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

National Security Advisor McMaster meets PM Modi

On his first official visit to the region, United States National Security Advisor H.R. McMaster,  met Prime Minister Narendra Modi in New Delhi, this week. McMaster is the highest ranking Trump administration official to visit India so far.

“The two sides discussed a range of bilateral and regional issues, including their shared interest in increasing defense and counter-terrorism cooperation,” the U.S. Embassy in New Delhi said after the meetings. “NSA McMaster emphasized the importance of the U.S.-India strategic relationship and reaffirmed India’s designation as a major defense partner,” it said, noting that the meetings were ‘productive’.

McMaster-Modi Meeting

The Indian side said, “The Prime Minister recalled his positive telephonic conversations with President Trump that reaffirmed the importance attached by both sides to the strategic partnership and to stepping up India-U.S. engagement across the board.”

During the meeting, both McMaster and Modi exchanged views on “how both countries can work together to effectively address the challenge of terrorism and to advance regional peace, security and stability,” reports the Indian Express.

 

April 20, 2017   No Comments

Templeton Buys $1.2 Billion India Government Bonds

New York City‘s Franklin Templeton Investments bought about $1.2 billion of Indian government bonds in two days end March. The purchases, made through broker JPMorgan Chase & Co, were largely for tenures maturing in 2021-2023.

Since March 11, when Prime Minister Narendra Modi’s party won an election in the state of Uttar Pradesh in the north, foreign funds have been pouring into India, driving stocks to a record high and pushing up bond prices, reports Mint.

Stock chart

“The outcome of state elections, a dovish hike by the Federal Reserve and relatively attractive valuations have been the key drivers of inflows,” said Nagaraj Kulkarni, a senior rates strategist at Standard Chartered Plc in Singapore.

 

March 30, 2017   No Comments

Westinghouse Nuclear Project in India Still Alive

The bankruptcy filing at  Westinghouse Nuclear threatened to scuttle the multi-billion-dollar reactor deal made by former U.S. President Barack Obama and India’s Prime Minister Modi during the Washington summit last June, , Westinghouse CEO Jose Gutierrez was in India for talks with state-run National Power Corp of India Ltd and the Department of Atomic Energy that reports to Prime Minister Narendra Modi.

India’s Larsen & Toubro, a potential partner that has signed a memorandum of understanding with Westinghouse to supply nuclear plant elements and do civil works, still views the India project as viable.”As long as the guarantees are in place, I see no reason why this won’t go ahead,” Shailendra Roy, head of L&T’s power business, told Reuters,.

Westinghouse Electric Company

The Export-Import Bank of the U.S. however, has lacked a quorum on its board of directors, preventing it from issuing loans over $10 million, and this may also slow down the financing of any deal.

 

March 21, 2017   No Comments

Global Automakers Seek Partnerships and Mergers in India

Germany’s Volkswagen and India’s Tata Motors signed a memorandum of understanding to develop components, and possibly new vehicles. Volkswagen’s Skoda Auto AS will join the project on behalf of the German automobile group. Volkswagen CEO Matthias Mueller said the partnership would help it “achieve sustainable and profitable growth in very different parts of the world.”

Toyota is in talks to form a business partnership with Japan’s Suzuki, in areas such as green vehicles, safety and information technologies, and mutual supply of products and components. Toyota President Akio Toyoda and Suzuki chairman Osamu Suzuki met with Prime Minister Modi. According to a statement from the prime minister’s office, the executives discussed manufacturing opportunities in India, and the possibility of exporting cars from the country, reports CNN Money.

a hand shake

 Toyota has taken full ownership of small car specialist Daihatsu Motor Co., and the latter’s products are expected to be introduced in India in 2019.

March 14, 2017   No Comments