of Lupin , is recalling over 54,000 vials of anti-bacterial injection Ceftriaxone , which were manufactured at the company ’ s Mandideep facility in Madhya Pradesh .
The ongoing voluntary recall is a class-III recall for the US and Puerto Rico markets , according to the US Food and Drug Administration website . The recall is being initiated by the company ' s US arm Lupin Pharmaceuticals Inc covering 54,472 vials of Ceftriaxone for injection in various strengths , it added .
As per the USFDA a class III recall is initiated in " a situation in which use of , or exposure to , a violative product is not likely to cause adverse health consequences ". Citing reasons for the recall , the USFDA said " finished products manufactured ( at Lupin Ltd ' s Mandideep plant were ) using active pharmaceutical ingredients whose intermediates failed specifications ".
INDO-JAPAN JOINT WORKSHOP TO IMPROVE RESEARCH COLLABORATION
The Ministry of Science and Technology , Government of India and the Science and Technology in Society ( STS ) forum , Japan organized a workshop on Monday to discuss and strengthen ongoing collaboration between the two countries in various research areas . Mechanisms to
improve the partnership in the areas of infrastructure , manufacturing and high technology , including solar power generation , space , biotechnology and advanced materials were discussed at the day-long workshop . The event was supported by the Japan External Trade Organization , the Confederation of Indian Industry and the Embassy of Japan .
Mr Koji Omi , Founder and Chairman , STS forum , Japan said ,” The Indian government has shown a keen interest in improving the country ’ s research and development capacities . Innovation and research have proven time and again to be the driver of social and economic growth of a country . India has immense potential in the various research fields and we intend to work together to create sustainable solutions for the future .”
“ Japan and India have significantly strengthened bilateral scientific cooperation in the biological , chemical , physical and earth sciences over the years and meetings like the one organized today are the perfect setting for cross-pollination of ideas for the progress and development of both our countries ’ people ,” said Dr K Vijay Raghavan , Secretary , Department of Biotechnology , Ministry of Science and Technology .
INDIA ’ S FIRST SIRNA DRUG TO TREAT RARE EYE DISEASE SOON
The rare eye disease , NAION ( non-arteritic ischemic optic neuropathy ) affects thousands of people in the 50-65 age group and there is no current therapy to cure it . The optical nerves once affected leads to loss of vision very rapidly . However , the reversal of the condition may be possible if treated quickly .
Now in a positive development , the Drug Controller General of India ( DCGI ) has given the approval to do phase II / III study of a novel small interfering RNA ( siRNA ) drug , QPI-1007 in the country by Biocon . The drug has been developed by US-based Quark Pharmaceuticals . In 2013 , Biocon and Quark Pharma signed an agreement to co-develop , manufacture and commercialize the drug in India and other key markets .
This is the first clinical trial of a drug developed using the siRNA technology in India . “ Biocon is committed to develop innovative therapies that address unmet medical needs and the initiation of phase II / III studies investigating QPI-1007 in NAION in India is an important step towards this goal ,” said Dr Kiran Mazumdar- Shaw , CMD of Biocon .
QPI-1007 inhibits the expression of caspase 2 to block the swelling at the tip of optical nerve that leads to the loss of vision due to the death of key retinal ganglion cells . A global trial of this injectable drug that uses the principle of inactivating the genes that lead to the condition has started in six other countries .
The global trials are being conducted in 95 hospitals across India , US , Israel , Germany , Australia , Italy and China . The trial process involves treating the patients over 12 months . A total of 465 patients will participate in the global trial . The drug may also help in the treatment of common eye disease glaucoma and has been tested for this in USA , Vietnam and Israel .
SERIES OF WORKSHOPS BY DBT ON ACCESS TO BIOLOGICAL RESOURCES
The Department of Biotechnology ( DBT ) conducted a series of ‘ Awareness Workshop on Guidelines for Access to Biological Resources under the Biological Diversity Act , 2002 ’ with participation of Biotech Consortium India Limited ( BCIL ) and Centre for Biodiversity Policy and Law ( CEBPOL ) National Biodiversity Authority .
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BioVoiceNews | July 2016