Category — Medical Technology

India Introduces New Medical Device Regulations

This blog post is a summary of an article that I have co-authored for MedDevice Online, regarding a 108-page notification published by Prime Minister Narendra Modi’s Ministry of Health in India, covering the regulation of the manufacture, sale, and possible recall of virtually all kinds of medical devices, whether imported or domestic.

Key Takeaways:

  • Device licenses now will be granted in perpetuity, not just for three-year terms.
  • The manufacturer simply has to pay a renewal fee every five years if the product still is being marketed.
  • For imported devices, the approval or rejection will take a predictable maximum of nine months; device registration will automatically imply an import license, without the need to wait an additional three months for the import license.
  • Multiple devices produced at the same factory can now be included in a single application, and the application must be filed completely online.
  • There is a proactive time commitment in the regulations. If the regulatory authority fails to complete the process within the specified time, a license shall be “deemed” to have been approved; this is a novel concept in Indian bureaucracy.

Professional companies from both India and the West, overall welcome the implementation of standards-based design and manufacture of devices, and general manager of Bloomington, Indiana-based Cook Medical in Chennai, Vijayan Govindaraman, calls the new rules “a positive step by the government to a long-standing demand by industry to frame separate regulations for medical devices.”

Blood pressure monitor

Both my co-author Rajnish Rohatgi and I think that device companies and patient advocates have much to celebrate. We expect that the Indian government will encourage foreign companies to leverage local manufacturing opportunities. To that end, it may make sense for Western companies to start looking at greenfield manufacturing in India; others may wish to buy and bolster small and medium-sized Indian companies, who will appreciate the global expertise in building up their own capabilities.

For specific questions about how the regulation may affect your business or how you can take advantage of the opportunities offered by them, send a note via the Contact Us page at Amritt.

 

May 17, 2017   No Comments

India Caps Prices on Coronary Stents Triggering Debates

After including drug eluting stents and bare metal stents in the National List of Essential Medicines in July last year, the government of India added them to the Schedule I of the Drug Prices Control Order, 2013, last December, and brought the devices under price control.

The National Pharmaceutical Pricing Authority has capped a drug eluting stent at $458 and a bare metal stent at $112.  All stent manufacturers as well as importers will now have to price their products below the notified ceiling price.

Since hospitals also function as retailers of stents they will also be required to display the prices prominently in the hospital premises, per the Drug Price Control Order 2013, reports BusinessLine.

Sahajanand Medical Technologies Stent

Sahajanand Medical Technologies Stent

Health groups, such as the Alliance of Doctors for Ethical Healthcare, expressed satisfaction with the decision. “After months of consultations, we welcome the strong and determined action of the government, particularly in the face of a concerted campaign by industry and profit-oriented hospitals to prevent any form of effective price control,” said Malini Aisola of the All India Drug Action Network.

The Medical Technology Association of India expressed disappointment with the decision saying the “move will reduce the options available for the Indian patient for their specific medical condition or deprive them the satisfaction of choosing from the most advanced and cutting edge technologies.” The Association asked for a 45-day transition time for implementing the price change.

 

April 11, 2017   No Comments

Scientists in India Develop Credit Card-Sized ECG Device

Scientists at the Bhabha Atomic Research Center have developed a credit card-sized Tele-ECG machine that can transmit an ECG over any smartphone to any part of the world. This 12-channel ECG machine works on an Android-platform, can be recharged via a mobile charger, and is priced at $61. It is likely the smallest of its kind.

“The quality of the ECG is excellent and it has come to me in two to three different formats for me to view,” Dr. Hemant Haldavnekar, a consulting physician, said.

 Hand-held ECG Device

“This is a small low-cost ECG machine that on a single charge can record 300 ECGs. It is rightly suited for rural areas,” the developer of the tele-ECG machine, Vineet Sinha, scientist, Bhabha Atomic Research Center, Mumbai, said reports NDTV.

March 21, 2017   1 Comment

India Creates Medical Caesium-137 from Nuclear Waste

India’s scientists at the Bhabha Atomic Research Center in Trombay, near Mumbai in the western state of Maharashtra, recover caesium-137 from radioactive waste to protect babies and vulnerable patients from adverse reactions to blood transfusions.

A rare and usually fatal complication from blood transfusion is Transfusion-Associated Graft Versus Host Disease, which is a major risk for fetuses and very premature newborns, as well as patients with suppressed immune systems, says World Nuclear News.

Doctors normally irradiate donated blood either with x-rays or gamma rays sourced from cobalt-60. However, cobalt-60 has a short half-life of 5.3 years which means technicians have to regularly make, transport and install new sources. Though Caesium-137 offers a longer-lasting alternative with a half-life of 30.2 years, it is usually presented in powdered form as caesium-chloride that has the potential hazard of dispersal if not properly handled and managed.

Making Vitrified Caesium Pencils at BARC

Making Vitrified Caesium-137 Pencils at BARC

Researchers at the Bhabha Atomic Research Center created a solid form of caesium-137 (from the stream of reprocessed spent fuel from India’s nuclear power plants), with the benefits of long life, reduced handling and no risk of dispersal. The same product will replace cobalt-60 for applications such as food irradiation, brachytherapy and sterilization of medical equipment.

 

March 21, 2017   No Comments

Baxter Acquires India’s Claris Lifesciences

To boost its position in the global sterile injectables market, estimated at more than $40 billion and growing at a 10% annually, Illinois-based Baxter International acquired Ahmedabad, India-based Claris Lifesciences, that deals in the specialty injectables business, for $625 million. The deal will close in the second quarter of 2017.

Baxter CEO Joe Almeida said, “The Claris injectables acquisition will expand Baxter’s presence in the fast growing, global generic injectable pharmaceuticals space and accelerate our growth trajectory with high-value, essential medicines that will benefit patients worldwide.”

Nitin Lifescience Injectible

Claris is projected to have about $100 million in revenue this year, and the combined company will launch seven to nine new products a year in the short term and up to 15 products a year beyond 2019, reports FiercePharma.

 

March 15, 2017   No Comments