Month: August 2021

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/

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.

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

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.