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  • Since the outset of our discovery of impurities called nitrosamines in some types of drugs more than two years ago, the U.S. Food and Drug Administration has undertaken a thorough investigation in an effort to protect patients. While nitrosamines are common in water and foods, nitrosamine impurities may increase the risk of cancer if people are exposed to them above acceptable levels and over long periods of time. For this reason, the discovery of unexpected nitrosamine impurities in some drug products is a serious concern, and the FDA has been working, in collaboration with regulatory counterparts around the world, to find and remove drugs with unacceptable nitrosamine impurities from the U.S. drug supply. As we do so, we’re also taking proactive efforts to help ensure that in the future, drugs can be free from unsafe levels of these impurities from the start of production.

    Ensuring that drugs are safe, effective and high-quality is a critical part of FDA’s mission. In our continued efforts to be transparent and provide guidance to manufacturers on how to detect and prevent unacceptable levels of nitrosamine impurities, today we’re publishing our guidance Control of Nitrosamine Impurities in Human Drugs for immediate implementation. This guidance recommends steps, including a comprehensive risk assessment strategy and other actions that manufacturers can take to reduce or prevent the presence of nitrosamine impurities in their drugs.

    There are many reasons why these impurities might appear in some drugs, and consequently many approaches to screening for and preventing the appearance of nitrosamines to help ensure drug quality and safety. The source of these impurities can be related to the drug’s manufacturing process, the materials used in manufacturing, the drugs’ chemical structure, or even the conditions in which drugs are stored or packaged. Under FDA’s oversight, manufacturers are responsible for mitigating these impurities.

    The most common nitrosamine impurity, N-nitrosodimethylamine (NDMA), is found at low levels in water and foods, including cured and grilled meats, dairy products and vegetables. The FDA and the international scientific community do not expect NDMA to cause harm when ingested at low levels. However, given the risk that genotoxic substances such as NDMA may increase the risk of cancer if people are exposed to them above certain levels and over long periods of time, manufacturers have recalled drugs with NDMA levels higher than the FDA’s recommended acceptable intake levels. Patients taking medications with potential nitrosamine impurities should not stop taking their medications and should talk with their health care professional about concerns and other treatment options.


    We believe that the guidance we’ve issued today will assist manufacturers in preventing unacceptable levels of nitrosamines in drugs. Protecting patients is the FDA’s highest priority, and we will continue to work with manufacturers and our international regulatory partners to investigate and definitively resolve this problem.

    The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.


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  • There was a tragic event that shook the world in the 1960’s, when a large number of babies were born with severe deformities whose mothers had been prescribed a drug called ‘thalidomide’ for morning-sickness. “The problem was a result of the consumption of two enantiomers without separation. One of the isomer was toxic, while the other was the drug”, says Prof. A. S. Achalkumar, Department of Chemistry, IIT Guwahati. Prof Achalkumar and Prof. Yasuhiro Ishida from RIKEN, Wako-shi campus, Japan, have developed a simple and novel method to separate chiral enantiomers.

    Chiral enantiomers are chemicals that have the same molecular formula but different three-dimensional arrangement of the constituent molecular segments. The separation of enantiomers is significant in bio-medical field because many biochemically active chemicals are found as mixtures of two enantiomers, one of which may be beneficial and the other, toxic.

    The chemical properties of enantiomers are similar, which makes it very difficult to separate them, or to synthesize specifically one without being contaminated from the other enantiomer. “Nature is master in the exclusive production of enantiomerically pure amino acids and sugars, but man is still trying to master the art of enantioselective synthesis”, observes Prof Achalkumar. The current method to separate enantiomers is by chromatography, which is slow, energy intensive, and requires environmentally harmful solvents.


    “Nature is master in the exclusive production of enantiomerically pure amino acids and sugars, but man is still trying to master the art of enantioselective synthesis”

    The researchers have separated enantiomers with the use of helical supramolecular polymers. The helical polymers are formed by the salt formation of aromatic carboxylic acid and chiral amino alcohols. In this simple one-pot process they could resolve racemic mixtures into materials rich in one isomer. The interaction sites in supramolecular polymer not only help in the connection of the monomers but also in the recognition of chiral guests. When two salts with the same chirality are mixed, they undergo copolymerization and became soluble, while those with opposite chirality do not form copolymer and hence precipitate. The precipitated compound can be separated easily. The present system can be used for the enantioseparation of the abundant class of chiral amino alcohols, which has huge commercial potential.”


    Prof. Ishida adds that although many supramolecular polymers are known, their enantio-separation ability has never been investigated so far. “Development of such process may help in reducing the price of chiral active pharmaceutical ingredients (APIs) and finally that of the medical treatment, itself. In addition, such process can be extended to other classes of chiral molecules”, he says.

    The group of researchers is led by Prof. A. S. Achalkumar, and Prof. Yasuhiro Ishida from RIKEN, Wako-shi campus, Japan. Their path-breaking work has recently been published in the prestigious journal, Nature Communications. The paper has been co-authored by Prof. Achalkumar, Prof. Ishida, Dr. Vakayil Praveen, Senior Scientist, CSIR-National Institute for Interdisciplinary Science and Technology, and research scholars Dr. Krishnachary Salikolimi, Ms. Kuniyo Yamada, and Dr. Noriko Horimoto. The research findings have been published in the journal, Nature Communications.

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  • Detailed results from the ground-breaking Phase III DAPA-CKD trial showed that AstraZeneca’s Farxiga (dapagliflozin) on top of standard of care reduced the composite measure of worsening of renal function or risk of cardiovascular (CV) or renal death by 39% compared to placebo (p<0.0001) in patients with chronic kidney disease (CKD) Stages 2-4 and elevated urinary albumin excretion. The results were consistent in patients both with and without type-2 diabetes (T2D). CKD is a serious, progressive condition defined by decreased kidney function affecting nearly 700 million people worldwide many of them still undiagnosed and the most common causes are diabetes, hypertension and glomerulonephritis.

    The primary composite endpoint was ≥50% sustained decline in estimated glomerular filtration rate (eGFR), onset of end-stage kidney disease (ESKD) and CV or renal death. The absolute risk reduction (ARR) was 5.3% over the median time in study of 2.4 years. The trial also met all secondary endpoints, including significantly reducing death from any cause by 31% (ARR = 2.1%, p=0.0035) compared to placebo.

    The co-chairs of the DAPA-CKD trial and its Executive Committee Prof. David Wheeler, University College London, UK and Prof. Hiddo L. Heerspink, University Medical Center Groningen, the Netherlands, said: “The impressive DAPA-CKD trial results are a remarkable development for patients with chronic kidney disease. These data have the potential to transform the standard of care for this patient population, which has a significant unmet need for new and improved treatment options.”

    Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, said: “With today’s results, Farxiga becomes the first SGLT2 inhibitor proven to significantly prolong the survival of patients with chronic kidney disease with and without type-2 diabetes and we look forward to sharing these data with regulatory authorities around the world. Farxiga is also the first medicine in its class to demonstrate benefit in treating both heart failure and chronic kidney disease in patients with and without type-2 diabetes, and reduce the risk of hospitalisation for heart failure and nephropathy in type-2 diabetes.”


    The safety and tolerability of Farxiga were consistent with the well-established safety profile of the medicine. In the trial, patients treated with Farxiga experienced fewer serious adverse events compared to placebo (29.5% versus 33.9%, respectively). Diabetic ketoacidosis was not reported in the Farxiga group versus in two patients in the placebo group.

    Detailed results from the DAPA-CKD trial were presented on Sunday 30 August at the ESC Congress 2020 – The Digital Experience.


    In May 2020, Farxiga was approved in the US to reduce the risk of CV death and hospitalisation for heart failure (hHF) in adults with heart failure (NYHA class II-IV) with reduced ejection fraction (HFrEF) with and without T2D. Farxiga is currently being assessed in patients with heart failure (HF) in the DELIVER (HF with preserved ejection fraction, HFpEF) and DETERMINE (HFrEF and HFpEF) trials, as well as in patients without T2D following an acute myocardial infarction (MI) or heart attack in the DAPA-MI trial – a first of its kind, indication-seeking registry-based randomised controlled trial.

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  • Bristol Myers Squibb announced that the Phase 3 IDHENTIFY study evaluating IDHIFA® (enasidenib) plus best supportive care (BSC) versus conventional care regimens, which include best supportive care (BSC) only, azacitidine plus BSC, low-dose cytarabine plus BSC or intermediate-dose cytarabine plus BSC, did not meet the primary endpoint of overall survival (OS) in patients with relapsed or refractory acute myeloid leukemia (R/R AML) with an isocitrate dehydrogenase-2 (IDH2) mutation. The safety profile of IDHIFA was consistent with previously reported findings. The company will complete a full evaluation of the IDHENTIFY data and work with investigators to present detailed results at a future medical meeting.

    “While we are disappointed by the outcome of the IDHENTIFY study, we remain confident in IDHIFA’s established role as a treatment option for patients with relapsed or refractory AML with an IDH2 mutation and are grateful to all those who participated in the study,” said Noah Berkowitz, M.D., Ph.D., senior vice president, Global Clinical Development, Hematology, Bristol Myers Squibb. “AML is one of the most difficult-to-treat blood cancers, and we’re committed to furthering our research and improving on the standards of care for patients living with this aggressive disease.”

    In August 2017, Bristol Myers Squibb received full approval in the U.S. for IDHIFA for the treatment of adult patients with R/R AML with an IDH2 mutation as detected by a U.S. Food and Drug Administration (FDA)-approved test. IDHIFA is the first and only FDA-approved therapy for patients with R/R AML and positive for an IDH2 mutation, which represents up to 19 percent of AML patients. IDHIFA is also approved in Australia and Canada.

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  • There was a tragic event that shook the world in the 1960’s, when a large number of babies were born with severe deformities whose mothers had been prescribed a drug called ‘thalidomide’ for morning-sickness. “The problem was a result of the consumption of two enantiomers without separation. One of the isomer was toxic, while the other was the drug”, says Prof. A. S. Achalkumar, Department of Chemistry, IIT Guwahati. Prof Achalkumar and Prof. Yasuhiro Ishida from RIKEN, Wako-shi campus, Japan, have developed a simple and novel method to separate chiral enantiomers.

    Chiral enantiomers are chemicals that have the same molecular formula but different three-dimensional arrangement of the constituent molecular segments. The separation of enantiomers is significant in bio-medical field because many biochemically active chemicals are found as mixtures of two enantiomers, one of which may be beneficial and the other, toxic.

    The chemical properties of enantiomers are similar, which makes it very difficult to separate them, or to synthesize specifically one without being contaminated from the other enantiomer. “Nature is master in the exclusive production of enantiomerically pure amino acids and sugars, but man is still trying to master the art of enantioselective synthesis”, observes Prof Achalkumar. The current method to separate enantiomers is by chromatography, which is slow, energy intensive, and requires environmentally harmful solvents.


    “Nature is master in the exclusive production of enantiomerically pure amino acids and sugars, but man is still trying to master the art of enantioselective synthesis”

    The researchers have separated enantiomers with the use of helical supramolecular polymers. The helical polymers are formed by the salt formation of aromatic carboxylic acid and chiral amino alcohols. In this simple one-pot process they could resolve racemic mixtures into materials rich in one isomer. The interaction sites in supramolecular polymer not only help in the connection of the monomers but also in the recognition of chiral guests. When two salts with the same chirality are mixed, they undergo copolymerization and became soluble, while those with opposite chirality do not form copolymer and hence precipitate. The precipitated compound can be separated easily. The present system can be used for the enantioseparation of the abundant class of chiral amino alcohols, which has huge commercial potential.”


    Prof. Ishida adds that although many supramolecular polymers are known, their enantio-separation ability has never been investigated so far. “Development of such process may help in reducing the price of chiral active pharmaceutical ingredients (APIs) and finally that of the medical treatment, itself. In addition, such process can be extended to other classes of chiral molecules”, he says.

    The group of researchers is led by Prof. A. S. Achalkumar, and Prof. Yasuhiro Ishida from RIKEN, Wako-shi campus, Japan. Their path-breaking work has recently been published in the prestigious journal, Nature Communications. The paper has been co-authored by Prof. Achalkumar, Prof. Ishida, Dr. Vakayil Praveen, Senior Scientist, CSIR-National Institute for Interdisciplinary Science and Technology, and research scholars Dr. Krishnachary Salikolimi, Ms. Kuniyo Yamada, and Dr. Noriko Horimoto. The research findings have been published in the journal, Nature Communications.

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  • “Call to Private Sector to collaborate with NHA and need to start component level manufacturing in medical Devices to reduce the import bill and having our devices like pacemakers in the hearts of UK and US citizens is being true Aatma Nirbhar”

    PHD Chamber of Commerce & Industry organized a Technical Session on Medical Devices Sector: Self Sufficiency (Atma-Nirbhar Bharat) in Medical Technology on the fourth day of the International (3D Virtual) Health & Wellness Expo & Conferences-2020.

    The eminent panellists present during the session were Dr. Praveen Gedam, Addl. CEO, Ayushman Bharat, Dr. Jitender Sharma, MD, AMTZ, Dr. Ashok Seth, Chairman, Fortis Escort Hospitals Mr. Ganesh Sabat, CEO, Sahajanand Medical Technologies Pvt Ltd, and Mr. Sunil Khurana, CEO, BPL Medical Technology.


    Giving brief about the medical device industry, Dr. Praveen Gedam mentioned that the Indian medical device market is of $11 bn growing at a CAGR of 15% and we will be expecting the market to touch $50 bn by 2025.

    Despite of having skilled manpower, scale and big market size, Dr. Gedam also mentioned that over $ 6.2 bn of medical devices are imported in India showing almost 75-80% of import dependency.


    He further mentioned that this Covid situation has given priority to healthcare now a days and made staying alive a key parameter during the Pandemic times.  He mentioned that this Covid situation and geo political reasons depicts India’s ability to innovate, produce and become self-reliant in Medical devices giving an example of PPE kits where there is were PPE manufacturers in India before Covid and now India is producing more than 6 lacs PPE kits per day.

    Dr. Gedam mentioned about the world’s largest Government funded insurance scheme which caters to more than 540 million people and about the Health ID being a part of National Digital Health Mission.

    Dr. Gedam encouraged and invited the private sector to collaborate and urged that both public and private sector needs to work hand in hand for the growth of the healthcare sector while ensuring the quality and help to the needy people by giving them accessibility and affordability in healthcare at the same time.

    Dr. Jitender Sharma talked about the biggest challenges in India with regards to the medical device industry which include skilled manpower which has now been managed through HR & skill development. Second is the the lack of infrastructure to support the manufacturing for which India needs to replicate the medical device park (AMTZ) model at more places. Third are the supply chain issues of critical components of the medical devices as the majority of the same are imported and not made in India.

    Dr. Sharma mentioned that as per the NMDPC data over 800cr of payment of manufacturers, Hospitals are pending from the Government. Dr. Sharma mentioned that while hospital and manufacturers come to support the Government in difficult times, the Government should ensure that the hospital, manufacturers and suppliers are made ethical payment in a timely manner.

    Dr. Ashok Seth apprised the Prime Minister’s vision by implementing the great initiatives like Ayushman Bharat and Aatma Nirbhar Bharat.

    Dr. Seth mentioned that we need to focus on the entire pipeline of the process starting from the innovation, Clinical research, production and not only manufacturing. Dr. Seth explained that the Government expenditure on innovation is little then 1% of the GDP and this should be encouraged at the University level. There should be a fast patent process, support of Government funding for innovation, fast regulatory approvals and a financial reward for R&D to encourage the innovation.

    Dr. Seth also mentioned that the quality measures and regulatory measures are vague and non-transparent in India which only differentiate for cost and not the quality and further told that people should have a right of quality with any cost.

    Dr. Seth also urged the Government to keep private sector on any panel making the decisions for the industry. Dr. Seth also mentioned that the real Aatma Nirbharta is when the Indian Stents and devices like pacemakers beats in the heart of US & UK citizens because of the quality and not come up only as a low price option, which makes the industry viable and shine across the world.

    Dr. Seth mentioned that there should be a financial reward for the R&D, Government support to R&D and policy to reduce the taxation. Dr. Seth added that we have everything right from talent and market and the ball is in the court of regulators and Government policy makers now.

    Mentioning about the Covid situation, Prof. Parag Singhal said that first time in the history of 60 years, United Kingdom has a deficit of 101% of their GDP. Before it was like 18 weeks as a turn-around time for a patient, starting from primary consultation with currently. Now a days the highest waiting time for elective orthopedic surgeries has increased to almost 3 years, which is the highest ever in the history of UK healthcare. 

    The innovation should be frugal not only in terms of technology but also in healthcare delivery. He mentioned that there is a need to develop cost-effective models of healthcare delivery. He emphasized that if we want to make any healthcare service sustainable then we have to ensure the adoption of two pillars i.e. self-care management and primary care management.

    He said that since India is currently the capital of diabetes, self-care management becomes very important, especially in the post Covid scenario where the contact with healthcare professionals is going to be minimal and remote consultations are going to be the key. Towards this he mentioned that this is where the role of technology and innovation comes into play and helps the patients to empower themselves with self-care management.. Prof. Singhal mentioned that we need to think differently and focus on self-care management and primary care management to create healthy workforce and a healthy population.

    Prof. Singhal mentioned that the type I diabetes patients received devices by NHS, UK and Indian Government needs to collaborate with Private sector to reduce the cost and we need to reduce the cost of healthcare without compromising quality using low cost model.

    Mr. Ganesh Sabat mentioned that Industry has wholeheartedly accepted Atmanirbhar Bharat and slowly we are developing our own strengths and I congratulate the Hon’ble Prime Minister for his thought-provoking speech on 15th Aug where he launched the National Digital Health Mission linking every citizen digitally via a Health ID which will have disease demographic profiling of each citizen. This has potential for unlocking India’s IT enabled Healthcare system and getting private sector initiatives involved.

    Mr. Sabat further mentioned that the PM also envisioned that Ayushman Bharat gets expanded to the middle class, and over the next few years all schemes and government programmes to be covered under one Health-one Card with an increased healthcare allocation in GDP. We have faith on the PMs flagship scheme Ayushman Bharat, which is a large scheme. For me, the Hon’ble PM’s call for Ayushman Bharat resonates with the manufacturers of Medical Devices Industry in India. These are welcome steps and encourage the Industry to play a catalyzing role.

    Mr. Sabat emphasized that today the need is to support the domestic manufacturers and expanding the ecosystem within the country. It is critical to build large markets if India has to be the new Pharma and medical device capital of the world. The 'Vocal for Local' push for domestic manufacturers is truly a unique opportunity for India to become self-reliant in healthcare.

    Mr. Sabat said that today there is a renewed interest in the medical device sector and significant investments and stimulus packages in this sector will surely enable to make meaningful progress for India to emerge as global leader. The narrative needs to get further pushed as Make in India and Buy in India.  However, in my opinion, to be Atmanirbhar, the Government of India needs to develop a larger domestic market to create a medical device ecosystem. The need of the hour is to invest in all healthcare areas and build critical volume that domestic players can tap onto.

    Mr. Sabat urged that Aayushman Bharat needs a National and Centralized Reimbursement Agency. The idea is to have a commonly recognized agency that has acceptance nationally and in every state. This will simplify processes that create undue hurdles and these include clear priority-setting processes, evidence-based decision-making, transparent processes, consideration of vulnerable population groups, making use of the latest and efficient devices through regular evaluations and strategic design of policy measures. Further, it should also be noted that there is continuous upgradation of technology and R&D in the device sector, and provisions should also be made to include state-of-the-art healthcare devices in the reimbursement segment too, as and when the newer version is available. This is being frequently done in countries like France, Japan etc., where the populations get the best device, getting better healthcare possibilities.  Again, for this to happen we need to have a healthy reimbursement rate which looks into the entire process that has gone to come up with a world-class product. That will encourage more manufacturing and R&D. 

    Mr. Sabat finally requested the Government to seize this opportunity to revive the domestic industry so that India ensures Self-sufficiency, accessibility, availability and affordability in Healthcare.

    Mr. Sunil Khurana mentioned that India is emerging as a large market and we have to have a quality mindset to collaborate. We all need to understand and have a technology transfer and make it available at affordable prices.

    Mr. Khurana mentioned that we need to take our local business from $ 2 bn to $ 20 bn while also increasing the import from $ 7 bn to $ 30 bn looking at the local demand. We need to leave the shortcuts and think that we are making product for global use.

    Mr. Khurana also told that Policy plays a very important role to encourage the industry and to have overseas export incentives like Korea has. Talking about the skilled manpower Mr. Khurana mentioned that bio medical engineers do not need to sit at Infosys as coder and look in to the medical technology innovation.

    Mr. Khurana further mentioned that we have quality of doctors and talent for innovation where all needs to merge properly to make India a hub and attractive destination. We need to get technology transfer, manufacturer and be open / flexible and by the next 10 years India can become $ 100 bn in medical device sector by adopting different approaches.  Motivation for innovations by Government also plays an important role.

    The discussion was concluded by the remarks of Dr. Sharma where he has mentioned that there is only 2.5% of the market is of innovation and Government really needs to focus on the promoting innovative products and including them on the tenders as you can not get 3 quotations for innovative products.

    Dr. Sharma also mentioned that there are only 9 countries in the world that have Bio Medical Skill Council approved by the Ministry and India is one of them.

    Dr. Sharma also mentioned that the matter is with advance authority for setting up National Institute of Bio Medical Education and Research like NIPER.

    Talking about the recognition to R & D, Dr. Sharma mentioned that in the PLI scheme 5% incentive has been given on annual sales up which has to count up to 20% of their R & D & Technology transfer and there is a committee on boosting R & D formed in the Department of Pharmaceuticals, Ministry of Chemicals & Fertilizers, Govt. of India

    Dr. Sharma also mentioned that Government has also approved a budget of Rs. 3,000 cr R & D fund for middle class companies which a company can pay back to country in 3-5 years.

    Mr. Vivek Seigell while proposing a vote of thanks said that we are optimistic after this session that we are well on our way to reduce our 86% dependency on imports of medical devices and many useful suggestions have come up during this session. The session was attended by 180 participants.

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  • The U.S. Food and Drug Administration issued an emergency use authorization (EUA) for investigational convalescent plasma for the treatment of COVID-19 in hospitalized patients as part of the agency’s ongoing efforts to fight COVID-19. Based on scientific evidence available, the FDA concluded, as outlined in its decision memorandum, this product may be effective in treating COVID-19 and that the known and potential benefits of the product outweigh the known and potential risks of the product.

    Today’s action follows the FDA’s extensive review of the science and data generated over the past several months stemming from efforts to facilitate emergency access to convalescent plasma for patients as clinical trials to definitively demonstrate safety and efficacy remain ongoing.

    The EUA authorizes the distribution of COVID-19 convalescent plasma in the U.S. and its administration by health care providers, as appropriate, to treat suspected or laboratory-confirmed COVID-19 in hospitalized patients with COVID-19.


    Alex Azar, Health and Human Services Secretary:
    “The FDA’s emergency authorization for convalescent plasma is a milestone achievement in President Trump’s efforts to save lives from COVID-19,” said Secretary Azar. “The Trump Administration recognized the potential of convalescent plasma early on. Months ago, the FDA, BARDA, and private partners began work on making this product available across the country while continuing to evaluate data through clinical trials. Our work on convalescent plasma has delivered broader access to the product than is available in any other country and reached more than 70,000 American patients so far. We are deeply grateful to Americans who have already donated and encourage individuals who have recovered from COVID-19 to consider donating convalescent plasma.”

    Stephen M. Hahn, M.D., FDA Commissioner:
    “I am committed to releasing safe and potentially helpful treatments for COVID-19 as quickly as possible in order to save lives. We’re encouraged by the early promising data that we’ve seen about convalescent plasma. The data from studies conducted this year shows that plasma from patients who’ve recovered from COVID-19 has the potential to help treat those who are suffering from the effects of getting this terrible virus,” said Dr. Hahn. “At the same time, we will continue to work with researchers to continue randomized clinical trials to study the safety and effectiveness of convalescent plasma in treating patients infected with the novel coronavirus.”


    Scientific Evidence on Convalescent Plasma
    Based on an evaluation of the EUA criteria and the totality of the available scientific evidence, the FDA’s Center for Biologics Evaluation and Research determined that the statutory criteria for issuing an EUA criteria were met.

    The FDA determined that it is reasonable to believe that COVID-19 convalescent plasma may be effective in lessening the severity or shortening the length of COVID-19 illness in some hospitalized patients. The agency also determined that the known and potential benefits of the product, when used to treat COVID-19, outweigh the known and potential risks of the product and that that there are no adequate, approved, and available alternative treatments.

    The EUA is not intended to replace randomized clinical trials and facilitating the enrollment of patients into any of the ongoing randomized clinical trials is critically important for the definitive demonstration of safety and efficacy of COVID-19 convalescent plasma. The FDA continues to recommend that the designs of ongoing randomized clinical trials of COVID-19 convalescent plasma and other therapeutic agents remain unaltered, as COVID-19 convalescent plasma does not yet represent a new standard of care based on the current available evidence.

    Terms of EUA
    The EUA requires that fact sheets providing important information about using COVID-19 convalescent plasma in treating COVID-19 be made available to health care providers and patients, including dosing instructions and potential side effects. Possible side effects of COVID-19 convalescent plasma include allergic reactions, transfusion-associated circulatory overload, and transfusion associated lung injury, as well as the potential for transfusion-transmitted infections.

    Mayo Clinic Expanded Access Program
    The FDA initially facilitated access to convalescent plasma for treating COVID-19 by using pathways that included traditional clinical trials and emergency single-patient investigational new drug (IND) applications.

    An Expanded Access ProgramExternal Link Disclaimer for convalescent plasma was initiated in early April to fill an urgent need to provide patient access to a medical product of possible benefit during a time that the FDA was working with researchers to facilitate the initiation of randomized clinical trials to study convalescent plasma. As the number of single patient IND requests started to number in the hundreds on a daily basis, the FDA worked collaboratively with industry, academic, and government partners to implement an expanded access protocol to provide convalescent plasma to patients in need across the country via the national expanded access treatment protocol. The program was developed with funding from the HHS’ Biomedical Advanced Research and Development Authority (BARDA), with the Mayo Clinic serving as the lead institution. To date, the program has facilitated the infusion of over 70,000 patients with convalescent plasma.

    The EUA was issued to the HHS Office of the Assistant Secretary for Preparedness and Response.

    The EUA remains in effect until the termination of the declaration that circumstances exist justifying the authorization of the emergency use of drugs and biologics for prevention and treatment of COVID-19. The EUA may be revised or revoked if it is determined the EUA no longer meets the statutory criteria for issuance.

    The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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  • Reliance Industries Limited (RIL) today announced that its subsidiary Reliance Retail Ventures Limited (RRVL) has acquired a majority equity stake in Vitalic Health Pvt. Ltd. (“Vitalic”) and its subsidiaries (Collectively known as ‘Netmeds’) for a cash consideration of approximately INR 620 crores. This investment represents ~60% holding in the equity share capital of Vitalic and 100% direct equity ownership of its subsidiaries, viz: Tresara Health Private Limited, Netmeds Market Place Limited and Dadha Pharma Distribution Pvt Limited.

    Incorporated in 2015, Vitalic and its subsidiaries are in the business of pharma distribution, sales, and business support services. Its subsidiary also runs an online pharmacy platform – Netmeds – to connect customers to pharmacists and enable door step delivery of medicines, nutritional health and wellness products.

    Speaking on this strategic investment, Ms. Isha Ambani, Director, RRVL, said, “This investment is aligned with our commitment to provide digital access for everyone in India. The addition of Netmeds enhances Reliance Retail’s ability to provide good quality and affordable health care products and services, and also broadens its digital commerce proposition to include most daily essential needs of consumers. We are impressed by Netmeds’ journey to build a nationwide digital franchise in such a short time and are confident of accelerating it with our investment and partnership.”

    Pradeep Dadha, Founder & CEO, Netmeds, said, “It is indeed a proud moment for “Netmeds” to join Reliance family and work together to make quality healthcare affordable and accessible to every Indian. With the combined strength of the group’s digital, retail and tech platforms, we will strive to create more value for everyone in the ecosystem, while providing a superior Omni Channel experience to consumers.”


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  • Starpharma Holdings Limited has announced that it has entered into a new DEP® partnership with Chase Sun Pharmaceuticals to produce numerous DEP® nanoparticle formulations for an anti-infective drug. The deal also includes the possibility of carrying out additional DEP® programs, which may extend beyond anti-infective therapeutic areas.

    Starpharma is an ASX 300 organization and a global pioneer in the production of dendrimer products for medicinal, life sciences and other applications. The company, headquartered in Melbourne in Australia, produces dendrimers that can be used to improve the properties of other drugs. The process is defined as drug delivery; the reason behind this is it seeks to ensure that a drug is delivered to the right area of the body at the correct time. This drug delivery technology is known as DEP®.

    Earlier in September 2013, Starpharma Holdings Ltd and Gowan Company LLC had announced their partnership using Starpharma's Priostar® dendrimer technology in crop protection formulations. Starpharma’s Priostar® dendrimers were evaluated as and believed to be potential enhancements for certain Gowan products intended for high value markets under this deal. Now, with the help of their latest collaboration, Starpharma would be producing DEP® nanoparticle formulations for an anti-infective product for Chase Sun. They aim to boost its efficiency while also extending its medical value at the same time. Furthermore, under this deal Chase Sun will fund all activities and their associated expenses with the further advancement of any DEP® product. It is also reported that if in the future Chase Sun decides to market any of the subsequent DEP® products, a licensing deal specific to this technology would be signed with Starpharma. Chase Sun is China's top pharmaceutical firm which is focused on R&D and the marketing of healthcare goods. In addition, it operates in one of the largest markets in the world and has more than 60,000 employees.

    The Starpharma CEO, Dr Jackie Fairley, stated in his comments that the company was delighted to enter in this new DEP® partnership with Chase Sun. Furthermore, he stated that this agreement highlights the broad applicability of the DEP® framework and will help DEP® expand its market potential in the anti-infectious environment.


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  • The Russian President Vladimir Putin has launched a coronavirus vaccine amid the global race to develop and distribute it. The world’s first vaccine comes even with the final stages of clinical trials to test efficiency and safety still going on.

    The announcement came in the wake of the Covid-19 pandemic that has infected more than 20 million people and killed around 0.75 million people all over the world. It has also resulted in crippling world economies.

    The Russian vaccine has been developed by the Gamaleya Institute in Moscow. The vaccine uses two strains of adenovirus that is known to cause mild cold in humans. Adenovirus vaccine is under trial in many other countries as well. The strains are genetically modified which can cause infected cells to create proteins from the spike of the coronavirus. This is a similar approach to a vaccine under development by AstraZeneca and Oxford University.

    As per reports, Russia has dubbed the newly created vaccine “Sputnik V” after its Soviet satellite. Kirill Dmitriev, who is the head of the Russian Direct Investment Fund, an organization responsible for financing the vaccine project, announced that the Phase 3 trials would start by Wednesday. This means that mass production can be expected from September. He also mentioned that around 20 countries have already pre-ordered more than a billion doses.


    Putin thanked everyone who has worked on the vaccine’s development and mentioned that this is a very important step for the world. He also hopes that the country’s research body should start the mass production of the vaccine very soon.

    When talking about the vaccine, Putin mentions that it works effectively, helps build strong immunity, and has passed all the needed checks. He also added that one of his two daughters have received a shot of the vaccine and is doing well.


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