Express Pharma

IPC 2015 The Quest For ‘Swasth Bharat’

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Industry leaders, analysts and opinion makers contribute their thoughts on important topics which will impact patients, the pharmacy profession and pharmacists to achieve the goal of ‘Healthy India – Swasth Bharat’ by 2020. By Sachin Jagdale

‘The pharma industry should come forward to give practical training to pharmacists’

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BR Sikri

With the changing domestic and global scenario, it is high time education institutes also upgrade themselves. ‘Digital India’ is not a mere slogan. Various government departments are seriously working towards this goal. A regulatory system, world wide is making drastic changes. The masses are also aware about the efficacy and safety of medicines. Government, institutes, academic groups have to think of the pharmacy profession. Today, we are called the global pharmacy but the speed with which China and our next door neighbour Bangladesh are entering overseas business, our alertness is equally important. It is observed that students of pharmacy are academically sound enough, but their practical experience is not up to the mark. This is due to lack of budget allocation of various institutions. It is top class institutes like NIPER who can fill the gap. The pharma industry should come forward to give practical training to pharmacists. With the combination of practical as well as academic training, we can produce world class pharmacists in India as our students are brainy and intelligent as they have good grasping power.

As regards online pharmacy, it is a high time that the government should sit together with the stakeholders to avoid misuse of this system. If the present system of online pharmacy being used by many agencies is observed, there is high chance of abuse. Fake prescriptions can be created easily. It can also lead to black marketing, especially by offering high discounts. It can also exaggerate the risk of mis-interpretation of handwriting. Scan of a signature is not a valid system and Drugs &Cosmetics Act clearly mentions that dispensing can happen only if the signature of the prescriber is present. A document with a scanned signature cannot be produced as evidence in a court of law. The possibility of self medication and non-compliance to therapy is also present.

Similarly there are mentally retarded patients who can be at risk by providing easy accessibility of medicines. The possibility of misuse of narcotics products is also a serious matter.

This system of online pharmacy is futuristic and convenient for patients, but unless the loopholes are plugged properly, it will be dangerous to allow people to start this system without legal clearance. Convenience can never be a reason for relaxing rules with regard to medicine dispensing as it can also lead to huge ease of abuse.

India is already grappling with so many youths taking to substance addition. Indian society cannot face such abuse by relaxing rules on dispensing. The system has to be foolproof.

While introducing the technology for online pharmacy, the factors to be taken into considerations are:

  • Sanctity of prescription has to be kept in mind.
  • There should not be any possibility of abuse for multiple dispensing.
  • There should be end to end transparency and visibility
  • Improvement in technology to reduce the errors, if any
  • It should be truly convenience to the customers and commercial angle should not be the hidden agenda in the mind of those entrepreneurs who want to start online business.
  • True enhancement in patient safety, convenience and improving overall compliance therapy.

In the end, I would like to mention that prescription directly from doctor to pharmacy with a valid digital signature with every prescription should be the only right future model. This should be introduced by a proper amendment in the Act and by bringing awareness to the doctors as well as to the patients. It should run on trail for couple of months before it becomes nation level drive. Let us create a safe and healthier nation.

BR Sikri, Co Chairman, Federation of Pharma Entrepreneurs (FOPE); Vice President, Indian Drugs Manufacturer Association (IDMA); Vice President, Confederation of Indian Pharmaceutical Industry (CIPI); Vice President, Bulk Drugs Manufacturers Association (BDMA)


‘India is today going in the direction of becoming more unhealthy by 2020’

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Ameesh Masurekar

Pharma Vision 2020: Healthy India — Swasth Bharat is a mirage. Health deteriorates due to lifestyle, pollution, food habits, stress and a variety of other reasons over which pharmacists have no direct control. So the disease burden of the nation, especially chronic diseases, is set to rise and much as we do not wish, the fact is India is today going in the direction of becoming more unhealthy by 2020.

This fact ushers in a much bigger responsibility – how to ensure affordable and quality treatment to the masses. The key players are listed below and there will be power shifts within them.

  • Doctors
  • Pharmacists
  • Pharma Companies
  • Hospitals
  • Medical Insurance Companies
  • Pathlabs

Government can be a player for populist reasons, but ideally they should make wise policies and implement them – competition will take care of the rest.

Let’s dwell on role of pharmacist in the retail channel. This is the area where maximum change is already happening and the business practices in 2020 will be vastly different. Some will evolve (rapidly) and there will be several thousand dinosaurs. There are big challenges and massive opportunities.

Regulations and laws will be enforced much more. So non-pharmacist dispensing will end and pharmacist will be a must to dispense each and every prescription – 300 per cent growth in job opportunity or demand. Imagine if all chemist dispensing boys are replaced with registered pharmacists! One may think India may not change, but let us understand competition brings faster change than government laws and enforcement. The organised/ online business will follow certain regulations (as they are large corporates, not individual owners). To survive and compete with them – the smaller pharmacies will have to match up – in compliance, service and cost.

The pharmacist will be more involved, as the patient is becoming highly educated due to internet and doctors does not have time to answer all his/ her questions. So right from medication timing, contraindications, lifestyle changes, food habits, counselling and other such services will be the key to maintain/ grow business by retaining loyal customers. The Indian pharmacist will have to step up and play the role like their US counterparts. As they do this, the respect they get will increase as a healthcare worker and pay will increase.

Finally as brand replacements and generics become rampant, the pharmacist will be in increasing control of which brand to choose and doctor will increasingly lose this control. The role of doctor will be to diagnose and choose the molecules. The role of pharmacist will be to decide the brand. Pharma marketing will change forever and there will be tremendous shift of power in favour of pharmacists. Hope we are wise and responsible to handle this. For non-believers, consider this fact: 28 per cent of medicine brands sold in India are decided by pharmacists today and every developed country has moved from a doctor led model of choosing a brand to a pharmacist led model over time! Example: the US, Canada, Europe and parts of South America.

Students graduating as pharmacists now and over the next few years will be at the right time and right place to serve the nation as well earn a rewarding career.

Ameesh Masurekar, Director – AIOCD AWACS


‘We are still at the bottom of all the levels of regulations — at industry, at sales and at education’

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Dr Suresh R Saravdekar

One of the important means to achieve the goal of ‘Healthy India- Swasth Bharat’ by 2020 is the provision of essential medicines. It might reasonably be assumed that the provision of safe, effective and affordable medicines of good quality and in the right quantity to the whole population would be a priority in the health policy of any country and relatively uncomplicated goal to achieve. Reality seems to show otherwise.

About half of the Indian population still continue to be denied their right to health. They lack reliable access to essential drugs, while at the same time overuse and abuse of medicines is frequently reported. This state of affairs highlights the regrettable fact that worldwide governments have little influence over the big private market. Waves of privatisations during the past decade have aggravated the situation and have in some countries reached absurd proportions. Private pharmacies are mushrooming in recent years and people buy whatever they want.

In India, too, the state’s spending on health is too low- about 1 per cent of the gross domestic product (GDP). This results in private expenditures accounting for 78 to 80 per cent of total health spending in the country. At an industry level, currently, due to high expenditure on innovation of new medicines, there are no breakthrough innovations. There is loss of patents on one side and cut throat price competition by the generics, and unreasonable price control by the states on essential medicines on the other side. This is resulting in a shrinkage of ethical market.

Today’s physician alone is not in a position to handle the complex task of pharmaceutical care effectively, as he is already overworked with his usual therapeutic responsibilities. As the situation changes in a rapidly evolving health system, it is therefore, internationally well accepted that the pharmacist is responsible for pharmal care in a health set up.

All these forces are currently, leading to the creation of new markets called ‘Mass Commodity Drugs’, where more and more drugs are pushed from prescription to non- prescription category, and would be easily available over the counter (OTC).

Pharmacies are becoming new market points and treatment centres for minor ailments. enhancing pharmacy’s role in self treatment and medication in categories such as analgesics, antipyretics, cough-n-cold, allergies, antacids, vitamins, insomnia etc. In developed countries there is a change in the supply chain too. The traditional mode of ‘Manufacturer-to-Wholesalers-to-Drugstore’ has adapted to ‘Direct-to-Pharmacy’ (DTP model), which is to encourage self medication and to demand prescription by the patients.

In India, we are still at the bottom of all the levels of regulations — at industry, at sales and at education. There is lack of adequate law enforcement leading to manufacturing of all sorts of non-essential drugs, fixed dose combinations of drugs, (already about one lakh medicines in the market), sale of ‘prescription only’ drugs without prescription by the pharmacists, prescribing medicines by unqualified quacks, and rampant irrational use by physicians, and extensive self medication by the patients.

Under these circumstances, irrational use and misuse becomes uncontrollable. Medication errors would be very widespread. The consequences of which are costly in terms of hospitalisation, physician’s visits, laboratory tests, and remedial therapy. In developed countries four to 10 per cent of all hospital in-patients experience an adverse drug reaction- mainly due to the use of multiple drug therapy, especially in elderly and patient with chronic diseases. In India, currently, there is no data available on these issues. What is needed is awareness and education of all stakeholders namely policy makers, regulators, industry, physicians, pharmacists and patients on all above issues. But no positive role is played by the govt or by the industry in this regard.

At education level too, there is a mushrooming of pharmacy colleges all across the country, without any regulation of the quality of education. Forget about D.Pharm. Even, today’s B. Pharmacy students too are not trained to shoulder these new emerging challenges.

I think, in India, there is a long way to go!!

What is needed is a clear, robust drug and education policy (without any backdoor). The essential elements of policy would be strong political will, removal of apathy at all regulation levels and patients safety at its core. Otherwise, promoting medicines as ‘Mass Commodity Goods’ through retail outlets and prescription monitoring through (Pharm –D) half-trained clinical pharmacists would not only be unsafe but would be disastrous and would risk/ endanger poor patient’s health and tarnish the image of pharmacy profession.

Dr Suresh R Saravdekar, Ex- Asst. Director & Consultant, Ministry of Medical Education, Health & Municipal Corporation of Greater Mumbai Chairman – IPA – MSB – Hospital Division


‘Reforms in pharmacy education especially for diploma in pharmacy should take place urgently’

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Dr MN Saraf

Challenges facing healthcare including pharmaceutical care in India continue to include rising cost of health care, limited financial resources, the huge burden of diseases, access of medicines of assured quality, rational use of medicines the pharmacist needs to be positioned at the forefront of healthcare system.

The role of community pharmacists in India is still largely confined to have suppliers of pharma products rather than providers of patient care. It is important to realise that efforts to communicate the correct information to patient is as important as providing medicines itself. Similarly, pharmacists have a significant contribution to make to patient care through managing drug therapy. Access to good quality medicines and competent and capable healthcare professionals are fundamental aspects of any healthcare system. Investment in transforming and scaling up professional education as per country’s needs is crucial as education provides the foundation for a capable healthcare work force. Ongoing efforts are needed to ensure capacity building of skilled medicine practitioners meet pharma care needs of populations.

Role of government and pharma companies in educating pharmacist:

Board of Apprenticeship Training (BOAT), Ministry of Human Resource Development, Government of India, provides support for job training in pharma industries. Persons acquiring skill during the training are eligible for gainful employment. However, very few fresh pharmacy graduates avail the opportunity and facilities extended by the Government of India probably due to lack of awareness. Efforts should be made by placement cells of pharmacy institutions to establish a dialogue with BOAT and to ensure that the benefit of the programme extended by Government of India reaches to the needy pharmacy graduates.

Education regulation (E.R.) was framed in 1953 and was subsequently amended in 1972, 1981 and 1991.For proposed new amendments in E.R. approval by the health ministry is awaited.

PCI has proposed Pharmacy Practice Regulation. Education and training provides the foundation for pharma services and professional development order to meet global societal needs for medicine expertise.

Reforms in pharmacy education especially for diploma in pharmacy should take place urgently. New paradigm for pharmacy requires that the pharmacist understands and applies the principles behind all activities necessary to manage drug therapy. There is a need to shift diploma in pharmacy education in the country from traditional laboratory based sciences to practice and clinical sciences.

Dr MN Saraf, Principal and Professor of Pharmacology, Bombay College of Pharmacy, Mumbai


‘The focus should be on skill development and enhancement of competency and employability’

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Sudhir Deshpande

Pharmacy profession in India is full of contradictions. On one hand, India is recognised as the pharmacy of the world and caters to the needs of majority of the population across the globe by providing quality generic medicines at affordable prices. On the other hand, it is claimed that majority of the population especially below the poverty line in India cannot afford medicines and therefore do not have proper access to medicines.

Pharmacists in India are not considered as one of the best and is not recognised as the vital component of healthcare delivery system. Though, the pharmacist contributes immensely in the area of research, product development, manufacturing and quality control, the society as a whole does not recognise the pharmacist and his contribution in the healthcare delivery system. Perhaps this is because of pharmacist’s failure to connect with the society. The major interface of the pharmacists with the society is through a retail pharmacist who comes in contact with the patients and his relatives and consumers etc.

However, the retail pharmacist in India is identified more as a person selling medicines across the counter and not as the healthcare provider. This perception can only change if the retail pharmacist plays his original role as community pharmacist and plays a major role in patient counselling, providing information about drug dosages, compliance drug interaction etc.

Policy makers in India have realised the need and have therefore issued Pharmacy Practice Regulations, 2015 in exercise of its powers under Pharmacy Act, 1948. Under the said regulations, pharmacist’s role, duties and responsibilities have been specifically defined and pharmacist’s is obliged to review the patient’s records and each prescription presented to him. The pharmacist is expected to identify factors such as therapeutic duplication, drug dosage interaction incorrect drug dosages or duration of drug treatment etc. He is also expected to initiate discussion with the patient or his relative on matters that will enhance or optimise drug therapy. The focus is thus shifted to patient counselling for the first time.

If a pharmacist performs his duties and discharges his responsibilities as envisaged in Pharmacy Practice Regulations, 2015, it will bring about qualitative changes in patient care. It will promote compliance of dosage schedule and rational use of medicines. The society will then certainly give recognition to the pharmacist for which he is craving. However, is the present day pharmacist equipped and trained to undertake these responsibilities? Unfortunately, the present curriculum for B Pharm or D Pharm is not good enough to prepare the pharmacist to perform his function either as a community pharmacist or as a professional in pharma industry. Many academicians are of the view that pharma education has extended in goalless and unmindful way producing unemployable graduates from substandard educational institutions. May be it represents an extreme view but the fact remains that the quantity has taken a front seat at the cost of quality. There is certainly a need to redefine pharmacy education, change the curriculum to give practical orientation. There has to be more industry academia coordination, exposure of students to the pharma industry and focus on patient counselling.

Internet pharmacy or online pharmacy has become a subject of intense debate, scrutiny and even controversy. Many divergent views are being expressed with promoters of e-pharmacy strongly advocating support and are demanding clear guidelines and regulations. On the other hand, pharmacists are strongly opposing this business model claiming adverse impact on public healthcare due to indiscriminate sale of prescription drugs. Perhaps such opposition is arising out of apprehension of losing business. Against this backdrop, when examined in the context of existing drug regulations, it can be seen that the existing regulations do not explicitly regulate online pharmacy and it also does not prohibit this activity. Online pharmacy can be operated as long as operations are in compliance with the existing provisions of the Drugs and Cosmetics Act, 1940 and Drugs and Cosmetics Rules, 1945.

It’s a myth that online pharmacies will operate without pharmacist, will sale without prescription and will lead to self medication etc. The fact is except same aberrations, orders are executed by the licensed pharmacies in compliance with conditions of licenses. It is a fact that it provides many advantages to the consumers, especially, ease and speed in procuring the required drugs. With entry of organised sector it will provide value addition to retail space. However, there is a need to formulate specific and clear regulations in the light of existing drug regulations and Information Technology Act, 2000. To conclude, it should be noted, law is need based and will change if there is a need. If Internet pharmacy is in the interest of consumer, necessary changes will have to be effected in the regulations providing necessary safeguards to protect interest and health of the consumer.

Sudhir Deshpande, Legal Consultant, Pharmalex


‘A foolproof regulated channel has to be brought in’

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Subramanian Vaidya

It is true that the market is flooded with newer and newer formulations every month and not every quarter. This happens to be the order of the day as we have that many manufacturers and that many state drug licensing authorities in the country. Though DCG(I) and CDSCO have pegged this exodus through demands of clinical and bio equivalent studies, still the exploitations through loopholes exist and we have many FDCs coming into the market. Retailers frankly are not interested in this sort of set up as their investments unnecessarily go up in building up stocks and thus there comes an expanded and enlarged inventory problem for them.

This is equally true with wholesalers as well as distributors. Influencing the medical profession with such trivial changes in the fixed dose combinations has been the order of the day and all sorts of lucrative promotional inputs are attempted at doctor’s level. Frankly this is not a good picture to relish and ultimately, the patient bears all the brunt. Pharmacists – the so called diploma holders who man the chemist shops are truly not interested in getting into the nitti gritty situations of healthcare and mostly are only employed in the retail shops as employees except for a few of them who own the shops.

It would really require an ardent attempt to make our retail chemists a more professional body and the shop manned by a true pharmacist – a B Pharm graduate who understands the subtle nuances of medicine and its true values. A pharmacist who is a B Pharm graduate becomes a more able counsellor when it comes to retailing and advising the patients. An appropriate skilled development programme is necessary to be conducted with all the diploma holders to make them understand their due role in the society as responsible dispensing pharmacists. These diploma holders need to obtain a continuous upgrading education on medicines, diseases and pharmaco-vigilance programmes to be adopted by them at the retail counters so as to help the patients understand the role and importance of the medicines. In return, the drug authorities too, do get the adequate data in these matters to take cognisance of.

The companies hardly play any role in educating the pharmacist, broadly. Of course the companies do talk about their individual products and make them aware of their availability in the market through their respective distributors. Government of India and FDA do have some skeletal programmes but a concerted effort has to be put in place in order to make the pharmacist more responsible to the society as a whole. Online pharmacies cannot be truly ruled out totally. The existing retailers of course are not in favour.

A proper foolproof regulated channel has to be brought in, with rigid regulations, thus enabling the access to medicines for the entire population including rural India. Anyway it is a long drawn process.

Risk as of now, is there in both forms of dispensing. Even retail shops are not able to control the dispensing of unwanted medicines in various locations.

FDA authorities have been trying to control this phenomenon with all their available resources. D Pharm curriculum has to be updated to the present day needs and there has to be a continuous educational programme taken up by the diploma holders from time to time and their licenses should be reviewed and renewed only after confirming the mandatory education inputs at due intervals.

The entire profession of pharmacy should be given a holistic recognition rather than as a commercial outlet to make profits alone, as is the situation now, in our country.

Exceptions are there but it is rare. An all India retail pharmacy magazine with authentic inputs from experts will go a long way in educating these diploma holders from time to time. The company intellectuals and experts can indeed contribute in these magazines and thus, their inputs can have a far reaching output in terms of education and up gradation to these retail chemists and pharmacists

Subramanian Vaidya, Director – BlissGVS Pharma, Chairman – IDMA – (MSME – subcommittee)

[email protected]

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