Pharma News

At its December 2019 meeting, EMA's Management Board agreed to the mandatory use of a consistent international format, the ISO ICSR format, for reporting individual cases of suspected side effects in patients across the world. This follows a recommendation from EMA’s safety committee (PRAC) in October 2019. The use of the new international standard will become mandatory as of 30 June 2022 for all reporting to EudraVigilance, the European database of suspected side effects with medicines authorised in the European Economic Area (EEA).

During their first physician visit, patients experiencing newly diagnosed chronic musculoskeletal pain are prescribed opioids more often than physical therapy, counseling, and other nonpharmacologic approaches, according to a new study published in the Journal of Pain. The use of opioids over other approaches stands in contrast with clinical recommendations for the use of nonopioid pain approaches and nonpharmacologic approaches. The study included authors from the National Center for Complementary and Integrative Health (NCCIH), part of the National Institutes of Health; the University of Montreal; and McMaster University in Hamilton, Ontario, Canada.

Dr. HarshVardhan, Union Minister of Health and Family Welfarehas been closely monitoring the situation after the reports of 41 confirmed cases of novel Corona virus (nCoV) including one death from Wuhan, China on 5thJanuary, 2020.  According to WHO, the situation is still evolving and preliminary investigations suggest link to the sea food market. Coronaviruses are large family of viruses, which cause illnesses to people and also circulate in animals including camels, cats and bats. Rarely, animal coronaviruses can also evolve and infect people.

Sun Pharmaceutical Industries Ltd announced that one of its wholly owned subsidiaries has entered into exclusive licensing and supply agreements with Rockwell Medical Inc. (Rockwell), to commercialize Rockwell's Triferic, a proprietary iron replacement and haemoglobin maintenance drug, for treating anaemia in hemodialysis patients in India. Triferic is approved in USA.

The 15th Finance Commission today received a presentation on India’s Health Sector.  The presentation was given by Smt. Preeti Sudan, Secretary, Health & Family Welfare and Dr. V.K. Paul, Member, NitiAayog in a meeting held in New Delhi today.  Chairman, Sh. N.K. Singh and all Members of the Commission were present at this meeting along with senior officials.

The World Health Organization (WHO) is working with officials in Thailand and China following reports of confirmation of the novel coronavirus in a person in Thailand.

An analysis of U.S. death certificate data by researchers at the National Institute on Alcohol Abuse and Alcoholism (NIAAA), part of the National Institutes of Health, found that nearly 1 million people died from alcohol-related causes between 1999 and 2017. The number of death certificates mentioning alcohol more than doubled from 35,914 in 1999 to 72,558 in 2017, the year in which alcohol played a role in 2.6% of all deaths in the United States. The increase in alcohol-related deaths is consistent with reports of increases in alcohol consumption and alcohol-involved emergency department visits and hospitalizations during the same period. The new findings are reported online in the journal Alcoholism: Clinical and Experimental Research.

Mylan N.V. U.S. based Pharmaceuticals business is conducting a voluntary nationwide recall, to the consumer level, of three lots of Nizatidine Capsules, USP (including the 150mg and 300mg strengths). While Mylan has not received any reports of adverse events related to these batches to date, this product is being voluntarily recalled due to detected trace amounts of an impurity N-nitrosodimethylamine (NDMA) contained in the API Nizatidine, USP, manufactured by Solara Active Pharma Sciences Limited.

Taro Pharmaceuticals U.S.A., Inc. is voluntarily recalling one (1) lot of Lamotrigine 100 mg Tablets, Lot # 331771 (expiration date June 2021) in 100 count bottles, NDC 51672-4131-1 to the consumer level. This single lot of Lamotrigine 100 mg Tablets Lot #331771 (expiration date June 2021) was found to have been cross-contaminated with a small amount of another drug substance (Enalapril Maleate) used to manufacture another product at the same facility.