The second wave of the Covid-19 pandemic has strained our public and private health systems. Amidst these challenges, the most important cry is the unavailability of drugs and resources. As global pharmaceutical companies operate at full capacity, not only in India but around the world, the availability, accessibility and affordability of life-saving medicines remain a challenge.
We started the year with the intention of stimulating public health systems and planning strategic investments to make manufacturing truly self-sufficient. As the stimulus to economic activity, employment and the health care state stagnate, what will make pharmaceutical manufacturing reliable?
It seems that there are only two key challenges on which a self-sustaining and export-worthy industry can pivot: the quality and availability of raw materials.
In 2019 alone, we recalled 40,000 batches of medicines exported to the USA. In 2020, India’s dependence on vital medicine imports was almost 90%. Over 70% of our key raw materials (KSMs), intermediates and active pharmaceutical ingredients (APIs) come from a single country: China. For any global supply chain, this is a huge obstacle to security of supply, which was particularly highlighted in the early stages of the pandemic.
Government efforts to boost domestic production should be synchronized with reducing imports and modernizing technology to create quality drugs. In my opinion, achieving “Atmanirbharta” is about developing an ecosystem of pharmaceutical parks that embrace next-generation technologies.
While experts put the average drug manufacturing utilization rate at just 75 percent, the real numbers are much lower. Most of the manufacturing sites in India use a batch manufacturing methodology. Built on legacy processes, they have high start-up costs, quality consistency issues, and create a lot of waste. These cost the industry millions of dollars each year in operating expenses. It is relevant to note that these losses can be optimized using Industry 4.0 technologies, which identify gaps and suggest areas for improvement to improve the efficiency of manufacturing processes.
Digital transformation enables early detection of machine line wear, flexible tracking of a defective batch in the event of a process failure and even enables rapid intervention, dramatically reducing waste. Through the integration of artificial intelligence (AI) and machine learning (ML), reams of data are converted into actionable intelligence, thus improving several aspects of the supply chain such as inventory management, trend analysis, forecasts, predictive equipment maintenance, etc.
For new manufacturing sites that are aided by the government’s PLI program, the incentive should be used to adopt Industry 4.0, the Internet of Things (IoT) and convert them into “smart factories”.
As the issue of drug safety escalated, many pharmaceutical majors planned for upstream integration and foray into the manufacturing of KSMs, APIs, and other intermediates. Along with the government, the industry has prioritized 53 APIs that cater to 41 bulk pharmaceuticals. Most of these materials manufacturing units require considerable resources – land, water, energy and, if not managed properly, can create effluents and pollutants. As the gestation period of these manufacturing units is long, now is the time for India to switch to zero defect solutions. The integration of these connected facilities with advanced effluent management systems such as zero / minimum liquid discharge (ZLD / MLD) in new pharmaceutical parks will pave the way for sustainable manufacturing, as in the case of the textile industry. . Along with centralized supply, water consumption and effluent management should be integrated into the ecosystem of smart pharmaceutical parks to reduce the burden on industry.
A view I share with industry stalwarts is that the transition to environmentally positive protocols should not be based on the voluntary actions of a private entity, but should form the basis for the creation of long-term sustainable manufacturing in the country.
I am personally convinced that the current geopolitical and economic climate has opened up a window of opportunity for us. We need to transition the way we traditionally approach production activities in India and take a sandbox approach that helps contain the impact of failures.
In India’s pursuit to reduce recalls and become globally competitive, technology can play a central role in achieving “zero defect, zero effect” – high product quality and no adverse effect on the market. environment by manufacturing. While building a self-sustaining and robust pharmaceutical supply chain, we must focus on building smart, high-performing fleets that can meet complex healthcare needs in the future.
(The author is Managing Director, ACG. Opinions are personal)