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Editorial Articles

Issue no 01, 01-07 April 2023

Making Healthcare Affordable Through 'Jan Aushadhi'

Ritesh Kumar

The delivery of healthcare has historically been premised on the notion that when treatment of patients is concerned, price should not be a hindrance. However, access to life-saving medication remains inadequate in reality. According to the World Health Organisation, over a third of the global populace lacks access to essential medications, and more than half of this group resides in impoverished regions of the developing world, such as Africa and Asia.

Numerous factors determine the accessibility of drugs in developing nations, with cost being a critical one. One approach to mitigate the rising cost of healthcare is to employ generic drugs. Generic medications present a significant opportunity to lower healthcare expenditures since they can be substantially less costly than branded pharmaceuticals.

The primary objective of every Government's health agenda should be to provide timely access to affordable, safe, and effective products. Despite the fact that most developing nations mandate the use of generic medications in their national health policy statements, majority of healthcare practitioners and consumers remain dubious about their effectiveness, quality, and safety. This skepticism is further compounded by the absence of initiatives by government and nongovernment organisations in developing countries to promote the benefits of generic drugs to consumers.

What are Generic Medicines?

Developing new medicines is a time taking and costly process. Prior to receiving marketing authorisation, pharmaceutical companies must subject developed molecules, or medicines, to animal and human testing to ascertain their safety and efficacy in treating the targeted condition. Moreover, the development process is fraught with risk, as medicines may fail to pass requisite tests, leading to substantial financial losses for the company. Consequently, those medicines that qualify the tests and make it to the market must recoup the costs of those that did not, leading to a high price point. In light of the high costs associated with drug development, the profit-driven nature of pharmaceutical companies, and the need to incentivize further research and development, a company that develops a new medicine is granted a period of exclusivity during which only it may produce and market the medicine. This period of exclusivity, commonly known as patent period, may be monetised by selling the molecule to other companies for a royalty fee. In this period of market exclusivity, companies typically sell the medicine at a premium. After the patent period expires, other companies may manufacture and sell these medicines, often at lower prices, thus becoming known as "generic medicines" or "generics." Hence, generic medicines have the same standards for purity, potency, and quality as their branded counterparts.

Use of Generic Medicines in India

Pradhan Mantri Bharatiya Jan Aushadhi Pariyojana: In 2008, the Indian Government launched a nationwide scheme to promote the use of generic medicines. The scheme, now known as the Pradhan Mantri Bharatiya Jan Aushadhi Pariyojana (PMBJP), is a flagship scheme that aims to make quality generic medicines available at affordable prices to the masses. The scheme is implemented through the Pharmaceuticals & Medical Devices Bureau of India (PMBI). Under the PMBJP, PMBI procures generic medicines directly from manufacturers and supplies them to Jan Aushadhi Kendras. The scheme also involves the branding and marketing of generic medicines under the name of 'Jan Aushadhi.' The generic medicines sold under the PMBJP are required to meet the quality standards set by the Central Drugs Standard Control Organisation (CDSCO).

The PMBJP has the following objectives:

·         To make quality generic medicines available at affordable prices to the masses.

·         To reduce the out-of-pocket expenditure on healthcare. 

·         To promote the use of generic medicines.

·         To ensure the quality of medicines sold under the scheme. 

·         To create self-employment opportunities for people through the setting up of Jan Aushadhi Kendras. 

·         Reduce government's budgetary support for medicines

Jan Aushadhi Kendras: Excellent Opportunity for Entrepreneurial and Career Growth The PMBJP is implemented through the setting up of Jan Aushadhi Kendras across the country. These Kendras are owned and operated by individuals, self-help groups, and organisations. The one-time financial assistance provided to the Jan Aushadi Kendra owners has been enhanced from existing Rs 2.50 lakh to up to Rs 5.00 lakh to be given @ 15% of monthly purchases made, subject to a ceiling of Rs 15,000/- per month, w.e.f. April 2021. The Kendras are required to sell generic medicines under the Jan Aushadhi brand at a discount of up to 90% compared to the market price of branded medicines. The Kendras are also required to maintain a stock of at least 500 medicines covering all therapeutic categories.

Eligibility criteria to open PMBJP Kendra:

·         Any Indian national including male, female and persons with disabilities of age 21 years and above.

·         Applicants must themselves possess D. Pharma/ B. Pharma or any pharma degree or should employ persons having such degree and produce proof thereof at the time of final approval.

·         For setting up Jan Aushadhi Kendras inside the premises of hospitals and medical colleges, the management of the establishment can recommend suitable organisations, charitable trusts or even individuals.

·         Applications can be submitted through both online and offline modes.

Infrastructure and logistics requirements:  

·         Built-up area of at least 120 square feet.

·         Pharmacist Licence

·         Non-refundable application fees of Rs. 5,000/- is to be deposited along with application form.

·         If the applicant belongs to the category of Women Entrepreneurs, Divyang, SC, ST & any entrepreneurs of aspirational districts (backward district) as notified by the NITI Aayog, in Himalayan, Island territories and North- Eastern states then there is no need to pay any application fee.

Eligibility for vendors and suppliers:

PMBJP also offers excellent opportunities for drug manufacturers and distributors to scale up their business by supplying generic medicines, surgical devices and consumables to Jan Aushadhi Kendras. Such Kendras procure medicines and devices covering all major therapeutic groups. They also procure nutraceutical products like chyawanprash, protein powder, malt-based food supplements and Ayush products like immunity boosters for adults and children. The kendras are also mandated to sell affordable sanitary pads for women's health and hygiene. (More details about applications for opening Jan Aushadhi Kendras are provided in the official website of PMBJP - http://janaushadhi.gov.in).

Procurement of Jan Aushadhi Products

Procurement of products is done from vendors/ suppliers/ manufacturers having WHOGMP certified facilities through e-tender portal (CPPP) of the Government of India. The product basket has been increased to 1759 Medicines and 280 surgical equipment and consumables from 600 medicines and 150 surgical items in 2017-18. The Kendras are provided with SAP (Systems Applications and Products) based inventory management and forecasting system. The portal also has a system of blacklisting/debarring vendors/ suppliers/ manufacturers for failure in supply, also penalty is imposed for late delivery.

Storage and Logistics

The Jan Aushadhi medicines are delivered to the kendras through IT-enabled end-to-end supply chain system. There is a central warehouse at Gurugram and three regional warehouses at Chennai, Guwahati and Surat. These warehouses cover all kendras existing in different parts of the country. So far, 36 distributors have also been appointed across States/UTs to strengthen the supply chain system. It has been targeted to establish 6 warehouses by 2025.

Impact of PMBJP

The PMBJP has had a significant impact on the Indian healthcare system since its launch. As of March 2023, there are over 9,000 Jan Aushadhi Kendras across the country, 1759 generic medicines, and 280 surgical equipments are being sold under the scheme. In the last eight years, there has been 100 times increase in the sale of generic drugs through the Jan Aushadhi Kendras.

According to latest Health Ministry data, on an average, 1.2 million persons visit Jan Aushadhi outlets every day. The key success factors of PMBJP include quality assurance of products, efficient logistics, incentivising the entrepreneurs, adequate product range, constant communication and awareness, savings to the citizens. Jan Aushadhi Kendras has resulted in huge savings in out-of-pocket expenditure of beneficiaries, amounting to approximately Rs 20,000 crore (more than USD 2 Billion) in past 8 years.

The PMBJP has also created self-employment opportunities for people. The setting up of Jan Aushadhi Kendras has provided people with a source of income and has helped to create local employment opportunities. In 2014-15, Jan Aushadhi Kendras sold generic drugs and equipments worth Rs 7.29 crore which has increased to Rs 1094.84 crore as on 28th February 2023.

Legal Framework and Regulations for Generic Drugs Use

The Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations 2002, mandates physicians to prescribe drugs using their generic names, in a clear and readable manner, preferably in capital letters. Additionally, the National Medical Commission (formerly known as Medical Council of India), had issued directives requiring all registered medical practitioners to adhere to these provisions. Further, the National Medical Commission Act of 2019, the State Medical Councils/Ethics and Medical Registration Board (EMRB) of the Commission are empowered to take disciplinary action against physicians who violate the aforementioned regulations. When complaints regarding the breach of the code of ethics for doctors are lodged, the EMRB forwards these complaints to the relevant State Medical Councils where the doctors or medical practitioners are registered. The states are also advised to ensure the prescription of generic drugs in public health facilities.

Spreading Awareness

Jan Aushadhi Diwas is celebrated every year on 7th March for dissemination of information and spreading awareness about the scheme. The Department of Pharmaceuticals/Pharmaceuticals & Medical Devices Bureau of India (PMBI) spreads awareness about the scheme through advertisements by Electronic Media, Print Media as well as through Outdoor publicity. In addition, information is disseminated about the benefits of Jan Aushadhi generic medicines and the scheme through social media platforms. PMBI also maintains a mobile application namely Jan Aushadhi Sugam, a single window platform to assist users in many ways like locating nearby PMBJK, searching Jan Aushadhi medicines, telephone numbers, etc. Further, besides focusing on consumers, efforts are also made in addressing specific issues related to generics to the healthcare professionals.

This year, on the occasion of Jan Aushadhi Diwas, a 7-day nationwide drive was implemented. Seminars for health care professionals like doctors, nurses, pharmacists were carried out across the country in collaborations with educational institutes. It is important to educate this group of people, especially on general concepts of bioequivalence, as this topic is not well understood by many practicing healthcare professionals. To overcome this problem, educational seminars were held across the country at Pharma Colleges and Universities where thousands of students/medical students/ paramedical students were imparted valuable information about generic medicines with focus on PMBJP. The students were encouraged to take up entrepreneurial endeavours by actively participating in opening Jan Aushadhi Kendras. Additionally, the programmes also saw discussions among stakeholders on the prospects of promoting such educational seminars on generic medicines to be made part of compulsory continuous professional development programs by respective professional bodies. Similarly, educational institutes delivering courses on medicines have been encouraged to incorporate topics on rational prescribing in their standard therapeutics course so that future health care professional who will be directly involved in patient care such as doctors, nurses, and pharmacists are well informed on every aspect of rational prescribing since their junior years.

The World's Pharmacy: India's Generic Drug

Industry India has gained a strong foothold on the global scene with its innovatively-engineered generic drugs and active pharmaceutical ingredients (APIs). India Generic Drugs market stood at USD 24.53 billion in 2022 and is expected to grow at a steady CAGR of 6.97% during the forecast period of 2018-2028. Consistent with India's guiding principle of 'Vasudhaiva Kutumbakam', the Indian pharmaceutical industry has taken a leadership role in the global market and has worked tirelessly towards the betterment of mankind, ensuring the abundant availability of highquality pharmaceuticals for mass consumption at reasonable prices. India's unwavering commitment to collaborating with partner countries demonstrates the country's dedication to creating strong relationships and further deepening such partnerships beyond mere trade, towards promoting welfare. It is fitting to describe India as the pharmacy of the world, with a 50% share of exports and the production of one out of every five generic pills globally, which has played a significant role in making medicines more affordable in numerous countries worldwide.

(The author is a Delhi-based journalist currently working with an international news platform. He can be reached at riteshkumar1926@gmail.com)

Views expressed are personal.