PHARMA LITERATI

Coming down heavily on Pharmacy Council of India (PCI) for its recommendation to universities to prefix 'Dr' before the names of those who pass out the Doctoral Pharmacy (Pharm D) course, the Indian Medical Association (IMA) has asked the national pharmacy education regulator to withdraw the contentious circular issued to the universities in this regard by the PCI Registrar last week. In a statement issued on May 29 against the circular of the PCI, the IMA says that the PCI’s circular is unlawful, and in violation of the rules and regulations governing the practice of modern medicine in the country. On several occasions, the Supreme Court of India held that only a person holding a registration with the ‘Medical Council of India’ or the state medical councils is entitled to practice modern system of medicines. As per the judgments and rulings of the apex court, the pharmacists cannot use ‘Dr’ prefix with their names. They are supposed to work under a medical supervision ...

Venue:    ,   Goa  ,   Goa   ,  India Starting Date:  30th May 2019 Ending Date:  31st May 2019 About the Event/Conference  : ISER- 595th International Conference on Science, Health and Medicine (ICSHM) is a prestigious event organized with a motivation to provide an excellent international platform for the academicians, researchers, engineers, industrial participants and budding students around the world to SHARE their research findings with the global experts. ICSHM 2019 will be held in Goa, India on 30th - 31st May, 2019.   Organized by:    ISER Contact Person:  Conference Coordinator Event enquiries email address:   info@iser.co Website :   http://iser.co/Conference2019/India/3/ICSHM/

The China-India joint summit held recently discussed bilateral trade to improve Indo- China pharma industry and address issues like long product registration time and high fees for product registration in China’s drug regulatory system, among other issues.  Besides this, other relevant key issues related to transparency in public procurement system in China and clinical trial related approvals were also deliberated at the summit organised under the aegis of Indian Pharmaceutical Association (IPA), Shengjie and SaSPinjara, China between May 16 and May 17, 2019 at Pullman Shanghai South, China. The summit was focused on enhancing export business for both the nations across the globe. Senior health ministry official from Government of Gujarat Punamchand Parmar was invited as the Chief Guest of the summit and Gujarat Food and Drugs Control Administration (FDCA) Commissioner Dr Hemant Koshia was invited as Guest of Honour.  Among other dignitaries, Dr. Anil Kumar Rai, Consulate Ge...

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Following its proposal to the state government to mandate issuance of sale licence for ayurvedic drugs, the Maharashtra Food and Drug Administration (FDA) has urged the state government for inclusion of the provision of “Licence for the sale of Ayurvedic drugs”, in the Drugs and Cosmetics (D&C) (Maharashtra Amendment) Act to effectively control spurious drugs sale.     Currently, the state FDA has no control on ayurvedic drugs beyond registering manufacturers. Under the existing norms, FDA has the power to seize spurious cosmetic or Ayurveda products but has no authority for prosecuting retailers found selling them. The state regulator in its ongoing crackdown for non-compliance to Drugs and Magic Remedies (Objectionable Advertisement) Act (DMR Act) 1954 revealed that ayurvedic drugs were mixed with allopathic medicines in contravention to the provisions of the DMR Act, 1954. Maharashtra also submitted reports of action taken for non-compliance to the state g...

Following Central Drugs Standard Control Organisation (CDSCO) having red-flagged three brands of pacemakers from US medical-device maker Medtronic and United States Food and Drug Administration (FDA) also issuing safety alert on the heart implants, Medtronic has advised physicians to continue normal patient follow-up with the pacemakers in accordance with standard practice and, where possible, to continue with remote monitoring.  While the devices continue to perform well within reliability projections, Medtronic has implemented additional process and component enhancements that have been reviewed and approved by FDA, Medtronic in a release stated.. A safety alert was also issued by the US FDA on these heart implants over concerns that their batteries drain out with no warning to the patient. The release further states, Medtronic has published a performance note about a rare mode in a population of Azure and Astra pacemakers and Percepta, Serena and Solara cardiac ...

The Pharmacy Council of India (PCI) should have conducted a feasibility study, situation assessment and gap analysis prior to the introduction of Pharm D course in the country. For a mega programme like Pharm D, healthcare providers and the Medical Council of India should also have been consulted on the viability of this course and whether the role of a clinical pharmacist would be relevant in a hospital environment, opined PS Bhagavan, former deputy director, Karnataka Health and Family Welfare Department.   Doctors are not recognising the role of a pharmacist in healthcare practice even as the job of a clinical pharmacist is to ascertain whether the prescribed medications are meeting the patients health needs, he added. When a dedicated six-year course was devised to fit into the healthcare system, it was necessary to stimulate the demand for the course to ensure supply of Pharm D professionals, Bhagavan told Pharmabiz.   The intent to create a pool of clini...

The Indian pharma is not the space to look at when discussing job creation in the country over the past four years. The sector, where the bulk of major players look to the US as the biggest market to drive revenues, is coping with its unique challenges in the market. Multiple factors have contributed to the cost pressures faced by leading players in the sector. For instance, channel consolidation (acquisition and merger between wholesalers and chains sourcing generic drugs) has given them tremendous bargaining power that raises the prices of drugs. There is also  the dimension of increased competition with new entrants joining in to tap the same market. In fact, many Indian companies are today competing with each other on the US soil.  Then, there is also the component of regulatory overhang, with some of the companies being pulled up by the US drug regulator and import alerts being imposed impacting the future supply plans of some of the companies. Though some are ge...

The Drugs Controller General of India (DCGI) has warned of stern action against those manufacturers and marketers of pharmaceutical formulations who change the contents of the formulations without changing the existing brand names. In a circular, the national drug regulator has directed the state drug controllers and the zonal & sub-zonal officers of the Central Drugs Standard Control Organisation (CDSCO) to consider legal measures to discourage the unethical practice of marketing formulations by changing their contents without changing the existing brand names by the pharma companies.  The DCGI wants the enforcement officers and drug controllers to ensure that contents changed formulations are not marketed in the country in the old brand names as it confuses both the prescribers and patients. He wanted the licensing authorities not to permit to sell formulations with changed compositions without changing the old brand names. In the circular sent to all central...

In the absence of a proper cadre such as clinical pharmacist, the Pharm D graduates seem to be staring at a bleak future. These well qualified candidates are either underemployed or unemployed in the country due to the absense of a separate cadre for them. This is even as the course content is relevant but paucity of jobs are impacting their future career prospects, said DA Gundu Rao, former president, Karnataka State Pharmacy Council. There is lack of opportunities in the hospitals for Pharm D candidates, despite being exposed to pharmacovigilance, drug information services, therapeutic drug monitoring, medication error monitoring and medication history analysis , he added.   When the course commenced in 2008, the requirement was that pharmacy colleges offering Pharm D should be attached to a 200-bed hospital and easily accessible for students. But now we see such requirements and standards are diluted. Now doctors and nurses are trained in hospitals but a pharmacist which...

U.S. Food and Drug Administration approved Vyndaqel (tafamidis meglumine) and Vyndamax (tafamidis) capsules for the treatment of the heart disease (cardiomyopathy) caused by transthyretin mediated amyloidosis (ATTR-CM) in adults. These are the first FDA-approved treatments for ATTR-CM. Vyndaqel and Vyndamax have the same active moiety, tafamidis, but they are not substitutable on a milligram to milligram basis and their recommended doses differ. “Transthyretin-mediated amyloidosis is a rare, debilitating and often fatal disease,” said Norman Stockbridge, M.D., Ph.D., director of the Division of Cardiovascular and Renal Drugs in the FDA’s Center for Drug Evaluation and Research. “The treatments we’re approving today are an important advancement in the treatment of the cardiomyopathy caused by transthyretin-mediated amyloidosis.” ATTR is caused by the buildup of abnormal deposits of specific proteins known as amyloid in the body's organs and tissues, interfering with their ...

Thank you so much for your interest in the Pharma Literati Internship for Summer 2019. We have received more than 300 applications for the internship for this year.  Based on our requirement and profile of the candidates, we have selected following candidates for the internship. This is the second list of candidates. We would be publishing the third and final list of candidates on Tuesday.  Please get in touch with  pharmaliterati@gmail.com  for details. SN Name of student Institute 1.        Sharayu Shewale Gahlot Institute of Pharmacy, Navi Mumbai, Maharashtra. 2.        Shikha Shah Dr. Bhanuben Nanavati College Of Pharmacy, Mumbai, Maharashtra. 3.        Ashwini Bhoir Konkan Gyanpeeth Rahul Dharkar College of Pharmacy and Research Institute, Karjat, Maharshtra. 4.    ...