PHARMA LITERATI

15. What is a Marketing Authorization Application? It is an application filed with the relevant authority in the Europe (typically, the UK's MHRA or the EMA’s Committee for Medicinal Products for Human Use (CHMP)) to market a drug or medicine. As per UK’s MHRA-Applications for new active substances are described as 'full applications'. Applications for medicines containing existing active substances are described as 'abbreviated’ or ‘abridged applications’. 16. What is an ASMF? Active substance master file is a submission which is made to EMA, MHRA or any other Drug Regulatory Authority in Europe to provide confidential intellectual property or 'know-how' of the manufacturer of the active substance. In simple words, “It is a submission made to European Drug regulatory agencies on the confidential information of Active Substance or Active pharmaceutical Ingredient (API)”. 17. What are the types of active substances for which ASMFs are submitted...

Today's Times of India, Mumbai Edition reports that the Maharashtra state's Food and Drug Administration (FDA) on Thursday raided the corporate office of e-commerce giant Snapdeal.com for selling prescription drugs online. The agency got decoy customers to place orders on the portal and raided their office once most of the orders were delivered to respective addresses.   FDA commissioner Harshadeep Kamble said the agency acted after receiving information that the portal was allegedly selling Ascoril cough syrup and Vigora tablets (commonly prescribed for erectile dysfunction) through the website.“These are prescription drugs and cannot be sold in unlicensed premises. These drugs are only supposed to be sold under the supervision of registered pharmacists and only when prescribed by a registered medical practitioner. They cannot be sold like regular commodities,“ he told TOI, adding they will check other online retailers for such violations.   Kamble added t...

Dear All, Every week of thousands of patent applications are published in India. The  patent applications filed by the pharma academic research institutes in India  go un-noticed. We publish a list of Indian applications published related to pharma academics. This would provide us an idea about the kind of academic research being carried out in these institutes. For details of these patents, please write back to us at  pharmaliterati@gmail.com Indian patent applications published on 17th April 2015 Invention Application No Inventors Institute A Novel Formulation For Anticancer Drug 268/KOL/2015 Pranab Kumar Das Not Known Benzothiazole Compounds And Process For The Preparation Thereof 55/DEL/2012 1)Ahmed Kamal 2)Rajesh Venkata Chenna Rama Narasimha Chennam Shetti 3)Ponnampalli Swapna 4)Shaik Azeeza 5)Adla Malla Reddy 6)Inshad Ali Khan 7)Sheikh Tasduq A...

Dear All, We are starting a new series on knowledge sharing from today. In this series, we would share relevant articles in the field of pharmaceutical industry.   Recently received an email sharing the information relating to regulatory affairs activities in pharmaceutical industry. We are reproducing the same for our readers.   1. What is Regulatory Affairs? Regulatory Affairs in a Pharmaceutical industry, is a profession which acts as the interface between the pharmaceutical industry and Drug Regulatory authorities across the world. It is mainly involved in the registration of the drug products in respective countries prior to their marketing. 2. What are the goals of Regulatory Affairs Professionals? Protection of human health Ensuring safety, efficacy and quality of drugs Ensuring appropriateness and accuracy of product information. 3. What are the Roles of Regulatory Affairs professionals? Act as a liaison with regulatory agencies Pr...

A recent article on “Self-assembled sorbitol-derived supramolecular hydrogels for the controlled encapsulation and release of active pharmaceutical ingredients”, reveals how a self-assembling hydrogel with nanofibres that specifically capture and release anti-inflammatory compounds has been created for applications in targeted drug delivery. The drug naproxen is only unleashed from the gel in basic solvents, a trait that could be exploited to avoid naproxen’s undesirable side effects. The hydrogel, devised by David Smith and coworkers at the University of York, UK , could form the basis of a naproxen formulation that only dispenses the drug under alkaline conditions, such as those found in the small intestine. ‘Preparing the system is extremely simple,’ says Smith. ‘You mix the gelator and drug in water, treat with ultrasound, heat and then cool to form the gel.’ He adds that ‘the nanoscale structuring of the gel fibres means that they have a large surface area, and can ther...

US spending on prescription drugs jumped 13.1% in 2014 to $373.9 billion, marking the highest level since 2001, as figures were swelled by a record spend on new brands, price increases and a lower impact from patent expiries.   According to the IMS Health report Medicine Use and Spending Shifts: A Review of the Use of Medicines in the US in 2014, a record volume of 4.3 billion prescriptions were filled, and the year saw the launch of 42 New Molecular Entities - the largest number in 10 years - with new drugs contributing $20.3 billion to growth, including $11.3 billion from four new hepatitis C treatments. 2014 also saw the largest number of orphan drugs launched in a single year and, looking forward, the trend looks set to continue, as 42% of the R&D pipeline is now comprised of speciality medicines - up from 33% a decade ago, IMS said. Spending growth was also driven by a lesser impact of patent expiries, which came in at $11.9 billion compared to the $29.3 billi...