news bytes
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.
42
BioVoiceNews | July 2016