Some Progress Made on India’s Medtech Regulations, but More Needs to Be Done

August 23, 2013 – 11:25 pm

Ajay Pitre, Managing Director, Sushrut-Adler Group, will be a featured speaker at MEDTEC India, which comes to Mumbai on 3 and 4 October 2013. He has contributed a guest blog to medtechinsider on India’s medical device regulations, or the lack thereof.

Pitre writes:

As is generally well known, regulators and industry were overtaken by a rather abrupt series of events, when the need to regulate with immediate effect was forced on the government and it unfortunately chose to notify selected medical devices as drugs for the sake of expediency. This was a fundamental mistake, and regulators needed to take stop-gap measures to correct the flaws, while pursuing the root objective of separately defining medical devices and developing suitable regulations for the medical device industry. Now that nearly six years have passed since the regulation was announced, it is appropriate to take stock of what has been achieved and what more needs to be done. Read more…

Healthcare-IT Convergence Has Potential to Solve Many Healthcare Challenges in India

August 23, 2013 – 10:45 pm

Ravi Ramasawamy, Senior Director and Business Manager, Philips Innovation Campus, will be a guest speaker at the upcoming MEDTEC India event on 3 and 4 October 2013 in Mumbai. He has contributed a guest blog on the convergence of healthcare and IT.

Ramasawamy writes:

If we look at the dispersion of medical services in India, we find that there is a disproportionate concentration of medical practitioners and paramedics in metropolitan areas as compared to Tier 2 and 3 regions. There are 400,000 doctors to support 85 million people in urban areas versus 50,000 practitioners to support 740 million people in the semi-urban and rural parts of India.

On the other hand, there is tremendous growth in telecommunications and the information and communication technologies (ICT) infrastructure. There are more than 700 million mobile phone users; Internet connectivity stands at close to 150 million. This growth has permeated the urban, semi-urban and rural environments with equal flair. ITC’s e-Choupal deployment in rural India is a testimony to this fact.

MEDTEC India

India’s premier tradeshow and conference for the medical technology industry comes to Mumbai on 3 and 4 October 2013. Find out more.

The logical question that arises is: Can we use this infrastructure to decentralise healthcare? If so, what are the pros and cons and what do we need to do to make this a success? This leads to a follow-up question: Can we achieve healthcare-IT convergence?

Convergence is a buzz word in healthcare these days. But unlike many fads that come and go, convergence is not only here to stay, it will be the defining characteristic of the industry moving forward. Convergence is powered mainly by broader acceptance and adoption of digital technology by doctors and patients.

ICT has immense potential to address some of the challenges we face by providing accessible, cost-effective, high-quality healthcare services. Telemedicine uses ICT to overcome geographical barriers and increase access to healthcare. This is particularly beneficial for semi-urban, rural and underserved communities. Read more…

Abbott’s Randeo: Medical Device Clinical Trials in India Must Follow ISO 14155 Norms

August 12, 2013 – 5:07 pm

India needs to reconsider its regulatory framework for medical device clinical trials, said Sumati Randeo of Abbott Vascular at the recent DIA regulatory conference. Applying international standards such as ISO 14155, as recommended by the Global Harmonization Task Force (GHTF), ensures that clinical investigations are conducted under appropriate scientific conditions, Randeo is reported as saying by Pharmabiz.com.

Stressing the need to differentiate drug and device clinical trials, Randeo noted that clinical trials are always required for new drugs but may not be required for devices. ISO 14155:2011 has just been revised, said Randeo, and it includes a step-based approach to assist sponsors, investigators, ethics committees and regulatory authorities involved in assessing medical device conformity. Read more…

Multisorb Showcases Quality by Design at PharmaPack

August 9, 2013 – 11:12 pm

Multisorb Technologies has announced that it will display Calculations through Operations, a quality by design programme, at PharmaPack in Mumbai. India’s biggest pharmaceutical packaging exhibition, PharmaPack will be held from 12 to 14 September 2013 at the Bombay Exhibition Centre. Read more…

India Poised to Become World’s Largest Hernia Repair Market by 2019

July 22, 2013 – 3:47 pm

India, the United Kingdom and United States will lead the global market for hernia repair, with India expanding its market share from the current 30% to 37% in the next five years, according to the latest report from research and consulting firm GlobalData.

According to MediPoint: Hernia Repair – Global Analysis and Market Forecasts, the value of India’s hernia repair market will climb from US$588 million in 2012 to US$789 million in 2019, an increase of 4.3% CAGR. Read more…

Can India Replace China as a Manufacturing Hub?

July 22, 2013 – 3:47 pm

Chinese workers holding an American CEO hostage in a Beijing factory made international headlines in the last week of June. Charles Starnes, CEO of Florida-headquartered Specialty Medical Supplies, was detained at his factory in Beijing after the company decided to move part of its production to Mumbai, India, where labour costs are lower.

Starnes has been released, but the episode rekindled the India-China debate. Can India replace China as a manufacturing hub? Recent revisions of Chinese labour laws have driven low-skilled manufacturing jobs from China to less-expensive countries such as Vietnam, Bangladesh, Pakistan and India. Read more…

Six Disruptive Technologies that Will Transform India’s Healthcare Landscape

July 16, 2013 – 4:26 pm

We are bombarded with new technologies every day, each claiming to be a breakthrough that will radically alter our existence. Not all technological advances live up to the initial hype, but some truly have the potential to alter our reality.

Disruptive technologies: Advances that will transform life, business, and the global economy, a report from the McKinsey Global Institute, cuts through the noise and identifies 12 technologies that could massively transform our economy in the coming years. The report also looks at exactly how these technologies could change our world, analyses their benefits and challenges, and offers guidelines to help leaders from the business world and other institutions respond.

The 12 disruptive technologies, according to McKinsey, are:

  • the mobile Internet
  • automation of knowledge-based work
  • the Internet of things
  • cloud computing
  • advanced robotics
  • autonomous and near-autonomous vehicles
  • next-generation genomics
  • energy storage
  • 3-D printing
  • advanced materials
  • advanced oil and gas exploration and recovery
  • and renewable energy.

Based on this list, here is our snapshot of technologies that we think will change the way healthcare is delivered in India.

Read more…

Piramal Launches India’s First Voice-Guided Diagnostic Device

July 15, 2013 – 9:05 pm

Piramal Enterprises, one of India’s largest diversified companies with a presence in the medical device, pharmaceutical, financial services and information management sectors, recently launched QDx A1c, India’s first voice-guided diagnostic device that measures HbA1c in less than three minutes. The company also makes the QDx HemoStat s, an innovative handheld device that uses electrochemical biosensor technology to monitor haemoglobin and haematocrit levels in blood in approximately five seconds, and the QDx VitD, which detects the presence of vitamin D in 10 minutes. Read more…

Self-Adjustable Eyeglasses Wow Visitors at Designs of the Year Awards

July 12, 2013 – 5:31 pm

Self-adjustable eyeglasses developed by Dow Corning and the Centre for Vision in the Developing World (CVDW; Oxford, UK) garnered the Visitor Vote at the recent Designs of the Year exhibition at London’s Design Museum.

Developed specifically for myopic teenagers in the developing world, the Child ViSion glasses are filled with an optical silicone fluid. The wearer adjusts the lens power by turning a dial on each arm of the glasses, which adds or removes the fluid. Once the optimal setting has been achieved, the adjusters can be detached until they are needed again. Before designing the prototype glasses, a team from CVDW travelled to India to gain insights from hundreds of schoolchildren to refine the design features and ensure that teenagers would find the glasses cool enough to wear. Read more…

Drug-Free Medical Device Regulations Coming Soon to India

June 24, 2013 – 2:28 pm

Recognising the need to effectively regulate medical devices, India’s Ministry of Health and Family Welfare has proposed a new bill that would differentiate medical devices and drugs and make way for the standardisation, monitoring and regulation of medical devices.

“Regulation of the medical device industry has been a major challenge for the government. At present, thousands of such [devices] are used in an unregulated manner,” Joint Secretary (Health) Arun Kumar Panda recently told attendees of a global congress on Investment Opportunities in Medical Electronics & Devices, organised by the Federation of Indian Chambers of Commerce and Industry (FICCI) in Delhi. The event was organised in association with the Ministry of Health and Family Welfare under the theme, Harnessing Medical Technology for Inclusive Healthcare in India. Read more…