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Smart factories, digital tech to drive pharma manufacturing

Nandita Vijay, Bengaluru
Thursday, January 28, 2021, 08:00 Hrs  [IST]

Pharmaceutical manufacturing will be driven by smart factories, digital technology, Industry 4.0 and good production practices. This will result in increased efficiency, fewer human errors, higher reliability, nearly zero downtime and improved service life for tools and equipment.
Globally, there is a major shift from large blockbuster drug volumes to increasingly manufacture at lower scales, which will require novel methods of operations resulting in savings of both CAPEX and OPEX.

From an India stand point, the pharmaceutical industry has shown resilience in the wake of the pandemic owing to the inelastic demand for drugs and resumption of manufacturing to pre-Covid levels, leading to seven to nine per cent growth for FY2021. With over 60 per cent of the API/KSM (active pharmaceutical ingredient /key starting material) being imported from China, reduced dependence on these items is critically important. The Covid-19 pandemic, leading to supply chain disruptions, coupled with geo-political issues, has brought to the forefront, the risk of such high import dependence, said Gaurav Jain, vice president, ICRA.

As a measure to address the problem, the Union government has already introduced a Rs. 10,000-crore bulk drug park and production-linked incentives (PLI) for the API manufacturers. The incentive scheme covers 53 APIs, which are critical from the point of view of import dependence on China, with a few of them being entirely imported. This augurs well in the long-term as it will not only lead to reduced dependence for the domestic formulators but also help manage long-run supply disruptions. The Government will do well to extend similar incentives through the Union Budget 2021 scheduled on February 1, 2021 for other import-dependent APIs, which will boost local manufacturing and further reduce import dependence, added Jain.

Being research intensive, the pharma sector spends a significant amount on R&D efforts. Providing higher tax deductions for R&D expenses will support higher investments in developing new drugs. Investments in novel and specialty drugs are subject to higher risk of failure, leading to risk averseness.

Higher tax incentives for R&D spends will incentivise Indian players to spend more, thereby providing the impetus for further R&D activities. Currently, R&D investments are 100 per cent tax deductible, which can be increased to 150 per cent to 200 per cent, especially for novel drug discovery, noted ICRA vice president, Jain.

PLI scheme to spur manufacturing
Production Linked Incentive (PLI) scheme for indigenous manufacturing of bulk drugs will help promote self-reliance in APIs and KSMs. The schemes will also result in significant generation of jobs. The government policy to encourage the fermentation-based industry will also help build self-reliance as China has gained importance in fermentation-based APIs namely, antibiotics and vitamins.

The investment in creating bulk drug parks is an important step in the right direction for the development of the industry. This would be helpful in exploiting the benefits arising due to the optimization of resources and economies-of-scale and help industry meet the requirements of standards of the environment at a reduced cost through innovative methods of common Waste Management System,” said Dilip Chenoy, Secretary General, FICCI.

Making India self-sufficient in APIs and KSMs will go a long way in enhancing India’s end-to-end pharmaceuticals capabilities and move towards an Atmanirbhar Bharat, said S Sridhar, chair, Ficci Pharma Committee and MD, Pfizer.

Mark Sawicki, CEO, Cryoport Systems, in a report stated, “The growth in demand for the manufacturing capacity seen in 2020 will continue into 2021, with many companies building their own internal manufacturing capacity to meet demand.”

Just as the countries have begun rolling out COVID-19 immunization, Indian pharma is playing a pivotal role known for its manufacturing scale in high quality, production capacity expansion and adoption of advanced technology to monitor the facilities.

“The push for additional capacity in the industry has impacted the workforce and there are talent wars going on. Companies ramping up manufacturing in anticipation of new biologics and vaccines being approved to treat COVID-19 realize that this cannot be done without having the right talent in place. This has led companies to build diverse and sustainable teams”, said Barbara Morgan, general manager, CDMO, Lubrizol Life Science Health in a media report.

“Going by the current demand, it is seen that high-potency active pharmaceutical ingredient (HPAPI) is set to grow to $33 billion by 2025, up from $16 billion in 2016. This is due to the growing importance of these ingredients in creating treatments that are not just more effective, but more patient-centric too, requiring fewer doses to achieve the same impact. Contract manufacturers will expand their aseptic and HPAPI manufacturing capacity in order to meet higher customer demand for both”, he added.

Globally novel raw materials will grow in importance. Vaccines by Pfizer and Modern such as mRNA and recombinant protein production require novel raw materials in manufacturing and formulation steps alongside will see improvements in scale, documentation and characterization of impurities, noted Ger Brophy, executive vice president, Biopharma Production, Avantor in an article in the public domain.

“Pharma had recently been reversing the trend from having a global supply network to buying more and holding on to more emergency supply for resiliency. But that will simply create inventory problems. So, pharma companies are now thinking about how they can bring manufacturing onshore in a tax-efficient fashion and then automate the process to lower costs”, he added.

Manufacturing technologies
Digitally integrated quality and manufacturing processes allow a pharma companies to deliver products quickly while maintaining the highest levels of required standards.  It is here we see that the USFDA has brought in regulations to support faster clearances.

During early November, 2020, in India, the Central Drugs Standard Control Organisation (CDSCO) and the UK Medicines and Health Products Regulatory Agency (MHRA) inked a pact for co-operation and exchange of information related to medicines and medical devices.

The pact focuses on bolstering trade ties and capacity building to scale up production of medicines and medical devices, and encourage scientific conferences between India and the UK. Working in an increasingly global environment, the sharing of intelligence on medicines and medical devices would reinforce good practices internationally, and identify emerging safety trends to protect public health.

According to the industry, this pact will ensure that regulatory processes are of global standards and will strengthen ties between companies of the two countries in the development of COVID-19 vaccine, medicines and devices during the ongoing pandemic.

With the ongoing pandemic leading to fast tracking approvals of medicines and medical devices, the MoU seeks to strengthen the two regulatory bodies of India and UK for Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP), Good Distribution Practices and Good Pharmacovigilance Practices (GpvP) come to the fore.

According to Dr Viranchi Shah, senior vice president, IDMA, India plays an important role as a global pharmacy. Signing of MoU between CDSCO and UK MHRA reflects that we are a strategic partner to UK for their pharma and devices supply chain. IDMA welcomes this development and shall continue to work closely with the government and CDSCO, and in helping Indian companies access the UK markets.

Chiming in Kaushik Desai, pharma consultant, noted that the pact was the beginning of a new era where India gets closer to global regulatory bodies. Sharing of best practices in GMP, GLP and GVP will help India to strengthen its regulatory systems meeting global standards as well as support in exports.

Pharma 4.0 is gaining traction. It focuses on the transformation with adoption of technology leading to extensive automation and leading to the flexible factory model. These cover Internet of Things (IoT), AI (artificial intelligence), robotics, augment and virtual reality where with digitalization services including healthcare will become far more transparent and efficient.

“Pharmaceuticals represent one of the most regulated industries, and thus, provide a good opportunity to demonstrate an optimal approach for digitization. Every aspect of a pharmaceutical product’s development, testing, manufacturing, packaging, marketing, storage, distribution, and use is subject to scrutiny as data is captured, analysed, and informed,” stated a report.

With the accelerated pace of automation adoption, robotics will transform the world by the introduction of digital work force in combining the major game changers of computer simulation, augmented reality, virtual reality, rapid prototyping, collaborative robots, big data analysis, AI, IOT, high speed internet and cloud computing, which is now being increasingly embraced by the pharmaceutical industry.

 

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