BioVoice News December 2016-January 2017 Issue 8 Volume 1 - Page 46

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HEALTH MINISTRY TO FRAME REGULATIONS FOR ORGAN DONATION
The Union Minister for Health and Family Welfare , Mr J P Nadda took a pledge to donate his organs amidst thousands of enthusiasts comprising officers , staffers , doctors , nurses and other paramedical staff members of all Central Government Hospitals of New Delhi who also pledged along with him , here today . Also present were thousands of participants from the walkathon that took place at the India Gate in the morning today to create and enhance awareness surrounding organ donation .
Speaking at the event , the Minister stated that the Ministry is presently framing rules , regulations and protocols for facilitating organ donation . There are about 1.5 lakh brain deaths happening in the country every year , and organs from them can be used for saving lives of several lakhs of patients , he stated . He added that it is a matter of concern that the current organ donation and transplantation rate is not close to the requirement within the country for organs . He said that we have started taking decisive steps for harvesting cadaver organs and tissues and saving many lives a result of this .
The Health Ministry is implementing the National Organ Transplant Programme with a view to promoting organ donation from deceased persons and thereby increase the availability of organs for transplantation , Mr Nadda said .
QUINTILESIMS LED ALLIANCE TO GENERATE INSIGHTS ON USAGE OF ANTI-CANCER THERAPIES
QuintilesIMS has announced recently that it will lead a collaborative initiative involving founding partners Bristol-Myers Squibb , Eli Lilly and Company , Merck KGaA , Darmstadt , Germany and Pfizer , which aims to provide clearer and more proactive insight into how anti-cancer treatments are used in a real-world setting across key European markets .
Currently , there are major information gaps and inconsistencies in knowledge about the real-world use of oncology products across Europe . Additional information about how oncology products are actually used , for which types of patients , with what sequences and combinations of therapies , and in which indications , is particularly important to help improve oncology patient care .
Treatment use information is typically based on historical data , thereby providing a view of the past , not a view of current practice . This new initiative is intended to provide more timely , consistent and comprehensive data resources that could be used to provide further insight for healthcare systems to make better-informed decisions on patient care in the future . Importantly , substantial steps have been taken to obtain these insights while respecting individual privacy .
MTAI REQUESTS GOVT TO CONSIDER INDUSTRY ' S RECOMMENDATIONS FOR MEDICAL DEVICE RULES
The Medical Device Rules were initially prepared with industry consultation , however the comments of the industry as well as certain elements where agreement was obtained between industry and Health Ministry officials were not incorporated in the draft that was published on October 17th , 2016 for stakeholder ’ s comments ( within 30 days ). This was stated in the statement issued by the the Medical Technology Association of
India on December 01 . 2016 .
MTaI has presented its recommendations to the government recently . The Industry is liaising with the Government and is hopeful that it ' s submission of comments will be favourably considered by the Government of India .
“ In their current form the Medical Device Rules could severely jeopardize the continued supply of critical care medical devices to India . They will also endanger the huge investments made in Manufacturing in the country by global companies & will dent the FDI which has been growing multifold since it was sagaciously brought on the automatic route by the current government . Having said that , we are engaged with the Health Ministry as well as the CDSCO on the Rules , and if the past is anything to go by , their inclusive approach and nuanced understanding of the issues will help us once again reach solutions so that the supply of critical care devices will continue uninterrupted to the Indian patient ,” commented Pavan Choudary , Director General , Medical Technology Association of India ( MTaI ).
MEDTECH RULES DRAFT FALLS SHORT OF THE EXPECTATIONS , SAYS ADVAMED
The Advanced Medical Technology Association ( AdvaMed ), a trade association representing prominent medical technology companies , has recently submitted its comments on the medical device draft rules 2016 . The rules in its current form lack harmonization with international norms of medical device regulation , which is necessary to provide the necessary fillip to the sector that provides extraordinary growth opportunity for the country through creation of high paying jobs , economic value and better patient outcomes . In addition to the device rules , the Association also , strongly , recommends inclusion of the globally harmonized definition of medical devices into the current Act , which is not part of the drug definition .
Mr Varun Khanna , Chairman , Advamed India Working Group , and Executive Committee Managing Director , BD India & South Asia said , “ All policy decisions need to be based on scientific due diligence . The Medical device draft rules 2016 , at this stage , need more clarity and alignment with global best practices to fully meet the sector specific requirements in order to ensure predictability in the Indian market , which is a critical factor when it comes to investment decisions . The current rules address some but not all of the issues that were deliberated upon during several industry consultations while working on this draft .”
HEALTH MINISTRY TO ACT TOUGH ON USE OF NEWSPAPERS FOR FOOD ITEMS
Expressing concern over the practice of wrapping , covering or processing foods with newspaper and printed recycled paper materials in India , Mr J P Nadda , Union Minister of Health and Family Welfare had earlier directed The Food Safety and Standards Authority of India ( FSSAI ) to issue an advisory
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BioVoiceNews | December 2016 - January 2017