Diagnostic services by drones! Redcliffe Labs launches its first commercial Drone corridor in Uttarakhand

Source: Financial Express, 23 May 2022

Redcliffe Labs opened its first commercial Drone corridor in the remote hills, Uttarkashi to Dehradun last week. According to the company’s press statement on Monday, the recently concluded project was a part of the Redcliffe and Skye Air tie-up. Over the past three months, they have done 40 successful trials in North India.

The company also announced that Redcliffe Labs from 10th June will be operating two flights daily for both routine and specialized tests sample collection, in an attempt to bring affordable & high-quality diagnostic services. With this Redcliffe Labs will also add on to its extensive and ever-growing network of collection centres in over 120+ cities making diagnostic care accessible to the remotest areas of the country, the diagnostic major claimed.

“Our agenda of opening the first commercial Drone corridor in the remote hills of Uttarkashi is purely based on the concept of ‘flying with purpose’. Uttarkashi is one of the remotest but very important towns of Uttarakhand. Moreover, this was a record of doing Dx in one of the difficult T5 town connectivity. Redcliffe Labs collected samples from local clinics that have so far struggled to get Dx samples collected. Consequently, it takes weeks to get the report. With the opening of the new commercial corridor the turnaround time (TAT) is reduced to 24 hours,” Dheeraj Jain, Founder, Redcliffe Labs said in a statement on Monday.

Jain also stated that this will help Redcliffe Labs move ahead in its journey of providing affordable and high-quality diagnostic services to people across the Indian subcontinent. Moving ahead with initiatives like this we will be able to connect the remotest corners, hilly regions, and other tough-to-reach terrains, to all our labs and change the landscape of diagnostics in India. 

“Our team is thrilled to connect the people of Uttarkashi with our Lab services, especially as Uttarkashi is a geography with poor road connectivity, people have limited access to quality diagnostic services. Now with easy and quality access people no longer have to travel to the bigger cities for meeting their diagnostic needs,” he added.

Uttarkashi to Dehradun by road is 144 km, 6-8 hours by road and 12 hours during a landslide. But using drone technology this distance was covered in 88 minutes with one battery swap in between. Redcliffe Lab delivered a 5 kg payload in temperature-controlled boxes from Gyansu, Uttarkashi to Vivek Vihar, Dehradun, which is 60 KM aerial distance. It is also worthwhile to mention that the diagnostic service provider aims to reach 500M+ Indians by 2027, it stated.

“Redcliffe Labs is planning to expand its operations in the country through a series of upcoming initiatives in the next 12 months. By leveraging drone technology to collect Dx samples is one such initiative.” further said Dheeraj Jain.

Genes2Me launches NGS-based clinical panels for oncology, personalised medicine and hereditary diseases in India

Source: Financial Express, 23 May 2022

Genes2Me announced on Monday the launch of its wide range of Next-generation sequencing (NGS)-based panels for oncology, personalised medicine, and hereditary diseases. According to the company’s press statement, by selectively targeting the clinically significant genes, these NGS panels enable comprehensive analysis with the most effective sequencing throughput. These panels have been designed and validated for all the common NGS platforms from Illumina, Thermo Fisher ION, and MGI, the company claims.

The company also informed that the Genes2Me PAN Cancer panel has coverage of 525 genes. “With just 50 ng of nucleic acid, the panel can detect the following biomarkers in one assay: single nucleotide variations (SNVs), insertions/deletions (INDELs), copy number variations (CNVs), microsatellite instability (MSI), fusions, splice variants and oncogenic viruses, as well as measuring the tumour mutation burden (TMB),” the IVD kit manufacturers said in a statement.

Moreover, the Liquid Biopsy NGS panels for colon, breast, and lung cancer are quite unique where superior detection sensitivity for low-frequency variants can be achieved from a limited amount of Blood samples. Additionally, the NGS panels for Personalised Genomics allow for precise selection and dosage of prescribed drugs, and detection of genetic variants associated with drug metabolism, epilepsy, and anti-tuberculosis, the company claims.

Genes2Me’s Clinical Exome Sequencing (CES) Extended panel allows comprehensive genomic profiling of a variety of genetic diseases including over 7,500 clinically significant genes that are not covered in any other panels, the company claimed. The other targeted panels for Cardiovascular disorders, Neurological conditions, Bleeding Disorders, Metabolic disorders, Dermatology, etc. will also ease the classification of these complicated conditions. All these NGS panels are backed with Automated Data analysis pipelines which simplify the Primary, Secondary, and Tertiary analysis.

 “The new range of NGS clinical panels from Genes2Me is an exciting development in the Molecular diagnostics space. Till now, most the Diagnostic Labs and Hospitals are having In-house Next Generation Sequencing platforms. These Instruments have been under-utilised as of now due to the unavailability of Easy-to-Use and Cost-Effective Clinical Assays on these platforms which can be directly used for Diagnostic purposes. The clinical panels from Genes2Me have been coupled with Analysis pipelines which allow every NGS lab for targeted testing of these complex disorders (with simplified wet lab and analysis workflow) enabling clinicians to make accurate decisions for Diagnosis, Prognosis, and Therapy against these conditions,” Neeraj Gupta, Founder, and CEO of Genes2Me said in a statement.

Covid-19 pandemic: Govt issues revised norms for international visitors

Source: Business Standards, 21 October 2021

Travellers from South Africa, Brazil, Bangladesh, Botswana, China, Mauritius, New Zealand Zimbabwe and countries in Europe, including the UK, would need to follow additional measures on arrival.

Travellers fully vaccinated and coming from a country with which India has reciprocal arrangements for mutual acceptance of WHO approved Covid-19 vaccines shall be allowed to leave the airport and need not undergo home quarantine and testing from October 25, according to the revised guidelines for international arrivals released on Wednesday.

They will, however, have to produce a negative Covid-19 RT-PCR report. If partially or not vaccinated, the travellers need to undertake measures which include submission of sample for post-arrival Covid-19 test at the point of arrival after which they will be allowed to leave the airport, home quarantine for seven days, re-test on the eighth day of arrival in India and if negative, further self monitor their health for next seven days.

These guidelines for international arrivals supersede of all guidelines issued on the subject on and after February 17, 2021, the Union health ministry said.

“The existing guidelines (issued on 17th February 2021 with subsequent addendums) for international arrivals in India have been formulated taking a risk-based approach,” the ministry said. This Standard Operating Procedure shall be valid from October 25 till further orders.

WTO members should start text-based talks on patent waiver proposal: India

Source: Financial Express, June 1, 2021

A proposal was submitted by 62 co-sponsors — including India, South Africa, and Indonesia — seeking patent waivers to manufacture COVID-19-related medical products.

The World Trade Organisation (WTO) members must infuse some certainty during this crisis by agreeing to initiate text-based talks on the proposed patent waiver proposal to deal with the COVID-19 pandemic, India has said.

According to India’s statement delivered at a TRIPS informal meeting held on May 31, the country has requested to find ways and means to commence text-based negotiations, even if few members continue with their repeated attempts to delay the process.

A proposal was submitted by 62 co-sponsors — including India, South Africa, and Indonesia — seeking patent waivers to manufacture COVID-19-related medical products.

In October 2020, India and South Africa had submitted the first proposal, suggesting a waiver on the implementation of certain provisions of the TRIPS Agreement in relation to the prevention, containment or treatment of COVID-19.

The agreement on Trade-Related Aspects of Intellectual Property Rights or TRIPS came into effect in January 1995. It is a multilateral agreement on intellectual property (IP) rights such as copyright, industrial designs, patents and protection of undisclosed information or trade secrets.

“The virus has not given us a timeout to go on endlessly discussing the need for or benefit of a waiver. We must rather infuse some certainty in these uncertain times by agreeing to start text-based negotiations on the waiver proposal,” India said in the statement.

Not allowing text-based negotiations will do “more harm” to WTO’s credibility and this collective failure will be remembered by posterity, according to the statement.

Several rounds of discussions on this proposal have taken place over the past months. The co-sponsors of the proposal have provided comprehensive responses, including written responses, to many of the concerns and questions raised by the members.

“There is no dearth of arguments, rationale and data provided to exhibit both the waiver’s significance and its urgency,” it added.

The TRIPS waiver is a necessary, proportionate and temporary legal measure for removing IP barriers and paving the way for more companies to produce COVID-19 vaccines, therapeutics or diagnostics by providing them with the freedom to operate without the fear of infringement of IP rights or the threat of litigation. “We as cosponsors of the waiver proposal recognise that IPs are not the only barrier to augmenting manufacturing and addressing supply-side constraints. However, we do believe that IPs are the biggest barrier in addressing supply-side constraints, and thus need to be addressed on priority. The waiver is not sufficient, but rather a necessary element of a multipronged strategy,” the statement said.

Govt gives nod to several firms under PLI scheme for medical devices

Source: Business Standard, Feb 11, 2021

New Delhi: The government has approved applications from several medical devices manufacturers under the Production Linked Incentive (PLI) scheme for the promotion of domestic manufacturing, an official statement said.

The companies include Siemens Healthcare, Sahajanand Medical Technologies,Nipro India Corporation and Wipro GE Healthcare, the Ministry of Chemicals and Fertilizers said.

The setting up of these plants will lead to a total committed investment of Rs 729.63 crore by the companies and employment generation for about 2,304 persons, it added.

“The commercial production is projected to commence from April 1, 2022 and the disbursal of production linked incentive by the Government over the five years period would be up to a maximum of Rs 121 crore per applicant per target segment,” the statement said.

The setting up of these plants will make the country self-reliant to a large extent in the specified target segments in the medical devices sector, it added.

Applications were invited under four different target segments, including cancer care/radiotherapy medical devices, radiology and imaging and nuclear imaging devices, anaesthetics and cardio-respiratory medical devices, including catheters of cardio-respiratory category & renal care medical devices, and all implants including implantable electronic devices, the ministry said. The Department of Pharmaceuticals had launched a PLI scheme for promotion of domestic manufacturing of medical devices to ensure a level playing field for the domestic manufacturers with a total financial outlay of Rs 3,420 crore for the period 2020-21 to 2027-28, it added.

Fujifilm to invest $200 mn to open 100 health-screening centres in India

Source: Business Standard, Feb 04, 2021

New Delhi: Fujifilm on Thursday said it plans to invest around USD 200 million (about Rs 1,450 crore) to open 100 health-screening centres in India to test 10 common cancers.

Fujifilm and Dr Kutty’s Healthcare on Thursday launched the first of these ‘NURA centres’, equipped with artificial intelligence (AI) enabled imaging and expert healthcare in Bengaluru, the companies said in a statement.

The centre can correctly test 10 common cancers — oral cancer, breast cancer, cervical cancer, lung cancer, stomach cancer, colon cancer, prostate cancer, esophageal cancer, laryngeal cancer and early signs of leukemia along with other lifestyle diseases.

Masaharu Morita, global marketing and new business manager, Modality Solution, Medical Div, Fujifilm said: “In the coming years, we plan to invest around USD 200 Mn to set up 100 such NURA centres across the country.”

With NURA, “our vision is to introduce the culture of periodic health screening in India, as we believe that early detection and treatment are very important to improve the survival rate of cancer patients,” he added.

“Together with Dr Kutty’s Healthcare expertise, we will continue to support the development of medical care by providing state-of-the-art products and services that contribute to improved health and quality of life of people worldwide,” Morita said.

Dr Kutty’s HealthcarePresidentMohamed Kasim said, “We are committed to providing sustained health through NURA by leveraging our experience in healthcare and high-quality scanning and image processing technology offered by Fujifilm.”

In addition to 10 cancer tests, the centres will provide total medical examination services such as early detection of risks of metabolic syndrome and locomotive syndrome, for the examination of lifestyle-related diseases such as chronic obstructive pulmonary disease and myocardial infarction, Fujifilm said. The health screening centres will actively leverage intelligent AI-technology to improve outcomes for both the patient and the doctor by making the screening process safe and more accurate, it added.

Thermo King expands its coldchain portfolio in India

Source: The Hindu Business Line, Jan 05, 2021

With India set to distribute Covid-19 vaccines, Thermo King, by Trane Technologies, whose cold chain products are used by FedEX and UPS to deliver Pfizer vaccine in the US, has launched its expanded portfolio of cold chain solutions in India. These cold chain solutions can keep vaccines at temperatures from a range of +25° C to as low as -70° C.

The company’s advanced cold chain technologies will help address the unique challenges of Covid-19 vaccine distribution in India, whose large population is spread across vast and varied geographies, from densely populated cities to far-flung rural communities, stated a company release.

“Safety and reliability of the cold chain is critical to meeting the urgent need for everyone to have access to vaccines,” said Allen Ge, president of Trane Technologies in Asia Pacific.

“Our recently launched SuperFreezers were initially developed to flash-freeze high-end seafood. Our teams quickly adapted and developed a good solution for Covid-19 vaccines transport, which require ultra-cold temperatures to prevent degradation.”

Thermo King’s refrigerated solutions can extend the life of dry ice or even eliminate the need for it, said the release. As more Covid-19 vaccines are approved, they will have different temperature requirements – some will need very low temperatures, while others will require typical refrigerated conditions.

Thermo King technologies can maintain and monitor temperatures across climate conditions, temperature needs, and modes of transportation – air transport, marine, rail, trailer, last-mile delivery, it added. Thermo King products are being used by transport companies such as FedEx and UPS which are directly involved in the transport and distribution of the Pfizer vaccine in the US.

Best time to invest in pharma, medical device sector: Sadananda Gowda

Source: Business Standard, Oct 01, 2020

New Delhi: This is the most opportune time to invest in theIndian pharma and medical device sector as the government is extending production linked incentives for new manufacturing units in the upcoming bulk drug and medical devices parks,Union Minister DV Sadananda Gowda has said.

The Indian pharma sector, currently valued at USD40 billion, has the potential to become a global pharmacy hub in the coming years, the Chemicals and Fertilisers Minister said in a statement.

The sector is likely to grow to USD 65 billion by 2024, and to USD 120 billion by 2030, he added.

The medical devices industry in India has the potential to grow at 28 per cent per annum to reach USD 50 billion by 2025,Gowda said.

The Indian pharma and medical device sector has immense potential to contribute towards making India a 5 trillion-dollar economy in the next 4-5 years, he added.

The government is supporting development of 3 bulk drug and 4 medical device parks with state-of-art infrastructure and world-class centres of excellence across the country, Gowda said.

“Government will also provide production linked incentives to eligible new manufacturing units to ensure a level playing field to domestic manufacturers,” he added.

It is expected that the schemes of the government for development of bulk drug and medical device parks will attract cumulative investment of Rs 78,000 crore and can generate about 2.5 lakh employment,he added.

“There is a need for the pharma industry to focus on R & D activities in order to remain as one of the leading global suppliers of medicines,” Gowda said.

The full potential of growth cannot be tapped unless the sector comes up with discovery of new drugs or repurposing in India,he added. Gowda also expressed hope that the Indian pharma sector will be among the first ones to develop and supply low cost vaccines for COVID-19.

Centre plans on tweaking drug policy that exempts foreign medicines from price control

Source: The Economic Times, Aug 06, 2020

NEW DELHI: The government plans to tweak a provision that allows new medicines developed by foreign companies to be exempt from price control for five years after criticism that it goes against the Make in India policy and discourages local drug manufacturers.

The Department of Pharmaceuticals and the National Pharmaceuticals Pricing Authority are in discussions about revisiting paragraph 32 of the Drugs (Price Control) Order of 2013, which lists out the exemptions, people aware of the matter told ET.

The government broadened the five-year exemption from price control for new foreign drugs patented in India through an amendment in January 2019. The amendment removed a requirement that the drugs should have been developed through indigenous R&D. This included orphan drugs used to treat rare medical conditions.

Senior officials in the Department of Pharmaceuticals said the move was aimed at giving Indian patients access to drugs that are available only abroad.

However, domestic drug makers and civil rights activists criticised the amendment and complained of high prices and unequal treatment. Experts said the move went against the government’s Make in India policy because it discourages Indian companies from developing and producing patented drugs. The government would also be helpless in an emergency, they said.

“The move will restrict the government from putting expensive drugs under price control, regardless of a public health emergency. Most likely, it would encourage foreign pharmaceutical companies to manufacture and commercialise their new patented drugs and medical devices in India,” said a pharma expert.
The National Pharmaceuticals Pricing Authority also faces the problem of companies launching products and excluding them from the price control regime without first applying for exemption.

“The companies have tried to utilise it and the government is fighting cases in the court with these companies. The government should scrap this amendment as it has only helped multinationals to launch their products at exorbitant prices by claiming that they are patented products,” another expert said.

Indian API makers benefit as global buyers ditch China

Source: The Economic Times, Jul 29, 2020

MUMBAI: India’s bulk drug manufacturing companies have reported increased enquiries from global customers seeking to reduce their dependency on China, rating company India-Ra, a part of the Fitch Group, said in a report this week.

However, India and other countries still remain largely dependent on China for the raw material used to make drugs, known as active pharmaceutical ingredients (API).

“Indian API players are witnessing benefits of better inventory management and thrust on supply chain continuity from customers. Customers’ procurement strategies are recalibrating and are now moving away from China or seeking alternative sources for the same API,” said Krishnanath Munde, associate director at Ind-Ra.

Price sensitivity among formulation companies is declining amid a receding threat of supply chain disruptions from Chinese suppliers, which had also occurred in the past, he said. Considering that India has the highest number of API facilities approved by the US Food and Drug Administration, it will remain a critical part of the global supply channel, Munde noted.

Indian pharma companies have seen a rush of demand for key drugs used in the treatment of Covid-19 in the past two months.