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Drug Prescription In Generic Names Only, No Branded Generics

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The World Bank Report released on April 07, 2023 highlights that patients’ Out-of-Pocket (OoP) expenses as a percentage of their total healthcare expenditure in India still accounted for as high as 50.59%. This means that patients in India generally pay for the majority of their healthcare costs themselves, rather than through insurance or government funding. The high level of OoP expenses in India has been a major problem for many patients, even today. Studies indicate it often leads to financial hardship, especially for low-income families.

A number of factors contribute to the high level of OoP in the country, as a whole, with regional variations. According to several studies, the healthcare costs in India are rising faster than inflation, making it increasingly difficult for more people to afford the care they need, especially for life threatening ailments, such as cancer.

Different union governments while in power have taken several steps to address this problem, such as, in 2018, the launch of the Pradhan Mantri Jan Arogya Yojana (PMJAY), a national health insurance scheme. It provides free coverage for poor and vulnerable families. The PMJAY is expected to have helped in reducing OoP for some patients, but it is not yet clear how much of an impact it has had overall.

On April 24, 2017, I asked on this blog – would drug ‘Prescriptions in Generic Names Be Made A Must in India?’. Interestingly, in August 2023, a new circular from the National Medical Commission (NMC) notified professional conduct regulations for Registered Medical Practitioners (RMP), including guidance to doctors on drug prescriptions.  This has raised a furor, as it were, among many medical practitioners and their associations. In this article, I shall deliberate on the pros and cons of this decision and its practicality in India. Let me start with the rationale behind such thinking, as I see it.

The rationales behind drug prescription only in generic names in India:

As I see it, there are several rationales behind doctors prescribing drugs only under generic names in India. Here are some of the most important ones:

  • Cost savings: Generic drugs are typically much cheaper than brand-name drugs. This is because generic drugs do not have to go through the same expensive clinical trials and marketing campaigns as brand-name drugs. As a result, they can be sold at a much lower price. This can save patients a significant amount of money, especially for expensive medications. 
  • Increased access to medicines: The lower cost of generic drugs can make them more accessible to people who might not otherwise be able to afford them. This is especially important in India, where a large proportion of the population lives below access, the poverty line. Generic drugs can help to ensure that everyone has access to the medicines they need. 
  • Improved competition: The availability of generic drugs can lead to increased competition in the pharmaceutical market. This can drive down prices even further and benefit patients.
  • Reduced risk of counterfeit drugs: Generic drugs are regulated by the government and must meet the same quality standards as brand-name drugs. This means that patients can be confident that they are getting a safe and effective product, regardless of whether it is a generic or brand-name drug. Counterfeit drugs, on the other hand, are often made with substandard ingredients and can be dangerous to take. By prescribing generic drugs, doctors can help to reduce the risk of patients getting counterfeit drugs. 
  • Transparency and accountability: In addition to these benefits, prescribing drugs under generic names can also help to promote transparency and accountability in the pharmaceutical industry. When doctors prescribe drugs under generic names, it is easier for patients to compare prices and choose the best option for their needs. This can help to drive down prices and improve the quality of care. 

A draft regulation was notified in 2022 for comments by all concerned:

For this purpose, a draft regulation was issued by the National Medical Commission (NMC) on May 23, 2022, for comments by all concerned, before it becomes mandatory in 2023. The NMC has also stated that it will take steps to ensure that the quality of generic drugs is maintained. The NMC will work with the Drug Controller General of India (DCGI) to ensure that generic drugs meet the required quality standards.

The final notification goes beyond drug prescription in generic names:

On August 03, 2023, The National Medical Commission (NMC) notified the professional conduct regulation for Registered Medical Practitioners (RMP). It not only provides guidance to avoid branded generic drugs and prescribing drugs with generic, non-proprietary and pharmacological names only, but also, restricts doctors from getting involved in any third-party educational activity like Continuing Professional Development, seminar, workshop, symposia, conference, etc., which involves direct or indirect sponsorships from pharmaceutical companies or the allied health sector. 

It justified its decision by saying, “India’s out-of-pocket spending on medication accounts for a major proportion of public spending on health care. Further, generic medicines are 30% to 80% cheaper than branded drugs. Hence, prescribing generic medicines may overtly bring down health care costs and improve access to quality care.” The notification also provided guidance on telemedicine consultation and prescriptions.  

The Indian Medical Association (IMA) Protested against it:

The Indian Medical Association (IMA) submitted a memorandum to the Indian regulator, the National Medical Commission (NMC), on February 7, 2023, protesting against the compulsory prescription of generic drugs. The memorandum argued that the regulations would harm patients and doctors, and that they were being implemented without proper consultation with stakeholders.

The IMA also stated that the regulations would violate the fundamental right to freedom of speech and expression of doctors. The memorandum said that doctors should be free to prescribe drugs based on their medical judgment, and that they should not be forced to prescribe generic drugs.

The IMA’s protest is significant because it is the first major challenge to the NMC’s regulations on compulsory prescription of generic drugs. The protest could have a significant impact on the implementation of the regulations, and it could also lead to changes in the regulations.

It is important to note that the IMA is not the only organization that has expressed concerns about the NMC’s regulations. Several other medical associations have also expressed concerns, and some doctors have also spoken out against the regulations.

The controversy over the NMC’s regulations is likely to continue for some time. It is important to note that there are valid concerns on both sides of the issue. It is also important to remember that the regulations are still in the early stages of implementation, and that it is too early to say what their long-term impact will be.

A few reasons why doctors in India may be hesitant to prescribe drugs under generic names. 

Here are some of the most common reasons:

  • Lack of awareness: Some doctors may not be aware of the benefits of generic drugs. They may believe that brand-name drugs are always better than generic drugs, even though this is not always the case. 
  • Influence from pharmaceutical companies: Pharmaceutical companies often give doctors incentives to prescribe their brand-name drugs. This can create a conflict of interest for doctors, who may be more likely to prescribe brand-name drugs even if they believe that generic drugs are just as effective.
  • Patient demand: Some patients may specifically ask for brand-name drugs, even if generic drugs are available. This can put pressure on doctors to prescribe brand-name drugs, even if they believe that generic drugs are a better option.
  • Quality concerns: There have been some cases of counterfeit generic drugs being sold in India. This can lead to doctors being hesitant to prescribe generic drugs, as they may be concerned about the quality of the drugs.

Some ways to encourage doctors to prescribe generic drugs:

  • Educate doctors about the benefits of generic drugs. Doctors need to be aware of the benefits of generic drugs in order to be willing to prescribe them. They should be taught about the cost savings, increased access, and improved quality of generic drugs.
  • Reduce the influence of pharmaceutical companies on doctors. Pharmaceutical companies should not be allowed to give doctors incentives to prescribe their brand-name drugs. This would help to ensure that doctors are prescribing drugs based on the best interests of their patients, rather than on financial considerations. 
  • Encourage patients to ask for generic drugs. Patients should be aware of the benefits of generic drugs and should ask their doctors to prescribe them whenever possible. This will help to create a demand for generic drugs and encourage doctors to prescribe them. 
  • Improve the quality control of generic drugs. The government should take steps to improve the quality control of generic drugs in India. This would help to reduce the risk of patients getting counterfeit drugs. 

By taking these steps, we can encourage doctors to prescribe generic drugs and make them more accessible to patients. This would help to save patients money, improve access to medicines, and reduce the number of counterfeit drugs in circulation.

Conclusion:

I now revert to this month’s notification of the National Medical Commission (NMC) on the professional conduct regulation for Registered Medical Practitioners (RMP), providing  new guidance for drug prescriptions in India. It clearly indicates that doctors should avoid prescribing branded generic drugs, instead prescribe drugs with generic, non-proprietary and pharmacological names only. ‘However, in the case of drugs with a narrow therapeutic index, biosimilars, and similar other exceptional cases, the practice of prescribing generic names only, can be relaxed,’ it elaborated.

Weighing the pros and cons of this notification, I reckon, despite the reasons articulated by doctors and their associations, besides the branded generic manufacturers, there are many benefits to prescribing drugs under generic names only. Generic drugs are typically much cheaper than brand-name drugs, and they are just as effective. They can also help to reduce the number of counterfeit drugs in circulation, besides several other benefits, as cited above. As a result, doctors should be encouraged to prescribe generic drugs whenever possible. Let me hasten to add, changing the prescribing practices of doctors and addressing concerns about the quality of generics can be a complex and gradual process.

By: Tapan J. Ray      

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.

 

India’s Drug Quality Concerns: Is Light At The End of The Tunnel In Sight Now?

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A brief chronology of some recent events on issues pertaining to patient-health-safety with drugs, as captured below, would possibly generate a mixed feeling for many. This includes a serious concern about, especially generic drug quality safety standards in India, on the one hand, and a ray of hope in the tools available to patients to know more about drugs that they have been prescribed. In this article, I shall dwell on this area. My intent is to bring to the fore the vital point – Is the beginning of the end of a long dark tunnel in sight now?

 A chronology of some recent events:

As reported on July 16, 2023, while talking on the subject, “Pharmaceutical Quality — What are we missing?”, the Drug Controller General of India (DCGI) made a notable comment. He, reportedly, said that the poor quality of drugs exported from India to foreign countries had tarnished the image of the country in the international market. The DCGI further added, pharmaceutical quality has become a subject of discussion on the global platform and the international community has started doubting whether India is capable of making quality pharmaceuticals for the global population.

He underscored, “We boast of our country as the pharmacy of the world, but it seems that it is too difficult to maintain the top position for long. If the position is lost, it will be painful and difficult to restore the faith of the international community. Further, we will lose the opportunity to serve the whole humanity of the world. The responsibility of the loss will not only fall on the manufacturers, but equally on all the stakeholders.”

Alongside, a news report on August 01, 2023, brings some hope in this regard, which I shall elaborate in course of this deliberation.  

A long saga of events: 

Yes, as it appears from the following backdrop:

Over the last several decades, there have been many instances where international drug regulators, including the U.S. FDA, expressed concerns about the quality standards of Indian manufactured drugs. These concerns have generally been related to specific manufacturing facilities – ranging from top domestic manufacturers to smaller ones, raising an uncomfortable apprehension – does India produce ’World-Class’ medicines, for all? 

About a decade ago, one of the most well-known cases was in 2013 when the U.S. FDA issued an import alert on products from the Ranbaxy Laboratories facility in India due to data integrity and manufacturing quality issues. This led to significant scrutiny of other Indian pharmaceutical companies as well. Issues related to data integrity, product quality, and good manufacturing practices lead to inspections, warning letters, import alerts, or other regulatory measures.

It continued. For example, around that time, even Sun Pharmaceutical Industries, one of India’s largest pharmaceutical companies, received a warning letter from the U.S. FDA in 2015 (Source: U.S. FDA). Similarly, Wockhardt, another top Indian pharmaceutical company, faced regulatory scrutiny in 2013 when the U.S. FDA issued an import alert and seized products manufactured at their facility in India. The FDA raised concerns about violations of good manufacturing practices and data integrity issues at the facility. This led to recalls of several products and affected the company’s reputation. (Source: Reuters).

As the juggernaut kept moving, on  December 08, 2016, I wrote in this blog, “Even Smaller Countries Now Question Indian Drug Quality Standard.” On March 04, 2023, the Mint reported, “Death of children in Gambia linked to consumption of India made cough syrups, as the US CDC report states.”  

As I write, the veracity of impact of such incidences remains as serious, if not more, although instances seem to be much fewer. For instance, as reported by Reuters on August 01, 2023: “India has directed Riemann Labs, a manufacturer linked to cough syrup deaths in Cameroon, to stop manufacturing activities, the country’s health ministry said in a statement on Tuesday.”

Thus, On May 27, 2019, I again wrote about: “Drug Quality Imbroglio And ‘Culture of Bending Rules’ in India” in this blog– and that was not the first time I flagged this menace in the country against patient safety.

Even big Indian pharma continued to be struggling with GMP issues:

Big Indian pharma companies are also involved in issues related to lapses in high drug quality standards even recently. Such as, even in 2021, Dr. Reddy’s Laboratories, received a warning letter from the U.S. FDA after an inspection of their manufacturing facility in India. The letter cited violations of good manufacturing practices, data integrity issues, and inadequate investigations of product complaints. Source: The Economic Times). Just a year before, in 2020, the U.S. FDA noted several observations related to good manufacturing practices and quality control. (Source: Moneycontrol).

Drug regulators fight the fire as and when it comes up:

Both the state drug regulators and the Drug Controller General of India (DCGI) fight the fire at the respective manufacturing locations, as and when these come up. No significant actions on the ground for patient safety against such drugs were visible on the ground.  

For example, as reported on August 03, 2023: “Following recent incidents of several countries reporting deaths allegedly linked to “contaminated” India-manufactured drugs, the government has set a deadline for mandatory implementation of the Good Manufacturing Practices (GMP) which were revised in 2018, bringing them on par with World Health Organization (WHO) standards.”

The government ponders making technological interventions for patients:

There are early signs of the government trying to embrace technology for patients’ safety. For example on November 17, 2022, the Union Health Ministry released a gazette notification no 823Eimplementing the Drugs (Eighth Amendment) Rules, 2022, making it mandatory for pharmaceutical companies to affix a QR code on the pack of top 300 formulations from August 1, 2023. A QR code, as reported, will contain the unique product identification code, generic name of the drug, brand name, name and address of the manufacturer, batch number, date of manufacture, expiry date and manufacturing license number.

This was part of the Ministry’s ‘track and trace’ mechanism, and of course, an intent at that time. However, a specific timeline for implantation has now been clearly enunciated.

This time it’s a two-pronged action:

For the first time, I think, a two-pronged action has been announced by the government – an enabling action for patients on the one hand against a strong punitive measure for the errant drug manufacturers on the other:

According to the above gazette notification of the Union Ministry of Health, on August 01, 2023, the central government announced stricter regulations for drug authentication and transparency by imposing mandatory QR codes on drugs. This will be effective from the same day. Patients will now be able to check the QR code on their medicines to ensure their authenticity. 

On August 03, 2023, the government set a deadline for adopting WHO-standard good manufacturing practices for drug manufacturers. Companies with a turnover of over Rs 250 crore will have to implement the revised GMP within six months, while medium and small-scale enterprises with turnover of less than Rs 250 crore will have to implement it within a year. 

Conclusion:

Besides all important patient safety, there are, at least, three other important factors for manufacturing high quality drugs for all and on an ongoing basis, sans lapses, as below:

  • Patients’ trust in the healthcare system relies on the availability of reliable medication. When patients have confidence in the drugs they are prescribed, they are more likely to comply with treatment regimens, leading to better health outcomes. 
  • A strong pharmaceutical sector that focuses on safe and effective drugs can foster economic growth by generating revenue, creating jobs, and attracting investments. It can also stimulate research and development efforts.
  • A reputation for producing quality drugs can boost India’s position as a global leader in pharmaceuticals, attracting international collaborations and partnerships.

Which is why, from the entire perspective, as above, amid India’s drug quality concerns, I reckon, one may still tend to wonder now – Is a light in sight now at the end of the dark and long tunnel? 

By: Tapan J. Ray      

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.

 

Covid Propels Healthcare Into A Virtual World: A New Growth Driver For Pharma?

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Amid ongoing Covid pandemic, most discussions on pharma specific ‘digitalization’ initiatives continue to predominantly hover around its traditional business growth drivers. In fact, even before the Covid time, it was no different, in a smaller scale and with a lesser intensity, though.

Incidentally, since quite some time, with the explosion of different types of web-based businesses, offering opportunities to buy and receive, virtually everything, at one’s doorstep, many things started changing rapidly. Almost all businesses started offering the state of the art, easy to use smartphone app-based e-commerce solutions, in different formats, to grow their businesses. Alongside, more and more people started managing their daily needs and wants online, even in India. Intriguingly, despite the availability of telemedicine, telehealth and e-pharmacies, even in the old normal, most people continue to prefer in-person health care solutions, including buying medicines.

Then came a bolt from the blue – the unprecedented global health crisis, caused by Covid-19. Almost overnight, amid requirements of maintaining stringent personal measures to keep Covid at bay, making in-person doctor-calls for brand demand generation activities, posed a great challenge. Doctors, too, became hesitant to meet general patients and medical representatives, in that situation. Thus, to keep the business up and running, most pharma companies gave top priority in finding out a digital solution for the brand demand generation processes. Interestingly, this was happening, when many patients, especially those with non-Covid ailments, also faced a similar situation to meet their health care needs.

Finding no other viable alternatives, many patients were pushed to search for a robust digital solution for health care needs, as well – just as they were already meeting their other regular needs – online. In that sense, Covid propelled many patients to step into a new virtual world of healthcare - telehealth or telemedicine. As mentioned above, although, these services were up there in pre-Covid days, many patients, apparently rediscovered them, in a new Avatar, to get relief from ailments and also save their lives.

On a hindsight, it appears, why the need to leverage telehealth or telemedicine in that crisis, did not appear to be a priority for most pharma companies to foster patient-centric growth of the business. Thus, continuing with the core concept of my previous article, – this article, will focus on the possibility of pharma spearheading the process, aiming for a win-win outcome – boosting access to high quality affordable care for all, on the one hand. And simultaneously, harnessing this new growth driver to excel in the business, on the other.  

Telehealth or e-health will grow just as other e-businesses, unhindered: 

With the Government of India issuing guideline for telemedicine practices on March 25, 2020 and later, on May 12, 2020, publishing those guidelines in the gazette, ‘Telemedicine’ has been made a high priority health care enabler. The notified guidelines also make telemedicine consultation provided by a Registered Medical Practitioner (RMP) under the Indian Medical Council Act, 1956, legally permissible. In addition, effective October 01, 2020, Telemedicine costs will be covered under medical insurance in accordance with the Insurance Regulatory and Development Authority of India’s (IRDAI) new guidelines.

The net effect of these measures will not just help reduce pressure on the fragile public healthcare infrastructure of the country, but will also expand access to lower cost and high-quality private care to a large number of people.  

Telemedicine is here to stay and be a key pharma growth driver:

With Covid propelling health care into virtual platforms, providing and receiving medical care through telehealth has become a necessity for many people, for different reasons. However, the question that surfaces, will patients return to the old normal, if and when the pandemic ends?

The article – ‘3 reasons telehealth is here to stay,’ published by the MedCity News on October 09, 2020, presents a practicing physician’s perspective on this issue. The author envisages, ‘telemedicine will continue to gain traction with my colleagues and most likely, become a permanent clinical option for patient care.’ Going by such hands-on experience, I reckon, telemedicine will continue to grow for several important reasons, such as:

  • Technology to make telehealth increasingly user friendly: Ongoing IT innovation is making telehealth platforms simple and more effective for doctors and a large number of patients belonging to all age groups. “All they have to do is click a link on their smartphones, which is sent to them via text automatically.” Thus, these tools will increasingly become the best option for treating a broad range of conditions, long after the pandemic subsides.
  • Telemedicine costs are covered under medical insurance, now: Effective October 01, 2020,Telemedicine costs will be covered under medical insurance, even in India. Moreover,‘Telemedicine’ has now been made a high priority health care enabler, carrying a permanent legal status in India. 
  • Health Equity and affordable care: Access to affordable health care is not evenly distributed across the India. Telehealth can help fill these gaps, with increased affordable access for all, even in rural India, as patient location won’t be a problem in getting prompt and quality care at a low cost.

From the above perspective, it appears, it’s high time for pharma to leverage Telemedicine and Telehealth as a major growth driver, powered by innovative business strategies.

Is there any difference between Telemedicine and Telehealth?

Very often these two words are used interchangeably. Mostly because, both telemedicine and telehealth are the practice of medicine using technology to deliver care at a distance.

Telemedicine offers remote clinical services, such as, virtual consultations, diagnosis, prescriptions, preventative care, monitoring via telecommunication platforms, including text, video chat, wearable devices or even phone calls. Whereas, telehealth, in addition, can include remote non-clinical services, such as health care training, administrations and continuing medical education.

Reasons for pharma’s cashing on this new growth driver at a low cost:

Besides Government’s support to telehealth and telemedicine, growing health care consumer demand and user-friendly technologies, are catapulting virtual care to the mainstream health care delivery systems. In tandem, driven by unique and long-term value offerings, telemedicine is being increasingly recognized as a critical means to get prompt care for minor but urgent ailments. Consequently, moreusers are getting attracted to its convenience and benefits, which may have a snowballing effect. Some of which are as follows:

  • Prompt access to disease treatment services, as and when needed by patients, without any long waiting time, for any reason.
  • Significant health care cost saving for all – more for rural population who will be able to avoid long distance travel, involving both time and money, besides associating hassles.
  • Prompt follow-up consultation facilities, will help avoid disease complications, reducing the burden to hospitals for secondary or tertiary care.
  • Further, pharma can offer even greater patient satisfaction by leveraging virtual healthcare platforms, as these will help ensure more effective follow-up and enhanced treatment convenience than traditional in-person visits. Several studies, such as the article, published in ‘The American Journal of Managed Care,’ on January 15, 2020, vindicate this point.

In short, accelerating rate of use – with the increasing need for prompt, easy and affordable access to care, are driving telemedicine to be an integral part of healthcare service delivery system. Which is why, expansion of pharma business in this new virtual space, with well-integrated collaborative strategies, could prove to be a key growth driver – over a long period of time.

Moreover, there doesn’t seem to be any need to deploy a large and cost-intensive field force, as is usually followed for expansion of pharma business in newer areas. This is because, ‘telemedicine requires a different approach to promotion.’

Telemedicine requires a different approach to promotion

That telehealth requires a different approach to marketing and promotion from traditional pharma marketing, was deliberated by ZS in the article -‘Four telemedicine myths for pharma to avoid,’ published on July 05, 2020. The paper underscored, ‘instead of building brand awareness and engaging patients in education and information, telehealth promotion needs to drive patients to take one specific action: call today!’ It further elaborated:

  • Brands that bury the telehealth link on page 8 of their website or make linking to a physician one of more than 20 different calls to action, will find low patient engagement and low pull through.
  • As virtual health care is here to stay, telehealth itself should be a strategy for active promotion, by optimizing the steps to get patients connected to a physician in the shortest and the easiest way possible.

From this perspective, brands that will find the right pathway for engaging in telehealth, will reap the benefits of increased engagement with patients and telehealth physicians. To achieve this objective, with a robust, commercial strategy, the first step for each brand will start with understanding the needs of patients and physicians that needs to be addressed on priority. Then comes, mapping out how the brand will get used to meet those needs.

Conclusion:

We are still in the midst of an unprecedented new Coronavirus pandemic. As of October 18, 2020 morning, India recorded a staggering figure of 7,494,551 of Coronavirus cases with 114,064 deaths.

With the pandemic severely curbing most patients’ access to care – following the traditional process, Covid propelled health care into a virtual world, almost in no time. Telemedicine brought to the fore, its game changing potential to provide expanded access to high quality and affordable health care, through multiple channels, sans physical presence. Location of a patient or of a competent physician isn’t an issue, any longer, in the disease treatment process. With telemedicine patients will be able to get treated as and when they will want.

The future of Telehealth or telemedicine appears to be promising even beyond Covid time, with more people preferring digital platforms for affordable and more convenient medical care than in-person visits. With virtual care getting integrated into traditional health care delivery systems, pharma players will need to explore this space, as a new growth driver – for wider reach, and greater share of mind of customers for their respective brands.

For Telemedicine to be successful – benefitting a vast majority of both urban and rural populations, country’s health policy makers and, especially the pharma industry should work in unison. Only then, the net outcome will offer a win-win situation – both for the Government and also for the drug industry. It will help expand access to high quality and affordable care to all – seamlessly, irrespective of location. Consequently, pharma marketers will get access to another powerful business growth driver – in telemedicine. Its time about time for all to act – sooner the better.

By: Tapan J. Ray    

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.

 

Criticality of Drug Quality In The Moment Of Truth

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When global health emergencies strike unannounced – in the scale and magnitude of new coronavirus, it shakes the health care system of all countries, in varying degree though, irrespective of the robustness of the economy. In such situation, the robustness of health care infrastructure, stringent manufacturing quality standards, operational flexibility for seamless sourcing of all drug ingredients in the required quantities, besides speed and agility of the delivery system – are put to the acid test.

Anytime readiness to effectively neutralize this crisis is of utmost importance. Accordingly, the key national goal should be to create a robust ‘whole’ that is much more than the sum total of each of each of the above factors – a sturdy ‘drug security system’ for the country. The most populous country of the world – China may have succeeded in building a 1,600-bed hospital coronavirus hospital in just 10 days, completing on February 05, 20120. But it is still looking for necessary drugs from other countries, such as the United States.

Curiously, China hasn’t yet disclosed its reason. More so, when the country is the top global supplier of Active Pharmaceutical Ingredients (API), including antiretroviral (ARV) drugs, along with India, according to the World Health Organization (W.H.O). This draws many to look at the general apprehension on the questionable quality of drugs that China, allegedly, produces. But, could this be the reason?

Nevertheless, regardless of inquisitiveness to know the reason, the question mark on its drug quality remains. And this is also not the risk-taking time for any nation, as it could possibly endanger lives of scores of the impacted population. The criticality of drug quality in ‘The Moment of Truth,’ such as, the new coronavirus emergency, can only be wished away at one’s own peril.

On the other hand, the confidence expressed in India, as we shall see below, in ‘drug security’, just based on adequate ARV drug availability appears to be coming from a different plane, although the drug quality issue is exactly the same in India, if not more concerning. From the above perspective, my today’s article will focus on this subject, purely based on available data, starting with the request of the Chinese authorities for ARV drugs from the United States.

Chinese request for ARV drugs:

‘U.S. Drugmakers Ship Therapies to China, Seeking to Treat Coronavirus – AbbVie, Gilead, others respond to Chinese authorities’ requests for antiviral drugs to test effectiveness against deadly respiratory illness.’ This was reported by The Wall Street Journal (WSJ) on January 27, 2020. It goes without saying that these antiviral drugs also include Anti-Retrovirals (ARVs).

AbbVie Inc. and Johnson & Johnson  are among the drug makers that have begun shipping drugs approved to treat HIV, while Gilead Sciences Inc. is exploring whether it should send an antiviral therapy it is developing.

It isn’t known whether the drugs would be able to help contain the explosion of respiratory virus infections sweeping the country or provide relief to infected patients. Chinese authorities have requested the shipments to test the drugs’ effectiveness in containing the new coronavirus, the report added.

An intriguing difference between India and China:

Interestingly, China is looking for sourcing some of these ARV drugs from the United States and not from India, either – one of the top producers of these drugs, as W.H.O reported.

In contrast, according to an Indian report of February 04, 2020: ‘Leading domestic drug companies have said they are ready with supply of anti-retrovirals (ARVs) that seem to work in treating the novel coronavirus (2019-nCoV).’

As I said earlier, although, China hasn’t yet specified the reasons behind their decision on ARV drug import from the United States, but could it have any link on the internal general apprehension of these drugs quality, safety and effectiveness?

Acknowledging for a moment that this is global allegation on Chinese drugs, in general. So is regarding India, as we shall see below. Then where does India stand on this score, especially in view of the confidence with ARV drugs, as exhibited in the above media report from India? That said, the logical question that surfaces now – why is the request for ARV drugs?

Why ARV drugs?

Although W.H.O said that there is ‘No known effective treatments’ for new coronavirus, as yet, various reports do indicate the use of ARV drugs in the treatment of 2019-nCoV:

  • A combination of flu and HIV medications are helping treat severe cases of the new coronavirus in Thailand.
  • Chinese health officials are already administering the HIV and flu drugs to fight the coronavirus, but the combination of the three together in a cocktail seemed to improve the treatment.

The Scientist, on February 02, 2020 reported that large doses of the flu drug oseltamivir combined with HIV drugs lopinavir and ritonavir, reportedly, improved the conditions of several patients in Bangkok, Thailand.

Global dependence on Chinese and Indian generic drugs:

About 80 percent of the Active Pharmaceutical Ingredients (APIs), including many ARVs, which are used for manufacturing of drug formulations in the United States are said to come from China and other countries like India. This appeared in the article titled, ‘U.S. Dependence on Pharmaceutical Products From China,’ published by the Council on Foreign Relations (CFR) on August 14, 2019.

India’s dependence on Chinese APIs:

Latest statistics from Directorate General of Commercial Intelligence and Statistics tabled in the Parliament show that in 2017-18, Indian imports of APIs and drug intermediates from China increased to 68.36 per cent. The same at 67.56 per cent in 2018-19, still remained the largest share in total Indian imports, with the overall India’s dependence on imports going up by 23 per cent from 2016-17 to 2018-19.

As reported in the media on November 22, 2019, India’s national strategies, such as, “2015 – Year of Active Pharmaceutical Ingredients” or ‘Make in India’ campaign, to promote indigenous means of production continue to be relegated on paper. Even, the current National Security Advisor had warned that Chinese dependence on API can be a national security threat.

According to the Department of Pharmaceuticals (DoP), Chinese API imports are due to economic considerations, which are essentially cheaper and more cost-effective for the Indian drug manufacturers, the above report highlighted.

Against this backdrop, the above local media report indicating, leading domestic drug companies are ready to supply anti-retrovirals (ARVs), may invite more questions than answers. Added to this come the critical quality issues with drugs manufactured in China and India.

Quality issues with Chinese drugs:

Credible documents highlight, as China’s pharmaceutical industry is not effectively regulated by the Chinese government, its regulatory apparatus is inadequately resourced to oversee thousands of Chinese drug manufacturers. Even if Beijing made such oversight a greater priority. This has resulted in significant drug safety scandals.

Although, the drug quality related concerns seem to be even more related to India, the drug industry of the country, reportedly, remains in a denial over most of such charges involving drug-quality.

India tops with the most quality related FDA warning letters in 2019:

The author of the above article reiterates, ‘Americans are expecting India, which supplies a significant percentage of the finished drug supply in the U.S., to get its act together to improve the quality of the medicines it makes, I am afraid they will be waiting a long time for that to happen. The only solution is for American lawmakers to enact new regulations focused on holding those who intentionally put public health at risk to account.’

To avoid ‘your-opinion-versus-my-opinion’ type of a debate with this article, let us look at some hard facts. These are from the ‘warning letters’ on drug quality, issued to various pharma companies, across the world, by the USFDA’s Center for Drug Evaluation and Research (CDER). The details were well captured in an article, titled ‘The country with the most FDA warning letters in 2019,’ published by Pharma Manufacturing on January 20, 2020.

Some key CDER findings:

As I consider, the top three CDER findings may be summarized as follows:

  • In 2019, CDER issued dozens warning letters for manufacturing issues to pharma companies outside the U.S. One country in particular – India – received the highest number of letters.
  • CDER’s office of Manufacturing Quality Letters issued 43 letters to companies outside of the U.S. Of those letters:

-   20 were aimed at facilities in India.

-   With 11, China received the second most manufacturing quality warning letters.

-   The rest of the letters were distributed among plants in Europe, Costa Rica, Singapore, Turkey and others.

  • The data from CDER shows that India has the poorest rate of FDA inspections with acceptable outcomes (83 percent) — much lower than China (90 percent) and the U.S. (93 percent).

Conclusion:

Today, a host of effective drugs and vaccines are available to treat a number of both non-infectious and infectious ailments, including many life-threatening viral diseases. However, the effectiveness of these medicines in treating such diseases, as well as many other illnesses, gets significantly compromised by questionable quality and distribution of these medicinal products. Even way back, a similar concern was deliberated in an article captioned, ‘Substandard drugs: a potential crisis for public health’, published in the British Journal of Clinical Pharmacology (BJCP), on November 29, 2013..

It may ordinarily remain undetected, sans stringent and wide-scale regulatory scrutiny. Additionally, a number of involved countries still remain in a denial mode. It’s also a fact, several governments may not have wherewithal for the same, particularly when the manufacturing units are too many, such as in China and India.

However, when a critical national health emergency strikes, unannounced, like the new coronavirus, the moment of truth dawns. Obviously, the national governments would want to be risk averse and prefer sourcing the best of drugs, to rapidly contain the spread of the disease, saving more lives. It’s not difficult to fathom, either, any country is unlikely to admit this reality, in public, even while taking measures for the same.

China’s sourcing of ARV and other drugs from the United States may or may not be due to the drug quality reasons. Nonetheless, I reckon, the criticality of drug quality issues can possibly be best realized, mostly when the ‘Moment of Truth’ arrives. Unannounced! Just like a bolt from the blue!

By: Tapan J. Ray

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.

Continues ‘The Cat And Mouse Game’ In Pharma Business?

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Many are already aware of the critical factors that make generic drugs so important for patients – virtually for all. These don’t just facilitate greater access to health care – offering affordable alternatives to high-priced off-patent innovative drugs. This is as relevant in the largest pharma market in the world – the United States (US), just as in India. Let me illustrate this point with two examples – one from the US and the other from India.

According to US-FDA, ‘9 out of 10 prescriptions filled, are for generic drugs’ in the United states, as off-patent branded generic drugs cost more than their generic equivalents. The US drug regulator explains, ‘Increasing the availability of generic drugs helps to create competition in the marketplace, which then helps to make treatment more affordable and increases access to healthcare for more patients.’

However, unlike the US, there prevails a unique perception difference even within generic drugs – between branded and unbranded generics. The Indian Survey, undertaken to review and analyze various facts on branded and equivalent unbranded generic medicines, found a huge difference in prices between them in the country. Interestingly, as the researchers also noted, although, more consumers want an economical alternative to high priced branded generics, most physicians do not prefer unbranded generic medicines.

There is another important point worth noting regarding India made generic drugs. Although, Indian pharma sector caters to around 40 percent of generic demand in the US, as IBEF reports, many Americans nurture serious apprehensions on the quality of generic drugs manufactured even by India’s top drug companies. 

This is quite similar to apprehension that exists in India between the quality branded and unbranded generic medicines in India. The only difference is – the above perception in India is not based on impartial and credible scientific studies, whereas it is not so in America. The New York Times report, published on May 11, 2019 vindicates this point. It questioned: “Americans Need Generic Drugs. But Can They Trust Them? The fake quality-control data, bird infestations and toxic impurities at the overseas plants that could be making your medication.” Incidentally, there aren’t any such large-scale accusations regarding dubious quality of drugs manufactured by Big Pharma. 

On the other hand, big pharma players have long been accused of drug price gouging or price-fixing of life-saving drugs, primarily to maximize earnings by ‘extending’ product patent-life. Curiously, in recent times, even the generic drug players are being accused of following a similar practice. Thus, in this article, I shall explore how generic drug players are also trying to hoodwink measures to bring down the drug price, either through price control or through the encouragement of intense competition – playing a ‘cat and mouse game’, as it were, whenever an opportunity comes. If it continues and probably it will, what is the way ahead? Let me begin by recapitulating a historic pace-setting move in the global generic market by an Indian drug player.

A historic pace-setting move by an Indian generic drug player:

Being a major exporter of generic drugs in many developed, developing and even poor countries around the world, India is often termed as ‘the pharmacy of the world.’ That apart, a historical move in this space, by a top domestic player – Cipla, earned global accolades, at the turn of this new millennium. In 2001, Cipla slashed the price of its triple-therapy drug ”cocktails” for HIV-AIDS – being sold by MNCs, ranging from USD 10,000/ USD 15,000 a year to USD 350 a year per patient to a doctors’ group working in Africa.With the generic industry’s focus on a deeper bottom line, the scenario has changed now. Finding ways and means for the price increase, evading both competitive pressure and also drug price control, as in India, has turned into a ‘cat and mouse game’, as it were.

Generic drug pricing – ‘a cat and mouse game?’

Pricing pressure, especially for generic drugs, from patients, payers, politicians and governments, is gradually becoming more intense. More the pressure greater is the effort of affected players to come out of it, in any way –akin to a ‘cat and mouse game’, as it were. Although, it has recently started in the USA, the same exists in India, since 1970, when the first drug price control was introduced in the country. Intriguingly, in the midst of this toughest ever drug price control, phenomenal rise of almost all top Indian companies, including the top ranked company in the Indian pharma market commenced – from scratch. Nonetheless, to get a feel of how is this game being played out, let me start with the Indian scenario.

How this game is played in India to evade price control:

Instead of taking a deep dive into the history of drug price control in India, let me give a bird’s eye view of a few mechanisms, out of many, used to evade price control, since it commenced. The idea is to give just a feel of how this ‘cat and mouse game’ game pans out, with a few of such examples in a sequential order, since 1970, as much as possible, by:

  • Including price decontrolled molecule in the FDC formulations.
  • Replacing a price-controlled molecule by a similar decontrolled one, keeping the brand name unchanged, when the number of controlled molecules came down.
  • Making a major shift towards selling more of higher-priced decontrolled molecules, jettisoning low priced controlled molecules.
  • Resorting to vigorous campaigns, when the government started encouraging prescription of low-priced generic molecules, to ensure further shift to branded FDC prescriptions, alongside image enhancement of branded generics over equivalent unbranded ones. Its outcome is visible in the above Indian Survey on the image of branded and unbranded generics.

Has Indian pharma industry succeeded in this game?

It appears so and gets reflected in the CAGR of the industry. According to IBEF, “The country’s pharmaceutical industry is expected to expand at a CAGR of 22.4 per cent over 2015–20 to reach US$ 55 billion.” I underscore, this is value growth.

Thus, the point, I reckon, that the government should ponder: How both can happen, at the same time – price control is bringing down drug prices, extending real benefits to patients on the ground, and at the same time the industry is recording an impressive growth rate in value terms?  Whatever it means, let’s now try to explore, how such ‘cat and mouse game’ is being played to increase generic drug prices in the United States.

How similar game is played in the US to increase generic drug price:

On May 10, 2019, international media reported that ‘44 US states announced a lawsuit alleging an anti-competitive conspiracy to artificially inflate prices for more than 100 drugs, some by more than 1,000 percent.’ This lawsuit is based on an investigation involving a number of generic drug companies. The process, which took five-years to complete, accused twenty generic drug players. Teva Pharmaceuticals USA, whose parent company is based in Israel was, reportedly, named as the ringleader of the price-fixing. The company raised prices of around 112 generic formulations.

Other companies, reportedly, named in the complaint, include Pfizer, Novartis subsidiary Sandoz, Mylan, and seven Indian drug companies, including Lupin, Aurobindo, Dr. Reddy’s, Wockhardt, Taro Pharmaceutical Industries (a subsidiary of Sun Pharma) and Glenmark. Some of the 15 senior company executives who were individually named in the lawsuit for their involvementin this alleged “multibillion-dollar fraud ”belong to Teva, Sandoz and Mylan.

The ‘cat and mouse game’ in this case is slightly different. Instead of government price control, the US drug regulator encouraged intense generic competition to bring down the price. When the priced did not come down as expected, the State of Connecticut, reportedly, began investigating select generic drug price increases in July 2014. Subsequently, other states also joined the investigation, and uncovered the reason for prices not coming down.

According to the complaint, between July 2013 and January 2015, Teva significantly raised prices on approximately 112 different generic drugs. Of those 112 different drugs, Teva had colluded with its competitors on at least 86 of them. The complaint noted: “Teva had understandings with its highest quality competitors to lead and follow each other’s price increases, and did so with great frequency and success, resulting in many billions of dollars of harm to the national economy over a period of several years.” In this way, the impact of intense competition on drug prices, was made ineffective.

Not the first time, it was detected:

The 2019 anti-trust lawsuit against the generic drug makers may be ‘the biggest price-fixing scheme in the US history’, but not the first lawsuit of this kind in America. A similar lawsuit for illegal price-fixing against six generic companies, was filed by the states in 2016, as well, which is still being litigated. The 2019 case is a sweeping version of the same and is the result of a much wider investigation. It indicates, instead of taking corrective measures, the ‘cat and mouse game’ still continues. However, almost all the companies have vehemently denied this allegation.

Is this game existential in nature of the business?

One may well argue that such ‘cat and mouse game’ with the government is existential in nature, for the generic drug business. When price control or intense market competition brings down the price to such a level, it becomes a matter of survival of most businesses. There doesn’t seem to remain enough financial interest for them to remain in the market. If and when it happens, causing shortage of cheaper generic drugs, patients’ health interest gets very adversely affected. It also prompts the manufacturers to find a way out for the survival of the business. This is understandable. But it needs to be established, supported by scientific studies.

An off the cuff solution:

A general and off the cuff solution to the above issue would naturally be, there should be a right balance between affordability of most consumers and the business interest of the drug makers. This broad pointer is also right and understandable. But again, no one knows the expected upper limit of the generic drug profit margin for their manufacturers – where hardly any breakthrough and cost-intensive R&D is involved. Equally challenging is to know – below what margin, generic players, by and large, loose interest in this business?

What do some available facts indicate?

According to the year-end report of the Pharmaceutical Export Promotion Council (Pharmexcil) the total pharma exports from India has been pegged at USD 19.14 billion for 2018-19. This represents a growth of 10.72 per cent over USD 17.28 billion in thelast year. It further reported, “The top 25 export destinations contribute 76.52 per cent of the formulation exports amounting to USD 10.38 billion. Among these, the US continues to be the largest export destination with over 38.62 per cent of the total generic exports to that country at USD 5.24 billion.” Does it mean business as usual, despite ‘price-fixing’ law suits in the US, since 2016?

Similar impression one would probably get from the Indian scenario, as well. Notably, despite price control, which is continuing since last five decades, the growth rate of the Indian pharma market, which is dominated by branded generics, remains very impressive.According to the January 2019 report of IBEF: “The country’s pharmaceutical industry is expected to expand at a CAGR of 22.4 per cent over 2015–20 to reach USD 55 billion.” So also the same game, probably!

Conclusion:

It appears, there is certainly a huge reputation or image crisis for the generic drug industry, as such, due to such alleged delinquencies. However, from the business perspective, the manufacturers are still having enough leeway to move on with similar measures, supported by fresh thinking. At the same time, it seems unlikely to have any form of drug price control in the United States, at least, in the foreseeable future. Nevertheless, price pressure due to cut-throat competition could even be more intensive, as it gets reflected even in the US-FDA statements.

Nearer home, the Indian generic drug business has been hit with a double whammy – allegations for dubious drug quality standards, on the one hand, and price manipulation on the other, besides dented reputation and image – widening trust gap with patients and governments.

Moreover, unlike the best export market even for generic drugs – the United States, India has been following some patchy policy measures for health care, as a whole. The drug price control system is one such. Till a holistic policy on health care is put in place for all, backed by an effective monitoring system, The Indian price control system may remain like a ‘maze’, as it were, with several ways to hoodwink it.

Hence, the ‘cat and mouse game’, albeit in a different format, is likely to continue, until one gets caught, or till all concerned puts their act together – putting patients at the center of the core business strategy.

By: Tapan J. Ray    

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.

Drug Quality Imbroglio And ‘Culture of Bending Rules’ in India

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“Bottle Of Lies Exposes The Dark Side Of The Generic-Drug Boom” – re-emphasized the book, released in May 2019.  This confirms, the raging debate on the questionable quality of many generic drugs manufactured in India and involving several top domestic pharma companies, is a never-ending one. Numerous articles also ascribe many different reasons to this saga, leaving an overall impression – as if, blindfolded persons are trying to describe an elephant, touching and feeling different parts of the animal’s body, each at a time.

Let me illustrate the point with the Bloomberg article of January 31, 2019. It reported, “Culture of ‘Bending Rules’ in India Challenges U.S. Drug Agency.” And further commented: ‘The FDA confronts creative improvisation in the world’s largest generic-drug exporter.’ Curiously, according to the above report it seems to be a general belief among many, even within India.

This article will take into account the above apprehension – specifically raised against Indian drug manufacturers of both branded and non-branded generics. Accordingly, my focus will be on just three points – as possible causative factors for this critical issue:

  • Is it an India specific concern – thus related to ‘Indian cultural mindset’? or it’s a global issue, involving both Indian multinational drug manufacturers.
  • Is it a systematic attempt to create a perception bias against low-cost generic drugs, worldwide?
  • Are generic drug makers resorting to such unacceptable shortcuts due to increasing margin pressure?

Having deliberated these points, I shall try to outline a set possible remedial measures to address this issue in a holistic way, ensuring a win-win outcome. Let me first explore, whether or not this issue is specific to India, involving Indian drug manufacturers.

Is the issue India specific?

Is the issue of questionable quality of generic drugs, irrespective of whether they carry a brand name or not restricted to the shores of India? One can find its answer in the same report, as quoted above. A yearlong investigation by Bloomberg News into the generic-drug industry concluded, ‘FDA inspections at factories from West Virginia to China have found reason to doubt the data meant to prove drugs are safe and effective.’

One possible reason for such perception could be, since India is predominantly a branded generic market, voices decrying ‘questionable’ safety and efficacy of cheaper non-branded generic drugs, are too loud. Nevertheless, amidst all this, who’s who of branded generic manufacturers continue getting caught on the wrong foot by overseas regulators in the quality quagmire. Ironically, multinationals are also included in it.

Multinationals are also included in such quality quagmire:

There are several examples of non-compliance to requisite drug quality standards by multinational drug companies. Let me illustrate the point with an example that involves a top global pharma player.

The March 04, 2019 ‘Warning Letter’ of US-FDA for the Irungattukottai (Tamil Nadu) plant of Pfizer in India, clearly said: “Your quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs you manufacture.”

This is not a solitary example of Pfizer’s generic hospital injectables manufactured in this plant. According to a media report dated July 17, 2018, twice before US-FDA had cited manufacturing and testing issues in this facility, containing 11 observations of the regulator, such as, workers “manipulated test sample weights to obtain passing results” for both batches of raw materials and finished product. It is a different matter that the company, later on, decided to close this plant for commercial reasons. Be that as it may, negative perception of generic drug quality is indeed an issue that needs to be addressed without further delay, holistically.

Studies have captured negative perception of generic drugs:

That this is a perception, has been well – elucidated along with its implications, in several studies. A few of which are as below:

A BMJ article concluded: “A significant proportion of doctors, pharmacists and lay people hold negative perceptions of generic medicines. It is likely these attitudes present barriers to the wider use of generics.” It further added, “Negative perceptions of medicine quality along with other drivers contribute towards choosing more expensive medicines in the private sector.”

Endorsing this point, yet another BMJ article inferred: “Negative perceptions of generic medicines and preferential promotion of branded medicines over generics by pharmaceutical companies could influence prescriber behavior and affect trust in healthcare provided in public services. To succeed, access to medicine programs need to systematically invest in information on the quality of medicines and develop strategies to build trust in healthcare offered in government health services.”

Again, in a separate survey of over 2700 physicians on perceptions of generic drugs, more than 23 percent of respondents expressed negative perceptions about their efficacy and nearly 50 percent. reported negative perceptions of generic drug quality. In the same survey, patients also expressed concerns that the lower cost of generics is associated with reduced medication quality.

Although, the above survey was conducted in the United States, the current situation in India, I reckon, is no different, but with one caveat. Here, preferential promotion of branded generic medicines over cheaper non-branded equivalents, by the respective drug manufacturers, could significantly influence prescriber behavior. Therefore, the question that follows: Is this perception-creation based on facts?

Is the negative perception fact-based?

Although, even the US-FDA clearly states that: ‘A generic medicine works in the same way and provides the same clinical benefit as its brand-name version”, I did try to find some conclusive evidence depicting brand name drugs are superior to their cheaper generic equivalents. While doing literature searches, two types of results emerged – there are studies that do not find any significant difference between generic drugs and their branded equivalents. At the same time, a few other studies do suggest that there is a difference between these two, but admitting that these studies are not conclusive. Let me give below examples of each.

No quality difference found between generic drugs and the branded variants: 

I shall quote here three studies, out of which one is India specific. The analysis reported in the above BMJ article, found that ‘the generic and branded variants of the medicines tested were of comparable quality.’

Another study, published by PLOS Medicine on March 13, 2019 also said, “In this study of 8 drug products conducted using 2 large US commercial insurance databases, we observed that use of generics provided comparable clinical outcomes as the brand products.”

An India specific researchon the same also reported, most generic and branded drug users believed that their drugs were effective in controlling their ailments with no significant difference in reported adverse effects and drug adherence.

Slightly different results were also reported with generics, but not conclusive:

One such study questioned, whether generic drugs are truly equivalent to the brand-name versions.This article was published on January 2019 by Harvard Health Publishing with the title, “Do generic drugs compromise on quality?”

This article quoted a Canadian study, published in the October 2017 issue of ‘Circulation: Cardiovascular Quality and Outcomes’, which found that patients who took generic versions of three different blood pressure medications in the months after the generic drugs became available saw increased rates of drug-related side effects.

Was it due to a perception bias?

To ascertain whether or not there is a perception bias, let us look into the following details of the same study along with its conclusion.

In this study, the researchers ‘looked at the numbers of emergency room visits and hospitalizations for 136,177 individuals ages 66 and over (60% of them women) who used any of three blood pressure medications: losartan (U.S. brand name Cozaar), valsartan (Diovan), and candesartan (Atacand). The investigators examined data for the periods 24 months before and 12 months after the generic versions of these medications went on the market. And found that before the generic versions became available, about one in 10 people taking the blood pressure drugs had to go to the emergency room or be hospitalized each month. In the month after each of the generics went into use, the rates of these adverse events went up: 8% for losartan, almost 12% for valsartan, and 14% for candesartan.’ The study authors commented, this might suggest performance differences between the brand-name and generic drugs.

However, analyzing this study, the Harvard article suggested further probe on the question: Did it result from quality problems with the generic versions of these medications or were there other factors that occurred in this time frame?

Another research, aimed at finding, whether patients are more adherent to generic statins than brand-name statins (lovastatin, pravastatin, or simvastatin) and whether greater adherence improves health outcomes, also concluded, “An 8% reduction in the rate of the clinical outcome was observed among patients in the generic group versus those in the brand-name group.” This also wasn’t a conclusive one, either.

Nevertheless, the key point of a ‘perception bias’, is captured in a separate study, where the researchers did find higher rates of psychiatric hospitalization for patients taking generic and AG escitalopram and sertraline, compared with those who initiated the brand-name product. Importantly, they noted that these outcomes were likely due to either residual confounding or generic perception bias.

No quality difference also found between branded and non-branded generics in India:

There are studies, which captured no quality difference between branded generics and non-branded generics in the country. One such India specific study concluded: “Quality of branded-generics is same as for their branded version. The study highlights the need to modify the drug price policy, regulate the markups in the generic supply chain, conduct and widely publicize the quality testing of generics for awareness of all stakeholders.”

Thus, so far, we have seen in this article that concern on quality of generic drugs is neither India specific, nor is it related to ‘Indian cultural mindset.’ And this is, undoubtedly, a global issue, involving both Indian and multinational drug manufacturers. There are also ample evidences available that a systematic attempt is being made to create a perception bias against low-cost generic drugs, worldwide. Let us now look at the third possible causative factor, as I listed above.

Is it due to margin pressure on generic drugs?

The answer to this question was deliberated in an article titled, ‘Generic drug makers feel pinch as prices crumble,’ published in the Financial Times on August 17, 2017. Quoting a top global financial analyst, it reported – global generic drug industry, where Indian manufacturers are major players,has maintained roughly 30 per cent operating margins over a long period of time, with improvements year on year. But, since last few years, there has been a margin degradation, which may possibly further go down – even lower than what it is today.

The article further highlighted, a round of consolidation among their main customers in the US: the wholesalers, have escalated the problem.  Many of these groups have clubbed together to form “mega buyers”, known as general purchasing organizations, that can command large discounts. Moreover, for the US market, another area of ‘concern’ is that the US-FDA has identified boosting competition in the generics market as one of its main priorities. As this reform opens up, it could squeeze the generic drug margins further.

Many envisage that intense cost cutting measures, could have transgressed in the drug quality assurance area, aggravating this issue. Although, it needs to be verified through credible studies, curiously, some signs of improvement in this area has recently been reported.

That said, there appears to be a strange coincidence between recent reports on Indian drug makers showing improvement in USFDA inspection outcomes and attempts to increase generic drug companies and some of their top executives slapped with price-fixing lawsuits in the U.S.This needs to be studied further.

The way forward:

The negative perception of generic drugs, in general, and non-branded generic drugs, in particular, is most likely a well-crafted business issue, rather than a genuine patient safety concern. It calls for an immediate two-pronged approach:

  • Vigorous awareness and educational campaigns on safety and efficacy of generic drugs targeted to patients, medical and paramedical professionals.
  • New regulatory measures, especially the following five:

- No pricing pressure or price control in any form of generic drugs

- Abolish brand names for generic drugs

- Make generic prescription compulsory to boost intense competition and thereby     reducing the price.

- Restrict the number of ingredients in FDC not more than two or three

- Make Uniform Code of Pharmaceutical Marketing Practices (UCPMP) mandatory.

Conclusion:

Thus, the questionable quality of generic drugs is not an India specific concern and involves both Indian multinational drug manufacturers. This is also evident from the analysis, as quoted above, that underscores, ‘FDA inspections at factories from West Virginia to China have found reason to doubt the data meant to prove drugs are safe and effective.’ Many studies have revealed that there is a systematic attempt to create a perception bias against low-cost generic drugs, worldwide.

A sequence of remedial measures, as described above, also include fostering competition, instead of introducing government controls on prices of generic drugs with stringent regulatory oversight being in place.

Thus, the so called ‘belief’ that the ‘culture of bending Rules’ is culpable for dubious generic drug quality in India, is more akin to a strong perception, prevailing in India, rather than based on any scientific analysis related to this issue. This ought to change with a well-coordinated intervention – for patients’ health interest sake.

By: Tapan J. Ray  

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.

For Affordable Access To Quality Healthcare in India, Invest Where The Mouth Is

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On September 25, 2018, well-hyped Ayushman Bharat – National Health Protection Scheme (AB-NHPS), touted as the largest health scheme in the world, was launched in India. Prior to its launch, while announcing the scheme on August 15, 2018 from the Red Fort,Prime Minister Narendra Modi said: “The healthcare initiatives of the government will have a positive impact on 50 Crore Indians,” as it aims to provide a coverage of Rs 5 lakh per family annually, benefiting more than 10 Crore poor families.

Before this scheme was introduced, there were several public funded health schemes in India, introduced by different governments, like National Rural and Urban Health Mission (NRHM and NUHM), Rashtriya Swasthya Bima Yojana etc. Reports also capture that since independence efforts were ongoing in this area. But none worked, due to shoddy implementation. Let’s await the outcome of yet another new health scheme, introduced by yet another government – AB-NHPS.

According to the Government Press Release of January 11, 2019: Ayushman Bharat – Pradhan Mantri Jan Arogya Yojana (PMJAY) aims to provide health coverage during secondary and tertiary hospitalization of around 50 Crore beneficiaries, allocating a sum of up to Rs. 5 Lakh per family per year. The key words that need to be noted is ‘the health coverage during hospitalization’. It also doesn’t cover primary care. Interestingly, some of the larger states, such as Punjab, Kerala, Maharashtra, Karnataka and Delhi are, reportedly, yet to come on board, Odisha has refused to be a part of the scheme.

Conceptually, the above new health initiative, aimed at the poor, is praiseworthy.  However, its relevance in reducing a significant chunk of one of the highest, if not the highest, ‘Out of Pocket (OoP’) expenses towards health in India, raises more questions than answers.

This is because, whether annual ‘OoP’ for health, incurred by the country’s poor population, goes more for hospitalization than Primary Health Care (PHC) involving common illnesses, is rather clear today. In this article, I shall dwell on this subject, supported by credible published research data.

But ‘the Primary Health Care (PHC) is in shambles’:

Since the focus of (AB-NHPS) on ‘secondary and tertiary hospitalization’, one may get a feeling that the primary public health care system in India is, at least, decent.

But the stark reality is different. The article titled, ‘Five paradoxes of Indian Healthcare,’ published inThe Economic Times on July 27, 2018 describes the situation eloquently. It says: ‘While the Supreme Court has held health care to be a fundamental right under Article 21 of the Constitution…The fundamental aspect of health care – the primary health care is in shambles. There is only one primary health care center (often manned by one doctor) for more than 51,000 people in the country.’

In addition, the World Bank Report also flags: ‘The tenuous quality of public health assistance is reflected in the observation that 80 percent of health spending is for private health services, and that the poor frequently bypass public facilities to seek private care.’ Although, World Bank underscored this problem sometime back, it persists even today, sans any significant change.

PHC has the potential to address 90 percent of health care needs:

For the better health of citizens, and in tandem to contain disease progression that may require hospitalization for secondary and tertiary care, government focus on effective disease prevention and access to affordable and high quality PHC for all, is necessary. ‘Evidences gathered by the World Bank have also highlighted that primary care is capable of managing 90 percent of health care demand, with only the remaining 10 percent requiring services associated with hospitals.’

Another article titled, ‘Without Primary Health Care, There Is No Universal Health Coverage,’ published in Life – A HuffPost publication on December 14, 2016, also vindicates this point. It emphasized: ‘Primary health care (PHC) has the potential to address 90 percent of health care needs. However, country governments spend, on average, only one third of their health budgets on PHC.’ The situation in India is no different, either.

This basic tenet has been accepted by many countries with ample evidences of great success in this direction. Curiously, in India, despite the public PHC system being in shambles, the government’s primary focus is on something that happens only after a disease is allowed to progress, virtually without much medical intervention, if at all.

Key benefits of a strong PHC system:

As established by several research papers, such as one appeared in the above HuffPost publication, and also by other research studies, I am summarizing below the key benefits of having an affordable and strong PHC network in the country:

  • Can manage around 90 percent of the population’s health care need, patients would require hospitalization for specialists care only 10 percent of the time.
  • Can help people prevent diseases, like malaria or dengue, alongside effectively assist them in managing chronic conditions, such as hypertension or diabetes, to avert associated complications that may require secondary or tertiary care.
  • At the country level, a strong PHC system would help detect and screen illnesses early, offering prompt and effective treatment. The system, therefore, will support a healthier population, and would ‘offer much more than simple reduction of the costs of a country’s health.’
  • A country can ensure greater health equity by providing PHC advantages of greater accessibility to the community, and across the social gradient.
  • In short: ‘The continuity and doctor–patient relationships offered by family oriented primary care, alongside the patient education, early intervention and treatment, chronic disease management, counseling and reassurance offered to patients would be impossible to provide in a secondary care setting.’

Thus, establishing a robust network of high-quality public PHC facilities in the country is a necessity. Simultaneously, patients should be made aware of visiting the nearest PHC as their first stop for affordable treatment, when they fall ill.

Annual ‘OoP expenses’ more on ‘out-patient care’ than ‘hospitalization’:

For illustration, I shall provide examples from just two studies, among several others, which found, average ‘OoP expenditure’ per family in a year, is more for ‘out-patient care’ than ‘hospitalization.’

Since long, ‘OoP expenditure’ on hospitalization was being considered as the most important reason for impoverishment. Probably, this is the reason why various governments in India, had launched various health schemes, covering hospitalization expenses of a large section of the poor population in the country. The most recent one being – Ayushman Bharat-National Health Protection Scheme (AB-NHPS), often termed as ‘Modicare’, launched in September 25, 2018.

That total ‘OoP expenses’ are more on ‘out-patient care’ than ‘hospitalization’ was emphasized even in the 2016 research article titled, ‘Out-of-Pocket Spending on Out-Patient Care in India: Assessment and Options Based on Results from a District Level Survey,’ published online by PLoS One on November 18, 2016.

Highlighting that ‘OoP spending’ at ‘Out-Patient Departments (OPD)’ or in clinics by households is relatively less analyzed compared to hospitalization expenses in India, the results indicate:

  • Economically vulnerable population spend more on OPD as a proportion of per capita consumption expenditure.
  • ‘Out-patient care’ remains overwhelmingly private and switches of providers -while not very prevalent – is mostly towards private providers.
  • High quality and affordable public providers tend to lower OPD spending significantly.
  • Improvement in the overall quality and accessibility of government OPD facilities still remains an important tool that should be considered in the context of financial protection.

Let me now cite the second example – analyzing the 60th national morbidity and healthcare survey of the National Sample Survey Organization (NSSO), the study found, ‘outpatient care is more impoverishing than inpatient care in urban and rural areas alike.’

Expert committee’s recommendations for focus on ‘primary care’ went unheeded:

That the government focus on public health care should be on PHC, along with prevention and early management of health problems, was recommended by ‘The High-Level Expert Group Report on Universal Health Coverage, for India.’ This committee was instituted by the then ‘Planning Commission’ of the country on November 2011. The report also suggested, such measures would help reduce the need of secondary and tertiary care, significantly. But not much attention seems to have been paid even on these critical recommendations.

Conclusion:

Going by what Indian government says, I believe, its ultimate goal is providing access to affordable Universal Health Care (UHC), for all. That’s indeed commendable. But as various research papers clearly indicates, the country will first ‘need to invest in a ‘primary-care-centered’ health delivery system, if universal access to health care is to be realized, ultimately.

From this perspective, Ayushman Bharat – National Health Protection Scheme (AB-NHPS) may be a good initiative. But it does not seem to merit being the primary focus area of the government in public health care. And, not more than establishing high quality and robust ‘primary health care’ infrastructure, across the country, for all. Nor will AB-NHPS be able to address higher average of out-of-pocket ‘outpatient expenses’ of those people who need help in this area, the most.

Considering the critical public health care issue in India holistically, I reckon, for providing affordable access to health care for all, the top most priority of the Government should be to invest first where the mouth is – to create affordable primary healthcare infrastructure of a decent quality, with easy access for all.

By: Tapan J. Ray   

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.

Access To Comprehensive Healthcare Merits Multipronged Approach

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Since the turn of the new millennium, several high profile and flagship health schemes are being announced in India by the Union successive governments. Some of the important ones will include the National Health Mission, Rashtriya Swasthya Bima Yojana (RSBY) - a Health Insurance Scheme for the Below Poverty Line families and now Ayushman Bharat – National Health Protection Mission - expected to cover over 100 million poor and vulnerable families providing coverage up to 500,000 rupees per family per year for hospitalization related to secondary and tertiary care.

Besides, the Mental Health Care Act 2017 has been operational since last year. It was passed by the Rajya Sabha in August 2016, and the Lok Sabha on March 2017. The right to mental health care is the core of the Act.

Each of these announcements look good on paper and was accompanied with lofty government promises. Riding on the waves of hypes thus created, public expectations increased commensurately for getting easy access to a comprehensive and affordable health care, which now includes ‘Mental Health’ as well. Unfortunately, the Gordian knot in Indian public healthcare space continued to exist. As various reports  indicate, for example, one that appeared on November 27, 2018, – even Ayushman Bharat is apparently moving towards the same detection driven by some critical basic issues.

Consequently, scores of people still do not have adequate and affordable access to basic health care, including essential drugs – clamping price control notwithstanding. The government knows it well, as it increases vigil on drug pricing. Pharma industry also feels its scorching heat. Overall storyline remains mostly unchanged. The vicious cycle continues.

In this article, I shall dwell on a system-approach to delivering comprehensive public health care. The key objective is trying to figure out what is the core problem that most of these schemes are either not addressing or doing it with a ‘band-aid’ approach. One of the key requirements for improving access to health care significantly, I reckon, is a clear understanding on the characterizations of the critical stages of healthcare access and their dimensions, from the patients’ perspective.

However, before doing so, let me glance upon some health care related current and important facts, as uploaded in the government’s National Health Profile 2018.  

National Health Profile 2018:

As available in the National Health Profile (NHP) of India – 2018, following are some of the important facts, which are worth noting:

  • In the current budget year, public (government) spending on health is just 1.3 per cent of the GDP against the global average for the same at 6 percent.
  • Just one doctor serves a population of 11,000 people, which is way below W.H.O recommended a doctor to population ratio of 1:1,000. The scenario is even worse in many states, such asBihar with 1: 28,391, Uttar Pradesh records 1:19,962, Jharkhand with 1:18,518, Madhya Pradesh shows 1:16,996 and Chhattisgarh at 1:15,916.
  • Per capita public expenditure by the government on health, stands at Rs 1,112 that comes to Rs 3 per day. This puts India below other low-income nations like the Maldives (9.4), Bhutan (2.5), Sri Lanka (1.6) and Nepal (1.1).

These numbers provide just a flavor of the Indian healthcare space, as it stands today. Some may of course talk about legacy factor, but to move ahead more important for all is what is happening today in this regard. Yes, one more health mission, as mentioned above, has been launched on September 25, 2018 with similar hype as the past ones, if not more. Only the future will tell us what changed it brings to the ground. That said, I am not very upbeat about it either, as providing a comprehensive health care access has always been multi-factorial and will remain so. Let me now dwell on why I am saying so.

Understanding health care access:

The 2013 research paper on “Improving Healthcare Access in India” by erstwhile IMS Consulting group (now IQVIA), said that ‘health care access characterizes 3 stages,’ which from the patient’s perspective has 4 key dimensions. In the Indian context, these three stages are:

  • Accessing care: Physical reach and location
  • Receiving care: Availability/capacity, Quality/functionality
  • Paying for care: Affordability

Accordingly, healthcare access is a function of 4 key aspects:

  • Physical reaches to health care facility
  • Availability of doctors and medicines in those places
  • Quality of care provided by these centers
  • Affordability of treatment, if available there

Access to healthcare is slowly improving, but far from being enough:

All the above schemes of the government are primarily focused on ‘paying for care’ stage and ‘affordability’ of treatment, including drugs. To a limited extent it makes sense as the above study vindicates that ‘availability’ and ‘affordability’ have good impact on ‘access to health care’.

Since the inception of NHM, this approach, no doubt, has made some improvement in the overall access to health care in the country, as many studies indicate. The IMS Consulting study also observes that compared to 2004, more patients received free medicines in outpatient care in 2013 – over 50 percent of patients going to Government hospitals say that they get free medicines there. However, the outcomes of the same across the Indian states vary quite a lot.

Inadequate healthcare infrastructure and physical reach in rural areas:

Having noted that, grossly inadequate availability of public health care infrastructure – or when available physical access to many of those from remote villages, coupled with lack of availability of required doctors, paramedics, nurses and medicines in those dispensaries – often become major issues. Moreover, their capacity to providing quality care, besides longer waiting time, often pushes many – either to remain virtually untreated or to go to private care centers costing much more.

The study finds that such movement of people from public to private facilities leads to higher health care costs. Consequently, high usage of private channels drives up the out of pocket (oop) cost of treatment. Some of the details are as follows:

  • 74 percent of patients sought private consultation
  • 85 percent of ‘oop’ spending on health care was in the private sector
  • 81percent of patients incurred ‘oop’ expenditure for medicines

Curiously, 35 percent of patients in the study rated public health facilities as – good. Whereas an overwhelming 81 percent said so for private facilities. Nevertheless, associated high ‘oop’ expenditure for the same often becomes an economic burden. The large number of patients with chronic ailments, are the major sufferers.

Application of mobile-health could help improve access:

On improving access to health care in India, an interesting ‘Review Article’ titled, “Applications of m-Health and e-Health in Public Health Sector: The Challenges and Opportunities”, appeared in the International Journal of Medicine and Public Health, April-June, 2018 issue, makes some thought-provoking observations.

It says, while the use of mobile phone (MPs) has become commonplace in many industry sectors, such as banking, railways, airlines – the public health sector has been somewhat slow in adopting MP technologies into routine operations. Its innovative use can benefit patients and providers alike by enhancing access to health care.Smartphones’ usefulness in the treatment of chronic diseases – for example, monitoring of blood pressure, blood sugar, body weight, electro- cardiograph (ECG), has already been established.

The paper also suggests, mobile health (m-H) is more effective when tailored to specific social, ethnic, demographic group using colloquial language. If implemented craftily and systematically, m-H can revolutionize the scenario of the health care delivery system, in many ways. Optimal doctor-patient engagement policy for m-H needs to be formulated, outlining a legal framework and with multi-stakeholder collaboration.

Mental health still largely ignored:

Another important aspect of comprehensive health care is ‘Mental Health’, as more than 60 million Indians suffer from mental disorders, suicides being one of the major killers in India (Source: W.H.O, IndiaSpend). However, it is disturbing to note that awareness and access to mental health treatment, especially in the hinterland of the country, continue to remain ignored. Increasing incidences of farmers’ suicides, for example, notwithstanding.

This was further elaborated by the IndiaSpend report of January 30, 2018, which underscored:“Allocation to the National Program for Mental Health has been stagnant for the past three years. At Rs 350 million, the program received 0.07 percent of India’s 2017-18 health budget.This is despite the fact that an estimated 10-20 million Indians (1-2% of the population) suffer from severe mental disorders such as schizophrenia and bipolar disorder, and nearly 50 million (5 percent of the population) – almost equal to the population of South Africa–suffer from common mental disorders such as depression and anxiety.”

The report further highlights that, notwithstanding 15 suicides every hour and 133,623 suicides in 2015, India is short of 66,200 psychiatrists and 269,750 psychiatric nurses. It is also noteworthy, while a frugal sum of 0.06 percent of India’s health budget is for mental health care, the same for even Bangladesh stands at 0.44 percent (Source: W.H.O, IndiaSpend).

Conclusion:

From the above perspective, I reckon, although access to health care in India, except ‘mental health care’, is improving at a modest pace, it doesn’t seem to be anywhere near adequate, as on date. A holistic approach for a comprehensive health care access to all, through the public health system, seems to be the need of the hour.

That said, currently India is not meeting the minimum W.H.O recommendations for healthcare workforce and also in bed density. A large section of the population continues to lack affordable access to quality health care. Moreover, the importance of mental health is still unknown to many in the country.

Thus, in tandem with addressing all the three stages and four key dimensions of comprehensive health care access, it is imperative to leverage new technology-based       e-healthcare and digital devices like m-Health. Together, these will help provide and facilitate not just quality care to patients, but also complement the healthcare infrastructure, including doctors and paramedics – making quality and affordable health care accessible to all.

As I said in my article, titled ‘Mental Health Problem: A Growing Concern in The Healthcare Space of India, the ‘Mental Health Care Bill’, which is now an Act, redefines mental illness to better understand various conditions that are persistent among the Indian population.This is a good development, as it aims at protecting the rights of persons with mental illness and promote access to mental health care. Since, the current ground reality in this area is a cause of great concern, when will it be effectively implemented for all, is the all-important question.

It is imperative for all concerned to understand that improving access to comprehensive health care is multi-factorial issue. Therefore, it needs nothing less than a well-thought out multi-pronged approach for an effective solution.

By: Tapan J. Ray    

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.