Tag Archives: events

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

Posted on by
Reply

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.

 

Time To Audit Pharma’s Doctor-Engagement And Other Digital Strategies

Posted on by
Reply

It’s now over a year since the unprecedented global health crisis commenced. In this grueling saga, a silver lining is also visible. It helped pharma industry gain a fascinating operational experience, while navigating through disruptive business changes. The changes in the health care ecosystem, ranges from rapid espousal virtual medical care to the meteoric rise of e-marketing and e-visits to physicians.Encouragingly, the entire industry displayed a remarkable resilience to quickly get on to its feet, after initially getting knocked down by the overpowering impact of the pandemic.

One critical pharma-brand demand generating tool – in-person engagement between doctors and pharma reps, also came to a grinding halt – almost overnight, as it were, for well-known reasons. Moreover, companies started facing a crippling situation for all physical business events, such as, Continuing Medical Education (CME), active participation in medical conferences, patient engagements, and so on – as an integral part of their brand or corporate value delivery strategy.

Catching many by surprise, almost in no time, finding no other effective alternatives, several drug companies imbibed e-marketing – many of them in bits and pieces, though. Interestingly, technology based organizational transformation, which was progressing at a snail’s speed, thus far, gained momentum during the pandemic. Since then, there hasn’t been any looking back in this area. Instead, the speed of digital transformation in pharma is expected to accelerate further, as we move on.

Notably, many doctors are still not inclined for in-person sales calls. But, they haven’t stopped looking for product and other information from drug companies. More importantly, after more extensive charting the cyberspace during lockdowns, information requirements of many doctors have changed significantly, as confirmed by various surveys. The same holds good regarding their preferred channels of information and interaction.

This prompts one to ponder over a critical question. Although, a shift towards digitalization, including pharma marketing, is necessary in the changing scenario, do companies need to audit their digital marketing strategies in this area – now?

Nonetheless, this performance audit needs to be an independent assessment of a company’s e-marketing operations to assess whether its digital programs or functions are working as intended to achieve the expected goals. This article will dwell on this subject.

Are companies satisfying doctors’ information needs digitally?

The answer to this question was captured in a recent survey conducted by Abelson Taylor/Veeva. Some of its important findings are as follows:

  • Amid peak of Covid pandemic, 42 percent physicians surveyed, wanted from drug companies, specific treatment protocols tailored to their patient populations. Alongside, they also need to know the latest Covid related developments in medical silences, information on how the outbreak impacts their day-to-day practice, and how they deal with patients. The survey revealed, most of these unconventional information needs were slow to arrive to many doctors.
  • 83 percent physicians reported they hadn’t received any new information from reps, even remotely, in the week before the survey – in late March 2020.
  • Despite reps’ visits being more preferred by doctors, which included e-visits and tele-detailing calls, these declined by 63 percent, while emails between the two increased by 263 percent during the same period.
  • The average time for online meetings is now 17 minutes, despite the above preferences of doctors – versus a pre-Covid average meeting time of just six minutes. One reason could be doctors had more time with them as patient calls were less.

Therefore, the question arises, couldn’t these visits be made more customer need oriented? The possible reason for the same could be lack of simultaneous feedback mechanism for pharma marketers. Similar assessment is essential in other related areas, as well. Because, for reps’ effective virtual ‘visits’, data based – right selection of customer-preferred digital channels, content and formats for communication is crucial.

For Rep’s effective e-visits – channel, content and format selection is vital: 

This area has been well-researched in an India specific article, published by Bain & Company on December 20, 2020. The study found that physicians in India are more likely to engage with certain channels, content and formats for virtual ‘visits’ of medical reps.

The study also found – otherwise, physicians’ click-rates for digital information from pharma companies has traditionally been low – at an average around 10 percent to 15 percent, with some variation for specialties. Thus, with well researched e-visit strategy, pharma companies will have the opportunity to double or even triple levels of engagement in many cases, the study assessed. However, the drug companies would need to necessarily tailor their digital programs to physician preferences.

The study found the preferences of Indian doctors’ in these areas, as below:

Preference

1

2

3
Channel 71% – WhatsApp 20% – E-mail 3% – SMS
Content 29% – Publication findings 26% – Clinical Case Study 12% – Promotional Brand
Format 55% – Videos 15% – Articles and infographics

The above data, therefore, suggest:

-  Physicians in India overwhelmingly prefer communication via WhatsApp, with click rates 3.5 times higher than email and nearly 24 times higher than SMS.

-  Content matters: Scientific content, such as published findings and clinical case studies, generated up to 2.5 times higher engagement than promotional brand content.

- And format makes a difference too, with physicians 3.5 times more likely to click on short video content than articles and infographics.

These vindicate the point – pharma players in India require to initiate a meaningful process of an independent periodic review of their digital strategies – now. More importantly – based on the company-specific emerging trends, if a player quickly adapts accordingly, the possibility of getting a bigger bang for its buck on physician outreach,’ would likely to be high – even in the new normal.

Some key points to consider during long-term digital strategy formulation:

Just as today’s pharma operations aren’t a replica of 2019 and before, the same holds good for tomorrow and thereafter, as the process, span and magnitude of digitalization will keep improving. A glimpse of the same is available in an article on digitally engaged physicians during the digital health transition, published in PLOS ONE, on September 28, 2020. Following are the two – among several other points, on further democratization of medical information, as articulated by the authors:

  • Broader role of doctors is during the digital transition. Companies need to spot and understand quickly how it’s evolving over a period of time.
  • Digitally engaged physicians may also consider themselves as a guide and participate in the medical information managing function – in the description, collection, and sharing of credible content in the online space.

Conclusion:

Nevertheless, a section within the pharma industry still nurtures the hope of a return to the ‘old normal.’ Whereas most others don’t really subscribe to this seemingly unrealistic hope. Hence, even after the pandemic gets over, some critical changes are likely to last longer. These include more e-visits of reps than in-person doctor calls, webinars for doctors and patients, in company virtual meetings for training and other strategic physical events. None of these are expected to happen in similar frequency, scale and manner as what used to happen in 2019 and before.

Further, in the new normal, with more enlightened and digital savvy customers around, just talking the talk of ‘patient-centricity’ will no longer suffice. Companies will need to walk the talk - mostly through more transparent digital platforms, henceforth. Similarly, just talking about data and analytics won’t just be enough, pharma companies need to marshal enough wisdom in their people inventory, to capture and make productive use of credible data and information.

Undoubtedly, pharma’s digital strategies in all these areas have started taking roots. However, the yield of the same, apparently remains much below their potential, in most cases, for various reasons. Which is why, I reckon, an independent, in-depth, and periodic audit of each pharma company’s doctor-engagement and other digital strategies, since the onset of Covid-19 pandemic, is now essential.

The objective is not to revert to the old traditional model – jettisoning the digital transformation pathway, especially in pharma marketing, especially when the yield is low. The idea is to review or redraft the digital strategy, based on periodic audits. Or it may even be just tightening some loose knots of a patient-centric and doctor-friendly contemporary game plan for business excellence in the new environment.

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.

 

Marketing Off-label Use of Drugs: A Path Much Abused?

Posted on by
Reply

As many would know, prescribing any medicine for disease conditions that are not approved by the drug approving authorities while granting its marketing approval, is generally termed as ‘off-label’ use of drugs.

It is also a usual practice in most of the regulated markets of the world that once the drug regulators give marketing approval of a medicine, which is indication-specific, physicians are free to prescribe these as they deem necessary. However, the drug manufacturers can seek prescription support from the doctors only for the indications as approved by the appropriate government authorities.

Even the USFDA had articulated, “the best way to address any concerns that the information about those (off-label) uses is not reaching medical practitioners is to get those uses in the labeling. We believe that the risks of allowing drug companies to distribute journal articles and other information about off label uses far outweigh any benefits.”        

Since long, most of the drug regulators across the world, including the Drug Controller General of India (DCGI) have prohibited the sales promotion for unapproved uses of drugs to doctors. Nevertheless, the practice continues ignoring its serious consequences.

Monitoring of ‘off-label’ use is challenging: 

Monitoring of off-label use of medicines is quite challenging too by the drug regulators, especially in India, where post marketing surveillance is generally just on paper.

In this regard, a recent research study that I shall refer to below in this article, has quite appropriately suggested, “Future electronic health records should be designed to enable post market surveillance of treatment indications and treatment outcomes to monitor the safety of on and off-label uses of drugs.”

As India intends to move towards the ‘Digital’ space, this suggestion would be quite implementable by the DCGI, as the ‘Smart Cities’ start coming up.

Some examples of extensive off-label usages: 

According to the study done by a team of experts in medical information – Iodine, using the top drugs by number of monthly prescriptions, the following is a list of 4 medications with surprising off-label uses:

Drug Approved Indication Off-label Indication
Abilify (Aripiprazole) Schizophrenia, Bipolar Disorder, Major Depressive Disorder (adjunctive), Autism-related Irritability, Agitation associated with Schizophrenia or Bipolar Mania, other Insomnia
Lyrica (Pregabalin) Management of: neuropathic pain associated with diabetic peripheral neuropathy, post herpetic neuralgia, fibromyalgia, neuropathic pain associated with spinal cord injury; adult patients with partial onset seizures (adjunctive) Anxiety
Namenda (Memantine) Moderate to severe dementia of the Alzheimer’s type ADHD, OCD
Synthroid (Levothyroxine) Low thyroid hormone levels, some types of goiters, management some types of thyroid cancers Depression

Off-label use and increasing risks of drug safety: 

In its November 02, 2015 online issue, JAMA Internal Medicine published an article titled, “Association of Off-Label Drug Use and Adverse Drug Events (ADE) in an Adult Population.” The objective of this study was to monitor and evaluate off-label use of prescription drugs and its effect on ADEs in an adult population.

This particular study assumes importance, as off-label use of prescription drugs without strong scientific evidence has been identified as an important contributor to preventable Adverse Drug Events (ADEs), especially in children. However, despite concerns in this regard, no systematic investigation on the effects of off-label drug use in adult populations is being performed, regularly.

The detail analysis of this study reveals that not only is the benefit of off-label prescription is uncertain, but the risks of ADEs could make the ‘risk-benefit ratio’ quite unfavorable. So much so that in a large number of cases, no drug treatment will be a much better option.

According to the authors, the risk for ADEs grew as the number of prescription drugs the patient used increased. For example, patients using eight or more drugs had more than a 5-fold increased risk for ADEs compared with patients who used one to two drugs.

The study involving 46,021 adult patients, receiving 151,305 prescriptions between January 2005 and December 2009 was done in Canada. Of those prescriptions, more than 10 percent were prescribed for off-label use. Interestingly, out of that group, more than 80 percent prescriptions were for off-label uses without any robust scientific evidence supporting the use.

Based on the findings the researchers concluded that off-label use of prescription drugs is associated with ADEs.

The article suggested:

  • Caution should be exercised in prescribing drugs for off-label uses that lack strong scientific evidence.
  • Future electronic health records should be designed to enable post market surveillance of treatment indications and treatment outcomes to monitor the safety of on and off-label uses of drugs.

Pharma industry strongly opposes off-label use, when it suits them:

Interestingly, pharma industry vehemently opposes off-label use of drugs, when it suits them.

To give just a couple of examples, recently a new law that permits prescribing of drugs for off-label uses in France has reportedly been strongly opposed by the pharmaceutical industry in Europe.

Pharma trade associations argue, “the above move of France is directly in opposition to European Union’s laws that prohibit member states from supporting off-label use for economic purposes, and is a trend that undermines the current regulatory framework and could put patients’ health at risk.”

Besides France, they have also submitted a complaint against Italy to the European Commission over the country’s new off-label rules.

Common methods followed for off-label marketing:

The other side of the story is that, reportedly many pharma companies continue promoting off-label uses of drugs aggressively, for significant commercial gains.

According to ‘The Centers for Medicare & Medicaid Services (CMS) – a federal agency within the United States Department of Health and Human Services, some of the off-label drug promotion methods of the pharmaceutical companies are as follows:

• Paying incentives to sales representatives based on sales for off-label use

• Paying kickbacks to physicians to prescribe drugs for off-label use

• Disseminating misleading posters promoting off-label use

• Paying physicians:

- To pretend to be the authors of articles about off-label uses when the articles were actually written by manufacturers’ agents

- To serve as members of “advisory boards” promoting off-label use

- To travel to resort locations to listen to promotions about off-label use

- To give promotional lectures in favor of off-label use to fellow practitioners

• Publicizing studies showing efficacy of off-label uses, while suppressing studies showing no efficacy.

Even the Uniform Code of Pharmaceutical Marketing Practices (UCPMP) of the Government of India does not allow such sales and marketing practices. But these all continue to happen, unabatedly.

A path much abused?

Although most of the drug companies publicly advocate self regulation to avoid unethical marketing practices, the situation on the ground is much different, across the world. 

The following are just a few examples of serious business consequences faced by some of the well-known global pharma and biotech majors, besides many others, from the United States Department of Justice, for alleged off-label promotion of drugs: 

  • On November 4, 2013, Johnson & Johnson (J&J) was asked to pay more than US$ 2.2 billion to resolve criminal and civil liability arising from allegations relating to the prescription drugs Risperdal, Invega and Natrecor, including promoting for uses not approved as safe and effective by the USFDA and payment of kickbacks to physicians and to the nation’s largest long-term care pharmacy provider.  
  • On July 30, 2013, Wyeth Pharmaceuticals Inc., a pharmaceutical company acquired by Pfizer, Inc. in 2009, agreed to pay US$490.9 million to resolve its criminal and civil liability arising from the unlawful marketing of the prescription drug Rapamune for uses not approved as safe and effective by the USFDA. 
  • On December 19, 2012, Amgen Inc. pleaded guilty and paid US$762 million to resolve criminal liability and false claims allegations.
  • On July 2, 2012 GlaxoSmithKline LLC (GSK) pleaded guilty and paid US$3 billion to resolve its criminal and civil liability arising from the company’s unlawful promotion of certain prescription drugs, its failure to report certain safety data, and its civil liability for alleged false price reporting practices. This resolution is the largest health care fraud settlement in the US history and the largest payment ever by a drug company, so far. 
  • On May 7, 2012, Abbott Laboratories Inc. pleaded guilty and agreed to pay US$1.5 billion to resolve its criminal and civil liability arising from the company’s unlawful promotion of the prescription drug Depakote for uses not approved as safe and effective by the USFDA.  This resolution is the second largest payment by a drug company and includes a criminal fine and forfeiture totaling US$700 million and civil settlements with the federal government and the states totaling US$800 million.  Abbott also was reportedly subjected to court-supervised probation and reporting obligations for Abbott’s CEO and Board of Directors.
  • On October 21, 2011, Pfizer Inc. agreed to pay US$14.5 million to resolve false claims allegations related to its marketing of the drug Detrol. 
  • On June 10, 2011, Novo Nordisk was asked to pay US$25 million to resolve allegations of off-label promotion of Novoseven.
  • On September 30, 2010, Novartis agreed to pay US$422.5 million to settle criminal and civil investigations into the marketing of the anti-seizure medicine Trileptal and five other drugs. The government accused Novartis of mislabeling, paying illegal kickbacks to health care professionals through speaker programs, advisory boards, entertainment, travel and meals. 

Hence, it appears that the path followed by many pharma players to inform the doctors about the judicious off-label use of drugs only in circumstances where approved treatments have failed, is being much abused. 

A conflict of interest? 

Many doctors believe that there is also a distinct upside for off-label use of drugs, as flexibility of a physician to prescribe drugs off-label offers important advantages too, especially in circumstances where approved treatments have failed. This is indeed true and indisputable.

However, the reality is, many pharma industry, in general, actively encourage off-label use of drugs for commercial benefits through expanded use of their respective brands.

Aggressive drug promotion for various off-label uses, reportedly being so widespread and indiscriminate, many physicians can’t even remember the approved indications of drugs. Hence, they do not necessarily go for off-label use only when approved treatments have failed.  In this context, on November 23, 2015, ‘The Wall Street Journal (WSJ)’ in an article titled, “Risk of Off-Label Uses for Prescription Drugs” reported as follows:

“A 2009 study published in the journal Pharmacoepidemiology and Drug Safety found that 1,199 physicians in a national survey were able to identify the FDA-approved indication of 22 drugs only about 55% of the time. The physicians surveyed included primary-care doctors and psychiatrists.” 

On the other hand, the patients generally expect that the prescribed drugs will be safe. They want to administer evidence based approved medicines. Some of them have even started expressing that these evidences must also be disclosed to them.

Hence, there seems to exist a clear conflict of interest in this matter between the patients, drug manufacturers and perhaps the doctors, as well.

Conclusion:

The magnitude of general off-label use of drugs is reportedly increasing and is likely to increase further, exposing patients to increased risks of ADEs.  Although the business consequences of getting engaged in this unwanted process indiscriminately could at times be quite adverse, in the balance of probability between slim chances of getting caught, and expected creamy return, many pharma players continue to feel that this risk is worth taking.

Therefore, the moot question that needs a pragmatic answer is, for patients’ safety, when the global and local pharma majors talk about prescriptions of only impeccable evidence based medicine, do they walk the talk?

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.

 

The stormy debate on wrongful grant of pharma product patents – a countdown of the news events, for a quick perspective.

Posted on by
Reply
To give a quick perspective to this debate, I reckon, a countdown of five reported news events on the subject will be helpful. I start from February, 2009 and gradually go one year back, to February, 2008, to capture the key elements of this stormy debate. Finally, I move to ‘ground zero’ to explore the basic remedial measures to effectively address the issue.Event 5‘The Economic times’ (ET) dated February 24, 2009 reported an interesting news item titled, “Dichotomy between patent law and practice”. The timing of this article, with its various quotes, highlighting the following points, evokes interest:

1.“Indian patent authorities are virtually not following the spirit of the Sections 3(d) and 3(e)”.

2.“A large number of patents granted in India since 2005 pertain to products first patented in 1970s, 1980s, and 1990s, most of which were launched in Indian markets long before 2005, the year of introduction of product patenting in the country”.

3.“The patent applicants are not making adequate disclosures, making it difficult for potential challengers to file post-grant objections which the law provides for. Since the International Non-proprietary Name (INN) is not of the drug is often not given along with the Title of the Patent, it is cumbersome for anyone to trace the patent to the original PCT (Patent Cooperation Treaty) application and have an idea about how new it is”.

4.“Many law firms refuse to take briefs from Indian companies, because their multinational clients do not permit them to do so! The result— post-grant objection facility is not effectively used by Indian companies.”

Why are these observations interesting?

These observations are interesting because for point number 1 to 3, as stated above, following three recourses are available to all:

1. After publication of the patent applied for, in the patent journal, one can file a pre-grant opposition.

2. Assuming that someone has missed this opportunity, the provision for filing post grant opposition will still be there.

3. Assuming that both the opportunities have been missed due to some reasons and one could not understand the details of the patent applied for, during the patent granting process, the opportunity of going to a Court of law with a request to make such patents (which have violated section 3.d) invalid, will still exist.

It is indeed very difficult to understand why such measures are not being taken by the aggrieved parties, as specified in the law.

Point number four is even more difficult to understand. When lawyers are available to the domestic companies to defend alleged patent infringement, why then lawyers will not be available to them to take such objections to a court of law?

Event 4

Mint dated October 7, 2008 in its article titled; “Cozy deals and conflicting interest mark patent granting process” reported the following:

“There are even local and multinational corporates who ‘seek’ help of examiners and controllers to get their applications drafted, thereby ensuring a grant for a price”.

Event 3

‘The Economic Times’ dated July 1, 2008 reported in its article titled, “Cipla gets patent for Nexium, Fosamax modified versions” that Mumbai Patent office granted these two patents to Cipla in April, 2008 for new forms of two well known blockbuster drugs, Esomeprazole (Nexium of Astra Zeneca) and Alendronate (Fosamax of Merck). This news came as a big surprise because Cipla is well known for its continuous accusation to innovator companies for trying to extend ‘monopoly’ period by ever-greening patent through similar means. The report, therefore, raised a very valid question, whether Cipla has ‘walked the talk’ in India? It will be interesting to know on what basis Cipla managed to overcome the ‘efficacy’ barriers under section 3(d).

On this ET report, well known IPR expert Shamnad Basheer wrote the following in his blog dated July 6, 2008:

“Reading the ET piece, Nathan Evans of Finnegan Henderson, who’s a very astute commentator on the Indian patent scene and has written a couple of articles in this regard posed this question to me:

“This makes me wonder if the patent office in India will apply the laws less strictly to Indian pharmas than MNCs (kind of like they apply the patent laws more strictly for essential medicines)”

Shamnad Basheer concluded his comment on this subject with the following observations:

“How ought section 3(d) to be interpreted when our very own generic manufacturers are applying for supposedly “incremental” inventions?”

Event 2

According to Federation of Indian Chambers of Commerce (FICCI) report dated March 7, 2008, FICCI and the Department of Industrial Policy and Promotion (DIPP), Ministry of Commerce and Industry have joined hands to set up a working group to improve Intellectual Property regime in India.
It will be interesting to know the view of this joint working group between the Government and the Industries, in this matter. I have not read anywhere any comments of this important working group on such matter, so far.

Event 1

‘Thomson and Reuters patent focus report’ dated February, 2009 observed absence of clear guidelines (Manual of Patent Practice and Procedure) about some of the complex provisions of patent law, particularly section 3(d). The report indicated that there should be clarity on what would qualify as “enhanced efficacy” under section 3(d) so that it can help the patent examiners to clearly make out which patent applications would fall under section 3(d).

Ground Zero:

Let us now try to ponder, realize and fathom the core issue of this problem, which lies at the ‘Ground Zero’. Thus far we have been reading constant allegations about the functioning of Indian Patent Offices and even on their integrity and honesty.

In absence of a well drafted, long overdue, Patent Manual, all concerned, including patent examiners will have their own ways of looking into “enhanced efficacy”. In such a situation, I shall not be surprised if the Patent Examiners suffer from the dilemma as to what exactly will constitute “enhanced efficacy”.

Protracted debate with the stakeholders on the ‘draft patent manual’ appears to be over now. The last stakeholders’ meeting on this subject was concluded in Kolkata following Delhi, Mumbai and Bangalore, several months ago. However, the final Patent Manual is still not in place, which has been kept for public inspection since 2005.

To address this stormy debate, in my view, we need to:

1. Push for expeditious release and implementation of the Patent Manual (Manual of Patent Practice
and Procedure).

2. Let FICCI – DIPP working group work more effectively and cohesively for better functioning of the
new IPR (Intellectual Property Rights) regime.

3. Let ‘capacity building’ exercise at the Indian Patent office (IPO) continue with greater speed.

Mere accusation and constant bashing of the IPOs, as we now see around, may not yield much result. After having taken the above measures, if similar dissatisfaction in any quarter still remains, let law take its own course. Despite great apprehensions by some, as quoted above under point 1, never mind, enough lawyers will be available to fight such cases.

By Tapan 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.