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.

Govt releases guidelines for schemes to boost domestic manufacturing of bulk drugs, med devices

Source: The Economic Times, Jul 27, 2020

NEW DELHI: The government on Monday released guidelines for four schemes to boost domestic manufacturing of bulk drugs and medical devices as part of its drive to reduce dependency on imports for these critical products.

“In line with the vision of Prime Minister Narendra Modi, the schemes have been conceptualised for making India ‘atmanirbhar (self-reliant) in the pharma sector, chemicals and fertilisers minister D V Sadananda Gowda said.

The schemes—a production-linked incentive (PLI) scheme and industry park scheme each for bulk drugs and medical devices—seek to make India self-reliant in pharmaceuticals raw materials such as drug intermediates, active pharmaceutical ingredients (APIs) and key starting materials (KSMs), and medical devices.

Currently the country almost entirely depends on imports—mostly from China—for production/supply of 53 critical bulk drugs, while 86% of medical devices, too, are imported.

Bulk drug parks “will be based on plug and play model with prior regulatory approvals, state of art infrastructure, excellent connectivity, affordable land, competitive utility charges, and strong R&D ecosystem and so on”, Gowda said.

This will significantly reduce time and investment cost for setting up new manufacturing units. In addition, new units will be eligible for PLI scheme of the government, he said. “Eligible manufacturers will be selected for the PLI scheme on the basis of marks obtained in the evaluation criteria as per the guidelines.”
Ashok Madan, executive director of Indian Drugs Manufacturers’ Association (IDMA), said the industry has been waiting for detailed guidelines of the schemes notified last week.

“It’s for the first time that an impetus of Rs 10,000 crore is being given to augment API production in the country,” he said.

“Limiting the import content for production of listed 41 APIs/KSMs up to 30% is to encourage local manufacture with value addition for the production Linked Incentive,” Madan said.

The list of 41 products will enable domestic production of 53 key bulk drugs.

“Given the right implementation, India can aspire to be selfreliant in APIs/KSMs in 8-10 years,” Madan said.

The industry would like the government to support utilisation of idle capacities of medium API units with blanket environment approvals “subject to their complying with the overall pollution loads”, he said.

Indian e-health sector projected to grow by 13x to $16 bn by 2025: Report

Source: Business Standard, Feb 05, 2019

Bengaluru: The Indian e-health sector is expected to become a $16 billion opportunity by FY 2025, growing from $1.2 billion, at a compound annual growth rate of 68 per cent, according to a report by research firm RedSeer Consulting.

This growth will be driven by increasing consumer receptiveness towards eHealth models and rising provider and supplier willingness to partner with eHealth platforms. This is further supported by an increased influx of investments and pro-eHealth regulations.

Anil Kumar, founder and CEO of RedSeer said Indian consumers face a host of challenges in the traditional healthcare system – be it the availability of specialists or medicines at a nearby pharmacy or long waiting times to get diagnostic tests done.

“We believe e-Health platforms have a strong potential in changing the experience of the Indian consumer across the entire spectrum of outpatient services, across doctor consultation, diagnostics and pharmacy,” said Kumar. “Over the next 5 years, we project the e-Health market to exponentially grow to a $16 billion-market touching 57 million households, driven by positive reception from both consumers and providers along with supportive government regulations and investments,” he added.

As per RedSeer, the overall Indian healthcare industry is set to grow at 17 per cent CAGR until FY 2025 to reach $353 billion (7 per cent of the expected nominal gross domestic product). The firm prepared the report based on the insights from over 1200 consumers about their ‘eHealth’ experience. The report said the consumers significantly value the benefits of eHealth over the traditional outpatient care system across pharmacy, consultation and diagnostics categories.

One such e-health company is Medlife which is delivering medicines to over 25,000 pin codes and diagnostics in more than 400 towns across the country.

“Medlife is poised to end this year with a GMV (gross merchandise value) run rate of $220 million. We believe E-health and not just e-pharmacy is the mantra for this sector,” said Ananth Narayanan, CEO and co-founder of e-health company Medlife. “Our lab diagnostic business scale-up, expansion of our private label portfolio and the e-consultation platform will allow us to achieve stellar growth from these additional areas. We target to be over a $2 billion player by 2024,” said Narayanan. He said one of the biggest challenges for the sector are the fringe players who do not follow the laws and rules properly and cause a wrong perception of the industry as a whole. “We are eagerly awaiting the legislation on e-pharmacy to continue scaling the business. We believe that technology is key to provide access and affordability in healthcare. We are committed to making this happen,” said Narayanan.