"Unveiling the Shadows: Navigating Pharmaceutical Realities in the Wake of 'Bottle of Lies'" a personal reflection.

All these years, I purposefully refrained from perusing "BOTTLE OF LIES," a New York Times bestseller with the enticing tagline "THE INSIDE STORY OF THE GENERIC DRUG BOOM." This is due to a number of factors, including my preconceived notion that this book is a form of conspiracy aimed at promoting the expansion of the Indian generic industry and the fact that I have personally observed our current company's culture over past 15 years, which emphasizes quality consciousness, strict adherence to GMP regulations, and transparency as one of the management's primary objectives, which is reflected in the company's culture. It may sounds funny, but it is possible that this context prevents me from accepting this book and causes me to constantly doubt its veracity.

As part of my professional responsibilities I visit factories throughout India and China, where I have had the privilege of observing and immersing myself in the operations and culture of over 150 companies engaged in pharmaceutical supply chain. Through my occupation as a sourcing manager, I am frequently granted access to their senior management, which enables me to gain insight into their business model, strengths, vulnerabilities, and other pertinent details. This is one of the simplest and most expeditious verification processes I conduct prior to initiating any business collaboration. This does not imply that we do not select the most qualified individuals in the industry who consistently uphold our core values. However, we can take the risk associated with our partnerships rather than blindly accepting them as lowest price offered is the basis ! Frequently, this aids in determining level of various risks involved with them, and we consistently clear our position to them to adhere to the highest standards and values.

Regarding the current subject matter, it is common for us to engage in numerous internal debates regarding the how to control cost of the product, internal overheads, throughput %, how competitors can perform better than us, the cost behavior of RM suppliers, industry benchmarking, and so forth. Such discussions are an integral part of the responsibilities of sourcing managers, and I am no exception.

I read somewhere that maturity is like a comb given to you after you've lost your hair. This completely pertains to me. Slowly, I'm trying to figure out how the same drug produced by numerous companies is offered at different price points, from lowest to highest. While the lowest price can be attributed to ultra efficient RM pricing, production processes, less profit margin, economies of scale, excellent chemistry, lowest overheads, and different quality specs, the highest price is the exact opposite.

We are able to comprehend and relate to the market's extreme price variation for new APIs, FDFs, which is attributable to the associated high R&D and marketing costs. Nevertheless, hundreds of thousands of APIs, medications have been genericized for decades, and in these cases, the parameters that can cause cost variation are relatively constant or vary little from manufacturer to manufacturer. Any pharmaceutical professional with moderate knowledge & effort can comprehend those details of same product / drug made by multiple companies.

Therefore, what causes this price disparity, and why are such large companies retreating from the market progressively due to low profit margins and lack of competitiveness in those drugs?

As I mentioned earlier, achieving maturity is an ongoing journey. When I am exploring the factors contributing to increased operational expenses for large corporations who has to keep higher price for their products without much flexibility. The aspects came in my mind are high investments in research and development (R&D), ensuring the presence of qualified employees to comply with standards like GMP and quality, investing in regular training, offering higher payments qualified manpower and to raw material suppliers who meet quality, compliance, and auditability standards, adhering to high-quality specifications, maintaining transparency in records, fulfilling obligations related to environmental, health, and safety (EHS) regulations and goals, prioritizing employee safety, implementing strict anti-bribery policies, establishing an independent ombudsman system, enforcing robust internal compliance policies and systems, and following stringent procedures to deal out-of-specification (OOS), deviations, reprocessing, and obtaining corresponding stage gate clearances, among other considerations.

These conditions can provide certain companies with significant flexibility in maintaining dynamic pricing, ultimately pushing larger corporations out of competition. While I am not personally asserting that these organizations compromise essential Good Manufacturing Practices (GMP) and compliance, allowing them to be the most cost-effective in the market (assuming other process-related and commercial parameters remain constant), there are numerous undisclosed practices still prevalent in the industry. This may be a guiding principle for many small to mid-level companies, though it is not prudent to attribute such perceptions to all organizations with the best industry costs. However, it has prompted me to read a recent book, and I strongly recommend every pharmaceutical professional to develop a firm understanding of what to do and what not to do.

Katherine Eban's Bottle of Lies challenges the prevailing notion that generic drugs, which make up almost 90 percent of the pharmaceutical market, are identical and just more affordable versions of their brand-name counterparts. Despite reassurances from doctors, pharmacists, and regulators, Eban exposes the deceit within the generic drug manufacturing industry, highlighting the substantial risks it poses to global health.

Bottle of Lies draws on exclusive accounts from whistleblowers and regulators, along with confidential FDA documents, to reveal an industry plagued by fraud, data falsification, and a disregard for safe manufacturing practices in the pursuit of cost reduction and profit maximization. The book sheds light on how companies routinely deceive inspectors, leaving patients unknowingly exposed to medications with unpredictable and perilous effects.

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