Rao Vadlamudi
President
The Indian Pharmaceutical Association (IPA)

Dr. Rao Vadlamudi, In a career spanning over three decades, has the unique distinction of excelling in both academics and the pharmaceutical industry. Currently the President of the Indian Pharmaceutical Association, Dr. Vadlamudi held teaching assignments at the Institute of Chemical Technology – erstwhile UDCT, and the Bombay College of Pharmacy, Mumbai, where he served as the first ever Director of the institute during 2004-07. He worked in the industry since 1990 and for over two decades, where he was associated with cutting–edge drug discovery & development programs in both multinational and Indian pharma companies, including Hoechst, Nicholas Piramal, Suven Life Sciences, Nektar Therapeutics and Vimta Labs. He also served as the editor of the Indian Journal of Pharmaceutical sciences for over two decades from 1994-2014. Rao Vadlamudi received several awards of which the most significant one is the Eminent Pharmacist Award of the IPA in 2013. Dr. Vadlamudi is the Director of St. Peter’s Institute of Pharmaceutical Sciences, Hanamkonda, Telangana. Dr. Vadlamudi has 25 publications and 13 patents to his credit.

Vision and Roadmap of IPA to Achieve Patient Safety

Ever since India achieved its independence in 1947, the nation and the pharmacy profession of the nation are making huge strides in the area of pharmaceuticals. The nation has achieved self-sufficiency in the production of pharmaceuticals and currently exports medicines and pharmaceuticals to more than 200 countries in the world. Our country has also scaled greater heights in the field of Pharmacy education and has established globally that India is a provider of well-trained pharmaceutical professionals to meet global healthcare needs. However, even after these developments, the state of Pharmacists and Pharmacy profession in India is yet to reach the level, in which pharmacists attain the status of being the key healthcare providers. In this report, the vision of the Indian Pharmaceutical Association and the initiatives taken by this association in realizing its major objective to position pharmacists as one of the important healthcare providers in our country.

Indian Pharmaceutical Association (IPA) is a 78-year old association of pharmaceutical professionals, registered as a charitable trust with an objective to promote the science and art of pharmacy in all aspects and impart suitable education and training to professionals working in the area of pharmacy and pharmaceutical sciences. As a member of the Drug Technical Advisory Board (DTAB), IPA is actively involved in advising the government on matters of drug regulation and drug industry. As a regular member of committees constituted by the Department of Pharmaceuticals (DoP), IPA has time and again, made recommendations pertaining to the issues on hand, keeping in mind the needs of the country, pharma industry and the patient community. As an esteemed invitee to deliberations of apex national bodies like the Indian Council for Medical Research (ICMR), IPA has been actively involved in discussions, deliberations and decision-making processes concerning crucial issues of national and global health importance like the Antimicrobial Resistance. IPA is actively involved in healthcare activities in collaboration with international organizations such as the World Health Organization (WHO), World Health Professional Association (WHPA), International Pharmaceutical Federation (FIP), Commonwealth Pharmaceutical Association (CPA) and Federation of Asian Pharmacy Associations (FAPA). IPA is the only professional body in the country representing all facets of pharmaceutical profession viz. industry, research, education, pharmacy practice and regulatory affairs and is committed to promoting the highest professional and ethical standards of pharmacy, focusing the image of pharmacists as competent healthcare professionals, sensitizing the community, government and others on vital professional issues and support pharmaceutical education and sciences in all aspects.

Towards that end, following are the objectives outlined by IPA:

To promote the sciences and arts of Pharmacy in all aspects.

To impart suitable education and training to the members preparing for the profession of pharmacy or to those already engaged in the profession.

To undertake, carry on or promote scientific and technical research, experiments and tests of all kinds in pharmaceutical and allied sciences.

To edit and publish, journals, books, magazines, documents and other publications for promoting the causes of the profession of Pharmacy.

To hold seminars, symposia, conferences and exhibitions for promoting the causes of the profession of Pharmacy.

ADVOCACY INITIATIVES FOR REINFORCING THE PHARMACISTS’ ROLE IN THE NATIONAL HEALTHCARE System

IPA remains committed to working for ensuring that the pharmacist is recognized as a vital link in the healthcare in our country and the pharmacists’ role is clearly defined and earmarked in the National Health Policy. Towards that end, IPA’s activities and initiatives are in sync with the resolutions adopted at the 67th Indian Pharmaceutical Congress (IPC), Mysuru, The resolutions were, to ensure that pharmacist is included as a health care professional in all governmental initiatives in public health programs including communicable and non-communicable diseases with specific emphasis on pharmacist’s role in rational use of medicines and containing antimicrobial resistance; to ensure that pharmacy practice regulations-2015 be implemented properly by all the concerned authorities like Ministry of Health & Family Welfare, both at the center and the states, pharmacy council of India and the state pharmacy councils; to urge the Government to create a separate Ministry of Pharmaceuticals immediately for the development of the pharmaceutical industry and the profession and for improving access to healthcare; and to ensure that a separate Directorate of Pharmacy Services and Training be created under the Ministry of Health & Family Welfare. This Directorate is to be headed by a pharmacy professional with a minimum qualification of M. Pharmacy or Pharm. D.

IPA continues with its efforts to sensitize the government about the presence of pharmacist as an indispensable member of the healthcare team and the only qualified and eligible professional for the drug regulatory, drug policy-making, drug handling and pharmacy education-related teams. The government ought to recognize the pharmacists’ role as the first – line provider of patient care and highlight the same in all pharma & health – related documents/notifications/policies. With the government’s thrust on physicians prescribing generic medicines, the role of pharmacist in the retail set-up becomes all the more crucial and critical, with the pharmacist alone having the professional competence to supply to the patient, the right drug product with the correct salt/polymorphic form of the drug molecule, in the prescribed dose and with the desired drug release attributes. The role of the pharmacist in prescription audits in the retail, as well as hospital setups, is something that needs to be developed if better and improved health care delivery has to be achieved.

Further, pharmacy graduate/post graduate degrees should be considered the most desired qualification for all positions at all levels in the Ministry of Pharmaceuticals, drug regulatory framework, drug policy-making bodies, drug industry, pharmacy education – related teams,  drug handling teams including drug distributors, wholesalers and stockists. Implementation of these measures would ensure building and maintenance of quality in all aspects pertaining to drugs and medicines.

CHAMPIONING THE CAUSE OF THE PHARMA INDUSTRY

IPA has always engaged with the industry, identifying and understanding gaps in the training & information needs of the professionals from Indian pharma industry and to design suitable symposia & workshops to fill the lacuna. It is the intention of IPA to provide the professionals from all sectors of the industry with the latest updates & training in the fast-changing technologies. All its state & local branches regularly organize short seminars & evening lectures to cater to this need. Some of the key events include the IPA convention, programs supported by European Directorate of Quality Medicines (EDQM), Pharmexcil, AIDCOC and Pharma Industries such as the Aptar Pharma, the ACG International to name some, that are organized at periodic intervals. IPA has always taken the lead in representing the industry’s case with the government & drug regulatory bodies.

Creation of Ministry of Pharmaceuticals – Single window regulatory clearances & better synchronization of operations:

IPA has been advocating with the government to look at creation of Ministry of Pharmaceuticals that can handle pharmaceuticals, biopharmaceuticals, medical devices and diagnostics, herbals and nutraceuticals, production and supply chain, sales, pricing, licensing and regulation, export promotion, dispensing, utilization of pharmaceuticals, pharmacovigilance, patient counselling and drug information, pharmaceutical care in community and Clinics, Pharmacy education, regulation and accreditation, NIPERs, and development and deployment of qualified human resources to improve national healthcare. This move would effectively bring in all regulatory and related activities of Drugs Controller General of India (DCGI), India Pharmacopeia Commission (IPC), Pharmacy Council of India (PCI), National Pharmaceutical Pricing Authority (NPPA), National Institutes of Pharmaceutical Education Research (NIPERs) and Pharmaceutical Export Promotion Council of India (Pharmexcil) under one roof. Besides, it would also include the control of public sector pharma enterprises like IDPL, HAL, RDPL, KAPL and BCPL within its ambit.

All requisite permissions/approvals for setting up manufacturing/clinical research/contract research/R&D/sales/ distributor/retail units can then be obtained from a single window, under the Ministry of Pharmaceuticals, as against the multiple approvals currently required from different ministries and government departments for setting up a business venture in this very important sector. The reduced approval timelines with a single-window regulatory clearance would contribute greatly to the ease of doing business and would bolster the growth of the industry.

According Infrastructure status to the pharmaceutical & biotech industry:

The Indian pharma industry is expected to grow by 15 per cent per annum between 2015 and 2020 and is expected to outperform the global pharma industry, which is projected to grow at an annual rate of 5 per cent during the same period. India has also maintained its lead over China in pharmaceutical exports with a year-on-year growth of 11.44 per cent to US$ 12.91 billion in FY 2015-16, according to the data from the Ministry of Commerce and Industry. In addition, Indian pharmaceutical exports are estimated to grow between 8-10 per cent in FY 2016-17. IPA has, in repeated submissions to the government, put forth the need to accord infrastructure status to the pharmaceutical & biotech industry so that better finance options are made available and capital inflow into the industry is facilitated and the potential of this promising sector is maximized to the fullest extent possible. IPA would continue to press forth its demand to earmark special designated zones / parks for encouraging production of APIs, critical intermediates and starting raw materials as well as finished pharma and biotech products and medical technology & devices in order to provide a fillip to this sector that has the potential to draft India’s success story as global economic superpower.

DPCO to move from price control of only scheduled drugs & devices to price monitoring of all drugs & devices:

The ceiling price fixed by NPPA for scheduled drugs & devices is viewed by the industry as a complete dampener, with many of the scheduled drugs & devices either getting withdrawn from the market after price control or getting reformulated as a new drug product along with other non-scheduled drug molecules, most often as irrational, unjustified and sometimes unsafe drug combinations. On the other hand, there are a whole lot of non-scheduled drugs including cosmeceuticals and AYUSH medicines that are exorbitantly priced. IPA believes that a better approach towards ensuring drug accessibility and availability, therefore, would be to shift from the excessive price control of only scheduled drugs and devices to the moderate price monitoring of all drugs and devices. The move would be well-received and accepted by the pharma industry and would also ensure accessibility and availability of improved and updated drugs and innovations in medical devices to the public at large.

TOWARDS UPGRADING STANDARDS OF PHARMACY PRACTICE IN THE COUNTRY

IPA’s vision is firmly aligned with Vision 2025 for the pharmacy profession, outlined at the 67th IPC. As per the vision document, the pharmacist would position himself as an accessible, patient-centric professional providing effective medicines management activities, primary patient care and actively participating in medicines research, so as to upgrade his knowledge base.

IPA’s vision is to ensure that the standards of pharmaceutical care accorded by practicing pharmacists in the country are on par with the best of the global practices. IPA regularly conducts training programs for community and hospital pharmacists for upgrading their professional skills so that they are able to render better services to the patients and public, at large. Many of these programs are supported by pharma companies including Abbott, Glenmark, GSK, Lilly, MSD, Novartis, Pfizer and Piramal.

In order to increase public awareness about the role of pharmacists in health care services, every year, in the third week of November, IPA organizes the National Pharmacy Week (NPW). The Celebrations are centered around a suitable theme and are organized all over the nation. The activities during the NPW include popular lectures, radio and TV talks, silent rallies, street plays & distribution of pamphlets & daily newsletters to the public for raising awareness about the profession. NPW themes of the last few years are given below:

IPA also observes the National Pharmacists Day on 25 September and played a key role in getting this day listed in the national list of health days. On this day, each year IPA adopts the theme put forward by the FIP and organizes programs for the pharmacists and the public to promote awareness of the role of the pharmacist and the importance of pharmacy profession. IPA also organizes the national elocution competition for pharmacy students each year in which students from all over the country with good speaking skills participate to win handsome prizes. The topics of this competition are always chosen to enhance the understanding of the participating and attending students about pharmacy profession and importance of pharmacists.

BUILDING QUALITY HUMAN RESOURCES BY BOLSTERING PHARMACEUTICAL EDUCATION & RESEARCH

The importance of quality and well-trained human resource in adequate numbers, in the growth of any sector, cannot be emphasized enough. IPA believes that pharmacy education in the country can be strengthened by increasing the government spend in terms of creating more NIPERs and providing increased support to state – funded and private educational institutes conducting quality research programs. The pharma industry support to the educational institutes is vital and industry should be encouraged to outsource activities like the mandatory BA/BE studies, preclinical research, drug development and scale-up projects (projects that do not entail serious confidentiality issues) to pharmacy academic institutes of repute.

IPA continues with its
efforts to sensitize the
government about the
presence of pharmacist as
an indispensable member of
the healthcare team and the
only qualified and eligible
professional for the drug
regulatory, drug policymaking,
drug handling and
pharmacy education-related
teams. The government
ought to recognize the
pharmacists’ role as the
first – line provider of
patient care and highlight
the same in all pharma &
health – related documents/
notifications/policies. With
the government’s thrust
on physicians prescribing
generic medicines, the role
of pharmacist in the retail
set-up becomes all the more
crucial and critical, with the
pharmacist alone having the
professional competence to
supply to the patient, the
right drug product with the
correct salt/polymorphic
form of the drug molecule,
in the prescribed dose and
with the desired drug release
attributes.

IPA is all for including pharmacy/pharmaceutical sciences as one of the subjects in the civil services examination so that pharmaceutical professionals who understand the needs and requirements of the pharmacy profession have a better opportunity to get involved in the civil services, thereby contributing in a more effective way towards pharma policy–making and implementation. In the years ahead, the government can also look at introducing the examination of Indian Pharmaceutical Services on similar lines as that of other civil service examinations which could be taken up by all those candidates keen on government service in the Ministry of Pharmaceuticals.

In 2015, IPA organized the hugely successful International Pharmaceutical Students’ Forum (IPSF) World Congress at Hyderabad. IPA is currently playing an active role in joining hands with Pharmacy Council of India (PCI) for implementation of the uniform syllabi for Bachelor’s & Master’s programs in the various regions of the country. IPA has also instituted 40 scholarships for B. Pharm. students in colleges from all over the country with the support of Ramanbhai Patel Foundation and Amrit Mody Foundation.

IPA PUBLICATIONS

• – Indian Journal of Pharmaceutical Sciences (IJPS)
• – Pharma Times
• – CPD e-times
• – Drug Information Bulletin

MAKING THE INTERNATIONAL MARK

IPA continues to align with its international counterparts in meeting the global requirements of the profession. As part of its vision to firmly entrench Indian pharmaceutical professionals as leaders in the international landscape, IPA has actively pursued nomination/election of its members at important decision – making positions in FIP, CPA and FAPA. IPA members have been accorded awards and honors by these international bodies, as recognition of their stupendous services to the various facets of the profession.

Contributor
Dr. Alka Mukne
Editor, Pharma Times