3-Dec-2019: A new vaccine against rotavirus launched
Vice President of India, Mr. M Venkaiah Naidu launched a new generation vaccine against rotavirus developed under a public-private partnership project involving the Department of Biotechnology in the Union Ministry of Science and Technology and Hyderabad-based Bharat Biotech and other international organisations.
Welcoming the new vaccine, Mr. Naidu urged media and medical professionals to create awareness about various health problems. There is a need for vaccination at the right time. While the government is doing its best, medical professionals should also take upon themselves the responsibility to remove apprehension about vaccination for prevention of diseases and to better the health of the nation and its people.
The Chairman and Managing Director of Bharat Biotech, Dr. Krishna Ella, said, the new vaccine is cost-effective as it is highly effective and has low cold chain footprint. It will be available in multi dose vials, resulting in savings of about US dollars 0.30 per dose in supply chain and delivery costs.
He also noted that his company has invested about US dollars 20 million to develop new manufacturing facilities and supporting infrastructure in its Genome Valley plant in Hyderabad, with an installed manufacturing capacity of about 200 million doses per year. The project was supported in part by the Bill & Melinda Gates Foundation.
The vaccine named “ROTAVAC 5D” has been evaluated in clinical trials in India and other countries. It is safe, effective and affordable, besides being cross-protective against a variety of rotavirus strains. The study results showed clear evidence of protection across different rotavirus strains and continued efficacy in the second year of life. Currently, over 25 countries have granted patents for it.
The vaccine was a miniaturized vaccine, delivering the product with a dose volume of a mere 0.5 milli litre. It enables complete delivery of the antigenic payload in 5 drops, avoiding spit-ups observed with larger dose volumes.
The vaccine can be stored at two to eight degrees Celsius for 24 months and is stable at 37 degree Celsius for 7 days. It will be available in multi-dose vials with cold chain footprints of about four cubic centimetre per dose. It has the smallest cold chain footprint for any rotavirus vaccine.
The occasion also marked the achievement of 100 million doses of worldwide supplies of the company’s ROTAVAC vaccine. The milestone was reached within two years of WHO Prequalification.
5-Nov-2019: Sodium Oligomannate can help inhibit Alzheimer’s disease progression
Chinese regulators have granted conditional approval to an Alzheimer’s drug that is derived from seaweed, potentially shaking up the field after years of clinical failures involving experimental therapies from major drug companies.
The announcement over the weekend has been met with caution as well as an eagerness from clinicians and others to see full data from the drug maker, Shanghai Green Valley Pharmaceuticals. The company said its drug, Oligomannate, improved cognitive function in patients with mild to moderate Alzheimer’s compared to placebo in a Phase 3 trial, with benefits seen in patients as early as week four and persisting throughout the 36 weeks of the trial.
It has been almost two decades since any Alzheimer’s drug was approved. Oligomannate has received scant attention in the United States during its development.
Oligomannate, also known as GV-971, will hit the market in China by the end of the year. The company will have to submit additional research on the mechanism of the drug and its long-term safety and effectiveness to the country’s National Medical Products Administration. Green Valley Pharmaceuticals also said it would launch a global Phase 3 trial next year in hopes of filing for approval in other countries as well.
Instead of being designed to sweep away protein buildups in the brain, as has been the case with dozens of other experimental Alzheimer’s treatments, Oligomannate was developed to modulate the connection between the brain and the bacterial communities in the gut known as the microbiome.
The connection between the microbiome and overall health is the subject of a relatively new and evolving field of research, with some scientists seeking to understand how bacteria can influence the emergence of disease, including Alzheimer’s.
24-Oct-2019: Guidelines Released for Evaluation of Nanopharmaceuticals in India
The Union Minister for Science & Technology, Earth Sciences and Health & Family Welfare, Dr. Harsh Vardhan released “Guidelines for Evaluation of Nanopharmaceuticals in India”.
These “Guidelines for Evaluation of Nanopharmaceuticals in India” is one of the most important steps for delineating quality, safety and efficacy assessment of the novel nano-formulations. These guidelines are intended to provide transparent, consistent and predictable regulatory pathways for Nanopharmaceuticals in India.
Nanocarrier based targeted drug delivery is an emerging field with introduction of Nanopharmaceuticals in the market. These nano-formulations have higher efficacy, lower toxicity and are safer than the conventional drugs. Indian researchers would be facilitated to undertake research in line with the regulatory guidelines and is expected that Industry would be keen to participate from the beginning of the research pipeline towards product development and commercialisation. Further, private investments would also be attracted since these guidelines would strengthen the regulatory system.
The guidelines apply to the Nanopharmaceuticals in the form of finished formulation as well as Active Pharmaceutical Ingredient (API) of a new molecule or an already approved molecule with altered nanoscale dimensions, properties or phenomenon associated with the application of nanotechnology intended to be used for treatment, in vivo diagnosis, mitigation, cure or prevention of diseases and disorders in humans
The guidelines would facilitate translational research in line with the regulatory requirements. Guidelines will also facilitate the decision making by regulator during clearances to newer products based on nanotechnology and similarly to researchers to get clearance for their products to launch in market. End users will also be benefited by the quality assured anticipated products in the market in accordance to the guidelines.
This document will give impetus to initiate activities for developing safety guidelines for other domains like Agri-inputs and Agri-products, cosmetics, implantable devices, through interventions of nanotechnology.
The guidelines will pave the way for significant benefits through such cutting edge technology and contribute to the mission on “Affordable Health Care for All”.
The Guidelines are developed by Department of Biotechnology (DBT), Ministry of Science and Technology, Indian Council of Medical Research (ICMR) and Central Drugs Standard Control Organization (CDSCO), Ministry of Health and Family Welfare and is an outcome of all concerned Inter-Ministerial efforts coordinated by DBT.