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Sep 25, 2024 NEW DELHI: Over 50 medicines, including those for diabetes, hypertension, vitamins, calcium D3 supplements, bacterial infections, and acid reflux, have failed quality tests conducted by India’s drug regulator. The Central Drugs Standard Control Organisation (CDSCO) issued a ‘Not of Standard Quality’ (NSQ) alert for August, highlighting that some of the top- selling medicines were produced by well-known pharmaceutical companies, including Alkem Laboratories, Hetero Drugs, Hindustan Antibiotics Limited (HAL), and Karnataka Antibiotics and Pharmaceuticals Ltd. Among the medicines flagged as NSQare paracetamol tablets (500 mg), the anti-diabetic drug Glimepiride, high blood pressure medication Telma H (Telmisartan 40 mg), acid reflux medication Pan D, and calcium supplements Shelcal C and D3. The list also includes the widely used antibiotic Metronidazole, manufactured by HAL, and Shelcal, distributed by Torrent Pharmaceuticals and produced by Pure & Cure Healthcare in Uttarakhand. Alkem Health Science’s antibiotics, Clavam 625 and Pan D, were also identified as substandard by a Kolkata state-run laboratory. This lab found that Cepodem XP 50 dry suspension from Hyderabad-based Hetero, prescribed for severe bacterial infections in children, did not meet quality standards. Further concerns were raised over paracetamol tablets from Karnataka Antibiotics & Pharmaceuticals Ltd. Additionally, Sun Pharma Laboratories Ltd.’s Ursocol 300, designed to dissolve certain gallstones, was flagged as spurious. Multiple batches of Telmisartan manufactured by Life Max Cancer Lab in Haridwar also failed quality tests. CDSCO has released two lists of drugs that did not pass quality checks: one containing 48 popular drugs and the other detailing responses from the pharmaceutical companies whose products failed. The manufacturers’ responses indicated that the actual manufacturers (as per the label claim) did not produce the flagged batches, suggesting that these may be spurious drugs. However, the final determination is subject to ongoing investigations. Companies such as Sun Pharma and Glenmark provided similar replies, asserting they had not manufactured the implicated medicines. Sun Pharma’s three drugs—Pulmosil for erectile dysfunction, Pantocid for acid reflux, and Ursocol 300 —were among those that failed the tests. Glenmark’s hypertension drug Telma H (Telmisartan) and Macleods Pharma’s Defcort 6 for arthritis treatment also did not meet quality standards. All three companies echoed that they had not produced these medicines. The drug regulator issues NSQalerts following random monthly sample checks carried out by state drug officials. In August, the CDSCO banned over 156 fixed-dose drug combinations deemed “likely to involve risk to humans. ” These included popular fever medications, painkillers, and allergy tablets, such as Cheston Cold and Foracet, commonly used for cold, fever, and pain relief. Since 2014, the regulator has prohibited 499 FDCs—combinations of two or more known drugs in a single dosage form Source: New Indian Express

Yes, our intestines contain germs. Germs aren’t all bad—in fact, some are helpful. For example, the common bacterium E. coli can be found in our intestines, and it helps us digest green vegetables and beans (also making gases). These same bacteria also make vitamin K, which causes blood to clot. Source: Britannica

Sep 23, 2024 New Delhi: A recent study published in Cell highlights the potential of metformin, a widely used diabetes medication, to slow ageing in monkeys. The research demonstrates that daily doses of metformin can preserve cognitive function and delay ageing effects in various tissues, especially the brain. This finding suggests that metformin could one day be used to delay ageing in humans. Metformin’s Impact on Cognitive Function The study, led by Guanghui Liu and his team at the Chinese Academy of Sciences, involved administering metformin to 12 elderly male cynomolgus macaques for 40 months, equivalent to about 13 human years. Results showed that metformin-treated monkeys experienced significantly slower cognitive decline than the non-treated control group. The neuronal activity in these monkeys resembled that of animals around six years younger, or approximately IS human years, indicating that metformin may help maintain brain health and cognitive function. Effect on Other Tissues Beyond the brain, the study explored metformin’s impact on other tissues, including the lung, kidney, liver, skin, and brain’s frontal lobe. The drug was found to slow the biological ageing of these tissues and reduce chronic inflammation, a common marker of ageing. These results suggest that metformin’s benefits extend beyond cognitive presewation, potentially offering broader anti-ageing effects. Mechanisms and Future Research Researchers proposed that metformin’s anti-ageing effects could be due to the activation of NRF2, a protein that protects cells from inflammation and injury. While the study primarily focused on healthspan—the period during which an organism remains in good health—it did not assess the drug’s impact on overall lifespan. Challenges and Next Steps Despite the promising findings, the study has limitations, including a small sample size of male monkeys. Fulther research is needed to determine if these effects are consistent across sexes and larger populations. Liu and his team are now conducting a trial with 120 human participants, in partnership with Merck, to test metformin’s impact on human ageing. Additionally, plans are underway for a larger-scale trial involving 3,000 individuals aged 65—79 to further explore the drug’s potential to extend healthspan and improve quality of life in older adults. The study offers new insights into metformin’s potential beyond diabetes treatment, highlighting its possible role in promoting healthier ageing. While these initial results are encouraging, more comprehensive studies are necessary to confirm metformin’s impact on human health and longevity. Source: Economic Times

Sep 25, 2024 New Delhi: StlYker, a medical technology company, announced the launch of its ‘1788 Advanced Imaging Platform,’ a visualization system designed for use across multiple specialties that provides surgeons with enhanced imaging capabilities for improved patient outcomes in India. The 1788 platform delivers high-resolution images that enable surgeons to visualize critical anatomy with greater clarity. It features advanced fluorescence imaging capabilities, offering clearer perfusion imaging and detailed visualization of complex anatomical structures, the company said. It is compatible with currently marketed imaging agents and is adaptable to new agents and fluorescence modes as they become available, the company added. Aman Rishi, Vice President and General Manager, India, said, “Fluorescence-guided surgery is emerging as a promising solution, enabling surgeons to better visualize perfusion, tumors, and critical anatomy intraoperatively. The 1788 imaging platform, with advanced fluorescence imaging capabilities, ensures better healthcare.” Stryker stated that the launched platform features a color gamut for 62.5 times more visible colors, high dynamic range with a new tone mode for more balanced lighting, and a Color Segmented Fluorescence mode, which shows a color map based on ICG intensities, especially useful for perfusion assessment and lymph node mapping. Source: Economic Times

Sep 22, 2024 • In a new study conducted in cynomolgus monkeys, researchers have shown that metformin, a medication used to treat type 2 diabetes, can slow aging in multiple organs, including the brain. • Over a three-and-a-half-year period, they found that monkeys treated with metformin showed reduced age-related decline, with some exhibiting a six-year regression in certain aging indicators. • While the study suggests promising anti-aging benefits, there is a need for further research, including human trials, to further explore the drug’s potential. Metformin, a drug traditionally used to treat type 2 diabetes, has garnered significant attention for its potential anti-aging effects. Its mechanism involves improving insulin sensitivity, reducing inflammation and promoting cellular repair processes, all important factors in aging. In this new research, experts in China, along with U.S. colleagues, have discovered that administering the diabetes drug metformin to cynomolgus monkeys can slow aging across multiple organs, including the brain. The study was carried out by teams from several institutions, including the Institute of Zoology and the Beijing Institute of Genomics, both part of the Chinese Academy of Sciences. Their study, published in Celle, details the researchers’ nearly three-and-a-half-year study on the   effects of metformin on the bodies of cynomolgus monkeys Cynomolgus monkeys (Macaca fascicu/aris) are a suitable model for aging studies because, like other nonhuman primates, their physiological and functional characteristics resemble those of humans. Source: Medical News Today

Sep 22, 2024 New Delhi: The Drugs Controller General of India (DCGI) has declared as many as 16 commonly-used medicines as spurious, after they failed the regulator’s quality and safety tests. These include Glenmark Pharmaceuticals’ Telma H, prescribed by doctors to manage blood pressure, and Sun Pharmaceutical’s Ursocol 300 used for gallstones treatment, a drug alert issued by DCGI, and seen by Mint, said. The other heavily-prescribed medicines that have failed India’s apex drug regulator’s tests include Pulmosil injection used for managing pulmonary arterial hypertension, and Pantocid for gastric issues. These tests come in the backdrop of some instances of Indian medicines failing quality checks abroad, following which Central Drugs Standard Control Organisation (CDSCO) along with state drugs controllers (SDCs) have conducted risk-based inspections of more than 400 premises in the last one year. As a result, over 300 actions like issuance of show-cause notices, stop production order, suspension, cancellation of licences /product licences etc. have been taken by state licensing authorities as per the provisions of the Drugs Rules, 1945. Paziva —40, Pantomed —40, Cefixime Oral Suspension IP, Moxymed CV, Frusemide Injection IP 20 mg, Tab Nodosis, Pantoprazole Inj. BP 40 mg — were listed in Inot of standard quality (NSQ)I by the regulator’s database for the month August. “Pulmosil, an indication used to treat pulmonary arterial hypertension, Pantocid used against gastroesophageal reflux disease (GERD), Ursocol 300 mg used for the treatment of gallstones manufactured by Sun Pharmaceuticals Ltd have been detected as “spurious”. Popularly used Telma H drug– manufactured by Glenmark Pharmaceuticals Ltd is used for managing high blood pressure. The drug has been declared spurious by the regulator,” stated the drug alert issued by DCGI. Sun Pharmaceutical Ltd and Glenmark Pharmaceuticals, in a reply to the drug regulator, have said that the impugned batch of the product has not been manufactured by them and that it is a spurious drug. “The product is purported to be spurious, however, the same is subjected to outcome of investigation,” they said. Quality control These poor quality and unsafe medicines have been reported by the drugs inspector, East Zone, CDSCO, that has a mandate to pick samples to ensure that genuine product is available in the market. During 2022-23, at least 3,053 drugs were found substandard and 424 spurious or adulterated, Union minister of state for health and family welfare Anupriya Patel said in Parliament in July. Earlier in February, the apex drug regulator instructed the states/Union Territories to keep a strong vigilance and surveillance on the quality of drugs available in the market by doing random sampling of the medicines. The initiative helps create a monthly database of spurious and NSQ medicines and keep a check on manufacturers. Another important drug, Defcort 6 Tablets, have been found to be unsafe by the Delhi drug regulator. The indication is used to treat Duchenne muscular dystrophy (DMD), a rare health condition. Source: Live Mint

Sep 24, 2024 Kerala: The Kerala health department announced plans to release revised guidelines for the prevention and treatment of Mpox, a decision that came in the wake of the southern state repolting the country’s first confirmed case of the new strain on Monday. The State Level Rapid Response Team (RRT) held a meeting to assess the overall situation in the state. After the meeting, state Health Minister Veena George said instructions have been given to take necessaiY action if the number of cases increases. “Isolation facilities have been set up in all districts, and monitoring has been strengthened, including at airports. Currently, testing facilities have been arranged in five laboratories. If required, testing facilities will be expanded to more labs,” she said in a statement. She said those arriving from other countries who show symptoms should inform the health department and seek treatment. The minister also instructed that if anyone with Mpox symptoms comes to government or private hospitals, the health depaltment should be informed. Earlier, official sources in New Delhi said India had repcn•tecl the first case of the Mpox strain in a patient from Kerala who tested positive last week. They said the Clade 1b strain was detected in a 38-year-old man from Malappuram district who had recently returned from the United Arab Emirates. The patient is stable, the sources said, adding, “This was the first case of the current strain that led the World Health Organization (WHO) to declare Mpox a public health emergency last month for a second time.” The earlier case of Mpox that emerged in the national capital was a 26- yem=old resident of Haiyana’s Hisar who tested positive for the previous West African Clade 2 strain earlier this month. Since the WHO’s 2022 declaration of Mpox as a Public Health Emergency of International Concern, 30 cases have been reported in India. Mpox infections are generally self-limiting, lasting between two and four weeks, and patients usually recover with suppcntive medical care and management. It is transmitted through prolonged and close contact with an infected patient. Mpox typically manifests itself with fever, rash and swollen lymph nodes and may lead to a range of medical complications. Source: Economic Times

Sep 25, 2024 New Delhi: Union Minister of State for Health and Family Welfare JP Nadda on Tuesday urged the National Medical Commission to expand 75,000 medical seats by 2029. Nadda made this statement while addressing the 4th-anniversary ceremony of the National Medical Commission today. He also noted that NMC achieved its target of MBBS seats in the country a year in advance. He fulther encouraged NMC to achieve the target set by the Hon’ble Prime Minister of India, Narendra Modi, of adding 75,000 medical seats over the next 5 years to meet the growing demand of aspiring medical professionals, as per the release. “Lauding recent technological methodologies adopted by NMC such as in assessing medical colleges through AI and introduction of Aadhar- enabled biometric attendance (AEBAS) for faculty, Nadda motivated NMC to continue its eff01ts to improve and enhance the quality of medical education in the country,” as per the release. He also highlighted the initiation of the National Medical Register (NMR), calling it “a dynamic database for all allopathic doctors which has already received about 20,000 applications”. The Union Health Minister said that recent eff01ts towards serving public health, especially the Family Adoption Program will prepare MBBS students to become more humane and skillful clinicians. He also pointed out the shift in mindset to preventive healthcare and wellness. “On the occasion, the Union Health Minister released an essay compilation book – ‘Making of a Family Physician: Reaching the Roots’ of selected 89 essays, a Collage book- ‘Art of Making of a Family Physician: Reaching the Roots’ of selected 67 collages and a First Survey report on medical camps conducted by colleges under Family Adoption Program through village outreach. The smvey has been carried out by 2nd year MBBS students in 2022 from 496 colleges from 28 states/ Union Territories participated,” as per the release. The Union Minister also felicitated the students who wrote the best essays and made the best collages. He concluded his address by congratulating the new students who took admission in MBBS courses around the country. Hekali Zhimomi, Additional Secretary, Union Health Ministly; Dr BN Gangadhar, Chailperson, NMC; Dr Aruna V Vanikar (Undergraduate Medical Education Board) and DrVijay Oza (Postgraduate Medical Education Board), Presidents, NMC and senior officials of the Union Health Ministry were present on the occasion. (ANI) Source: Economic Times

Sep 25, 2024 Hyderabad: The Drugs Control Administration, Telangana conducted raids at a medical shop in Nagulbanda, Falaknuma, which was being operated by Mohammed Ayub Pasha without a valid drug license, and seized 23 varieties of medicines, including antibiotics, antihistamines, analgesics, antipyretics, etc that were illegally stocked for sale. The drug samples in the medical shop, which did not have the mandatory drug license, have been collected and sent to the DCA laboratory for quality testing. The DG, TSDCA, V B Kamalasan Reddy urged wholesalers and traders to ensure that they supply drugs in bulk only to individuals or medical shops that have valid DCA drug license, which is issued under the Drugs and Cosmetics Act. Quack held In a separate raid by the DCA, Telangana, the drug inspectors seized large stocks of medicines from a quack’s clinic in Konne village, Bachannapet mandal, Jangaon district. The DCA inspecting team raided the clinic of a quack K Laxminarayana, who was practicing allopathy without any qualification in Konne village. During the course of the raid, the DCA teams seized 34 varieties of medicines including antibiotics, steroids etc, worth Rs 20,000, which were stocked at the premises without any drug license. The DCA has reported that several higher generation antibiotics were seized at the clinic during the raids. Source: Telangana Today

Sep 15, 2024 New Delhi: The Drugs Controller General of India (DCGI) has issued a new code for drug inspectors posted across the country to make their inspections, sample collections and permits uniform, predictable and accountable. In a guidance issued on 12 September to all zonal, sub-zonal and port offices, the drug regulator directed drug inspectors to follow a uniform drug sampling method and focus on identifying risks during selection of sample drugs, cosmetics and medical devices moving in the supply chain. The new code replaces a more-than-decade-old set of guidelines in view of changes in the procedure and advancements in the regulatory system. As per the new set of rules, each drug inspector in consultation with their authority shall prepare a sampling plan on a monthly and annual basis for finalizing the sampling locations to cover the entire jurisdiction. The sampling plan shall include rural areas and drugs used in areas endemic for certain diseases, drugs for seasonal diseases etc. This will be useful for effective surveillance for quality and efficacy of drugs and cosmetic available in the market by adopting uniform drug sampling methodology. Inspector will have to collect samples of drugs, cosmetics, medical devices and vaccines. Drugs are regulated under the Drugs & Cosmetic Act, 1940 to ensure safety, efficacy and quality of the drugs available in the country. Centralized list According to the guidance note, the drug inspectors will have to maintain a centralized monthly list of sub-standard or spurious drug and put it in public domain to avoid their further use and ensure the availability of true product in the market and initiate quick actions for NSQ product declared by the Government Analyst. For conducting uniform enforcement, the drug inspectors have to do onsite inspections to evaluate compliance of the quality system and infrastructure with nationally & internationally accepted Good Manufacturing Practices (GMP) Standards. However, the inspection will have to be conducted in the knowledge of manufacturer with proper evidence and documents. Notably, DCGI is the head of Central Drugs Standard Control Organization (CDSCO) which has 8 Zonal offices, 7 Sub-Zonal offices, 8 Central Drugs Testing Laboratories and 9 Airport & 19 Sea port Offices. Last year, Parliament was informed that the number of sanctioned posts and filling of the vacant post of Drug Inspectors in the states come under the respective State Government. Such information is not maintained centrally. However, CDSCO, till December last year, has 504 sanctioned posts, 201 is working strength and 303 are still vacant post. Shortage of drug inspectors This indicates that there is a major shortage of drug inspectors in CDSCO and at the level of state government. “There’s an acute shortage of competent medical devices officers at CDSCO and State Licensing Authorities from the Engineering and science background to adequately regulate medical devices that have recently came under regulations. Due to these shortages pharmacists drug inspectors have been redesignated as Medical Devices Officers and in many cases these are not experts at the diverse range of engineered medical devices they are supposed to regulate. This becomes a huge challenge to manufacturers as they struggle to communicate with these regulators who see products like Defibrilator and ventilators from eye of a medicine . It’s like an airforce officer trying to insist on a naval officer what’s expected by the Airforce,” explained Rajiv Nath, forum Coordinator, AiMeD ( Association of Indian Medical Devices) Industry adding that the government needs to address this issue urgently. Source: Live Mint