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Indian Pharma Leadership: A Glimpse of Changing Mindset Post Pandemic

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A recent survey of physicians, published by the CMI Media Group, provides fresh evidence that Medical Representatives meetings with the physicians that have become trickier to arrange since COVID-19, still continue. This was also reported in the March 29, 2023, edition of Fierce Pharma.  

The survey objective was to capture what are physicians’ preferences, when asked whether they want to meet with pharmaceutical reps in person more often, less often or in equal frequency as pre-pandemic. Some of the key findings of this recent study include the following: 

  • 25% of the doctors, reportedly said they are reducing face-to-face interactions.
  • With 10% of doctors responding never seeing reps, it could be challenging for many pharma players to call on these doctors via the traditional in-person route. 
  • However, another 51% of physicians replied that the frequency of their in-person interactions is unchanged from pre-pandemic and 14% seeing reps more frequently than before. 
  • It also found that digital channels have potential to compensate for the pullback from in-person meetings.  
  • Most of such doctors prefer receiving resources for talking to reps via video or phone. 
  • Interestingly, 70% and 78% of physicians said digital resources are more convenient, educational and valuable than remote rep visits. 

Let me hasten to add that the above study was carried out mostly in the European countries. Thus, in today’s deliberation, I would focus mainly on two areas:

1. How is this situation evolving in India and the way some of the Indian majors are gearing up to convert this challenge into opportunities to gain a competitive edge, and 

2. What, in my view, needs to be a pharma marketing leadership mindset change, alongside its traits for effective change management, to excel in the changing market dynamics. More importantly, whether or not this trend is also visible within some of the Indian pharma majors.

The comparable situation in India:

I find some interesting data on the Indian pharma industry in this regard, from several public domain. These indicate that while some physicians may be open to virtual interactions with medical representatives during and after the COVID pandemic, there are also examples of physicians who were not too keen to meet with pharma reps. These seem to be for several reasons. Some reported examples are as follows:

  • Delhi Medical Association (DMA), which represents more than 15,000 doctors in the Indian capital, has banned pharma med reps from entering hospitals or meeting with doctors in person. The DMA has cited concerns about the influence of pharma reps on prescribing practices, besides potential conflict of interest.
  • With over 3.5 lakh memberships, the Indian Medical Association (IMA) appears to have discouraged physicians from meeting with MRs. Instead, the association has urged them to rely on evidence-based information and guidelines while prescribing drugs to patients.
  • Some private hospital chains in India have also restricted or banned pharmaceutical sales representatives from interacting with physicians. This includes Fortis Healthcare, which has banned pharma reps from its hospitals in Delhi and Mumbai, and Max Healthcare, which has restricted interactions to virtual meetings only. 
  • The Indian Psychiatric Society (IPS) has issued guidelines for its members recommending that they avoid interactions with pharma med reps. The IPS has stated that interactions with pharma reps can create conflicts of interest and bias in prescribing practices and may not always provide accurate and reliable information.
  • Some physicians in India are increasingly turning to online platforms to access unbiased information about medications and treatments, rather than relying on information provided by reps. Online platforms such as Medscape and Docplexus provide physicians with access to up-to-date medical information and peer-reviewed research studies.

With a changing mindset, some Indian players are facing this challenge:

Evidence suggests that there is a growing awareness among several physicians in India about the potential biases and conflicts of interest that can arise from interactions with pharma representatives. While virtual interactions and non-promotional information may still be acceptable to some physicians, others may prefer to rely on more objective sources of information or avoid interactions with pharma reps altogether. 

There are several examples in this area highlighting how some Indian pharma majors are trying to stay ahead of the technology curve. As reported, some specific responses of Indian pharmaceutical companies to the restrictions on interactions with physicians

include, Cipla’s launch of a digital platform called CiplaMed to provide healthcare professionals with access to non-promotional medical information and education.

Post-pandemic changes in the mindset and outlook of marketing leadership:

As I see, the COVID pandemic experience has brought significant changes in the mindset and outlook, especially, in the marketing leadership of several Indian drug companies. One key reason could be the success requirements in contemporary pandemic market dynamics are going through a metamorphosis. Which is why the emerging situation demands new approaches and strategies for success.  

Many pharma marketing leaders are now trying for early identification of even the nuanced change requirements relevant to their respective organizations for sustainable business success in the current paradigm. Some of these requirements were identified as:

Agility and Adaptability: The pandemic has highlighted the importance of being agile and adaptable. Pharma marketing leaders must now be able to quickly pivot their strategies and tactics based on changing market conditions and consumer needs.

For example, Cipla adapted quickly to the changing market conditions during the pandemic by ramping up the production of essential medicines and medical supplies. The company also developed innovative product solutions, such as a portable mechanical ventilator, to address the critical shortage of medical equipment during the pandemic. 

Similarly, Lupin demonstrated agility by diversifying its product portfolio to include COVID-19 testing kits, PPE, and other pandemic-related products, besides helping to develop innovative solutions to address the pandemic, such as a telemedicine platform that enables patients to consult with doctors remotely. 

Digitalization: The pandemic has accelerated the shift towards digitalization in the pharma industry. Marketing leaders must be able to effectively leverage digital channels such as social media, online advertising, and telemedicine to reach and engage with consumers.

For instance, Dr. Reddy’s Laboratories leveraged digital technologies to enhance its customer engagement efforts. The company developed a mobile app called - ‘Medznat.’ It is touted as a one-stop solution for physicians, medical students and other healthcare professionals to stay abreast with the latest medical knowledge. It offers an umbrella of offerings, such as news, scientific articles, case studies, regulatory updates, medical events, drug flashcards, and many more. The app offers some key features, such as: personalized quality content, any time, anywhere and patient education materials.

Customer-centricity: The pandemic has increased the need for customer-centricity in the pharma industry. Marketing leaders must now prioritize customer needs and preferences and tailor their marketing strategies accordingly.

Sun Pharma appears to be another leading example that, reportedly, demonstrated customer-centricity by developing patient assistance programs that provide financial support to patients who cannot afford their medications. The company also partnered with healthcare providers to develop disease management programs that improve patient outcomes and reduce healthcare costs.

Data Analytics: The pandemic has highlighted the importance of leveraging data science and data analytics in the pharma industry. Marketing leaders must be able to effectively analyze data to understand customer behavior and preferences and to measure the effectiveness of their marketing campaigns. 

The name of Glenmark Pharmaceuticals comes to the top of mind in this area. The Company is now using data analytics to analyze sales data and identify trends in the market. The company is also using analytics to track physician interactions and ensure compliance with government regulations.

Continuous Innovation: The pandemic has created new opportunities for innovation in the marketing domain. Thus, marketing leaders must be willing to experiment with new approaches and technologies to stay ahead of the competition and meet changing customer needs.

As is known to many, Zydus Cadila has developed a COVID-19 vaccine and has also been working on the development of a COVID-19 drug. The company has also been involved in the development of new drugs to treat various other diseases.

Collaboration: The pandemic has underscored the need for collaboration across the healthcare ecosystem. Pharma marketing leaders need to work closely with other stakeholders, including healthcare providers, payers, patient advocacy groups, and government agencies, to develop solutions that meet the needs of all stakeholders.

In this area, Biocon, for instance, collaborated with government agencies and NGOs to distribute COVID-19 vaccines and treatments to underserved communities. The company also worked with healthcare providers and patient advocacy groups to develop education and awareness campaigns that promote better health outcomes.

Similarly, Dr Reddy’s Laboratories partnered with IQVIA to rollout IQVIA’s OCE application to its entire field force and marketing users in India to drive more meaningful and impactful customer engagement.

 Conclusion: 

These are a few areas with examples from a few Indian pharma majors that would give a sense of how the mindset and outlook of their marketing leadership teams are changing. This is happening, as is widely believed, after having experienced the last two years’ unprecedented disruptions in business and customer behavior.

It’s equally interesting to note that our domestic drug industry, which was not traditionally well known for effecting significant proactive changes – is transforming itself while stepping into the post-pandemic world – in pursuit of excellence. 

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.

 

 

‘Patent Linkage’: Can The Core Issue Be Resolved?

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On February 10, 2015, a leading business daily of India, quoted the Commerce Secretary of India – Rajeev Kher, saying, “India needs to relook at its Intellectual Property Rights (IPR) Policy with a view to bring in a differentiated regime for sectors that have a greater manufacturing potential.”

In the present Government regime, it appears virtually impossible to make such important comments out of turn by a senior bureaucrat without the blessings of the Prime Minister’s Office (PMO). I hold this view, despite the fact that the Commerce Secretary reportedly added that his suggestion is “a highly controversial subject and if I discussed this in the government, I think I will be shot down in the very first instance”.

Be that as it may, as I indicated in my just previous article, several recent media reports also speculated, around the same time, that the Government of India is probably considering putting in place ‘Patent Linkages’ and ‘Data Exclusivity’ through administrative measures, without making any amendments in the Patents Act 2005 of the country.

As I had indicated in my blog post of January 19, 2015 titled, “New ”National IPR Policy” of India – A Pharma Perspective”, these speculations originated mainly from the following events:

  • During Prime Minister Narendra Modi’s visit to the United States in September 2014, a high-level Indo-US working group on IP was constituted as a part of the Trade Policy Forum (TPF), which is the principal trade dialogue body between the two countries.
  • Almost immediately after the Prime Minister’s return to India, in October 2014, the Government formed a six-member ‘Think Tank’ to draft the ‘National IPR Policy’ and suggest ways and legal means to handle undue pressure exerted by other countries in IPR related areas. The notification mandated the ‘Think Tank’ to examine the current issues raised by the industry associations, including those that have appeared in the media and give suggestions to the ministry of Commerce and Industry as appropriate.

Speculations arising out of these two events were almost simultaneously fuelled by the following developments:

A. US Trade Representative Mike Froman’s reported affirmation of the following to the US lawmakers during a Congressional hearing held on January 27, 2015:

- “We have been concerned about the deterioration of the innovation environment in India, and we have engaged with the new government since they came into office in May of last year about our concerns.”

- “We held the first Trade Policy Forum in four years in November. I just returned from India yesterday as a matter of fact … and in all of these areas, we have laid out a work program with the government of India to address these and other outstanding issues.”

- “We are in the process of providing comments on that draft policy proposal on IPR, and we are committed to continuing to engage with them to underscore areas of work that needs to be done in copyright, in trade secrets as well as in the area of patents.”

- “We’ve got a good dialogue going now with the new government on this issue, and we’re committed to working to achieve concrete progress in this area.”

B. Union Minister of Commerce and Industry of India specifically seeking American Government’s inputs in the finalization process of the new National IPR policy of the country.

Keeping these in perspective, let me try to explore whether or not it would be fair for India deciding to put in place ‘Patent Linkages’ and ‘Data Exclusivity’ through administrative measures, without making any amendments in the Patents Act of the country.

In this article, I shall deliberate on my personal take on ‘Patent Linkage’ and in the next week’s article on ‘Data Exclusivity’.

Definition:

Patent linkage is broadly defined as the practice of linking market approval for generic medicines to the patent status of the originator reference product.

A brief background in India:

The ‘Patent Linkage’ saga has an interesting background in India. I would now try to capture the essence of it, as stated below.

About 7 years ago, probably prompted by intense lobbying by the Pharma MNCs, the then Drug Controller General of India (DCGI) reportedly informed the media, on April 28, 2008, the following:

“We (DCGI) are going to seek the list of the drugs from innovator companies that have received patent in India. Once we have the database of the drugs which have been granted patent, we will not give any marketing approval to their generic versions…The DCGI has issued internal guidelines to this effect and it will also co-ordinate with the health ministry to give a formal shape to the initiative. The government expects to finalize a proper system within the next 2-3 months.”

It was also reported in the same article that Patent attorney Pratibha Singh, who along with Arun Jaitley was representing Cipla in the Tarceva case against Roche said:

“The DCGI does not have the authority to reject marketing application of a generic drug on the grounds that an innovator company has received the patent for the same drug in the country.”

Immediately following the above reported announcement of the DCGI on ‘Patent Linkage’, another media report flashed that the domestic drug companies are strongly objecting to the DCGI’s plans to link marketing approval for a drug with its patent status in the country, citing requirement of additional resources for the same and concern that it could block access to affordable medicines by suppressing competitive forces.

Despite this objection of the domestic Indian pharma companies, a senior official in DCGI office reportedly reaffirmed the DCGI’s intent of establishing the linkage so that no slips happen in the future. The same media report quoted that Government official as saying:

“We will have to amend the rules in the Act. We have to put it before the Drugs Consultative Committee first and this could be around the end of this year.”

Current ‘administrative’ status in India:

Currently in India, there is no provision for ‘Patent Linkage’, either in the Statute or through any administrative measure.

After those potboiler reports, it is quite challenging to fathom, what exactly had happened for the reverse swing thereafter at the DCGI’s office. The bottom line is, the above initiative of the then DCGI for ‘Patent Linkage’ in India ultimately got killed in the corridors of power. Hence, there does not exist any direct or indirect measure for ‘Patent Linkage’ in India, as I write this article.

Current legal status:

In 2008 Bayer Corporation had filed a Writ Petition before the Delhi High Court against Union of India, the DCGI and Cipla seeking an order that the DCGI should consider the patent status of its drug, Sorefenib tosylate, and refuse marketing approval to any generic versions of this drug.

It is worth mentioning, Sorefenib tosylate is used to treat renal cancer and was being reportedly sold in India by Bayer at Rs. 2,85,000 for 120 tablets for a monthly course of treatment.

The appeal in the Delhi High Court was filed against a judgment delivered by Justice Ravindra Bhat on 18 August 2009, rejecting Bayer’s attempt to introduce the patent linkage system in India through a court direction. But, in a landmark judgment on February 9 2010, a division bench of the Delhi High Court dismissed the appeal of Bayer Corporation in this regard. Thereafter, Bayer Corporation moved Supreme Court against this Delhi High Court order.

However, in December 01, 2010, a Division Bench of the Supreme Court rejected the appeal filed by Bayer Corporation against the February 2010 decision of the Delhi High Court. The Apex Court of India ordered, since the Drugs Act does not confer power upon the DCGI to make rules regarding the ‘Patent Linkage’, any such attempt would constitute substantive ultra vires of the delegated power.

RTI helps to get the marketing approval status of drugs:

Currently relevant information on marketing approval application status of generic drugs are not available at the CDSCO website. Hence, some innovator companies have resorted to using Right To Information (RTI) Act to ferret out such details from the DCGI office and initiate appropriate legal measures for patent infringement, well before the generic version of the original drug comes to the market.

A middle ground:

In view of the above order of the Supreme Court, the government of India may try to seek a middle ground without amending any provision of the Patents Act, in any way.

Even avoiding the word ‘Patent Linkage’, the Ministry of Health can possibly help the pharma MNCs achieving similar goal, through administrative measures. It can instruct the DCGI to upload the ‘Marketing Approval’ applications status for various generic products in the Central Drugs Standard Control Organization (CDSCO) website. If for any patented drugs, applications for marketing approval of generic equivalents are made, the available information would enable the patent holder taking appropriate legal recourse for patent infringement, much before the drug is marketed at a heavily discounted price.

It is quite possible that the interested constituents had put requests for such administrative measures even before the earlier Government. As no tangible action has been taken even thereafter, the erstwhile Government probably felt, if introduced, such a system would adversely impact quick and early availability of the generic drugs in the market place.

Conclusion: 

I wrote an article on similar issue in my blog post of August 24, 2009 titled, “Recent Bayer Case Judgment: Patent Linkage: Encouraging Innovation in India.”

Taking all these into consideration, in my view, it is quite possible for the present Indian Government to resolve the core issue related to ‘Patent Linkage’ through administrative measure, without amending any Acts or breaching any case laws of the land.

In the present IPR imbroglio, the above administrative measure could well be a win-win solution for all.

It would help facilitating early judicial intervention by the patent holder in case of prima facie patent infringements, enabling the Government to send a clear reiteration that the patents granted to pharmaceutical products will be appropriately enforced and protected in the country.

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.