Irrespective of a significant investment involved in it, the Indian pharma industry has no option but to embrace automation to achieve their global ambitions. By Sachin Jagdale
Today, Indian pharma industry manufactures a range of medicines and a significant chunk of it is exported to various countries across the globe. As per a report by Equity Master, it ranks third in terms of volume and the 13th in terms of value, globally. Whatever so far the industry has achieved been attributed to various factors, of which, automation is perhaps the most significant one. The use of automation is no longer a choice but a compulsion for those who want to leave their footprints in the international markets.
Rapid strides towards automation…
In the early days of automation, it was confined to a shift from mere mechanical machines to electro-mechanical devices like motors. However, technological advances have redefined automation and taken it to unprecedented levels. Initially, automation was predominant in the manufacturing processes, however, today it encompasses areas like labs too and continues to expand.
Satish Varma, Managing Director, Fermenta Biotech says, “The last few decades have seen concerted efforts across various disciplines in the pharma/ biotech industry with respect to automation. We all are aware that the manufacturing industry has always been the first to embrace automation. This was solely due to its initial apparent merits based on increase in productivity, improvement in quality and moreover minimisation of waste which all led to a significant reduction in the overall cost. As our industry matured, over the decades, with increased exposure to earlier unknown benefits, more and more disciplines of the sector started adopting automation”.
The Indian pharma industry is in a bid to establish itself as a major player in the global market. Though there are several Indian pharma companies operating globally, the recent years saw Indian pharma’s reputation taking a hit due to the quality concerns raised by regulatory authorities such as the US FDA. Industry experts believe that automation can be one of the tools that can help douse these concerns and appease the global regulatory authorities.
“The increase in stringency of regulation led to a large number of companies switching over to automation as it ensured compliance to guidelines and safety considerations. With biotech products gaining more importance and an increasing focus on research, the R&D section of the industry have accepted automation to a significant level. The recent advancements in robotics have made the dream of a fully automated laboratory a reality. Laboratory Information Management Systems (LIMS) have seen wide acceptance across the industry in recent times. Automation is also being used by local druggists and pharmacies to maintain patient information. It has also helped in reducing drug dispensing time, especially for patients with chronic ailments. Lastly, the problem of spurious drugs has been curtailed by novel automated packaging solutions,” adds Varma.
According to Ketan Zota, Director, Zota Healthcare, most successful organisations are rigorous about their processes, manufacturing operations, validation and quality improvement through the use of automated processes.
…yet a lot of ground to cover
Western countries have been at the forefront in the invention and implementation of new automations. With changing times, Indian pharma companies are also rapidly adopting automation and adapting to it. However, lack of awareness about the new technologies and scarcity of funds are still holding them back from going full throttle when it comes to automation.
Dr Girish Mahajan, Vice President-Microbiology Division, HiMedia Laboratories, says that as far as automation in Indian organisations are concerned, we have kept pace with the global trends in the healthcare sector. “However, when we move to small scale industries, the automation level comes down exponentially. This perhaps will get upgraded only if more and more awareness programmes are conducted by the automation industry. Government funding agencies are facilitating innovative ideas and supporting automation by funding for capex. The automation industry has to move one step ahead to bring more and more such awareness programmes in universities and other research –academic institutions,” says Mahajan.
Varma feels that other industries are more receptive than the pharma and biotech sector when it comes to adopting automation technologies. Highlighting the major deterrents, especially for the smaller players, he elaborates, “It is a well-known fact that our pharma and biotech industry has come a long way with respect to automation, however in comparison to other industries we are still slow paced in embracing it. Highly precise processes or ones with high repetitiveness are excellent candidates for automation. However, lack of expertise, high investment costs with no structured model to evaluate return on investment (ROI) from automation of certain processes and the apparent misperception about the complexity of programming required as well as the peripheral investments in infrastructure persist as concerns, especially among small and medium sized pharma companies. They are delaying the adoption of automation in the pharma industry.”
Zota identifies a few operational hurdles for the industry. According to him, in the pharma sector technology transfer can take relatively more time compared to other sectors in India. “Newly invented technologies can take a long time to become integral part of pharma production and processes. These technologies tend to become obsolete rapidly in other sectors as compared to the pharma industry. Technology and automation can possibly face huge challenges in the pharma industry as even the slightest error can cause lethal damage and can also affect the overall quality of the product,” explains Zota.
Every new innovation is making operations more complex in the pharma and biotech sectors. Some tasks are beyond human capability and sometimes extremely hazardous too. According to automation experts, robotic technology is providing answers to these challenges to some extent, especially in laboratories. However, though cash rich pharma companies can afford to have robotic machineries at their units, it is not a viable option for smaller players.
Yet, it cannot be denied that robotics is furthering progress in the lifesciences sector. Genomics, particularly gene sequencing has created new opportunities for drug discoveries. Methods like statistical genetics, sequencing, gene expression analysis etc are performed at the laboratory level. Various sensitive samples are handled/ processed in the laboratory for the same. This is where robotics has contributed a lot. Advancements in genomics were hardly possible without the support of robotics.
Hiranjith GH, Director, MedGenome, opines, “As the sequencing process developed over time into a routine, one that utilised the same series of steps and the same components at each iteration, implementation of robotics provided scope to revolutionise genomics. For instance, high throughput screening (HTS) employs the use of robotics to do much of the tedious, repetitive work that was previously done by scientists, leaving them with more time to design experiments and analyse data. Robotics in the use of processes like DNA template preparation, reaction assembly, liquid handling, fragmentation and size selection, simplify and standardise sample handling.” He adds, “Devices like oligosynthesizers, DNA shearing, plaque and colony pickers/ gridders, template preparation systems, sequencing reaction robotics, and thermal cyclers help in elimination of manual errors, ease of sample tracking (usage of bar codes) and the reproducible nature of the product. Implementation of these robotic devices not only reduce the time and expense of method development and optimisation, they also enable a highly enhanced scale of operations”.
Varma explains how the benefits offered by robotics outweighs cost involved in its implementation with examples. He says, “Increased efficiency, consistent quality and reduction in overall product cost are few of the obvious benefits that robotics will offer to our industry. The perception of high initial investment needs to be looked at with a different perspective as the implementation of robotics will completely eliminate errors and reduce time in certain aspects of operations viz. packaging. A glaring example is the use of the auto-cartoner which has revolutionised the way tablets and capsules are packed. Another example is in biotech labs where routine, mundane operations can be done with the help of robotics thus freeing the time of our scientists which can be deployed for more creative and innovative tasks. Simply speaking, in any operation where the cost of error is pretty high to such an extent that even fairly low error rates can have significant impact on the end result, one has to appreciate the benefits of robotics.”
Hurdles to cross
Though automation is being deployed to a considerable level, experts unanimously agree over the fact that machines can’t replace humans completely. There are still a few processes in the pharma and biotech operations where there is no alternative yet to manual intervention.
“Pharmaceuticals are prone to get degraded if not handled with care or if not stored properly. It can become very difficult to introduce automation where visual analysis, recognition or comparisons with colour changes are required. A small deviation can lead to huge errors. Identification of particles and micro particulate matters are extremely difficult with automated processes. Moreover, automation in clinical research can also be tough despite the implementation of semi-automated devices and computer software,” informs Zota.
Varma also reiterates, “Though a majority of operations and critical lab activities can be automated, key important factors like technical managerial decision making, defining and implementing critical success parameters, contingency planning cannot be a completely automated. I feel that automation should complement human innovation and creativity, it should not be considered as a substitute. It may offer various alternatives to solve critical problems but one cannot ignore the ability of human intervention in picking up the right choice which is the best fit for a particular issue at any given time in a specific environment.”
Dealing with the cost factor
Whether it is manufacturing, buying or selling, cost has always remained a deciding factor in the Indian market.
If automation has the potential to reduce the cost of medicines, then the government should consider giving tax exemption or subsidy to the pharma and biotech companies to automate the processes. After all, affordability of medicines to the final consumer is a crucial factor.
Varma asserts, “Indeed a major hindrance in accepting atomisation is the initial investment cost. Any efforts towards addressing this issue will definitely help the industry operations.”
India is known to produce low cost products. So, if the government encourages and assists local manufacturers to produce automated machinery under the ‘Make in India’ programme, it will also accelerate the pace at which pharma and biotech companies automate their operations.
Varma signs off, “Academia – industry partnerships needs to be looked into more specifically to develop cost effective, industry friendly automation solutions.”