Pharmacy

...says Dr K V Krishnan, Practice Head, Life Sciences, Mindteck. With a doctoral degree in Analytical Spectroscopy and an experience of over 29 years in the life sciences vertical, one of the leaders at Mindteck shares his expertise on the present and future industrial scenario.

Parita Dholakia

Tell us how Mindteck helps a pharma company in achieving performance optimization along with cost reduction.

Mindteck works in all areas of life sciences, with a strong focus on pharma industry. We provide a strong set of product engineering and IT service offerings to our clients in pharma business. Our offerings are comprehensive and cover software development, electronic design and independent verification & validation apart from other support services. Our technical solutions help life science companies to:

• Reduce product development cycle time and quicker time to market

• Increase productivity by enhancing the engineering bandwidth within the organization

• Meet the regulatory/compliance requirements

IT has become an indispensible factor for almost all sectors. How important is it for the healthcare industry?

IT covers all aspects of requirements of hospital, pharmacy, clinic and health insurance units. Drug development, clinical trials data management, Electronic Medical Records (EMRs), Electronic Health Records (EHRs) are the major areas where IT plays a dominant role in healthcare. Patients are able to identify the best healthcare personnel and doctors are able to gain comprehensive patient view with the help of healthcare IT. Labs and hospitals are able to integrate the data with medical equipments, enable token issue system, display boards, etc, using today's IT services available for the healthcare industry. Hospital management    solutions    provide multiple functionalities for patient care, clinical lab management, hospital administration and other ancillary services such as financial management, human resource management and supply chain management.

Over a period of time, has the approach of pharma companies changed for IT-based solutions?

Pharma industry is loaded with a huge volume of information, and inefficiencies do exist in searching and retrieving data. So, issues related to information sharing and management of knowledge assets require IT-based solutions. Better utilization of data and shortened time to market can lead to time saving up to 1 year per drug. Due to these factors, the global approach of pharma companies has rapidly changed for IT-based solutions. Today, IT investments are widely spread across various functions of the pharmaceuticals industry such as R&D, clinical development, manufacturing/ supply chain, sales, marketing and corporate management.

How has Mindteck kept pace with the technological revolution?

The life sciences segment encompass companies in the fields of scientific instruments pharmaceuticals, medical devices, biotechnology, food processing,  environmental and organizations and institutions that devote a majority of their efforts in the various stages of research, development, technology transfer and commercialization.  In all these segments, global players are witnessing number of key technology trends such as convergence and mobility, cloud computing, adoption of energy efficient  technologies, enterprise adoption of Web 2.0 etc, that are impacting their business. Hence, it is essential for any vendor to keep pace with these technologies. We have been actively focussing on the emerging trends of the industry and are currently equipped with exclusive centres of excellence in all the above areas.

How important is quality adherence for such solutions? How does one monitor and evaluate the same?

Quality adherence is very critical when you offer solutions to medical device and other segments of life sciences industry as they are extensively governed   by   strict   regulations. Mindteck is well accredited by international quality standards. Apart from being ISO 9000 certified, we also possesses ISO 13485 accreditation, which is essential for providing services to medical devices industry. Information security is another important concern of this industry, which is taken care of through our ISO 27000 certification.

Experts from the pharma machinery industry believe that we still need to import a few products such as analytical lab instruments. Your take.

It is true! Since pharma industry relies on the precision and accuracy of analytical instruments to obtain valid data for its various functions, such   high   precision   analytical instruments    involving    various characterization techniques are not presently manufactured in India and the industry still relies on import.

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Modern pharma labs need a large number of chromatography analyses of samples, but at the same time they do not invest in the same brand of instrument for various obvious reasons. This has resulted in the concept of Chromatography Data Systems (CDSs), which enable the user to control, acquire and analyze data from instruments of multiple vendors. Such interoperability requires multiple device integration with the specific CDS. Mindteck has specialized service offerings in this area that is supported by two state-of-the-art in-house analytical instrument laboratories. Today, they possess rich expertise in all the available CDS apart from having worked in all the areas of separation sciences from Flash Chromatography to Ultra Performance Liquid Chromatography (UPLC) and Supercritical Fluid Chromatography (SFC).

How do you perceive the future of the medical device and pharmaceutical industry?

There has been a technological revolution in the medical device industry in recent years. The pace of medical invention is accelerating with the Convergence of many scientific and technology breakthroughs. These medical technology innovations are bound to fundamentally transform the scenario by providing new solutions that will challenge the existing paradigms. Medical devices that offer less invasive treatment options, with better clinical outcomes and shorter recovery times, will create tremendous value in the next few years.

With some average figures for the FY 2010, how is Mindteck planning to surge back in the profit-making charts?

Our  revenues  have   grown  to Rs. 240.87crore for FY11, as against Rs. 226.54 crore during FY10. Profit After Tax (PAT) for the year also grew to Rs.9.14 crore, as against Rs. 3.35 crore last fiscal. A significant part of this profit can be attributed ta the life sciences vertical. And now with our renewed vertical focussed approach, we are keen on acquiring deeper customer domain knowledge and experience. Such a go- forward business strategy is bound to enable dramatically faster growth than the industry average. As mentioned earlier, we have an anticipated growth of around 60 to 70 per cent this year for the life sciences business.

Can you an provide example that explains how Mindteck helped a pharma company achieve the desired results?

The life sciences industry in general and pharmaceutical industry in particular is governed by a stream of regulatory requirements.    For example, the pharma industry relies on the precision and accuracy of analytical instruments to obtain valid data for research, development, manufacturing, and quality control. Regulatory agencies require pharmaceutical companies to establish procedures assuring that the instruments supporting regulated product testing are fit for use. Analytical Instrument Qualification (AIQ) is the documented evidence that an instrument performs suitably for its intended purpose and that it is properly maintained and calibrated. Use of a qualified instrument in analyses contributes to confidence in the veracity of generated data.

Of late, many automated protocols are   provided   by   instrument manufacturers to perform such qualifications.  Recently,  Mindteck developed such a qualification protocol for a series of gas chromatographs that are extensively used in pharmaceutical industry.   With   strong   domain knowledge in method development supported by technological expertise, we were able to provide a valuable solution   to   pharma   industry through to a leading life science instrument manufacturer.