Pharma News

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended granting a marketing authorisation in the European Union (EU) for Amglidia (glibenclamide), a medicine indicated for the treatment of neonatal diabetes mellitus (NDM), for use in newborns, infants and children.

In its continued efforts to protect consumers and ensure food safety, the U.S. Food and Drug Administration has begun testing fresh cilantro, parsley and basil, as well as processed avocado and guacamole, for certain microbial contaminants. These two large-scale sampling assignments will help the FDA assess the rates of bacterial contamination in these commodities, as well as help to identify possible common factors among the positive samples.

FDA is advising caution before prescribing the antibiotic clarithromycin (Biaxin) to patients with heart disease because of a potential increased risk of heart problems or death that can occur years later.

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In the meeting, the MoS stressed on the need to increase the Viral Research Diagnostics Laboratories (VRDL) in the states, including UP. Smt. Anupriya Patel, Minister of State (Health & Family Welfare), in a high level meeting, reviewed the activities and achievements of Department of Health Research (DHR) and Indian Council of Medical Research (ICMR).  Dr. Sanjay Mehendale, Additional Director General, ICMR and Smt. Sarita Mittal Joint Secretary, Department of Health Research were also present.

Drug price regulator NPPA  said it has decided not to stop any coronary stent manufacturer from withdrawing products from the Indian market.

The U.S. Food and Drug Administration announced the voluntary destruction and recall of a large volume of kratom-containing dietary supplements manufactured and distributed nationwide under the brand names Botany Bay, Enhance Your Life and Divinity by Divinity Products Distribution of Grain Valley, Missouri. In cooperation with the FDA, the company has also agreed to stop selling all products containing kratom.

U.S. Customs and Border Protection (CBP) announced a new formal partnership arrangement with Procter & Gamble (P&G), as part of the Donations Acceptance Program, to prevent counterfeit P&G products from entering the United States. As part of the partnership, P&G will donate testing devices to verify the authenticity of various P&G products.

In the 78th meeting of the Drugs Technical Advisory Board (DTAB) held on 12th February, 2018 under the Chairmanship of the Director General of Health Services deliberated the directions of the Hon’ble Supreme Court of India dated 15.12.2017 in regard to the notifications issued by the Govt, of India prohibiting 344 FDCs +05 FDCs vide S.O.No. 705(E) to 1048 (E) dated 10.03.2016 and S.O. No. 1851(E) to 1855(E) dated 08.06.2017 respectively.

The Central Drugs Standard Control Organisation (CDSCO) has decided to make the regulations more stringent to tackle the menace of the widespread misuse of Oxytocin, a neurotransmitter and peptide hormone, in dairy and horticulture industry crop up on a daily basis. The Regulatory body will hold a crucial meeting on February 22 at 11:00Am in Delhi with all the manufacturers of Oxytocin formulation for human and animal use in the country.

FDA amended its regulations on the acceptance of data from clinical investigations for medical devices. The rule updates the FDA’s standards for accepting clinical data from clinical investigations conducted both inside and outside the United States to help ensure the protection of human participants, and to help ensure the quality and integrity of data obtained from these clinical investigations.