Pharmaceuticals

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How Biologics are going to be the Driving force for Indian Pharma

As the healthcare scenario is experiencing the paradigm shift from cure to care, preventive health has received generous importance and hence the biologics. Growing demand for vaccines, monoclonal antibodies and biosimilars are creating excellent business space for Indian pharma.

Indian pharmaceutical sector has great potential to earn the identity of global hub for manufacturing biologics. The ability to invent globally competitive, affordable and novel vaccines and biosimilars is emerging as one of the greatest driving forces for Indian pharma. As the industry is shifting from chemical-based drugs to biosimilars and biologics, this scenario presents excellent opportunities for Indian pharma industry in the space of life sciences and biotechnology.

Till September 2019, India received over 98 biosimilars approvals in the domestic market, more than any other country. Moreover, the approvals which we are receiving for biosimilars in regulated market, further boosting the confidence and willingness of Indian pharma players to contribute in global market shares. Owing to the rising domestic demand, potential and investments in biologics in India, according to the reports, more than 40 biosimilars reached clinical development stage in India which is far more than that of United states and similar to European Economic Areas.

Following elements will ensure India’s march towards achieving the title of ‘fastest-growing bio hub’-

Vaccines establishing strong presence

Fulfilling over 60% of global vaccine requirements, India is now the largest volume supplier of vaccines to public market. This is the outcome of ongoing critical focus on R&D and mass manufacturing. Moreover, companies in India increasingly investing in innovative approaches toward vaccines for common diseases further making the space lucrative. Some of the examples of this innovative approaches include typhoid conjugate vaccine, “eco-friendly” recombinant Hepatitis-B vaccine (free of cesium chloride and thiomersal) and Serum Institute’s liquid rotavirus vaccine of Bharat Biotech. Such approaches target different aspects like improving compliance, improving stability by adjusting formulations and several other fundamentals to upgrade and enhance existing products.

Moreover, government is also boosting India’s presence in vaccine market through funding and investing in R&D. Department of Biotechnology (DBT), the Ministry of Health and Family Welfare (MoHFW) and the Indian Council of Medical Research (ICMR) are playing wisely to propel the vaccine market.

Market players are driving biologics

Indian market players are all set to propel the growth of biologics and biosimilars in India and globally. Their efforts are paying off and positive outcomes are seen in terms of revenue generation and overall reputation in the international markets. Domestic biosimilars market generated over US$576 million in 2019 while achieving the growth rate of about 11% (2018 revenue- US$520 million).

By developing novel monoclonal antibodies (BIOMab EGFR for head and neck cancer treatment in 2006 and Alzumab (itolizumab) for psoriasis treatment in 2013), Biocon became very first company to launch indigenously developed novel biologics in India. In collaboration with global companies, these antibodies have been launched in many other countries which has greatly influenced Indian pharma industry to dive deeper in the world of biologics. The company aims to generate around INR7,460 crore by 2022 alone from biosimilars business. Looking at the revenue of INR1,951 crores in 2019-20, the target looks genuine too. Moreover, the company in collaboration with Mylan has entered in US market with their first biosimilars for Herceptin and Neulasta, which further opening the revenue streams for the nation.

Zydus Candila, who is exploring the use of long-acting interferon alpha-2b for treating Covid-19, can also generate significant opportunities for Indian biologics in international markets. The biosimilar version of this immunomodulator is already being commercially manufactured by the company for the treatment of Hepatitis B and C.

Government priority- bio-tech based drug development

Under ‘Make in India’ campaign, Indian government is actively promoting the biotech-based drug development in the country through various approaches including effective fundings and investments. Initiatives introduced by DBT and the Biotechnology Industry Research Assistance Council (BIRAC) are favourable enough to transform India into biotechnology-based innovation and research hub. Such initiatives are policy making, promoting industry-institute partnership, generating entrepreneurship cells, etc. Moreover, Public Private Partnerships are also motivated in order to captivate investments and fundings from investors, industry and other agencies.

Securing future with Biologics

Being the largest provider of generics globally, Indian is now looking for expansion beyond generics while exploring opportunities in biologics and biosimilars. More than 10 blockbuster biologics (with total revenue of USD 60bn) are losing their patents in next 2-3 years, creating amazing revenue stream for India through biotech sector. Moreover, first-time ANDA approval from USFDA makes the scenario even more favorable for Indian pharma.

We have over 200 biosimilars in pipeline with the collective contribution from more than 52 Indian companies. However, the number of companies penetrating the US and European market is significantly low despite of the largest number of approved biosimilars in India. One of the restraining factors could be nonalignment of India’s regulatory guidelines with these markets. More efforts are necessary in the regulatory space.

Moreover, strengthening testing requirements for biosimilars, improving animal testing and increasing the number of patients in clinical trials are some of the elements of development which need attention and efforts to emerge as a ‘fastest-growing bio hub’ in the future.
The article is written by Dr. Smarta and is published by Healthcare India Today

https://www.healthcareindiatoday.com/how-biologics-are-going-to-be-the-driving-force-for-indian-pharma/

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Leaders lead even if they are not leading

how correct it is to say that leader must command a group, organization or a country??

Few people will say it's absolutely correct to say that…Actually, yes, it is a generalized definition of a leader which we have followed for ages and still following … But for me, the perfect leader doesn’t always lead or command. An ideal leader in my eyes is a person who takes a step back and lets others lead. Letting others take the lead is one of the essential, hard and premier qualities of a best leader which gives rise to an organization which is strong enough to chase success, sustain that success and scale it up to the very next level.

Now some may think, how can a leader afford to lose his lead?? But in reality, it’s not about losing the lead, it’s all about using that lead, wisely… How?? Following points will explain…

1. Using the lead to train the team- When the leader lets other team members lead, one of the objectives behind it is ‘teaching leadership’. This action of a leader gives an opportunity to other members to learn and improvise the skills required to lead the
team.
2. Using the lead to delegate the task- For the better exposure of challenges and opportunities, best leaders always try to delegate certain tasks to team members which are essential for the members to grow in each and every aspect.
3. Using the lead to bring out the expertise- Leader is never versatile in his own eyes, instead, whenever possible, he tries to learn new qualities from his team members while working with them. Transferring the leadership role can bring out the hidden expertise of team members which can sometimes be responsible for the success of a particular project.
4. Using the lead to teach the strength of unity (We) over disunity (I)- With delegating the leadership tasks to team members, leaders give birth to the next leader with the inherent ability to work in a team with the feeling of gratitude.

When leaders lead, they share their vision and excitement with the team. But when leaders let the team members share their different visions and their excitement, the working environment becomes much more enjoyable and fruitful. Such teams give rise to the leaders which follow
the rule of ‘Sometimes let others take the lead’ in future and become ideal leaders.

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Why integrated medicine is more than just a passing craze

Integrated medicine looks for the root cause of an illness and not just the symptoms. But how effective is it?

In a recent interview to India Today, Delhi-based designer Rina Singh, who had suffered from Covid in mid-April, talked about how even weeks into her recovery, she was far from her pre-Covid self. Dealing with erratic sleeping patterns, digestive issues and compromised energy levels, among a host of other problems, she spoke of a need “to evolve an everyday living practice that is more holistic. “Like fashion, even medicine is a creative pursuit and no one-size-fits-all works in this scenario,” she said.

In this lies the draw of integrative or integrated medicine. Dr R.B. Smarta, CMD-interlink and vice-president of Health Foods and Dietary Supplements Association (HADSA) explains: “Integrated medicine is a patient-centric approach and not related to only one particular Pathy (allopathy, homeopathy, etc) of medicines. Integrated medicinal approaches can be described as the coordinated and evidence-based way of combining conventional and less conventional medicinal practices to deliver overall care to a patient”. Integrated medicine, he adds, covers conventional, complementary and alternative medicines.

“There are enough medicines to take care of the symptoms, but there’s no system to look at the root cause of an illness and integrative medicine addresses that,” says Luke Coutinho, holistic lifestyle coach-integrative and lifestyle medicine, and founder of YouCare by Luke Coutinho. For instance, he says, there are pills to suppress a headache, but headaches keep coming back. The root cause could be anything, ranging from dehydration to constipation, lack of sleep, or emotional stress. So, asks Coutinho, can a pill help when a headache is actually caused by inadequate water intake?

An important question to ask here is, why is it that some of those who test positive for Covid are asymptomatic, while others suffer terribly? Why is it that some heal at home while others need a ventilator and oxygen support?

According to Dr Smarta, “The pandemic has focussed tremendous attention on immune health and, consequently, on preventive measures through complementary and integrative approaches. Lockdown-induced lifestyle changes including lack of exercise, sleep disorders, unhealthy eating patterns and several psychological symptoms, including depression, have resulted in the need for such integrated approaches along with conventional medicines.” An integrated medicinal approach includes health supplements and nutritional medicines (nutraceuticals and traditional medicines), exercise, nature therapy, botanical medicines and holistic intervention to help people strengthen their physical and mental resilience during and post infection, adds Dr Smarta.

However, it is important to remember that using an integrated approach does not mean skipping conventional practices entirely. “Diseases are classified into two parts: low involvement, low risk; and high involvement, high risk. Based on the type of ailment, integrated medicine is employed in the treatment. For example, for minor ailments like mild pain and anxiety, hot flashes, etc, integrated medicines can be employed under a doctor’s supervision. However, for major illnesses, conventional medicine that has evolved over ages is the first line of treatment. Integrated approaches are employed at the disease prevention and the recovery (rehabilitation) stage,” says Dr Smarta.

For Coutinho, it’s a basic set of questions you need to ask yourself. Do you expect a burnt-out body and mind to really support your immune system? Do you expect a sleep-deprived body to have sufficient energy to drive its complex immune system? Do you expect a body riddled with inflammation and lifestyle ailments to support your immunity the way you expect it to? Do you expect your lungs burdened with smoking and substance abuse to really support you in this crisis? Do you expect a stressed-out mind to have a positive impact on your physical self? Do you expect a sedentary body to be physically fit? “Nutrition-performance and nutrition-fitness-meditation would be my mantra through which we can practice an integrated approach to healing and wellness in everyday life. Healthy dietary habits are the key to a disease-free body and healthy mind. Performance nutrition can be described as the extra nutrition required to boost energy levels. In order to multi-task, basic nutrition is not enough. Hence performance nutrition is necessary,” says Dr Smarta.

Diet educationist, pharmacist and author Lokendra Tomar agrees: “Healing takes place with internal effort; it is not carried out by medicines alone. Anti-infectives and steroids may help, but internal capacity to bolster healing comes with nutrition. Internal structure requires nutrients, metals such as zinc and selenium, vitamin C to repair and heal tissues, protein and minerals. All of these are derived from food and help the body repair and heal damage.”

Coutinho sums it up: “Medicines with zero focus on lifestyle are a failed approach. One prescription after another with no emphasis on lifestyle change is the reason why the world is stuck in chronic illnesses today.” The focus needs to be on building a strong immune system holistically.

Source: The interview was published in India Today on 12th August’21. 

https://www.indiatoday.in/india-today-insight/story/why-integrated-medicine-is-more-than-just-a-passing-craze-1840077-2021-08-12

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Drug Safety- Indian Scenario

Drug safety and monitoring is a continuous scientific process which is consist of detection, assessment, perception and prevention of Adverse Drug Reaction (ADR). The process is essential to understand the potential benefits of the medicines along with the risks associated with it. We call it a ‘continuous process’ as it starts with drug development and continues till the launched drug/product is available in the market in patient care.
This process has to be prolonged till the life of particular medicine, as many times the side-effects come into the picture in the post-marketing scenario and after the prolonged use of the drug in the population.

Three barriers

Evolving over the decades, drug safety systems (or pharmacovigilance) are making significant progress. However, the challenges are still there which are inevitable and require new thought every time. Some of those common roadblocks are related to patient engagement, informatics, business and lack of globalized approach toward pharmacovigilance. Discussed below are some social, technical and business-related aspects of drug safety issues in India-

1. Social barriers for drug safety-
In my opinion, social barriers which are depressing the drug safety systems are occasionally hard to identify and challenging to nullify. Public belonging to different levels in the society have different pitch of understanding and awareness about drug safety which makes it difficult for organizations and government to resolve the issues. Following are some of those major obstacles-

  • Ignorance toward minor side effects– This particular issue is very common and serious at the same time. Because of this, pharmacovigilance systems are not getting prioritized in the society despite of tremendous efforts of government. One of the major reasons behind this is lack of knowledge about the severity of adverse drug reactions and varying mentalities of people. Frequent use of antibiotics and injections is an issue of concern in recent times. Nations are struggling to put light on these issues and find the ways out.
  • Medical professionals seemingly lacking experience, up-to-date knowledge and drug information– This is another major issue in the society. This can be complementary to the previous issue as medical professional play crucial role in shaping the reliable healthcare. Inadequate treatment guidelines are passed on through such medical professional. Poor prescribing practices can also be seen.
  • Prevalence of counterfeit products and use of traditional medicines (without any knowledge)– This issue is gaining much attention in today’s scenario. Cheap, substandard and spurious drugs in the market used to put the drug safety systems in questionable circumstances. Although, as the research and development is advancing, various government initiatives through regulatory actions are making a big difference between today’s and a decade ago scenario in pharmacovigilance.

Another issue is use of traditional medicines without any fundamental background knowledge. As many alternatives are available in the market at cheaper prices, the public is seemed to be inclined toward them through the word-of-mouth information.

Technical barriers for drug safety

The gaps between guidelines and law for drug safety is one of the matters of concern for nation like India. Lack of harmonization of guidelines due to presence of different ministries for drug regulation make it hard to coordinate and maintain transparency in the process. Discussed ahead are some of these regulatory issues which require serious attention-

  • Ambiguity in licencing mechanisms- In India, there is a thing called as dual licencing mechanism which has emerged as a roadblock for effective implementation of regulatory processes in India. Moreover, transparency in licensing procedures need to be further improved. Lack of better clarity on patentability of pharmaceuticals for which any organisation applies for compulsory licences leads to legal dispute between MNCs and local firms.
  • Interpretation issue of GMP guidelines- Inadequate and not correct interpretation of rules and guidelines of drug development in India generate multiple barriers for effective implementation of drug safety programmes. Experts who have very less knowledge about strict legal terminologies in documents such as Schedule M, Drugs and Cosmetics Act, 1940 and, Drugs and Cosmetics Rules, 1945, can’t interpret the things efficiently which result in difference in the assumptions of regulatory officials and drug developer.
  • Compliance in clinical trials- Noncompliance of ethically documented clinical trial practices result in unethical practices in clinical trials of drugs in India. This is a product of corruption, poor compliance, low-cost trials and the conniving acts of drug developing company and medical professionals. Such cases are on the rise in the current scenario. Moreover, unavailability of basic facilities and sophisticated instruments lead to unethical clinical practices by producers.
  • Issues of pharmaco-negligence- This is one of the factors behind proliferation of substandard and spurious drugs. In India, huge number of patients having malaria and tuberculosis died because of such counterfeit drugs and products. Lack of coordination between centre and state regulatory bodies has resulted into very tough time for pharmacovigilance in India in earlier times.
  • Inadequate recall mechanism- In India, it takes about three to four months for laboratory to process through the fraudulent product. During this large timespan, the huge percentage of batch gets consumed in the market. The recall mechanism is unclear and the information of the product recalled are not available in public domain. This makes the situation even more complicated and tough to deal with.

Business-related barriers for drug safety-

Many times, processes at drug producers level/company level are also responsible for the failure of pharmacovigilance programmes in India. Following are some of those issues which need legal consideration-

  • Organizational insufficiencies and malpractices- Unavailability of required funds, inadequate and unprofessional staff, etc result in weak organizational functioning. Frustration resulting from extra-working hours and the ignorance arising through it is responsible for poor quality end product.

Many drug producers, manufacturing poor quality products, invade the supply chain of slow-moving products (products which usually have slow turnover rate and likely to be stored into the warehouse for longer timespan) to avoid the detection procedures.

  • Unclear third-party agreements- This involves entitling a manufacturer to do the manufacturing on behalf of other party. This entire process is a big question mark owing to the unclear legal liabilities associated with quality of the product rolling in the market through third-party manufacturing.
  • Unawareness about handling new technologies- Most of the stakeholders are not technically competent and some of the reasons behind it are affordability and lack of knowledge. Indian stakeholders, many a times, avoid costly and complicated technologies like ‘track and trace technology’ which make their growth less sustainable and such situations result in adoption of cheaper ways of making money, E.g., Counterfliet products.

Change is essential

Social conflicts associated with drug safety require considerable attention in the form of public campaigns for pharmacovigilance and awareness-enhancing initiatives in rural areas. The adverse drug reactions can be minimized to the great extent through such social approaches. Communication is the key to knowledge, government and regulatory bodies should design these initiatives in much comprehensive manner. Such approaches are essential for health professionals as well for the better healthcare outcomes.

Technical issues, particularly regulatory system related issues, are need to be tackled with thorough understanding about the current scenario of pharmacovigilance in the nation. Uniformity in the regulations as well as in the interpretation of the same is mandatory for ‘up to the mark product’. Various technologies used abroad can be utilized in India to achieve efficient licensing mechanism, ethical clinical trials and accelerated recall processes.

Such approaches require active participation of the stakeholders with the dedicated and honest efforts in producing the high-quality pharmaceutical product. Drug safety programmes can be successful only if the data provided by the stakeholders to the regulatory bodies is accurate in all the aspects in order to device the essential policies.

Global approach is mandatory to develop a science-based, patient centric healthcare through high quality products. To strengthen the pharmacovigilance system in the world, regulatory harmonization is the key…

  -Dr. R.B. Smarta
CMD-Interlink
Vice President (HADSA)

About Author:
Dr. R. B. Smarta- Founder and Managing Director of Interlink Marketing Consultancy Pvt. Ltd. Being a thought leader in Pharmaceutical, Nutraceutical and wellness industry, he has been contributing globally through Interlink Consultancy and building business performance of his clients for 36 years. Having a Master’s degree (M.Sc.) in Organic Chemistry in Drugs, MMS in Marketing, PhD in Management, and FRSA (Fellow of Royal Society of Arts) London, he is-perusing his passion of converting science to Business. Besides being a consultant, he has been teaching at IIM, prestigious management institutes, Pharmacy College, Pharmacists Associations, guiding PhD students and written as many as 7 Books on Management, Pharma, Nutra, Foods domain, and many articles in prestigious journals/magazines.

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PHYTODRUGS – NEW PARADIGM IN HEALTHCARE

Healthcare systems are undergoing a paradigm shift, especially in this age of innovation. The focus today is on care rather than cure thus proving the age old proverb “prevention is better than cure” to be right. “Under the present situation, people are gaining trust on herbal medicines. Owing to changing trends among people, who want to be healthy and not to fall sick, they are opting for preventive options. This shift from cure to care has been one of the crucial reasons for the acceptance of herbal drugs including phytodrugs, a purified bio-active fraction made from the extract of medicinal plant or its part,” Dr. R.B. Smarta, Founder and Managing Director of Interlink, a business performance consulting firm operating in the pharmaceuticals, phytopharmaceuticals, nutraceutical and wellness space for over 35 years, says in an exclusive e-mail interview with Trinity Mirror. Dr. Smarta shares his views on phytopharmaceuticals and the emerging opportunities in the Indian market in a free-wheeling interview. Excerpts:

In what ways are phytopharmaceutical medicines better than the traditional drugs?

Even though, both traditional medicines and phytopharmaceuticals are derived from plant sources (and other natural sources except for phytomedicines), in India, regulatory bodies controlling these two medicinal practices differ significantly. ASU (Ayurvedic, Siddha and Unani) medicines are regulated under the purview of Department of AYUSH, while, phytopharmaceuticals are regulated by CDSCO (Central Drugs Standard Control Organisation). Owing to this, phytopharmaceuticals are controlled in the similar manner as conventional chemical drugs. Their safety, quality control and efficacy are proved and supported by randomised, double-blind, placebo-controlled clinical trials which result in evidence-based drug development. This scientific evaluation of phytopharmaceuticals makes them more admissible than traditional medicines which are often supported only by non-clinical data which is not so reliable. Moreover, to develop phytodrugs, only therapeutic actives are isolated from plant sources through specialised extraction techniques so that the highest therapeutics efficacy of the particular bioactive can be employed for a specific disease.

Can you share your journey on the drugs and phytopharmaceuticals domain?

I have been in the pharma industry for the past 50 years and in the nutra, plant-based products, phytopharmaceutical industry for the last 20 years. Interlink being a consultancy firm, along with my team, we are provide go-to market strategies, launch new companies with a focus on top line products and profitability. This is the journey that has been going on so far.

Medical fields like allopathy promise cure for over 85 per cent of the current day diseases. Can you assure an equal or better cure?

As phytopharmaceutical field is still at a formative stage in India, it can’t be entirely compared to allopathic medicines which have established an irreplaceable place in healthcare practices after decades of research and development. True efficacy and the frequency of side effects of herbal medicines are not known as very few have undergone large clinical trials such as allopathic drugs. Although, till today, very few herbs are scientifically evaluated and have the potential to be used in medical treatments, extensive research in this area can bring out the true potential of phytopharmaceutical market in the near future.

What are the milestones crossed by phytopharmaceuticals in terms of human health?

Traditional herbal medicines in India and even Chinese traditional medicines have emerged as an excellent source of phytopharmaceutical bioactive, which is extensively being studied and utilised today.

Most of the people are comfortable with the current allopathy treatments and medicines. Do you think that phytopharmaceutical drugs earn people’s trust?

Yes, they can and the pandemic has led a rigid platform for this trust in plant-based medicines. The changing perspective of patients towards chemical drugs due to increasing incidences of side effects and addiction is further propelling the acceptance of herbal medicines. The initiatives by the Government of India and Ministry of AYUSH during COVID have promoted herbal medicines to a very huge extent, people are gaining trust in herbal medicines, which is a great sign for phytodrugs as well. Owing to the changing trends among people today, they don’t want to fall sick and want to remain healthy using possible preventive measures, there is a paradigm shift from cure to care. This has been one of the crucial reasons behind the acceptance of herbal drugs. Allopathic drugs can’t be replaced entirely from the regimen but looking at the increasing prescription of herbal medicines from physicians, use of synthetic drugs for longer time period can be prevented and further treatment can be followed by herbal medicines for the long-term to avoid addiction and risk associated with allopathic drugs.

Where do phytopharmaceuticals stand in cancer treatment?

Naturally occurring phytochemicals such as vinca alkaloids (vincristine, vinblastine, podophyllotoxin), taxol analogs have been extensively studied for the cancer therapy. Such bioactives proved to be responsible for inhibiting growth and progression of cancer through mechanisms such as proliferation inhibition, carcinogen inactivation, cell cycle arrest induction, increasing antioxidant and apoptosis. In current cancer therapies with phytochemical drugs, four major classes of anticancer compounds namely, vinca alkaloids, camptothecin derivatives, epipodophyllotoxin, and taxane diterpenoids are employed. Additionally, other plant-derived anticancer agents are also being used and some of them are under investigation. Although, several pre-clinical and clinical trials give satisfactory evidences about such anticancer phytochemicals, some challenges such as molecular interaction with different ligand molecules, different mechanism of action,etc need to be validated with further research and large scale in-vitro/in-vivo studies to full proof the therapy.

How useful are phytopharmaceutical drugs in treating COVID? Are there any studies conducted to prove the efficacy of the drugs on COVID-affected?

 

Several phytochemicals have proved to be efficacious against various viral infections. Chinese traditional medicines is a well-established practice in this area. In India, the very first phytopharmaceutical drug for the treatment of COVID-19, called AQCH (derived from the tropical shrub Cocculus hirsutus), received approval from the Drugs Controller General of India for clinical trials. However, it did not receive grant for ‘Emergency authorization status’ from government. Various efforts are still going on in this space to develop a promising plant-based treatment for COVID-19. Moreover, herbs like Glycyrrhiza glabra, Withania somnifera, Timospora cordifolia and AYUSH-64 (Polyherbal AYUSH drugs) have been taken up for clinical trials against SARS-CoV2 virus by Ministry of AYUSH and CSIR.

When it comes to branding of traditional medicines, people tend to develop a reluctance. What do you think is the reason for this behaviour? How can this be rectified?

This is because of the huge difference between the marketing approval process and criteria in India and abroad for traditional herbal medicines. India is facing challenges in terms of regulations due to which uncontrolled and substandard formulations along with misbranding is an uncontrollable scenario. India is exporting herbal ingredients but the speed and quantum is relatively less. Moreover, production of fraudulent herbal medicines, which are deficient in clinical data are very common in India ,and is emerging as a roadblock for branding and marketing of such products. We need a modern regulatory system all the way from cultivation and export of herbal medicines in order to develop a huge source of income. Quality control, standardisation, clinical trials, marketing strategies require certain policies through Government interventions to meet international standards of selling plant-based products. Additionally, checking therapeutic claims is one of the crucial steps that needs to be followed vigilantly.

Why does research take a back seat when it comes to traditional medicine in India?

Variable and inconsistent results along with inadequate research designs for herbals is one of the major limitations while promoting plant-based products. Studying plant-derived extract is pretty complicated owing to the presence of cluster of complex chemical compounds in a single herb. Such research and development require highly specialised techniques, devices and technologies which are deficient in India. In clinical studies, availability of small sample size, poor controls, insufficient comparison data between other treatments or placebos or compound, and inconsistent description of treatment/ product are some of the holdings back factors due to which research scenario for herbal entities are struggling. We need to adapt advanced technological interventions right from laboratory to production level in order to overcome such challenges. Government policies are mandatory along with the contribution from pharmaceutical players.

 

The article is written by Dr. Smarta  (CMD-Interlink) & published by Trinity mirror. The link is https://www.trinitymirror.net/news/phytodrugs-new-paradigm-in-healthcare/

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Ethno-pharma- An emerging sector

Healthcare sector in 2021 is evolving to the greater extent owing to the initiatives and advancements taking place to futureproof the healthcare facilities from uncertain, unwanted, and deadly event like Covid-19. These advancements are happening while keeping the patients at the centre with the more focus on preventive and immune health.  

Now while talking about preventive immune health, we can see at large, traditional medicines and integrative medicinal practices are emerging in the modern scenario of healthcare. Ethno-pharma, an ethnomedicinal field, which majorly deals with traditional and folk medicines is also set to bloom in upcoming years. 

While focusing on the cultural determinants for traditional medicines and also pharmaceuticals, ethno-pharma deals with the investigational approaches in finding the possible use/perception of traditional medicines (and also pharmaceuticals) in the culture. 

Ethno-pharma and ethnopharmacology follows the ‘multidisciplinary scientific approach’ through which various holistic approaches can be made to innovate novel treatment strategies for the management of various chronic diseases and to explore their relevance to modern healthcare. 

India is widely known as the ‘home to medicinal herbs’ as traditional and integrative medicines are well-accepted and established in the country. However, the concept of ethno-pharma is yet to establish in India as very small cluster of population is aware about this field. Following are some promising approaches which can put light on ethno-pharma sector in India in coming years.  

New research and progressions in the field of herbals  

Traditional medicinal plants contain a wide variety of chemical groups which exert different biological effects through which several chronic diseases can be cured in a natural way. As ethnopharmacology majorly deals with the pharmacognostical, phytochemical and pharmacological aspects of natural drugs and medicinal plants, looking at the current advancements in Indian research and development, some promising novel herbal drugs can be invented in the years ahead.

Moreover, to develop new molecules which are safe as well as affordable, number of pharmaceutical companies are showing rejuvenated interest in natural drugs. Covid-19 and increased prevalence of lifestyle diseases and non-communicable diseases have led down a rigid platform for herbal drugs which in turn boosting the research and development in the area at 2× speed. 

Changing attitudes, driving markets

Besides Pharmaceuticals and Chemically derived entities, most of the consumers due to awareness are looking for natural medicines. Pharmaceutical medicines have its own place in curing patients and through vaccines, even preventing certain diseases, however, the movement towards natural products and enthnopharmaceuticals has social impact besides medical impact. Due to this, a great market transformation can be seen in the herbal and natural ingredients area.   

The Indian traditional medicines market is expected to grow at CAGR of 16.06% through INR 300 billion in 2018 and can account INR 710.87 billion by 2024. This market growth can be beneficial in increasing the evidence-based research in the area of ethnomedicines.  

 

Government bodies supporting traditional knowledge

Ayurveda and Homeopathy medicines covered under AYUSH system of medicines have a strong correlation with the ethnopharmacology as the field is associated with the traditional medicines to the greater extent. Owing to this, Ministry of AYUSH is taking several efforts to involve the ethnopharmacology model in the syllabus of alternative medicine systems. Due to such approaches, an individual subject can also be expected in the syllabus of AYUSH which can further propel the growth of ethnomedicinal sector. 

AYUSH initiatives to boost the immune health in Covid-19 through traditional remedies have emerged as an uplifting factor for natural medicines and further advancement in this area by the major companies like Dabar, Patanjali, Baidyanath, Himalaya, etc. are opening the doors wide open for the future astonishing growth in the herbal field.  

Moreover, Society for Ethnopharmacology (SFE) in India is working with the reputed academicians, researchers and industry dignitaries with the goal of ‘Globalization of local knowledge and localizing global technologies’. This society can be of great benefit in spreading the knowledge of traditional ethnomedicines to stabilize ethno-pharma sector in the country. 

To effectively march toward the healthy future of Indian population and the economy, ethnomedicinal sector should be well equipped with the technological advancements like pharmaceutical industry. Scientific-evidence based approaches for herbs, herbal products, ethno-herbal extracts are important which will drive this field much effectively and it can become more approachable for modern healthcare practices. 

Along with all these, quality control and quality assurance are the key parameters which major herbal products fail to follow as compared to pharmaceuticals. Certain policies in this area can also help to develop the natural sector in much flawless and productive manner.

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Walking with Adversities

Years ago, I saw a picture which etched itself in my memory. Protruding from a dead stump, there was a green healthy branch which seemed destined to live and grow.

Below the picture there was a word Reviresco. I was little intrigued to find out the meaning of this word. The liberal translation is – ‘I flourish in adversity’, what a powerful thought.

How wonderful it would be if we could learn early in our life that we can only grow strong in adversity.

Hardships, as Abrahm Lincoln expressed, are too precious to lose. Adversities are inevitable and, in my opinion, the person who knows the art of converting adversities into opportunities, can achieve the impossible.

Covid-19, one of the adversities in today’s scenario which has turned the entire world upside down, made us strong and sustainable in many ways. Many businesses which were on the urge of losing their identity have somehow managed to endure the losses and ready to bloom again while walking with adversities. Moreover, during covid, some of the business who discovered ‘opportunities into adversities’ have made an exceptional revenue which was never made before when the things were normal. That’s the magic hidden inside adversities which we can experience if our eyes and heart are open to it.

It’s all about learning the art of walking with adversities. Discussed ahead are the techniques which can be implemented to find the way out through hard times in an artistic way.

Art of decision making

We all are aware about the market transformations happening every single day. If the decisions made are based on the out-of-date information, they will never result in successful business, moreover, the losses would be unbearable.

One should be awareness about how far they can go with their strengths and whether those strengths will withstand that risk. Avoiding making unrealistic decisions is a smart choice to endure adversities.

In addition to this, we should be able to recognize our prioritize and problems and the ways to handle them. One should know where to handle by themselves and where to distribute the responsibility. Creating a system which looks after such issues can make the things much easier to handle in future.

Art of Moving ahead

Moving an inch every day forward, communicating and building relationships are some essentials to create a strong base to deal with adversities. As the business circumstances keep evolving, we also need to revisit and update our business strategies regularly.

Art of consistent efforts with new initiatives

Consistency accompanied by persistent efforts never fail to pay off. We might fail a hundred times, however, we get filled with valuable experiences with each failure which are enough to keep us moving toward success while trying new things every time.

positive attitude toward our inherent strengths and practicing resilience can fetch us our desired goal.

Art of Mindfulness and managing self

Practicing mindfulness is a way to heal, experience peace and happiness throughout the period of adversities.

To have the sense of being in present, mindfulness is a kind of energy which helps us to be in touch with life deeply.

Strengthening our mind, body and soul is crucial to remain calm yet energetic in critical situations. Nothing is more important than being health; wealth can wait.

Walking with adversity means ensuring that all you do is always with mindfulness. It is also equally important to understand that adversities are part of life and not vice versa.

As a result, it is better to be in present, mindful, managing self and time with meaning and keep our aim at going forward with chosen initiatives…That’s the way we walk with adversities…

 

About Author-

Dr. R. B. Smarta- Founder and Managing Director of Interlink Marketing Consultancy Pvt. Ltd.

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Three Crucial Parameters for Sustainable Business Model

All organisations are looking for sustainability after pandemic and hence it is clear that each one of us need to articulate this model to sustain in our business.
Experience shows that it is always to be remembered that-

1) Who we are?
Are we deploying resources for today and tomorrow? It may need strategic thinking.

2) What are we doing?
Is each activity profitable?

3) How do we sustain and grow?
Do we disrupt our ways of deploying resources, methods of doing business, and retaining our customers to sustain?

‘Market transformation’ aids the business sustainability and competitive positioning of an organization. Nowadays, companies are not waiting for such market shifts. They are creating those market shifts to achieve desired level of organizational sustainability. This is possible because of a well featured business sustainability model. Many organizations are now developing various business models, following are the three crucial parameters which can be considered while designing organizational level sustainability model-

Sustainable Business Model should be-

1. Futuristically viable- Organization building based on limited resources will be a short-term yield. Availability and access to resources and its pricing are the constantly fluctuating entities. Sustainable business model should be designed in such a way that it should never be the waste in future.

2.Commercially profitable- Attracting new costumers and re-engaging old ones will always be the challenge for any organization. This strongly depends on the value proposition of business. Once the efficiency and effectiveness of your business is positively conveyed to the costumer, ground is yours! This vital point should never be ignored while developing sustainable business model.

3. Equipped with long term resources- Choosing accurate resources would be one of the important moves while operating any organization. Organizational management has to make a good choice between cheap resources with short term benefits and expensive resources with long term side effects. Organization’s decision-making abilities with situational analysis will play crucial role while looking for resources with long term benefits.

Every business needs a sustainable business model and polishing this model with newer and innovative concepts it is going to be a mandatory thing in coming years. With increasing development of sustainability strategies, products and services along with appointments of sustainability department and sustainability officers, new sustainable business models are expected to come up in this competitive era of businesses.

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Volume to Value Shift

With the transforming behaviour and needs of consumers, reforming healthcare and new trends in industry, pharma business models are moving on from their traditional way of working towards a more promising and persistent approach of functioning. Adaption of a value-driven business model is what an industry is exploring nowadays which is of course much profitable and sustainable in many aspects for the business. 

Why ‘Volume to value’ shift is happening? – 

It is very essential in today’s market place that the company should explore new ways to tighten the bond between their brand and target audience. Ethics, feeling of surety and reliability is what today’s generation consumer is looking for along with quality, quantity and functionality of the brand. 

Evolving mindsets of consumers from ‘Spending on volume’ to ‘Spending on value’ is making pharma companies adaptive toward patient’s changing needs. This abruptly changing mindsets making pharma companies to rethink and develop in terms of building Value proposition which can sustain their business in the longer run. 

What are the ways to create value for your customers? 

Understanding customer’s changing needs- In today’s world, One-size-fits all approach will never lift you up at any cost. Customers are evolving, their needs are changing and they are the sole decision makers whose assessment is one of the primary tasks which no one can afford skipping. Identifying customer interest and strategizing the way of delivering value will never disappoint any business.

Educating the customer segment to make a right choice- Educating customers is one of the game changing strategies which a company can follow to improve the engagement of customers. Many consumers could not make a better purchase owing to the lack of exposure to all the attributes of products or services, or they might be also having some misconceptions about the product/service, we never know!!

Sharing valuable content like case studies, infographics, articles, guides, etc via emails, blogs will create a necessary brand awareness and will promote value of your brand. An intensive approach and strategic implementation in this regard can influence consumers to get engaged with your product/service. 

Prolonging the engagement of customers- It is always beneficial to engage the existing customers in more fruitful manner than searching for new ones. Presenting discounts, giving special offers, subscription services and many other ways which can be employed to make your customers believe in your values. Promoting loyalty programs to make them realise that how much you value them is an essential tactic which every business should follow in order to deliver the value.  

Company’s value proposition has got immense importance like never before. Customer’s upgrading mindset resulting in market transformations which are inclining more towards brand value. This shifts in market positively boosting the growth of deserving products/services and customers are delivered with best possible outcomes. Gathering market insights is crucial in this scenario if we want to stay dynamic in the Value-driven industry and make profit.

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Practice Changing Initiatives

Physical appointments and even the referrals have been declined due to pandemic as there was no active and physical consulting going on. This is leading to increased adaptiveness toward Telehealth platforms which are emerging at a rapid pace in various hospitals and private clinics, enabling the hospitals to expand their services in multiple and beneficial ways.

Tele-ICUs are one of the biggest examples arising in today’s scenario, where number of hospitals placed at distant from one another, are able to communicate with hospital critical care units and achieve real-time services via technological advancements.  

Surging incidences of infectious disease is the factor which shaping patients’ mindset in such a way that they obliged to choose such virtual platform which making hospitals to rethink about their old practice and service models. Although, quite a good number of healthcare systems have become well-equipped with this new platform, many are still struggling to maintain their identity in this new normal of healthcare practices. Reasons might be many- lack of right awareness about the platform, over reliance on old-practice and service model, weak promotional tactics, etc. 

So, following are the components of Telehealth through which hospitals are evolving and will continue to evolve in 2021 and beyond…

Tele-appointments-

They have turned out as an amazing option in pandemic. Tele-appointment is the facility which was earlier seen at the hospitals with huge infrastructure. But the situation is different and evolving nowadays. Many reasons associated with Covid fear are the fuelling factors for hospitals to adapt Tele-appointment technology even if the infrastructure is not huge. 

Afterall everyone wants to be in the race!  

Physicians who are carrying out telemedicine appointments, penetrating into their patient’s health without ever having to see them in the hospital. This is actively helping elders and patients with chronic conditions, making a big revolution in healthcare practices. 

This technology is making impressive moves in providing services and giving entry to the medically inaccessible areas such as rural areas where hospital services are difficult to reach, which is ultimately propelling the establishment of telemedicine hospital centres in various rural areas. 

Tele-diagnosis-

With increasing work load as hospitals turning into Covid centres, tele-diagnosis is reducing the burden on hospitals. Screening multiple patients is now possible while maintaining the treatment of others. Many technologies such as china’s virtual diagnosis of coronavirus using 5G network are rooting in hospitals giving relief to physicians, hospital staff and patients regarding possible spread of infection.  

Nowadays, ESA-supported robotics technology making good moves in radiology examination. This system is already in force in Europe and Canada and examining heart, abdominal, pelvic, and urinary tract diseases remotely. Being on the video conferencing, radiologists and cardiologists are remotely moving robotic arms and adjusting settings to capture best possible images. These technologies are incredibly helpful while dealing with Corona-patients with other allied health issues. 

Number of researches are going on to develop the best technology-based methods to provide virtual diagnosis, where necessary hardware installation in hospitals to make tele-diagnosis possible will always be the matter of concern for many under-developed hospitals. 

Tele-treatments & surgeries- 

Real time interaction with the specialists providing ease in getting proper and timely treatment and therapies making patients and hospitals more adaptive toward telehealth. 

Many hospitals have adopted the digital way of prescribing i.e., E-prescribing which is constantly increasing and the market is its expected grow at a CAGR of 23.3%, will reach USD 3.3 billion by 2025. So ultimately, Tele-treatments are making the doors wide open for already emerging E-pharmacy sector. 

Various E-therapies are becoming more and more promising in today’s scenario. Much impressive moves are seen in E-psychotherapy, where psychiatrists are directly engaging themselves in patients’ room virtually and taking deep insights about patients’ problems and recovery.

Although many delicate surgeries are performed aboard, Tele-health and technologies associated with it are helping patients and surgeons in the hospitals to be at their own county and operate the surgeries efficiently. 

Hospitals having 5G network and robot-assisted equipment and hardware will provide fast data transfers with little to no latency in the procedure giving excellent outputs while performing virtual surgeries. 

Tele-monitoring & E-rehabilitation-

Post-surgery monitoring is always important when patient is discharged, hospitals are now evolving in the field of post-surgery consultation. Tele-monitoring provides a better option to virtually meet the physician while lying on to the bed at home, without struggling with paining stiches on the way to hospital. Elderly patients or patients with decreased mobility are extensively monitored with these technologies, helping them to recover much faster.

E-rehabilitation is much useful for patients with musculoskeletal conditions, multiple sclerosis, osteoarthritis, and recovery of motor function. Doctors in hospitals can monitor the movements of patients in Yoga and provide therapy in much effective manner, allowing patients to recover much faster than expected. 

 

Although many hospitals are actively participating and adopting all these technologies, few are still not using it to its full potential. Many hospitals are well-equipped with all the technologies, hardware, infrastructure, etc but the factor which drags down the profit of some of the hospitals is- poor marketing of hospitals’ services. 

Telehealth and technology related to it are the practice changing initiatives taken by many hospitals in 2020. It is a reality and every hospital need to accept and adopt it. Old hospital practice models will no longer remain superior. Years coming ahead are already showing the clear picture of technology-based services in every part of industry, healthcare is not an exception, hospital managements have to be ready to absorb and emit all these changes efficiently and wisely.   

The article is written by Dr. Smarta and published by Asian hospital healthcare management in Jan’21 

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