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- Read more about DBT propose to support research on 'Vitamin D deficiency in India: public health significance and interventions'
In view of the recent reports of escalating burden of biochemical VDD and its known skeletal and potential extra-skeletal effects, the Department of Biotechnology proposes to support research on its public health significance and potential interventions to address this malady.
- Read more about CDSCO issue guidance documents for Approval Of BA/BE NOC for Export Purpose
A large number of applications are being filed to the office of DCG (I) at CDSCO (HQ) by Pharmaceutical companies, both manufacturers and CRO’s on behalf of them, requesting for the approval to carry out Bioequivalence studies on Indian subjects for export purpose.
- Read more about FDA issue warning to three duodenoscope manufacturers about failure
The U.S. Food and Drug Administration issued warning letters to all three duodenoscope manufacturers for failing to comply with requirements of federal law under which they were ordered to conduct postmarket surveillance studies to assess the effectiveness of reprocessing the devices.
- Read more about Market report on CAR-T cell therapy for liver and lung cancer
Technavio’s market research report on CAR-T cell therapy for liver and lung cancer provides comprehensive insights about pipeline molecules across this approach of treatment. The key objective of the report is to establish the understanding of all the pipeline molecules, which fall under CAR T-cell therapy for liver cancer and lung cancer.
- Read more about FDA authorizes, with special controls, direct-to-consumer test that reports three mutations in the BRCA breast cancer genes
The U.S. Food and Drug Administration authorized the Personal Genome Service Genetic Health Risk (GHR) Report for BRCA1/BRCA2 (Selected Variants).
- Read more about FDA approves Trogarzo for patients who have limited treatment options
U.S. Food and Drug Administration approved Trogarzo (ibalizumab-uiyk), a new type of antiretroviral medication for adult patients living with HIV who have tried multiple HIV medications in the past (heavily treatment-experienced) and whose HIV infections cannot be successfully treated with other currently available therapies (multidrug resistant HIV, or MDR HIV).
- Read more about FDA expands approval of heart valve of small size in newborn to treat heart defects
The U.S. Food and Drug Administration expanded the approval of a heart valve to include a size small enough to be used in newborn pediatric patients to treat heart defects. Specifically, the agency approved the Masters Series Mechanical Heart Valve with Hemodynamic Plus (HP) Sewing Cuff to include the 15-mm valve size, making it the smallest mechanical heart valve approved in the world.
- Read more about FDA approves first tests to screen for tickborne parasite in whole blood and plasma
The U.S. Food and Drug Administration approved the Imugen Babesia microti Arrayed Fluorescent Immunoassay (AFIA), for the detection of antibodies to Babesia microti (B. microti) in human plasma samples, and the Imugen Babesia microti Nucleic Acid Test (NAT), for the detection of B. microti DNA in human whole blood samples.

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The government is encouraging enrichment of food items with micronutrients to remove dietary deficiencies among its citizens, Minister of State for Health and Family Welfare Ashwini Kumar Choubey said.

In order to promote fortification as a means to address micro nutrient deficiencies, the Food Safety and Standards Authority of India (FSSAI) has operationalised the draft Food Safety and Standards (Fortification of Foods) Regulations, 2016 in October 2016, he said in a written reply to the Rajya Sabha.

Choubey said FSSAI has established Food Fortification Resource Centre in collaboration with Tata Trusts and various international NGOs working in the field of nutrition as a resource centre to promote large-scale fortification of food and to nudge and facilitate food businesses to adopt fortification as a norm.

At present, all the major oil producers in the country are voluntarily fortifying at least one brand in their product portfolios, he said.

The regulations include provisions regarding standards for fortification of food articles namely wheat flour, rice, milk, edible oil and salt with vitamins and minerals, said the minister to a query on the laws for food fortification in the country.

The FSSAI may from time to time mandate fortification of any food article under the regulations on the directions of the Central or the state governments in consultation with stakeholders, he added.

The Women and Child Development Ministry and the Human Resource Development Ministry have advised the use of double fortified salt with iron and iodine, wheat flour with iron, folic acid and vitamin B-12, and edible oil with vitamin A and D under their Integrated Child Development Scheme and Mid-day Meal Scheme.

Under Food Safety and Standards (Prohibition and Restriction on Sales) Regulations, 2011, sale of only iodized salt is permitted for direct human consumption.

Further, Food Safety and Standards (Food Product Standards and Food Additives) Regulations, 2011 provide that vanaspati should contain synthetic Vitamin A.

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- Read more about FDA announce the guidance for industry entitled “E18 Genomic Sampling and Management of Genomic Data.”
The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled “E18 Genomic Sampling and Management of Genomic Data.” The guidance was prepared under the auspices of the International Council for Harmonisation (ICH), formerly the International Conference on Harmonisation.