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Making medicines safer_-_express_pharma


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Challenges in the Changing Pharmaceutical

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Making medicines safer_-_express_pharma

  1. 1. Making medicines safer - Express Pharma FORTNIGHTLY INSIGHT FOR PHARMA PROFESSIONALS 1 - 15 July 2011 Sections Home - Management - Article Printer Friendly Version Market Opinion Management Research Making medicines safer Pharma Life Pharma Ally J Ramnivas, Chief Executive Officer, Sai Pharma Solutions, lists the many reasons how life saving medicines can turn out to be Specials just the opposite Express Biotech Every day we read the news of tragic deaths after Services receiving vaccines. These incidents are putting question mark on the safety of medicines. Rational Editorial Advisory Board usage of medicines is the need of the hour. If the Open Forum corrective and preventive measures are not taken in Subscribe/Renew time, the people will refuse to vaccinate their Archives children and which in turn can lead to breakouts of diseases that Search would have been easily preventable. Instead of shifting blame, Media Kit there is need for introspection otherwise there is a great risk lurking right from manufacturing to prescription and ultimately Contact Us usage by patients. Network Sites The official reason for the deaths as per government records is Express Computer adverse events following immunisation. But it is difficult to Express Channel Business believe how they have arrived at these conclusions. Deaths after Express Hospitality vaccination could be a reaction to the components of vaccine. Express TravelWorld Either it could be due to preservatives or the content. The other Express Healthcare reason may be standard procedures laid down for the usage of Group Sites these vaccines are violated. If vaccine vials are not used within stipulated time hours of opening, they can get contaminated and ExpressIndia vaccination of such contaminated medicines can lead to serious Pharma Indian Express tragic incidents. Formulation Financial Express METTLER Before launching the medicine in the market it has to pass TOLEDO through preclinical studies followed by clinical studies. The formulation manufacturer has to file IND prior to initiation of clinical trials software and toxicological studies of the medicine are undertaken. On… being found safe with least toxicological concerns, clinical studies can begin only when preclinical studies have been successfully completed and an approval has been received from the drug Jobs in regulating authority for the conduct of clinical trials. During Pharma clinical trial studies where safety and efficacy of medicines is Vacancies in top determined. The clinical trials for the medicine is started in companies. different phases which cover treatment trials, prevention trials, Submit Your diagnostic trials, screening trials and quality of life trials Resume Free. (supportive care trials).The purpose of conducting clinical trials in Now! different phases is to monitor and evaluate the safety, efficacy, purity and quality of medicines to mitigate the risks. During clinical trials if anything goes wrong and is not investigated, the Clinical medicine which is supposed to be life saving can turn out to be Research the medicine of death. Courses Clinical Research Lack of adequate post marketing surveillance is one of the root Courses from Top[7/8/2011 4:32:26 PM]
  2. 2. Making medicines safer - Express Pharma causes of such eventualities. This is a matter of great concern. Universities. Apply Once the medicine gets the nod of drug regulatory authorities Now & Get Info! for marketing approval. This is very important phase because it… often garners additional data about the safety and efficacy of medicines where it has been marketed for patient use. At this Drug stage, if there is no co-ordination between medical practitioners Interaction and drug regulatory authorities, there will be no reporting of Center adverse drug reactions and no corrective and preventive action Learn about will be taken. At this stage, the involved agencies and drug commonly regulation enforcing authorities should understand their misunderstood respective responsibilities. Efforts should be made to make the food-drug system more effective and foolproof. But unfortunately post interactions. marketing surveillance is lacking in our country and outcome www.druginteractionc… thereof is observed when we come across the news of tragic eventualities in the news papers, TV etc. There are several reasons for the contamination of medicines leading to deaths. If these following factors are ignored, life saving medicine can become medicine of death: 1. Lack of adequate quality systems during manufacturing of medicines: During the manufacturing, testing, packing labeling and storage of medicines if there no adequate quality systems in place and GMP regulations are violated, there are possibilities for the medicine to get contaminated and can pose health hazards. 2. Lack of adequate transportation: Shipping of medicines plays very important role. If during transportation, the required storage conditions are not maintained, this can lead to the degradation of the medicines and impurity formation. The toxic nature of impurities can also trigger health hazards to the patients and can result in any eventuality. 3. Lack of proper storage conditions: The situation of pharmacy stores is very pathetic. Hardly there is any pharmacy store meeting pharmacopoeial storage conditions. Yet they have approval from the drug regulating agencies. This is matter of great concern. Within the pharmacy store medicines become poison if their required storage conditions are not met. In addition to the storage issues, there is lack of control for the expired date medicines. The ignorance of drug regulating authorities and lack of awareness in patients is causing a threatening situation which needs to be addressed on priority basis. 4. Lack of adequate prescription: In India, quacks prescribe medicines which need to be prescribed by qualified medical professionals. The reason is the redily available treatment at cheaper cost from quacks. These quacks do not know the right usage of medicines and ultimately prescription by such quacks can become a bone of contention for health issues and instead of remedy, this practice jeopardises the health of patients. In some cases pharmacists play the role of doctors and deliver schedule H medicines as the over the counter (OTC) medicines. Irrational use of medicines is a global problem and particularly more common in developing countries like India because of under surveillance from the regulatory agencies and less awareness among medical professionals and public in general. It is widely assumed that use of drug by a qualified doctor is[7/8/2011 4:32:26 PM]
  3. 3. Making medicines safer - Express Pharma rational but in reality irrationality abounds in many aspects of medicines, i.e. selection, procurement, storage, prescribing, dispensing, monitoring and feedback which may lead to inappropriate, ineffective and economically inefficient use of medicines. Irrational prescribing and poor dispensing adversely impact morbidity and mortality in general population and also leads to wastage of resources, unwanted side effects and adverse psychological suffering. Interventions to improve prescribing and dispensing practices can be educational (by conducting CME, seminars etc) and regulatory. The need of the hour is the rational usage of medicines and all agencies involved have to accept this challenge and prove to the world that our medicinal system is world class! (The author can be contacted at info@ FEEDBACK: We would love to hear from you -- what you like about our content, what you dont, and even how you think we can improve. Please send your feedback to: © Copyright 2001: The Indian Express Limited. All rights reserved throughout the world. This entire site is compiled in Mumbai by the Business Publications Division (BPD) of The Indian Express Limited. Site managed by BPD.[7/8/2011 4:32:26 PM]