Roche launches its next-gen COVID-19 rapid antibody test

Source: Financial Express, 04 October 2022

Roche on Monday announced the launch of the SARS-CoV-2 Rapid Antibody Test 2.0 in markets accepting the CE Mark. According to the pharma company, the test is the next generation of Roche’s existing SARS-CoV-2 Rapid Antibody Test, which was launched in July 2020.

“The SARS-CoV-2 Rapid Antibody Test 2.0 offers broader use than its original configuration, which focused on recovered patients, to now include vaccinated individuals as well. The test has also been updated to improve the detection of antibodies against variants of the virus, and continues to be investigated against new variants of concern,” the company claimed.

According to Roche, the SARS-CoV-2 Rapid Antibody Test 2.0 can be used by healthcare professionals in point-of-care settings outside clinical labs and near to patients with a capillary sample.

“The test should help healthcare professionals to identify patients that have developed antibodies against SARS-CoV-2, indicating prior infection or vaccination. The SARS-CoV-2 Rapid Antibody Test 2.0 is beneficial in situations where timely decisions are needed, laboratory SARS-CoV-2 testing is not available, or finger prick sampling is the better option over a venous blood draw,” the company stated on Monday.

Moreover, healthcare professionals can further use the test to help patients check their antibody status and to determine whether they still have a detectable antibody response from prior vaccination, it claimed.

“The next-generation of our SARS-CoV-2 Rapid Antibody Test demonstrates Roche’s continued commitment to innovate as the COVID-19 pandemic evolves. We are proud to introduce an improved antibody test that, given its point of care use, offers healthcare professionals greater speed and accessibility in providing the right care to those that need it,” said Ian Parfrement, Head of Point of Care at Roche Diagnostics.

The test’s launch is in partnership with SD Biosensor Inc., with whom Roche reportedly has a global distribution agreement and launched a range of rapid antigen and antibody tests in more than 50 countries worldwide.

The SARS-CoV-2 Rapid Antibody Test 2.0 joins Roche’s comprehensive diagnostic portfolio of solutions to help healthcare systems combat COVID-19, which also includes molecular, serology and digital solutions.

“When performed 3-4 weeks after vaccination, when IgG antibody levels are anticipated to reach their plateau, the test has a sensitivity of 98.67% and 100.00% after the second and booster shot, respectively. When performed at least 15 days after symptom onset for a non-vaccinated population, the test has a sensitivity of 95.83% and a specificity of 100.00%. The test’s ability to detect antibodies after vaccination against SARS-CoV-2 was confirmed through a clinical trial which included patients vaccinated with vaccines from Moderna, Pfizer/BioNTech, AstraZeneca and Johnson & Johnson,” the company claimed on Monday.

Pharma major Lupin collaborates with Accenture to enhance its operational efficiency

Source: Financial Express, 21 June 2022

Lupin Limited (Lupin) announced on Monday that it has collaborated with Accenture for improved business agility, performance, and operational efficiency. According to the company’s press statement, Accenture deployed a digital platform based on SAP S/4HANA® and it provides decision-makers with real-time visibility into integrated data from multiple sources including supply chain, people, and sales networks spread across 100+ countries and its fifteen manufacturing and research facilities in India, United States of America, Brazil and Mexico.

Moreover, the consolidated view of global business operations and performance has enabled informed decision-making. Additionally, SAP Fiori apps have also helped enhance the user experience for Lupin employees with simple and easy-to-access data models and analytical reports, the company claims.

“Lupin is committed to providing affordable healthcare to people across the world, and our data-driven digital platform will play a crucial role in this mission. Through our collaboration with Accenture, we will unlock the value of enterprise data in order to increase efficiencies and accelerate innovation across all our functions and processes, including manufacturing, testing, supply chain, and finance and accounting,” said Sreeji Gopinathan, CIO, Lupin.

“As Indian multinational pharmaceutical companies look at navigating supply chain disruptions and gaining a stronger foothold in the global economy, digital transformation will play a key role in advancing competitiveness by running more efficient business processes, improving research and development capabilities, and creating better customer experiences. With our deep industry experience and technology capabilities, we are helping Lupin become an intelligent enterprise by enabling data-driven decisions that will help accelerate product innovation and enable faster access to market,” Sameer Amte, lead for Accenture’s Life Sciences practice in India stated.

Domestic manufacturing of key ingredients must be ramped up to reduce dependence on other countries: Sudarshan Jain, IPA

Source: Financial Express, 11 May 2022

According to an IBEF report, the Indian pharmaceutical market is set to grow at a CAGR of 37% from 2020-2025 and is expected to reach US$ 50 billion. Also, India is the world’s largest producer of generic drugs globally and supplies over 50% of world’s demand for various vaccines. India ranked 3rd in terms of pharmaceutical production by volume and 14th by value. India’s position is getting strengthened in the global pharmaceuticals sector. The government of India has recognized the vital role of the pharma sector in realizing India’s vision of ‘Atma Nirbhar Bharat’. In an exclusive interaction with FinancialExpress.com, Sudarshan Jain, Secretary General, Indian Pharmaceutical Alliance said that the Indian pharma industry is ready to expand in terms of innovation, research and development capabilities to offer cutting-edge products at competitive prices. Excerpts:

What are the urgent interventions needed to fuel innovation and R&D in the sector?

Today India has a strong starting position in generic drugs, but India will need to move up the value chain and get into the innovation space which accounts for 2/3rds of the total global market. The key interventions that are critical are:

Creating an enabling regulatory environment in the country that encourages and enables innovation and research in the drug discovery and development of the pharma sector. For instance, having a ‘single window system’, elimination of multiple regulatory bodies, establishing detailed guidelines, ongoing dialogue between the regulator and the industry , among others.

Incentivizing and funding research: Explore mechanisms to incentivize private sector investment in research and evaluate various funding mechanisms – research-linked incentives Budgetary support, Venture capital, fiscal and non-fiscal incentives

Enabling Industry-academia collaboration to promote industry-oriented research. Strong policy framework for collaboration for moving academic discoveries into the commercial. Setup of strong governance framework to build accountability through strong program management; Development of conducive external ecosystem through setup of independent bodies to catalyze collaboration. It will require infrastructure support such as technology transfer offices, centers of excellence to harness academic talent and development, incubation centers, provision for exclusive licensing deals and more

Monitoring progress and impact: An “Innovation index” can be a holistic yardstick to track progress across the building blocks, course correct as required and assessing the deliverables

What are the key growth drivers for the Indian Pharma sector post the pandemic?

The Government of India has also recognized the vital role of the pharma sector in realizing India’s vision of an ‘Atma Nirbhar Bharat’. The sector is now ready to expand its innovation, research and development capabilities to offer cutting-edge products at competitive, affordable prices. If we talk of key growth drivers – the industry needs to build capacities across business functions to help India achieve its vision of growing its pharmaceutical industry to $130 bn by 2030. Consolidating extant export markets and exploring newer markets thereby expanding global footprint will be important. More and more pharmaceutical companies need to venture into specialty and innovation-areas such as biosimilars, complex generics, novel biologics, customized medicines, preventive medication and in addressing unmet patient needs to expand our market.

As the industry’s product portfolio shifts towards more complex products, the demand for operations and highly skilled personnel for the manufacture of these products will also increase. Expanding and upskilling the talent pool to handle complex technologies will become crucial. An enabling policy environment is required that encourages drug discovery and new research, streamline drug development processes by avoiding multiple levels of regulatory approval, facilitating fast-track approvals and new funding sources to encourage private sector investment in R&D and innovation. An overarching core multi-sectoral committee involving key stakeholders should be created to enable thought leadership, cross-stakeholder dialogue, collaborations, partnership models and integrated initiatives.

What are your views on FTA with Australia? What are the new markets India can look at?

India and Australia have signed a Comprehensive Economic Cooperation Agreement (CECA) with the aim of increasing bilateral merchandise trade. It will further cement the already deep, close and strategic relations between the two countries. This agreement contains scope for enhancement in bilateral trade through improved access.

One of the major positive steps forward provided by the Agreement is that the Therapeutic Goods Administration (TGA) of Australia will utilize reports from a comparable regulator as recognised by it in relation to the pre-market evaluation of products. Further, the TGA may utilize Good Manufacturing Practice (GMP) inspection reports from regulatory authorities recognised by it as a comparable regulator in relation to the quality assessment of manufacturing facilities in India. This opens the pathways for fast-track approvals for Indian pharmaceutical products and manufacturing facilities having approvals from at least one of the Regulatory Authorities/ reference countries. This is an important milestone as Indian companies approved by Comparable Overseas Regulators (COR) will have expeditious approvals, and thereby, rapid market access in the Australian pharmaceutical market.

What are the new funding avenues that can be explored to encourage private sector investment in R&D?

The Government has a key role in facilitating funding access to enable India to elevate R&D to the level of advanced countries. Firstly, the regulatory bottlenecks to funding must be dealt with; and a focused strategy is important. Also, the risks associated with investing in R&D are high and many organizations do not have the capacity to garner funds on their own. An ecosystem view is necessary for funding as well, because after the early-stage, pharma companies, investors, and the equity market need to support late-stage funding. The Government can also provide direct support through tax deduction, subsidies and research grants similar to what is being initiated in other countries. Research-Linked Incentive Schemes can also be beneficial to drive increased investment in innovation. A recent example is a statement by our Health Minister, on how amid the pandemic, the PLI scheme by the Government helped India reduce imports and initiate production of more than 35 drugs in India.

Also, financial markets could be supported in offering incentives for investing in innovation such as private equity, innovation bonds, crowdfunding and P2P lending, among others. Further, as an indirect enabler, it is critical to enhance the credibility of Indian talent to encourage investors to fund innovation in India. It is important to leverage our skills in data and digital and move from classical research to new technology platforms and digital analysis.

What kind of policy changes will help in the growth of domestic manufacturers?

A fundamental enabler for a vibrant innovation ecosystem is a strong and efficient regulatory setup which facilitates a ‘single window system’, eliminates multiple regulatory bodies, establishes detailed guidelines and fosters dialogue between regulators and the industry. The Government could create immediate and direct impetus through initiatives such as research-linked incentives, grants, subsidies as well as higher tax aids for R&D. Further, financial markets could be supported in offering incentives for investing in innovation through varied, non-traditional pathways. In addition, there is a need to strengthen academic industry linkages, collaborating across institutions and sectors and building supporting infrastructure.
API requirements must be given top priority – Domestic manufacturing of key ingredients for vaccines and medicines must be ramped up to reduce dependence on other countries. Investors and innovators are keen to work together to overcome this challenge. The Government has also taken some important steps to fulfil India’s domestic healthcare needs and help the industry to be self-reliant, utilize technology and boost volumes through production-linked incentive schemes for APIs, Key Starting Materials (KSM) and intermediaries, among others, with a sizeable financial outlay of 6940 crores.

Involvement of the Department of Biotechnology (DBT), Department of Science and Technology, Council for Scientific and Industrial Research (CSIR) to foster ‘Make in India’ is of critical significance. Continuation of the national Bio-pharma Mission, and Mission Covid-Suraksha, conceptualized by DBT, is necessary, as it turned out to be a great facilitator for innovation in vaccines. Sustained focus on National Biotechnology Development Strategy (2021-25) which will also be one of the catalysts for change, going forward. The formation of innovation and API clusters should help to catalyse these areas going forward.

How important is it for the Indian pharma sector today to match global quality standards and benchmarks?

Driving excellence in pharma quality through capability building, global benchmarking and sharing best practices is one of the focus areas of IPA. The IPA has had a focused Quality Forum since 2015. IPA is driving several initiatives around quality standards in pharma manufacturing. This includes helping Indian pharma manufacturers to be the global benchmark in quality, be the conduit of change in the industry through leadership, knowledge development, best practice sharing and engagement across the industry. We engage in benchmarking activity with companies, share best practices on pertinent topics of quality and conduct capability building programmes such as advanced GMP workshops every year.

We have come out with several guidelines and best practices documents – such as Best Practices on Cleaning Methodology and Validation, Best Practices in Media Fills, Focus on First Cycle Approvals of ANDAs and Visual Inspection of Sterile Products. Our Quality Conference is held every year where regulators from developed countries and India along with company representatives exchange knowledge on the latest developments and standards. While the industry is moving towards complex products, driving automation and integrating new technologies, the current good manufacturing standards (cGMP) are evolving rapidly across the globe. IPA is committed to quality. The thrust is to position India being recognized as the Pharmacy of the World, providing affordable and quality medicines. We want to move up the value chain from “Make in India” to “Make and Discover in India”.

DGFT extends deadline for track and trace system in pharma exports till April 1, 2022

Source: The Hindu Business Line, Mar 30, 2021

The Directorate General of Foreign Trade (DGFT) has extended the deadline for implementation of the track and trace system in pharma exports till April 1, 2022.

A public notice has been issued by the DGFT in this regard.

According to the DGFT’s previous order, the system was to be implemented from April 1, 2021.

“With this, the date for implementation of Track and Trace system for export of drug formulations with respect to maintaining the Parent-Child relationship in packaging levels and its uploading on Central portal has been extended till April 1, 2022,” R Uday Bhaskar, Director General, Pharmaceutical Export Promotion Council told BusinessLine. The Pharmexcil had earlier represented to the Commerce Department on the difficulties expressed by its member exporters with respect to the implementation of track and trace and had requested for an extension of timeline.

Biocon partners with Libbs Farmaceutica to launch generic drugs in Brazil

Source: Business Standard, Mar 30, 2021

New Delhi: Biotechnology major Biocon on Monday said its subsidiary has joined hands with Libbs Farmaceutica to launch generic drugs in Brazil, the world’s sixth most populous country.

Biocon Pharma, a unit of the company, has tied up with Brazil-based Libbs Farmaceutica to introduce generic formulations in the Latin American country, Biocon Ltd said in a statement.

This partnership, which marks the entry of Biocon’s generic formulations into Latin America, builds upon a successful association with Libbs, which began in 2017 to launch biosimilar Trastuzumab in Brazil, it added.

As part of the out-licensing deal with Libbs, Biocon Pharma will be responsible for drug development and manufacturing, while Libbs will leverage its deep expertise and reach in Brazil to import, distribute and market, subject to approvals from the Brazilian health regulatory agency, ANVISA.

“Expanding our association with Libbs Farmaceutica, a trusted partner, to our generic formulations, will help us establish a firm footing in Latin America, starting with Brazil,” Biocon Ltd Chief Executive Officer and Managing Director Siddharth Mittal said.

The company remains committed to expanding its global presence with high quality and affordable medicines and invest in strengthening capabilities that enables it to serve patients globally, he added.

Libbs Executive President Alcebades de Mendona Athayde Junior said the partnership that is going to make a difference in patients’ lives. “We started with Biocon Biologics years ago, and we were very successful: our Trastuzumab became a leader in the private market, a milestone for our company. We will now continue making a difference in people’s lives with Biocon, with the goal to expand access to quality, safe and effective treatments to our patients,” he added.

Govt okays 33 API applications with Rs 5k cr investment under PLI scheme

Source: Business Standard, Mar 11, 2021

New Delhi: The government has approved a total of 33 applications with a committed investment of Rs 5,082.65 crore under the production linked incentive scheme for active pharmaceutical ingredients, an official release said on Thursday.

Setting up of these plants will make the country self-reliant to a large extent in respect of these bulk drugs, it noted.

The Department of Pharmaceuticals has launched a PLI scheme for the promotion of domestic manufacturing by setting up greenfield plants in four different target segments with a total outlay of Rs 6,940 crore for the period 2020-21 to 2029-30.

In total, 215 applications have been received for the 36 products spread across the 4 target segments, the Ministry of Chemicals and Fertilizers said in the release.

Nineteen applications with a committed investment of Rs 4,623.01 crore have already been approved under Target Segment I, II and III, it added.

Besides, 174 applications were received for 23 eligible products under Target Segment IV.

Out of 174 applications, 79 applications received for 11 eligible products were considered as per the decided evaluation and selection criteria by the Empowered Committee in its meeting held on February 27, 2021, the release said.

The applications of 14 companies that have committed minimum/more than the minimum proposed annual production capacities and fulfil the prescribed criteria have been approved, it added.

The setting up of these plants will lead to a total committed investment of Rs 459.47 crore and employment generation of about 3,715 by the companies, the release noted.

The commercial production of these plants is projected to commence from April 1, 2023, onward.

It has been further decided to take up the remaining 95 applications under the Target Segment-IV till March 31, 2021, for scrutiny and approval, as per the release. The government on February 25 also approved a production-linked incentive (PLI) scheme for the pharmaceutical sector, entailing an outlay of Rs 15,000 crore.

As demand for India’s Covid-19 vaccines rise, export of general vaccines slides

Source: The Hindu Business Line, Feb 24, 2021

Hyderabad: Even as overseas demand for Covid-19 vaccines from India has been picking up, the export of other vaccines in general has declined.

As per data of Pharmaceutical Export Promotion Council’s (Pharmexcil) data, there was a dip in vaccine exports in the current financial year up to January, 2021.

Compared with $695 million of vaccine exports during April-January in the last financial year, it decreased to $648 million in the same period this financial year.

“At the same time, over all pharma exports are showing double-digit growth. We expect vaccine exports to pick up soon as Covid-19 threat fades away,” R Uday Bhaskar, Director General, Pharmexcil told Business Line.

Covid vaccines

The demand for India-made Covid-19 vaccines, however, has been steadily increasing, Bhaskar said.

As per official data, over 25 countries had already received Indian vaccines and about 60 had already expressed interest and are in the ‘waiting list’.

India’s mass vaccination programme is currently on with two vaccines, Covishield of Serum Institute and Covaxin of Bharat Biotech which have attracted global attention.

According to Krishna Ella, Chairman and Managing Director, Bharat Biotech,the company is in the process of filing regulatory documentation in more than 40 countries.

According to a senior executive of the Hyderabad based vaccine-manufacturer, the general dip in the vaccine exports is a `one-time’ phenomena mainly due to `special’ circumstances created by Covid-19 pandemic for the last one year.

“There are gaps and discontinuities in general immunisation programmes in many parts of the world in the last one year on account of Covid and general restrictions. There has been drop in procurement from some NGOs too,” he said. Many experts at Asia’s biotech platform, which concluded here on Tuesday, stressed the need to continue general immunisation programmes along with measures to tackle Covid-19 to ensure the well being of people across the world.

Covid push: Pharma exports surge 16%, defy broader gloom

Source: Financial Express, Jan 15, 2021

India’s pharmaceutical exports grew an impressive 16% year-on-year in the first eight months of this fiscal, defying an almost 18% contraction in the overall mechandise exports, as the Covid-19 pandemic caused a spurt in demand for medicines, especially from the largest market — the US.

The rise is remarkable, especially in the light of initial Covid-induced disruptions in the supply chain and the temporary restrictions on the exports of 26 drug formulations and active pharma ingredients (APIs) — including paracetamol, tinidazole and metronidazole — to keep domestic supplies steady.

Exports of the pharmaceutical products — comprising drug formulations and biologicals, bulk drugs and drug intermediates — hit $15.3 billion between April and November, against $13.2 billion a year ago, showed the commerce ministry data. The data don’t include exports of certain fine chemicals.

Excluding the outbound shipments of pharmaceuticals, overall goods exports would have shrunk at a faster pace of almost 20% until November this fiscal, against 18%. The US, which was hit the hardest by the pandemic, typically makes up for about 30% of India’s exports.

The commerce ministry data showed that while exports of drug formulations and biologicals jumped by close to 18% to $12.4 billion, those of bulk drugs and intermediates rose by just over 10% to $2.9 billion.

Meanwhile, imports of these pharmaceutical products rose by close to 9% on year in the April-November period to $4.2 billion. The Indian pharmaceutical industry is both an exporter to as well as importer of bulk drugs (APIs and intermediates that give medicines their therapeutic value) from China, the epicentre of the Covid-19. As much as 65-70% of these raw materials are imported from China. The increase in exports suggests raw material imports from China have largely stabilised now. A rise in India’s pharmaceutical exports also propped its outbound shipments of the borader chemicals segment and reversed a potential fall. Exports of chemicals and related products rose to $30.7 billion until November, up 2.4% from a year earlier.

India’s largest pharma IPO worth Rs 6,500 cr set to hit market next week

Source: Business Standard, Nov 04, 2020

Mumbai: Hyderabad-based Gland Pharma is set to launch its initial public offering (IPO) on November 9 to raise Rs 6,500 crore. One of the largest IPOs in the pharmaceutical sector in recent times, it will comprise a fresh issue of Rs 1,250 crore and an offer to sell up to 34.9 million shares.

The price band has been fixed at Rs 1,490-1,500 per share for the issue that will close on November 11. The primary issue is to raise Rs 1,250 crore, which the company plans to utilise for funding incremental working capital requirements of the company and funding capital expenditure requirements.

China’s Fosun Pharma Industrial Pte. is offering to sell 19 million equity shares. Gland Celsus Bio Chemicals is planning to sell 10 million shares. The other two shareholders — Empower Discretionary Trust and Nilay Discretionary Trust — are offloading 3.5 million and 1.8 million shares, respectively.

Fosun Singapore — a subsidiary of Shanghai Fosun Pharmaceutical Co. — holds 74 per cent stake in the company. Other investors of the company include Gland Celsus Bio Chemicals, which owns 12.97 per cent, while Empower Discretionary Trust and Nilay Discretionary Trust own 5.08 per cent and 2.42 per cent stake, respectively.

One of the largest pharma IPOs in recent times was Eris Lifesciences in 2017, which raised Rs 1,741 crore. Alkem Laboratories and Laurus Labs hit the capital markets in 2015 and 2016, respectively.

Shanghai-based Fosun had picked up 74 per cent stake — the largest such acquisition of an Indian company by a Chinese firm — in 2017 for around $1.2 billion. Interestingly, the IPO comes at a time when India-China relations are tense. The firm, however, claimed it runs its business independently and has had many investors on its board earlier. The bilateral relations of the two companies do not affect the day-to-day operations or business.

Gland Pharma reported a revenue of Rs 2,772.4 crore in 2019-20 (FY20) and a profit of Rs 772.8 crore. The revenue from operations has grown at a compound annual growth rate (CAGR) of 27.4 per cent between 2017-18 and FY20, while earnings before interest, tax, depreciation, and amortisation has grown at a CAGR of 36.9 per cent.

Established in 1978, the company has presence in sterile injectables, oncology, and ophthalmics and also focuses on first-to-file opportunities in the US.

The future plan

The Hyderabad-based pharma firm draws 97 per cent of its revenue from the business-to-business (B2B) model, and the US is the biggest market, contributing around 63 per cent of revenue in the first quarter this financial year.

In India, apart from a B2B business, it has a targeted business-to-consumer segment, too, and operates mainly in the hospitals segment.

Speaking to Business Standard, Srinivas Sandu, managing director and chief executive officer of Gland Pharma, said its business model involves focusing on margins. “We make all products at sites that are US Food and Drug Administration-approved. They are not always competitive in the Indian market,” he said.

One-third of its employees works on quality assurance and control. He also pointed out that they are scouting for opportunities in the fermentation-based bulk drug space. “We look at setting up a facility that may take years. We are open to acquiring a facility that makes fermentation products, which may be in India or outside the country. It can be Italy or China as well,” he added. The merger and acquisition activities, however, will not be funded through the IPO proceeds but through internal accruals and debt.

Indian pharma sector can grow to $ 65 billion industry by 2024: Sadananda Gowda

Source: LiveMint.com, Oct 15, 2020

Chemicals and Fertilisers Minister D V Sadananda Gowda has said India is one of the largest manufacturers and exporters of generic medicines across the world. During initial phase, he said, HCQ and Azithromycin was identified as one of medicines under treatment protocol for Covid-19 in emergency cases. Referring to India supplying these medicines to more than 120 countries across the world; he underlined that India thereby earned the reputation of reliable supplier of medicines.

Addressing a video conference ‘FICCI LEADS 2020’, the minister highlighted that India is one of the largest manufacturers and exporter of generic medicines across the world.

India is the only country with the largest number of US Food and Drug Administration (USFDA) compliant pharma plants (more than 262 including APIs) outside of USA and exports USD 20 billion worth of pharma products to various countries, including high standards complying countries like the US and Europe, he added.

“We are confident that the Indian pharma sector can grow to USD 65 billion industry by 2024,” Gowda said.

“This is a very very good time to invest and set up manufacturing base in India in pharma sector. One can enter India market through joint ventures also. The advantage is that you can get access to big markets like domestic Indian market, US, Japan, EU and South East Asia through India as far as pharma sector is concerned,” he said.