April 2024

Apr 13,2024 New Delhi: To make the Human papillomavirus (HPV) tests affordable to the people, the All India Institute of Medical Sciences (AIIMS) has started a study of indigenous HPV tests for cervical cancer screening in India. The study will be conducted to assess the “indigenous HPV test” by three laboratories that include AIIMS, NICPR Noida and NIRRCH Mumbai. According to Dr Neerja Bhatla, HOD, Obstetrics and Gynaecology, AIIMS, Delhi, the results will be quick and cost-effective. “There are several HPV tests that are now being manufactured in India, but we have taken three tests that are a point of care. The results will come within one hour or one and a half hours and we can plan for the next step,” Dr Bhatla said. “The results of the indigenous HPV tests study are expected to come in a few months then we will be able to say that we have internationally validated indigenous tests and then these make-in-India tests will be fit to export to any country in the world because they meet the international specifications,” said Dr Bhatla Currently, the cost of an HPV test varies between Rs 1500-2000, but with Indian kits, the cost is expected to be reduced significantly with more accuracy. “It will definitely be more cost-effective than what is in the pocket now. And secondly, it will be more cost-effective than any of the other tests because it is more accurate,” she added. “With this vision, we are launching a multi-centre study with the support of DBT-BIRAC Grand Challenges India in collaboration with WHO’s International Agency for Research in Cancer (IARC). The testing will be performed at AIIMS, New Delhi, NICPR Noida and NIRRCH Mumbai,” stated AIIMS. Worldwide, cervical cancer is the fourth most common cancer in women. In India, it is the second most common cancer among women after breast cancer. Every two minutes, a woman dies of cervical cancer around the world. According to GLOBOCAN, an online database that provides global cancer statistics, in 2022, an estimated 663,301 women were diagnosed with cervical cancer worldwide and about 348,874 women died from the disease. Low-middle-income countries (LMIC) like India contribute to nearly 80 per cent of the disease burden. Source: Healthworld

Apr 04,2024 New Delhi: COVID-19 replaced stroke to become the second-leading cause of death globally in 2021, causing 94 deaths per one lakh population and slashing life expectancy by 1.6 years, an international research published in The Lancet journal has found. Disrupting more than three decades of consistent improvements in life expectancy and deaths, COVID-19 reversed this long-standing progress to emerge as “one of the most defining global health events of recent history,” researchers said. In 2020, deaths around the world rose by 10.8 per cent compared to 2019, and in 2021, they rose by 7.5 per cent relative to 2020. Death rates too followed a similar trend, rising by 8.1 per cent in 2020 and an additional 5.2 per cent in 2021, the study estimated. Globally, COVID-19 and related deaths were responsible for slashing life expectancy by 1.6 years between 2019 and 2021, even as reduced deaths from infections, stroke, and of newborns, among others, had helped steadily enhance life expectancy between 1990 and 2019, the researchers found. India lost 1.9 years of life expectancy due to COVID-19, resulting in a net gain of 7.9 years of life expectancy between 1990 and 2021, the study showed. “COVID-19 had a pronounced influence on the reduction in global life expectancy that occurred,” the authors wrote. The researchers forming the Global Burden of Disease (GBD) Causes of Death Collaborators estimated mortality and years of life lost from 288 causes of death across 204 countries and territories for every year from 1990 until 2021. Region-wise, death rates from COVID-19 were the highest in the sub-Saharan Africa. In Latin America and the Caribbean, it was at 271 per one lakh population and almost 200 deaths per one lakh population, respectively. The rate was the lowest in southeast Asia, east Asia, and Oceania at around 23 deaths per one lakh population, the researchers estimated. The impact of COVID-19 on life expectancy was found to be wide-ranging in severity, with Andean Latin America seeing a loss of 4.9 years and the southern sub-Saharan Africa seeing a reduction of 3.4 years, to the east Asia, which witnessed almost no change, they said in the study. The leading cause of death worldwide in 2021 continues to be ischaemic heart disease, as was the case in 2019 and 1990, the researchers found. The disease is caused by a reduced blood flow to a certain body part due to clotting or constricting blood vessels. Stroke, at the third position amongst the top five causes of death, was found to be followed by chronic obstructive pulmonary disease (COPD) at fourth, and other pandemic-related mortality at fifth. COPD is a lung condition usually seen to affect heavy smokers. The GBD study, providing “latest comprehensive estimates of cause-specific mortality,” gives insights about the global landscape of disease before and during the first two years of the pandemic, revealing changes in disease-burden patterns that followed, according to the researchers, coordinated by the Institute for Health Metrics and Evaluation (IHME), University of Washington, US.

Apr 05,2024 New Delhi: The Delhi High Court on Thursday expressed happiness over the Delhi health minister and health secretary deciding to implement the central government statute- ‘The Clinical Establishments (Registration and Regulation) Act, 2010- to regulate clinical establishments in the national capital. The Delhi government informed the high court that the health minister and the department’s secretary have agreed to forward the Delhi Health Establishments (Registration and Regulation) Bill to the Government of India for necessary approval. “This court is happy to note that after the last hearing the Delhi health minister and the secretary (Health and Family Welfare) have agreed that the already prepared Delhi Health Establishments (Registration and Regulation) Bill will be forwarded to the government of India for necessary approval. “They have further agreed that during the interregnum the Clinical Establishments (Registration and Regulation) Act, 2010 shall be adopted in the NCT of Delhi in compliance to a 2023 letter of government of India and a 2022 order passed by the high court,” a bench of Acting Chief Justice Manmohan and Justice Manmohan PS Arora said. Taking note of the decision taken by the authorities, the high court disposed of a 2018 petition by Bejon Kumar Misra, represented by advocate Shashank Deo Sudhi, who alleged that unauthorised laboratories and diagnostic centres were functioning in the national capital with unqualified technicians and giving incorrect reports to patients. “Accordingly taking note of this decision of the minister and the secretary, the petition is closed,” the bench said and made it clear that the law will be implemented within two weeks. The high court had on March 21 warned Health Minister Saurabh Bharadwaj and Health Secretary SB Deepak Kumar, who were present during the proceedings, of sending them to jail for their failure to comply with judicial orders on enactment of a law to regulate clinical establishments. The bench had said the minister and the secretary were “servants of government” and can’t have “large egos”. The petitioner had argued before the court that pathological labs in the city were unregulated and posed a threat to the lives of citizens. The plea said, “Such illegal labs continue to mushroom in and around Delhi-NCT and it can be easily estimated that the total number of such illegal pathological and diagnostic labs can be anywhere between 20,000 and 25,000, and every street in the capital has such illegal pathological labs.” Source: Healthworld

Apr 04,2024 New Delhi: Experts are sounding the alarm over the potential for a bird flu pandemic that could be significantly more devastating than the COVID-19 crisis, with the H5N1 strain posing a particularly dire threat. According to recent briefings, virus researchers have indicated that H5N1 is inching “dangerously close” to triggering a global pandemic, with the White House saying it is actively “monitoring” the evolving situation. The urgency of the matter was underscored by the discovery of multiple H5N1 infections across a variety of mammals, including cows, cats, and humans, which raises concerns about the virus mutating to become more easily transmissible among humans. This development comes on the heels of a dairy farm worker in Texas testing positive for the virus, along with infections reported in 12 herds of cows across six states and three cats in Texas that succumbed to the virus, a Daily Mail report said. Dr Suresh Kuchipudi, a prominent bird flu researcher, warned that we are nearing the threshold of a potential pandemic caused by H5N1. He emphasised that the virus has already shown the ability to infect a wide range of mammalian hosts, including humans, making it a formidable pandemic threat. Echoing this sentiment, John Fulton, a pharmaceutical industry consultant, highlighted the grave implications of H5N1 mutating while maintaining its high fatality rate, which could result in a pandemic far worse than COVID-19. “This appears to be 100 times worse than COVID, or it could be if it mutates and maintains its high case fatality rate,” Fulton said. The World Health Organisation has estimated the fatality rate for H5N1 at a staggering 52 percent, based on the data collected since 2003. In contrast, COVID-19’s fatality rate is significantly lower, emphasising the potential severity of a widespread H5N1 outbreak. Recent cases since 2020 show that nearly 30 percent of individuals infected with the new strain of H5N1 have died. As the situation unfolds, the White House and health experts are urging for increased vigilance and preparedness. The White House press secretary assured the public that the health and safety of Americans are a top priority and that measures are being taken to monitor and address the bird flu outbreak. Beyond the immediate health risks, the spread of H5N1 has broader economic implications, particularly for the dairy and poultry industries. With infected cattle showing symptoms and a requirement to cull infected birds, there could be a significant impact on the supply and pricing of milk and eggs. Source: Healthworld

Apr 06,2024 London: The U.S. Food and Drug Administration on Friday allowed the use of cell therapy Abecma from Bristol-Myers Squibb and 2seventybio in less severely affected patients with a type of blood cancer. The decision comes after a panel of expert advisers voted in favor of Abecma’s use as an earlier treatment for multiple myeloma, a common form of cancer that affects older adults. The cell therapy is already approved in the U.S. to treat patients with multiple myeloma who have received four or more prior lines of treatment. The health regulator is also reviewing cancer cell therapy, Carvykti, from Johnson & Johnson and its partner Legend Biotech for use in less severely affected patients. The FDA is set to decide on it by April 5. Abecma and Carvykti belong to a class of treatments known as chimeric antigen receptor (CAR) T-cell therapies that work by modifying white blood cells known as T-cells to attack cancer. Bristol Myers ‘ application included late-stage data that showed Abecma helped extend the time before disease progression by 13.3 months on average in patients whose cancer has returned or stopped responding to at least two prior treatments. This compared to 4.4 months progression-free survival seen in trial patients who received standard of care. Analysts estimate $601 million in sales for Abecma in 2024, according to LSEG data. The current standard of care includes use of non CAR-T therapies or regimens in less severely affected patients. Approved medications for the condition include J&J’s Darzalex and generic cancer drugs such as pomalidomide and bortezomib. Source: Pharma

Apr 06,2024 New Delhi: Drug firm Sanofi on Friday said it has obtained approval for IMOVAX-Polio, an alternative injectable vaccine, to replace the Inactivated Polio Vaccine (IPV) ShanIP in India. IMOVAX-Polio is an alternative IPV vaccine that has been used in more than 100 countries for over 40 years, a Sanofi India spokesperson told PTI. The vaccine has the same composition/formulation as ShanIPV, the spokesperson added. “We wish to assure all stakeholders that there will be no shortage of IPV vaccines in India on our account, towards safeguarding the nation’s status of remaining polio-free. We remain fully committed to fulfilling our public health mission in India,” the spokesperson noted. To ensure that there is no interruption to the availability of IPV vaccines, the French firm has already obtained approvals for IMOVAX-Polio. “…Sanofi has had to adapt its strategy and portfolio to these (emerging) trends. Accordingly, Sanofi Healthcare India Pvt Ltd (SHIPL) announced that by the end of 2023, it will discontinue ShanIPV, which was only filled and packaged at our factory in Hyderabad, India,” the spokesperson added. Launched in India in 2015, ShanIPV is a trivalent inactivated injectable vaccine. Under the government’s immunisation programme, the vaccine was injected in two stages – at six weeks and 14 weeks of age. Sanofi and Serum Institute of India are the leading suppliers of IPV vaccines in India. Source: Pharma

Apr 06,2024 Hyderabad: Dr Reddy’s Laboratories Ltd and Bayer have entered into a partnership to market and distribute a second brand of chronic heart failure drug Vericiguat in India. Under the terms of this agreement, Bayer has granted non-exclusive rights to Dr Reddy’s under the brand name Gantra. Vericiguat, a soluble guanylate cyclase (sGC) stimulator, in India, is indicated, along with guideline-based medical therapy, in adults with symptomatic chronic heart failure with reduced ejection fraction (less than 45 per cent), following a recent event of worsening heart failure which required hospitalisation or outpatient intravenous (IV) diuretics. Vericiguat works on a pathway not currently targeted by existing heart failure treatments and can reduce the combined risk of cardiovascular death and heart failure hospitalisation in such patients, Dr Reddy’s said. Shweta Rai, managing director, Bayer Zydus Pharma and country division head (CDH) for Bayer’s Pharmaceuticals business in South Asia said, “Despite therapy, chronic heart failure patients can experience disease progression that disrupts their lives and leads to worsening heart failure events. Vericiguat can help slow down disease progression, reduce hospital admissions and improve their chances of survival.” “The introduction of a second brand of Vericiguat in India, through our partnership with Dr Reddy’s is a reaffirmation of our commitment to making innovative healthcare solutions accessible to as many patients as possible.” MV Ramana, CEO, Branded Markets (India and Emerging Markets), Dr Reddy’s said: “Strengthening our chronic therapy portfolio in India continues to be a focus area for us. Vericiguat is a first-in-class sGC stimulator indicated for adults with symptomatic, chronic HF and ejection fraction less than 45 per cent following worsening heart failure.” “The addition of Vericiguat bolsters our heart failure management portfolio that includes Cidmus, Daplo and beta blockers. The partnership with Bayer is part of Dr Reddy’s continuous efforts to make innovative medicines available to patients in India through strategic collaborations,” he said. Ramana said Dr Reddy’s will use its strengths in marketing and distribution to widen access to this novel treatment in metros and beyond into tier-I and tier-II towns in India. India is estimated to have between 8-10 million people with heart failure, making it one of the largest populations with this condition. Source: Pharma

Apr 02,2024 New Delhi: Two domestic drugmakers are set to start production of penicillin G and clavulanic acid this year, supported by the government’s production-linked-incentive (PLI) scheme, a development seen boosting India’s efforts to cut dependence on China for crucial drugs. Industry executives told ET that the decks have been cleared for Hyderabad-based Aurobindo Pharma and Mumbai-headquartered Kinvan to begin production of the key starting materials (KSMs) penicillin G and clavulanic acid, respectively, and that their first batches will come this year. Penicillin G is used in making several antibiotics while clavulanic acid is used for manufacturing Amoxyclav, a combination drug whose most popular brand is Augmentin. India stopped producing the two input drugs about three decades ago and since then it has relied on China for their supplies. “As of now, we are largely dependent on China. With the initiative of the production-linked-incentive scheme, companies like Aurobindo are coming up with fermentation-based products like PenG,” said Ravi Uday Bhaskar, director general, Pharmaceutical Export Promotion Council (Pharmexcil). “We will be in a better position in the coming few months.” Aurobindo’s PenG plant is expected to start trial production this month and move into commercial production in a few months, the people cited earlier said. The ₹2,400-crore plant has been commissioned in Andhra Pradesh. It has a production capacity of 15,000 tonnes per annum. The government initiated the PLI scheme which is aimed at boosting domestic manufacturing of active pharmaceutical ingredients (APIs)/ KSMs, widening its scope to encourage export of these raw materials. India’s pharmaceuticals industry is the third largest in the world, but is dependent on China for crucial raw materials. The PLI scheme seeks to reduce this dependency and ensure adequate domestic supply of bulk drugs and APIs. The focus on self-reliance became sharper following the disruptions in global supply due to COVID-19. Dinesh Dua, former chairman of Pharmexcil, said that China is a major player in penicillin G and the initiative of starting its production in India will be a major victory for India. “About 30,000 metric tonnes of penicillin is imported from China. China ensured closure of production in the entire world, including India, on account of huge government support in terms of subsidies, infrastructure support, ease of doing business (EODB) in regulatory landscape, cheap labour, etc.,” Dua said. “This new initiative by India, however, is a major victory for India as it is going to compress demand from China.” Source: Pharma

Apr 03,2024 London: The U.S. FDA approved Vanda Pharmaceuticals’ drug to treat manic and mixed episodes associated with a type of bipolar disorder, the company said on Tuesday, marking the second approval for the treatment. Shares of the Washington, D.C.-based company jumped 16 per cent after the bell. Fanapt, which was initially approved in 2009 as a treatment for schizophrenia, faces a potential loss of exclusivity in 2027. The decision could help revive prescriptions for Fanapt, which has seen sales declining in recent quarters due to increased competition. With the approval, the drug can be used to treat adults with Bipolar I disorder, in which patients experience manic episodes that last at least seven days, or severe manic symptoms like extreme mood swings. The approval is based on a late-stage trial in which the company’s drug, chemically known as Iloperidone, helped reduce severity of core symptoms of mania when tested across 400 patients. About 40 million people worldwide suffer from bipolar disorder, according to the World Health Organization. Sales of Vanda’s sleep disorder drug Hetlioz have also been falling due to increased competition from cheaper versions. Fanapt’s sales fell 4.1 per cent to $91 million in 2023, while sales of Hetlioz declined 37.3 per cent to $100.2 million. Both the drugs accounted for more than 99 per cent of the company’s total revenue last year. Source: Pharma

Apr 04,2024 New Delhi: The Union Ministry of Health and Family Welfare has refuted the news reports in a section of media indicating that medicine prices will witness a significant hike by up to 12 per cent from April, 2024. These reports further claim that more than 500 medicines will be affected by this increase in price, which is also false, misleading and malicious. As per the provisions of Drug Price Control Orders (DPCO) 2013, drugs are categorised as scheduled and non-scheduled formulations. The formulations which are listed in Schedule-I of DPCO 2013 are scheduled formulations and the formulations that are not specified in Schedule-I of DPCO 2013 are non-schedule formulations. National Pharmaceutical Pricing Authority (NPPA) under the Department of Pharmaceuticals annually revises the ceiling prices of scheduled medicines on the basis of Wholesale Price Index (WPI). The scheduled medicines included in the Schedule-I of the DPCO, 2013 are essential medicines. During the calendar year 2023 over the corresponding period in 2022, the annual change in WPI with base year 2011-12 was (+) 0.00551 per cent as per data published by Department for Promotion of Industry and Internal Trade (DPIIT). Accordingly, the Authority in its meeting held on 20.03.2024 has approved the WPI increase @ (+) 0.00551 per cent for the scheduled medicines. The ceiling prices on 923 medicines are effective as on date. Based on the above mentioned WPI factor of (+) 0.00551 per cent, there will be no change in the prevailing ceiling prices for 782 medicines and the existing ceiling prices will continue to prevail up to 31.03.2025. Fifty-Four medicines with ceiling price ranging from ₹90 to ₹261 will have miniscule increase of ₹0.01 (one paisa). As the permissible price increase is miniscule, the companies may or may not avail this increase. Thus, in the year FY 2024-25, there will be almost no change in the ceiling price of medicines based on WPI. The WPI increase is the maximum increase permissible as per the DPCO, 2013 and the manufacturers may or may not avail this increase, keeping in view the market dynamics. The companies adjust their Maximum Retail Price (MRP) depending upon the ceiling price of their medicines, as MRP (excluding GST) can be any price which is less than the ceiling price. The revised prices will be applicable from 1st April 2024 and the detail of revised prices is available on NPPA’s website www.nppaindia.nic.in. In case of non-scheduled formulation, a manufacturer is at liberty to fix the price. However, no manufacturer of non-scheduled formulation can increase the MRP by more than 10 per cent during preceding 12 months under Para 20 of DPCO, 2013, the ministry clarified. Source: Healthworld