Address by Ambassador at the Inaugural Retail Phrmacists Association Conference Held at The Meikles Hotel on 14 September 2019
Mrs Jocelyn Chaibva, Chairperson, Retail Pharmacists Association
Mr. Simbarashe Malandu, Convener of the Conference
Mr. Portifar Mwendera, President, Pharmaceutical Society of Zimbabwe
Mr. Kuda Chapfika, Chairperson, Pharmaceutical Wholesalers Association
Mrs. Mabel Torongo, Trustee, Pharmaceutical Society of Zimbabwe
Mr. Richard Rukwata, Medicines Control Authority of Zimbabwe
Mr. L. Chapanga, Pharmaceutical Manufacturers Association
Mr. Luckmore Bunu, Secretary, Retail Pharmacists Association
Invited guests, sponsors, Ladies and Gentlemen
It is indeed a great honor to be in your midst at the Inaugural Retail Pharmacists Association Conference in Zimbabwe with the theme “Pharmaceutical Care in the 21st Century”. I thank the organisers for inviting me to address this August gathering. I must congratulate the organizers for choosing this relevant topic for deliberation in this conference- relevant for developing countries like India and Zimbabwe where respective governments are faced with numerous challenges to provide quality and affordable pharmaceutical care to its public.
Since you have invited me, I assume that you would like me to briefly touch upon Pharmaceutical industry in India. What you see today is the effort of the last seven decades when the government initiated steps to start a domestic pharmaceutical Industry which would be capable of Meeting India’s requirement by initiating to start basic pharmaceutical manufacturing public sector units. These units were manufacturing essential drugs, like Antibiotics, Analgesics and some essential vitamins etc. Starting of Public sector units has given an impetus to India’s Pharmaceutical industry development.
India does not have a full-fledged medical Insurance schemes and so more than 70% of the cost of Pharmaceutical expenditure is met out of the Pockets of individuals. Thus affordability has become a paramount importance. This prompted Government of India to take the initial step of bringing in Maximum Retail Price (MRTP act in 1972) which was further refined to be industry specific in the form of rationalizing of prices depending on the classes of medicines and other nuances involved in making it. This has resulted in products availability at affordable prices. GOI has brought in reasonable rationalization of distribution and retail margins.
Government has also made policies more country specific like promoting healthy competition by issuing sufficient number of licenses as long as prescribed GMP (good manufacturing practices) levels were met. This has resulted in almost 15-20 companies making each essential combination and in some cases even far more.
The above policies have resulted in the country having over 3000 manufacturing units meeting world class standards. Today India’s pharmaceutical industry is able to meet 100% of its domestic generic requirement which is around $ 18 billion of its $ 20 billion market size.
India’s domestic consumption of medicines today has almost 1.2 std units percapita per day which works out to approx. 6.7% of global consumption in terms of Standard units (Volumes). India’s Pharma industry is able to meet this requirement at cost of just $ 20 billion which is just 1.6% of total global market size of $ 1197 billion- thus bringing to the doorstep of its citizens a responsible pharmaceutical care offering best of both of Quality and affordability to the world.
Indian firms produce nearly 60,000 generic brands in 60 therapeutic categories and between 350-400 bulk drugs. Approximately 80% of domestic production consists of formulations, and more than 60% of those formulations are sold in the domestic market, rest being exported.
Ability of India’s Pharmaceutical industry to meet any manufacturing standards like USFDA [US Food and Drug Administration], EUGMP [EU Good Manufacturing Practice] and any quality meeting all parameters like bioequivalence etc has made India’s generic most sought after even in highly developed markets like USA, EU and other markets like Africa (India meets almost half their requirement of generics and in Cases of ARVs & Vaccines India meets almost 70% of their requirement). It is interesting to know that 40% of market authorizations granted By USFDA in 2018 are to Indian companies.
Policies adopted for Domestic Requirement: GOI, in fact has initiated International Non Proprietary Name (INN) mode even in early nineties of the last century, though not on compulsory basis. GOI has levied reduced of taxes and internal duties on to encourage production of such products and help people to stay affordable. Though at appropriate forums, GOI was initiating prescription of Medicines in INN format, it has not brought in desired results. However companies on their own promoted these INN which has made fairly noticeable results.
Government has setup a well-functioning regulatory system. The Central Drugs Standard Control Organisation (CDSCO) is the apex national drug regulatory authority. The primary objective of the CDSCO is to ensure the delivery of safe, superior quality effective drugs, cosmetics and medical devices to the public.
The National Pharmaceutical Pricing Authority (NPPA), which was instituted in 1997 fixes or revises the prices of decontrolled bulk drugs and formulations at judicious intervals; periodically updates the list under price control through inclusion and exclusion of drugs in accordance with established guidelines; maintains data on production, exports and imports and market share of pharmaceutical firms; and enforces and monitors the availability of medicines in addition to imparting inputs to Parliament in issues pertaining to drug pricing.
Introduction of Jan Aushadi:
The Jan Aushadhi Scheme (Public Medicine Scheme) is a direct market intervention scheme launched in 2008 by the GOI, to make available quality generic medicines at affordable prices, equivalent in quality and efficacy as expensive branded drugs, to all citizens through a special outlet known as Jan Aushadhi Store (JAS) opened in each district of the States. JAS can be opened and operated by any NGO/Institution/Co-operative Society identified by State Governments on the free space provided in the premises of Government Hospital by the State Governments.
The present Government has taken it up with more enthusiasm and has revamped the scheme in September 2015 as 'Pradhan Mantri Jan Aushadhi Yojana' (PMJAY). In November, 2016, to give further impetus to the scheme, it was again renamed as "Pradhan Mantri Bhartiya Janaushadhi Pariyojana"
Ayushman Bharat [National Health Protection Scheme]
Currently government has sought to implement a radical overhaul of the healthcare system in its entirety. One of the major policy initiatives of the government has been the announcement of the Ayushman Bharat - National Health Protection Mission (AB-NHPM) for 100mn vulnerable and underprivileged five-member families.
Pradhan Mantri Jan Arogya Yojana (PM-JAY) will provide financial protection (Swasthya Suraksha) to 100.74 million poor, deprived rural families and identified occupational categories of urban workers’ families as per the latest Socio-Economic Caste Census data (approx. 500 million). It will have offered a benefit cover of $7140 per family per year (on a family floater basis).
PM-JAY will cover medical and hospitalization expenses for almost all secondary care and most of tertiary care procedures. The scheme will be cashless & paperless at public hospitals and empanelled private hospitals. The beneficiaries will not be required to pay any charges for the hospitalization expenses. The benefit also includes pre and post-hospitalization expenses. The scheme is an entitlement based; the beneficiary is decided on the basis of family being figured in SECC database. When fully implemented, the PM-JAY will become the world’s largest government funded health protection mission.
This may become the world’s largest health assurance cover, aims to provide health insurance to nearly 40% of the population - ie more than 100mn poor and vulnerable families - with the premium paid by the government.
Ladies and Gentlemen, The purpose of unfolding the above is not to boast of India’s achievement, neither is an effort to benchmark the best Pharmaceutical care practices to India’s experience but to throw up a challenge for all participants both Government and private stakeholders gathered here to provide a quality and affordable Pharmaceutical care to the people of Zimbabwe. What we are today in India does not happen in a day but consistent efforts of decades of all stakeholders to ensure that our population have access to quality and affordable medicines.
The quest by His Excellency E D Mnangagwa, the President of the Republic of Zimbabwe, for the attainment of a middle income status by 2030 cannot exclude this aspect in Zimbabwe. “The world is one family” is an old Indian dictum reiterated by my Prime Minister when he was talking of the progress made to date on the achievement of Sustainable Development Goals (SDGs). Let us envision a world where no one is left behind. We have the convergence of visions of two leaders of two friendly countries. And we can do it together.
While it is the primary responsibility of Governments to create policy environment, the private health care industry should take advantage of enabling legislation and invest in high quality medical facilities. “The future depends on what you do today” said Mahatma Gandhi. “the time to act is now,” He added.
Ladies and Gentlemen,
The community pharmacist should stand up and be counted as an active member of the primary healthcare team. They should be proactive and provide extended services to the communities within the national legal framework. They ought to engage policy makers for review of policies to be able to better respond to the changing landscape on the global arena of delivery of pharmaceutical care. I understand that in the absence of Price Regulatory/Control Act/framework particularly at retail stage,( unlike in India where any pharmacist selling any product beyond (MRP) is punishable by Law), the temptation is very strong to put unreasonable margin to the products. Allow me to remind ourselves that in this industry we are dealing with human lives and any profit margin which goes beyond reasonable limit is depriving some fellow human being of their lives.
Indeed, as a people we aspire change to see diseases get eradicated, poverty being alleviated and, all children attaining basic primary education among other aspirations as articulated in the SDGs. However, these and other sustainable development goals cannot happen on their own, we need to work hard towards achieving these milestones.
The Governments of Zimbabwe and India among others, have taken several strides to implement the SDGs, towards achieving Universal Health Coverage by 2030. In India, the community pharmacist has been involved in the provision of primary healthcare services by participating in the distribution of medicines for tuberculosis. This has increased access to essential medicines. This was with effect from 2011, when the Indian Government signed a declaration in collaboration with the International Pharmaceutical Federation (FIP) and the World Health Organisation, which acknowledged that community pharmacists have a role to play as public healthcare practitioners, whereby patients can now access their tuberculosis treatment from community pharmacies. This highlights the commitment of Indian government towards pharmaceutical care. It is my great desire to see the pharmacist in this room take up the challenge of increasing their participation in public health and primary healthcare programs as they take steps towards the achievement of universal health coverage. It is my pleasure to be in the same room with more than 100 community pharmacists, who are gathered here to discuss how best the private sector can work together with the Government to ensure that all the citizens of this country have access to quality health services and essential medicines, as enshrined in the Constitution of Zimbabwe.
This is a call for innovative ideas from all concerned. As we make our deliberations today, let us keep in mind that we should create ways of ensuring that the quality of service provided by this noble profession is second to none. I wish to urge policy makers, regulators, manufacturers, wholesalers, community pharmacists and educators to work together for the benefit of the patient. I would like to remind you that as pharmacists dispensing medicines to patient means you are the interface between the pharmacy supply chain and the patient. Community pharmacists should be accessible to the public and give expert advice as required. They should promote adherence by patients. There are other services which pharmacists can provide as part of public healthcare service. You are also primary healthcare practitioners who are accessible and available all the time, since pharmacies should operate under the continuous personal supervision of a pharmacist.
On a note of caution, we do not want to waste resources due to expiries, but when it happens you should dispose the expired health commodities in an environmentally friendly manner. I would like to congratulate you for investing time and money in lifelong learning to keep up to date with new technologies since the pharmaceutical field is dynamic and new innovations can be disruptive and thus make you redundant.
It is important for the three pillars of pharmacy to work together for the good of the profession. The three pillars are Practice, Regulatory and Education. Regular curriculum reviews are an important process so that institutions of higher learning continue to produce practitioners with relevant competences; a regulatory pharmacist adaptable to the ever-changing industry, an industrial pharmacist with research skills for the development of new medicines, a community pharmacist of the future who is responsive to public health needs of the citizens. The regulatory framework should support the practice and education of the pharmacist, so that he/she is able to provide first class pharmaceutical care.
Ladies and gentlemen, with these remarks it is my singular honor to declare this conference officially open and wishing you fruitful deliberations.
Thank you.
mea.gov.in,hoc.harare