Greetings to everyone who read my “I, Mak” column every issue! Wishing you all a very happy New Year!

In a 2011 special report, Pathway to Global Product Safety and Quality,  the FDA covered the following essential information:

• Half of all medical devices used in the U.S. are imported
• 80% of the active pharmaceutical ingredients in medications sold in the U.S. are imported
• FDA-regulated products account for about 10% of all imports into the U.S., arriving from more than 300,000 facilities in 150 different countries
• It is estimated that imports of FDA-regulated products is growing at around 15%

In its report, FDA continues to state that the goods entering the U.S. will come from new and different markets, flowing through long, multi-step processes to convert globally-sourced materials into finished goods. The shift in global product flows will make it difficult to identify the “source” of a product and to ensure that all players along the supply chain meet their safety and quality responsibilities. 

Under the FDA’s Food Safety Modernization Act (FSMA) enacted in 2011, the agency has been granted new authorities that allow it to better ensure the safety of food. Under the law, FDA has a new legislative mandate to require comprehensive, prevention-based controls across the food supply and new tools to hold all players in the supply chain accountable.

This is also a matter that the U.S. Pharmacopeia (USP) highlighted in its recent January 2012 briefing, Good Distribution Practices-Supply Chain Integrity, noting, “As the pharmaceutical industry continues to globalize, the challenges of securing complex supply chains and protecting patients from counterfeit medicines, as well as the consequences of lapses in security or proper handling, have mounted. In an effort to encourage comprehensive public standards across the pharmaceutical industry, [USP] is proposing a set of recommended best practices that will help ensure that medicines can be traced back to their original manufacturer, are not adulterated or counterfeited, and are transported to their intended destination with their quality intact.” 

It is clear that there is a heightened effort to strengthen the ability of regulators to ensure the safety of products being imported into the U.S. from contract manufacturers around the world.

Turning to the EU, the implementation of GMP as laid down in Directive 2003/94 and in the EU GMP Guide (including Annexes). Annex 11, “Computerized Systems,” was revised in January 2011 together with Chapter 4 of the EU GMP Guide. Both documents must have been implemented by the pharmaceutical industry by June 30, 2011. The increased use of computer systems and their complexity prompted a revision to this Annex.

Furthermore there are EU laws on falsified or counterfeit medicines. The EU has a strong legal framework for the licensing, manufacturing and distribution of medicines. At the end of the distribution chain, only licensed pharmacies and approved retailers are allowed to offer medicines for sale, including the legitimate sale via the internet. In July 2011, the EU strengthened the protection of patients and consumers by adopting a new Directive 2011/62/EU of the European Parliament and of the Council of June 8, 2011 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, as regards the prevention of the entry into the legal supply chain of falsified medicinal products on falsified medicines for human use. This Directive aims to prevent falsified or counterfeit medicines entering the legal supply chain and reaching patients. It introduces harmonized safety and strengthened control measures across Europe by applying new measures, including (among others):

• obligatory features on the outer packaging of medicines to demonstrate that they are authentic,
• strengthened requirements for the inspection of the manufacturers of pharmaceutical ingredients, and
• the obligation for manufacturers and distributors to report any suspicion of falsified medicines.

The Directive came into force on July 21, 2011. Member states will have to start applying these measures from January 2013. 

Amid the Pharma industry’s concerns surrounding the urgent and increasingly complex issue of drug safety under difficult economic conditions, the most prominent topic of discussion is the question of outsourcing. Questions being asked by the outsourcing companies include

• Does outsourcing make sense for our company?
• How do we choose the right outsourcing partner?
• Can we be certain that outsourcing will not compromise our drug safety standards and leave us exposed to greater risks in the name of cutting costs? 

From the viewpoint of contract pharmaceutical manufacturing in some of the emerging countries, these issues and concerns need to be adequately addressed by the implementation of appropriate systems and adoption of information technology. It will ensure a healthy and continued growth of pharma’s contract services industry. 

Track and Trace technology of some kind is expected to be helpful in providing the needed data and information. A drug tracking system consists of at least two parts:

1. The item to be tracked must have a unique identification (serial number)
2. An efficient means of applying and reading these numbers as products move through the supply chain

The FDA released a final guidance (in March 2010) on a standard form for serial numbers, suggesting that the number be an alphanumeric code of as long as 20 digits following the product’s national drug code. The FDA stated in its guidance that this “serial¬ized national drug code” is compatible with existing serialization systems such as the Global Trade Item Numbers system put forward by the GS1, a nonprofit standards-setting organization. The serial numbers would be applied to the items, allowing wholesalers and pharmacies to scan the unique identifier of the products as they are moved around.

Data management systems are required to store the transaction and movement information, which can be queried by stakeholders with relevant level of authorization to check a product’s transaction history. Various Track and Trace engines are offered by various companies.

According to Ravi Chivukula of Adiro Systems, IBM and its partner Adiro Systems (www.adirosys.com), which has an integrated background in Enterprise IT, Supply Chain, Manufacturing and Automatic Identification (viz. Barcode and RFID), are focusing on many of these aspects. Other companies offering solutions for various parts of the complete pharmaceutical value chain include Oracle, Kezzler (www.kezzler.com), Werum (www.werum.com) and some others. Bilcare Research (www.bilcare.com) has introduced a unique non-clonable ID system that also is gaining grounds in Asia and making waves in Europe. 

It remains to be seen as to which company would capture the market leadership positioning to be the vendor of choice for the pharmaceutical contract manufacturers globally to enhance their competitiveness and regulatory compliance and continued success in the global marketplace. Emerging markets surely hold the key to getting the Track and Trace vendors fine-tuned and make it safe for the patients and consumers around the globe. 

Makarand (Mak) Jawadekar most recently served as Director, Portfolio Management and Performance at Pfizer Global R&D, until February 2010, when he opted for an early retirement after 28 years at Pfizer Inc. He currently serves on several companies’ advisory boards and also consults with bio/pharmaceutical companies for global outreach in emerging market regions. He can be reached at mjawadekar@yahoo.com.