Drugs

Order of the Supreme Court regarding ART drugs for people living with HIV/AIDS, 24/02/2025

Order of the Supreme Court of India in the matter of Network of People Living With HIV/AIDS & Others Vs Union of India & Others dated 24/02/2025. The Supreme Court (SC), February 24, 2025 has directed all states to file their affidavits addressing concerns raised about antiretroviral therapy (ART) drugs …

Vibriocidal antibody responses to a bivalent killed whole-cell oral cholera vaccine in a phase III trial in Kolkata, India

During the development of a vaccine, identification of the correlates of protection is of paramount importance for establishing an objective criterion for the protective performance of the vaccine. However, the ascertainment of correlates of immunity conferred by any vaccine is a difficult task. While conducting a phase three double-blind, cluster-randomized, …

Draft formula to determine the quantum of compensation in case of clinical trial related injury (other than death)

The Drugs and Cosmetics Rules, 1945 provides under Rule 122DAB that in the case of clinical trial related injury/death, the trial subject is entitled for the financial compensation. A committee was constituted under the Chairmanship of Shri R. K. Jain, AS & DG to deliberate and work out formula to …

Antimicrobial resistance: global report on surveillance

A new report by the WHO – its first to look at antimicrobial resistance, including antibiotic resistance, globally – reveals that this serious threat is no longer a prediction for the future, it is happening right now in every region of the world and has the potential to affect anyone, …

Diverse antibiotic resistance genes in dairy cow manure

Application of manure from antibiotic-treated animals to crops facilitates the dissemination of antibiotic resistance determinants into the environment. However, our knowledge of the identity, diversity, and patterns of distribution of these antibiotic resistance determinants remains limited. We used a new combination of methods to examine the resistome of dairy cow …

SC asks ministry to seek clarification from drug cos on clinical trials

Pharma companies must specify whether risk involved in testing new formulations on human beings justified by benefits expected from exercise The Supreme Court today directed the Union Health Ministry to make drug companies, which want to experiment with new formulations, to answer three queries in a format to be prepared …

U.S. healthcare usage and spending resumes rise in 2013 -report

Americans used more health services and spent more on prescription drugs in 2013, reversing a recent trend, though greater use of cheaper generic drugs helped control spending, according to a report issued on Tuesday by a leading healthcare information company. Spending on medicines rose 3.2 percent in the United States …

Swine flu drugs like Tamiflu not effective: Study

Scientists have found that the two drugs used across the world to treat swine flu — Tamiflu and Relenza — are no better than Paracetamol in relieving flu symptoms and are next to useless in preventing a pandemic. Many countries including India have spent millions of dollars in stockpiling these …

Mind the gaps - the epidemiology of poor-quality anti-malarials in the malarious world - analysis of the WorldWide Antimalarial Resistance Network database

Poor quality medicines threaten the lives of millions of patients and are alarmingly common in many parts of the world. Nevertheless, the global extent of the problem remains unknown. Accurate estimates of the epidemiology of poor quality medicines are sparse and are influenced by sampling methodology and diverse chemical analysis …

Delhi spends highest on public health

This was informed to the High Court in a case of free treatment to a minor Delhi is the highest spender on public health in the country, the Delhi Government has claimed before the Delhi High Court. The assertion was been made by its Directorate of Health and Family Welfare …

Have population declines in Egyptian Vulture and Red-headed Vulture in India slowed since the 2006 ban on veterinary diclofenac?

Populations of three vulture species of the genus Gyps, the Egyptian Vulture Neophron percnopterus and Red-headed Vulture Sarcogyps calvus have declined markedly on the Indian subcontinent since the mid-1990s and all are now Critically Endangered or Endangered. Gyps vultures have been killed by the widely used non-steroidal anti-inflammatory drug diclofenac, …

Panel rejects clinical trial plea by some drug makers

The govt as well as the central drug regulatory agency have been cautious on approving any clinical trial after SC instructions Proposals from leading pharmaceutical companies such as Novo Nordisk, Cadila Pharmaceuticals, Wockhardt, Novartis, Roche and Reliance Life Sciences for conducting clinical trials were recently rejected by a regulatory committee, …

Banned painkiller behind death of 21 endangered vultures?

The death of 21 highly endangered Himalayan Griffon vultures in a Haldwani village has come as "very shocking news" for the Uttarakhand wildlife department. The birds, sighted in the state after a gap of several years and cause of much cheer for bird lovers and the wildlife department, were reportedly …

‘Pharma firms will get CSR benefits only if they donate medicines to the poor’

The Ministry of Corporate Affairs on Tuesday informed the Delhi High Court that pharmaceutical companies would get benefit under corporate social responsibility (CSR) rules if they donate medicines to poor patients afflicted by life threatening or other diseases and cannot afford expensive treatment. Earlier, the government had said work done …

Most drug-resistant TB patients in India: WHO

One in every three tuberculosis cases in the world goes undetected despite the advances made in medical science, according to data from World Health Organization. TB is the main cause for high morbidity and mortality in such patients. On World TB Day on Monday, doctors will stress on need to …

Clinical trials dip, DCGI decides to lift cap soon

The decline in the number of clinical trials in India has the authorities worried. The Drug Controller General of India (DCGI) has, therefore, decided to lift the cap on the number of clinical trials an investigator can conduct. Earlier experts had made it mandatory that there should not be more …

Only 2% of drug samples are ‘not of standard quality’, says regulator

During nationwide surprise checks last year, Jammu region had the highest number of substandard drugs A special nationwide drive to check the quality of drugs by the national regulator for pharmaceuticals and medical devices has found that just a little over two per cent of the drug samples were not …

SC seeks details on deaths during clinical trials from Centre

The Supreme Court on Monday directed the centre to provide details on the number of deaths and severe adverse effects caused to people who were subjected to clinical trials. A bench headed by Justice R M Lodha expressed concern over the issue, saying the government must take a balanced approach …

Technologies for detecting falsified and substandard drugs in low and middle-income countries

Falsified and substandard drugs are a global health problem, particularly in low- and middle-income countries (LMIC) that have weak pharmacovigilance and drug regulatory systems. Poor quality medicines have important health consequences, including the potential for treatment failure, development of antimicrobial resistance, and serious adverse drug reactions, increasing healthcare costs and …

Option B Plus to cut risk of perinatal HIV transmission

Three southern States and Maharashtra adopt new drug regimen. To reduce mother-to-child transmission of HIV, three southern States and Maharashtra have adopted a new drug regimen as part of the National AIDS Control Programme. The new Option B Plus brings down transmission levels from 30 per cent to just two …

Clinical trials show dip in India

Contrary to the popular belief that India is becoming dumping ground for clinical trials, the recent data, in fact, shows that the number of clinical trials are on a downward spiral. As per the government data, in 2011 the Drug Controller General of India (DCGI) received 306 applications for approval …

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