April 2024

Apr 27,2024 New Delhi: The ICMR has planned to expand its Indian Clinical Trial and Education Network (INTENT) and invited tenders from public and private medical research institutes for coordinating regulatory clinical trials for drugs and devices. These expressions of interest would help in the growth of the national network, which encompasses 47 institutes that include public and private medical colleges, hospitals, and research institutes including the ICMR institutes. The ICMR established INTENT, a network of medical colleges and research institutes, with an overarching goal of providing evidence-based, and culturally sensitive solutions to health issues of national priorities by conducting large, decisive, regulation compliant clinical trials. This network is invested in providing an end-to-end solution for clinical trials for the Indian researchers. “The ICMR now plans to expand the national network and accordingly invites expressions of interest (EOI) from public and private medical research institutes in India to contribute to the INTENT activities,” an official document said. The broad objectives of the network are to generate high quality evidence by conducting and coordinating hospital-based and community-based trials in the diseases or health conditions of public health importance in India. The aim is also to guide health policies and informed management practices based on the evidence generated and build capacity of clinical researchers in India for the planning, conduct, analysis and scientific dissemination of the clinical trials, the document stated. The INTENT proposes to co-ordinate regulatory clinical trials or clinical investigations for drugs, devices, vaccines, biologics developed or co-developed with academia, start-ups or industry that address the national health priorities. Additionally, trials that are planned through inter-ministerial collaborations may also be conducted by INTENT. The INTENT is being coordinated by Clinical Studies and Trials Unit (CSTU) under Division of Development Research at ICMR, Delhi. The selected centres from the EOI applicants will have the privilege of first preference as sites in case of trials conducted under the ambit of INTENT. Source: Healthworld

Apr 24,2024 Hyderabad: Some medical shops were found to be selling certain anti-fungal medicines at almost double the actual cost, the Drugs Control Administration (DCA) said. Stocks worth 5.5 lakh were seized during two separate raids conducted on Tuesday. DCA officials seized two medicines from shops in Vanasthalipuram and Hayathnagar mandal of Rangareddy district, which were being sold at much higher prices than the central government fixed price. The medicines — Itrazole 100 and Itrazole 200 — are commonly used to treat fungal infections. The drugs were manufactured by Sunfine Health Care in Solan, Himachal Pradesh, and marketed by a company in Haryana. Officials said that Itrazole 200 was being sold at 43 per tablet instead of the actual price of 24 per tablet. Similarly, Itrazole 100 was being sold at 31 per tablet instead of 18, which means a patient has to cough up an extra 100-150 for a strip of ten tablets. “Selling overpriced medicines is not only illegal, but it also means that healthcare is inaccessible to many,” the DCA said, adding that strict action would be taken against offenders. Hyderabad: Some medical shops were found to be selling certain anti-fungal medicines at almost double the actual cost, the Drugs Control Administration (DCA) said. Stocks worth 5.5 lakh were seized during two separate raids conducted on Tuesday. DCA officials seized two medicines from shops in Vanasthalipuram and Hayathnagar mandal of Rangareddy district, which were being sold at much higher prices than the central government fixed price. The medicines — Itrazole 100 and Itrazole 200 — are commonly used to treat fungal infections. The drugs were manufactured by Sunfine Health Care in Solan, Himachal Pradesh, and marketed by a company in Haryana. Officials said that Itrazole 200 was being sold at 43 per tablet instead of the actual price of 24 per tablet. Similarly, Itrazole 100 was being sold at 31 per tablet instead of 18, which means a patient has to cough up an extra 100-150 for a strip of ten tablets. “Selling overpriced medicines is not only illegal, but it also means that healthcare is inaccessible to many,” the DCA said, adding that strict action would be taken against offenders. Source: TOI

Apr 20,2024 London: The World Health Organisation is likely to issue a wider warning about contaminated Johnson and Johnson-made children’s cough syrup found in Nigeria last week, it said in an email. Nigeria’s regulator recalled a batch of Benylin paediatric syrup last Wednesday, having found a high level of diethylene glycol in the product during routine testing. The contaminant, alongside another closely related toxin, ethylene glycol, has been linked to the deaths of more than 300 children in Cameroon, Gambia, Indonesia and Uzbekistan since 2022, though there is no evidence that these incidents are linked with the latest recalls. The U.N. health body said it puts out global medical product alerts to “encourage diligence” by national authorities and was likely to do so in this instance, “subject to confirmation of certain details from parties”. The recalled batch of Benylin syrup was made by J&J in South Africa in May 2021, although Kenvue now owns the brand after a spin-off from J&J last year. J&J has referred requests for comment to Kenvue. In an emailed statement on Friday, Kenvue said it had carried out tests on the batch recalled by Nigeria and had not detected either diethylene or ethylene glycol. “We continue to work closely with health authorities and the WHO and are engaging with NAFDAC to understand their test results, including verifying the authenticity of the sampled product, the testing methodology used, and results reported by the agency,” the statement added. Since Nigeria’s recall, five other African countries have also pulled the product from shelves – Kenya, Rwanda, Tanzania, Zimbabwe and South Africa, where the drug was made. South Africa’s regulator has also recalled another batch of the syrup, which is used to treat coughs, hay fever and other allergic reactions in children. Diethylene glycol is toxic to humans when consumed and can result in acute kidney failure, although there have been no reports of harm in the latest incident. In the 2022 cases, the contamination in the syrups came from the raw materials used by manufacturers in India and Indonesia. The WHO said it was collaborating with both the manufacturer and regulatory authority in South Africa to investigate the Benylin paediatric syrup, and had information on the source of the ingredients used. Kenvue has previously said it tested its ingredients before manufacture. The agency said the possibility that the syrup was counterfeit was also “under consideration as part of investigations”. Earlier this week the WHO sent out a separate alert on five batches of contaminated cough syrup ingredients found in Pakistan that appeared to have been falsely labelled as Dow Chemical products. It was the first alert the WHO has sent on excipients – elements of a medicine other than the active pharmaceutical ingredient – rather than finished products, the agency confirmed on Friday. The batches of propylene glycol were contaminated with ethylene glycol. Source: Pharma

Apr 21,2024 With a view to widen the market and foster adequate protection from healthcare expenses, insurance regulator IRDAI has removed the age limit of 65 years for individuals buying health insurance policies. This marks a significant departure from the conventional constraints that limited individuals in securing comprehensive coverage. By abolishing the maximum age restriction on purchasing health insurance plans, the Insurance Regulatory and Development Authority of India (IRDAI) aims to foster a more inclusive and accessible healthcare ecosystem, ensuring adequate protection against unforeseen medical expenses. As per the earlier guidelines, individuals were allowed to purchase a new insurance policy only till the age of 65. However, with the recent amendment, which has been effective from April 1, anyone, regardless of age, is eligible to buy a new health insurance policy. In a recent gazette notification, IRDAI said, “insurers shall ensure that they offer health insurance products to cater to all age groups. Insurers may design products specifically for senior citizens, students, children, maternity, and any other group as specified by the Competent Authority.” Besides, insurers have been mandated to offer health policies to individuals with pre-existing medical conditions of any kind. Consequently, insurers are prohibited from refusing to issue policies to individuals with severe medical conditions like cancer, heart or renal failure, and AIDS. According to the notification, insurers are allowed to offer premium payment in instalments for the convenience of policyholders. Travel policies can only be offered by general and health insurers, it said. There is no limit on AYUSH treatment coverage. Treatments under systems like Ayurveda, Yoga, Naturopathy, Unani, Siddha, and Homeopathy will receive coverage up to the sum insured without any cap, it said. Policyholders with benefit-based policies can file multiple claims with various insurers, enhancing flexibility and options, it said. The proposed regulation seeks to handle the complaints and claims of senior citizens via a specialised channel, ensuring a more tailored and responsive approach to their requirements, it added. Source: Business Standard

Apr 21,2024 Vaccines mark one of the most significant milestones in public health, having prevented morbidity and mortality for millions yearly. Traditionally, vaccine technology has focussed on live attenuated or inactivated, but nanotechnology has revolutionised the development in this field. In this, lipid nanoparticle (LNP) technology has emerged as highly promising. Progress in medical science has facilitated the seamless integration of lipid nanotechnology into standard therapy, including developing several vaccines, which have yielded notable outcomes. The recent COVID-19 vaccines based on mRNA-contained LNPs have propelled this ground-breaking technology from being seen as speculative research to transformative in genetic medicines and vaccines. The inception of lipid nanotechnology dates back to 1965, when liposomes were first discovered. These closed lipid bilayer vesicles self-assemble in water, forming fatty capsules. Their potential for drug delivery was immediately recognised due to their ability to encapsulate small-molecule drugs and enhance their aqueous solubilities—a critical advantage since over 40% of these agents have low solubility in water. From this initial discovery, the technology has evolved, with continuous tweaks and refinements optimising the functionality of lipid nanoparticles, leading to the creation of highly versatile drug delivery platforms and liposomal drugs. In general, nanomedicine involves applying nanoparticles and the utilisation of lipids from natural or synthetic sources in disease diagnosis, monitoring, control, and treatment. A significant advantage of this technology is the ability to customise lipid-based nanoparticles to surpass the constraints imposed by the human body’s natural biological barriers, systemic or cellular. Introducing vaccines that utilise lipid nanotechnology has created a remarkably effective and innovative vaccine platform. LNPs are currently considered the most sophisticated non-viral gene delivery system in clinical use. They are a secure and highly efficient method of transporting nucleic acids, successfully overcoming a significant challenge in developing and applying genetic medicines and vaccines. Source: Healthworld

Apr 24,2024 Mumbai: Lupin Limited announced that it has received the Establishment Inspection Report (EIR) from the United States Food and Drug Administration (US FDA) for its Aurangabad manufacturing facility. The inspection was conducted from March 6–15, 2024. The US FDA has determined that the inspection classification of the facility is Voluntary Action Indicated (VAI). “We are pleased to receive the EIR with VAI status from the US FDA as an outcome of the recent inspection of our Aurangabad facility. It is a testament to our commitment to consistently upholding the highest standards of compliance and providing high-quality healthcare solutions to patients worldwide,” said Nilesh Gupta, Managing Director, Lupin. Source: Pharma

Apr 18,2024 The Drugs Controller General (India) (DCGI) has informed all state drug regulators that the Central regulatory authority has not approved manufacturing and marketing of antibiotic combination of meropenem 1 mg and EDTA for injection and it is against the rules to produce and sell the drug without its approval. The drug regulator said that it has come to its notice that some manufacturers are involved in manufacturing and marketing the combination, which is not yet approved by the Central Drugs Standard Control Organisation (CDSCO) for manufacturing or marketing in the country and falls under the category of new drug. DCGI Dr Rajeev Singh Raghuvanshi in a notice to all the concerned stakeholders said, “No new drug shall be manufactured for sale unless it is approved by the Licensing Authority as defined in Rule 3 of New Drugs and Clinical Trial Rules, 2019”. Further, as per Rule 80 of New Drugs and Clinical Trial Rules, 2019, a person who intends to manufacture new drug in the form of active pharmaceutical ingredient (API) or Pharmaceutical formulation, as the case may be for sale or distribution, shall make an application for grant of permission to the Central Licensing Authority in Form CT-21 along with a fee as specified in Sixth Schedule. It may be noted that last month, the DCGI has directed the state drug regulators in the country to cancel the product permission granted by them for manufacturing and marketing of certain antibiotic drug combination meropenem and disodium EDTA for injection since it is a new drug and needs approval from the Centre also. The DCGI during the time said that it has come to the notice of the CDSCO that some manufacturers are involved in manufacturing and marketing of unapproved drugs which is not yet approved by his office for manufacturing or marketing in the country and falls under the category of new drug. “…you are hereby directed to convey the matter to all the manufacturers under your jurisdiction and cancel the product permission granted by you of the subject drug,” said the DCGI. The necessary information about the status and action taken in the matter may be intimated to the CDSCO at the earliest, he added. According to the online trading portals, the drug combination meropenem and disodium EDTA for injection is sold by a manufacturer as an ultra broad spectrum antibiotic and claimed as effective and well-tolerated for the treatment of infections including bacterial meningitis, lower respiratory tract infections and used in treatment of certain types of cancer.  Source: Pharmabiz

Apr 25,2024 Venezuela: Some of the 10 women and teenage girls who recently came to a medical clinic in eastern Venezuela for free contraceptives fidgeted a bit when a community health worker taught them how to use an IUD, condoms and birth control pills correctly. The health worker also asked what they knew about HPV, the most common sexually transmitted infection in the world and the cause of nearly all cervical cancer. Of the 10, ages 16 to 33 – two of whom had traveled to Putucual by boat and bus – only one had learned about human papillomavirus in middle school. The rest had talked about it with friends or cousins, but never their parents. None knew HPV vaccines exist, even though Venezuelan pediatricians have long recommended giving all children the vaccine starting at age 9. Venezuela’s government has repeatedly broken its promise to provide the shots for free, and many public-school teachers have failed to implement the requirement to teach sex ed. President Nicolas Maduro ‘s administration claims the well-being of youth and women is a priority, but the onus is on parents to talk to their kids about HPV and pay for the vaccines at private clinics. That’s out of reach for most in a country where private-sector workers earn $202 a month on average, and public employees’ monthly minimum wage is $3.60 plus $100 in bonuses. Most HPV infections are asymptomatic and go away without treatment. But some can lead to genital warts and cancers, primarily of the cervix, but also of the anus, penis and throat. Official health care statistics are elusive in Venezuela, making it virtually impossible to know the rate of HPV infection or how many people have been vaccinated either privately or by nongovernmental organizations. HPV vaccine coverage estimates from the World Health Organization show a blank space for Venezuela. In 2022, Maduro’s administration estimated 30% of Venezuelan women are affected by cancer-causing strains of HPV. But the Ministry of Popular Power for Health did not publicly provide the data nor historical figures to show how the rate may have changed. Health care professionals in the South American country told The Associated Press that the government’s figure is an undercount. “With HPV, all governments have a social and moral debt to the female population,” said Dr. Carlos Cabrera, an OB-GYN in private practice and director of the maternal fetal medicine program at the Central University of Venezuela. “But people don’t like to talk about sexual and reproductive health.” When HPV shots first hit the market in the mid-2000s, the oil-dependent state’s coffers were flush. The price of oil – Venezuela’s most valuable resource – was steadily climbing and the country produced more than a million barrels a day. In 2009, doctors urged the government of President Hugo Chavez to introduce the HPV vaccine into the country, but they were ignored. In 2015, Ministry of Health officials appeared ready to start offering HPV shots, mentioning in the agency’s annual performance report that the country’s vaccine schedule would include them and they “would be administered starting in 2016.” By this time, Venezuela’s budget holes due to financial mismanagement were apparent, but U.S. economic sanctions had not yet crippled the oil industry. Venezuela’s last vaccine promise came in late 2022 after it reached an agreement with GAVI, a public-private global alliance that helps poor countries procure vaccinations. Government officials said shipments were expected for 2023, but no shots were distributed then, and they are also not listed among those being offered during national vaccination week. The Ministry of Popular Power for Communication and Information did not respond to questions from the AP about the status of the vaccines, including reasons for the delay. Source: Healthworld

Apr 25,2024 New Delhi: A group of genes could be common to both depression and heart disease, a finding that researchers said could explain why having one of them increases risk of developing the other. The “puzzling” link between the diseases has been known to exist since the 1990s, they said. Studies have found that people with depression run a greater risk of cardiovascular disease, with early and effective treatment of the mental illness lowering the risk of developing heart-related conditions. Conversely, studies have also shown that people having cardiovascular disease tend to have depression as well. The researchers, including those from the Tampere University, Finland, said that the link between the two conditions could be partly explained by lifestyle commonly observed in depression patients such as poor diet and lack of exercise. However, they said, it is also possible that the two diseases could be related on a “deeper level” by sharing biological processes such as inflammation, which are important to developing these conditions. The findings are published in the journal Frontiers in Psychiatry. The researchers collected blood samples from close to 900 men and women aged between 34 and 49 years, who were participants in the Young Finns study. The study, examining cardiovascular risk factors in children and adolescents as they grow into adults, started in 1980. The participants were followed-up since then. The blood samples were analysed for gene expression, which is the process by which information in a gene eventually translates into observable traits in an individual. The researchers identified a specific group of genes that expressed themselves in a similar manner across both the conditions — depression and cardiovascular health. This group of genes, or gene module, was found to be associated with a high score for depressive symptoms as well as a low score for cardiovascular health. “We looked at gene expression profile in the blood of people with depression and CVD and found 256 genes in a single gene module (group of genes) whose expression at levels higher or lower than average puts people at greater risk of both diseases,” first author Binisha H. Mishra, a postdoctoral researcher at Tampere University, said. The genes forming the module are involved in biological processes such as inflammation known to play a role in the development of both depression and cardiovascular disease, the researchers said. Source: Healthworld

Apr 26,2024 Serving as a valuable opportunity to acknowledge the indispensable role of Intellectual Property (IP) in driving innovation and a spirit of scientific enquiry in the pharmaceutical sector, the World Intellectual Property Day is an occasion to commemorate the crucial role of intellectual property protection in advancing scientific frontiers, catalysing medical breakthroughs and nurturing ideas aimed at enhancing human well-being. In the pharmaceutical realm, IP ensures patient access to novel medicines while facilitating the research and development of future treatments and cures. Moreover, it serves as a catalyst for collaboration among industry players, academic institutions and small biotech firms, leveraging scientific expertise and capabilities to enhance healthcare outcomes and introduce approaches that benefit economies and strengthen the industry while improving the overall quality of life of the masses. A recent report of a study conducted by the Organisation of Pharmaceutical Producers of India (OPPI) and EY Parthenon has underscored the immense potential of the Indian pharmaceutical industry to not only meet but surpass expectations. This potential hinges on strategic investments and a commitment towards transformative innovation driven by value. The report is based on the feedback of 40 Chief Experience Officers (CXOs) from leading Indian and global pharmaceutical companies, where 30 per cent of the respondents highlighted the need for putting a robust research and innovation system in place. India is more inclined towards its generic manufacturers than innovators, which is evident from its stance against the inclusion of data exclusivity provisions, especially in Free Trade Agreements (FTAs), with the aim of safeguarding the interests of the domestic generic drug industry. Data exclusivity protects technical data or clinical trials data generated by innovator companies to prevent competitors from producing cheaper versions of medications unless they collect their own clinical trials data or wait for the exclusivity rights of innovators to lapse. This can compel generic manufacturers to either wait out the exclusivity period or undergo costly clinical trials afresh. Data exclusivity can also impede the process of issuing compulsory licences to generic manufacturers, limiting access to lower-priced medicines. The scope and terms of data exclusivity are, therefore, highly relevant to the pharmaceutical industry as well as the public, particularly with regard to the supply of new medicines and access to existing ones. Moreover, the vast financial resources and extended time required for gathering and generating pharmaceutical registration data for a new drug can create a market barrier that is too high for generic manufacturers. There is a pressing need for the government to enhance support for disruptive innovation, particularly through the enactment of more stringent IP laws, especially in cases involving rare diseases and diseases of critical nature. Currently, rare diseases pose a less attractive investment proposition for the industry due to a disproportionate investment-to-return ratio. The government should incentivise research in such areas so that the innovation ecosystem is not guided by profit considerations alone. By enforcing regulations for IP pertaining to medical solutions in critical care segments, India can leverage its research potential and demographic diversity to emerge as a global hub of research in this field. IP laws have historically catalysed diverse treatment options, addressing global health challenges effectively. Extending IP protection can empower more pharmaceutical and research firms to invest in the demanding process of innovation. Yet, it’s imperative that such laws are crafted and implemented in a way that continues to facilitate access to affordable medications, especially in low and middle-income regions. Striking the right balance will be crucial for India as it seeks to enhance its role as a global leader in pharmaceuticals and uphold its commitment to public health. The article is written by Saransh Chaudhary, President, Global Critical Care, Venus Remedies Ltd and CEO, Venus Medicine Research Centre (VMRC) Source: Pharma