Team JGJ

May 23,2024 New Delhi: The Delhi High Court on Tuesday reserved its order on a plea by several doctors’ associations against yoga exponent Ramdev over his alleged “unsubstantiated” claim about ‘Coronil’ being a “cure” for COVID-19 and not just an immunity booster. The plea forms part of a 2021 lawsuit by doctors’ associations against the yoga guru, his aide Acharya Balkrishna as well as Patanjali Ayurveda founded by Ramdev, and seeks an interim relief of removal of statements from various media platforms with respect to the claim. According to the lawsuit, Ramdev made unsubstantiated claims about ‘Coronil’ being a cure for COVID-19, contrary to the licence granted to the drug for merely being an “immuno-booster”. The senior counsel appearing for the plaintiffs also sought a direction to restrain the defendants from making further similar statements. Ramdev’s senior lawyer said he was bound by the undertaking given in the Supreme Court in the case concerning advertisements of Patanjali products, adding that he was willing to make a similar statement in the high court as well. The plaintiffs’ senior lawyer, however, urged the court to pass an order on the interim application stating that the undertaking before the apex court was with regard to not making “causal statements” that are not in compliance with the law. Justice Anup Jairam Bhambhani said the matter before him concerned “specific instances” and reserved the order. Three Resident Doctors’ Association of the All India Institute of Medical Sciences at Rishikesh, Patna and Bhubaneswar as well as Association of Resident Doctors, Post Graduate Institute of Medical Education & Research, Chandigarh; Union of Resident Doctors of Punjab (URDP); Resident Doctors’ Association, Lala Lajpat Rai Memorial Medical College, Meerut, and Telangana Junior Doctors’ Association, Hyderabad had moved the high court in 2021 against Ramdev and others. In their lawsuit filed through advocate Harshavardhan Kotla, the associations have submitted that the yoga guru, who is a highly influential person, was sowing doubts in the minds of the general public about the safety and efficacy of not only allopathic treatments but also COVID-19 vaccines. They alleged that the “misinformation” campaign was nothing but an advertisement and marketing strategy to further the sales of the product sold by Ramdev, including ‘Coronil’, which he claimed to be an alternative treatment for COVID-19. On October 27, 2021, the high court had issued summons to Ramdev and others on the lawsuit, saying it was not a frivolous matter and a case was “definitely” made out for its institution. Source: Healthworld

May 23,2024 New Delhi: Spices play a key role in making the Indian culinary experiences a worthy one. But, the recent buzz about contamination of spice mixes by MDH and Everest with cancer-causing chemical called Ethylene oxide has raised eyebrows and concerns in the national and international market. Keeping the same in view, the Food Safety and Standards Authority of India (FSSAI) recently collected samples from across India and released the report. FSSAI recently announced that it did not find ethylene oxide (ETO), a food contaminant flagged by foreign countries, in MDH and Everest product samples. As per a report by ANI, FSSAI made the announcement after testing of the samples of spices sold by the two companies. It is reported that FSSAI collected 34 samples of Everest and MDH spices for testing, 9 from Everest’s facilities in Maharashtra and Gujarat, and 25 from those of MDH’s in Delhi, Haryana and Rajasthan. According to the same ANI report, the tests also included several parameters including moisture content, insect and rodent contamination, heavy metals, aflatoxins, and pesticide residues. The samples were tested for ethylene oxide at NABL-accredited laboratories as well. The FSSAI received around 28 lab reports so far and the chemical was found absent in them. However, the body awaits the results from 6 more samples. If reports are to be believed, the Food Standards Agency (FSA) said that it had already been issuing early warning alerts for ETO in various spices from India since before January 2023. Source: Healthworld

May 23,2024 NEW DELHI: Healthcare emerged as the most violative sector in India with respect to advertising rules in 2023-24, with majority of violations took place due to misleading claims, an annual analysis of Advertising Standards Council of India (ASCI) showed. Among the violators, healthcare ads contribute 19% of cases, followed by illegal offshore betting (17%), personal care (13%), conventional education (12%), food and beverage (10%), and realty (7%). Babycare emerged as a new contender in the top violators category, with influencer promotions (by celebrities without proper disclosure) contributing to 81% of cases. In 2023-24, the analysis studied 10,093 complaints and 8,299 advertising campaigns. Nearly half of the advertisements picked up by ASCI were not contested by the advertisers. The majority of violations were on account of misleading claims at 81%, followed by ads that promoted harmful situations or products at 34% (the same ad can be processed for multiple objections). Manisha Kapoor, CEO & secretary general of ASCI, said, “2023-24 has been a truly challenging year and ASCI stepped up to this by focusing on digital. About 3,200 advertisements were shared with various regulators, such as MIB, Ayush, and MahaRera, for direct violations of the law. We see this as a continuing area of focus. With the highest number of violative ads seen online, advertisers and platforms must work more closely with regulators and self-regulators to keep consumers protected.” Further, digital media remained the primary source of violations, accounting for 85% of ads processed and had a lower compliance rate of 75%, compared to 97% for print and TV. This raises serious questions about the online safety of consumers, a point highlighted last year as well, ASCI said. In 2023-24, the number of complaints regarding misleading and violative ads was 12.8% higher over 2022-23. Saugata Gupta, ASCI chairman said, “As digital emerges as a dominant media in which advertisements thrive, ASCI has geared up to challenges through constant investment in technology’. And, celebrities continued to appear in ads that were in violation of ASCI code. ASCI processed complaints against 101 ads featuring celebrities, 91% of which required modification, the analysis said. About 104 celebrities appearing in these 101 ads were found to be in violation of guidelines as they could not provide any evidence of due diligence. The analysis pointed to lack of due diligence of marketing and advertising campaigns by social media influencers. Due diligence is a requirement under the Consumer Protection Act, 2019. Source: TOI

May 20,2024 Indian Council of Medical Research (ICMR) has castigated Banaras Hindu University (BHU) researchers for “incorrectly” associating it with an observational study on the side effects of the Covid-19 vaccine Covaxin, and asked why it should not take legal and administrative action for it. The premier research body has also directed BHU to immediately remove the “acknowledgement to ICMR” for the study and publish an erratum. According to a recent research by a team of researchers at BHU, nearly a third of the 926 participants of an observational study on the side effects of Bharat Biotech’s Covid-19 vaccine, Covaxin, reported adverse events of special interest (AESI). The study covered a one-year period after the vaccine was administered. In its letter to the researchers, ICMR said the research body is not associated with this “poorly designed” study and has not provided any financial or technical support for the research. “You have acknowledged ICMR for research support without any prior approval of or intimation to ICMR, which is inappropriate and unacceptable,” ICMR’s director general said in the letter. “ICMR cannot be associated with this poorly designed study, which purports to present a safety analysis of Covaxin.” The director general said the study has flaws like it has no control arm of unvaccinated individuals for comparing the rates of events between the vaccinated and unvaccinated groups. “Hence, the reported events in the study cannot be Iinked or attributed to Covid-19 vaccination,” the letter said. The director general said the study does not provide background rates of observed events in the population, making it impossible to assess the change in incidence of observed events in the post-vaccination period. “Baseline information of study participants is missing”, the letter said. According to ICMR, the study tool used is inconsistent with “adverse events of special interest” as defined in the reference provided in the paper for AESI. “The method of data collection has a high risk of bias. Study participants were contacted telephonically one year after vaccination and their responses recorded without any confirmation with clinical records or by physician examination,” the letter said. “We have also noticed that you have similarly acknowledged ICMR in similar previous papers without permission. Please explain why ICMR should not seek Iegal and administrative action against you,” the letter said. Source: Economic Times

May 21,2024 New Delhi: Centre has asked drug controllers of all states and UTs to share a list of antibiotic combinations licensed by them for manufacturing and marketing in their respective jurisdictions. It has also asked states/UTs to monitor the availability of unapproved antibiotic combinations, if any, present in markets under their jurisdiction and take action, reported. In 2018, Central Drugs Standard Control Organisation (CDSCO) had banned 26 antibiotic combinations. However, a follow-up study published in the Journal of Pharmaceutical Policy and Practice in 2022 showed that a significant number of such antibiotics remained available in the market. Also, the study found, sales of antibiotic combinations containing chemical compounds belonging to the same drug classes as the banned drugs increased after the ban. Sales of similar non-banned formulations also went up. Some pharma companies promoted products containing new non-antimicrobial components to the banned combination to dodge the govt order, therefore nullifying any attempts to reduce antibiotic resistance caused by the consumption of such drugs. An antibiotic combination refers to fixed dose combination medicine comprising two or more antibiotics in a fixed ratio of doses and available in a single dosage form. “Although antimicrobial FDCs (fixed-dose combinations) have been critical in improving clinical outcomes among patients with certain infections such as tuberculosis and HIV, use of such FDCs for routine bacterial infections is inappropriate as it drives AMR (antimicrobial resistance) by selecting co-resistant microorganisms. Thus, their indiscriminate use is widely discouraged, including in World Health Organisation’s AWaRe framework of antimicrobial prescribing,” the study said. It added that many FDCs marketed in India were never approved by CDSCO, their approval comes from state-level regulatory bodies that, at times, lacked sufficient technical expertise to make such decisions. Source: Healthworld

May 19,2024 New Delhi: The Food Safety and Standards Authority of India (FSSAI) has alerted traders, fruits handlers and Food Business Operators (FBOs) who are operating ripening chambers to strictly ensure compliance with the prohibition on Calcium Carbide for artificial ripening of fruits, particularly during the mango season. FSSAI is also advising Food Safety Departments of States/UTs to remain vigilant and take serious action and deal stringently against person(s) indulging in such unlawful practices as per the provisions of FSS Act, 2006 and Rules/Regulations made thereunder, the Ministry of Family and Health Welfare informed in a press release. Calcium carbide, commonly used for ripening fruits like mangoes, releases acetylene gas which contains harmful traces of arsenic and phosphorus. These substances, also known as ‘Masala’, can cause serious health issues such as dizziness, frequent thirst, irritation, weakness, difficulty in swallowing, vomiting and skin ulcers, etc. Additionally, acetylene gas is equally hazardous to those handling it. There are chances that calcium carbide may come in direct contact with fruits during application and leave residues of arsenic and phosphorus on fruits, the release stated. Due to these dangers, the use of calcium carbide for ripening fruits has been banned under Regulation 2.3.5 of the Food Safety and Standards (Prohibition and Restrictions on Sales) Regulations, 2011. This regulation explicitly states, “No person shall sell or offer or expose for sale or have in his premises for the purpose of sale under any description, fruits which have been artificially ripened by use of acetylene gas, commonly known as carbide gas.” Considering the issue of rampant use of banned calcium carbide, FSSAI has permitted the use of ethylene gas as a safer alternative for fruit ripening in India. Ethylene gas can be used at concentrations up to 100 ppm (100 ml/L), depending upon the crop, variety and maturity. Ethylene, a naturally occurring hormone in fruits, regulates the ripening process by initiating and controlling a series of chemical and biochemical activities. The treatment of unripe fruits with ethylene gas triggers the natural ripening process until the fruit itself starts producing ethylene in substantial quantities. Further, the Central Insecticides Board and Registration Committee (CIB & RC) has approved Ethephon 39 per cent SL for the uniform ripening of mangoes and other fruits. The Ministry emphasised that FSSAI has published a comprehensive guidance document titled “Artificial Ripening of Fruits – Ethylene gas a safe fruit ripener” suggesting the Food Business Operators to follow the procedure for artificial ripening of fruits. This document outlines a Standard Operating Procedure (SOP) incorporating all aspects of artificial ripening of fruits by ethylene gas viz. Restrictions, Requirements for Ethylene Ripening System/Chamber, handling conditions, Sources of Ethylene Gas, Protocol for application of Ethylene gas from various sources, post treatment operations, safety guidelines etc. “In case any use of Calcium Carbide or any wrong practice of using ripening agents for artificial ripening of fruits is noticed by the consumers, the same may be brought to the notice of concerned State Commissioners of Food Safety for taking action against such violators,” the release added. Source: Healthworld

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