As the pharma industry continues to evolve, pharmacy education in the country will have to transform itself to help India Pharma Inc leverage emerging opportunities and nullify the challenges. Leaders and experts reflect on the strategies needed to bring about this metamorphosis

Pharmacy education has a major role to play in the the progress of the pharma sector. Yet, in India, it is entangled in several issues. One of the major issues is the implementation of the right courses as academic programmes are structurally not organised to meet industry expectations. This has resulted in a large number of vacancies in the organised sector along with a high rate of unemployment among the skilled category.

Understanding the criticality of the issue, Express Pharma spoke to industry experts to find out how these issues can be resolved.

The topic was also addressed at the recently held FDD Conclave organised by Express Pharma. An expert panel discussed the various challenges faced by the sector due to qualitative and quantitative paucity of talent and the role of academic
institutions in creating better talent in terms of quality and quantity.

Right talent pool

In the recent years, we have seen a lot of pharmacy colleges mushrooming across the country, especially in rural India. However, a constant lament is that students from many from these institutes lack exposure due to an outmoded curriculum changes and various other factors. So, how can we ensure that we create the right talent pool which is industry-ready?

Dr Amelia M Avachat, Professor, Department of Pharmaceutics, Sinhgad College of Pharmacy points out, “It is not that we don’t have the right talent pool but the main problem is lack of exposure. Students belonging to rural areas have never seen a pharmacy college in their life and upgrading the talent pool remains a big challenge.”

Stressing on the urgent need to create the right talent pool via the academia route, Roop Krishen Khar (KILAM), Professor & Principal, BS Anangpuria Institute of Pharmacy, says, “The talent pool can be created by focussing and shortlisting pharmacy academic institutions in different regions of the country on the basis of their academic and research

outcomes and identifying their industrial partners in respective regions in the first place. Academic staff can move to industry on short-term sabbaticals from time to time and get trained in accordance with industrial needs. Industrial experts can be formally aligned with the academic institutions in different capacity, which can be mutually worked out. This can set a chain of activities together which will include, the process of curriculum changes, sharing of expertise and many others.”

Pointing out the reasons for lack of skill-based training at the academic level, Dr Arun Garg, Dean, SMAS KR Mangalam University, highlights, “The quality of education in Pharmacy Council of India (PCI) approved diploma colleges is a concern because most of the institutes provide education through distance mode/non-attending mode. This prevents student from learning necessary practical skills expected by the community/hospital/industry. Hands-on training in any course is the necessary gap that needs to be urgently bridged so a student can understand the value and essence of the programme he/she is undertaking. It also helps a candidate analyse his/her role to play as a pharmacist in the society.”

However, with regulatory reforms and technology upgradation happening at a fast pace, creating a niche number of talents for QbD, dissolution, patent search, IVIVC, pellet manufacturing, bioavailability and bio-equivalency testing, dossier preparation and filing, seems to be a challenging task for pharma institutes.

Nevertheless, the problem can be resolved, provided a thorough and rigorous screening process is undertaken, recommend some experts. Khar replies, “In under graduate courses, students should be directed to develop some practical skills in various areas of pharma technology, which can finally assist them to develop professionally in future. At present, we can see the potential impact of the outdated syllabus on the current industrial needs. With new technologies and regulations in place, the requirement for change in pharmacy education curriculum cannot be neglected. Hence, perfect courses and guidance should be provided to students, which will assist them to move in the direction of professional development.”

Upgrading the syllabus

The current syllabus followed in pharmacy colleges, as per the industry experts, is outdated.This, in turn, has taken a toll on nurturing the right talent. With advancements in pharma technology, students, alongwith, industry stakeholders should remain updated on the current scenario.

Khar points out that the outdated pharmacy syllabus is affecting industrial growth and there has been a large hue and cry to revise the syllabus, however, nothing much has happened on this front.

Dr Avachat talks about the required changes in pharmacy education and says, “The syllabus lacks in-depth study of excipients. Flexibility in syllabus can be in the form
of electives designed by the industry and academia during the first or final year of PG studies or final year of UG level and can be need-based as per industry requirements.”

She continues, “The elements of the course have become outdated and provide no or little interaction with the status and growth of the pharma industry. It becomes necessary to follow the rapid and continuous changes in pharma industry, which makes academia-industry interaction a necessity. The curriculum should be revamped to have more case study or actual practical-based syllabus. This would require inputs from the industry during the point of framing of syllabus. Practicals need to be designed based on problems encountered by the industry during the product development process, right from pre-formulation stage to regulatory filing.”

Pointing out that there is a complete disconnect between theoretical education and its application in practice, Dr Avachat says that there is an urgent need to bridge the gap. She also lists down a few points that needs to be considered to bridge the gap.

These include:

• How much theory is connected to industrial practice or pharmacy practice or to other requirements at the place of work?
• In what way is the ‘theory’ connected with ‘practical’ work?
• What is the real outcome of theoretical training? Can’t it be translated into some tangible outcomes?
• We need to understand and be very clear about as to which basic concepts have been imparted or strengthened by theoretical courses. Can these be actually documented or measured?
• Which specific skills have you been able to impart through the practicals attached to the theory course included in the syllabus?
• What are the specific applications or outcomes?
• How do you connect the basic concepts and the skills imparted? What is their actual application in industry/ market/work place etc?
• Can all these be documented or quantified, in order to highlight the achievements and the added value to the knowledge body acquired in this manner?
• How many times you give an opportunity to the students to give a feedback so as to whether he has understood the concepts or skills imparted by you?
• Can these facilities be effectively used by opting for initial R&D work of formulation development to be carried out in such type of institutions? She also says that this can be done mutually by the pharma industry and the academic institutions together. It could turn out to be a win – win situation.

She highlights that this could be a dynamic and a continuous process as per the needs and requirements.

Agreeing with Dr Avachat’s idea of involving representatives from pharma companies in the process of revising pharma curriculum, Dr Mahesh D Burande, Director, Institute of Pharmaceutical Education & Research, Pune says, “All companies should devote at least one person from their company and form a committee and this committee with the chairman should suggest the syllabus for M.Pharm. It should have a problem-solving approach and the process needs to be repeated every three years. Top 50 academicians in the country should come together to work with this committee to implement the revised syllabus. Initially, 50 per cent upgradation in syllabus is required but later 20 per cent is required every three years. This will give the industry the right talent pool.”

Dr Burande further says, “We have around 10000 pharma companies in the
organised sector and more than 500 pharma companies have their formulation development department while less than 50 companies are involved in basic research and drug development. To attract the talent, if all companies come together and conduct innovative research conclave every year and select the best 100 students with a starting salary of `50000 per month, we can attract the best students in R&D for formulation development and drug delivery.”

Innovation drives drug delivery

Innovation in drug delivery method is the future of Indian pharma industry and pharmacy course structure in India mainly consists of two facets of profession: patient (pharmacy practice) and product (industrial pharmacy)-oriented pharmacy
in different proportions together. However, this approach didn’t witness much success as the course structure for practising pharmacy is not relevant to the requirements of an industry and vice-versa.

Even after having more than 700 pharmacy colleges which offers M.Pharm every year and 15000 students passing out from these colleges looking for a career in R&D have suffered at the behest of quantity, Dr Avachat informs, “On one hand, the number of colleges imparting B.Pharm and M.Pharm have mushroomed to an exorbitant number over the last 10 years while on the other hand the quality of students has suffered at the behest of quantity. This has completely skewed the demand-supply ratio as there is no dearth of students who major in pharmaceutics (branch dealing with F&D and drug delivery). Besides this, the F&D work in industry may not match with what is done in the academics. For example, research in academics is mainly happening in areas like nanotechnology while that is not so in the industry.”

Dr Avachat chalks down the following suggestions to expand India’s talent pool in F&D:

a. Every M Pharm. Pharmaceutics project can be guided by people from the F&D of the Pharma industry available in the local area.

b. After thorough screening by a panel of academicians and industry select students can be made to do an industrial internship in F&D and later on be absorbed by the same industry.

c. Novel ideas in the development of drug delivery till the level of proof of concept can be initiated and developed in the academia and then can be taken up by the interested industry partners.

d. Long-term projects can be given to academics or can be jointly taken by both industry and academics so that the students can get to work in the academic set up but under the guidance of industry.

e. The main problem facing academics is procuring funds, so the industry can donate some of their instruments or equipment so that the students can be well equipped and skilled before they join the industry

f. ‘Train and Hire’ system can be adopted

Avachat informs that since the last 25-30 years, the first choice of a student desirous of doing his post graduate is pharmaceutics as it is the only subject where you don’t find a parallel in any other course taught throughout the world. She suggests how to encourage student in opting formulation and development as a career choice and lead the Indian pharma industry to the next level.

She says, “It is not that students are forced to take up a programme leading to
formulation and development (F&D). It is only the lack of industrial exposure which
is the main setback which students face during their programme.”

Most of the institutes have the capability to develop novel drug delivery methods, however, due to unavailability of funds and opportunities, most of the ideas die in the beginning itself.

As Dr N Udupa, Professor and Research Director (Health Sciences), Manipal Academy of Higher Education suggests, “Pharma companies willing to develop their drug delivery research centres should come forward to collaborate with highly ranked pharma institutions to train talented students and in collaboration should conduct and explore joint research projects in drug delivery. They should bring out novel patents and technology transfer should take place in right time as per future needs.”

Volume to value

To move from volume to value, we need to find an answer to the questions whether we have skilled talent available within the industry. We also need to create an ecosystem which appreciates and acknowledges quality and excellence. Our
experts have diverse views on achieving this objective.

Khar too feels that government should work together in creating an ecosystem which encourages innovation right from the academic level.

Burande opines, “Volume to value is a great mission. If we publish a successful story and give respect to contributors with academy-industry collaboration, everybody will think of the output with quality. We have to create certain standards to measure the effectiveness of such associations, then only we can progress towards value addition. This will encourage many colleges and industries to go for collaboration.”

Khar opines, “The industry can make their own assessments and identify talented students/staff from the academic institutions from time to time and work on short and long-term projects. Students and staff can be given incentives in the form of some rewards or scholarships. This will also initiate specific and relevant projects that are applicative and translational in nature.”

Smoothing the path for talented freshers whose knowledge is in line with the industry requirements will also lead to encouraging value. Khar informs, “Even after 4000 students passing out from B.Pharm institutes, the industry was unable to recruit them as they lacked experience. Hence, it becomes the responsibility of educational institutions to make students updated on the knowledge in the respective subjects. Students have enough time and are highly motivated but lack skillful knowledge and directions which are essential to work on the true problems and their solutions.” While informing about the existing opportunities in private and governmental institutions, Khar says, “There are huge infrastructural facilities available with private and governmental institutions which remain underutilised and unutilised to their full capacity. This is a great loss to the exchequer.”

Government’s initiatives

Fortunately, recognising the need for an overhaul in the education system and build a talent pool, the government too is introducing measures to meet this goal. For instance, the Life Sciences Sector Skill Development Council (LSSSDC), has been established by and for the life sciences sector in India, to address the skill gaps across functional areas and levels in the sector, by helping to generate a sustained stream of high quality skilled individuals.

Ranjit Madan, CEO, LSSSDC, informs about the steps required to been taken by LSSSDC jointly with DCG(I), MoH&FW. Madan says, “GoI has been working with a great focus on the quality of pharma products served to the common man in India. LSSSDC by now has engaged 64 industry houses for their existing workforce, skill assessment and certification with an objective to evaluate the current skill sets with employees in manufacturing units and standardising the skill set. This has been driven by LSSSDC to implement an advisory circular released by DCG(I), CDSCO, MoH&FW in August 2016.”

Madan further elaborates and says, “LSSSDC has joined hands with Council of Scientific & Industrial Research (CSIR), Karnataka Biotechnology & Information Technology Services (KBITs) and many other reputed universities for utilising their expertise and align them with the industry to enable a faster throughput for industry needs in terms of skilled resources.”

However, the industry feels that there is a lot more that the government can do to
promote and improve education and skill building for the pharmacy sector in the country. Khar suggests, “The government needs to draw out priorities for the next three to five years and align with the industry with specific objectives relevant to the country and according to the context of the new environment. Funding provided by government agencies can be directed on such projects of national importance in order to make a match with the industry. All such projects should have commercial value so that the industry is attracted to pursue them.”

Burande is in favour of government’s support and suggests an action plan. He says, “If the government decides to encourage innovation, I think right from the graduation level, we should start subjects on innovation and R&D. Certain funds should be provided to such colleges where R&D cell has been established with minimum infrastructure and ask colleges to solve problems through students of small scale pharma industries. A separate person besides the regular teacher with
industrial experience should be appointed for such work and the government should pay him 50 per cent salary to lead this cell. Students who are interested in going to R&D, after proper counselling should be taken in this cell right from the first year of the pharmacy course and these students, under the leadership of such teachers, should devote time besides their regular study to develop themselves as future R&D managers.”

Going forward

Pharmacy education in India needs to be at par with global standards, where students armed with all required expertise, can grow up the career ladder. This can be achieved only if industry and academia come on a single platform for a better tomorrow.

u.sharma@expressindia.com

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The conference will be a mega event with expected participation of 8000 delegates
from the pharma industry

69th Indian Pharmaceutical Congress (IPC) will be held at Chitkara University, Rajpura, Punjab from December 22 to 24, 2017. The event will see professionals and academic representatives come together to discuss matters relating to pharmacy with an aim to project the image of pharmacist as a healthcare professional and to create the awareness about the pharmacy and pharmacy profession amongst the public.

The event is supported by Confederation of Indian Pharmaceutical Industry, Indian Drug Manufacturers’ Association, Organisation of Pharmaceutical Producers of India and Pharmexcil.

The theme ‘Skill and Will to Make and Serve Quality Pill’ envisages how pharmacists can play a leading role in the country to promote and realise the vision of healthy India as well as to stimulate discussions and thought process centered around how the country and the pharmacy profession respond to utilise the vision.

The conference will be a mega event with expected participation of 8000 delegates from pharma industry engaged in drug discovery, operation, marketing, students of undergraduate and post graduate institutes across the globe and other professionals. The event will have technical sessions by experts on new drug discovery, industrial pharmaceutical technology, clinical research, pharmaceutical management, pharmaco-economics, nano pharmaceuticals and other recent development. An exhibition and job fair will also be held.

Express Pharma is the media partner of the event.

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How is the 69th IPC Congress unique and different from previous editions, which is hosted by Association of Pharmacy Teachers of India (APTI) along with Indian Pharmaceutical Congress Association (IPCA)?

The quality of the manufactured products has always been a matter of concern worldwide. The theme of IPC 2017, ‘Skill and will to make quality pill’ is unique in the context to envision the importance of quality and safe medicines. Moreover, the topic was selected in line with the skill India mission of government of India. Focus of the current congress would be on exploring new avenues in capacity building, critical monitoring and evaluation of pharmaceutical products to produce quality medications for universal use by patients in need. This congress would provide an opportunity to professionals from academic and industry sectors to discuss and come up with solutions to improve the quality of pharma products.

Any particular reason for choosing the theme to be ‘Skill and Will to Make and Serve Quality Pill’

To improve the quality of products, key prerequisite is knowledgeable and skillful manpower. The theme was selected in view of the need to showcase the capabilities of Indian pharma industry as a provider of quality medicines at affordable prices; capabilities of skilled pharmacy professionals in India and Indian regulators to ensure standards for safe and efficacious medicines. This IPC will provide industry personals, academicians, researchers, and regulatory authorities a single platform, which will definitely help to brush-up their skills and receive motivation to prepare quality medicines.

Why do you think pharma education needs focus? How will this focus help boost the overall pharma industry?

The pharma industry has always been developing and sprouting themselves to compete at international level for quality and standards. Academic education always lags behind in terms of the methods of analysis and manufacturing of formulations owing to limited monetary resources. Meetings like IPC provide unique opportunity to pharma educationalists to interact with industrial and regulatory professionals and allow them to acquaint them with recent technologies through pharma expo. It would help academicians to look into their curriculum and incorporate content beyond syllabus as per the current need of the industries. This will further facilitate the creation of skilled and knowledgeable manpower to meet the demand of pharma industry. Thus, it will be a boost for the growth and development of pharma industry.

How many scientific research papers will be presented in the 69th IPC Congress?

People from different pharma fields have shown great enthusiasm towards IPC 2017. I am very glad to state that we received around 2450 abstracts this year. Out of which, 1950 abstracts have been selected through peer review by expert committee for the presentation in various sessions.

How many pharmacy students will participate? What message would you like to convey to the student community?

I would like to proudly mention that around 9000-10000 delegates will participate in this congress with around 8500 registrations. The registered delegates mainly include UG and PG students, research scholars, academicians, pharmacists and industry professionals. Pharmacy is an interesting and ever-changing field. An intriguing aspect of this profession is the wide spectrum of opportunities available. So, I urge upon all budding pharmacists to come together and work for the community.

Do you think there is enough emphasis made to bridge the gap between industry and academia? How much can the IPC Congress help in this endeavour?

This time we have arranged an assortment of invited talks by the experts from pharma industry and academics. It will certainly help young pharmacy professionals. They will be updated on the recent advances as well as trends and opportunities related to the pharma industry. Further, we are going to arrange state-of-the-art and one of the best professional exhibitions to showcase new innovations in pharma machinery, laboratory equipment etc., from India and overseas. This time, we have also arranged placement drive and also training opportunities by the pharma industry for UG and PG students. I sincerely think that these efforts will definitely help to bridge the gap between industry and academia.

Being the Chairman of LOC, can you tell us what would be the major issues discussed at 69th IPC?

The major focus of the discussion during this congress would be on;

• Measures to improve the quality of pharma products
• Improving quality of pharmacy education in India
• Generation of skilled manpower
• Possible paths to establish the conduit between pharma academic institutes and industries
• Production of indigenous API for pharma industry.

When we talk about higher education in pharmacy, many students opt to go abroad like Ireland, China, Malaysia and US. Is there not enough opportunity here in India?

I do not agree with the statement completely as pharmacy education in India has grown exponentially and we have a number of good educational institutes, which are catering to the need of our country. It is fulfilling the dynamic need of the world leading pharma industries, regulatory authorities, pharma research and academics. Yes some of students are moving out of country for higher education specifically for PhD and post doctoral studies. But the current scenario is inverting from the previous situation as people are coming back to the country due to better opportunities available on the home front.

The dual control of pharmacy education by Pharmacy Council of India and All India Council for Technical Education has been an issue for a long time and it is affecting quality and prospects of pharmacy professionals for some time now. Your comments.

Yes, the dual regulation of pharmacy education is creating hardship for pharmacy profession in general and educators in particular. The Pharmacy Council of India is empowered by the act to regulate the pharmacy profession in India and can register pharmacy graduates to work as pharmacy professionals. The Pharmacy Council of India is making all round efforts to resolve the problem and we are hopeful that very soon the problem will be resolved.

prathiba.raju@expressindia.com

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What will be the theme for 69th Indian Pharmaceutical Congress (IPC). How will it be different from the previous editions?

This year’s theme for the 69th IPC is ‘Skill and Will to make and Serve Quality Pill.’ Previous editions were emphasising on patient welfare at every stage. This year’s IPC theme is concentrating on skill development and evovling role of pharmacists. It lays emphasis on various skills needed to be developed during pharmacy education so that students can get better job opportunities and industry will recognise them for their knowledge and skill. In Sanskrit there is shloka Sarvada Vigyata Vijaya means skill always wins. The theme is will also focus on areas related to inventions, manufacturing, analyses, distribution, sales and marketing activities as well as efficiencies in patient care. We will list out the skills for various jobs a pharmacist has to perform in his /her pharmacy career.

Is the industry in sync with this year’s IPC theme?

India is promoting skill development on all sectors . Pradhan Mantri Kaushalya Vikas Yojana (PMKVY) is initiated to develop skills in young generation to increase their employability. Many pharma industry experts are of the opinion that students who pass out from pharmacy colleges lack the required skills. Industry therefore, needs to invest their time and resources to develop these skills in them, which will help to increase their productivity and maintain quality and efficacy of medicines. Drug Controller General India (DCGI) has issued a circular to all pharma companies that their manpower should be trained and certified for specific skills before January 2018. So this year’s theme is in sync with requirements and importance of skill development in pharmacy profession.

Being the president of IPC, what will be your responsibilities, how do you plan to execute it?

As the President of 69th IPC, I have to travel to meet pharma industry leaders, pharma educators, pharma regulators, pharma students and discuss various issues related to skill development and bring all experts on one platform during IPC and develop a strategy to address solutions related to skill development. In the last three months, I myself and LOC team of 69th IPC travelled throughout India and organised approximately 100 meetings. Presidential address is a document for future to suggest various solutions to build skill in pharmacy profession.

Every year at IPC or at different platforms, we discuss about bridging the gap between industry and academia, but hardly there are any significant changes. Do you think this year some concrete steps will be taken?

Change is the only stability in life. We have to change as per the need of situation. Need is to have academy and industry interaction and collaboration. Out of 2000 pharmacy colleges in India, 100 colleges have excellent academic and industry interaction on various fronts like research, guest lectures, seminars, industrial training, faculty exchange, hospital training. This is hardly 5 per cent and we have to increase this per cent every year from 5 to 100 per cent. Colleges who are emphasising on this aspect will grow and attract students not only from India but even from the world and those who will not change has to close down, since students will be unemployable from such institutes. Pharmacy regulators like PCI, AICTE is already taking steps in this direction and making Accreditation NBA/ NAAC a compulsion for granting permission to pharmacy colleges.

List down the five major issues in pharmacy education and how can teachers mitigate this problem?

• Incoming student quality
• Teachers lacking teaching skills and professional experience
• Syllabus not as per industry requirements
• Lack of practical exposure of industrial practices to students
• Entrepreneurship is not the subject.Teachers are the backbone of an education system. If the pharma sector can attract efficient teachers for pharma colleges both in the government and private sector then we can be rest assured of solving these challenges.

What kind of collaboration is required to bridge the gap between industry and academia? How can the pharma curriculum and profession be made more attractive?

A) For every college one pharma company should be attached like hospital is attached to Pharm D students.

B) In every two years, teachers should take two months industrial or hospital training in respective subject to know applications of this subject.

C) Pharma companies should send minimum five people for two days to pharmacy colleges to take some lectures and practicals.

D) Minimum six month industrial training should be given to students in four years curriculum and it should be evaluated.

F) Uniform syllabus and updating with industry experts every four year. PCI made it now.

G) Entrepreneurship should be taught and every year one entrepreneur should visit a college and guide students.

F) PCI should be the only regulatory body to monitor pharma academia.

Like the IT industry, do pharmacy professors prefer teaching abroad?
Getting a teaching job in a foreign university is very difficult since our curriculum is industry oriented whereas in the developed countries, it is healthcare oriented. Our good teachers go abroad for post doctorate work in research areas.

What will be your message to the pharmacy students?

Love pharmacy profession, develop passion for pharmacy profession, give performance by knowledge, constantly develop your skill, work hard and always think positive., Initially, don’t think of a big salary but think of gaining experience to become expert. Pharmacy profession will give you everything if you put your best efforts. We are number three in the world in manufacturing quality medicines and let our every effort build the pharmacy profession to make it number one by 2022 in serving mankind.

u.sharma@expressindia.com

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Tell us about the emergence of Madhavbaug and the role played by the company to uplift the Ayurveda sector.

Madhavbaug was established in 2006 as a tribute to my father, Dr Madhav Sane, who expired in 2004 due to a cardiac failure. It was then that I realised the importance of preventative cardiac care and strengthening heart exercise capacity — also known as Vo2 max. Thus, we started operating 128 clinics and two hospitals in Maharashtra, Goa and now in Madhya Pradesh. Our first hospital became operational in 2006 in Khopoli with a mere nine patients’ IPD. At that time, treating heart diseases through Ayurveda seemed like an impossible task but an Ayurvedic panchakarma procedure called SampurnaHridayashuddhikar- designed by me, proved to benefit several patients suffering from heart failure. Our hospital experiences gave us confidence in treating heart failure patients, so we began our chain of clinics, always keeping in mind patient comfort and convenience. Madhavbaug is a pioneer in modern Ayurvedic medical practice and has treated over three lakh patients in the last 10 years.

Madhavbaug has a set of defined protocols and Ayurvedic treatments for various cardiac disorders including chronic heart failure, ischemic heart disease, and low ejection fraction after a heart attack.

Madhavbaug has also designed treatment protocols to treat type II diabetes, high blood pressure, deranged lipids, obesity, and other risk factors leading to heart disease. We have presented over 20 research papers on national and international cardiology platforms such as Lancet, World Cardiology Congress, and British Journal of Medicine. Recently, we published a randomised controlled trial for chronic heart failure patients comparing Madhavbaug’s therapy with conventional modern management in the Indian Heart Journal, which is the official publication of Cardiological Society of India. Additionally, several herbs have been studied using reverse pharmacology through animal trials for their efficacy in treating health issues such as diabetes, high blood pressure, atherosclerosis, and anti-platelet activity, among others.

Madhavbaug has been instrumental in standardising Ayurveda therapies in the preventive cardiology sector. Till date, we have trained over 500 doctors in the science of Preventive Cardiology so as to benefit mankind. Although we live in an era where only a few people have faith in Ayurvedic therapies for their heart disorders, Madhavbaug has been successful in treating more than 3 lakh heart patients through a wide network of clinics and hospitals. Earlier, Ayurveda was a science that lacked the necessary parameters to prove the efficacy of its treatments but Madhavbaug fused the parameters of modern medicine with Ayurvedic therapies to prove that the benefits of Ayurveda are still very relevant to today’s society.

What are the challenges faced by the company?

Since 2006, our journey has been very interesting. The single biggest challenge we have faced and continued to face is helping patients understand the importance of improving their health and making preventative cardiac care a priority. Apart from this, the process of fine-tuning our treatment protocols require considerable time and effort but we overcame all obstacles. We also faced challenges related to the shortage of trained manpower and developed a training system to increase the availability of manpower effectively.

Tell us about your on-going research project.

We are planning to invest into multiple domains of cardiac care. Atherosclerosis remains one of the most common heart diseases in India. The likelihood of the disease increases with age and poor lifestyle and diet are the major causes. With the number of cases increasing year-on-year, we plan to invest into anti-atherosclerosis regimen to add to our already existing non-invasive treatment for the same.

Another area of research will be in the treatment regime for Dyslipidemia. Dyslipidemia or abnormally high levels of cholesterol in blood is one of the major causes of plaque deposits in arteries which cause further complications for the heart. Treating dyslipidemia effectively will be in line with our preventive heart care approach as it is one of the leading factors in coronary heart disease and stroke.
Finally, we look forward to assess and document the efficacy of existing therapies with globally accepted criteria such as NT-ProBNP for chronic heart failure, and Stress Thallium test for Ischemic Heart Disease.

What steps should the government take for standardising regulation in Ayurveda?

Ministry of AYUSH was formed in 2014 which was a big initiative in standardising and regularising Ayurveda and other traditional Indian healthcare systems. AYUSH is responsible for policy formation, development and implementation of programmes for the growth, development and propagation of Ayurveda. Strategies to globalise and promote Ayurveda are currently being developed under AYUSH initiatives. These strategies focus on safety-efficacy-quality aspects of ayurvedic formulations, along with rational usage of Ayurveda. The safety, efficacy and quality profiles of formulations are globally accepted parameters that help in standardisation. Going forward, there is a need for more government investment into research and standardising regulations in Ayurveda, as there is a fierce financial investment wave from institutes that promote modern medicines. Increased investment into standardising regulations in Ayurveda will help achieve global acceptance of this highly effective Indian traditional practice at a faster rate.

Brief us on the course provided by Madhavbaug’s Institute of Preventive Cardiology.

The course provided by Madhavbaug’s Institute of Preventive Cardiology is for BAMS ,BHMS and MBBS graduates who want to add additional qualification and acquire professional training in cardiology. The courses include ‘Cardiac Emergencies’, ‘Cardiac Rehabilitation’, ‘Cardiac Investigation’, ‘Cardiac Therapist’, and more. Certified by Maharashtra University of Health Science (MUHS), the coursework is an integration of modern diagnostics and ancient knowledge of ayurveda. It gives a holistic perspective of role of lifestyle management, homeopathic medicine with respect to cardiac disease, role of specific Panchakarma with respect to cardiac disease, and skills with respect to diagnostic exploration. This extensive course prepares and equips the participants to be equipped with interpreting results of advanced diagnostic tools and suggesting effective researched therapies accordingly.

Tell us about your expansion plan PAN India.

Over the next 10 years, we want to push ourselves more into the digital space while also expanding our foothold into both rural and urban areas of other states.
There are four ways we want to do the expansion. This document will be produced across all the states of India where Madhavbaug will expand its foothold.

a.) Save My Heart: Save My Heart is a combo of prevention and emergency management. Save my heart is an app, connected with physical devices, which will be there in the house whenever needed. There will be a set of devices that will monitor the vitals of a person, such as BP, heart rate, SPO2, etc. This will reduce the number of deaths due to heart attacks as the time to reach a hospital will reduce drastically and the correct medical advice will be given on time. We expect about 1 lakh patients to be in this Save My Heart Care in next three to four years, 10 lakhs users by 2025. However, with one person using it in one family and therefore more users joining in, the numbers are expected to reach around 1 crore.

b.) Preventologist vertical: We will have a preventologist, who will visit home every three months in a year to evaluate heart health of senior citizens as well as other individuals. Based on that, it gives the patient a clear understanding as to what to eat, what to exercise, which asanas to perform, how to relieve stress, how much not to exercise, etc. This creates a monitoring through the app as well as personal guiding system. Based on the year’s data, the preventologist will give them targets, e.g in the next year, reduce BMI from 28 to 25. Preventologist will serve about 420 patients per year. In such a way, we will have 20,000 preventologists in the next five to seven years. Hence, total patients served will be 1 crore a year.

c.) Madhavbaug Clinics and hospitals: In future, every state, every year, we will build 20 more ‘company clinics.’ Franchise will then come up as it is in Maharashtra. Our franchisee option is only available to the doctors. So in next seven to eight years, we will have about 1,000 clinics all over the nation. These 1,000 clinics will, at the end of completion of their five years, will have a minimum footfall of 7-8k patients in a year. Also, by 2025, we plan to have 10 hospitals with 60,000 footfalls per year per hospital.

d.) OPD: A large number of people reside in rural areas. In next seven years, we plan to build 5000 OPDs all over nation. Every state will have 500 OPDs, completely franchised. These OPDs will be run by trained preventive cardiologists. With this model in place, Madhavbaug will be able to serve rural population, which has right now very little access for cardiac treatments.

In total, we expect to have about three to four crore people under Madhavbaug care with these four models by 2025.

What is the company’s road map for 2018?

By the end of 2018, we aim to inaugurate 60 new clinics across North Western and South India. Part of these will be Madhavbaug-owned clinics, while others will work on the franchise model. The clinics will operate in the semi-urban and urban areas. In case of rural areas, we will open 50 new Out Patient Departments (OPDs) which will work completely on a franchise model.

swati.rana@expressindia.com

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“Every cloud has a silver lining”, it is said, “There is always light at the end of the tunnel”. Be it adages, maxims, proverbs and axioms or soothsayers’ predictions, crystal ball readings, priceless priestess Pythia’s Oracle at Apollo- statements, in current scenario of devastating confusions, FDC conundrums and Supreme Court hearings and pronouncements, they all become relevant for Indian pharmaceutical industry. The Indian pharma industry has been growing by leaps and bounds to the dismay of developed country peers. In calm regulatory waters, Indian pharma industry have been growing steadily, till recently when a plethora of problems cropped up, like the proverbial water hyacinth spreading in a pool with calm waters. The FDC controversy has evolved as the front-runner and the rest, like Lord Tennyson’s ‘Charge of the Light Brigade’, problems to left of them, problems to right of them, volleyed and thundered. I have always admired the Indian Pharma entrepreneur’s amazing ‘never say die’ attitude. The Big B, AB have parallels in this Industry and my prediction or prescription is to convert all adversities into advantages and challenges to opportunities. The Indian pharma entrepreneur is adept at it. This is the bottom line of this story.

Thanks to ‘Kokate Committee Report’ or the NGO sponsored tirades against combination therapies in pharma dosage forms, it is introspection and self-appraisal time for combinations, be it 344 or 294. For the Indian pharma entrepreneur, these adverse times should serve as an ideal time to fuel the skill and will to serve the quality pill to the global patient communities by igniting innovative instincts and coming with decades long experience in creating rational combination therapies for patient convenience and prescriber’s preferences. The more rational and evidence-based therapies with embedded quality and delivery systems, the better. More than ever, the road map is getting drawn, the regulatory pathways are being cleared and the rules of the ‘FDC’ game are being spelt out. This is the most ideal god-given or NGO thrusted gift that the Indian pharma industry must grab. While stability and BA/BE studies are becoming almost mandatory and clinical trial guidelines are clearly getting in place, Indian pharma entrepreneurs must take this as an opportunity and not only to put the house in order, but also to build better ‘quality’ houses to adorn with bright ‘FDC’ bulbs and ‘NDDS’ lamps.

Over the years, last many new drug policy proposals promises have been made, time and again to reward innovations and ‘patented’ processes and products, but the promises in the policies were never kept or implemented or delivered to the innovators. In this era of ‘start-ups’ and ‘jugaads’, pharma industry has been repeatedly let down by the National Pharmaceutical Pricing Authority (NPPA), refusing to follow the drug policy expectations to ‘innovative patented’ New Drug Delivery Systems such as MR, XR, ER and other delayed or prolonged release dosage forms, which not only reduce the toxicity and adverse side effects by keeping the blood level concentrations to the minimum desired or optimum levels, but also provide patients the convenience of a once-a-day or once-a-week pill with uniform blood level concentrations. While patented imported medicines are fully exempted from scrutiny and price control, medicines patented by Indian companies do not enjoy such exemptions. Time and again proposals, promises and provisions were incorporated in drug policies and DPCOs, but grossly ignored under NGO pressures, leading to arbitrary extension of price control by NPPA on Indian patented drugs. Having painfully traversed the onslaught of the NGOs through the judicial scrutinies and consequent pressures on DCG(I) and Central Drugs Standard Control Organisation (CDSCO), a clear guideline is emerging for pursuing these innovatively evidence-based new drug delivery systems and rational combination therapies.

Combination Therapy Systems and FDC dosage forms have originated predominantly from the creative stable of Indian pharma. While this ‘necessity is the mother of invention’ scenario, emanated or was created by excessive and indiscriminate extension of price- controlled basket or schedules violating the DPCO norms, the Indian pharma, for survival, opted for innovative exceptions, by inventing newer and novel combination therapies, often with built-in ‘immediate release/ delayed release,’ multilayer tablets or pellets or cores and coats. While many of these innovative combinations were welcomed by the medical profession and considered as a boon by the patients, as it happens in all such well-conceived innovative initiatives, a few irrational ones also crept in or were pushed in, spoiling the fair reputation and advantage of FDCs, in general. The irrational ones brought a bad name to all FDCs across the board. These FDC innovations from Indian pharma were not taken kindly by developed countries and their pharma giants and overseas regulators, too. The role played by Indian as well as overseas-sponsored NGOs harmed the progress and thrust made by Indian pharma in FDCs causing severe set-backs, albeit temporarily. The Indian pharma and regulators must be proud that the US FDA set up a ‘combination therapy’ window eventually and commenced granting permissions to FDCs for chronic and critical diseases. The lead that Cipla took in anti-retroviral combo therapies has made the world to wake up and take note. As if going by the adage ‘every action has an equal and opposite reaction,’ the success of the Indian FDCs fuelled the anti-propaganda and opportunistically motivated judicial challenges which led to the current adverse scenario. Instead of calling it a day or accepting defeat, Indian pharma industry should pursue the FDC plus NDDS route deploying already existing skills and renewed will to offer regulatory compliant pills with built in patient convenience and evidence-based consumer benefits.

The Indian pharma industries’ skills will be put to test in coming years, not only in their will to make a quality pill, but also in their will to pursue innovative and inventive processes and products which are patentable and also non-infringing. Currently, innovation in novel dosage forms and new delivery systems are receiving attention of researchers globally. Indian researchers will need to do their due diligence in pursuit of newer drug delivery systems and combination therapy to steer clear of infringing mine fields of already patented or published patent technologies.

With a view to attract attention of Indian pharma researchers to the alarming array of innovations in delivery systems and devices, a few examples of recent patents/ patent applications in the field are re-produced herein.

The technological advancement in novel delivery systems, targeted delivery dosage forms and device-based dosage delivery systems is extremely exciting as well as challenging. Exciting because newer vehicles, systems and concepts are emerging. Challenging because what is already patented cannot be worked, will be infringed and need to develop work-around strategies. For brevity and due to space constraints, only a few samples and examples can be quoted here, which is just a selection of nearly 5000 related patent applications on the database. Let us see one or two abstracts of pending patent applications in India for example.

Drug Delivery (IN201618041241)
(University of Leeds, UK)

A method and apparatus is disclosed for ejecting drug bearing material. The ejected material is ejected as liquid and liquid vapour via an explosive process which provide a very fast ejection as well as an ejection which has a large throw. The apparatus can provide a nebulizer, inhaler or needleless injector.

Nanoparticle Drug Conjugates (IN201617043358)
(Memorial Sloan Kettering Cancer Center & Cornell University)

Nanoparticle drug conjugates (NDCs) which in certain embodiments comprise a non-toxic multi modality clinically proven silica-based nanoparticle platform with covalently attached drug molecules/ moieties. The nanoparticle drug conjugates (NDCs) demonstrate imaging capability and targeting ligands which efficiently clear through the kidneys. Furthermore, the conjugates incorporate therapeutic agents for cancer detection prevention and/ or treatment.
A representative list of pending patent applications in the field as reproduced below provides insight to interested researchers on the vast array of advanced technologies on the anvil.

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“Mirror, mirror on the wall, do I need antibiotics at all?” was the slogan seen in some pharmacies across Thailand. What was it all about? The Community Pharmacists Association of Thailand developed an innovative campaign to convince patients not to insist on antibiotics for viral infections, and prevent unnecessary use of antibiotics for non-bacterial infections. People were encouraged to check their throats in a mirror placed in the Pharmacy. Pharmacist explained the differences in the symptoms of bacterial infections and other conditions. Involvement of the patients themselves in the decision making process and the right education did have its positive impact and unnecessary antibiotic usage did decrease in the campaign areas. Pharmacists in Spain launched a communication campaign with the slogan: “Do not ask us for antibiotics but for information”. The aim was to discourage patients from using antimicrobials without prescription and to improve responsible use of antimicrobials. In parts of the US, pharmacists carry out strep throat test using rapid diagnostic toolkit in the pharmacy and refer patients to physicians as per the need. Such point of care testing (POCT) gives immediate diagnosis, avoids any unnecessary use of antibiotics and patients get quicker relief. In some countries pharmacists are legally allowed to prescribe antimicrobials in clearly specified cases. For example, in Canada pharmacists are given the authority to prescribe antimicrobials for certain minor fungal and bacterial infections. Thus pharmacists can facilitate quick and appropriate use of antimicrobials for their patients. In New Zealand, pharmacists can prescribe and dispense trimethoprim for short-term treatment of an uncomplicated urinary tract infection. In several countries, pharmacists are involved in vaccine administration and there is growing evidence that vaccination by pharmacists increases vaccination rates and this subsequently reduces the prevalence of infections and use of antibiotics.

These are just a few examples of pharmacists’ work from around the globe. Publication from International Pharmaceutical Federation (FIP) “Fighting Antimicrobial Resistance: Contribution of Pharmacists” gives several such examples. All over the world, as the problem of Antimicrobial Resistance (AMR) becomes more serious, there is increasing importance gained by the role of community pharmacists. Community pharmacists are often the first point of contact for the public. They are often the entry gate to the health system on account of their easy accessibility. Patient with symptoms first approach the pharmacist rather than visiting the doctor and patients coming from doctors’ clinics come to the pharmacy with prescription before going home. Thus, pharmacists are in the most strategic position to advise patients on minor ailments, refer them to physicians when needed and to provide counsel about medications prescribed by the doctor. Thus, the pharmacist has ample opportunity and wide scope to impact patient behaviour. With regards to responsible use of antibiotics and to combat AMR, the WHO has defined roles for every stakeholder, from patients to policymakers. As per www.who.org/waaw , a poster saying “What Can Pharmacists Do?” summarises key roles of pharmacists by asking them the following questions:

• Do you only dispense antibiotics when they are needed, according to current guidelines (e.g. does the patient have a valid prescription, is it for the right drug/dose/duration)?
• When patients are seeking treatment for cold or flu, do you explain that antibiotics are not needed? Do you talk to patients about how to take antibiotics correctly, antibiotic resistance & the dangers of misuse?
• Do you remind patients to contact their health professional if symptoms persist?
• Do you talk to patients about preventing infections (e.g. vaccination, hand washing, safer sex, covering nose & mouth when sneezing)?

Above is an excellent summary of what pharmacist should do and many countries have policies, education, regulations and overall ecosystem to nurture such antibiotic guardian role of the pharmacists.

In India, the situation is very different. Pharmacists are still more or less traders/ shop keepers rather than health care professionals. In approximately 6.5 lac pharmacies across the country, the presence of pharmacist during all working hours of the pharmacy is often a big question. Needless to say that the role of a pharmacist as patient counsellor, as medication expert, is still far away. Neither is pharmacy practice well developed nor are health and medicine literacy established among consumers. This creates a dangerous situation with regards to use of antibiotics. Overuse, underuse and wrong use of antibiotics is common. On the one hand, consumers are keen on self-medication and on the other, they won’t complete the course of antibiotics when prescribed by the doctor. Easy availability of antibiotics over the counter encourages self-medication. Irrational prescribing and irrational Fixed Dose Combinations (FDCs) further complicate the situation. Antibiotics are special drugs which don’t act on a particular cell of the body but on the bacteria which can fight back, so the enemy is strong, smart and dynamic. By overuse, underuse or misuse of these medicines, we are making antibiotics weaker and making the enemy much stronger. This basic understanding has been lost by most stakeholders.

Pharmacists Making the Difference

Case one: A pharmacy on the busy street of Mumbai! A patient walks in, tells the pharmacist that he has an upset stomach and had loose motions since last night. He has no other complaints like fever etc. Patient insists on being given a known common brand of Ofloxacin. The pharmacist listens to him with patience, and then explains to him that what is most needed is to replace the lost water and electrolytes from the body, not an antibiotic. The pharmacist explains in simple language that an antibiotic cannot be given without doctor’s prescription. He explains to patient politely that if he goes to a doctor and the doctor does write prescription for ofloxacin or any other antibiotic, he will be most happy to dispense it. But at the moment, he can give what is known as Oral Rehydration Salts (ORS) which would treat the dehydration and will take care of situation. He tells patient that patient should see the doctor if he doesn’t feel better in a day.

The patient, though a bit irritated and in a mood to go to another nearby chemist whom he believes would have given anything and everything over the counter, feels there is some logic in what this pharmacist says and accepts the advice and buys ORS packets. Two days later he returns to the pharmacy to thank the pharmacist for timely and useful advice and a word of wisdom. Pharmacist feels happy to help the patient and is glad that he could avoid misuse of antibiotics in this case.

Case two: A patient is diagnosed with TB by a physician from the private sector and has just started anti-TB treatment. He purchases his medicines from a chemist shop near the physician’s clinic. Few days later the patient happens to walk into another pharmacy where he reads a board that anti-TB medicines are available free, and that it is a Government DOTS centre. The patient feels curious and asks the pharmacist for more details. The pharmacist explains that the patient can also get benefit of free treatment, provided that  he gets diagnosed by the government hospital and directs him for the same. The patient follows these instructions and his TB is confirmed. His DOTS medicine box reaches the pharmacy and patient completes the treatment under direct observation of the pharmacist.

What exactly is the significance of above intervention by the pharmacist? TB Treatment lasts for a minimum of 6 to 8 months and the full course needs to be completed for complete cure. The patient in this case was poor with very meagre monthly income and if he had stayed with paid treatment, he would have most likely stopped taking the medicine once his condition visibly improved in a month or two. Thus, the default might have led to development of Drug Resistant TB (DR TB) later on in life. The pharmacist’s guidance brought the patient to free and supervised treatment ensuring complete adherence and avoiding probable case of DR TB.

Some discussion with pharmacists brings out interesting facts about the consumer demands and expectations:

1) Some patients who had taken antibiotics previously, walk into the pharmacy asking for the same old antibiotics, with old prescription or left-over medicine or by just describing how the medicine looked like.
2) Some people, even though not much educated somehow know names of antibiotics, especially commonly known are amoxicillin, erythromycin, ofloxacin, penicillin. Cold and cough, stomach upset, sore throat, fever, skin infections are common complaints for which consumers ask antibiotics.
3) Some don’t know the exact names but know the term antibiotic. They don’t know what are antibiotics, how they act etc but know that these are the medicines which are like magic bullets and will make them feel better very soon.
4) Some walk into the pharmacy and tell the pharmacy attendant to give them “strong medicine” for their symptoms.
5) Some walk in with valid prescription, but won’t buy full course of antibiotics due to insufficient money or due to lack of faith in the treatment and so will end up buying the course halfway. In contrast, some may buy full course, but would stop it halfway as soon as they start feeling better.
6) Some patients buy the antibiotics with valid prescription and would also comply fully to the prescribed treatment.

Pharmacist can and need to play a very proactive role to improve the situation of antibiotic usage.

• Counselling patients when antibiotics are not needed, pharmacists can reassure patients and correct any misunderstandings.
• Infection control and prevention: It’s important to educate patients about hygiene, cleanliness and self-care. Importance of proper handwashing, cough etiquettes, use of condoms are some of the important preventive measures for infection control. Health day such as Global Handwashing Day 15th October can be observed, and it can be turned into a big campaign to create awareness in the society.
• Information about vaccinations: In India, vaccination rates are still not satisfactory. Pharmacists, especially in rural areas, and those who are near urban slums, have a great opportunity to check with patients if the vaccination schedule is being followed for their children. Immunisation chart also can be displayed in the pharmacy.
• Adherence: Whenever there is an antibiotic in the prescription, pharmacist needs to counsel the patient regarding need for completion of the course and should emphasise completing course even if patient starts feeling better with few days of the treatment. Tuberculosis patients need to be paid special attention for adherence. Patients can be followed up by phone calls/sms/whatsapp messages for treatment adherence. All TB patients should be informed at the very beginning of treatment about the free anti-TB drug treatment from the Government sector.
• Medication Counselling: Patients need to be told about purpose of an antibiotic, how to take it, when to take, before or after food, common side effects and importance of following the dosage schedule, antibiotic resistance etc
• Timely referrals:  Patient with minor symptoms can be handled by the pharmacists with OTC medicines but those with any serious symptoms should be immediately referred to the physician.
• Written Counselling tools: Pharmacists can use auxiliary labels, patient information leaflets as a supplementary method to support verbal counselling.

It is not easy to perform the above tasks. It is very challenging for even knowledgeable and responsible pharmacists. Today if a pharmacist refuses to dispense an antibiotic and starts counselling the patients not to self-medicate with antibiotic, patient may simply just go to another shop and buy the antibiotic there. Thus, it is not only a financial loss for the pharmacy but is demotivating as well. Some employed knowledgeable pharmacists may be discouraged by pharmacy owners to offer any patient care services as they may consider it as waste of time. After working closely with community pharmacists across India for more than a decade, I have found “true” pharmacists but this number is still very low. The cases described here under Pharmacists Making The Difference are real-life cases from the field. But such pharmacists face massive struggles because of the unfavourable ecosystem. To develop and get the full benefit of this healthcare team member’s potential, various enabling factors are required such as appropriate policies, law implementation, patient oriented education, continuing pharmaceutical education and consumer sensitisation. IPA’s DOTS TB Pharmacist project (a public private partnership project) and few other pilot projects have demonstrated the value of pharmacists’ service in public health. It is a very big missed opportunity not to have developed the role of pharmacist as a healthcare professional. Policymakers and all other stakeholders need to urgently look into it to rectify this state. And the catastrophic problem of AMR should itself trigger the actions in this direction. If not, then the pharmacists will continue to be untapped potential human resources.

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With around 1000 colleges churning out more than 60,000 pharmacy graduates every year and still permissions being granted for newer colleges, are we waiting for a catastrophe?

The fact that a large number of engineering colleges closing their shop over the last few years, indeed, should be an eye opener for us.

Are we chasing quantity at the behest of quality?

There is no dearth of pharmacy graduates but are we doing enough. It is a wake-up call to all of us: the pharma education regulatory authorities, the industry and the academia.

On the other hand, is the pharma industry aware what is in store for future after 10 years, after 25 years?

With the Buzz word of ‘Industry 4.0: the fourth industry revolution’ in which computers and automation will come together in an entirely new wa. It is the age where robotics are connected remotely and where artificial intelligence would take over manufacturing. Software/ computer industry has already started thinking about what is expected in future from them, but are we ready?

The generic industry is facing problems, pipelines are drying up, no new molecules have come even after so many years so what lies in future for the Indian pharma industry? Is it going to be biosimilars, or transition from small molecules to large molecules, or tailor made medicines? With talks about stem cell therapy, 3 D printing, chip-based drug delivery system all getting a US FDA nod, how do we stop the outflow of our best pharma graduates.

While we mull over this state of the affairs, the current scenario has to undergo a change so as to improve the talent pool from volumes to value. There are obviously no short-term solutions. We have to take a hard look at various aspects. First, do we really need that number of pharma graduates and post graduates, which are churned out every year? Has the industry spelt out the need for so many students?

Industry should give their requirement in different areas and accordingly generate such graduates and also modify the curriculum. This will happen only if some flexibility is given for modifying the syllabus at a local level. Secondly, a survey has to be taken for graduates and post graduates passing out every year versus jobs that they are doing and accordingly take steps.

Though we have been talking about community and hospital pharmacists, it has still not found its solid footing and so pharma industry is still driving the education sector. As far as the graduates or post graduate students count,  the retail business has and will be the main domain area for diploma holders. New avenues like clinical data management, pharmacovigilance, medical coding and transcription or data analytics is reaping benefits, yet it cannot be the do it all solution for all graduates. So, we really have to take a stock of the demand versus supply ratio as far as students graduating out every year are concerned.

One change which can be done is at the PG level. The main problem in self financed institutions is the paucity of funds and so quality research takes a back seat. Why can’t we have thesis and a non-thesis programme where thesis students are absorbed in F&D or R&D (Formulation as well as medicinal chemistry or pharmacology) while the non-thesis students can be taken up in departments like QA, QC, regulatory affairs, IPR, production, project management etc. However for the non-thesis students, additional courses can be run to train them in that domain. The students who opt for thesis programme can be chosen on the basis of merit. In the process of churning out so many students, we have some where forgotten that pharmacy is a professional degree.

In this scenario, the teacher or the academician has been neglected. To stem the flow of students, projects can be taken up by teachers who can mentor students in niche areas. For up-gradation of their skills or to enhance their knowledge base more number of professors should be deputed for training at universities in developed nations for at least a year. This will give them an opportunity to upgrade their skills and understand the global scenario with respect to pharma research. At the same time, multidisciplinary research should be encouraged or collaborative research with universities abroad should be initiated which can also stop outflow of our students.

Besides this, one revolutionary concept which can be taken is to have a conglomerate of academia, industry and government. Under this common umbrella, a centralised research and knowledge park can be constructed with state-of-the-art infrastructure in many cities. It can have all the latest instruments and equipment where the financial contribution can be shared by all so that there is consolidation of resources. The industry/s and institutes could contribute 25 per cent each while the government would contribute 50 per cent. The entire centre would be run by a completely independent body. Besides the high Tech Facilities available for students, the knowledge park would also have a well stacked library and online journal data base and also run short industry aligned courses which students can avail of; all at a fee, so that the maintenance of instruments and facility can be done using this contribution. The industry can take this as a corporate social responsibility drive and can also avail tax benefits . The tax benefit can be as proportionate to their contribution in the knowledge park. This can be both for drug discovery as well as drug delivery. Though most promising talent moves overseas to pursue academic and professional growth, we can ask the expatriates to come back to India so that they can also contribute in their own way.

It is not that our students cannot do better, the only difference is lack of exposure and I think the students can do wonders if they are given the right exposure, contacts and opportunities as to upgrade from volume to value. Aligned with the Make in India Programme, start ups in the pharma sector are few and this has to be encouraged at all levels of graduation. The entrepreneurship development cell just remains on paper without any entrepreneur seeing the light of the day. Also, in keeping in line with the ‘Industry 4.0 : the fourth industry revolution,’ we have to bring about the amalgamation of engineering and software industry. Morever, the medical profession and the pharma professionals needs to join hands to bring out the next generation drug delivery platforms and drug delivery devices, as future medicines and drug delivery devices would be more complicated which cannot be managed alone by the pharmacy professional and hence a joint effort of all these multidisciplinary groups.

SO ARE WE READY??

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Part I of the article dealt with the traditional methods of detection, identification and quantification in HP-TLC i.e. image documentation, scanning densitometry in UV and fluorescence, spectra recording and post chromatography derivatisation (PCD).

In HP-TLC, because there are two chromatograms to begin with viz. the physical chromatogram on the plate and the instrumental chromatogram(s), one can have the cake and eat it too!

In fact, after chromatographic separation, it is possible to generate as many as 15 “chromatograms” by instrumental means (image documentation and scanning, both before and after PCD) and by bio-activity studies. HP-TLC plate, with multiple chromatograms of same sample, can be cut (!) and each ‘piece’ evaluated by a different detection mode to get different information about the sample. That’s a truck load of data, from just one ‘physical’ chromatogram, useful for QC as well as R & D! All this without repeating anything!!

Studies on effectiveness of a molecule as a potential new drug candidate are done on a micro or nano-scale. HP-TLC plates usually contain enough amount of unknown substances or a group of substances for in-situ bio-studies.

One physical “Chromatogram”

Multiple detection methods can be used

If a separated ‘fraction’ shows promise, that fraction may be further resovled by 2-D HP-TLC into more fractions for the same study. This narrows down the molecules with potential, within a day or two for further studies by MS, IR, NMR etc. Using 2mm thick layers, it is possible to isolate sufficient amounts of a pure substance.

By far, mass spectrometric detection is most popular in chromatography. HP-TLC too can be very simply hyphenated with it. The “physical chromatogram” is available on the plate and using an interface, any desired fraction(s) can be eluted and fed to a MS. Such a cycle of band location and elution takes 3-4 min. The interface is an ideal, very highly productive, off-line accessory for an existing LC-MS or a LC-MS-MS. Many R&D labs abroad have a standalone MS with TLC/ HP-TLC MS interface as common facility. As many as 70-80 mass spectra of selected fractions can be obtained in a day. The days of monitoring reactions by TLC and then wait for MS from LC-MS in next 2-3 days are history.

Some of the common bio-detection techniques in HP-TLC are as follows:

• Anti-oxidant study – Dip the plate in __% DPPH solution. Anti-oxidant fractions appear light on a dark background in __ hrs.
• Toxicity study – Vibrio Fischeri is a bioluminescent bacterium. It is also very weak and easily killed in the presence of even mildly toxic substances. The plate is dipped in a solution containing V. fischeri & kept inside a completely dark chamber, mounted with a cooled, long exposure camera. The dark bands are observed where the bacteria die due to absence of luminescence. The test is practically instant, a very big advantage in drug discovery.
• Anti-bacterial or Anti-fungal study – The plate is similarly dipped in a suitable medium containing bacteria or fungus. Those fractions that have “anti” properties are evident due to zones of inhibition, against the normal growth all over the plate.
• Effect directed analysis  – It has been reported for estrogens, seed oils, insecticides

In PCD, the plate is sprayed with the derivatisation reagent and heated to complete the reaction. However, for bio-assays, heating is usually not necessary. Here the suitably cut part of the plate is immersed in the reagent or a solution containing live organisms like bacteria or fungus. Then it is straight forward to observe the results, usually with naked eye.

It may be concluded that HP-TLC offers numerous possibilities of detection that can give tremendous possibilities of detection that can give detailed insight about the sample. This is feasible due to separated fractions on the plate, are available for further analysis.

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Pall Corporation, a global leader in filtration, separation and purification, is formally introducing the Stax mAx clarification platform, a robust solution for the economic clarification of monoclonal antibody cell cultures without centrifugation or process additives. The single-use harvesting platform features a 4-layer concept, and has been optimised to maintain performance as cell density and viability change to minimise the impact of process variability between batches. Media configurations are available in many formats to scale directly from bench-top testing up to large-scale clinical production.

“As cell densities increase, demand has grown for less challenging, more economical—both footprint and cost-wise—clarification solutions,” said Mario Philips, VP and GM, Pall Life Sciences. “The Stax mAx clarification platform was born from Pall’s legacy strength in filtration, and leverages our proven Stax single-use capsule system. This latest addition to our portfolio, once again, reflects our commitment to delivering innovative total solutions to our customers.”

The pre-selected 4-layer, 2 stage platform features sequentially finer grades to remove aggregates, whole cells and cell debris. Constructed to retain a small footprint across a wide range of feed streams (with cell densities of up 35 x 106 cells/mL, and feed turbidities of up to around 3,000 NTU), the Stax mAx clarification platform is scalable to support 1,000 to 2,000 L cell culture volumes.

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