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India offers promising opportunities and cannot be ignored

Monday, August 29, 2022, 08:00 Hrs  [IST]

MikeCommission Agents Inc. (CAI) is a 26-year-old company with offices across US, Canada, Australia, Netherlands, Korea, Switzerland, India, Ireland, Italy, China, Singapore, United Kingdom, and Malaysia serving pharmaceutical clients globally. Its global team comprises over 850 qualified personnel to deliver mission critical engineering, technical, and consulting services with reliability. “We are in India since a year now as this country cannot be ignored to strengthen our operations," said  Mike Martin, CEO, CAI, during his recent visit to India from the US.

What are the opportunities that Indian pharma offers for CAI to chip in its expertise?
India brims with opportunities for CAI. What attracted us to India is the highly qualified intelligent workforce who have capabilities to deliver high quality global solutions. Here CAI can help Indian pharma rapidly launch advanced production plants and mission critical data centres on time and operate sustainably. Our support can be specifically devised for an ‘in India, for India, and by India’ strategy.

In 2019, the United States imported a staggering $452 billion of goods from China. Only five low-cost countries have GDPs larger than that: India, Mexico, Indonesia, Brazil, and Thailand. India has the largest economy among these countries and a great untapped potential for filling part of the supply chain vacuum. India has emerged as an alternative country that can have the scale, skills, and space to service world demand effectively. As the Indian economy resurrects from the COVID-19 abyss and witnesses a boost in economic activity, it appears to be the right time for professional service firms like CAI to enter the Indian market.

In the backdrop of this emerging scenario, CAI India will contribute to the world’s rapidly burgeoning data centre and the ever-growing pharma market, especially with the surge in COVID 19 vaccine & drug manufacturing business. CAI fully understands the forces driving and transforming the pharma industries in India and is prepared for the next wave of growth in these sectors in the Indian market.
How does CAI plan to tailor their services to the needs of the Indian pharma industry?
With India possessing the kind of scale, skills, and space to service world demand effectively, CAI intends  to utilize its globally demonstrated industry-leading organizational best practices to help national and international clients in India achieve high-performance manufacturing with reduced risk, cost, and time to market. CAI lends its  proficiency short-term, or applies it on a long-term, on-going basis to contribute to the success of client projects and the burgeoning Indian market.

CAI provides well-trained resources to improve the delivery, reliability and efficiency of pharma industry’s  equipment, facilities, and production operations. For manufacturing start-ups, smart operations, asset maintenance and reliability programs, energy use optimization, and regulatory and process consulting, we add value to  the company’s  bottom line. The last two scope of work mentioned helps improve the delivery, reliability and efficiency of equipment, facilities, and production operations.

Further in Construction Quality Program Management, CAI leads programs on behalf of its  clients and is responsible for the overall project construction quality. Teams lead the building commissioning for the whole project, providing quality to overall “constructed” final products.

In Commissioning, Qualification and Validation, CAI provides resources for process equipment, Utility, Facility, HVAC, and Automation system/equipment commissioning, qualification, and validation too. We specialize in cleaning validation, process validation, project PPQ, Aseptic Filling Simulation, etc.

In Automation and CSV, we work as our client’s representative on automation system qualification and validation including BMS, EMS, MES and Clean Utility and Process Equipment PLC control systems. This will also include support to IT infrastructure validation and IT lifecycle management.

How is Indian pharma industry positioned in your game-plan for the growth of CAI?
The workforce talent here is recognised globally. We have experienced in the last year, the power of the workforce here. We believe there can be a symbiotic relationship with the Indian pharma industry and CAI. We bring worldwide experience and proven programs to drive speed to patient through operational readiness and thereby extend the reach of India’s pharma reputation and products worldwide. Successful delivery will enhance the India’s pharma growth, reputation and drive growth for CAI as well. We plan to grow our team to meet the needs of our clients as opportunities develop.

So in the first year of our operations, the intent is to build an initial, talented team in India and introduce ourselves and capabilities to the marketplace.  India offers promising opportunities and we know we can have a positive impact on pharma manufacturing.  

The overall pharma contract manufacturing industry in India is currently growing at a rate of 20 percent, an impressive figure that is paving the way for burgeoning opportunities. A substantial 40 percent lower cost of operation and production is clearly the highlight for companies to consider India for their outsourcing needs. The government is also looking at incentivizing the upgradation of Schedule M facilities to WHO GMP complaint units with the help of soft loans, which would lead to additional 1,000 units being certified WHO-GMP compliant, further corroborating the manufacturing processes. The contract manufacturing space in India is expected to gain ground soon and grow by 17-18 percent on a compound annual growth rate as efficiency in manufacturing and maturity of business models lead to containment of manufacturing cost.

With an increasing shift towards contract manufacturing that the industry is witnessing, CAI India looks towards associating with leading Indian contract manufacturing players within the pharma, food, and fragrance spaces through innovation and assistance in implementing and enhancing validation and related systems.

What is the kind of change that you have sighted during the COVID-19 pandemic that CAI could support for Indian pharma to be resilient to such untoward incidents?
Contract manufacturing continues to rise within the Indian pharmaceutical industry, paving the way for small and medium enterprises to capitalize and grow.  This market has unique expertise in manufacturing generics through reverse engineering, which has helped some companies streamline their manufacturing process. Costs are very competitive and are only two-fifths of those involved in setting up and running a new manufacturing facility in the West. The Indian market can operate on significantly lower margins, with lower development and labour costs. CAI’s focus on operational readiness includes planning for sustainability and continuity of business operations.  These key learnings can be implemented across the enterprise both in India and around the globe.
How CAI help Indian pharma to become a net exporter for APIs going by the Union government support through the Productivity Linked Incentive and the bulk drugs parks along with pharma and medical device hubs?
We see the potential of many pharma projects of global companies shifting from China to India. In addition, Indian expertise can be leveraged to handle critical plant operations across the Asia-Pacific region. Supporting this growth will help CAI to widen its operations and grow our Indian and wider Asia Pacific team. Currently.  we are headquartered in Bengaluru as we support both pharma and data centre clients in the area but we have plans to expand to and support pharma and data centres across India as demand rises.

CAI is committed to studying the horizon, watching for trends and even influencing them, and adjusting our strategy and execution plans based on what we see coming. There are constantly shifting market forces, ever advancing science and technology, and even regulatory, political, and societal changes. All of these require analysis, wisdom, and proper action to position ourselves for success in the future.

Our company  only hires staff who are suitable for the position.  Staff will be qualified for the assigned role through a combination of experience and training.  Training may be on-the-job (OJT), internal courses, or training from outside providers. CAI provides well-trained resources to projects who utilize our technical and consulting services to improve the delivery, reliability and efficiency of your equipment, facilities, and production operations. For manufacturing start-up, smart operations, asset maintenance and reliability programs, energy use optimization, and regulatory and process consulting – we add value to your bottom line.

At the core of Commissioning Agents' quality program is implemented at each of the CAI organization, is the concept of a standardized process.  A standard process is supported by procedures, policies, guidelines, templates, training and other job aids such as checklists and forms.  The Global Operations group also contributes to a standard process by providing support to the Client Services Team for project setup and delivery.  Doing things the same way across all projects promotes efficiency and consistency in the quality of services.  By clicking on the tiles below or links to the left, you'll find information on the standard process related to each fundamental area of project delivery.

The robust Quality Management program is implemented to ensure fundamental aspects of Quality system is the foundation of the success of the organization via hiring Qualified staff, Continuous improvement via Global Operational Support by implementing robust training on Industry updates, Regulatory Standards, guidelines & standard operating procedures and Measurement & Improvement via Regular Project Reviews, Performance Reviews   

The Global Operations Management Program is implemented to guide the operations team in providing the support, oversight, measurement, and improvement related to operations.  The program also includes operations reporting requirements for each region.  We  also have  a Client Feedback and Corrective & Preventative Action (CAPA) program.  This program exists to collect customer feedback and define a process for handling complaints and other situations where a corrective and/or preventative action is needed to live up to our tag line ‘when you need to meet a higher standard’.

We provide a variety of products and services.  All our services help our customers operate at higher levels of performance and reliability.  Think about it:  well-commissioned equipment = solid initial operations and lower energy costs.  Well maintained equipment = reliable operations.  A focus on product and process = better performing manufacturing operations.  Enhanced human performance = reduced scrap, reduced errors, and improved cost of goods sold.  Optimum automation, adroit project management services, intelligent quality systems and approaches to compliance all yield enhanced performance and reliability of operations.  In short, we help clients maximize the value of their intellectual capital, their physical assets, and their human capital.

How long has CAI being in India and would you be able to tell us which are the Indian companies your company is servicing?
CAI is working with major pharma clients in India, due to NDA signed mutually names cannot be disclosed.
What are the likely future services from an Indian pharma standpoint to be offered by CAI?
Operational Readiness, Operational Excellence, Quality Compliance & Regulatory.

CAI will drive integrated solutions to achieve operational readiness & excellence for continuous improvement and sustainable growth. This is achieved by following a strategic approach that formulates integrated solution to manage risk, accelerate speed to market & provide cost effective solution & have a cutting edge over competition for sustainable growth. Also removing wasteful activities from the process workflow, and fixing that process when it breaks down. Competent & trained people, optimized processes, robust procedures, efficient operations, supply chain, logistics and robust quality systems, robust tracking/monitoring process to track post marketing product performance, patient/customer feedback together contribute to the operational excellence to target yields, production, release, and helping the pharma industry to optimize cost and operational efficiency and have competitive advantage.


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