Category — Medical Technology

India’s Largest Medical Device Park Opens for Business

At 250 acres, India’s largest medical devices park started operations in the outskirts of Hyderabad in the state of Telangana. K.T. Rama Rao, Minister for IT, Municipal Administration and Urban Development and Industries, who inaugurated the park, said, “We will provide all the necessary facilities to develop this park into a dedicated ecosystem for MedTech innovation and manufacturing of medical devices.”

With an aim to promote innovation through incubation, the facility will work closely with the Indian Institute of Information Technology Hyderabad, which will provide expertise in medical technology utilization for alloy works, plastics and medical electronics. It will also provide guidance in the use of biotech components such as DNA proteins and reagents, IoT, imaging, voice and data processing, among others, reports Pharmabiz.

Medical Devices Park Telangana

Fourteen companies, including Apollo Hospitals, Cyient Limited, Sandor Medicaids, Healthware Private Ltd, Sanofi Shantha Biotech, and Hetero Drugs have been allocated 50 acres of land in the park, where they will invest over $65 million (Rs 425.59 crore) and create direct employment for nearly 4,000 people.

July 20, 2017   No Comments

India’s Health Ministry to Regulate Prices of Critical Medical Devices

Critical medical devices and diagnostic equipment will be  regulated by India’s health ministry. Under the Medical Devices Rules, 2017, which will come into effect from January 1, 2018, prices of devices such as catheters, stents and orthopedic implants, heart valves, intra-ocular lenses, syringes and needles will be regulated by the government.

“The devices intended for internal or external use in diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals, as may be specified from time to time by the central [federal] government by notification in official gazette, after consultation with the Board, fall under the definition of drugs,” Drugs Controller General of India G.N. Singh said in a notice, giving out a list of 15 medical devices notified so far .

The new rules will also require critical devices to undergo trials in India before they are approved for launch. Implantable devices such as stents will be part of the high risk category and will be monitored directly by the government regulator, reports the Times of India.

Medical Equipment

July 20, 2017   No Comments

India Launches National Pharma Mission

The Government of India launched the National Pharma Mission for the development of bio pharmaceuticals through industry-academia collaboration. This program will focus on the development of specific products such as vaccines, biotherapeutics, and newer platform technologies for medical devices and diagnostics.

Funded by India’s central government and through a loan from the World Bank, the Mission will be implemented by the Biotechnology Industry Research Assistance Council (BIRAC), a unit of the  Department of Biotechnology. Renu Swarup, managing director of BIRAC said, “This mission is not for new discovery, but for creating infrastructure to move important early leads, which are in different stages, through the pipeline, and create products.”

Research

The National Biotechnology Development Strategy 2015-2020 announced by the Department of Biotechnology lays emphasis on making India ready to meet the challenge of achieving a $100 billion biotech industry by 2025, reports the Indian Express.

June 8, 2017   No Comments

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