In today’s globalized economy maintaining Supply Chain Security (SCS), especially in the pharmaceutical sector across the world, is more critical than ever before. We have many instances of SCS being seriously breached, not only in the emerging pharmaceutical markets but also in the developed markets of the world.
Global examples of serious SCS violations:
Following are some at random examples of serious SCS violations globally in the recent times:
- In 2007, over 300 people died in Panama in Central America after consuming a cough medication containing diethylene glycol, which was labeled as glycerin. The adulterant diethylene glycol was sourced from China and was relabeled as glycerin by a middleman in Spain, as reported by the media.
- In March 2008, the US FDA prompted by around 81 drug related deaths in the USA, announced a large scale recall of Heparin injection, a well-known blood thinner from Baxter Healthcare suspecting contamination of a raw material sourced from China. Standard technology used by Baxter could not detect the contaminant, which the regulator considered as a deliberate adulteration. The contaminant was eventually identified as an over sulfated derivative of chondroitin sulfate, which costs a fraction of original heparin derivative. The ‘Heparin tragedy’ raised, possibly for the first time, the need of working out an algorithm to put in place a robust system for ‘supply chain security’. This need has now become critical as many pharmaceutical players, including those in India, are increasingly outsourcing the API, other ingredients and almost entire logistics from third parties.
- ‘Business Standard’ dated August 24, 2011 reported that Ranbaxy Laboratories and the US health regulator are negotiating a settlement to lift a ban on the sale of the drugs produced at 2 of the company’s plants in India, which could involve payments and fines exceeding $1 billion. This ban, as the report says, dates back to 2008, when the US regulator banned 30 generic drugs produced by the company at its Dewas (Madhya Pradesh) and Paonta Sahib and Batamandi unit in Himachal Pradesh, citing gross violations of approved manufacturing norms.
- ‘Business Ethics’ – the Magazine of Corporate Responsibility reported, “GSK facility in Puerto Rico suffered from long standing problems of product mix-ups, which caused tablets of one drug type and strength to be commingled with tablets of another drug type and/or strength in the same bottle…the subsidiary’s manufacturing operations failed to ensure that Kytril, an anti-nausea medication, and Bactroban, a topical anti-infection ointment, were free of contamination from micro organisms.” As a result, the US Justice Department reportedly announced, “GlaxoSmithKline, PLC (GSK) and the subsidiary agreed to pay US$750 million to settle charges that between 2001 and 2005 they distributed adulterated drugs made at GSK’s now-closed manufacturing facility in Cidra, Puerto Rico”.
- As reported by Reuter, on April 30, 2010 recalled over 43 children’s medicines involving 136 million units and 12 countries in response to complaints from regulators and customers. This recall included liquid versions of Tylenol, Tylenol Plus, Mortin, Zyrtec and Benadryl, as they “may not fully meet the required manufacturing specifications.”
Despite presence of one of the most stringent drug regulators, the issue bothers even the US:
In the wake of all these, ‘The New York Times’ dated August 15, 2011 reported, despite the fact that US now imports more than 80% of APIs and 40% of finished drugs mainly from India, China and elsewhere, the agency conducts far fewer foreign inspections as compared to domestic inspections. The US FDA Commissioner Margaret Ann Hamburg was quoted saying, “Supply chains for many generic drugs often contain dozens of middlemen and are highly susceptible to being infiltrated by falsified drugs.”
At another conference Ms. Hamburg said, “I think people have no idea in this country and around the world about the vulnerability of things that we count on every day and that we have a system that has big gaps in our protective mechanisms.”
FDA inspects only a fraction of foreign drug plants in the global outsourcing wave:
The investigative arm of US Congress, the Government Accountability Office reported, while US FDA inspected 40% of domestic manufacturing facilities in 2009, it inspected just 11% of the foreign manufacturing facilities, as the later outnumbered the domestic sites since 2008.
|
INSPECTIONS BY FDA |
ESTIMATED PLANTS IN FDA INVENTORY 2009 |
||||
|
2007 |
2008 |
2009 |
TOTAL | ||
| India |
64 |
64 |
59 |
187 |
502 |
| China |
19 |
36 |
52 |
107 |
920 |
| Germany |
26 |
34 |
36 |
96 |
228 |
| Italy |
28 |
28 |
30 |
86 |
168 |
| Canada |
20 |
19 |
35 |
74 |
310 |
| U.K. |
16 |
17 |
32 |
65 |
191 |
| France |
24 |
14 |
26 |
64 |
188 |
| Japan |
22 |
17 |
20 |
59 |
207 |
| Switzerland |
17 |
15 |
18 |
50 |
100 |
| Ireland |
14 |
11 |
19 |
44 |
63 |
| All others |
83 |
69 |
97 |
249 |
888 |
| Total |
333 |
324 |
424 |
1,081 |
3,765 |
NOTE: Most frequently inspected foreign countries. SOURCE: Government Accountability Office.
US FDA’s Counterfeit Drug Initiative:
The initiative includes the following measures:
- Secure the product and packaging
- Secure the movement of drugs through the supply chain
- Secure business transactions
- Ensure appropriate regulatory oversight and enforcement
- Increase penalties
- Heighten vigilance and awareness
- International cooperation.
If such instances are available from the developed markets of the world, especially from the US, one can well imagine what is happening in the emerging markets of the world. In the developed markets, at least these are detected and rectifying measures are taken. Unfortunately, in the emerging markets scores of such criminal instances go undetected taking innocent lives of the patients.
Fast growing global outsourcing initiatives have increased the risks by manifold:
Thus even the US FDA acknowledged that fast growth of globalization in drug manufacturing has outstripped the agency’s resource pool for effectively inspecting all overseas outsourcing facilities.
As a result of the outsourcing wave in the US, the number of US FDA approved local drug manufacturing sites in the country is gradually coming down since 2008, with a commensurate increase in the number of foreign sites.
|
2000 |
2002 |
2004 |
2006 |
2008a* |
|||||
|
Domestic |
Foreign |
Domestic |
Foreign |
Domestic |
Foreign |
Domestic |
Foreign |
Domestic |
Foreign |
|
2625 |
1150 |
2700 |
1500 |
2900 |
2000 |
3000 |
2500 |
2480 |
3800 |
NOTE: US FDA-registered drug-manufacturing sites with at least one product listed in FDA database. *a Preliminary estimates. SOURCE: US FDA
Stakeholders need to be extremely vigilant:
Pharmaceutical players and the drug regulators from across the world should put proper ‘fool proof’ systems in place to eliminate the growing menace of criminal adulteration of APIs, drug intermediates, excipients entering in the supply chain together with preventing any breach in their logistics support systems.
Regulators fail to keep pace with the fast growth of global generic industry:
Many feel a shift in prescription towards generic drugs, especially in the largest pharmaceutical market of the world – the US, is making the regulatory task of the FDA to inspect all drug ingredient suppliers indeed quite challenging.
Currently, 70% of all prescriptions in the US are contributed by the generic drugs, which indeed play an important role to contain the health care cost. However, as an innovative drug goes off patent a single manufacture’s product gets transferred to multiple manufacturers located across the world, making the task of the drug regulator to ensure high quality and safety standard of the same drug extremely challenging.
Conclusion:
SCS, therefore, deserves to be of prime importance for the pharmaceutical companies across the globe. Recent high profile SCS related cases, as mentioned above, have exposed the vulnerability in addressing this global menace effectively. All pharmaceutical players should realize that an integrated approach is of paramount importance to eliminate this crime syndicate, which is taking lives of millions of patients the world over.
It is worth repeating, securing pharmaceutical supply chain on a continuous basis is of critical importance for all the pharmaceutical players across the globe. However, the process will no doubt be expensive for any company, especially when counterfeiters find ways to bypass any such system very quickly.
Like other industries, in the pharmaceutical sector, as well, cost effective procurement is critical, which makes many pharmaceutical players, especially, in the generic industry not to go for such expensive process just to maintain the SCS.
Thus a strong corporate governance mechanism in all pharmaceutical companies must ensure, come what may, putting in place a robust SCS system is not compromised in any way… ever… for patients’ sake.
Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.