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Would “Digital Health Equity” Augment Healthcare For All in India?

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A June 2014 report titled “Digital Health Equity: Humanizing e-Health” published by ‘ZeroDivide’, which helps transform communities through technology in the United States, highlighted that the digital revolution of daily life has significantly impacted healthcare in many parts of the world.

As a result, the relationship between the consumers and healthcare providers has just begun to change significantly, though in bits and pieces at present. Wherever it is happening, the consumers expect to get highly engaged in managing their own health, primarily using online and mobile tools and other devices.

“Digital Health”/ “e-Health” to ensure equity in healthcare:

Advancement in e-Health is currently restricted mainly to economically and socially privileged populations. Those with the access, resources and basic digital skills are reaping disproportionate benefits from the technology and other associated infrastructure available for this purpose.

Unfortunately, underserved population, mostly in rural hinterland and some in urban areas still do not have much access to this technical advancement in the healthcare space.

Ensuring “Digital Health” in the new age digital India, would help augmenting quality healthcare support with equity to all in the country.

A beginning has been made:

It is good to note that key stakeholders in health related areas both in public and private sectors are now exploring the ways in which the Internet, digital devices and other related applications can improve patient care, reduce the cost of care and improve overall population health.

Central and State Governments, policymakers, technologists and health insurance providers are eager to connect underserved consumers to online health services and other e-Health applications. Regrettably, few digital tools have been designed with these consumer populations in mind, to date. The nascent field of e-Health research has thus far poorly characterized the impact of race, ethnicity, gender and socioeconomic status on e-Health adoption and use.

General barriers to e-Health:

The previous policy paper of ‘ZeroDivide’ titled, “e-Health and Underserved Populations,” identified 8 barriers, though in the US perspective, that underserved communities face in accessing and utilizing e-Health tools. These are as follows:

• Lack of health literacy

• Lack of linguistic and cultural competency in e-Health

• Access limitations for people with disabilities

• Privacy concerns and distrust in the health system

• Lack of digital literacy

• Limited or no access to broadband and mobile data

• Limited or no access to technology platforms and interoperability

• Lack of awareness of e-Health

Very surprisingly even today all these 8 barriers are very relevant to India, as well.

A key concern:

‘ZeroDivide’ report also highlighted a key area of concern in e-health initiatives. This is ‘Interpersonal relationships’ between the healthcare consumers and the healthcare providers. Consumers’ perception in the study was that technology interfered with the patient-provider relationship.

In their view, technology can alienate providers from their patients, impeding the relationships that are important to providing quality care.

In India, it appears, this perception is equally valid and needs to be addressed effectively, in the process of implementation of e-healthcare in the country.

e-Health in India:

In August 2014, the Director General Health Services (DGHS), Ministry of Health and Family Welfare reportedly announced that his Ministry “has already prepared the white paper of the e-Healthcare service, which will be a boost to raise awareness among the people in the country, who remain completely deprived of the health services initiated by the government,”

He also said, e-Healthcare system basically being a web portal, would help the government connecting with the people on every health-related program and various schemes that would enable them getting free medical treatment.

Accenture – a global management consulting, technology services and outsourcing company, in one of its reports of 2014 titled, “Delivering e-health in India – Analysis and Recommendations” also echoed that a ‘Citizen Portal’ is expected to serve as a single point of access for consolidated health information and services.

It also recommended that keeping population diversity in mind, the web portal should have multi lingual support and be available both on web and mobile (also through an SMS/IVR gateway). People in rural areas would, therefore, be able to access citizen portal more easily through mobile applications as mobile penetration is quite significant in India.

Accenture also acknowledged that a small fraction of population now uses a web portal to interact and share information with providers. With the introduction of state health portals for the citizens, the use of health portals is likely to skyrocket in the coming years. If that happens, its impact on healthcare would indeed be phenomenal.

Moving towards this direction, some experts have also suggested the Government to set up ‘National e-Health Authority of India (NeHAI)’ immediately to formulate the National e-Health Strategy (NeHS) and chart an innovative actionable pathway in this area.

It is interesting to note that according to the Ministry of Health, over 39 million people in India still remain deprived of basic healthcare services, which in most cases lead to death.

Types of e-Health program in India and challenges:

According to a 2014 paper titled, “In e-Health in India today, the nature of work, the challenges and the finances: an interview-based study”, published in ‘BMC Medical Informatics and Decision Making 2014: 14:1’, a range of e-Health programs is currently being run in India, including point-of-care in rural and urban areas, treatment compliance, data collection and disease surveillance, and distant medical education. Most programs provide point-of-care to patients or other beneficiaries in rural areas.

The article states that technology is not a limiting factor, but the unavailability of suitable health personnel is a major challenge, especially in rural areas. Financial sustainability is also a concern for most programs, which have rarely been scaled up. Government facilities have not been very effective in e-Health on their own, just yet, but collaborations between the government and non-profit (in particular) and for-profit organizations have led to impactful programs.

Though increasing number of various e-Health service providers is coming up in India, lack of general awareness and also acceptance of e-Health among potential healthcare consumers continue to remain a critical challenge.

I deliberated on different issues with e-Health in my blog post of May 9, 2011 titled, “e-healthcare: A new vista to improve access to quality and affordable healthcare in India”

Conclusion:

India is a nation with vast unmet medical needs. At least now, every citizen of the country should be provided with the facilities to meet most of those unmet medical needs.

e-Health through “Digital Health Equity”, has the potential to improve the quality of healthcare in India and ensure its adequate access, especially, to the underserved population of the country.

It is imperative, therefore, to scale up design and development of innovative and cost-effective e-health related digital tools to ensure equity in healthcare and, at the same time, augment quality healthcare services for all in India.

This endeavor would entail much stronger efforts towards health literacy programs and translating existing digital tools into multi-lingual versions to reach the underserved health consumer, especially in rural India.

As e-Health continues to evolve in India in an organized manner, many critical challenges currently faced in the health systems of the nation, would potentially be mitigated through wide deployment of Information and Communications Technology (ICT).

Some of these key challenges are:

  • Shortages of health workers, especially in rural India
  • Variable quality of cares; between urban and rural, as well as, public and private healthcare providers
  • Uncertainty in patient compliance
  • Fraud in healthcare delivery system

Propelled by the Government initiative all stakeholders; such as technology designers/engineers, healthcare providers, policymakers, payers and especially the consumers; should work in unison to achieve the long cherished health outcomes in India: “Health For All”.

In the next five years, would the ‘Digital India’ spearheaded by the “Smart Cities” be able to ensure “Digital Health Equity” to augment healthcare services for all in India?

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.

FDC Saga: Defiant Manufacturers, Sloppy Regulators and Humongous Inaction

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“TO SIN BY SILENCE WHEN THEY SHOULD PROTEST MAKES COWARDS OF MEN”       – Abraham Lincoln

The ghost of untested, irrational and even of bizarre kind of Fixed Dose Combination (FDC) drugs, which continue to be launched, promoted, prescribed and sold freely across the length and breadth of India, has started haunting the Ministry of Health of India, yet again, in 2013. 

Though the issue originated decades ago, in 1988 appropriate ‘Rule’ of the Drugs and Cosmetics Act of India was amended suitably to have a firm regulatory grip over this situation. Despite this much awaited amendment, the situation almost went astray with incessant market entry of a large number untested FDC medicines of dubious medical rationale.

A free for all situation, as it were, in the FDC arena, continued to be facilitated by blatant laxity on the part of, especially, the state drug regulators by allowing unfettered market entry of such drugs, ignoring the CDSCO directive.

On the other hand, the Central Drugs Standard Control Organization (CDSCO), despite its statutory powers,  continued to suffer from humongous inaction untill the issue resurfaced again in 2007 and then of course, now in 2013.

The WHO Model:

The 2005 ʹProcedure to update and disseminate the WHO Model List of Essential Medicines, Criteria for Selection’ includes the following statement regarding Fixed Dose Combination products (FDCs):

ʺMost essential medicines should be formulated as single compounds. Fixed‐dose combination products are selected only when the combination has a proven advantage over single compounds administered separately in therapeutic effect, safety, and adherence or in delaying the development of drug resistance in malaria, tuberculosis and HIV/ AIDS.ʺ

Thus, FDCs:

  • Need to demonstrate clinical efficacy and safety beyond the individual drugs when given alone.
  • Need to ‘demonstrate bioequivalence of the single combined dose unit with the components administered in the same doses separately but concomitantly’.

‘Adherence’ aspect of WHO Model for FDCs is also important. Problems with ‘adherence’ could lead to inadequate and inconsistent dosing, which in turn could lead to development of drug resistance.

With robust and unquestionable medical rationale, FDCs are expected to provide superior efficacy and improved compliance without causing any untoward risk to patients.

A major disadvantage:

However, one of the major disadvantages with the FDCs is lack of flexibility in adjusting dose of individual ingredients, even if it is required for some patients. Internationally, most popular example is the FDCs of antiretroviral drugs for HIV infected patients like, Combivir, Trzivir, Kaletra etc.

Interestingly, in India there are FDCs for almost all disease areas from allergic disorders to Wolf-Parkinson-White syndrome (exaggerated), as it were.

Market attractiveness for FDCs in India: 

The domestic market for FDCs is very large and growing much faster, in sharp contrast to the western world. The following table will vindicate this point:

% Share

Drug

2008

2009

2010

2011

Plain

55

55

55

54
Combinations

45

45

45

46

Domestic Market: USD 13 Billion; MAT Apr 2013

Source:IMS

Thus, because of growing market demand, pharmaceutical companies in India tend to market FDCs of all different permutations and combination, at times even crossing the line of any ‘sound medical rationale’. For this reason, we find in the website of ‘Central Drugs Standard Control Organization’ (CDSCO), the banned list of so many FDCs.

A messy regulatory situation:

Introduction of new FDCs does not only warrant a ‘sound medical rationale’ but also ‘strict conformance to all prescribed regulatory requirements’ for patients’ interest. 

To check unfettered market introduction of potentially harmful FDCs, the Ministry of Health issued a Notification in September 1988, including FDCs in Rule 122 E of the Drugs & Cosmetics Rules (D&CR) 1945.

In effect, it removed the powers of the State FDAs to give manufacturing or marketing approval of FDCs. After the notification was issued, all manufacturers/marketers of all new FDCs are required to apply only to the Drug Controller General of India (DCGI) under Rule 122E of the D&CR 1945 as a new drug, along with the stipulated fees by way of a Treasury Challan.

Since this entire process entails appropriate regulatory data generation, besides  time and expenses involved, the above ‘Rule’ was continuously and deliberately broken and manufacturing and marketing approvals for various types of FDCs falling under ‘new drug’ category were regularly sought and granted by the State Drug Controllers.

Many believe that the State FDAs were equally responsible for knowingly flouting the Law, as were the pharmaceutical manufacturers.

Patients’ safety – the foremost concern:

Despite serious concerns expressed by a Parliamentary Standing Committee, this complicity resulted in the market being flooded with ‘irrational combinations’ which posed a real threat to patients’ interest and safety. The State FDAs were reminded of the notification by the earlier DCGI.

294 FDCs were banned by the DCGI in 2007. Thereafter, the important issue of patients’ interest and safety got converted into a legal quagmire, as many FDC manufacturers chose to go to the court of law to protect their business interest and also managed to obtain a ‘Stay’ order from the Madras High Court. The matter is still subjudice.

Be that as it may, those 294 FDCs banned by the Ministry of Health of India on health and safety grounds continue to be promoted, prescribed and sold to patients across India without any hindrance, whatsoever.  

Untangling the messy knot:

As the issue got entangled into prolonged litigations, the CDSCO took initiative of resolving this contentious issue again in 2009 with the help of an expert committee, involving the manufacturers.

This subcommittee cleared 48 FDCs under ‘similar FDCs already approved’, after discussing the merits and demerits, including pharmacodynamics, pharmacokinetics, side effects, dosage, medical rationale etc. of each ingredient and the combinations. The decision of the Sub Committee was then submitted to the Drug Technical Advisory Board (DTAB).

After formal approval of DTAB, these combinations are construed to be new drugs and any company wishing to market/manufacture the formulation would require submitting its Application in Form 44 to the DCGI to get approval in Form 45.

This decision was expected to send a clear signal to all concerned that resorting to any form of shortcuts to bypass strict adherence to prescribed regulatory requirements, could seriously jeopardize patients’ interest and safety. The same process was subsequently followed for the balance 142 FDCs, as well.

Thereafter, a special committee was again appointed by the CDSCO in 2013 to look into this matter in a holistic way. However, such sporadic knee-jerk reactions have failed to deliver any tangible results in this area – not just yet.

The saga continues:

Even after the above critical decision of the DTAB the saga still continues.

In March 2013, by a written reply, the Minister for Health and Family Welfare reportedly informed the Lok Sabha (the lower House of the Parliament) that in twenty three cases of new FDC, licenses have been granted by the State Licensing Authorities (SLAs) without the mandatory approval of the DCGI and action will be taken in all these cases.

However, no one seems to know, as yet, what action the Government has taken against those errant officials.

Current scenario:

Recently, the Directorate General of Health Services (DGHS) by a notification to State Drug Controllers has reportedly ordered all manufacturers of new FDC products, licensed locally before October 2012 without CDSCO permission, to submit safety and efficacy data prior to 30 August 2013.

This decision of DGHS has created a furore within the concerned FDC manufacturers, yet again, the possible outcome of which is yet to be ascertained.

The State Drug Controllers had issued manufacturing licenses for these FDCs prior to October 2012. At that time concerned manufacturers were given 18 months time period to prove efficacy and safety of these medicines to the DCGI. Regrettably, as per the above report, the DCGI has confirmed that he has received hardly any response from the FDC manufacturers till date on this regulatory requirement.

CDSCO has also stated that manufacturers, who will fail to submit the required data by the deadline run the risk of having their products banned from the market.

Before this, the State Drug Controllers were informed about this requirement on January 15, 2013.

At this point it is worth mentioning, the DCGI in October 2012 had reportedly also barred the State Drug Controllers from granting manufacturing licenses to pharmaceutical companies under brand names of the drugs, directing them to strictly issue licenses under generic name of the molecule. Additionally, he also asked the state licensing authorities not to grant licenses to combination drugs, which are technically ‘new drugs’ and fall within the domain of DCGI only.

Conclusion:

This logjam with FDCs certainly cannot continue in perpetuity, neither should such regulatory sloppiness be acceptable to any right thinking stakeholder.

All blatant violations of Drugs and Cosmetics Act of India must be stopped forthwith and the violators be brought to justice without delay. Patients’ health interest, as required by the drug regulators, is non-negotiable.

The order of DGHS asking all manufacturers of new FDCs, licensed locally before October 2012 without CDSCO permission, to submit safety and efficacy data prior to 30 August 2013, should not follow recently reported Pioglitazone type of volte face, once again, under similar outside pressure.

It is high time now for the Government to bring the unending saga of  irrational and harmful FDCs, orchestrated by defiant manufacturers, encouraged by sloppy regulators and catalyzed by humongous systemic inaction, to its logical conclusion, for patients’ 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.