Requirement Regulatory Guidelines in Pharma Marketing

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Requirements of Regulatory Guidelines in Pharma Marketing
Nitesh Kumar*, Shakshi Tiwari, Prof. Dr. B. P. Nagori, Mr. Akash Midha *Nitesh Kumar is presently pursuing M. Pharmacy in Pharmaceutical Management & Regulatory Affairs branch at Lachoo Memorial College of Science & Technology, Pharmacy Wing, Jodhpur, India. Sakshi Tiwari is presently pursuing M. Pharmacy in Pharmaceutical Management & Regulatory Affairs branch at Lachoo Memorial College of Science & Technology, Pharmacy Wing, Jodhpur, India. Professor Dr. B. P. Nagori is Professor and Director at Lachoo Memorial College of Science & Technology, Jodhpur, India.

Abstract: Recent article provide a nexus relationship between Health Care Professionals (HCP’s) and pharmaceutical companies. HCP’s are lured by promises of costly gifts and foreign trips for prescribing company products. This tends to arises a conflict between HCP’s interest in patient safety and personal gain. Indian regulators effectively monitor the professional conducts of medicinal practitioner and pharmaceutical companies. The Department of Pharmaceuticals (DOP) under Ministry of chemicals and fertilizers, Government of India look after all activities of pharmaceutical industry and in order to check irregulatories the DOP introduced a voluntary draft uniform code of pharmaceutical marketing practices (UCPMP) for the Indian pharmaceutical industry in June 2011 which covers the area of claims and comparisons of medicinal product, advertisements, promotion etc. On the other hand Medical Council of India (MCI) amended its guidelines in 2009 to regulate the conduct of medical practitioner. These guidelines and code of marketing providing two tier approaches that covers HCP’s and pharmaceutical pharmaceutical companies operating in country. This presentation will highlight major loopholes in Pharma marketing regulations and discusses the requirement or strong Regulatory guidelines in Pharma marketing.

Keywords
Health Care Professionals, code of marketing, Pharma marketing regulations, Pharma marketing, medicinal practitioner and pharmaceutical companies

Introduction
India has one of the fastest-growing pharmaceutical markets in the world, and its market size has pharmaceutical market is expected to reach US$20 billion by 2015 from US$11.5 billion in 2009 at a CAGR of 11.7%, and establish its presence it is the third-largest market in the world in terms of volume and 14th in terms of value. Pharmaceutical marketing, sometimes called medico-marketing or pharma marketing in some countries is the business of advertising or otherwise promoting the sale of pharmaceuticals or drugs. There is some evidence that marketing practices can negatively affect both patients and the health care profession.  Many countries have measures in place to limit advertising by pharmaceutical companies. The relationship between medical practitioners and the pharma industry goes a long way back, since they are dependent on each other. What initially began as an information-sharing practice has evolved over a period of time into aggressive marketing strategies targeted at HCPs, to ensure greater coverage and translate into enhanced sales for pharma companies. The draft UCPMP for the Indian pharma industry aims to marketing their products to HCPs and their relationship with the latter.

The regulator intends to ensure that promotion of pharmaceuticals to health care professionals and interactions between pharma companies and the latter is carried out in a responsible, ethical, professional and legal manner. This will help to assure consumers that their choices in respect to their medication individual health care needs of patients.

Key Characteristics of the Indian Pharma Sector:
The Indian pharmaceutical market is marked by the following significant features: · Self-reliance displayed by the production of 70% of bulk drugs and almost the entire requirement of formulations within the country; · Low...
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