May 2024

May 19,2024 Drug makers Dr Reddy’s Laboratories, Sun Pharma, and Aurobindo Pharma are recalling products from the US market due to manufacturing issues, according to the latest Enforcement Report by the US Food and Drug Administration (USFDA). Dr Reddy’s Laboratories is recalling nearly 20,000 cartons of a medication used to control blood phenylalanine levels in adults and children. Dr Reddy’s Laboratories, Inc, based in Princeton, New Jersey, is recalling Javygtor (sapropterin dihydrochloride) Powder for Oral Solution (100mg) because it is sub-potent, according to the USFDA. The company is also recalling another lot of sapropterin dihydrochloride for the same reason. Sapropterin dihydrochloride is used to treat hyperphenylalaninemia (HPA), a condition characterized by high levels of phenylalanine in the blood. It is specifically indicated for individuals with phenylketonuria (PKU), a genetic disorder in which the body cannot break down the amino acid phenylalanine, leading to its accumulation in the blood. High levels of phenylalanine can cause various health problems, including intellectual disabilities, developmental delays, and other neurological issues. The USFDA stated that the company initiated the Class I recall on April 8 this year. A Class I recall, as defined by the US health regulator, pertains to defective products that can cause serious health problems. The USFDA also reported that Sun Pharma is recalling 11,016 vials of Amphotericin B Liposome for Injection, used to treat fungal infections, from the US market. Sun Pharma’s US-based arm initiated the Class II recall on April 19 this year due to being “Out of specification for assay,” according to the USFDA. Similarly, Aurobindo Pharma is recalling 13,605 bottles of Clorazepate Dipotassium Tablets (3.75 mg and 7.5 mg), used to treat anxiety, from the US market. The recall is due to “Discoloration: Dotted and yellow spots on tablets,” as stated by the USFDA. Aurobindo Pharma’s US-based arm initiated the Class II recall on April 24 this year. Additionally, the USFDA reported that FDC Ltd is recalling 382,104 units of Timolol Maleate Ophthalmic Solution, used to treat glaucoma, from the US market. The Aurangabad, Maharashtra-based drug firm is recalling the affected lot due to a “Defective Container.” According to the USFDA, a Class II recall is initiated when the use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or when the probability of serious adverse health consequences is remote. The US generic drug market, valued at approximately $115.2 billion in 2019, is the largest market for pharmaceutical products. Source: CNBCTV18

May 15,2024 Copenhagen: Cardiovascular disease is responsible for 40 percent of deaths in Europe, the WHO said on Wednesday, urging Europeans to cut their salt intake. That amounts to 10,000 deaths a day, or four million a year, “Implementing targeted policies to reduce salt intake by 25 percent could save an estimated 900,000 lives from cardiovascular diseases by 2030,” Hans Kluge, the director of the Europe branch of the World Health Organisation said in a statement. In Europe, one in three adults between the ages of 30 and 79 suffer from hypertension, often due to salt consumption. Fifty-one of the 53 countries in the WHO’s European region have an average daily salt intake above the WHO’s recommended maximum of five grams, or one teaspoon, largely due to processed foods and snacks. High salt intake raises blood pressure, which is a leading risk factor for cardiovascular diseases such as heart attacks and strokes,” the WHO said. Europe has the highest blood pressure prevalence in the world, it said. According to the WHO Europe report, men in the region are almost 2.5 times more likely to die from cardiovascular diseases than women. There is also a geographic divide: the probability of dying young (30-69 years) from cardiovascular disease is nearly five times as high in eastern Europe and central Asia compared to western Europe. Source: Healthworld

May 15,2024 Bengaluru: On account of ‘World Hypertension Day’, Dr Devi Shetty, Founder and Chairman, Narayana Health, emphasised the critical importance of monitoring and controlling one’s blood pressure. This year’s theme, ‘Measure Your Blood Pressure Accurately, Control It, Live Longer’, succinctly captures the essence of our collective goal: to empower individuals with the knowledge and tools necessary to safeguard their health. Undoubtedly, one of the most pressing concerns is undiagnosed hypertension. According to the World Health Organisation (WHO), a staggering 188.3 million individuals in India are affected by hypertension. Shockingly, only 37 per cent of these individuals receive a formal diagnosis, and an even smaller percentage initiate treatment. These statistics underscore the urgent need for proactive measures. Dr Shetty implored every individual to prioritise regular blood pressure checks, especially once they reach the age of 20. Hypertension frequently exhibits no discernible symptoms. However, its consequences can be dire, ranging from debilitating brain strokes to life-threatening heart failure and kidney damage. Therefore, regardless of whether one experiences overt symptoms, please prioritise routine blood pressure monitoring. Your health is your most precious asset, and vigilance is key to preserving it, concluded Dr Shetty Source: Healthworld

May 15,2024 New Delhi: The Supreme Court on Tuesday said its 1995 judgement which brought the medical profession within the ambit of Consumer Protection Act needs to be reconsidered. A bench of Justices Bela M Trivedi and Pankaj Mithal said the decision of the three-judge bench deserves to be revisited and considered by a larger bench. “In our humble opinion, the said decision deserves to be revisited having regard to the history, object, purpose and the scheme of the Consumer Protection Act and in view of the opinion expressed by us hereinabove to the effect that neither the ‘Profession’ could be treated as ‘business’ or ‘trade’ nor the services provided by the ‘Professionals’ could be treated at par with the services provided by the Businessmen or the Traders, so as to bring them within the purview of the CP Act,” the bench said. The bench referred the matter to the Chief Justice of India for his consideration. In 1995, the Supreme Court delivered a decision in Indian Medical Association Vs VP Shantha case which brought the medical profession within the ambit of a service as defined in Section 2(1)(o) of the Consumer Protection Act, 1986. Section 2(1)(o) of the Act defines the word “service” to mean a “service of any description, which is made available to potential users and includes, but not limited to, the provision of facilities in connection with banking, financing, insurance, transport, processing, supply of electrical or other energy, boarding or lodging or both, housing construction, entertainment, amusement or the purveying of news or other information, but does not include the rendering of any service free of charge or under a contract of personal service”. The apex court’s observation came while pronouncing a judgement which held that the lawyers do not come within the purview of Consumer Protection Act and cannot be sued for “deficiency in service” before the consumer courts. The bench clarified that this does mean that the professionals could not be sued or held liable for their alleged misconduct or tortious or criminal acts. “In the process of overall depletion and erosion of ethical values and degradation of the professional ethics, the instances of professional misconduct are also on the rise. Undoubtedly, no professional either legal, medical or any other professional enjoys any immunity from being sued or from being held liable for his professional or otherwise misconduct or other misdeeds causing legal, monetary or other injuries to his clients or the persons hiring or availing his services. “The fact that professionals are governed by their respective Councils like Bar Councils or Medical Councils also would not absolve them from their civil or criminal liability arising out of their professional misconduct or negligence. Nonetheless, as discussed hereinabove, we are of the opinion that neither the Professions nor the Professionals were ever intended to be brought within the purview of the CP Act either of 1986 or 2019,” it said. Source: Healthworld

May 16,2024 New Delhi: Privatisation reduces the quality of care and worsens health outcomes of patients, a study published in Lancet suggests. The study analysed several studies conducted in high-income countries on the fallout of public hospitals being converted to for-profit or not-for-profit facilities and of services by public hospitals being outsourced. The paper published by researchers at the department of social policy and intervention in Oxford University reviewed studies from the US, Germany, the UK, Sweden, South Korea etc. It found that hospitals converting from public to private ownership status tended to make higher profits than public hospitals that do not convert, primarily through the selective intake of patients and reductions in staff numbers. The authors stated that their analysis provided evidence that challenges the justifications for healthcare privatisation and concluded that the scientific support for further privatisation of healthcare services is weak. The review found that the conversion reduced “the comprehensiveness and generosity of care”. Privatised hospitals decreased their staffing levels, especially of the highest qualified nurses. It found that outsourcing corresponded with fewer staff members employed per patient, especially true of cleaning staff. Interestingly, the number of physicians was not reduced after privatisation, whereas most other staffing categories were. “Overall, the results suggest that accessibility of care might be affected in different ways, with more precise appointment times and reduced waiting times in some cases, but with effects that could disadvantage some groups, particularly those whose treatments have low profits for the private sector,” stated the paper. Those who advocate outsourcing services to the private sector argue that financial accountability compels private companies to ensure patients’ well-being and eliminates unnecessary bureaucracy. It is also argued that competition from private facilities improves performance across the entire health system as all providers are incentivised to deliver better quality services, especially in a single-payer or purchaser system when the pricesare largely fixed. However, the review noted that “the profit motive might not always result in desired outcomes”. It pointed out that competitive markets could also discourage providers from revealing information on the quality of their services. “The evidence compiled here does not align with the expectations of mixed markets, namely that they would improve quality by increasing competition,” stated the study, adding that the findings suggested that some areas of the welfare state, such as education and health care, might be structured in ways that make them less amenable to the kinds of incentives that operate in other markets. Source: Healthworld

May 15,2024 New Delhi, There is a need to increase the number of qualified doctors to more than 50 lakh and also add 30 lakh more hospital beds in the country in order to achieve India’s healthcare vision 2047, according to a report. The increase in the number of doctors and beds in hospitals would help India get closer to the average of developed countries, as per a FICCI-EY Report titled ‘Decoding India’s Healthcare Landscape’. India has witnessed a significant increase in the number of medical colleges and MBBS seats, addressing the growing demand for healthcare professionals, it said. The number of registered allopathic doctors witnessed substantial growth, rising from 6,60,801 in 2005 to 13,08,009 such doctors in 2022, the report said. Similarly, the bed capacity in government hospitals across India has consistently grown from 4.7 lakh beds in 2005 to 8.5 lakh beds in 2021. The report also highlighted the importance of having 100 per cent health insurance coverage for the country’s population. It also cited the need to establish one medical college in every district of India. As per the latest report by FICCI, the total market size of the Indian pharmaceutical industry is expected to reach USD 130 billion by 2030. India currently ranks third globally in pharmaceutical production by volume, known for its generic medicines and low-cost vaccines. The country is a major supplier of essential vaccines, catering to a significant portion of global demand. 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. 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