By Vipul Doshi
The Covid-19 pandemic presented an unprecedented challenge to public health. The Indian pharmaceutical industry showed its resilience by providing medicines to over 200 countries, thereby being named the “pharmacy of the world”. The world’s dependence on vaccines and medications made in India can be gauged by the fact that the Serum Institute of India’s (SII) Covishield vaccine has been imported to 80 countries since its launch in January 2021. India’s pharmaceutical exports in 2020-21 touched $24.44 billion. In the Union Budget 2022, the government projected threefold growth of the sector in the next decade. The pharma industry’s vision is to grow to $120-130 billion by 2030.
Across geographies, pharmaceutical companies are under huge pressure to develop and distribute medicinal products quickly, and the demand created by COVID-19 has only compounded the need. Since patient safety must be accorded top priority, the guarantee of the quality and dosage of a product is of utmost importance. Quality excellence is key to maintaining the promise of trust, reliability, and efficacy. Ensuring quality needs a multi-pronged approach. An IPA-McKinsey collaboration for a study on Quality Excellence suggested steps to ensure quality. At the top of the list is the establishment of robust and seamless data management to help eliminate questions of data reliability. Accurate and contemporaneous data recording, access controls for sensitive data, audit trails, and data storage and maintenance practices are some of the areas that need to be improved.
Digitization/automation in GMP processes have overcome the document control and data reliability issues and accomplished traceability of end to end GMP activity. Indian pharma companies have implemented GMP software like QMS software, SOP management software, Online training management, eLog, eLIMS (Paperless lab), etc.
To overcome the recurring findings on cleaning and cross-contamination during recent regulatory inspections, the pharmaceutical industry is strengthening the FMEA-based cleaning procedures and equipment maintenance review process along with cleaning automation. Indian pharmaceutical industry is improving sterility assurance compliance at sterile manufacturing sites. Statistical product evaluation plays a vital role in early warning systems and robust product evaluation. The pharma industry developed and implemented continued process verification by using statistical tools.
The pursuit of quality must also ensure effective and robust investigations because a weak investigation system means that companies often face recurring deviations which impact product quality. Improvement areas include problem definition, root-cause analysis, and comprehensive risk management processes. There must be process controls, monitoring, regular checks, and feedback on data to ensure that all production processes are within their intended specifications.
Another step to scale up quality is to align management systems with increasing operational complexity. These include metrics to help managers understand quality performance and risks to quality and forums to enable decision-making and tracking until effective implementation.
Quality also entails expanding and upskilling the talent pool to keep pace with the rising scale and complexity of operations. This aspect has been a difficult one to follow because it needs intensive work to train fresh graduates to be industry-ready while experienced professionals also need major retraining. Another fundamental challenge in pharmaceutical manufacturing is embedding quality into product development and technology transfer. Companies must devise ways to move towards a structured approach that incorporates quality processes at every stage of the product life cycle. A culture of quality needs to be built across the organization to ensure that products pass muster. A company with a stronger quality culture has better operational outcomes overall.
As the Indian pharma industry expands its global footprints, it will need to continuously invest in upgrading quality standards to keep its promise of being a high-quality and reliable supplier of medicines to the world. A natural corollary of the expansion is that concerns about the quality of imported drugs will increase globally and there will be greater scrutiny from regulators on quality norms. India has already faced the highest number of USFDA inspections since 2009. A high standard of quality maintenance is the only way to ensure that the industry will pass all scrutiny from regulators. Indian pharma companies must also pull up their socks for higher USFDA approval rates. India is currently behind China and the EU/US for approval rates.
Currently, pharma companies have to adhere to various standards (state-level GMP, WHO-approved GMP, USFDA) to get approval for their drugs which makes the regulatory process a tedious one. While many Indian pharma companies are robust entities, there is a need for streamlining regulation that will speed up approvals without compromising on quality. India should become a member of the Pharmaceuticals Inspection Convention (PIC/S) and the International Council for Harmonization (ICH). PIC/S aims to baselining the standards and reducing the repeated inspections by multiple regulatory bodies. ICH aims to promote public health by achieving greater harmonization through the development of technical guidelines and requirements for pharmaceutical product registration. It also seeks to prevent unnecessary duplication of clinical trials in humans and promote high-quality medicines in an efficient and cost-effective manner.
Indian pharma companies can also draw upon success stories across industries, such as airports, airlines, hospitality, automotive, steel, and information technology (IT) which have built a culture of outstanding discipline and quality through a holistic approach towards quality. The Indian Pharmaceutical Alliance is committed to addressing the quality challenges comprehensively and upgrading quality management systems to deliver world-class outcomes. To that end, it organizes a host of activities such as workshops on good manufacturing practices (GMP) and regulatory affairs. Such workshops provide insight to participating companies on key areas of regulatory affairs in the US, EU, and ASEAN region, and GMP practices. The IPA’s Quality Forum aims to help Indian pharmaceutical manufacturers to achieve parity with global benchmarks in quality. The forum focuses on priority areas such as Data Reliability, Best Practices and Metrics, Culture and Capability, Investigations etc. Quality is non-negotiable as far as the healthcare industry is concerned. However, quality has a cost that is unavoidable.
(The author is Chief Quality and Compliance Officer, Zydus Lifesciences. Views expressed are personal and do not reflect the official position or policy of FinancialExpress.com.)