India should introduce nutrition-specific policy and budget : Dr Antaryami Dash

The scale of the challenge in tackling child malnutrition is undeniable. Millions of children are malnourished because of who they are and where they live.

by Dr Antaryami Dash Head- Nutrition, Save the Children

The scale of the challenge in tackling child malnutrition is undeniable. Millions of children are malnourished because of who they are and where they live. According to Global Hunger Index 2019, India’s ranked has slipped to 102 position of 117 countries. In the recent Lancet report which analysesstate level disease burden in India, malnutrition was the predominant risk factor for under-five mortality in every state of the country in 2017, accounting for 68·2% of the total under-5 deaths....read more

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Health Sutras By Dr K K Aggarwal

If nature wanted you to eat mangos in winter, she would have grown mangoes in winter. Eat seasonal fruits.

Healthcare News Monitor

CDSCO mandates processing of post approval changes in clinical trial applications within 15 days

Pharmabiz India - Shardul Nautiyal

The Central Drugs Standard Control Organization (CDSCO) has mandated post approval changes in clinical trial applications to be processed within 15 working days of the receipt of application. It has been decided that cases of post approval changes will be processed by CDSCO within 15 working days of receipt of application for approval or acknowledgment or otherwise, as per a Drugs Controller General of India (DCGI) notice. Post approval changes includes changes in protocols, study site and principal Investigator, among others. Permission to conduct Bio-availability/Bio-equivalence (BA/BE) study of new drug for export purpose is granted by Central Licensing Authority (CLA) as per the New Drugs and Clinical Trials Rules, 2019 in Form CT-07. Import license in Form CT-17 is also granted for import of study drug for this purpose. The conditions of permission for conduct of BA/BE study are prescribed under Rules 35 of the said Rules. Detailed requirements and guidelines in this regard are also prescribed under Fourth Schedule of the said Rules. New Drug and Clinical Trial Rules, 2019 effective from September 21, 2019 has also stipulated timelines for review and approval of CT applications as 30 days for Investigational New Drugs (INDs) being developed in India. If no response from DCGI, automatic approval is given by DCGI via Form CT-4 A.

WHO Global TB Programme includes ICMR-developed TrueNat as initial test for diagnosing TB

Pharmabiz India – Neethikrishna

The World Health Organizations (WHO) Global TB Programme has included Indian Molecular assay TrueNat as initial test for diagnosing tuberculosis (TB) and Multi-drug-resistant tuberculosis (MDR-TB). Developed by Indian scientists, the TrueNat TB test is a new molecular test to diagnose TB as well as testing for resistance to the drug rifampicin in about 90 minutes. The Indian Council of Medical Research (ICMR) and Department of Health Research (DHR) have been promoting “Indigenous diagnostic technologies for diagnosis of TB and MDR/XDR–TB”. It has also been supported by DHR and Department of Biotechnology (DBT) for promoting various indigenous technologies. “Endorsement of the TrueNat by WHO would enable other low and middle income countries to procure TrueNat for TB and rifampicin resistance thus supporting TB elimination in developing countries” said Dr. Balram Bhargava, secretary DHR and director general (DG) ICMR. After a stringent review and a series of validation and subsequent feasibility studies and continuous follow-up, the ‘TrueNat M TB & Rif assay was found to be at part with the internationally recognised molecular assay Gene Xpert in terms of sensitivity and specificity and detection of rifampicin resistance. National TB Elimination Programme took it up after recommendations from ICMR. In another major effort as part of WHO pre qualification a multi-central, prospective field evaluation study was conducted in India, Ethiopia, Peru, and papua-New Guinea. Based on the interim analysis of the data, WHO included TrueNat as test to diagnose TB (replacing sputum smear microscopy) and to sequentially detect rifampicin resistance in view of its high diagnostic accuracy.

MRI scans may help detect breast cancer risk: Study

ET Healthworld – PTI

Magnetic resonance imaging (MRI) scans can be used to identify several potentially useful biomarkers of breast cancer, which could help detect the disease early, according to a study. Researchers from Memorial Sloan Kettering Cancer Center in the US compared healthy breast tissue of patients with malignant -- which can spread in the body -- and benign or non-cancerous breast tumours. They found that multiple differences in biomarkers can be assessed with Positron-emission tomography (PET) or MRI imaging, which could help in the screening, and risk-reduction strategies. In breast cancer, early detection remains key to improved prognosis and survival, according to the study published in The Journal of Nuclear Medicine.While screening mammography -- which uses low-energy X-rays to examine the human breast -- has decreased mortality for breast cancer patients by 30 per cent, its sensitivity is limited and is decreased in women with dense breast tissue. "Such shortcomings warrant further refinements in breast cancer screening modalities, and the identification of imaging biomarkers to guide follow-up care for breast cancer patients," said Doris Leithner, a research fellow at Memorial Sloan Kettering Cancer Center.

‘Govt hospitals now compete with private ones on quality’

ET Healthworld – TNN

There is a wrong perception that medicines being provided free of cost to patients in government-run hospitals lack quality, said health commissioner Jai Prakash Shivahare. He was speaking at a regional seminar on “Availability, accessibility and affordability of medicines for all”, which was held in Ahmedabad on Tuesday. Stating that government hospitals are now competing with private hospitals to provide quality healthcare, Shivahare said that Gujarat has the third largest number of drugs on the essential drug list (EDL). The government, through Gujarat Medical Services Corporation Ltd (GMSCL) procures medicines from pharmaceutical companies through a bidding process and provides these free of cost to patients of lower socio-economic sections under schemes of the central and state governments. “Quality of drugs remains a challenge. I think it is more of a perception that drugs available through EDL list lack in quality. We want to change that perception. We are also very keen that all the good companies should also participate in the bidding process. We have some of the best pharmaceutical companies in Gujarat,” Shivahare said. Stating that the government intended to provide a level playing field to new and established companies, Shivahare stated that there is a need to change the perception that quality drugs cannot be provided to the public health system. “We want to organize a meeting with various stake holders. Why some good companies are not participating in the bidding process that is being run by GMSCL. If they are having any difficulty, we would like to address those issues also. We want the best brands also to compete for supplying to the public health system,” he said.