Industry News

Highlights on market developments and company updates from India and around the world. Stay tuned!

Premaitha Health to partner with leading diagnostic laboratory to offer NIPT

Premaitha Health announced a partnership with a leading diagnostic laboratory in India to offer non-invasive prenatal screening.  The NIPT technology acquired through the acquisition of Taiwanese company Yourgene in 2016  is developed on a Thermo Fisher Scientific next-generation sequecing platform. The acquisition provided Premaitha access to Yourgene's existing customers in Taiwnan, India, Thailand, Indonesia and Malaysia.

The three year NIPT agreement with an undisclosed partner will be operational by fourth quarter of 2018 with the NIPT analysis being performed at the bioinformatics center in Taiwan. 

India promises to be a significant growth market for Premaitha with a population of 1.28B1 and growing at 1.17%1.

Source: Premaitha Press Release


1. Index Mundi

India amends Clinical Establishment Rules to prescribe minimum standards for medical laboratories

The Department of Health and Family Welfare under the Ministry of Health and Family Welfare, Government of India has amended the Clinical Establishment Amendment Rules of 2012 to prescribe minimum standards for laboratory facilities performing pathological, bacteriological, genetic, radiological, chemical or other biological investigations tests related to diagnosis or treatment of disease. 

The standards provide guidance on scope of services, infrastructure, safety measures, human resources, space requirement, legal, records and standard operating procedures for medical laboratories to operate and provide services. The amended rules will be called Clinical Establishments Amendment Rules, 2018 and were published in The Gazette of India on May 18, 2018. (The Gazette of India is a legal publication for all all Governement of India publications)

Source:  Ministry of Health and Family Welfare, Government of India

India’s premier policy think tank reviewing policies to promote ‘Make in India’ initiative for medical devices

In a move to further incentivize local production of medical devices and boost the growth of the medical device industry in India, India's premier Government of India policy think tank Niti Aayog,  is taking  a fresh new look at how it can promote the local medical device sector. 

A meeting was recently held with senior government and industry representatives to review ways to remove roadblocks for the medical device industry.  On the table for consideration were easing  regulatory processes, tax breaks, land lease rates, retailer margins and import duties. Since launching the ‘Make in India’ campaign in Sep 2014, the government has initiated several efforts including 100% FDI in medical devices to ignite local manufacturing. Though medical devices are currently regulated under the Drugs and Cosmetics Act, the government is also considering the introduction of an independent new Act exclusively for medical devices. 

The Federation of Indian Chambers of Commerce & Industry estimates the Indian medical device industry to be valued around USD 4.9 B with CAGR at approximately 17%.  The import of medical devices had grown from USD 2.46 billion in 2012 to USD 2.87 billion in 2016. About 40% of consumables used locally are imported, technologically intensive devices such as implants and other patient aids market is met mostly by imports.

Source: The Economic Times 

Source:  Federation of Indian Chambers of Commerce & Industry

Apollo Hospitals to implement IBM Watson for Oncology and Genomics to improve patient care

Indias leading hospital chain, Apollo Hospitals recently announced their partnership with IBM to offer precision medicine enabling IBM Watson for Oncology and Watson for Genomics to improve patient care within their hospital network in India. 

According to an IBM press release, the cognitive computing platforms will be implemented in 10 out of Apollo's 64 hospitals. Bangalore, Chennai and Delhi will be the first cities to offer this to Apollo oncologists followed by Mumbai, Kolkata, Madurai, Bhubaneshwar, Hyderabad and Madurai in the coming months. This is the first dual implementation of Watson for Oncology and Watson for Genomics in India. Manipal Hospitals, another leading Indian healthcare brand was the first to implement Watson for Oncology in 2016 to help patients being treated for breast, colorectal and lung cancer.

Neuberg Diagnostics expands global footprint into Western Asia and Africa

Neuberg Diagnostics, a newly formed international alliance of five laboratories from Bangalore, India;  Ahmedabad, India; Chennai, India; South Africa and Dubai is further expanding its global footprint into Africa and Western Asia regions. 

Chennai headquartered Neuberg will be opening new labs in Kenya and Tanzania this year with Nigeria and Ghana in the pipeline. Through an acquisition of Global Clinical & Viral Lab, a center for virology in Durham, South Africa, Neuberg will focus on addressing tuberculosis and HIV testing in the African market. 

Neuberg Diagnsotics Chairman GSK Velu had earlier this year talked about investing INR 300 crore for further expansion and growth. The company will also be expanding its portfolio into other personalized medicine initiatives. 

Co-Diagnostics provides key updates in annual report

In it’s initial annual report filed in form 10-K, Co-Diagnostics provided important updates on its expansion in the US, Indian and Dominican Republic markets. Co-Diagnostics, a molecular diagnostic Utah corporation, develops and manufactures molecular diagnostic tools and tests for infectious diseases, liquid biopsies and agriculture. 

In 2017, Co-Diagnostics formed a joint venture ‘CoSara Diagnostics’ with Synbiotics Private Limited to build a diagnostic test manufacturing facility in India. The company also signed a purchase agreement with MEDCIS Pathlabs Private Limited to purchase diagnostic tests for tuberculosis, Hepatitis B, Hepatitis C, HIV and human papillomavirus. Sales of these tests will commence third quarter 2018 through  CoSara Diagnostics. 

In addition, the company also discussed it’s new lease on a BSL-2 facility in Utah that will manufacture tests for the US market followed by exports outside the US. Working in collaboration with the Ministries of Health in the Caribbean region, Co-Diagnostics has made strides to tackle outbreaks of Zika virus, tuberculosis, malaria, West Nile virus, chikungunya and dengue with its vector control program. 

Co-Diagnostics reported annual revenue of $7662 in 2017 versus none for 2016.