May 2024

May 11,2024 Thane: A case has been registered against two pharmaceutical agencies for allegedly distributing spurious drugs to hospitals in Maharashtra’s Thane city, police said on Saturday. Based on a complaint lodged by the Food and Drug Administration (FDA), a first information report (FIR) was registered under sections 420 (cheating), 468 (forgery), 273 (sale of noxious food or drink) and other relevant provisions of the Indian Penal Code and the Drugs and Cosmetics Act of 1940, an official said. According to the complaint, FDA officials inspected medicines at the government hospital in Thane on December 11, 2023, and found that some were spurious, he said. The two agencies allegedly sold spurious medicines to the Thane Civil Hospital and other hospitals and supplied these drugs to different parts of the country, the official said. Source: Pharma

May 12,2024 New Delhi: Food labels on packaged items can be misleading, apex health research body ICMR has said stressing that consumers should read the information carefully to make informed and healthy choices. It also pointed out that sugar-free foods maybe loaded with fats, while packed fruit juices may contain only 10 per cent fruit pulp. In its recently issued dietary guidelines, the Indian Council of Medical Research (ICMR) said health claims on packaged food are designed to catch the consumer attention and convince them that the product is healthy. “Though the Food Safety and Standard Authority of India (FSSAI) has strict norms, the information presented in labels could be misleading,” the dietary guidelines for Indians issued by the Hyderabad based National Institute of Nutrition (NIN) under the apex health research body said on Wednesday. Giving some examples, the NIN said a food product can be called ‘natural’ if it doesn’t have added colours and flavours or artificial substances and goes through minimal processing. “This term is often used rather loosely. It is often used by manufacturers to identify one or two natural ingredients in the mix and this can be misleading,” it said, urging people to read the label, specifically the ingredients and other information carefully to cross-check the claims. The NIN presented some examples of statements on labels that could be misleading. For the claim ‘real fruit or fruit juice’, the NIN said that according to the FSSAI regulation, any food item with even a small amount, for example, fruit juices containing only 10 or less percent of fruit added to a product is allowed to state that the product is made with real fruit pulp or juice. But the product claiming to have real fruit may have added sugar and other additives with only 10 per cent actual fruit pulp. As for ‘Made with whole grain’, it said these words could be misinterpreted. Such a statement does not necessarily imply that the food items are not tertiary or ultra processed. When a food label says ‘organic’, it may simply mean that it is free of all artificial preservatives, flavours and colours and that the food ingredients are free from pesticides and chemical fertilizers. If both the above are met, then the label can state 100 per cent organic and have the ‘Jaivik Bharat’ logo approved by the FSSAI. Further, it said that people often associate sugar-free foods with lower calories and perceive these to be beneficial for diabetics and weight watchers. “Sugar-free foods may be loaded with fats, refined cereals (white flour, starch) and even hidden sugars (maltitol, fructose, corn syrup, molasses). These would imply high glycemic index and high calories in the food item,” the NIN stated. Although nutrition and health claims are regulated by FSSAI, consumers are advised to exercise caution by cross-checking the claims with ingredients and nutrition information on the label, the guidelines recommended. According to the guidelines, manufacturers also use labels to make incorrect and incomplete claims about their food products. Source: Healthworld

May 02,204 Following recent regulatory modifications by the Insurance Regulatory and Development Authority of India (IRDAI), the insurance sector is poised for adjustments that could impact policy premiums. The revised guidelines include a reduction in waiting periods, now capped at a maximum of three years, down from the previous four years. This alteration, mandated by IRDAI, is anticipated to prompt most insurers to consider adjustments in premiums across various policies. Some insurance companies, including HDFC ERGO, have already communicated adjustments in premium rates to their customers. HDFC ERGO said they will have to increase premium rates by an average of 7.5% to 12.5%. “We have an obligation to ensure long-term financial stability of our products. After a careful assessment of product performance in recent years and taking into account both the current and projected medical costs, we are constrained to undertake an increase in premium rates. Do note the actual rate increase could vary basis the age and location of insured members,” the insurer said in a mail sent to its customers. The company said that premium increase may be a bit concerning for policyholders but such adjustments are made only when absolutely necessary and with communication to IRDAI. “This adjustment in rates may impact the renewal premium and policyholders will receive timely communication closer to renewal due date,” HDFC Ergo said. “Insurers can increase the cost in range of 10% to 15%,” said Rupinderjit Singh, Vice President – Retail Health, ACKO General Insurance. The recent regulatory changes also include the elimination of age restrictions on health insurance policies by IRDAI, removing the age limit of 65 years for individuals. Singh of ACKO General Insurance explained that premium adjustments often correlate with age due to heightened health risks associated with aging. “On average, premiums tend to increase by approximately 10% to 20% for every five-year age bracket, reflecting insurers’ experiences and the challenge of increasing health inflation, which stands at around 15% in India,” he told CNBC-TV18.com. Data from online insurance broker PolicyBazaar reveals a surge in the average ticket size of retail health insurance in India. Over six years, from FY19 to FY24, the average ticket size has increased by nearly 48%, reaching ₹26,533, according to a Business Standard report. Source: NCBCTV18

May 12,2024 New Delhi: Food labels on packaged items can be misleading, apex health research body ICMR has said stressing that consumers should read the information carefully to make informed and healthy choices. It also pointed out that sugar-free foods maybe loaded with fats, while packed fruit juices may contain only 10 per cent fruit pulp. In its recently issued dietary guidelines, the Indian Council of Medical Research (ICMR) said health claims on packaged food are designed to catch the consumer attention and convince them that the product is healthy. “Though the Food Safety and Standard Authority of India (FSSAI) has strict norms, the information presented in labels could be misleading,” the dietary guidelines for Indians issued by the Hyderabad based National Institute of Nutrition (NIN) under the apex health research body said on Wednesday. Giving some examples, the NIN said a food product can be called ‘natural’ if it doesn’t have added colours and flavours or artificial substances and goes through minimal processing. “This term is often used rather loosely. It is often used by manufacturers to identify one or two natural ingredients in the mix and this can be misleading,” it said, urging people to read the label, specifically the ingredients and other information carefully to cross-check the claims. The NIN presented some examples of statements on labels that could be misleading. For the claim ‘real fruit or fruit juice’, the NIN said that according to the FSSAI regulation, any food item with even a small amount, for example, fruit juices containing only 10 or less percent of fruit added to a product is allowed to state that the product is made with real fruit pulp or juice. But the product claiming to have real fruit may have added sugar and other additives with only 10 per cent actual fruit pulp. As for ‘Made with whole grain’, it said these words could be misinterpreted. Such a statement does not necessarily imply that the food items are not tertiary or ultra processed. When a food label says ‘organic’, it may simply mean that it is free of all artificial preservatives, flavours and colours and that the food ingredients are free from pesticides and chemical fertilizers. If both the above are met, then the label can state 100 per cent organic and have the ‘Jaivik Bharat’ logo approved by the FSSAI. Source: Healthworld

May 11,2024 Thane: A case has been registered against two pharmaceutical agencies for allegedly distributing spurious drugs to hospitals in Maharashtra’s Thane city, police said on Saturday. Based on a complaint lodged by the Food and Drug Administration (FDA), a first information report (FIR) was registered under sections 420 (cheating), 468 (forgery), 273 (sale of noxious food or drink) and other relevant provisions of the Indian Penal Code and the Drugs and Cosmetics Act of 1940, an official said. According to the complaint, FDA officials inspected medicines at the government hospital in Thane on December 11, 2023, and found that some were spurious, he said. The two agencies allegedly sold spurious medicines to the Thane Civil Hospital and other hospitals and supplied these drugs to different parts of the country, the official said. Source: Pharma

May 08,2024 India stands at the brink of a transformative era, with the pharmaceutical industry poised as a key player in shaping the country’s future. Driven by a dedication to groundbreaking innovation and supported by government initiatives aimed at achieving universal health coverage (UHC), the industry aims to exceed the $450 billion milestone by 2047. India’s pharmaceutical industry is a global leader, not just in terms of sheer production volume but also in its profound impact on global health and innovation. Since India’s independence, this sector has evolved into a powerhouse that caters not only to domestic healthcare needs but also plays a significant role in supplying affordable medicines worldwide. Among other things, the industry has played a huge role in the consistent decline in communicable diseases in India, the eradication of a few deadly diseases, and increasing life expectancy. The Indian pharmaceutical industry encompasses a vast network of 3,000 drug companies and 10,500 manufacturing units. Approximately 500 API manufacturers also play a significant role and contribute around 8 per cent to the global API industry. Government initiatives such as allowing 100 per cent FDI through automatic routes for greenfield pharmaceutical projects, implementing the PLI scheme for Key Starting Materials (KSMs) and APIs to enhance manufacturing capacity, strengthening infrastructure facilities, and adopting robust pricing policies, represent pivotal steps in the right direction. India has earned the moniker of ‘pharmacy of the world’ due to its role in supplying cost-effective generic medicines globally. According to the Pharmaceuticals Export Promotion Council of India (Pharmexcil), India exported pharmaceuticals worth $25.39 billion in the financial year 2022-23, recording a growth of 3.25 per cent over the previous year. The ever-increasing exports showcase India’s pivotal position in the global pharmaceutical trade. The industry’s focus on generic drug manufacturing has significantly improved access to essential medicines, especially in developing countries. For instance, India is a major supplier of antiretroviral drugs for HIV/AIDS treatment, providing affordable options that have helped millions access life-saving treatment. At the turn of the century, India’s pharmaceutical industry blazed a trail by bringing down the cost of fighting HIV/AIDS to about a dollar a day from annual costs of $10000+ that western pharma majors were pushing. It remains one of the greatest success stories of India’s pharmaceutical industry. Over the years, the industry has gone on to become the biggest supplier of TB drugs, and an array of vaccines. India’s pharmaceutical companies are not just generic drug manufacturers but also hubs of research and innovation. With a growing number of patents and investments in research, the industry is at the forefront of developing new drugs and treatments. During the first nine months of 2023, Indian pharmaceutical companies secured a notable increase in Abbreviated New Drugs Applications (ANDA) approvals for the US FDA. Within this time frame, the US FDA approved a total of 618 ANDAs marking a rise from the 570 ANDAs approved during the same period in the previous year. Among the 618 approvals, Indian companies and their subsidiaries accounted for a significant share of 284 ANDA approvals, constituting 46 per cent of the total approvals. The high number of approvals highlights the industry’s innovative capabilities. Source: Healthworld

May 13,2024 New Delhi: The number of pathological tests conducted by two private diagnostic laboratories at mohalla clinics has registered a decline of nearly 80 per cent since the anti-corruption branch of Delhi govt submitted its report on a preliminary enquiry into alleged irregularities to CBI in Feb this year. According to a report prepared by the health and family welfare department of Delhi govt, linking Aadhaar with patients’ mobile numbers was made mandatory after an initial inquiry in Dec 2023 indicated the possibility of irregularities and ghost patients, which led to a huge drop in the number of path tests. According to the report, both the number of patients tested and tests conducted at the two laboratories registered a sharp decline. Between Feb 2023 and April 2023, the two laboratories together tested 2,40,850 patients and conducted 7,52,186 tests. However, the number fell to 50,959 patients and 153,902 tests between Feb 2024 and April 2024 (till April 21). AAP govt in Delhi has outsourced the lab investigation services to Agilus Diagnostics and Metropolis Healthcare for mohalla clinics and state-run dispensaries, hospitals and polyclinics. Anti-Corruption Bureau’s preliminary findings suggested a potential scam involving “fake or manipulated” tests. When contacted, Delhi govt said there was a lot of pressure on doctors of mohalla clinics to reduce the number of pathological tests. It added that a number of patients from lower and middle-income groups were widely using the free pathological tests services of mohalla clinics and even those who were consulting central govt hospitals like AIIMS, Safdarjung and Ram Manohar Lohia were availing of this facility. Agilus Diagnostics Ltd, in a statement, said that patient registration, including the linkage through Aadhaar or other IDs for each patient, was the responsibility of Delhi govt staff at health facilities. “Agilus Diagnostics solely manages the testing process for samples received at its laboratory from these health facilities. We would like to mention that there has been a significant increase in referrals and tests conducted since mid-March 2024,” the company said. There was no response from Metropolis Healthcare Limited. ACB had conducted an analysis of pathological tests done at the city’s mohalla clinics between Feb and Dec last year and found “massive irregularities”. The investigating agency, in its PE report, stated that the two pathological laboratories had together conducted nearly 2.2 million tests across the city between Feb and Dec 2023, of which at least 65,000 tests, out of a random sample of 1.15 lakh, were “found to be fake or manipulated”. “There is a serious lapse/misconduct on the part of the district nodal officer, cluster in charge, and project director who failed to supervise and monitor the scrutiny of tests properly. The data indicates a massive fraud, manipulation of records by the outsourced labs with an intention to create a huge loss to the govt exchequer amounting to crores of rupees,” an ACB mentioned in the PE. Following an impact assessment study conducted earlier in seven mohalla clinics by the health and family welfare department of Delhi govt, LG VK Saxena had recommended a CBI investigation into it. A separate inquiry by ACB was also recommended in the case. According to ACB’s PE report, mentioning the name and mobile number of the patient was compulsory for making an entry in the Lab Information Management System, as the reports were also required to be sent to the registered mobile number. Since the system was designed and developed by the outsourced agencies, they had full control and access over the entire data. “Hence, the possibility of manipulation of data by the outsourced lab vendors could not be ruled out,” the report added. ACB had also conducted random tele-verification of mobile numbers of patients at both private labs, which revealed that a large number of tests were conducted on either invalid mobile numbers or mobile numbers not related to the patients. A large number of tests was allegedly done without the presence of treating doctors. Source: Healthworld

May 10,2024 Covid-19 may have gone away but controversies over vaccine side-effects refuse to die. Covishield, the Covid-19 vaccine developed by UK-based drug major AstraZeneca and Oxford University and produced in India by Serum Institute of India, has triggered a big controversy in India with political parties too jumping in. There are demands for compensation for family members of people who died allegedly due to the vaccine side effects and to review the science behind all Covid vaccines. It all started with a submission made by Astrazeneva in a British court. It said in court documents that its Covid vaccine can cause a rare side effect, the UK’s Daily Telegraph newspaper reported nearly 10 days ago. The pharmaceutical giant is being sued for over £100 million (a little over Rs 1,000 crore) in class action over claims its vaccine caused death and serious injury in 51 cases, according to court documents seen by the Daily Telegraph, a British newspaper. AstraZeneca is contesting the claims but has accepted, in a legal document submitted to the high court in February, that its Covid vaccine “can, in very rare cases, cause thrombosis with thrombocytopenia syndrome”, which causes people to have blood clots and a low blood platelet count. One of the claimants is Jamie Scott, a father of two, who was left with a permanent brain injury after developing a blood clot and a bleed on the brain that prevented him from working after he received the AstraZeneca vaccine in April 2021. Lawyers representing families suing the drugs company argue that the vaccine was not as safe as individuals were entitled to expect. They are suing the firm under the Consumer Protection Act of 1987, arguing the maximum £12,000 (more than Rs 12 lakh) payout they could get from the UK-govt-run vaccine compensation scheme is inadequate. In India, the said vaccine was sold under the brand name Covishield manufactured by the Serum Institute of India (SII) in Pune. After the revelation about Astrazeneca’s submission in the UK court, parents of a woman who allegedly died after taking Covishield decided to file a case against SII. Venugopalan Govindan, father of Karunya, who died after taking the vaccine, said the admission by AstraZeneca is “too late” and has come after so many lives have been lost. ” The parents have already filed a writ petition seeking compensation, appointment of an expert medical board independent of the government to forthwith inquire into and investigate the deaths of their daughter, and to share the report of the investigation with them. A group of parents who lost their children to alleged adverse effects after taking Covishield, believes the number of deaths or serious injury could be much more in India than the government figures even as more parents join in to fight it out in the court. A plea has been filed in the Supreme Court, seeking setting up of an expert medical panel to study and assess the possible risk factors associated with the vaccine. It calls for a direction to the Centre to implement a vaccine damage payment system to compensate citizens who are severely disabled or deceased as a result of the vaccine. A doctors’ group has urged the government to review the science behind all Covid vaccines and audit their commercialisation as well as implementation of active surveillance and monitoring mechanisms to ensure vaccine adverse events are identified as early as possible. Source: Economic Times

May 12,2024 In the realm of herbal supplements, few hold as revered a status as Tulsi powder, derived from the sacred Tulsi plant. Renowned for its multifaceted health benefits, Tulsi has been a cornerstone of Ayurvedic medicine for centuries. In this article, we embark on a journey to explore the best Tulsi powders available in the market today. From the best products to its myriad uses, we delve into the intricacies of Tulsi powder, examining purity, potency, and quality across a spectrum of brands. B Naturall offers Holi Basil Leaf Powder, also known as Holy Basil Leaf Powder, in a convenient pack of 500 grams x 2, totaling 1 kilogram. Sourced from the finest leaves and traditional farms, the Tulsi powder is packed under hygienic conditions to preserve its freshness and flavor. Tulsi, revered in traditional Indian medicine for centuries, contains numerous beneficial compounds known as phytochemicals. These compounds exhibit strong antioxidant, antibacterial, antiviral, and immune-enhancing properties. Holi basil powder can be utilized in various ways, from consumption to external application, and is recommended for daily use. It supports the alleviation of skin and hair problems, including acne, pimples, eczema, and itchy scalp, thanks to its antibacterial properties Herbal Hills presents Holi Tulsi Powder in a convenient 1 kg pack. Pregnant or lactating women are advised to consume herbal products under the guidance of a healthcare practitioner. It is recommended to store the powder in a cool, dry place and keep it out of reach of children, protecting it from sunlight. The suggested dosage is 2 grams of powder, 1 to 2 times a day. The product contains only Tulsi powder and is made from quality ingredients. It is essential to read labels, warnings, and directions before use and to avoid contact with items that may damage the product. byPureNaturals offers 100% Natural Organic Holi Tulsi Leaf Powder designed for skin and hair care, available in a pack of 2, with each pack containing 115 grams. This Tulsi leaf powder is entirely organic and pure, without any added chemicals, making it suitable for both men and women. It is specifically formulated to stimulate hair growth and is intended for external use only. This versatile product can be applied to both as Tulsi powder for hair and as Tulsi powder for skin, offering a natural solution for various beauty needs. CARMEL ORGANICS presents Tulsi powder for skin Powder in a 340-gram pack, certified by Jaivik Bharat. This Holy Basil Powder is intended for promoting health, skin, and hair benefits. It is non-GMO and free from added preservatives, ensuring purity and quality. The Tulsi powder is known to reduce stress and anxiety, stimulate and revitalize the body, and ease inflammation and joint pain. Additionally, it can be used externally in hair and skin packs for enhanced benefits. CARMEL ORGANICS is committed to improving consumer health sustainably, offering healthy products at fair prices through a sustainable process. SAPTAMVEDA presents Premium Tulsi Leaf Powder in a 150g pack, revered in Ayurveda for its numerous health benefits. Tulsi, or Holy Basil, is widely used in households as a home remedy for various issues due to its easy availability and effectiveness. Rich in phytonutrients, essential oils, Vitamin A, and C, Tulsi leaves support eye health, immunity, and overall wellness. Sourced from organic farms, the Tulsi powder is free from harmful chemicals and pesticides, ensuring purity and quality. It acts as an immunity booster and stress reliever, calming nerves and enhancing overall well-being. Additionally, it aids in detoxification, cleansing, and nourishment of the skin and hair, promoting inner and outer health. The Online Quality Store offers Tulsi Leaf Powder in a convenient 100g pack, known for its multiple benefits for skin and hair. Also known as Ocimum Sanctum or Holy Basil Powder, it serves as an all-in-one herbal solution. This herbal powder is formulated to promote healthy hair and skin. Each order contains 100g of this versatile herbal powder, suitable for various beauty and wellness applications. Kriday Herbs presents Pure and Natural Dried Tulsi Leaves Powder, known for its versatility and health benefits. Whether used fresh or in its dry form, it adds value to both sweet and savory dishes. Tulsi powder is a powerhouse of nutrients and vitamins, serving as a rich source of antioxidants that combat free radicals and aid the body in fighting common colds and coughs. Additionally, it can be brewed into Tulsi tea, offering relief from fever, sore throat, and respiratory problems. Embrace the natural goodness of Tulsi for boosted immunity and overall well-being. Source: Economic Times

May 02,2024 AstraZeneca, the company that sold the vaccination in India, acknowledged in court a day ago that the Covid injection can have an uncommon side effect. As a result, the parents of the woman who is said to have died after taking the vaccine have chosen to sue Serum Institute of India (SII). With the revelation of AstraZeneca ‘s admission, the parents are optimistic of justice. The multinational pharmaceutical company is facing legal action from a class-action lawsuit alleging that the Covid-19 vaccine, which it co-developed with the University of Oxford, resulted in fatalities and severe injuries, including thrombosis with thrombocytopenia syndrome (TTS), a dangerous side effect that lowers platelet counts and causes blood clots. Karunya, the daughter of Venugopalan Govindan, passed away in July 2021 following her Covishield vaccination. Nonetheless, the government-appointed national committee found insufficient evidence to draw the conclusion that the vaccine was the cause of her death. This is the result of AstraZeneca’s admission in court documents that a rare adverse effect of their vaccination could be reduced platelet count and blood clotting. AstraZeneca is being sued in a class-action case in the UK. The father daughter Karunya, who passed away following the vaccination, Venugopalan Govindan, stated that AstraZeneca’s admission is “too late” and that it comes too late in the aftermath of so many lives lost. “AstraZeneca and SII should have stopped the manufacture and supply of these vaccines when 15 European countries either suspended or age-limited these due to deaths from blood clots that happened in March 2021, within a couple of months of the rollout of the vaccine itself.” In their writ petition, the parents are requesting restitution, the appointment of an impartial medical board to look into their daughter’s death as soon as possible, and access to the investigation’s findings. SII stated that they “won’t be commenting on this matter” when questioned. AstraZeneca reportedly acknowledged that the Covid vaccination “may, in very rare cases, cause TTS” in a court filing. “In spite of the uncommon risk of TTS, Covishield, which was used to vaccinate 90% of India’s population, has done well in India,” a senior member of the Covid working group told ET, downplaying worries of unfavorable outcomes. Experts also emphasized how much immunization can do to lessen the effects of the illness. According to Govindan, the government and the vaccine’s maker marketed the Covid shots as “safe and effective” across the country at great financial expense without providing enough evidence. According to him, they decided not to halt the rollout or at the very least raise awareness within the medical community and public about the unfavorable events as data from all over the world started to surface. “The regulatory bodies that approved it and subsequently didn’t intervene to stop it when data emerged about the dangers, are all culpable in the death of my daughter and countless others who have died after taking this so-called vaccine,” he claimed. Until the very end, he said, the current cases. “If sufficient remedies aren’t obtained, for the sake of justice and to prevent recurrence of this atrocity that was perpetrated in the name of public health, we will file fresh cases against any and all of those perpetrators because of whose actions the deaths of our children ensued,” he stated. Source: TOI