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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.

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/

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.

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.

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.