Category — Healthcare

India’s Federal Government Withdraws Drugs and Cosmetics Bill

Keeping in mind the ‘Make in India’ initiative, India’s Federal government has decided to comprehensively review and revise the existing 76-year old drug laws on two important features: 1) to facilitate the ease of doing business, and 2) substantially enhancing the quality and efficacy of its products. The rewrite of the laws will take into account the regulation of biologics, regenerative medicines and clinical trials.

The Ministry of Health and Family Welfare has framed separate rules under the existing Act for regulating medical devices.The ministry is also working to bring about separate legislations for regulating medical devices and drugs and cosmetics.

A draft of the revised drugs law is expected to be ready in two months, top drug controller G.N. Singh told Reuters last week. “We thought it was better to revise the law than to put more bandages on it,” Singh said. He also mentioned that the government had requested regulators from the U.S. and Europe for input.

 

capsules

Meanwhile, the medical devices industry has welcomed the Cabinet decision. “AdvaMed appreciates the government of India’s efforts over the years to press forward with legislation that would create separate and appropriate regulations for medical devices,” said a statement issued by AdvaMed India, a forum of medical devices manufacturers.

“We view the withdrawal of the Drugs and Cosmetics (Amendment) Bill, 2013 as an opportunity to start fresh and consult with relevant stakeholders to draft new and globally harmonized legislation that would once and for all carve out distinct regulations for medical devices. This step is critical to the growth of the industry and — equally as important — to ensure that patients have access to innovative and lifesaving technologies,” added Advamed.

 

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June 23, 2016   No Comments

Indian Startup Markets Neonatal Hypothermia Alert

Bangalore-based company Bempu has devised the Bempu Hypothermia Alert Device – a continuous temperature monitoring bracelet with an inbuilt thermometer, which indicates whether a premature baby or one with a low weight at birth, is maintaining a healthy temperature.

Hypothermia alerting braceletsThe device is wrapped around the neonate’s wrist, and in five minutes an inbuilt algorithm indicates if the baby is hypothermic or is slipping into a state of hypothermia. If the baby is warm, a blue light starts blinking every 30 seconds. If the baby is cold, the bracelet sounds an alarm and an orange light starts blinking. This means the baby is entering the first stage of hypothermia, giving care givers enough time to take action. As an initial step, care givers are advised to keep the baby warm by holding him/her against the skin or by swaddling. If the device continues to beep it means that the baby is slipping into hypothermia because of some infection that needs medical attention, reports The Better India.

“In India,  92% of newborns  become hypothermic. One of three babies is born with low birth weight and 18-42% newborn deaths can be prevented with thermal care,” says Gini Morgan, Public Health and Partnerships Manager at Bempu.

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June 22, 2016   No Comments

Yoga Day Marked in Times Square and Across the Globe

Last year, the United Nations proclaimed June 21 as International Day of Yoga, and many countries marked this day performing yoga exercises, report both NBC News and the BBC.

On June 20, at Times Square, New York City, traffic came to a standstill as people practiced for a yoga session during the summer solstice on Monday. In the Philippines, Australia, Malaysia, China, Belarus and India, young students and adults practiced yoga breathing exercises and yoga poses to mark the International Day of Yoga.

On Yoga Day with Prime Minister Modi of India

On Yoga Day with Prime Minister Modi of India

Venues were as varied as the Sydney Harbor Bridge, the Sydney Opera House, Gorky Park in Minsk,  schools, parade grounds, parks, a glass sightseeing platform on the outskirts of Beijing, and even a swimming pool!

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June 22, 2016   No Comments

Boston Scientific to Make India its Biggest R&D Hub

Marlborough MA-based  medical devices maker Boston Scientific Corp., plans to make India its biggest research and development location  outside the U.S. where it will develop devices such as stents, catheters and pacemakers at its Gurgaon facility for the Asia Pacific, Middle East and African markets, and roll them out by 2017.

“As one of seven strategic global R&D sites for Boston Scientific, the R&D center in India has the potential to be the largest outside of the U.S.,” said Prabal Chakraborty, vice president and managing director at Boston Scientific Company India Pvt.Ltd, the Indian unit of Boston Scientific.

SYNERGY Stent

SYNERGY Stent

The company  is seeking to expand its market share and increase sales through geographic expansion, especially in high-growth emerging markets such as India, with rising coronary angioplasties, reports the Live Mint.

“The R&D center will focus on developing products to meet the clinical needs in high-burden diseases specific to emerging markets in the Asia Pacific, Middle East and Africa regions, and to serve as a global product engineering site,” Chakraborty said.

 

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June 20, 2016   No Comments

J&J’s Janssen Pharma Supplies Tuberculosis Drug Free

Jannsen Pharmaceuticals, a part of New Jersey-based Johnson & Johnson Pharmaceutical Research and Development, has made available the drug Bedaquiline free to India  for use in hospitals in the cities of Guwahati, Ahmedabad, Chennai, Mumbai, and New Delhi only on patients who meet certain criteria for multi drug-resistant tuberculosis.

The Lokapriya Gopinath Bordoloi TB Hospital in the north eastern part of India has become the first state in Asia to offer this drug exclusively to patients who have failed to respond to standard first-line and second-line anti-TB drugs, reports BioSpecturm.
Syringe
Nayan Jyoti Das, the joint director of health services and the state officer for India’s TB control program, said, “Many TB patients develop resistance to several drugs. But with the launch of bedaquiline, it will be possible to treat such patients.”
TB remains a global epidemic with over two billion people harboring its latent infection and more than 9 million cases of which 500,000 are multi-drug resistant (MDR-TB). India accounts for 23 per cent of global TB cases and deaths. An estimated 2.2 million people suffer from TB in India with over 70,000 MDR TB patients.
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June 20, 2016   No Comments