Remedy of US’s Drug Supply Chain Shortages and Domestic Production of Generic and Brand Drugs

USA is the largest consumer of Brand and Generic drugs. Discussion here is centered around generics as they are the largest volume (84%) ⁽¹⁾ to serve the needs of US population but is very applicable to brand drugs also. Most of the US drugs are imported. Threat of US not having sufficient supply of these drugs has been there and is real. It has been talked about and discussed for quite some time. Conversations and congressional hearings ⁽²⁾ have been held. Projects ^{(3, 4, 5)} have been initiated by HHS (BARDA) and others to alleviate problem/s have no meaningful results and the problems still prevail. From my perspective all these attempts have been a charade. There is nothing meaningful on the horizon. With potential of tariffs on drugs, US needs to wake up and remedy the situation before it is too late. 

                                                               

National Academy of Sciences ⁽⁶⁾ in its most meaningless report even suggested that US should build foreign alliances to curb shortages ⁽⁷⁾. For national security reasons these recommendations ⁽⁶⁾ should have been questioned. Different US presidents have issued executive orders as far back as 2011 ^{(8, 9)} and nothing meaningful has resulted to reduce shortages or attain self-sufficiency. To bring pharma manufacturing home revamp of pharma’s business model, discussed later, along with US’s creativity and imagination is needed. This is critical. Since the industry is profitable need to change has never been a consideration. 

 

Why US has not made any progress in brining pharma manufacturing home when it can send man to the moon and bring him back. Pharma, my conjecture, has not addressed issue and/or may be does not understand the real root cause of the problem even after repeated discussions and attempts. Perspective presented is my own and is not influenced by any for profit and/or not for profit organization.  

 

Pharma companies are stuck in the current business mode (Figures 1 & 2) since middle of the last century. This is due to what I label as “equipment centricity ⁽¹⁰⁾” (Figure 1) rather than “process centricity ⁽¹¹⁾”. Since pharma has been profitable it considers itself invincible and no need to change its operating and business model has been on their radar. Figure 2 is the result of Figure1. 

Pharma’s “equipment centricity ⁽¹⁰⁾” i.e. fitting different chemistries in the same equipment has forced companies to follow stringent drug safety regulations and prescribed cGMP regimen. Downside has been low asset utilization ⁽¹²⁾. All the related costs become part of the product cost. It also has the highest hydrocarbon emissions per kilo of product ⁽¹³⁾. All of the related costs are passed on to the patients. Since the customer pays for the added costs, need for “process centricity ^{(11 )}” has not been a consideration.

With the prospect of tariffs on pharmaceuticals unless immediate steps are taken US population could suffer immensely. If US is really serious about bringing generic and brand drug manufacturing home, it has to emulate an effort like going to moon and/or create a consortium that has no outside political and regulatory meddling. Alternate business and operating model, not a rocket science, has to be adopted. Pharma manufacturing has to move from “equipment centricity ⁽¹⁰⁾” to “process centricity ⁽¹¹⁾”. If it does not this discussion will continue. 

 

Why Equipment Centricity:  

 

Why has the pharmaceutical industry dwelled on and is content with “equipment centricity”? The answer is simple. Since inception ^{(14, 15, 16)} manufacture of active pharmaceutical ingredients (API) and their formulations can be accomplished by modifying the processes to fit in the available existing equipment. This minimized new capital investment. With this pathway it accepts rigorous drug safety regulations and less than optimum use of processing equipment ⁽¹²⁾. “Equipment centricity ⁽¹⁰⁾” related costs are born by the patients.  

 

Process Centricity ⁽¹¹⁾:

 

This is not a new concept for the chemists and chemical engineers. It is pure and simple application of fundamentals of chemistry, chemical reaction engineering, processing and economics taught in our business, science and engineering curriculums ^{(14, 15, 16)} to create an excellent process. It is widely used in the fine/specialty chemical industry, older cousin of pharma. It is ironic that every reaction chemistry tells us how the “process centricity ^{(11 )}” works and how it can be exploited. Even then pharma lives in its old tradition of fitting a square plug in a round hole “equipment centricity ⁽¹⁰⁾” (Figure 1). 

 

By overlooking “process centricity ⁽¹¹⁾” especially in active pharmaceutical ingredient (API), pharma is not involving the “village” ^{(14, 15, 16)}from product inception. As a result it misses out on applying nuances of mutual and social behavior of chemicals, Sociochemicology ^{(14, 15, 16, 17)}, to create excellent processes. Some might consider this combination to be difficult. It is not. We are taught everything we need to know but have not fully capitalized on their value. We have the knowledge, creativity and imagination to accomplish the impossible. 

 

Path Forward:

 

If US wants to bring pharma manufacturing home, companies will have to internalize move from “equipment centricity” ⁽¹⁰⁾ to “process centricity” ⁽¹¹⁾. My estimate at least 180 days working 24/7 hours might be needed for each product provided it has the needed processing equipment, infrastructure, available raw materials, approved site and process. It is very possible that US might not have properly trained manpower for such task. 

 

In order for US to bring pharma manufacturing every “t” will have to be crossed and every “i’ will have be dotted. Brand and/or generics cannot be manufactured tomorrow in any available equipment . It will take time as the process and the facilities have to be approved. Processes to manufacture products just cannot be fitted in any available equipment. On top of it US does not have much of any raw materials needed for the drugs. Processing methods, equipment centric or process centric, have to be tested. Drug efficacy has to be tested. All of the above issues have to be dealt with and addressed. 

 

Companies interested in reducing/alleviating drug shortages and bringing pharma manufacturing to USA should be carrying the baton from product identification, process development, their commercialization and distribution. They have to transition from “equipment centricity” ⁽¹⁰⁾ to “process centricity” ⁽¹¹⁾ based model for the API and their formulations. Village ^{(14, 15, 16)} would have to be involved. This can happen by as stated earlier by capitalizing on mutual social behavior of chemicals ^{(14, 15, 16, 17)}, proper unit operations ⁽¹⁸⁾ and incorporating “process centricity” ⁽¹¹⁾. It will be able to accommodate variable volumes to meet patient needs in a properly designed plant. 

 

Simply said pharma’s marriage and addiction to “equipment centricity” ⁽¹⁰⁾ has been insurmountable and inseparable as significantly less effort is needed to commercialize a product. Had the chemical/pharmaceutical industry been “process centric” ⁽¹¹⁾ things would have been different. It would have had the agility to produce many different products with minimal investment. It is possible that the industry would not have gone “offshore” as USA would have led the manufacturing technology knowledge curve.   

 

CDMOs (contract development and manufacturing organization) and equipment suppliers will resist the suggested shift to “process centricity” ⁽¹¹⁾ based manufacturing. For their success they will have to support “process centricity ⁽¹¹⁾. Since CDMOs rely on “equipment centricity” ⁽¹⁰⁾ there should not be any surprise if US based CDMOs move overseas. It is time for pharma to consider alternate business model if it wants to bring pharma manufacturing to the largest market, USA. 

 

FDA will have to reconfigure itself and its approval processes for NDA (new drug application) and ANDA (abbreviated new drug application) by reducing their approval times to 90 days ⁽¹⁹⁾. Environmental and other regulatory approval times will have to be reworked. Every “K Street” ⁽²⁰⁾ residents would be an influencer. Legislators will have to participate in bringing manufacturing home by creating a FOUR STATE model and rejuvenating “Puerto Rico” ^(21,22) type model. It will be an added opportunity to bring jobs home. 

 

Companies (pharma and Pharmacy Benefit Managers (PBMs) will have to guarantee product quality and would have to accept sever penalties for any and every deviation ⁽¹⁹⁾. Companies will have to have total complete knowledge and command of the production and distribution process. Since every NDA and ANDA drug is FDA approved drug tiers ⁽²³⁾ have to go. They artificially raise prices. Direct sales to patients have to be allowed. Price, quality and drug efficacy based competition is the best way to reduce shortages. 

 

Unlike the past efforts that have resulted in nothing a collective thought through effort needs to be made. There will be resistance from every vested interest. 

 

Recent announcements by Eli Lilly ⁽²⁴⁾ $27 Billion, Johnson & Johnson ⁽²⁵⁾ $55 billion, Novo Novartis ⁽²⁶⁾ $23 billion are “equipment centric” ⁽¹⁰⁾ projects for their brand products. These are not going to be commercial at least for the next 4-5 years and will not produce products to fill tariff related immediate needs. Once patents for their drugs expire these investments could become the “white elephants” of no value looking for home.   

  

Simply said pharma’s marriage and addiction to “equipment centricity” ⁽¹⁰⁾ that has been inseparable and insurmountable needs to change. My conjecture is that “process centricity” ⁽¹¹⁾ effort will be a  “win-win” situation for the companies and a BIG win for the patients. Task is going to be challenging. US has never shrugged from any challenge. Let us be brave and get going.  

 

Girish Malhotra, PE

EPCOT International 

 

References:

1.     U.S. Pharmaceutical Statistics

2.     Woodcock, Dr. Janet: SECURING THE U.S. DRUG SUPPLY CHAIN: OVERSIGHT OF FDA’S FOREIGN INSPECTION PROGRAM December 10, 2019 

3.     Phlow Corporation Pharmaceutical Technology July 16, 2020

4.     DOD Awards $69.3 Million Contract to CONTINUUS Pharmaceuticals to Develop US-based Continuous Manufacturing Capability for Critical Medicines   January 15, 2021

5.     API Innovation Center  

6.     BUILDING RESILIENCE into the Nation’s MEDICAL PRODUCT SUPPLY CHAINS National Academies of Sciences, Engineering, and Medicine, 2022

7.     Malhotra, Girish: Has US lost its Business Acumen, Creativity and Imagination for its Healthcare Needs? Profitability through Simplicity, June 6, 2022

8.     EO 13588 Reducing Prescription Drug Shortages October 31, 2011

9.     EO 13944 Combating Public Health Emergencies and Strengthening National Security by Ensuring Essential Medicines August 6, 2020

10.   Equipment centric https://images.app.goo.gl/Qi2UZKqu4qHdLWvu6

11.   Malhotra, Girish: Process Centricity is the Key to Quality by Design, Profitability through Simplicity April 6, 2010

12.   Schrader, Ulf: McKinsey & Co. Operations can launch blockbuster in pharma, February 16, 2021

13.   Sheldon R.A. The E factor 25 years on: the rise of green chemistry and sustainability, Green Chemistry

14.   Malhotra, Girish: Active Pharmaceutical Ingredient Manufacturing: Nondestructive Creation De Gruyter May 2022 

15.   Malhotra, Girish: Chemical Process Simplification: Improving Productivity and Sustainability John Wiley & Sons, February 2011

16.   Malhotra, Girish: Chapter 4  “Simplified Process Development and Commercialization” in “ Quality by Design-Putting Theory into Practice” co-published by Parenteral Drug Association and DHI Publishing© February 2011

17.   Malhotra, Girish: Sociochemicology, May 30, 2013

McCabe W. L & Smith J. M. Unit Operations of Chemical Engineering McGraw-Hill Book Company Second Edition 1967

19.   Malhotra, Girish: ONE PAGE Road Map to Reduce Drug Shortages, Assure Quality and Improve Affordability, Profitability through Simplicity, December 6, 2019 

20.   K Street

21.   Malhotra, Girish: US’s Self Sufficiency for Generic Drugs: A Supply Dilemma and Potential Solutions, Profitability through Simplicity, March 31, 2022 

22.   MacEwan, Arthur: The Effect of 936 May 2016  

23.   Understanding Drug Tiers Accessed October 22, 2023 

24.   Eli Lilly  April 14, 2025 

25.   Johnson and Johnson April 14, 2025

26.    Novartis April 14, 2025

 

A road map for driving pharmaceutical manufacturing back to the USA by 2025

This perspective was also presented at CPhI 2020 Festival of Pharma held in Europe October 05-16 2020. It's link is:

https://www.cphi-online.com/46/resourcefile/10/93/83/CPhI%20annual%20rep%202020%20vJ.pdf 

There is a saying that thundering clouds seldom rain. Does this apply to pharmaceutical manufacturing coming back to USA, especially for the generic and essential drugs is anyone’s wild guess? But it seems that this proverb could become a fact.

 

In this perspective, an attempt is made to outline what has happened in the last ten years of drug shortages, high prices and the ongoing rumble of ‘bring manufacturing home’. Perspective presented in my own and devoid of any financial relationship with any profit or non-profit making entity. 

 

History:

 

The faint, but increasing rumble of the last few years to bring manufacturing home and improve affordability has picked up again with the arrival of COVID-19. 

 

A Presidential executive order ⁽¹⁾ was issued on August 6, 2020. Per this Executive Order, the FDA is now tasked with enlightening us on a pathway and plans to remedy the drug shortage and bring pharma manufacturing home to the US. Yet this design forces me to recap on the futile efforts that have been made by earlier US administrations ⁽²⁾ and the FDA ^{(3, 4, 5)}, which have not resulted in any meaningful change. The regulator has been proposing, for some time now, that the use of advanced technologies ⁽⁶⁾ will also reduce shortages. But companies should be the ones selecting and evaluating technology rather than a regulatory body, which has no commercial experience. Thus, the possibility of something meaningful coming from the August 2020 Executive Order ⁽¹⁾, if we use results of earlier attempts as a benchmark ^{(2, 3, 4, 5)}, are going to be minimal to none. 

 

The primary underlying reason for shortages and high prices are PROFITS. Yes, profits are a necessity for any company to be in business. But my conjecture is that the pharmacy benefit managers ⁽⁷⁾ (PBMs) have total control of US drug supply chain and they prevent any meaningful competition. Remarkably – perhaps outrageously – as a result of their massive turnovers they make up four of the top ten Fortune 500 companies ⁽⁸⁾. To give an idea of what we are dealing with. A company as large, influential and groundbreaking in its supply chain innovation as Amazon has tried and failed to break the PBM juggernaut - twice. Their 1999 investment in drugstore.com failed to disrupt the prescription drug business ⁽⁹⁾, and Amazon’s second attempt buying PillPack ⁽¹⁰⁾ has not yet made a visible impact. 

 

PBMs negotiate buying and selling prices to maximize their profits. They are uninterested in a manufacturers or seller’s profits, instead PBMs push the manufacturers to sell at the lowest price. If the manufacturers cannot make their desirable profit they don’t make the product and shortages result. This suggests, at least to me, patients exist in the PBM supply chain just as a medium to make profit.

 

Another puzzle is “Formulary Lists” ⁽¹¹⁾. They complicate the landscape. Why are they needed and what value do they have especially when FDA has approved a drug and checked its efficacy? Drugs should be available to the patient and if it is higher priced, then competition will readdress their availability. So the addition of drug on the Formulary list to me suggests it is effectively used by the PBMs as a bargaining tool to drive their purchasing price down and improve their own profits. Once this happens there are no checks and balances on the selling price. Since US population pays a co-pay amount, it is fascinating that no one in US prescriptively – excuse the pun – knows the real price of drugs. 

 

What would it take to bring pharma manufacturing home?

 

Reviewing the timelines outlined in the recent Executive Order ⁽¹⁾ very high and precise expectations are laid out. However, my own perspective is that FDA does not have enough experienced manpower to assess manufacturing, technologies needed, supply chain, economics, process development, design and commercial needs. Unless a very capable team with proven expertise is assembled, their feet are held to the fire and a concerted effort is made, it is possible the Essential Drug Shortage conversation may be repeated again after two or five years. This team could work under FDA’s umbrella, but vested interest influence has to be avoided. The reason for this is that after multiple attempts the United States has made no visible progress ^{(2, 3, 4, 5, 6)}, and no one wants to take responsibility for drug shortages, quality or high prices ⁽¹¹⁾.

 

My conjecture is that PBMs do not want manufacturing to come home, as profits remain a major stumbling block. If drugs are manufactured in US, PBMs and supply chain conglomerates will have to raise their prices to retain profits. This means the patient’s prices will go up, making drugs unaffordable. To counter this price hike, there will be legislative pressure and a tug of war will ensue, which could result in higher shortages, quite contrary to the very goal of reducing shortages. 

 

Landscape:

 

The WTO and TRIPS agreements ⁽¹³⁾ in 2006 essentially changed the landscape completely. It is well known that most of the active pharmaceutical ingredients (API) and their formulations are now produced outside USA. China and India produce the majority of the APIs used for the generic drugs used in US. In addition, most the raw materials that are needed for the API manufacturing have also moved overseas. Companies from China and India capitalized and fulfilled the developed country pharma needs. PBMs profited from low-priced drugs supplies. These facts are not only important, but critical. We in the United States have ignored and failed even with repeated warning signs and suggested proposals to pay attention ^{(14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24)}. 

 

Obstacles that need to be overcome:

 

Like with any task that needs to be improved, one has to understand the landscape and obstacle creators. On the US pharma landscape PBMs (pharmacy benefit managers) are the middlemen between drug manufacturer and the pharmacies ⁽⁷⁾. In US, except for about 8.5%, the population (employer or government provided and individual) is covered by some kind of healthcare insurance. About ~92% of the population is covered by mutually subsidized healthcare system and no one knows the exact price of drugs. But we do know that prices in the United States are substantially higher than rest of the world ⁽¹⁵⁾ and are continually rising ^{(25, 26)} – but despite this we see ongoing shortages. COVID-19 amongst its waves of effects has exposed vulnerabilities of the US drug supply chain. A Presidential Executive order is asking now to remedy the situation, but the question that needs addressing is: “do the people entrusted with the job cohesively understand and are capable of doing what all is needed”. 

 

My conjecture is that FDA personnel do not have the expertise to identify the candidates, the right manufacturing technologies, processing equipment, sites, process economics, environmental compliance, raw material supply chain. They are regulations experts. Thus, the expectations of the Executive Order ⁽¹⁾ will most likely not be met. Another obstacle will be compliance with FDA’s cGMP regulations and its arcane outdated rules and regulations that are over ten years old. Maybe it is an opportunity to update the filing and review processes which could reduce approval process and ensue competition ^{(23, 24)}. 

 

Challenges:

 

It is expected that by bringing pharma manufacturing home generic drug prices will be lower and reduce/eliminate shortages. On the contrary PBMs in order to retain their profits will need to raise their selling prices. This is due to higher US operating costs. But this could be countered with better methods and technologies, yet even in this case the likelihood of lower costs being passed on to patients is low. Most likely shortages and prices will go up and this will be counter the very purpose of the Executive order. 

 

An argument could be also made that US should produce the raw materials for the API and excipients and it is a valid argument. However, the economies of scale, for companies in the United States, do not exist to be able to really rely on domestic market sales. Thus, dependence on imported raw materials like imported APIs and excipients will be still be there, it has after all rightly or wrongly moved overseas for a reason.

 

The good news about financial incentives ⁽²³⁾, improved generic drug applications submission, and faster approval process ⁽²⁷⁾ is that they would bring pharmaceutical manufacturing home. But for streamlining and implementation it could take as much as five years or more. And, the US is at a strategic disadvantage. Many of the vested interest groups and that includes PBMs, legislators, regulators, pharma lobbyists – which includes pharma companies and consultants – could or will attempt to impede the process of bringing pharma manufacturing (API and/or finished dosage form) home. If any of the pharma manufacturing has been brought home by 2023-2024 or earlier, it will be a significant achievement, but all or more of the following has to happen first.

 

Task force team:

 

A team that has proven expertise of chemistry, process engineering, economics, supply chain, regulations (environment and drug manufacturing) and construction of green field or revamping brown field operations is needed. Basically, we need to explore creating plants (existing or grass root) from scratch with efficiencies as their core drivers with NO interference from the vested interests.

 

·       Products have to be defined and their processes tested in laboratory. Process simplification might require selection of appropriate equipment. Parameters and methods that will produce quality products from the get and all the time will have to be tested, approved and used. 

·       Raw materials that will be used have to be sourced and tested. Buyer/supplier relationships will have to established.

·       Sites and the equipment will have to be modified if necessary and tested. 

·       FDA, once it has approved the manufacturing methods, processes and product quality, needs to minimize its interference. 

Landscape Change:

 

For the pharmaceutical manufacturing to come back to USA, the current landscape has to be revised and overhauled. The following needs to be considered. 

 

·       US Congress and the Legislator has to create four or five pharmaceutical manufacturing hubs (call it economic hubs) evenly distributed around the country where the pharma companies will have financial tax incentives for a limited time (e.g. ten years) to produce the drugs needed by the US population. API and formulation excipients will be US produced ⁽²⁴⁾. These companies cannot be subsidiary of any foreign entity. 

·       Companies located in these pharmaceutical hubs would be able to sell and distribute the drugs directly to patients ⁽¹⁴⁾. Current PBMs can participate in the drug distribution but their selling prices would be available to patients so they can make a choice. 

·       FDA regulations and approval processes will have to be revamped ^(28,29) so that the necessary approvals instead of the current generic drug approval time of 36-48 months from filing date has to be done in 90 days. This will be give companies participating in the manufacturing hubs incentive to get to the market quickly and brew competition on quality and price. Such a revamp will reduce regulatory costs. There will be very high resistance from many vested groups for such change. 

·       Since the drugs are approved by the FDA, every approved drug has to be available to patients. Thus, the need for different formularies has to evaluated. They could be considered hinderance to free competition.

·       Companies instead of receiving 483 citations for cGMP variances would be barred from producing and selling less than quality drug for four years ⁽²⁰⁾. Currently PBMs and their supply chain partners have never been held accountable for the less than quality drugs that get distributed. They have to be held accountable ⁽²⁰⁾.  

·       FDA and equipment vendors and manufacturers should refrain from suggesting which technology and how to use them. It should be the responsibility of the manufacturing company to select the best and most economic technology for the product. FDA as stated above also has to revamp its processes so that manufacturing companies have incentive to use the best technologies and manufacturing processes as long as the drug performance is not compromised. 

·       Establishment of a governing body that is independent of the FDA, which samples drugs sold in the US market and tests them for quality. They will have the oversight for continued manufacturing if companies meet established product quality. Companies would be publicly recognized for continued product quality.

·       Along with the above any company exporting pharmaceuticals into the United States will have to comply with US environmental, health and safety or equivalent standards. Laws similar ⁽³⁰⁾ to US laws could be set under World Trade Organization or a similar trade body. 

 

All of the above calls for a re-configuration of the current landscape. There will be significant resistance but the right team will make the plan to “Make drugs in USA” very feasible and plausible. It is national security and strategic need. Task at hand is not easy. If it was, we would not be discussing this. This can be achieved in the next five years if a concerted effort and plans are established. 

 

Girish Malhotra, PE

EPCOT International

 

References

 1.     Executive Order 13944 of August 6, 2020, Accessed August 13, 2020  

2.     Executive Order 13588 -- Reducing Prescription Drug Shortages October 31, 2011, Accessed August 31, 2020

3.     Agency Drug Shortages Task Force, https://www.fda.gov/drugs/drug-shortages/agency-drug-shortages-task-force, Accessed September 1, 2020

4.     Woodcock, Dr. Janet: To Help Reduce Drug Shortages, We Need Manufacturers to Sell Quality — Not Just Medicine, October 24, 2019 Accessed November 6, 2019

5.     FDA Report | Drug Shortages: Root Causes and Potential Solutions, October 29, 2019, Accessed November 6, 2019

6.     FDA is Advancing New Efforts to Address Drug Shortages, https://www.fda.gov/news-events/fda-voices/fda-advancing-new-efforts-address-drug-shortages, November 11, 2018 Accessed 

7.     What Is A Pharmacy Benefit Manager (PBM) and how does a PBM impact the pharmacy benefits ecosystem? TRUVERIS, August 15, 2017, Accessed August 31, 2020

8.     Fortune 500 List 2020, https://fortune.com/fortune500/ Accesses August 31, 2020

9.     Ross, Casey: Amazon failed to disrupt the prescription drug business with Drugstore.com. Could a second try succeed? StatNews.com, April 26, 2018, Accessed August 31, 2020

10.  Malhotra, Girish: Amazon PillPack Marriage can Alleviate Drug Shortages and May be Lower Drug Prices, Profitability through Simplicity, July 5, 2018, Accessed August 31, 2020

11.  Formulary List, https://www.canopyhealth.com/en/members/articles/what-is-a-formulary.html, January 8, 2019, Accessed September 3, 2020

12.  Malhotra, Girish: Drug Shortages, Quality and Prices: Who is Responsible?, Profitability through Simplicity, November 6, 2019, Accessed August 31, 2020

13.  Abbott, F. M. The WTO Medicines Decision: World Pharmaceutical Trade and the Protection of Public Health, American Journal of International Law, February 2017, Accessed August 31, 2020 

14.  Malhotra, Girish: Improving Drug Affordability for the United States Populous through Alternate Business Models, Profitability through Simplicity, May 4, 2018, Accessed August 31, 2020 

15.  Malhotra, Girish: Identifying the Root Causes of Drug Shortages and Finding An Enduring Solution, Profitability through Simplicity, December 7, 2018, Accessed August 31, 2020

16.  Malhotra, Girish: Opportunities to Lower Drug Prices and Improve Affordability: From Creation (Manufacturing) to Consumption (Patient), Profitability through Simplicity, March 19, 2018, Accessed August 31, 2020 

17.  Malhotra, Girish: Impact of Regulations, Drug Manufacturing and Pharma Supply Chain (PBMs and allies) in Drug Shortages and Affordability Part 1, Profitability through Simplicity, March 8, 2019, Accessed August 31, 2020 

18.  Malhotra, Girish: Impact of Regulations, Manufacturing and Pharmaceutical Supply Chain (PBMs) on Drug Shortages and Affordability Part 2, Profitability through Simplicity, April 3, 2019, Accessed August 31, 2020

19.  Malhotra, Girish: Drug Shortages, Quality and Prices: Who is Responsible? Profitability through Simplicity, November 6, 2019 Accessed August 31, 2020 

20.  Malhotra, Girish: ONE PAGE Road Map to Reduce Drug Shortages, Assure Quality and Improve Affordability, Profitability through Simplicity December 6, 2019 Accessed August 31, 2020

21.  Malhotra, Girish: Long Term Drug Quality Supplies for US, FDA and A New Reality, Profitability through Simplicity, April 3, 2020 Accessed August 31, 2020

22.  Malhotra, Girish: Health and National Security Issues for the USA and Is The United States of America Prepared, Profitability through Simplicity, May 8, 2020 Accessed August 31, 2020

23.  Malhotra, Girish: Euphoria to Bring Pharma Manufacturing Home to United States its Reality and Challenges, Profitability through Simplicity, May 23, 2020 Accessed August 31, 2020

24.  Malhotra, Girish: Bring Pharmaceutical Manufacturing Back to USA: Additional Thoughts and Recap, Profitability through Simplicity, May 29, 2020 Accessed August 31, 2020

25.  Snoga, J. L. et.al. Containing Drug-Costs, US Pharm. 2019;44(6)(Generic Drugs suppl.):32-35 Accessed August 31, 2020

26.  What’s happening to generic drug prices? 46Brooklyn Research, March 24 2020 Accessed August 31, 2020

27.  Malhotra, Girish: Simplified Roadmap for ANDA/NDA Submission and Approval will change Pharma Landscape, Profitability through Simplicity, November 25, 2018, Accessed August 31, 2020

28.  Malhotra, Girish: What Is Needed for a Regulatory Approval of NDA/ANDA Filings in 90 Days? Profitability through Simplicity, October 24, 2018

29.  Malhotra, Girish: Strategies to Increase Generic Drug Competition and Bring Manufacturing to The United States of America, Profitability through Simplicity, March 16, 2020

30.  Malhotra, Girish: Can Uniform Safety, Health and Effluent and Manufacturing Standards Create Process Technology Innovation and Competition in Pharmaceuticals? Profitability through Simplicity, January 10, 2017