Dr. Ashwani Kumar, Ex-Chief Manufacturing & Compliance Officer, Unichem Laboratories Limited
Dr. Ashwani Kumar, Ex-Chief Manufacturing & Compliance Officer, Unichem Laboratories Limited, in an exclusive interview with India Pharma Outlook, shares his views on how the pharmaceutical industry manages cost efficiency while maintaining compliance, innovations that drive the pharma sector's ability, how the industry balances environmental compliance with cost efficiency in manufacturing and more. He is a seasoned strategist with over 34 years of industry experience leading diverse teams and driving growth across manufacturing businesses, infrastructure expansion and more.
Key Insights
With rising raw material costs, how is the pharmaceutical industry managing cost efficiency while maintaining compliance with stringent regulations?
The RM cost varies in the range of 20 to 50 % for the pharmaceutical industry depending upon whether One is in the low volume / middle volume/high volume segment. Regarding maintaining competitiveness, the input costs are regularly reduced by scale-up, conversion coefficient improvement, waste reduction, etc., without altering the field process. Besides, it is essential to observe yields, and the conversion coefficient must be regularly improved. For the concept of golden batches, firms need to witness the good batches they produce and how they have resulted in good yields. It is an ongoing process for survival before any change for cost improvement that requires adequate regulatory study and alignment with stakeholders. It shall be part of Product Life cycle management.
As automation increases, how is the industry balancing cost reduction with compliance, particularly in areas like data integrity?
As the industry moves from Pharma 3.0 to Pharma 4.0 in the coming decades, the Focus shifts from document-based data integrity to system-based data integrity as the industry has not yet fully adopted and assimilated automation because of multiple reasons like incompleteness of automation systems, processes not being adapted to hardware, more Focus on keeping the manual documents and untrained and unwilling workforce towards automaton. Instead of performing things manually, machines handle the work, and instead of writing things by hand, the data is recorded electronically. This utilization of automation helps accomplish compliance and ensures data integrity.
Data integrity happens as the individual either does not write on time or cannot write multiple tasks and the same data in various places. As manpower costs appreciate and automated systems depreciate, the key is to make automation part of life.
With global regulatory scrutiny intensifying, how is the industry managing cross-border compliance without escalating operational costs?
In the case of any stringent regulatory audit, it could be some or the other form of compliance, whether it is documentation, hardware, training resources, redefining the processes, or redoing the analysis, which is the cost. Warning letters and serious non-compliances require remediation, which is expensive and time-consuming. Over the last decade, there has been a shift in regulatory scrutiny from documentation to testing to manufacturing facilities and now to DI and electronic data. It is ever-evolving and will continue with more intensity. It is the only way to stay compliant all the time.
For example, if a company receives a warning letter due to incomplete vial filling, such as half-filled vials, any firm involved in vial filling should assess its own operations. The process requires time, effort, and a firm commitment to identifying and addressing potential issues before they arise. Sites shall not allow the water to boil, control issues in time, stay agile, look for others' noncompliance and be proactive in working prognostically.
Supply chain disruptions are a growing challenge; how is the industry addressing these while ensuring product quality and regulatory adherence?
Covid has taught the lessons of self–reliant or robust supply chains to Indians and Europeans alike. Many Indian companies either started in-sourcing or double-sourcing RM / API / KSM / Excipient and packing material, depending on a case-to-case basis. GOI’PLI initiative has also helped the country to reduce reliance on China and other supplier countries.
Some of the critical materials like 6APA or clavulanic potassium, for instance, were the key starting material or the intermediate manufacturing where India used to depend on Europe and China, have come as a part of production incentives as a part of the government of India PLI scheme. Regarding adherence to quality and regulatory compliance, the key is to have a good relationship with the supplier and perform audits regularly so that the industries do not get an alarm.
Sustainability initiatives are essential; how is the industry balancing environmental compliance with cost efficiency in pharmaceutical manufacturing?
Sustainability initiatives are often considered expensive misnomers. Indeed, sustainability is cheaper. For instance, if effluent treatment is performed at the source, treatment costs one-third to one-fourth of the cost when everything is pumped through an effluent treatment plant, creating a mixture of waste. Companies focusing on sustainability at the root cause level can ensure that sustainability costs remain lower. However, this is essential. Whether it's sustainability regarding raw material availability, the environment, or human capital, it is a must. In the olden days, the Focus was primarily on product sustainability. Companies used to keep stock of raw materials and ensure that critical manpower, mainly high-potential employees, were always available to avoid operational stoppages. However, the government of India is now also making significant strides, working to improve the situation and ensuring that data is considered in the process.
Besides, working on human capital sustainability helps save costs in the long run. As a primary look, it seems cost-incurring, but the impact is the other way around. BRSR has also moved gradually from qualitative to quantitative and comparative with the previous year, along with the plan for next year. This brought sustainability into Focus.
Looking ahead, what innovations will drive the pharmaceutical industry’s ability to maintain cost efficiency and regulatory compliance in the future?
The transition from Pharma 3.0 to Pharma 4.0 is a crucial development that will drive the pharmaceutical sector from a manufacturing perspective. This change necessitates the digitization of data, and before this, whatever incompleteness of the machine in terms of automation currently exists, the way people or companies operate has to be entirely standardized with data transfer. There are companies working with the digital computerized system followed by MES, but there are very few. By adhering to this, manufacturing is in control and can have data integrity.
In API, running the planned using a control system and MES will make manufacturing in control and compliant with data integrity and regulatory issues. Even today, some of the best-designed plant operations are sub-optimal regarding automation. In FDF, more and more companies will go for integrated lines for manufacturing with overall SCADA for data storage and analysis. AI shall play a role in manual data like CSA and manual BMR, as that will bring transparency; it shall bring data for optimization and improve efficiency. One can see regulatory bodies like the USFDA and the EU are asking for more and more manufacturing control.
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