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Summary
The performance of India’s pharmaceutical industry has been impressive.
It has emerged as a producer of quality drugs complying with the global
standards. It has learnt the nuances of the generic drug market dynamics –
Manufacturing IT solutions will help identifying medicines that are going off patent, fil-
pharmaceutical industry in India ing the necessary abbreviated new drug
improve brand image, achieve applications (ANDA) and drug master files at the
operational excellence, efficiencies along appropriate time, securing the appropriate FDA
the value chain, and regulatory approvals and such others, including willingness
compliance.
to overcome legal tangles. The industry has grown
both organically and inorganically though global acquisitions and mergers.
Despite the size of the pharmaceutical industry and its rapid growth and
the important role that manufacturing IT solutions play during drug dis-
covery, its manufacture, and distribution, the industry is perceived as
being reluctant to take the enabling technology route for achieving opera-
tional excellence, efficiencies along the value chain, ensuring quality and
compliance, and such others. ARC believes that this status must change for
the industry to live up to its full potential.
neric drug market dynamics – identifying medicines that are going off pa-
tent, filing the necessary abbreviated new drug applications (ANDA) and
drug master files at the appropriate time, securing the appropriate FDA
approvals and such others, including willingness to overcome legal tangles.
The industry has grown both organically and inorganically though global
acquisitions and mergers.
Despite the size of the pharmaceutical industry and its rapid growth and
the important role that manufacturing IT solutions play during drug dis-
covery, its manufacture, and distribution, the industry is perceived as
being reluctant to take the enabling technology route for achieving opera-
tional excellence, efficiencies along the value chain, ensuring quality and
compliance, and such others.
Process Analytical Technology (PAT) helps the industry in both the lab and
plant to understand, design and control the processes in a way that mini-
mizes any error or deviation, and thereby leads to consistent product
quality.
Manufacturing Execution System (MES) can help the plant to track activi-
ties and resources, link administration to the shop-floor activities, and are
very useful in plant scheduling activities. It can be integrated with supply
chain, inventory control, maintenance and other such applications.
Management of firms’ supply chain with key aspect of SCM, such as opti-
mization, collaboration and analytic solutions ensures a company’s ability
to forecast demand, take an order, give an accurate delivery date, source
and manufacture the right goods, position inventory properly, pick, pack
and ship efficiently, and thus manage the complex functioning of pharma-
ceutical companies.
Last Word
ARC plans to conduct a survey to understand the pharmaceutical industry
issues and challenges and chart a roadmap about investing in enterprise
solutions and automation solutions. On the anvil is our forum “Driving
Innovation, Sustainability, and Performance for Process and Batch Indus-
tries” in Hyderabad on July 16-17, 2010 that will discuss a roadmap for the
pharmaceutical, food, and beverage industries to emerge world class. We
plan to write a strategy report aimed at creating necessary awareness
among pharmaceutical industry with case studies and a roadmap for it to
adopt enabling technologies. For details about ARC forum, please visit
http://www.arcweb.com/Events/ARC-India-Hyderabad-Forum-
2010/Pages/Process-Batch.aspx or contact varshag@arcweb.com or praka-
sha@arcweb.com or call 080 – 25547116 080 – 25547116.
For further information or to provide feedback on this Insight, please contact your
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