PSM News

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. 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 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. Let’s take a look at the positive impact and contributions of India’s pharmaceutical industry. 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. The pharmaceutical sector is a significant contributor to India’s economy, employing millions directly and indirectly. The industry’s growth has led to the establishment of research centres, manufacturing units, and a robust supply chain, boosting economic development in various regions of the country. Source: Healthworld

May 12,2024 New Delhi: The Indian Council of Medical Research (ICMR) National Institute of Nutrition (NIN) has released the dietary guidelines for Indians in which it has shed light on the intake of protein supplements which is commonly in practice especially among youngsters. In the 148 page guidelines, the ICMR has warned against the consumption of protein supplements to build body mass, a common fitness trend set by youngsters. Protein supplements have become increasingly popular among individuals looking to enhance their athletic performance, support muscle growth, or meet their daily protein needs. ICMR guidelines on protein powder It lays emphasis on whey protein, which is rich in branched-chain amino acids or BCAAs. These BCAAs are linked to higher risk of non-communicable diseases. Branched-chain amino acids (BCAAs), including leucine, isoleucine, and valine, play vital roles in protein synthesis, muscle repair, and energy production. Supplementation with BCAAs is popular among athletes and bodybuilders to enhance muscle growth, improve exercise performance, and reduce fatigue. Research suggests BCAAs may also benefit individuals with liver disease, improve insulin sensitivity, and aid in weight loss. However, excessive intake may lead to adverse effects such as insulin resistance and disruption of neurotransmitter balance. Though protein supplements or protein powders are obtained from plant-based sources such as soybeans, ICMR warns against the additives used in them for marketing purposes. Added sugars, artificial sweeteners and flavorings reduce the health benefits given by the protein powders. “Appropriate combination of cereals: pulses in a ratio of 3:1 or by substituting 30g of recommended level of pulses with 80g meat per day would improve the quality of protein to fulfill the needs of a normal person,” ICMR has said. Source: Healthworld

May 13,2024 Nagpur: Vidarbha has been experiencing a dramatic shift in weather conditions. On certain days it experiences a searing heat wave with temperatures as high as 42 degrees Celsius. On other days, there is heavy rain and cloud cover, which lowers the minimum temperature to 30 degrees Celsius or even less. While a break from the heat is welcomed, citizens are at risk of health hazards due to this abrupt and frequent change in weather. TOI spoke to doctors who explained how this rapid shift in temperature can strain the cardiovascular system, lungs, immune system and who needs to take extra care. “Present weather conditions have led to a spike in autoimmune health conditions like Asthma, COPD, Arthritis which further leads to increase in respiratory infections,” said pulmonologist Dr Akash Balki. “People with Asthma or allergies should be particularly cautious. The humidity change and potential dust and pollen increase can trigger attacks. It’s advisable for patients to keep their inhalers readily available and consult a doctor if they experience difficulty in breathing,” he added. Cardiologist Dr Amar Amale said the condition of patients with pre-existing heart conditions may deteriorate and they may land in ICU due to prevailing weather patterns. “There has been a rapid rise in patients with cough and breathing difficulties even at OPDs,” he said. “We recommend vaccinations to avoid respiratory infections. Influenza vaccines once a year and pneumococcal vaccine once in 5 years for all ages and high risk patients is advisable,” he added. Infectious disease specialist Dr Nitin Shinde shared a similar view. “Drastic weather shifts can weaken the immune system, making a person more susceptible to common illnesses like cold and flu. Vaccine works well, especially for vulnerable populations like elderly and adults living with pre-existing health conditions,” he said. Dr Shinde also suggested common preventive measures to avoid infections. “Maintaining good hygiene, washing hands frequently, and getting adequate sleep are essential to boost the body’s defense mechanism,” he said. Dr Anita Patil, who is a general physician, emphasized on the importance of precautions. “Staying hydrated is crucial during these transitions. Drink plenty of water, even if you don’t feel thirsty. Additionally, avoid strenuous activity during peak heat hours and wear loose, cotton clothing to allow your body to regulate its temperature,” she said. Physical trainer Allan Morde, however, emphasized on the importance of maintaining physical activity. “You may feel like skipping your workout due to rains and cloudy weather, but avoid lethargy. Follow your exercise schedule irrespective of weather conditions and stay healthy,” he said. Clinical dietician Priti Patel warned against neglecting diet during fluctuating weather. “People disturb their diet charts and stop following schedule attributing it to changed weather,” she said adding that doing so may disturb the health cycle. 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 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