Category — Medical Technology
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.
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 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.
“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 No Comments
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.
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
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.”
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
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 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