Standard to increase pharma sourcing strength

Within an effort to protect complicated supply chains and shield individuals from counterfeit medicines, the US Pharmacopeial Convention (USP) is proposing several best practices. The organisation stated the measures are to be created to make sure that medicines can be traced back to their original producer, aren't adulterated or counterfeited, and are transported to their intended location with their high quality intact.

USP pointed out that supply chain excellence entails minimising dangers that arise anywhere across the supply chain, from sourcing pharmaceutical raw supplies to their manufacture and distribution. The brand new standard being proposed isn't mandatory, and it is contained within the proposed USP Common Chapter <1083> Best distribution practices - supply chain integrity. The proposal is meant to serve like a central advice document outlining the important components of a simple yet effective approach.

While individual pharmaceutical companies have their own approaches to addressing this issue, the size and sophistication of companies and their suppliers vary widely, as do their quality systems and risk-management approaches. Broad consensus around issues such as track-and-trace technology does not exist, and smaller companies that may be relied upon for sourcing pharmaceutical ingredients may or may not have security approaches comparable to their larger counterparts," USP said in statement.

""There is incentive for all players in the pharmaceutical industry - large and small companies, regulators and standards-setting bodies - to come to some agreement on issues such as track and trace technology and, at the larger level, to codify what constitutes a solid, universal approach to global supply chain integrity," added Praveen Tyle, chief science officer for USP.

"USP has developed an initial proposal that we expect to evolve as industry, FDA and others weigh in. Our role as an independent body provides an opportunity to convene all these parties and advance this critical issue. While some pockets of information are available via FDA guidances, trade organizations and other sources, an overall approach is lacking. USP can move forward something more concrete than a technical report, as part of a mechanism that can be regularly updated to best meet the needs of all."

The proposed standard addresses importation, recommending importers ought to undertake to assist to stop and detect possible dangers: supply chain risk management, improvement of existing supplier partnerships and creating a supply chain quality system

Additionally, it consists of measures to counter the threat posed by counterfeit drugs and health-related gadgets and suggests measures like packaging technologies (tamper-evident styles, authentication technologies and serialisation), collectively with drug pedigrees and machine-readable information carriers.

USP also suggests measures to deal with elements that increase the danger of theft of drug goods, drug elements and health-related gadgets; safety methods, gadgets and procedures that ought to be implemented to cut back danger; and vital info to become gathered following discovery of a theft.

The issues facing the procurement function in the Pharmaceutical Industry will be addressed at the ProcureCon Pharma Conference on 28th February 2012 find out more at www.procurecon-pharma.com 

Indian pharmaceutical industry-growth story to carry on

International pharmaceutical MNCs have adopted prudent methods to expand their footprint in emerging nations. Ajit Mahadevan, Partner - Life Sciences, Ernst & Young analyses the same

The international pharmaceuticals market grew rapidly within the 1990s and in the early 2000s, spurred primarily by market demand in North America and Europe. However, with impeding patent expiries, declining R&D productivity, increasing regulatory and pricing pressures, growth in these markets have been scaling down. Consequently, pharmacy companies are trying to find new avenues of driving growth and ways to improve operational efficiencies. In this context, emerging markets represent a potential growth driver for the business - its contribution to the growth of the international pharma market increased from eight per cent in 2003 to 40 per cent in 2010. Consequently, international pharma MNCs have adopted prudent methods to further expand their footprint in emerging markets such as Brazil, Russia, India and China.

Burgeoning Indian pharma business

India is considered the most significant emerging markets for that international pharma business, given that it'll feature one of the world’s top ten sales markets by 2020. Currently, it is thought to be one of the fastest-growing pharma industries globally, primarily driven by a large population, evolving patient demographics, increasing health care expenditure, growing urbanisation, rising life expectancy, and active private-sector participation. (Source: Sanofi and Kantar health presentation at EphMrA)

Domestic companies are transforming their business model to play a more substantial role in international pharma market

The Indian pharma business has been able to claim a share in the international market by leveraging its strengths and enhancing its regulatory and technical maturity. Formulations manufactured in India constitute 20 % of the international generics market by value, as well as the overall share of Indian manufactured formulations is as high as 46 per cent in the generics segment in the emerging markets. However, using the onset of the patent regime, the traditional reverse engineering capabilities of Indian pharma companies are no longer helpful, as they would not be able to replicate the patented product and launch it in the domestic market. Hence, going forward, India could be necessary to leverage its strengths in supply of low priced medicines across the world and invest in newer areas to drive growth. Opportunities exist ranging from the low-value added segment, containing NDDS ($134 billion opportunity by 20131), super generics ($135 billion worth of product expiring between 2010 and 20152) and biosimilars ($115 billion price of biologics expiring by 20153), to the top quality New Chemical Entity (NCE)/New Biopharmaceutical Entity segment. Thus, domestic companies can look forward to pursue all these opportunities and build capabilities to conduct drug discovery and in house development.