Pharma News

The Health Ministry  held a video conference with the States/UTs on various issues relating to regulation of Oxytocin including the status of preparedness of the State Governments for implementing the amended rules in regard to manufacture, distribution and sale of Oxytocin. The video conference also assessed the stock of Oxytocin in the States to ensure that there is no shortage after the restriction order on its manufacture for domestic use comes into effect from 1st September, 2018.

U.S. Food and Drug Administration’s comprehensive framework for regulating nicotine and tobacco. FDA is developing policies that support the possibility of a world where combustible cigarettes could no longer create or sustain addiction. A key part of this framework are steps to pave the way for products that help currently addicted smokers move away from the deadliest form of nicotine delivery.

The U.S. Food and Drug Administration  issued new scientific recommendations aimed at encouraging more widespread innovation and development of novel medication-assisted treatment (MAT) drugs for the treatment of opioid use disorder (OUD). New draft guidance outlines new ways for drug developers to consider measuring and demonstrating the effectiveness and benefits of new or existing MAT products. This new draft guidance is part of the FDA’s ongoing commitment to promote more widespread development, access to and adoption of MAT.

EMA is conducting a review of the possible health effects in patients who may have taken  valsartan medicines  containing N-nitrosodimethylamine (NDMA) – an impurity found in the active substance manufactured by Zhejiang Huahai Pharmaceuticals.

India’s health supplement and nutraceutical industry is rapidly growing and is poised to be USD 10 Billion industry by 2025. As this sector grows, FSSAI is gearing itself to strengthen the regulatory ecosystem through cross-border collaboration and learning from international best practices.

On Aug. 3, the U.S. Food and Drug Administration review data from the most recent assessment of the Risk Evaluation and Mitigation Strategy (REMS) with Elements to Assure Safe Use (ETASU) for transmucosal immediate-release fentanyl (TIRF) products. The FDA will be asking the Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee to discuss the findings from the assessments conducted by manufacturers of these products, as well as additional data about their use patterns and adverse events.

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The Ayush ministry has cancelled the bidding process for establishment of All India Institute of Ayurveda, Yoga & Naturopathy in Goa.

An estimated 78 million babies or three in five are not breastfed within the first hour of life, putting them at higher risk of death and disease and making them less likely to continue breastfeeding, say UNICEF and WHO. Most of these babies are born in low- and middle-income countries.

The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use(CHMP) has recommended granting two new paediatric-use marketing authorisations (PUMAs), for Kigabeq (vigabatrin) and Slenyto (melatonin).

The European Medicines Agency (EMA) has concluded its review of the cancer medicine Xofigo (radium-223 dichloride), and has recommended restricting its use to patients who have had two previous treatments for metastatic prostate cancer (prostate cancer that has spread to the bone) or who cannot receive other treatments.