Category — Healthcare

Regulators Publish New Rules for Medical Devices in India

After exhaustive stakeholder consultations, the Government of India published the new medical device and in vitro diagnostic regulations (IVD) on Jan 31, 2017. The Medical Device Rules, 2017, issued by the Ministry’s Central Drugs Standard Control Organization, will replace India’s longstanding Drugs and Cosmetics Act upon implementation. The new rules will go into effect January 1, 2018.

The term “medical device” includes any instrument, apparatus, appliance, implant, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specially for human beings or animals for one or more of the specific purposes, reports the Economic Times.
Central Drugs Standard Control Organization Logo
Highlights:
  • The new rules endorse a risk-based classification plan for medical devices and IVDs.
  •  Unique identification of medical devices and IVDs will be required by regulators, starting January 1, 2022.
  • Licenses issued to device registrants will remain valid indefinitely, along with payments of license retention fees, unless cancelled or surrendered.
  • The rules include fee revisions based on device classification.
  • Test licenses will remain valid for three years (currently, these are valid for one-year periods).
  • It is mandatory to have Notified Bodies (legal entities) conduct audits of device-manufacturing sites in India before manufacturing licenses can be issued.
  • Licenses and registration certificates obtained prior to implementation of the new rules will remain valid either until expiry or after an 18-month period following implementation, whichever is later.

The Medical Device Rules 2017 in its entirety is available on request. Please use this link to get a copy.

 

 

February 11, 2017   No Comments

Ionic MSM Inc Expands to India

Illinois-based Ionic MSM Inc., a health and wellness firm, has setup a fully integrated production unit at Jaipur in the northwestern state of Rajasthan, to manufacture products based on an organic form of sulfur called methyl sulfonylmethane (MSM) for India and other Asian markets.

The new entity, Ionic MSM Ltd., is promoted by industrialist Dr. Santosh Kumar Bagla (not related to me!) who said that in India, the company had launched more than 40 products used in cosmetics, health care, pain management, and veterinary products, reports Business Standard.

Ionic Logo

The parent company estimates that the India and Asia markets will provide business worth $80 million  in the next 5 years.

February 8, 2017   No Comments

India’s Institute of Technology Develops Cardio Implant

The Indian Institute of Technology Madras located in Chennai, India has developed Asia’s first ‘life-saving’ implant called SynkroScaff — A tissue engineered bovine pericardial patch — for critical cardiovascular patients. A Chennai-based firm, SynkroMax Biotech, has been appointed as the commercial partner. C.V. Seshadri, managing director of Synkromax Biotech said, “This sack is harvested and processed with biomaterial for ten days followed by quality control parameters to ensure it is microbial free.”

Tissue Engineering

The  pericardial patch (sack of buffalo’s heart) has inherent properties of regeneration and integration in the body, and its medical application is based on innovator Guhathakurta’s doctoral research in the institute in 2004, under the guidance of Venkatesh Balasubramanian, professor, Department of Engineering Design. Guhathakurta says, “Its applications are immense in cardiovascular and other surgical practices.  So far, 800 patches have been manufactured and over 12 surgeons are using them across India.  The feedback from doctors and patients has been encouraging, with a 100 percent success rate,” she said, adding that the product is manufactured in a facility complying with drug applications and current good manufacturing practice (cGMP) guidelines, reports the New Indian Express.

 

December 29, 2016   No Comments

Corning Life Sciences Bullish on India

In an interview with the Economic Times’ Healthworld, Dr. Richard M. Eglen, vice president and general manager of Corning Life Sciences, discussed the company’s business growth in India.

On Corning Life Science’s business in India

Eglen: India is one of our fastest growing markets in the Asia Pacific region. As a market, India has shown great potential and continues to grow significantly and drive growth for Corning Life Sciences outside of the U.S. With India’s population slated to reach 1.4 billion by 2022 (per the 2015 UN Report on World Population), this growing population demands not only large-scale production of vaccines, but also research for newer vaccines relevant to India.
Corning’s bioprocess products provide a full range of tools to successfully perform vaccine scale-up and production. Our cell culture products are of great interest to Indian pharmaceutical companies.

Corning's Cell Culture Tools

On Corning’s India’s revenue share

Eglen: The total sale of Asia represents over 50% of Corning’s total sales of US $ 9.1 billion worldwide in 2015. We can also tell you that we have more than doubled our revenues in India since 2009. 2015 was our strongest performance in Corning Life Science India history and we have kept the momentum going in 2016.

On future plans for the Indian market

Eglen: The Indian pharmaceutical market is currently at $25 billion and is expected to continue to grow at a CAGR of 12% till 2020. India is 3rd largest pharmaceutical market in the world by incremental growth and 7th largest by volume which gives Corning Life Sciences an immense growth opportunity. We have opened a warehouse for life sciences products for Indian customers in Mumbai which shows our commitment to be a reliable supplier for our customers in India.

 

December 29, 2016   No Comments

Microsoft Collaborates with India’s Prasad Eye Institute

Microsoft India, and the L. V. Prasad Eye Institute, a not-for-profit comprehensive eye care institution in Hyderabad, India, have launched the Microsoft Intelligent Network for Eyecare (MINE), a machine learning network that will help doctors in India fight eye disease and reduce the risk of avoidable blindness.

Silicon ANGLE reports that Microsoft’s new AI network combines eye care data and research from a consortium of eye health institutes from around the world, including Bascom Palmer at the University of Miami, Flaum Eye Institute at the University of Rochester, the Federal University of Sao Paulo and the Brien Holden Vision Institute, Australia. Some of this data includes information specific to eye health in children, such as the rate of change of myopia in children and the conditions that impact children’s eyesight. Microsoft also hopes that MINE will be able to generate predictive models for eye surgery, allowing doctors to personalize treatment for each patient to maximize the chance for success.

L.V. Prasad eye Institute

Globally, 285 million people are visually impaired; 55 million of them live in India. “At L.V. Prasad Eye Institute, we have been using Microsoft Azure Machine Learning and Power BI to drive clinical interventions and improve patient outcomes,” said Dr. G.N.Rao, the eye institute’s founder-chair.

December 20, 2016   No Comments