BioVoice News July 2016 Issue 3 Volume 1 | Page 47

certification body for the ICMED scheme ( Indian Certification for Medical Devices ). This quality certification scheme for medical devices is an initiative by the Association of Indian Medical Device Industry ( AIMED ) in collaboration with the Quality Council of India ( QCI ) and the National Accreditation Board for Certification Bodies ( NABCB ) in quality certification for medical devices in the country .
Through the introduction of this quality certification scheme , the associations intend to enhance patient safety , and increase consumer protection along with providing much needed product credentials to manufacturers to instil confidence among buyers . The scheme is also intended to significantly eliminate trading of substandard products or devices where supply chains are unknown , a widespread and injurious occurrence in the Indian market .
Intertek ’ s full suite of medical quality and compliance solutions include : Regulatory Requirements for Medical Equipment , Medical Product Testing Solutions and Medical Management Systems Certification & Auditing .
FSSAI REGULATIONS FOR NUTRACEUTICALS REACH FINAL NOTIFICATION STAGE
In his address at the recent ASSOCHAM conference , Mr Kumar Anil , advisor ( standards ), Food Safety and Standards Authority of India ( FSSAI ) said that regulations for nutraceuticals industry have reached the final notification stage .
“ We had realised the need for establishing standards earlier on and initiated the process four years ago , today I am happy to inform that these regulations have reached the final notification stage ,” said Mr Kumar adding , “ These regulations are very comprehensive and provide for manufacture and sale of food for special health supplements , nutraceuticals , special dietary use , special medical purposes , functional food and normal food .”
The official also informed that for any new ingredients , plants or botanicals to be added to the list , these schedules offer any deletion if need be . “ FSSAI intends to review these regulations on a regular basis as this exercise will help it in further evolving these regulations as per the stakeholders ’ requirement .”
RESEARCHERS UNCOVER BENEFITS OF YOGA FOR HEALTHY AGEING
Participation in yoga programs can improve balance , provide a safe and enjoyable form of exercise and may reduce the risk of falls for the older people , researchers say . Researchers from The George Institute for Global Health have found that yoga can have a positive impact on the balance and physical mobility of people aged over 60 . A summary of the results of published trials provides preliminary evidence that yoga may be effective in reducing the risk of falls and promoting independence in older age .
Dr Anne Tiedemann of The George Institute for Global Health and the University of Sydney says that attracting older people to take part in exercise programs that boost their balance is a challenge , and that yoga may be part of the solution .
According to Dr Vivekanand Jha , Executive Director , The George Institute for Global Health India , “ In India , falls are one of the major causes of accidental deaths in older people . The rate of injuries due to fall in the older people is quite substantial and sometimes results in long term disability . Further research is now needed to determine if yoga-related improvements in balance and mobility translate to prevention of falls for older people ”.
COURT ORDER GIVES A RAY OF HOPE FOR TREATMENT OF LYSOSOMAL DISORDER PATIENTS
On the 31st of May , the Delhi High Court , under the jurisdiction of Justice Manmohan , passed an interim order directing the Employees State Insurance Corporation ( ESIC ) to provide interim treatment to 6 children suffering from LSDs . This order has come as a welcome relief to the families whose children have been waiting to receive funds for their treatment . This is not the first order of this kind from the Delhi High Court , and earlier this year , the ESIC was directed by the court to grant three patients suffering from Gaucher disease , a type of LSD , with interim treatment as well . These orders from the court are giving hope to many more families whose children are suffering from these
debilitating diseases and are the beneficiaries of ESIC . Out of the six children who have been granted interim treatment , four suffer from Gaucher disease and two from MPS I disease .
GOVT WITHDRAWS DRUGS & COSMETICS BILL , 2013 ; FRESH DRAFT FOR REVIEW SOON

The Union Cabinet , chaired by the Prime Minister Mr Narendra Modi , has decided to withdraw the Drugs and Cosmetics ( Amendment ) Bill , 2013 , which had been introduced in the Rajya Sabha on August 29 , 2013 . The Bill had been examined by the Standing Committee of Parliament which had made a number of recommendations for changing the provisions of the Bill . health

The Cabinet has , keeping in view the role of the sector in managing public health , decided on June 22nd that it will not be appropriate to carry out further amendments in the present Act especially as newer areas of biological , stem cells and regenerative medicines , medical devices and clinical trial / investigation , etc . cannot be effectively regulated under the existing law .
The Ministry of Health and Family Welfare has , accordingly , undertaken an exercise to frame separate rules under the existing Act for regulating medical devices ; and to bring out separate legislations for regulating medical devices and Drugs and Cosmetics . While , after extensive discussions with all stakeholders , the draft rules for regulating medical devices have been prepared and will be draft notified shortly , work on drafting the new legislation has also commenced .
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