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Pharmaceutical Industry


Pharmaceutical Industry 


Industry Features

Drug counterfeiting has become a $200 billion business annually, according to the World Customs Organization. By those high grey profits driven, there are hundreds and thousands of patients lost their lives. The serious consequences brought by counterfeiting drug have raised global attentions.  Up to now, there are 40 countries in the world with active serialization regulations which count 90 percent of the world’s population and consume 90 percent of the world’s pharmaceuticals. 


In China, the implementation of drug electronic supervision is an important system since the CFDA established traceability of drugs from production to circulation. Since drug electronic supervision implementation was started from 2006, narcotics, psychotropic drugs, blood products, injections of traditional Chinese medicine, vaccines, and all varieties of essential drugs have been brought into electronic supervision in three phases by the end of February, 2012. There had been 56,000 electric supervision drugs with approval document number by the end of February, 2012.


To further strengthen drug electronic supervision, improve public medication safety, promote social harmony as well as stability, and realize the whole process supervision of drugs of all varieties, the CFDA developed "2011-2015 Drug Electronic Supervision  Plan" which put forward to achieve the whole process electronic supervision of all varieties drugs by the end of 2015; ensure the drug safety in every link, including production, circulation, and use; crack down on counterfeit drugs the most effectively; realize the traceability and recall of unqualified drugs the most quickly; and maximize the protection of the legitimate interests of enterprises to ensure drug safety for the masses.


A Brief Introduction of the Plan


Drug Production Line Serialization System

Drug Electronic Supervision Serialization System developed by Acctrue grants drugs the only identification (barcode, 2D, RFID, etc.) according to the specific global regulatory compliance and supervision demand as well as management requirements of pharmaceutical enterprises. Products quality traceability management system which realizes quality traceability in all links from raw materials, production, circulation such as warehousing to final sales on the basis, can trace and recall unqualified products quickly and effectively to reduce the economic loss of drugs production enterprise and harm to consumers.


Drug Quality Safety Tracing System Solutions

The basis for pharmaceutical production enterprises to establish a complete drug quality tracing system is to perform drug serialization. The drug quality safety tracing system solution developed by Acctrue is based on serialization system and provides customers with a comprehensive as well as complete drug quality tracing management system in many business links, such as raw materials input, production control, sales management, etc. In the current stage, the system can help customers to realize the tracing and recall of unqualified drugs fast and effectively in order to eliminate hidden dangers of products quality and safety as possible. In the long run, the informatized degree of links such as customer production, storage, sale, etc. is further improved, which lays a good foundation for GMP informatization implementation in the future.


Typical Customers of the Solution 

Sino Pharm Group, Shanghai Pharm Group, Harbin Pharm Group, Guangzhou Pharm Group, Huarun Pharm, Kelun Pharm, Pfizer, Bayer, Sanofi-Aventis, AstraZeneca, Eli Lilly and Company, etc.



1. Grifols Biologicals Inc.

Grifols Biologicals Inc. (http://www.grifols.com/en/web/international/home) was founded in Spain in 1940. It is a global pharmaceutical enterprise and a leading company in global blood products. Grifols’ mission is to improve the health and well-being  of people around the world. They accomplish the mission by producing life-saving protein therapies for patients and by providing hospitals, pharmacies and healthcare professionals with the tools they need to deliver expert medical care. They have three primary divisions – Bioscience, Diagnostic and Hospital – which develop, produce and market their innovative products and services to medical professionals in more than 90 countries around the world.

Implementation Time: January 2013

Implementation Place: Grifols Spain


Project Background

According to“Notice of China Food and Drug Administration on the Electronic Supervision Implementation of Import Drug”, electronic supervision agencies for overseas pharmaceutical companies whose import drug shall be implemented electronic supervision before December 31, 2013, shall submit report before February 28, 2013 and register their related agencies on China Drug Electronic Supervision website.


According to practical situations of Grifols Spain and requirements of China drug electronic supervision, Acctrue sent a professional implementation team to start Grifols HAS product production line packing reform project in January 2013 and implemented Acctrue ESC to quickly finish electronic supervision for Grifols.


•  Implementation Effects

Completely meet all requirements of barcode quality by China Food and Drug Administration: all barcodes quality of cartons or cases must be better than C.

Serialization efficiency is high and have little impact on production efficiency.

•   Improve supply chain management efficiency of drugs for Grifols.

•   Strengthen product quality management and control ability for Grifols.


Project Comment

According to the survey by quality management department of Grifols Spain, barcode quality must achieve A. It is an ordeal for serialization software suppliers. As the only enterprise with overseas pharmaceutical serialization implementation experience in China, Acctrue’s solution perfectly meets Grifols’ drug electronic supervision demands in China. It became a typical case of overseas drug electronic supervision with high technical achievements.



2. Ranbaxy Laboratories Ltd

Ranbaxy Laboratories Limited (http://www.ranbaxy.com/) is a research based international pharmaceutical company serving customers in over 150 countries. 

Ranbaxy is a member of the Daiichi Sankyo Group. Daiichi Sankyo is a leading global pharmaceutical innovator, headquartered in Tokyo, Japan. 

Ranbaxy has ground operations in 43 countries and 21 manufacturing facilities spread across 8 countries. They cover all the top 25 pharmaceutical markets of the world and have a robust presence across both developed and emerging markets.

Implementation Time: March 2014

Implementation Place: India 

Production Line No.: 1



Project Background

In recent years, Indian generic drugs are popular worldwide with very low price, which arouse a purchasing boom in China as well. With a large number of foreign generic drugs expiring and related domestic policies becoming loose, China generic drug industry is welcoming an unprecedented “opportunity period”, the market size may be close to 500 billion RMB in 2015. 

However, there is supervision over import drugs according to China drug electronic supervision policies. If Indian pharmaceutical companies would like to enter China drug market, they shall implement drug electronic supervision Serialization system. Based on this, Ranbaxy Laboratories Ltd (India) chose Beijing Acctrue Technology Co., Ltd to build product Serialization system to meet China drug electronic supervision demands.


Implementation Effects

Make Ranbaxy products meet China drug electronic supervision demands.

Help Ranbaxy strengthen enterprise production process management.

Realize enterprise logistics management.

Keep well defined record of drug flow direction for Ranbaxy.


Project Comment

Because Indian laws only protect the process patent of pharmaceutical instead of protecting the product patent of drugs, the phenomenon of imitating new western medicine is serious in India drug market. As“a leading enterprise” of India pharmaceutical industry, Ranbaxy selected independent innovation. The cooperation with Acctrue is of great significance for Ranbaxy to standardize its enterprise production process management and enter China drug market.



3. Cipla Ltd


Enterprise Introduction

Cipla (http://www.cipla.com/) is the second largest pharmaceutical company in India in terms of retail sales. Cipla manufactures an extensive range of pharmaceutical & personal care products and has presence in over 170 countries across the world. Cipla's product range includes Pharmaceuticals, Animal Health Care Products, OTC, Bulk Drugs, Flavours & Fragrances, and Agrochemicals. Cipla also provides a host of consulting services such as preparation of product and material specifications, evaluation of existing production facilities to meet GMP, definition of appropriate plant size and technologies etc.

Implementation Time: Febuary 2014

Implementation Place: India 

Production Line No.: 1



Project Background

Generic drug refer to a copy of the brand drug with same dosage, safety, strength (no matter how to take it), quality, performance and intended use. Because of the patent protection limitation, many drugs are prohibited to be copies in most countries of the world; however, due to the protection of special patent law in India, Cipla can produce many cheap generic drugs.

If generic drug does not possess the approval, it will be regarded as “fake” in China. In order to meet China drug electronic supervision demands, India second largest pharmaceutical company—Cipla cooperates with China drug electronic supervision No. 1 brand—Beijing Acctrue Technology Co., Ltd to implement Acctrue ESC Production line Serialization system.


•  Implementation Effects

• Cipla meets China drug electronic supervision demands: it can enter China drug market legally.

• Effectively utilize drug electronic supervision code information: currently basic drugs have realized drug electronic supervision, supervision code information upload, which helps Cipla be able to utilize current supervision code information to manage anti fake and bug selling prevention itself.

• Reduce logistics cost: Improve the efficiency and accuracy of warehouse reception and dispatch; reduce the logistics cost due to wrong delivery, over delivery, less delivery or redirecting delivery.


Project Comment

Cipla drug electronic supervision implementation is one of Acctrue overseas implementation cases. Cipla is the first India enterprise to realize China drug electronic supervision. It set an example for India drug market.



4. CSL Behring


Enterprise Introduction

CSL Behring (http://www.cslbehring.com/homepage) is a global leader in the plasma protein biotherapeutics industry. They research, develop, manufacture and market biotherapies that are used to treat serious and rare conditions. 


Their products are produced at facilities in Bern, Switzerland; Marburg, Germany; Kankakee, Illinois and Broadmeadows, Australia, in accordance with international safety and quality standards. The company also operates CSL Plasma, one of the world’s largest plasma collection networks throughout the United States and Germany. CSL Behring employs more than 9,000 people in 19 countries. 


Implementation Time: February – December 2013

Implementation Place: Germany, Switzerland and U.S. 



Project Background

According to the news on China Food and Drug Administration website, CFDA recently issued a notice on import drug electronic supervision requirement. However, due to the cultural difference among different countries, import drug enterprises may have inadequate understanding about China drug electronic supervision implementation policy standards.

In order to better meet China drug electronic supervision demands, CSL cooperates with an important supporting enterprise of China electronic supervision website—Beijing Acctrue Technology Co., Ltd. Acctrue provides CSL with China policies consultation, technical document consultation of network access test, production line technology implementation and utilization consultation services.


•  Implementation Effects

•  Help CSL finish China drug electronic supervision production line reforming.

•  Let CSL have a more detailed understanding of China electronic supervision policies and standards.


•  Project Comment

In face of China policies change, import drug enterprises have a hard time to adapt quickly. As one of important supporting enterprises for China drug electronic supervision website, Beijing Acctrue Technology Co., Ltd has provided over 3,000 pharmaceutical enterprises with electronic supervision Serialization and consulting solutions. Although CSL factories disperse in German, Switzerland and America, Acctrue has successfully implemented services for it and CSL has become one of Acctrue’s typical consultancy service customers.



5.Bayer

Bayer has selected Acctrue to integrate and renovate its electronic supervision code serialization system for the implementation of drugs electronic supervision, tracking as well as tracing its products, and anti-counterfeiting. For Bayer 450 boxes per minute high-speed production line, Acctrue designs photographic identification technology for Bayer, which not only solves the problem of speed, but also realizes the tracing function and lays the foundation for the future upgrading of the production line serialization system.


Acctrue serialization system is utilized to make cost investment to the maximum. Its technical support in the production implementation process, effective linkage with ERP, logistics as well as warehousing management, and combination with a variety of barcode data acquisition technology are used to ensure the normal operation of the Bayer pharmaceutical production line.


6.AstraZeneca

Acctrue serialization system successfully operates in AstraZeneca pharmaceutical production lines, which completes the import, serialization and aggregation of supervision codes internally; realizes friendly docking with China drug electronic supervision net externally. At the same time, it helps achieve docking completely with existing database of AstraZeneca, which ensures the information security and meanwhile lays a foundation for the preparation of production scale upgrade and expansion for AstraZeneca in the future. 



7.Sanofi-Aventis

According to the actual production situation and market management requirement of Sanofi, Acctrue deploys drug electronic supervision serialization system for Sanofi. At present, the system is stable, which completes the import, serialization and aggregation of supervision codes internally; realizes friendly docking with China drug electronic supervision net externally. The system realizes good use effects; achieves the anti-counterfeiting and bugselling prevention functions; is well received by users.


8.Sino Pharm Group

Sino Pharm Group is the largest pharmaceutical health industry group in China. Acctrue has implemented frameworks of multiple production lines electronic supervision serialization systems and related services for Sino Pharm Group.


According to the characteristics of Sino Pharm Group, such as many products varieties, a lot of departments being involved, large number of production lines, etc., Acctrue provides Sino Pharm Group with the most applicable "Five" solutions: packaging diversification; cross operation diversification; workshop condition diversification; database support diversification; unified data management. Through the expert seminars, Acctrue has conquered technical difficulties and provided Sino Pharm Group with serialization solutions applied to various production lines.



9.Shanghai Pharm Group

Acctrue provides over 100 production lines in over 20 pharmaceutical factories under Shanghai Pharm Group with production line serialization system reconstruction projects. Acctrue has deployed the most advanced serialization system in China for Shanghai Pharm Group, which not only achieves docking with the data of national drug electronic supervision network system, but also achieves functions such as anti-fake, warehouse management, subordinate distribution management, bug sale prevention management, etc. at the same time in order for Shanghai Pharm Group decentralized management platform to be centralized. It helps products realize bidirectional tracking and tracing, which set up a model for drug electronic supervision.

Process Design

Through the user's actual business process, provide strategic assessment to users, business analysis, system application and feasibility of the solutions, to help enterprises to locate information construction, provide guidance for the user information construction scheme