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Business Prospects

PMBJP
By BPPI- Implementing Agency
Ministry of Chemicals &
Fertilizers
Department of Pharmaceuticals-
Govt. of India

Presented by Krafters Logistics


office@krafterslogistics.org, 9540005555
Objective of Scheme
Making quality medicines available at affordable prices for all, particularly the
poor and disadvantaged, through exclusive outlets “ Pradhan Mantri Bhartiya
Janaushadhi Kendra”, so as to reduce and redefine the unit cost of treatment per
person.
PMBJP Vision
To bring down the healthcare budget of every citizen of India through
providing Quality generic Medicines at Affordable Prices.
PMBJP Mission
• 1. Create awareness among public regarding generic medicines.
• 2. Create demand for generic medicines through medical practioners.
• 3. Create awareness through education and awareness program that high price need not
be synonymous with high quality.
• 4. Provide all the commonly used generic medicines covering all the therapeutic groups.
• 5. Provide all the related health care products too under the scheme.

Implementing Agency:- Bureau of Pharma PSUs of India (BPPI)


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Introduction to Jan Aushadhi
• The Idea
• Over the years India, has developed a strong capability in producing quality branded and generic medicines in most of the
therapeutic categories, evolving from an mere Rs 1,500 crores industry in 1980 to a more than Rs 1,19,000 crores industry in
2012. However, although these medicines are reasonably priced, as compared to the prices of their equivalent medicines in
most other countries, yet a large population of poor people in the country, find it difficult to afford the more expensive
branded category of medicines. Accordingly, 'ensuring availability of quality medicines at affordable prices to all', has been a
key objective of the Government. some of the important steps taken to enable this are:

A. Price control of Scheduled Drugs through the National Pharmaceutical pricing authority (NPPA): Under the Drug Price
Control Order, 1995, NPPA): Under the Drug Price Control Order, 1995, NPPA has been given the mandate to control and
fix the maximum retail prices of a number of scheduled/listed bulk drugs and their formulations, in accordance with well
defined criteria and methods of accounting, relating to costs of production and marketing Notably therefore, the prices of
these medicines have remained quite stable and affordable.
• B. Price regulation of Non-Scheduled Drugs: Apart from the scheduled medicines under DPCO, 1995, the NPPA monitors
the prices of other medicines not listed in the DPCO schedule, such that they do not have a price variation of more than 10%
per annum. This has further helped in keeping the prices of most of the non-scheduled medicines stable and affordable.

C. Uniform VAT of 4% on medicines: Government has fixed a uniform and low rate of 4% VAT on medicines in the
country. This policy has been adopted, in almost all the States in the country, and has reduced the incidence of sales tax on
medicines and thereby assisted in keeping their prices low.
• D. Reduction in Excise duty from 16% to 4% Further and in addition to above low, VAT rates, the [present government had,
as part of the Budget for the year 2008-09 reduced the excise duty on medicines from 16% to 8%. This has been further
reduced to 4 percent as from 8th December, 2008. This has again, played a crucial role in keeping the prices of most of the
medicines at reasonable levels. Not satisfied with the above regulatory and financial steps for ensuring greater availability of
medicines at affordable prices to all, specially the poorer masses, the government has decided to launch a country wide Jan
Aushadhi Campaign.
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What is the Jan Aushadhi Scheme?
• To ensure the quality and efficacy of the drug in the Jan
Aushadhi scheme, each batch is procured from CPSUs and
private suppliers tested from NABL approved laboratories.
• They are tested as per standard requirements before being
supplied to Jan Aushadhi Stores by the Bureau of Pharma
Public Sector Undertakings of India
• To ensure the quality and efficacy of the drug in the Jan
Aushadhi scheme, each bach is procured from CPSUs and
private suppliers tested from NABL approved laboratories.
• They are tested as per standard requirements before being
supplied to Jan Aushadhi Stores by the Bureau of Pharma
Public Sector Undertakings of India (BPPI) and further certified
by Quality Council of India (QCI).
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What is the Jan Aushadhi Scheme?
• The Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers,
Govt. of India had launched the Jan Aushadhi scheme in 2013 with an aim
to cater to the public quality generic medicines at affordable prices through
government regulated outlets in each district of all the states. Ideal for
unemployed pharmacists, physicians and registered medical practitioners,
it can be opened in just 120 square feet area.

• Jan Aushadhi is a campaign launched by the Department of Pharmaceuticals,


Ministry of Chemicals and Fertilizers, Government of India, in association with
Central Pharma Public Sector Undertakings. It aims at providing good quality
generic medicines to the common people at affordable prices to the masses.

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What is the Jan Aushadhi Scheme?
Continued
• According to the official website of Jan Aushadhi, such generic drugs will be
cheaper than branded medicines from 50 to 95% but will have equal efficacy
and therapeutic value.
• To ensure the quality and efficacy of the drug in the Jan Aushadhi scheme, each
bach is procured from CPSUs and private suppliers tested from NABL approved
laboratories.
• They are tested as per standard requirements before being supplied to Jan
Aushadhi Stores by the Bureau of Pharma Public Sector Undertakings of India
(BPPI).
• As already mentioned above, this business is not a typical franchise business.
However it can be compared with a government backed individually operated
retail business very much like a FOFO model.

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Profit margin and incentives
The profit margin for Jan Aushadhi Store owners is 20 percent of the sale price. In fact the
MRP is decided to accommodate that margin. For Distributorship another 10% is given by
BPPI
• We have been appointed Distributor cum Franchisee, hence have a percentage of
30% at our disposal from the total sales as our margin.
• The Expenses and Payoff in All the Business Models proposed like FOFO, COCO,
FOCO etc. as adopted as per suitability would be approx. 6-8% expenses & 7-8%
take home profit to the Channel Partner i.e approx. 12% to 15% total payoff from
our side. Hence the take home for us would be approx. 12% to 15% on mass
organized operations.

Government (BPPI) financial assistance for opening Jan Aushadhi Store


• The owners of JAS may avail one-time financial assistance of Rs. 2 lakhs as
establishment cost and up to Rs. 50,000 as one time startup cost for purchase of computer
hardware and so on. This is given as reimbursement. Bills of actual purchases and/or
documents for establishment costs have to be furnished to get the reimbursement amount.

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Key Features
 Tender for medicines shall be only through e-tendering. All the tendering process shall be
completely transparent giving equal opportunity to all the participants.
 BPPI may establish warehouses, C&F agents, distributor & franchise agent at different
locations in all the states/UTs.
 On receipt of goods at their warehouse, BPPI shall draw samples and send them to NABL
accredited laboratories for inspection. Only after receipt of equal certifications from the
inspecting laboratories, goods shall be dispatched to C&F agents and distributers.
 BPPI shall plan and undertake suitable media activities to popularize the usage of generic
medicines and to achieve the objectives of the PMBJP.
 Financial support to applicants: State Govt. applicants will provide the space free of charge
in the premises of Medical College Hospitals, District Hospital of at any other suitable
location as may be decided by the state Government for running of Pradhan Mantri
Bhartiya Janaushadhi Pariyojana (PMBJP) Kendra by operating agency.
PMBJP Kendra may also be opened by State Government or Government agencies in any
Government building owned by Government bodies like Railways / State Transport
Department / Urban Local Bodies / Panchayati Raj Institutions / Post Offices / Defence /
PSU's etc. In all the above cases, the financial assistance will be as follows:-
a. Rs 1 Lakh by way of free medicines in the beginning
b. 1 Lakh reimbursement for the furniture and fixtures
c. 0.50 Lakh as reimbursement for computer & peripherals, internet, etc.

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Key Features
For the Pradhan Mantri Pradhan Mantri Bhartiya Janaushadhi Kendras established anywhere else by
private entrepreneurs / pharmacists / NGOs / NGOs & Charitable organizations that are linked with
BPPI headquarters through internet (using BPPI provided software) will get incentive upto 2.5
lakhs. This will be given @15% or monthly sales subject to a ceiling or Z 10,000/ per month upto
total limit of 2.5 lakhs. In NE states, and naxal affected areas, tribal areas, the rate of incentive will
be 15% and subject to monthly ceiling of Z 15,000/- upto to total limit of 2.5 lakhs.
The Applicants belonging to weaker sections like SC/ST/Differently-abled may be provided
medicines worth Z 50,000/- in advance within the incentive of Z 2.5 lakhs which will be provided
in the form of 15% of monthly sales subject to a ceiling of Rs. 10,000/- per month up to a total limit
of Rs. 2.5 lakh.

 20% trade margins shall be included in MRP for retailers and 10% for distributors.
 Pradhan Mantri Bhartiya Janaushadhi Kendras and distributors will be allowed 2% of total sales
or actual loss, whichever is lower, as a compensation against expiry of medicines. Stocks
expiring at the C&F level will entirely be the loss of BPPI.
 Credit facility will be given to all Pradhan Mantri Bhartiya Janaushadhi Kendras for 30 days
against post-dated cheques. Distributors will also get credit of 60 days against post-dated
cheques. C&F agencies will have to deposit a security amount depending upon the business.
 BPPI shall arrange suitable training program for the entrepreneurs who do not have any
experience in running medicine shops.
 Institutions/Charitable Organizations/ NGOs who are procuring medicines for own
consumptions/ free distribution to poor and needy will be allowed to procure medicines from the
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BPPI CFA agents.
In addition to medicines and surgical items supplied by BPPI, Pradhan Mantri Bhartiya
Janaushadhi Kendras will be allowed to sell Gereric medicines not covering in the
product basket of BPPI and also cosmetics and provisions so as to improve the viability
of running the Pradhan Mantri Bhartiya Janaushadhi Kendras.

Worldwide Information OTC


• This year, Evaluate’s World Preview 2017 shows that prescription drug sales are forecast to grow at
an impressive annual compound rate of 6.5%, eventually hitting $1.06trn worldwide in 2022. Much
of this growth is set to come from some of the industry’s hottest therapy areas including new cancer
immunotherapies like Opdivo and Keytruda, as well as much higher-risk assets like Biogen’s
Alzheimer’s project aducanumab.
• Worldwide prescription drug sales forecasted to grow at a robust 6.5% (CAGR) through 2022
to reach $1.06trn
• 32% of the 2022 increase in sales to come from orphan drugs (+$95bn)

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Worldwide Prescription Drug & OTC Sales by Therapy Area in 2022
Oncology still the fastest growing therapy area with a +12.7% CAGR during the 2016-22 period.
Evaluate finds that oncology will remain the most dominant therapy segment in 2022 with an expected annual
growth of 12.7% per year and sales reaching $192.2bn in 2022. Growth in oncology through to 2022 is driven by
Keytruda, Revlimid and Opdivo with contributions from the expected launches of AstraZeneca’s Imfinzi and Incyte’s
epacadostat to compensate for the impact of biosimilars on key brands such as Roche’s Herceptin and Rituxan.
Biosimilars are expected to have a larger impact in the antirheumatics segment which is forecast to grow at a
modest 0.6% CAGR through 2022 despite the sustained growth of Otezla and Xeljanz and the launch of many
promising therapies such as Lilly’s Olumiant, AbbVie’s ABT-494 and Sanofi/Regeneron’s Kevzara. Anti-diabetics is
forecast to be the second biggest therapy area with sales of $57.9bn in 2022, fuelled by the continuous uptake of
Trulicty and the upcoming launch of Novo Nordisk’s semaglutide.
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2022: Top 50 Selling Products in the World
Opdivo knocked off the top spot in 2022 due to setbacks in NSCLC, with Keytruda now hot on its heels; Humira continues to be key
player despite risk of biosimilar launch.
Evaluate consensus forecast finds that sales of Opdivo in 2022 will be significantly lower than previously thought, following phase III
trial setback in first-line NSCLC, consequently boosting prospects for company’s rival, Keytruda which continues to expand its label.
Humira is back at the top, with peak sales forecast in 2019, and an overall CAGR of -1%. Following the recent approvals of highly
anticipated drugs such as Dupixent, Ocrevus and Tecentriq, sellside forecasters do not expect any R&D product to make it to the top 50
in 2022, with the exception of Gilead’s Bictegravir/F/TAF which is currently in phase III and expected to launch in 2018.

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Proposed Business Strategy
A helpline no. would be setup that will provide information
regarding the Generic drugs availability to the caller in the areas of
operations by our SPV. Also information regarding the second
opinion can be provided in case so desired against the payment to be
made to the JAS. There would be different product mix of OTC
products at URBAN, SEMI-URBAN & RURAL JAS.

OUR MAIN FOCUS WOULD BE TO MAKE AVAILABLE QUALITY


MEDICINES & OTC PRODUCTS AT AFFORDABLE RATES WITH EASE
TO THE FINAL CONSUMER MOST PROBABLY BY HOME DELIVERY
ARRANGEMENT.
Another USP would be Brand value addition & increased sales revenue over the
counter of offering genuine AYUSH products (Ayurveda, Unani Sidha &
Homeopathy)

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Our Thoughts
• Another USP can be to train & create awareness about medical emergencies & how to deal
with them within the 5 Km area of the particular JAS-this can be done through the CSR route
or the Local area MP’s/MLA’s, LOCAL AREA DEVELOPMENT FUND, so that more &
more people contact the JAS & when their database is maintained there, it would be
beneficial for the JAS & further the connection made always add upto the goodwill of the
concerned CSR agency/MLA/MP
• Corporate hospitals are paying a salary of *1½ lakh* per month to their doctors.
• But they have monthly targets. the target condition for them to remain in job is that, *they
have to write tests & scans worth *3 lakhs* & *trap 25 patients* for surgery every month.
This is not happening in *Charity Hospitals.* In many hospitals, unwanted surgeries & risky
premature cataract surgeries are being carried out. One has to be fearful of corporate
hospitals. Never show your medical Insurance card or say *"Doctor, don't bother about
expense, please save Me"* *If they terrify u & do not give time to think then, You must be
alert & come out and not join there* If they advise a surgery or a medical procedure,then.
Take time & call at *70266 46022* or send ur medical reports at
*medical@medisense.meor* else visit at *medisensehealth.com* They will get u a 2nd
opinion from an expert doctors panel. It is a free service for patients. This free service for
patients is available in *21 cities in India* which includes *Udupi, Mangalore, Bangalore,
Pune, Mumbai, Chennai, Hyd* etc.

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Our Thoughts
• At Jan Aushadhi you can offer a concept called *Sushruta* where
common man can get all medical support, private trained nurses for
geratric care or ICU at home or nedical equipnents for rent.
• Apply your mind and you can launch a servuce as good as Protea..
Nation wide launch..
• Opportunity to add a new curriculum for advanced nurse training in
skill development as well..
• Sushruta, or Suśruta (Sanskrit: सश्रु तु , lit. "well heard") was an ancient
Indian physician, known as the main author of the treatise The
Compendium of Suśruta (Sanskrit: Suśruta-saṃhitā)
• Elderly care in sweden and skill development certification..
• A model that can be adopted with Govt’s collabaration
• Elderly care in sweden and skill development certification..
• A challenge for our future Confidential© Krafters Logistics
Our Thoughts
• Further JAS can also take the cue from the following Health Care Model being implemented in
SWEDEN:-
• Health and social care for the elderly are important parts of Swedish welfare policy. Of Sweden’s 9.8
million inhabitants, 20 per cent have passed the standard retirement age of 65. This number is projected
to rise to 23 per cent by 2040, partly because of the large number of Swedes born in the 1940s.
• Largely funded by taxes
• Life expectancy in Sweden is among the highest in the world: 79.9 years for men and 83.7 years for
women. In Sweden, 5.2 per cent of the population are aged 80, which is slightly more than the EU
average of 5.1 per cent. Since more and more citizens in this age group are in good health, their care
requirements have declined since the 1980s.
• Most elderly care is funded by municipal taxes and government grants. In 2014, the total cost of elderly
care in Sweden was SEK 109.2 billion (USD 12.7 billion, EUR 11.7 billion), but only 4 per cent of the
cost was financed by patient charges. Healthcare costs paid by the elderly themselves are subsidised and
based on specified rate schedules.
• Public or private
• More municipalities are choosing to privatise parts of their elderly care, letting private care providers
run their operations. In 2013, private care provided services for 24 per cent of all elderly people getting
home help. All recipients can choose whether they want their home help or special housing to be
provided by public or private operators. The municipality always has overall responsibility, however,
for areas such as funding and allocating home help or a place in a special housing facility.
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• The number of private companies in the social service sector increased fivefold between
1995 and 2005. Media investigations have unearthed alarming shortfalls among several
private care companies. In subsequent criticism, the companies were accused of letting profit
have a negative impact on the standard of care.
• Home help makes life easier

• One of the aims of elderly care is to help elderly people and those with disabilities live
normal, independent lives. This includes living in their own homes as long as possible.

• Elderly people who continue to live at home can obtain various kinds of support to make life
easier. For example, almost all municipalities in Sweden offer ready-cooked meals that can
be home-delivered.

• In 2014, home help staff assisted around 221,600 people aged 65 or over. Almost half of the
country’s municipalities also provide communal meals for the elderly at special day centers,
while a few organise small groups of elderly people into teams that cook their own meals.

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• Around the clock
• When an elderly person is no longer able to cope with the demands of everyday life, he or she can
apply for assistance from municipally funded home-help services. The extent of such care is subject to
an assessment of need. Elderly people with disabilities can receive assistance around the clock, which
means that many are able to remain at home throughout their lives. The severely ill, too, can be
provided with health and social care in their own homes.

• Each municipality decides its own rates for elderly care. The cost depends on such factors as the level
or type of help provided and the person’s income. The maximum charge for home help, daytime
activities and certain other kinds of care is SEK 1,772 per month (2016).

• Municipalities offer daytime activities for elderly and disabled people in need of stimulation and
rehabilitation. These activities primarily target those with dementia or mental disabilities. Daytime
activities help many to continue to live in their homes.

• Transportation services
• The elderly and disabled also qualify for transportation services in taxis or specially adapted vehicles.
This option is available to those who are unable to travel by regular public transport. In 2014, 11
million such journeys were completed across the country, a national average of 35 per eligible person.

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Business Volume
Opening JAS across India in the shortest possible time & taking the support of
specially chosen OTC products to boost the footfall of the particular outlet.
Further align other health care products that can give a sustainable revenue to
the particular outlet with customer friendly schemes to create a genuine pull
for the JAS store.
Maintain a database of the customers in the vicinity of the JAS outlet &
provide the products at doorstep thus, giving the customer a solution & reason
to shop from JAS outlet.
Key assumptions:
BPL category approaches Govt. Hospitals for their medical needs. Daily OP
crowd at a PHC public health centre in any district headquarters/taluk
hospitals is more than 2,500 patients
At an average daily patients approaching pharmacy stores for their medical
needs are couple of lacs in any state.

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Key statistics
• Some key statistics published in Times of India survey of year 2014

• The 06 month survey conducted from January to June 2014 was aimed at generating basic
quantitative information on the health sector.

• Though the number of people in need of treatment is lesser in rural India, the untreated spell was
higher in rural areas.

• the survey found that in the urban population 4.4% were hospitalized at some time during a
reference period of one year while this ratio was 3.5% in rural India.
• In rural India, 42% of hospitalized treatment was carried out in public hospitals. In urban
India, the corresponding figure were 32%.
• Since both rural and urban India depended on private hospitals for treatment, their
spending for hospitalization was also higher. The average cost of treatment in a private
hospital was Rs 25,850 as compared to Rs 6,120 charged in a public hospital.

• The highest expenditure was recorded for treatment of cancer (Rs 56,712), followed by that
for cardiovascular diseases (Rs 31,647). Average medical expenditure per non-
hospitalization case was Rs 509 in rural India and Rs 639 in urban India.

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Key statistics
• Rates of DPT (diphtheria, pertussis and tetanus) immunization in India is
72 per cent compared to 82 per cent in Nepal, 96 per cent in Botswana, 96
per cent in Bangladesh and 99 per cent in Sri Lanka.
• According to 2011 calculations by the Organisation for Economic
Cooperation and Development (OECD), India spent around 3.9 per cent on
heath care—lower than any OECD country and much less than the OECD
average of 9.3 per cent.
• World Bank statistics show that we have 0.9 beds per 1,000 of population
(and that's why it is not surprising that in our hospitals so many patients
actually sleep on the floor)
• OECD statics also show that in 2011, India had only 0.7 physicians per
1000 population well below the OECD average of 3.2. There was less than
one nurse per 1,000 population in India in 2010, much lower than the
average of 8.7 in OECD countries. And the number of hospital beds in
India was 0.6 per 1,000 population in 2010, much lower also than the
OECD average of 4.8 beds per 1,000 population.
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Key statistics
• The World Bank calculates that India is one of the countries in the world where
people have to spend maximum from their pocket in private healthcare—as
opposed to government paid healthcare or insurance—and from 2008 to 2011 we
moved from 87.1 per cent privately paid for to 86 per cent. China is at 78.8 per
cent.
• The data journalism initiative, India Spend, calculated in 2012 that rural India has
a shortage of over 12,300 specialist doctors and a shortfall of 9,814 health centres.
• The World Health Organisation (WHO) estimates that at least 3.2 per cent of
Indians are falling below the poverty line each year because they cannot afford
healthcare.
• And what is India losing in the process? In 2000, India lost 9.2 million productive
years due to heart disease alone and is likely to lose 17.9 million years in 2030—
just to get a sense, that's 570 per cent and 900 per cent more than the US.
• The Harvard School of Public Health estimates that economic losses to India due
to non-communicable diseases will be around $6.2 trillion between 2012 and
2030.
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Key Statistics
• According to WHO estimates, India has 21 percent of the ‘disease burden’ of the world
even through it only has 17 percent of the global population. A world Bank report
calculated in 2010 that India was losing up to 6 percent of its GDP in premature deaths
and preventable illness.
• As early as 2007, a PricewaterhouseCoopers and Assocham (The Associated Chambers
of Commerce and Industry in India) report had warned that 53 per cent of all deaths in
India come from chronic disease, as do 44 per cent of disability-adjusted life years. By
2020, such deaths will rise to more than eight million, from four million before 2000.
• Even if you take some slightly higher estimates, India's total expenditure on health is
4.2 per cent of GDP, the current public expenditure is only at about 1.2 per cent of
GDP. With abysmal public health infrastructure and a largely exploitative insurance
system, 70 per cent of healthcare spend is 'out of pocket expenditure' and mostly 'at the
point of service’. This basically means, unlike in civilised parts of the world where you
get treated for illness first and then either the government pays for the treatment or you
can leave it to the insurance company to be settled later, in India most people have to
pay immediately and out of their own pocket. And in most cases, unless they pay
immediately, they get zero treatment. India remains among the five countries with the
lowest public health spending in the world. One more thing happens because of this—it
makes the poor even poorer.
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Key Statistics
• Around 40 per cent of Indians would die of heart diseases by 2020
compared to 24 per cent in 1990, and doctors in our country now say that with
three million people dying of heart diseases each year, we will soon the heart
disease capital of the world.
• We also have around 40 million diabetes patients and are also about to
become-if not already become-the diabetes capital of the world.
• With 15 to 20 million asthma patients and more than 20 per cent of the world’s
tuberculosis patients, we could also be called the lung disease capital of the
world. For instance, in India, one person dies of cancer every 50 seconds.
India has more cases of oral cancer than pretty much anywhere in world and
breast cancer is now the country’s fastest growing disease. The Harvard School
of Public Health calculates that India will lose $20 billion (Rs 1,254,20 crore)
between 2012 and 2030 to breast cancer. India has the highest number of
tuberculosis patients in the world. But even then, 930,000 of them are missed
by the health system and don't get treated. Do you know many people died of
tuberculosis in India in 2012? 270,000.

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Our Suggestions- How Generic
Medicine Business can Grow in India.
• IMPROVE BUSINESS for JAS
• There are Only Two Conditions under Which Customers Will Change Their Behaviour.
• When it’s a Matter of Life & Death (and Then Not In Every Case)
• If They Want to- if They Are Given a Reason to Change
• . Key Players .
• ↓︡ ↓ ↓
• BPPI LOGISTICAL PARTNERS CUSTOMERS

• BPPI has done a lot and is doing BETTER day by day
• Need of the hour- LOGISTICAL Partners together with BPPI evolve ways & methods to further
IMPROVE.
• There are different segments in the society and hence to cater to all those different methods have to
be deployed: Let us go by IDENTIFY→AIM→SHOOT
• Let us start with opening of JAS:
• Our Marketing Officer (MO) should do first identify under what category to classify the particular
application received by BPPI to open a JAS. i.e. what type of product mix is required for what outlet
viz. Maternity, Surgical, General etc.
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Our Suggestions- How BPPI Generic
Medicine Business can Grow in India- continued….
• Once the category has been identified a training to be imparted to the MO and the
applicant on a curriculum designed on the advice of experienced personal in the field to
make them FOCUS accordingly towards the success of that strategic Business Unit
(SBU) as Govt. of India’s considerable funds and efforts are also at stake.
• Necessary inputs/efforts to create “AWARENESS” in the particular are where the JAS is
opened to be taking the assistance of specialized agencies who can provide requisite data
of the families in the vicinity of the JAS.
• JAS to register at least 500 families in the vicinity with an aim to make them
“SATISFIED” prospects through the JAS PRODUCTS and SERVICES.
• Provide home delivery either free or at a monthly minimal operational cost.
• Try to establish a “CONNECT” as soon as possible and upload the whole data in the ERP
effectively managed through backend operations by a member Institution in cooperation
with MO of BPPI.
• Follow up with the customer through Back-End management by the designated ERP
managing Member Institution to create BETTER SATISFACTION of JAS Products and
services. This is very important because “JO DIKHTA HAI VOH BIKTA HAI”.

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Directive from
Medical Council of
India for
prescribing
Generic Drugs-
After Supreme
Court of India
Intervention.

As per the Directions of


the Prime Minister, a
legislation is on the way
shortly to make it an
Please read the last two lines of this Directive offence for the Doctor to
On the orders of Supreme Court prescribe a branded Drug
in Normal Circumstances
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NEW DELHI: In a major step to break the nexus between pharmaceutical companies and doctors pushing expensive branded medicines, PM Narendra Modi on
Monday said that the government would put in place a legal framework to ensure doctors prescribe low cost generic medicines to patients.
"Doctors write prescriptions in such a way that poor people do not understand the handwriting and he has to buy that medicine from private stores at high
prices," Modi said while inaugurating a multi-speciality hospital in Surat. "We will bring in a legal framework by which if a doctor writes a prescription, he has
to write in it that it will be enough for patients to buy generic medicines and he need not buy any other medicines".
Experts say more than 70% of the over Rs 1 lakh crore domestic pharmaceutical market is dominated by branded generics, whereas patented drugs make up 9%.
As with demonetisation+ , the PM sought to underline that he was ready to take on influential interests to push for "pro-poor" causes. "We have done this work,
and you can imagine how angry the manufacturers of medicines will be. Despite the wrath of a very powerful lobby, the government is taking one step after
another so that poor people and middle class get quality health services," Modi said.
The PM outlined a series of measures planned by the health ministry in line to regulate cost of medical care in the country with recent price control or caps on
medical devices being one such initiative. The health ministry has recently issued a draft gazette notification making it mandatory for pharma companies to
carry generic name of drugs on packs that is at least two fonts larger than the brand name. "This clause will be a legal provision as a rule under the exisiting
Drugs and Cosmetics Act and any violation will be punishable under the provisions of the law," a senior health ministry official told TOI. The ministry has
sought public comments on the draft within 45 days, after which it is likely to become part of the drug law. Besides, the ministry has also issued orders to the
Medical Council of India (MCI), state governments and all central government hospitals asking them to ensure that doctors write prescriptions with generic
names of medicines in legible hand writing. The move assumes significance as medicines account for 70-75% of a household's out of pocket expenditure on
health. While generic medicines are good quality low cost drugs with equal efficacy as branded drugs, doctors and chemists often push the more expensive
alternatives. Despite stringent price control, big pharma companies manage to spend exorbitantly on marketing and branding of their drugs. Since advertisement
of prescription medicines are not allowed in India, companies or medical representatives push their products through doctors, chemists and distributors in lieu of
freebies, junkets and incentives. Modi said his government brought in a health policy after 15 years and capped the prices of medicines and stents, which has not
gone down well with some pharmaceutical companies. "In our country doctors are less, hospitals are less and medicines are expensive. If one person falls ill in a
middle class family, then the financial health of the family gets wrecked. He cannot buy a house, cannot conduct the marriage of daughter," Modi said, adding
the government's responsibility is that everybody should get health services at minimal price. In last three years, the government has capped prices of around
700 essential medicines. It has also capped prices of stents and is working to make drugs for critical diseases like cancer and heart disorders available through
various schemes. It has also launched several programmes to make free drugs and diagnostics available under the National Health Mission. Modi assured the
government will continue to take steps in welfare of common man and take steps to make healthcare affordable despite an opposition for the pharma industry.
He said he is committed to providing affordable healthcare for the poor and the middle class. Calling for focus on preventive healthcare, the Prime Minister said
that the Swachh Bharat Abhiyan is linked to efforts towards a healthier India.
Cheap generic vs costly branded:
Issues in picking right drug in India
• Prime Minister Narendra Modi wants doctors to prescribe generic medicines over branded ones.
KAUNAIN SHERIFF M answers key questions on the pricing of drugs and beyond.
• What exactly has Prime Minister Narendra Modi said on generic drugs?
• Speaking in Surat on April 17, the Prime Minister referred to the Pradhan Mantri Bharatiya Janaushadhi
Pariyojana (PMBJP), which aims to provide cheaper medical drugs to the people. “In the coming days, the
government will bring a legal framework under which doctors will have to prescribe generic medicines which
are cheaper than equivalent branded drugs, to patients,” the Prime Minister said. “…If a doctor writes a
prescription, he has to write in it that it will be enough for patients to buy a generic medicine, and he need not
buy any other medicine,” he added.
• Is this a completely new intervention?
• Not exactly. After seeking approval from the central government, the Medical Council of India — which
registers doctors to ensure proper standards of medical practice in the country — had on September 21 last year,
notified an amendment in Clause 1.5 of the Indian Medical Council (Professional Conduct, Etiquette and Ethics)
Regulations, 2002. This clause now reads: “Every physician should prescribe drugs with generic names legibly
and preferably in capital letters and he/she shall ensure that there is a rational prescription and use of drugs”. The
words “legibly and preferably in capital letters” were not there originally.
• Also, the UPA government had from time to time, issued circulars and instructions to government hospitals and
Central Government Health Scheme (CGHS) dispensaries to “prescribe generic medicines” to the “maximum
extent possible”. In December 2012, the UPA government had issued a “statutory direction” to state
governments under sections of the Drugs and Cosmetics Act, 1940 to “grant/renew” licences to manufacture for
“sale or for distribution of drugs in proper/generic names only”. This was intended to build a mechanism for
wider use of generic drugs.
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Cheap generic vs costly branded: Issues in picking right
drug in India Continued…
• Most recently, a countrywide campaign has been under way to ensure availability of generic medicines under
the Pradhan Mantri Bharatiya Janaushadhi Pariyojana. A total 861 PMBJ Kendras are functional in 28 states —
at which 99 private manufacturing companies, certified by the World Health Organisation, have been
empanelled to supply generic drugs, specially manufactured and packed for the PMBJP.
• Okay, but what exactly is the difference between a generic drug and brand- name drug?
• When a company develops a new drug — often after years of research — it applies for a patent, which prohibits
anyone else from making the drug for a fixed period. To recover the cost of research and development,
companies usually price their brand- name drugs on the higher side. Once the patent expires, other
manufacturers duplicate and market their own versions of the drug. Since the manufacture of these generic drugs
do not involve a repeat of the extensive clinical trials to prove their safety and efficacy, it costs less to develop
them. Generic drugs are, therefore, cheaper.
• However, because the compounds in the generic versions have the same molecular structure as the brand-name
version, their quality is essentially the same. The generic drug has the same “active ingredient” as the brand-
name drug. This ingredient is the one that cures the patient; and other, “inert ingredients”, which give the drug
its colour, shape or taste, vary from the brand-name drug to the generics.
• And exactly how much cheaper is a generic than a brand-name drug?
• In the United States, the Food and Drug Administration notes that the cost of a generic drug is 80% to 85%
lower than the brand-name product on average. In India, prices of drugs in the National List of Essential
Medicines (NLEM) included in the First Schedule of the Drugs (Prices Control) Order, 2013, are fixed as per
the provisions of the Order.

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Cheap generic vs costly branded: Issues in picking right
drug in India- Continued…
• These prices are uniformly applicable to all branded and generic medicines containing the “same
molecule/Active Pharmaceutical Ingredient”. All manufacturers of scheduled drugs/formulations have to
comply with the price fixed by the National Pharmaceutical Pricing Authority, from the date of its notification.
• In the case of non-scheduled medicines, i.e., medicines not included in the First Schedule of the DPCO, 2013,
manufacturers are free to fix the launch prices. However, they cannot increase the Maximum Retail
Price(MRP) by more than 10% of the MRP of the preceding 12 months. Currently, in the case of Cetirizine,
one of the most common anti-allergy drugs, the branded drug costs about Rs 35 for a strip of 10 tablets,
whereas the generic drug costs approximately Rs 25.
• How can the government ensure that generics, apart from being cheap, are also safe for the patient?
• Experts say the priority of the government should be to bring a legal framework to ensure “quality” in generic
drug testing. No more than 1% of generic drugs sold in India undergo quality tests. Generic drugs should work
“therapeutically” and the government should ensure “uniform quality”, experts say — only then can doctors
prescribe them with confidence. The number of drug inspectors — approximately 1,500 now — must be
increased, they say.
• Also, the government has to clarify how it will ensure that once a doctor prescribes the generic drug, detailing
its medical composition, the pharmacist or chemist will give the most appropriate drug to the patient. Even on
the question of price, studies have shown that it is the retailer’s margin that often plays the key role in
deciding how much the patient pays for a drug. To take the example of Cetirizine again, while the difference
between the brand-name drug and the generic could be Rs 10 (Rs 35 and Rs 25 respectively), depending on
what the retailer keeps in each case, the actual difference in the price paid by a customer of a brand-name drug
and that of a generic could be, perhaps, only Rs 4 (Rs 27 and Rs 23).

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Modi govt. plan on generic drugs makes
pharma companies, doctors jittery-
• To make health care affordable in the country, the Narendra Modi-led central government is looking to make
it mandatory for doctors to prescribe generic drugs. As reported earlier, the health ministry, in line with
Finance Minister Arun Jaitley’s Union Budget announcement, has started work on amending the Drugs and
Cosmetics Act.
• After the Act has been amended, doctors will not be allowed to mention brand names in their prescriptions.
Instead, they will have to mention the generic name of a drug. The prime minister’s Monday announcement on
this has made the pharmaceutical industry jittery. Generic drugs' share of the market, 80 per cent at present (20
per cent is accounted for by branded and patented drugs), is expected to go up to 90 per cent in the next three
years.
• The managing director of a domestic pharmaceutical company who does not wish to be named says the move
is a serious one and will shift the thrust from quality to price.
• Some industry veterans view this from the angle of marketing ethics. Veeramani, formerly the president of the
Indian Drug Manufacturers' Association (IDMA), says the move will keep a check on doctors and ensure the
medical fraternity doesn’t favour any company. However, he fears the problem will now shift from the
doctor’s desk to the chemist’s. “Now, (since the doctor will mention only the generic name of a drug on the
prescription), the chemist might sell medicines that suit him the best. He might push those that yield him better
profits.” There are over 800,000 chemists in India.
• The pharma industry, meanwhile, does not seem enthused. Industry players believe the idea will complicate
things for doctors and be very difficult to implement. Doctors may face difficulty in prescribing combination
drugs or medicines with multiple ingredients, analysts say.

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Modi govt. plan on generic drugs makes pharma
companies, doctors jittery- continued….
• “We do not think making generic prescriptions mandatory will make drugs cheaper. A drug manufactured
by a top company will still carry a premium to one that is produced by a less-known company. While the
budget does not make it very clear, we believe the amendment might be meant to make generic
prescriptions mandatory. Prima facie, it is a negative step. I think the government might be able to
introduce it in its own hospitals, but how will it be implemented at a country-wide level is difficult to
understand,” D G Shah, secretary-general, Indian Pharmaceutical Alliance, had said after the budget
announcement.

• Dr S S Agarwal, former president, Indian Medical Association, says: “While the idea of only prescribing
generics is good, it is not practical in India. The doctor’s job will now be only to diagnose the ailment.
Using standard procedures of treatment for an ailment, the chemist will start selling drugs.” Agarwal also
highlights that procuring generics is a problem in India, as domestic manufacturing is not robust. He cites
the example Jan Aushadhi Stores where generics are sold at lower prices. “At any time, only 200 of the 600
drugs that the government planned to sell at the Pradhan Mantri Jan Aushadhi Store are available. There
has never been a day when all 600 drugs are there.” The Bureau of Pharma PSUs of India (BPPI) is the
nodal implementation agency for this programme.

• This is not the first time the government has planned such a policy. In 1978, there was a similar attempt
which the pharmaceutical industry had challenged in court.

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Doctors to prescribe generic
drugs only or face action,
says MCI – (PTI)
• The country's apex medical regulator has warned the doctors of action if they fail to adhere to its guideline on
prescribing the drugs only in generic names and writing prescriptions legibly.
• The Medical Council of India (MCI) has also asked the medical practitioners to ensure that there is rational
prescription and use of drugs, failing which "strict disciplinary action" will be taken if they fail to adhere to it
orders.
• The MCI reiterated its 2016 directive, few days after Prime Minister Narendra Modi stressed on putting in
place a legal framework to ensure that the doctors prescribe low cost generic medicines to the patients.
• It has asked the medical community to follow its 2016 notification in which the MCI had amended the clause
1.5 of the Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002 mandating
the doctors to prescribe medicines by generic names in place of brand names.
• Recently, while inaugurating a multi-speciality hospital in Surat, Modi had said that the doctors write
prescriptions in such a way that the poor people do not understand their handwriting and they end up buying
medicines from the private stores at high prices.
• "All the registered medical practitioners under the IMC Act are directed to comply with the aforesaid
provisions of the regulations without fail," said the MCI circular, issued to the Deans, Principals of Medical
Colleges, Directors of all the hospitals, Presidents of all State Medical Councils.
• The government is also revising the National List of Essential Medicines of 2015 to include more medicines.
• The Jan Aushadhi programme, under which the government provides essential medicines at reasonable rates
at specially established shops, is also being reinforced.
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Prescribe generic drugs
without fail: MCI to doctors
• In a circular issued to medical colleges, state medical councils and state governments
on Friday, the MCI has asked the medical community to follow its 2016 notification
• The Medical Council Of India (MCI) has once again told all the practising doctors to
abide by its guidelines to prescribe generic drugs to patients. In a circular issued to
medical colleges, state medical councils and state governments on Friday, the MCI
has asked the medical community to follow its 2016 notification in which it had
amended the clause 1.5 of the Indian Medical Council (Professional Conduct,
Etiquette and Ethics) Regulations.
• The amended section reads: “Use of generic names of drugs: every physician should,
as far as possible, prescribe drugs with generic names and he/she shall ensure that
there is a rational prescription and use of drugs.”
• “All the registered medical practitioners under the IMC Act are directed to comply
with the aforesaid provisions of the regulations without fail,” said the MCI. The
circular comes days after Prime Minister Narendra Modi had expressed concern about
the legibility of prescriptions.

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Govt pharmacy
records
Rs 7-crore sale
in a month

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Jan Aushadhi FAQ’s
1. What is Pradhan Mantri Bhartiya Janaushadhi Pariyojana ?
‘Pradhan Mantri Bhartiya Janaushadhi Pariyojana’ is a campaign launched by the Department of Pharmaceuticals, Govt. Of India, to provide
quality medicines at affordable prices to the masses through special kendra’s known as Pradhan Mantri Bhartiya Jan Aushadhi Kendra. Pradhan
Mantri Bhartiya Jan Aushadhi Kendra (PMBJK) have been set up to provide generic drugs, which are available at lesser prices but are
equivalent in quality and efficacy as expensive branded drugs.
2. What is a Generic Medicine?
Generic medicines are unbranded medicines which are equally safe and having the same efficacy as that of branded medicines in terms of their
therapeutic value. The prices of generic medicines are much cheaper than their branded equivalent.
3. What is BPPI?
BPPI (Bureau of Pharma Public Sector Undertakings of India) has been established under the Department of Pharmaceuticals, Govt. of India,
with the support of all the CPSUs for co-coordinating procurement, supply and marketing of generic drugs through Pradhan Mantri Bhartiya Jan
Aushadhi Kendra (PMBJK).
4. How the quality, safety and efficacy of medicines are ensured?
The quality, safety and efficacy of medicines are ensured by getting each batch of medicines procured from CPSUs as well as private suppliers
tested from NABL approved laboratories and conforming to the required standards before the same are supplied to Super stockists /PMBJK’s
from the Warehouse of BPPI.
5. Are generic drugs as effective as branded ones?
The generic drugs are having the same efficacy and therapeutic value as that of branded medicines.
6. How do generic medicines benefit the patients?
The cost of generic medicines having the same quality as that of branded medicines is much cheaper than their branded equivalent.
7. What are the medicines available from Pradhan Mantri Bhartiya Jan Aushadhi Kednra and what are their prices ?
The endeavour of BPPI is to make available all therapeutic medicines from PMBJK’s. A list of medicines with their MRP which are presently
available are given under the heading “Price List of PMBJP medicines” on website: janaushadhi.gov.in. More medicines are being added to this
list.
8. How many Pradhan Mantri Bhartiya Jan Aushadhi Kendra (PMBJK) have been opened and what are their
locations ?
Approx 3000 Pradhan Mantri Bhartiya Jan Aushadhi Kednra’s are presently functional spread over 28 States/UTs. List of State-wise / District-
wise JAS along with their locations are available under the heading “PMBJK” of the website of Jan Aushadhi.
9. What is timing (opening and closing) of the Pradhan Mantri Bhartiya Jan Aushadhi Kendra ?
The normal working hours of JAS are 8 Am to 8 PM.
10. Who can purchase medicines from Pradhan Mantri Bhartiya Jan Aushadhi Kendra?
OTC products can be purchased by any individual without a prescription. A prescription from a registered medical practitioner is necessary for
purchase of schedule drugs.
11. How the medicines are procured and supplied to Pradhan Mantri Bhartiya Jan Aushadhi Kendra?
Earlier, only medicines manufactured by CPSUs were being supplied to Pradhan Mantri Bhartiya Jan Aushadhi Kendra. Since CPSUs are not
able to make supply of all the medicines proposed to be supplied to PMBJK, procurement of medicines which the CPSUs are not able to
supply are being made from the private manufacturers. These medicines after getting tested from empanelled NABL Laboratories and sent to
PMBJK through Super stockists/CEF agent/Distributors appointed by BPPI.
12. What incentives are available to a Pradhan Mantri Bhartiya Jan Aushadhi Kendra owner ?
An amount of Rs.2.5 lakhs shall be extended to NGOs/agencies/individuals establishing JAK in government hospital premises where space is
provided free of cost by Govt. to operating agency: Rs. 1 lakh reimbursement of furniture and fixtures Rs. 1 lakh by way of free medicines in
the beginning Rs. 0.50 lakh as reimbursement for computer, internet, printer, scanner, etc JAK run by private entrepreneurs / pharmacists /
NGOs / Charitable organizations that are linked with BPPI headquarters through internet shall be extended an incentive up to Rs. 2.5 lakhs.
This will be given @ 15% of monthly sales subject to a ceiling of Rs. 10,000/- per month up to a limit of Rs. 2.5 lakhs. In NE states, i.e. naxal
affected areas and tribal areas, the rate of incentive will be 15% and subject to monthly ceiling of Rs. 15,000 and total limit of Rs. 2.5 lakhs.
For SC/ST and differently abled persons applied in individual category shall be benefited with free medicines worth of Rs. 50,000/- to set up
their Pradhan Mantri Bhartiya Janaushadhi Kendra in the beginning. Remaining amount i.e. Rs. 2.00 lakhs will be given in the form of
incentive, as per above norms.
13. What is the procedure for opening a Pradhan Mantri Bhartiya Jan Aushadhi Kendra?

BPPI writes to all the State Governments with a request to open Pradhan Mantri Bhartiya Jan Aushadhi Kendra in their states. The State
Government, Department of Health would make recommendations in favour of the operating agency who would run the Kendra and also
instruct the District Hospital Authority to provide the minimum space conforming to standards as approved by BPPI in the Hospital premises.
The location of the Kendra should be at such a place which is easily accessible to the OPD patients, preferably at the entry of the hospital &
given to the agency free of cost. The State Government needs to issue suitable instructions to the Hospitals/ Doctors for prescribing generic
medicines. Other entities may approach BPPI either on the basis of advertisement issued by BPPI or suomoto with a complete application
along with the supporting documents mentioned at sl. no 13 above. An agreement is to be entered into between BPPI and the operating agency
before the JAS starts functioning and BPPI makes arrangements for dispatch of medicines.
14. Who can open a Pradhan Mantri Bhartiya Jan Aushadhi Kendra ?
The main objective of the Bureau of Pharma PSUs of India (BPPI) is to open maximum number of Pradhan Mantri Bhartiya Jan
Aushadhi Kendra (PMBJK) in the country. Under the Jan Aushadhi Scheme, the State Governments are required to provide
space in Government Hospital premises or any other suitable locations for the running of the Jan Aushadhi Kendra. PMBJK
may also be opened by any Government agencies in any Government building owned by Government bodies like Railways/
State Transport Department/ Urban Local Bodies/Panchayati Raj Institutions/ Post Offices/ Defense/ PSUs etc. Any NGOs/
Charitable Society/Institution /Self help Group/Individual Entrepreneurs/Pharmacist/Doctor can also open the Jan Aushadhi
Kendra at outside of the hospital premises or any other suitable place. BPPI have simplified the application format so that a
common man can easily fill up the same. Besides above, the application fee of Rs. 2000/- which was charged earlier have been
waived of to make the scheme popular. Financial support to Pradhan Mantri Bhartiya Janaushadhi Kendras: An amount of
Rs.2.5 lakhs shall be extended to NGOs/agencies/individuals establishing JAK in government hospital premises where space is
provided free of cost by Govt. to operating agency: Rs. 1 lakh reimbursement of furniture and fixtures Rs. 1 lakh by way of free
medicines in the beginning Rs. 0.50 lakh as reimbursement for computer, internet, printer, scanner, etc JAK run by private
entrepreneurs / pharmacists / NGOs / Charitable organizations that are linked with BPPI headquarters through internet shall be
extended an incentive up to Rs. 2.5 lakhs. This will be given @ 15% of monthly sales subject to a ceiling of Rs. 10,000/- per
month up to a limit of Rs. 2.5 lakhs. In NE states, i.e. naxal affected areas and tribal areas, the rate of incentive will be 15% and
subject to monthly ceiling of Rs. 15,000 and total limit of Rs. 2.5 lakhs. For SC/ST and differently abled persons applied in
individual category shall be benefited with free medicines worth of Rs. 50,000/- to set up their Pradhan Mantri Bhartiya
Janaushadhi Kendra in the beginning. Remaining amount i.e. Rs. 2.00 lakhs will be given in the form of incentive, as per above
norms. Trade margin to retailers and distributors: Trade margins have been revised from 16% to 20% for Retailers and from 8%
to 10% for Distributors/ Franchisee.
15. What are the requirements for opening a Pradhan Mantri Bhartiya Jan Aushadhi Kendra by
organization/individual other than government nominated ?
(a) Own space or hired space duly supported by proper lease agreement;
(b) Minimum required space conforming to standards as approved by the BPPI i.e. 120 sq. ft.
(c) Sale license from competent authority (Retail drug license in the name of the applicant and/or Tin No.);
(d) Proof of securing a pharmacist with computer knowledge (name of the pharmacist , Registration with the State Council etc. needs to
be furnished ) ;
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i. The present pattern of financial assistance to NGOs/ institutions/ cooperative societies,
identified by the State Government will continue. On receipt of a complete application with
necessary particulars, a one-time assistance of Rs. 2.00 lakh as establishment cost and Rs.
50,000 as a one-time start-up cost would be released from BPPI directly to the NGOs on
completion of required procedures and opening of the JAN AUSHADHI Outlet, in the case
of Govt. Premises & Rs 10,000 (Ten Thousand) per month for 25 months totaling Rs. 2.5
Lacs in the case of JAN AUSHADHI Kendra in Private Premises.
ii. In case of any other entity, such as reputed NGO/ charitable society/ Self Help group and
individuals, preferably a pharmacist/ doctor/ registered medical practitioner, financial
assistance as incentive linked to sale of medicines at the rate of 10% of the monthly sales
amount subject to a ceiling of Rs. 10,000 per month for a period of first 12 months will be
provided. In case of stores being opened in North Eastern States and other difficult areas i.e.
Naxal affected area, tribal areas etc., the rate of incentive would be 15% of monthly sale
amount subject to a ceiling of Rs. 15,000 per month. Before, considering any application for
such assistance, a specific recommendation to this effect from the district level authorities
such as District Collector would be required.
iii. Priority would be given to those NGOs/ individuals, who wish to open stores without
availing any financial assistance under the scheme.

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