Category — Healthcare

Jubilant Pharma Expected to Buy American Pharma Company

Noida, India-based Jubilant Life Sciences‘ subsidiary Jubilant Pharma will negotiate a potential acquisition of a specialty business in the U.S., subject to due diligence, satisfactory agreements, and final approval of Jubilant Life Sciences.

A vial of medicine for injection

 

BusinessLine reports on a company filing at the Bombay Stock Exchange that says, “the proposed acquisition is a niche, profitable specialty pharma business with a strategic fit and is expected to provide a competitive edge for Jubilant Life Sciences’ existing business, if it materializes.”

June 11, 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

Zydus Cadila Wins Pharma Patent Lawsuit in the U.S.

The U.S. Court of Appeals for the Federal Circuit has affirmed judgement in favor of Zydus Pharmaceuticals (USA) Inc., holding that its proposed generic version of Lialda does not infringe a U.S. Patent. Zydus is the first pharmaceutical company to file an abbreviated new drug application for a generic version of mesalamine in the U.S.

Zydus Cadila chairman and managing director Pankaj R. Patel said, “We welcome this decision which is a positive step and will help us further our mission of making available high-quality, affordable generic products to our customers and their patients.”

zydus logo

Shire Plc., a Jersey-registered, Irish-headquartered global specialty bio-pharmaceutical company reported an annual sales of $714 million for this product in 2016 in the United States, reports the Economic Times.

May 22, 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

‘Make in India’ Attracts Business from Italy

On a three-day business mission to New Delhi, India in April, a delegation led by Italy’s deputy minister for economic development, Ivan Scalfarotto, aimed to strengthen bilateral ties and make the most of the plentiful business opportunities that India has on offer.

The platform, promoted by the Italian Ministries of Economic Development and Foreign Affairs, in partnership with India’s trade bodies FICCI and CII, saw participation by various state representatives, along with 140 big enterprises and SMEs, across varied sectors, from both India and Italy. 80 companies, out of the total industry representation in the forum, in areas such as automotive, healthcare, defense, aviation and railways were from Italy exploring growth opportunities in India.

Ivan Scalfarotto at the India-Italy Business Forum

Ivan Scalfarotto at the Italia-India Meet

Speaking at the event, Scalfarotto said that more than 60 Italian automotive companies were working with 80 manufacturing facilities in India — most of them located in the Maharashtra belt — “and yet keeping an eye on the immense future potential,” reports Autocar Professional.

 

May 12, 2017   No Comments