By Invitation | Reimagining pharma parks to be “smart”

Karan Singh | Updated on June 04, 2021

‘Government’s efforts to boost domestic production should be synchronised with reducing imports and upgrading technology’

The second wave of the Covid-19 pandemic has challenged our public and private healthcare systems alike. Amid these challenges the most prominent cry is the unavailability of medicines and resources. While global pharmaceutical companies are running at full-capacity, not just in India but across the world, availability, accessibility, and affordability of life-saving drugs continues to be a challenge.

We started the year with the intent to boost public healthcare systems and planning strategic investments in making manufacturing truly self-reliant. As the stimulus to economic activity, employment, and state of healthcare stagnates, what will make pharma-manufacturing reliable?

There seem to be only two key challenges on which a self-reliant and export worthy industry can pivot – quality and availability of raw materials.

In 2019 alone, we recalled 40,000 batches of drugs exported to the USA. In 2020, India’s import dependence for life-saving drugs was nearly at 90 per cent. Over 70 per cent of our key starting materials (KSM), intermediaries, and active pharmaceutical ingredients (APIs) come from just one country – China. For any global supply chain this is a huge deterrent to supply security, which was particularly highlighted in the early stages of the pandemic.

The government’s efforts of boosting domestic production should be synchronised with reducing imports and upgrading technology to create quality medicines. In my opinion attaining ‘Atmanirbharta’ lies in developing an ecosystem of pharma parks which embrace next-generation technologies.

While experts peg average drug manufacturing utilization rate only at 75 per cent, actual figures are much lower. Most manufacturing sites in India employ batch manufacturing methodology. Built on legacy processes, they have high start-up cost, quality consistency issues, and create a lot of wastage. These cost the industry millions of dollars every year in operating expenses. It is pertinent to note that these losses can be optimised with the use of industry 4.0 technologies, that identify where the gaps exist and suggest improvement areas for enhancing efficiency of manufacturing processes.

Digital transformation enables early detection of wear and tear of machinery lines, flexible tracking of a defective batch in the event of a process failure, and even allows for timely intervention thereby significantly reducing wastage. Through integration of artificial intelligence (AI) and machine learning (ML) reams of data converts into actionable intelligence, improving several aspects of supply chain such as inventory management, trend analysis, forecasting, predictive equipment maintenance etc.

For new manufacturing sites which are aided by government’s PLI scheme, the incentive should be utilized towards adoption of Industry 4.0, Internet of Things (IoT) and convert them to ‘smart factories.’

As the drug security issue intensified, many pharmaceutical majors have planned for backward integration and foray into manufacturing of KSMs, API and other intermediaries. Along with government, the industry has prioritized 53 APIs which cater to 41 bulk-drug products. Most of these material manufacturing units, require extensive resources – land, water, energy and if not managed properly can create effluents and pollutants. As the gestation period for these manufacturing units is long, the time for India to leapfrog to zero defect solutions is now. Integrating these connected facilities with state-of-the-art effluent management systems like the zero/minimal liquid discharge (ZLD/MLD) in the newly developed pharma-parks will pave a way for sustainable manufacturing, like it has in case of textile industry. Along with centralized power, water consumption and management of effluents should be weaved into the ecosystem of the smart pharma parks to decrease burden on the industry.

A view that I share with industry stalwarts is that the transition to environment positive protocols should not rest on voluntary actions of any private entity but should form the basis of creating long-term sustainable manufacturing in the country.

I am personally convinced that the current geo-political and economic climate has opened a window of opportunity for us. We need to make a transition in how we traditionally approached production activities in India and go for a sandbox approach that helps in containing the impact of failures.

In India’s pursuit for reducing recalls and becoming globally competitive, technology can play a pivotal role in achieving the ‘Zero Defect, Zero Effect’ - high quality of the products and no adverse effect on the environment by manufacturing. While building a self-relianct and robust pharma supply chain, our focus must be on creating high-performing and smart parks that can support complex healthcare needs in the future.

(The writer is Managing Director, ACG. Views are personal)

Published on June 04, 2021

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