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.
BIOVOICENEWS. COM 47