First-in-human clinical trials represent a critical juncture in the translation of laboratory discoveries. However, because they involve the greatest degree of uncertainty at any point in the drug development process, their initiation is beset by a series of nettlesome ethical questions: has clinical promise been sufficiently demonstrated in animals? Should …
After months of prevarication, the European Union has stated publicly that the free trade agreement (FTA) it signs with India will include provisions for data exclusivity because “it is extremely important for research and innovation’’. That’s what European Union ambassador Daniele Smadja told journalists in Delhi on January 21. Smadja’s …
A recent shift in the drug product environment for Africa has seen a score of new products being developed specifically for diseases of the developing world, creating new challenges for regulators in Africa and elsewhere. However, it is not at all certain that African regulatory authorities currently have the capacity …
COLORECTAL cancer is a leading cause of mortality in both developed and developing countries. Screening methods for colon cancer depend on detecting the precancerous changes. Generally, colonoscopy is carried out but the test is expensive (Rs 25,000-Rs 30,000) and the procedure highly invasive. An alternative is Fecal Occult Blood Test …
This is set to become a landmark case for the Indian pharmaceutical industry—and for patients. When Natco Pharma of Hyderabad wrote to Pfizer, the world’s largest drugs manufacturer, that it wanted a voluntary licence (VL) to make a low-cost version of its antiretroviral drug maraviroc, it was setting the stage …
Nearly 2 billion people (a third of the world's population) lack access to essential medicines. In low-income and middle-income countries, drugs account for 20
CHRONIC diabetics are at a greater risk of kidney problems. As the kidneys overwork to filter high blood sugar, its filtering system gets damaged, eventually leaking blood proteins into urine. Poor filtration also pushes the blood pressure up. Doctors usually recommend ACE inhibitors, available under trade names of capton and …
It is now final. Two weeks ago, the final text of the Anti- Counterfeiting Trade Agreement (ACTA), a plurilateral pact ostensibly aimed at stamping out the trade in counterfeit goods, was put out by the cabal of countries that have been negotiating it in secret for the past three years. …
In 1947, a Boston shipyard worker’s child fell sick. Examining the twoyear- old’s blood through the microscope, Sydney Farber, a city doctor, saw billions of malignant white cells “dividing in frenzy, their chromosomes condensing and uncondensing, like tiny clenched and unclenched fists.” The child was suffering from leukaemia and by …
Arestless crowd outside an auditorium seems quite out of place at Wai. The lush green temple town at the foothills of Panchgani in Maharashtra is used to prayer-chanting pilgrim throngs. But at Chitra Talkies it is a cacophony of wolf whistles. The crowds get more raucous when the amplifiers inside …
The union health ministry is finalising the national antibiotics policy to check indiscriminate use of drugs. The move comes close on the heels of the detection of multi-drug resistant bacteria, dubbed superbug, in foreign patients who underwent treatment in India and Pakistan; it was reported in The Lancet Infectious Diseases …
A recent civil society-led investigation has highlighted serious ethical violations in a trial of the Human Papilloma Virus vaccine on girls in Khammam district in Andhra Pradesh. The findings are presented along with a review of clinical trials of the hpv vaccine in India and an analysis of the Drugs …
MALARIAL parasites are known to develop quick resistance to drugs. Two groups of scientists, working independently on alternative drugs for malaria, have identified a couple of compounds that could treat drug-resistant malaria. One team synthesised and evaluated a compound called spiroindolone NITD 609. It is effective against drug resistant strains …
FOOD Safety and Standards Authority of India (FSSAI) has issued an advisory stating that residues of antibiotics and pesticide are not allowed in honey. The authority said India follows stringent safety standards similar to the EU and the US, where use of antibiotics in honey is illegal. The move was …
David Henry discusses a research article by Geoffrey Spurling and colleagues that examined the relationship between exposure to promotional material from pharmaceutical companies and the quality, quantity, and cost of prescribing. Original Source
India is, today, the fourth largest producer of drugs in the world and a world class supplier of relatively cheap generic medicines. It is the largest supplier in the world of low-priced anti-retrovirals and exports medicines to over 200 countries. However, major concerns regarding access to medi cines in the …
On July 15, 1962, a Washington Post story, ‘Heroine of FDA keeps bad drug off market,’ shocked Americans. The heroine in question was Frances Oldham Kelsey. She had joined the US Food and Drug Administration two years earlier as a drug application investigator. With her expertise in pharmacology, she was …
India’s pharmaceuticals industry tends to be in the eye of the storm for one reason or the other. If it is not about its aggressive generics thrust globally, it is about high-profile patent infringement cases at home and abroad. The gamut of laws governing the sector, therefore, are keenly watched …
Universally, honey is believed to be a natural product. Regulations across the world say as much. The Codex Alimentarius Commission is a global body set up jointly by the UN’s Food and Agriculture Organization (FAO) and the World Health Organization (WHO) to develop food standards for international trade; it defines …
Antibiotic resistance is the ability of a microorganism to withstand the effects of an antibiotic. If even at a large dose, the antibiotic is not effective in treating an infection, then the microorganism that is responsible for the infection is declared resistant to that antibiotic. Antibiotic resistance is a global …
