Swot Analysis of Piramal
Content
STRENGTHS i). Existence of an enabling strategic policy context and political will as reflected in key policy documents such as the Health Policy Framework, Protocol on Health, , Pharmaceutical Programme. ii). All indian Member States have an official or draft national medicines policy, iii). as well as medicines legislations and regulations; iv). Existence of the Pharmaceutical Regulatory Shared Network; v). The Indian government has developed pharmaceutical guidelines for medicines regulation and other strategies aiming to improve access to medicines; and vi). Indian countries are members of the World Trade Organization (WTO), which automatically makes them signatory to the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS).
WEAKNESSES i). outdated medicine laws and Intellectual Property Laws which are not TRIPS compliant; ii). Government expenditure on health is below the 15% of the total national budget as per Abuja Declaration for most Member States thereby hampering provision of adequate health care delivery; iii). weak regulatory systems leading to concerns on quality, safety and efficacy of medicines with many unregistered products on the market, and also the mushrooming of unlicensed wholesalers and retailers with instances of medicines being sold on street markets in some countries; iv). lack of regulatory capacities and abilities of medicines authorities in Member States to ensure the quality, safety and efficacy of medicines circulating in their markets; v). predominance of Private Sector expenditure on essential medicines in a region with high poverty levels and substantial price disparities
which has implications on affordability particularly for the poor and disadvantaged population; vi). inadequate national and regional medicine quality control laboratories; lack of adequate capacity and properly trained laboratory personnel to conduct relevant tests; inability to access laboratory services due to the high cost of analysis of samples from member states; vii). Over dependence on imported medicines both patented and generics. For instance, about 85% of the generic ARV medicines used in the region are imported from India viii). Lack of research and development of medicines for diseases of public health importance and the selection of products is driven largely by market demand. As a result, medicines for some diseases and health conditions are neglected because no viable market exists for these products; ix). Inappropriate use of medicines in all Countries. More than half of all medicines in the region are prescribed, dispensed or sold inappropriately, and half of all patients fail to take them correctly; x). Inconsistent medicine regulatory procedures and divergent treatment guidelines and essential drug lists; xi). Under utilization of installed manufacturing capacities and failure to comply with national medicines regulatory requirements including Good Manufacturing Practice Standards (GMP); xii). Unreliable medicine supply systems due to the following: insufficient procurement and supply management capacity; lack of established mechanisms for procurement quality assurance; lack of consumption data and inadequate estimation of needs and forecasting of medicine requirements; xiii). Lack of information on prices and use of medicines; xiv). Changing clinical needs;
xv). Unpredictable rate of scaling-up and lack of effective management information systems to aid evidence based decision making; xvi). Lack of pricing policies and substantial variation in prices of essential medicines for the same or similar products both within and between countries; and xvii). Lack of adequate trained personnel and inappropriate use of available pharmaceutical professionals whereby these are usually tied up with activities that can be dealt with by other trained middle level health workers. OPPORTUNITIES i). The piramal healthcare has developed pharmaceutical guidelines for medicines regulation and other strategies aiming to improve access to medicines; iii). A large regional market for the pharmaceutical manufacturing industries, which was estimated in 2000 at U$2.5 - 3 billion, creates opportunities for regional investment and trade, growth of local entrepreneurship, creation of job opportunities as well as the development of viable pharmaceutical industries thus ensuring sustainable supply of quality and affordable essential medicines to meet public health objectives; iv). Advanced medicines quality assurance systems in some Member States can be used for building capacities in other Member States through training and exchange programmes; v). Improvement of efficiency in supply chain management systems through regional collaboration and sharing of best practices in public sector procurement. An estimated U$1 billion per year is used in procurement and a 1 % improvement in efficiency could therefore translate into realization of savings in the region of U$1 0 million; whilst an achievable efficiency gain of 5% can translate into U$50 million savings per year; vii). Improvement of local research and development capacity through transfer of technology and improved public-private partnership. The WHO Commission on Intellectual Property and Public Health issued its
final report in April 2006, calling for increased collaboration between industrialized and developing countries as well as South - South Collaboration to facilitate technology transfer in the manufacturing of pharmaceuticals; viii). There is great scope for strengthening the Public - Private Partnership (PPP) given the important roles these sectors are already playing in the pharmaceutical industry; and ix). Increase in additional funding sources and mechanisms can continue to improve access to essential medicines.
THREATS i). Implementation of approved guidelines will require substantial resources and continued effort both at regional and individual Member State level; ii). Current and future bilateral trading agreements could potentially impact negatively on public health concerns, especially on improving access to affordable and quality medicines, unless closely monitored; iii). The multiplicity of procurement agencies and unregulated donations with separate administrative and supply system management requirements are stretching the already overwhelmed public sector medicines supply systems;
iv). Brain drain - Many of the pharmaceutical personnel migrate outside the region thereby aggravating the problem of inadequate human resource capacity to effectively implement the various components of national and regional medicine policies and programmes; v). Unethical promotional activities by pharmaceutical manufacturers and suppliers that aggressively promote their products through various means.
These promotions entice health professionals including pharmacists and managers dealing within the medicine chain management to engage in unethical activities. These unethical activities include: a)the production of substandard/counterfeit medicines; b)conduct of unethical clinical trials; c)unethical inspection and registration of medicines and premises; d) corruption in the procurement processes; d)distribution of unregistered medicines; e)irrational prescribing practice; and f)irrational dispensing practice.
WEAKNESSES i). outdated medicine laws and Intellectual Property Laws which are not TRIPS compliant; ii). Government expenditure on health is below the 15% of the total national budget as per Abuja Declaration for most Member States thereby hampering provision of adequate health care delivery; iii). weak regulatory systems leading to concerns on quality, safety and efficacy of medicines with many unregistered products on the market, and also the mushrooming of unlicensed wholesalers and retailers with instances of medicines being sold on street markets in some countries; iv). lack of regulatory capacities and abilities of medicines authorities in Member States to ensure the quality, safety and efficacy of medicines circulating in their markets; v). predominance of Private Sector expenditure on essential medicines in a region with high poverty levels and substantial price disparities
which has implications on affordability particularly for the poor and disadvantaged population; vi). inadequate national and regional medicine quality control laboratories; lack of adequate capacity and properly trained laboratory personnel to conduct relevant tests; inability to access laboratory services due to the high cost of analysis of samples from member states; vii). Over dependence on imported medicines both patented and generics. For instance, about 85% of the generic ARV medicines used in the region are imported from India viii). Lack of research and development of medicines for diseases of public health importance and the selection of products is driven largely by market demand. As a result, medicines for some diseases and health conditions are neglected because no viable market exists for these products; ix). Inappropriate use of medicines in all Countries. More than half of all medicines in the region are prescribed, dispensed or sold inappropriately, and half of all patients fail to take them correctly; x). Inconsistent medicine regulatory procedures and divergent treatment guidelines and essential drug lists; xi). Under utilization of installed manufacturing capacities and failure to comply with national medicines regulatory requirements including Good Manufacturing Practice Standards (GMP); xii). Unreliable medicine supply systems due to the following: insufficient procurement and supply management capacity; lack of established mechanisms for procurement quality assurance; lack of consumption data and inadequate estimation of needs and forecasting of medicine requirements; xiii). Lack of information on prices and use of medicines; xiv). Changing clinical needs;
xv). Unpredictable rate of scaling-up and lack of effective management information systems to aid evidence based decision making; xvi). Lack of pricing policies and substantial variation in prices of essential medicines for the same or similar products both within and between countries; and xvii). Lack of adequate trained personnel and inappropriate use of available pharmaceutical professionals whereby these are usually tied up with activities that can be dealt with by other trained middle level health workers. OPPORTUNITIES i). The piramal healthcare has developed pharmaceutical guidelines for medicines regulation and other strategies aiming to improve access to medicines; iii). A large regional market for the pharmaceutical manufacturing industries, which was estimated in 2000 at U$2.5 - 3 billion, creates opportunities for regional investment and trade, growth of local entrepreneurship, creation of job opportunities as well as the development of viable pharmaceutical industries thus ensuring sustainable supply of quality and affordable essential medicines to meet public health objectives; iv). Advanced medicines quality assurance systems in some Member States can be used for building capacities in other Member States through training and exchange programmes; v). Improvement of efficiency in supply chain management systems through regional collaboration and sharing of best practices in public sector procurement. An estimated U$1 billion per year is used in procurement and a 1 % improvement in efficiency could therefore translate into realization of savings in the region of U$1 0 million; whilst an achievable efficiency gain of 5% can translate into U$50 million savings per year; vii). Improvement of local research and development capacity through transfer of technology and improved public-private partnership. The WHO Commission on Intellectual Property and Public Health issued its
final report in April 2006, calling for increased collaboration between industrialized and developing countries as well as South - South Collaboration to facilitate technology transfer in the manufacturing of pharmaceuticals; viii). There is great scope for strengthening the Public - Private Partnership (PPP) given the important roles these sectors are already playing in the pharmaceutical industry; and ix). Increase in additional funding sources and mechanisms can continue to improve access to essential medicines.
THREATS i). Implementation of approved guidelines will require substantial resources and continued effort both at regional and individual Member State level; ii). Current and future bilateral trading agreements could potentially impact negatively on public health concerns, especially on improving access to affordable and quality medicines, unless closely monitored; iii). The multiplicity of procurement agencies and unregulated donations with separate administrative and supply system management requirements are stretching the already overwhelmed public sector medicines supply systems;
iv). Brain drain - Many of the pharmaceutical personnel migrate outside the region thereby aggravating the problem of inadequate human resource capacity to effectively implement the various components of national and regional medicine policies and programmes; v). Unethical promotional activities by pharmaceutical manufacturers and suppliers that aggressively promote their products through various means.
These promotions entice health professionals including pharmacists and managers dealing within the medicine chain management to engage in unethical activities. These unethical activities include: a)the production of substandard/counterfeit medicines; b)conduct of unethical clinical trials; c)unethical inspection and registration of medicines and premises; d) corruption in the procurement processes; d)distribution of unregistered medicines; e)irrational prescribing practice; and f)irrational dispensing practice.
