Month: August 2021

by Rajkumar Natekar Rajkumar Natekar No Comments

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

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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
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.

by Rajkumar Natekar Rajkumar Natekar No Comments

You need to know this!!!

What does this equation in the picture mean?

Let me elaborate it a little,

If any one of the elements out of S, E or A is replaced with ZERO, ultimately, P is going to be ZERO!! Simple math, isn’t it?

But what exactly this mysterious P, S, E and A stand for?

So, here you go…

P- Performance

S- Support

E- Efforts

A- Attitude

Makes scenes?

Perfect blend of support, effort and attitude results into the perfect performance. Absence or deficiency of any one of these elements leads to poor performance which aims at nothing but failure and eventually loss of interest.

When I speak about Support, what I exactly mean is- Money, Material and Emotional support. Who doesn’t need money? Although not every task has to be financially supported, big dreams need big pockets, at least at the individual level. And at organizational level, money (incentives) matters the most. A bad pay will never entertain the employee in the long run. Likewise, material support, such as proper guidance, effective mentorship by leader at work, efficient working goods and supply are also necessary to attain a better performance with desired outcomes.

Emotional support at right time sometimes plays very crucial role in the challenging working environment. Over here, leader has an important duty to play to boost the confidence of the team. Best leaders never let his team fight alone, instead, he joins in and shares the sense of responsibility with the entire team which make the things easier.

Now speaking about Efforts, it has two aspects- Individual efforts and organizational efforts. At individual level, we know what kind of efforts we are putting in, hence, certainly we are totally aware about what could be the possible outcomes. If the organization is giving its 100% to bang on the task, the results entirely depend on employees’ efforts and in that case, employees have no rights to blame the company for the task failure. Best outcome is a product of collaborative efforts of each employee and the concerned organization.

Last but not the least, is our Attitude to perform. We all are always ready to put everything which is needed to achieve our dream success. But the thing which describes our true potential and determines the quality of outcomes is our attitude. Nobody on this planet can rule over your attitude unless you willingly giveaway all the controls.

However, while working in an organization, being surrounded by people possessing different attitudes, leader plays a very important role in positively reshaping those scattered attitudes. Best leader resonates his positive attitude in his team members which makes the working environment productive and like-minded.

I personally follow this me-made equation for giving my best performance in whatever task I wish to succeed. I hope it would be helpful for my connections as well…

by Rajkumar Natekar Rajkumar Natekar No Comments

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.

by Rajkumar Natekar Rajkumar Natekar No Comments

Overview of Indian Botanicals

Global Botanical Extracts Market was valued at USD 4.57 billion in 2019 and is projected to reach USD 8.51 billion by 2027, growing at a CAGR of 8.7% from 2020 to 2027.

Indian herbal extract market is expected to reach over INR16,000 crore by  FY 2022.

Regulatory dynamics in Indian botanical sector:

Botanicals have been used in a number of formulations in India, including traditional medicines, Nutraceuticals, dietary supplements, etc. The regulatory framework for pharmaceuticals is well established and organized. However, the regulatory system for traditional medicines and other plant-based products is still evolving and not much organized. 

In India, Food and Drugs Administration, Food Safety and Standards (Health Supplements, Nutraceuticals, Food for special dietary use, food for special medical purpose, functional food, and novel food) regulations, 2016, Drugs and Cosmetic Act 1940, Ministry of Ayurveda, Yoga and Naturopathy, Unani, Siddha and Homoeopathy (AYUSH) and several allied bodies are responsible for the regulatory provisions for herbal health products and foods. 

As the regulatory framework is not very rigid, many constraints are faced by Indian herbal market right from formulations to sales and marketing of these products.

Japan and China mainly use the term health food, but with different regulatory processes. The general concept of health food is that the food contains nutrient as well as health benefits. Thus, some permitted health-related claims can be made. In Japan, health and nutrition claims handled separately, processing via different regulatory route while, in China, the claims are restricted to the pre-defined twenty-seven health claims.

Following excel sheet gives an overview of regulatory dynamics of botanicals in India as well as two Asia-pacific markets- China and Japan. 

Risk of food fraud in India and present traceability mechanisms:

According to the authentication solution providers’ association (ASPA) state of counterfeiting in India 2020 report, overall counterfeit incidents in India rose by 24% y-o-y between 2018 and 2019 especially for food and beverage items. 

FMCG sector is most vulnerable as counterfeit incidents in the sector increased by 63% between 2018 to 2019.   This counterfeiting includes adulteration, smuggling, trademark infringement, packaging and labelling fraud and manufacturing of products that purposefully closely imitates the appearance of an original product to mislead a consumer. 

Most counterfeited food and beverage items in India are – cumin seeds – made from stone powder and broom bits), mustard cooking oil and ghee. Illegally produced liquor. 

Moreover, in herbal sector, unauthenticated plant materials and issues arising due to substandard variety of plant material in health foods and medicines is one of the biggest matter of concerns in India. 

However, as the new advancements in research and technologies are taking place, traceability mechanisms for herbal material are evolving which might result in promising footprints in Indian botanical sector. 

Following excel sheet gives an overview of food fraud scenario in India and present traceability mechanisms employed.

Trend and promising ingredients in Indian botanicals:

One of the most promising trends in Indian botanicals are herbal immunity boosters. Owing to the increasing prevalence of lifestyle-diseases and the pandemic scenario, Cure-to-care shift can be seen in India. Increasing awareness about health concerns driving the growth of herbal health products in India. 

Following excel sheet gives an overview of some trends which can be seen in Indian botanical market along with some promising immune health boosting herbal ingredients which can gain high demand in coming years.

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Direction regarding Recommended Dietary Allowances (RDA)

On 2nd August’21 Food Safety and Standards Authority of India (FSSAI), has published new Recommended Diary Allowances (RDA) values for vitamins, minerals and amino acids for compliance by food Businesses.

The regulations shall come into force from 1st July, 2023. Food businesses may comply RDA 2010 or RDA 2020 till that time.

For more information kindly refer below data.

View PDF

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The Ever-growing World of Nutraceutical

On one hand, the accelerating impact of COVID-19 is adversely affecting the entire economy, on the other hand, people are becoming much concerned about their immune health which is a blessing in disguise. Why I call it a blessing in disguise is because- the shifting perspective of consumers from treatment to preventive care causing increasing adaptiveness toward natural, chemical-free remedies. And being the area of natural formulations, Nutraceuticals, as a sector, is flourishing like never before during the pandemic. Thus, along with the pharmaceutical industry, the Nutraceutical sector can also evolve as an industry supporting nation’s economy in a much fruitful manner in the pandemic and the years ahead.

Nutra-ingredients and Nutra-excipients- Market scope 

As per the research, the global Nutra-ingredient market is set to encounter an astonishing growth of USD 167.3 million by 2026 with a CAGR of 4%. The market was accounted for USD 127 Million in 2019 and it is growing inevitably every year. The same goes for Nutra-excipients as well which are projected to reach USD 5.2 billion by 2026 growing at the CAGR of 8.1% from USD 3 billion in 2019.

This impressive growth in the Nutra-ingredients area is expected to be governed by probiotics as several innovative end products getting launched into the market nowadays are some or the other form of probiotics which are gaining much popularity among the population. Functional foods being always the topic of enthusiasm in the Nutra industry will generate sizable revenues in coming years.

Now talking about Nutra-excipients like fillers, diluents, coating agents, binders, disintegrants, flavouring agents, and many more, out of which binder segment is expected to gain much yield owing to the increasing formulations of natural-ingredient based tablets and capsules which require binding of powders, granules, and other ingredients.

Looking at the large population with increasing demand for natural supplements owing to the changing lifestyle and rising incidences of lifestyle diseases, the Asia Pacific region is poised to witness much growth in the Nutraceutical sector in coming years.

Growth boosters

The growth engine of the Nutra industry has many drivers which are efficiently traveling toward the prosperous future of Nutraceuticals. In the pandemic situation, rising awareness about immune health and preventive care is one of the highly distinguishable growth drivers of Nutraceuticals. Other than this, below discussed are four major growth boosters of nutraceuticals that will continue to drive this growth engine even after the pandemic.

  1. Life-style diseases- This growth driver will never disappoint the Nutra sector in terms of gaining revenues in recent times. Ever-growing incidences of heart-related diseases, diabetes, obesity, etc insisting consumers to opt for safe and natural nutraceuticals which not only prevent such diseases but also improve the quality of life. An aging population is also on the rise which is making a way for the entry of new nutraceuticals into the market.
  2. Changing preferences- Owing to the rising awareness about the nutritional benefits, safety, and therapeutic efficacies of Nutraceuticals, consumers are increasingly becoming adaptive toward chemical-free natural solutions to manage the diseases. Health consciousness coupled with increasing disposal income leading to a new lifestyle which is much oriented around the natural world of nutraceuticals than pharmaceuticals.

A high preference for a balanced diet and food fortification is trending nowadays which is further fuelling the growth of dietary supplements and functional foods.

  1. Escalating healthcare cost- Expensive pharmaceutical drugs and high charges of hospitals are some of the biggest factors which are forcing consumers to focus on their immune health to avoid the healthcare facilities which no more pocket-friendly.
  2. Innovations- With the increasing interventions of government to boost the research and development in the field of nutraceuticals, new technological innovations are taking place which are not only more efficacious than before but also are cost-effective. Excipients used nowadays mostly poses multifunctional properties which lower the cost of the end product. This ultimately generates high scope for innovative end results in the nutraceutical market.

The nutraceutical industry is all set to explore new market opportunities and support the economy of the country in a much constructive way. The only thing which the producer should keep in mind is- keeping an eye on evolving consumer needs and responding to them. Consumers have always loved experimenting and exploring innovations, producers should offer new experiences to consumers in order to gain attention and secure a sustainable position in the Nutraceuticals market.

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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
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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