1

IN THE HON’BLE HIGH COURT OF DELHI AT NEW DELHI

Writ Petition (CIVIL) No. of 2018

In the matter of:

DR SANJAY KULSHRESTHA,
1/171, DELHI GATE, GULAB RAI MARG,
AGRA 2 (UTTAR PRADESH)
drsankul2008@gmail.com, 9897078456
………….. Petitioners
Versus

Union of India & others ………………… Respondents

NEW DELHI PETITIONER

Dated 25.07.2018

Counsel for the petitioner

Mobile No
 2

INDEX

SI. NO. PARTICULAR PAGE NO.

1. SYNOPSIS & LIST OF DATES ……….

2. Application with Affidavit ……

3. Annexure- 1 ………
Circular from Medical Council of India to principals and directors of all
medical colleges and hospitals

4. Annexure- 2 ……
Report showing commitment of our Hob’ble PM to bring law to ensure
prescription of generic drugs compulsary : Apr 18 2017 : The Times of
India

5. Annexure- 3 ….……
Research on generic drugs: Review and experiences from South India,
J Family Med Prim Care. 2015 Jul-Sep; 319–323. Philip Mathew

6. Annexure- 4 ………..
Generic Drugs: Indian Medical Association Perspective; Dr KK Aggarwal,
IMA National President , May 3, 2017

7. Annexure- 5 …………
Cheap generic vs costly branded: Issues in picking right drug in India
Indianexpress. Apr 20, 2017

8. Annexure- 6 …………
central public sector enterprises, ministry of chemicals and fertilizers
http://pharmaceuticals.gov.in

9. Annexure- 7 …………
India plans to lessen its drug reliance on China, to Tighten Regulatory
Norms For Good Quality Medicine Supply , Oct 08 2017 :
 3

IN THE HON’BLE HIGH COURT OF DELHI AT NEW DELHI

Writ Petition (CIVIL) No. of 2018
In the matter of:
Dr Sanjay Kulshrestha ………….. Petitioners
Versus
Union of India & others ………………… Respondents

DR SANJAY KULSHRESTHA,
1/171, DELHI GATE, GULAB RAI MARG,
AGRA 2 (UTTAR PRADESH)
drsankul2008@gmail.com, 9897078456
………….. Petitioners
Versus

1. UNION OF INDIA
THROUGH SECRETARY
MINISTRY OF HEALTH AND FAMILY WELFARE
NIRMAN BHAWAN, MAULANA AZAD ROAD
NEW DELHI- 110001

2. THROUGH SECRETARY
MINISTRY OF CHEMICALS & FERTILIZERS,
344, A-WING, 3RD FLOOR,
SHASTRI BHAWAN,
NEW DELHI-110001 ………………… RESPONDENTS

NEW DELHI PETITIONER

Dated

Counsel for the petitioner

Mobile No
 4

SYNOPSIS
This is a Public Interest Litigation under Article 21 and 32 of
the constitution of India. The petitioner is a Senior Consultant
Pediatric Surgeon. As a medical professional and as a conscious
citizen of India, he would like to attract your kind attention towards
some facts on serious health risks arising as a result of legislation that
makes it mandatory for all registered medical practitioners in India to
prescribe generic only drugs to all patients under the existing Drugs
and Cosmetics Act and any violation will be punishable under the
provisions of the law. There are some apprehensions or shortcomings
in the present form of generic drugs business that petitioner is sharing
with this honb’le Court.
The concept of generic medicines is good and it would certainly
make the treatment more economical or cheaper. However, this would
be possible only if government take precautions and make necessary
arrangements against loop holes in the generic system of medicines. In
other words unless government ensures that standard of drugs are
maintained at par not only quantitatively [i.e. contains the exact
amount of compound, we would not achieve the very basic goal of this
concept i.e. to provide a cost effective drug of equally good quality.
This may be further risky as now this patient can’t buy other branded
medicine and patient is totally on the mercy of chemist or pharmacists
with fair possibility of substandard drug having more margins by
chemist.
There are basically two groups of drugs i.e. branded and generic:
[a] In branded medicines, companies are free to decide the name and
price of drug that are usually marketed and promoted through the
doctors using organized set up of well-trained medical sales
representatives. Out of branded medicines some are patented when a
company develops a new drug, often after years of research, which
prohibits anyone else from making the drug for a fixed period. Once
the patent expires, other manufacturers duplicate and market their own
 5

versions of the drug either as branded or as generic name. [b] Generic

one is mostly made and marketed by local companies in the
unorganized sector and usually promoted through the trade chemists in
unorganized sector without any Medical Sales Representative and
other Marketing Staff.
We humbly submit some important points in favour of our prayer
“why there is a need for public sector pharmaceutical company to
manufacture some selected commonly used drugs”. Or in other words
what are the risks if generic medicines are made by private companies.
When patient is buying some branded drug it is trust of doctor and
patient in that particular brand. However, if some doctor writes some
generic medicine then it is totally discretion of chemist to choose the
particular company or what he gives to patient. Here we are
straightway transferring legal authority of a doctor to a chemist or
pharmacist who has not even seen the patient, who may not be held
responsible if some complication arises due to substandard drugs that
he provides. Therefore, if generic comes from government, this trust
of doctor in govt company would remain intact and doctor will more
confidently write to patients.
Generic companies can also exploit consumers if not properly
controlled. Since the basic compound is same in generic drug, there is
no logic why the price of one generic medicine should vary from other
generic products with same compound produced by other generic drug
makers. But practically this is not so as there are great variation in
pricing even in generic drugs [like branded ones]. The difference
between procurement prices and retail prices in some of generic
medicines, are as high as 28 times. Distributors and Retailers have a
strong financial incentive to push specific generic drug. Thus like
branded drugs, if we allow many companies to make generic drugs,
there would be an unethical competition among generic makers to
keep maximum selling price more and more to retailer and this will
defeat the purpose of government’s basic aim to provide cheaper rate
of drugs through generic medicine. Such high discounts and price
 6

variations in generic drugs can be stopped if Government insists with

policy to ensure manufacturing these drugs under one drug- one price-
one company policy and that is only possible with government owned
company.
To ensure a good quality of generic drug in India is also a big
issue. A 2014 study has shown that 10.9% of the products tested were
of poor-quality with presence of none or less than required dosage of
active pharmaceutical ingredients. Thereby, causing a huge risk of
major adverse reactions to patients including death and sufferings. For
example due to poor quality of drugs or contaminated drugs was one
of the major reasons for number of deaths that had occurred in the
sterilization camp in Chhattisgarh due to sub-standard generic drugs
used during the operative course. The quality assurance mechanism in
our country is very weak. India has more than 67,000 drug
formulations, the quality assurance mechanism in our country can
ascertain the quality control of only 15753 drugs annually (Combined
testing capacity of all the Central Drugs Testing Laboratories). That
means to the maximum only 25% drug formula can be checked in a
year in India by government machinery. So if there is one generic
brand that too by government itself, this would not only make it easy
for government to keep a quality check but also discourage or reduce
the mushrooming of new substandard generic drug companies.
Many Central Public Sector pharma companies are already doing
an excellent job in drug manufacturing like Karnataka Antibiotics &
Pharmaceuticals Limited (KAPL), Rajasthan Drugs and
Pharmaceuticals Limited (RDPL), Hindustan Antibiotics Ltd. (HAL),
Indian Drugs & Pharmaceuticals Limited (IDPL).These all have been
continuously generating profits for the last many years. Therefore our
government owned or public sector pharma companies are quite
dependable and capable to produce cost effective good quality drugs
in sufficient quantity in India. Another important reason to promote
production by our public sector pharma companies is that currently,
India gets 70-80% of its medicines including raw material for
 7

pharmaceuticals (Active Pharmaceutical Ingredient) from China. This

is not only affecting the growth of pharma sector [having more than 1
lakh crores in India] but more importantly, India’s relations with china
are very strained, therefore, it poses a major risk of severe drug
shortage if India's diplomatic relations with China worsen or china
suddenly stops these life saving items!
Common people do not know much about pricing of pharma
industry. They may know well about their daily needs items of grocery
or eatables and can decide easily about quality and pricing of daily
needs items but they can’t decide about the drugs and for that they are
totally dependent on faith of doctors and doctors in turns depend on
the reputation of company or purity of drugs.Even majority of our day
to day commodities or gadgets carry ISI mark by Bureau of Indian
Standards (BIS) before they come into the market. Similarly there is a
statutory body in medical profession like MCI to regulate and
prescribe minimum standards in medical education and the yardstick
of ethics so that we can maintain some minimum standards in teaching
and treatment in medical colleges and hospitals in India. Then why not
to maintain standards of generic medicines also. Drugs make an
integral part of treatment and any spurious drug may cause serious
complications but despite that no batch of generic drugs available in
the market carries the seal of quality. Thus the most appropriate way
to ensure quality is to allow only one chemical compound [drug], one
company, one price through Public Sector Company.
Audit of top or most commonly used drugs is necessary for
ensuring genuineness of MRP of generic as well as branded drugs.
Like fixing the rate of crop every year, government should fix up the
rate of generic medicines. Except the company that has invented drug
by R & D, no other company should be allowed to add a
disproportionate price to a medicine. Since, the difference between
procurement prices and retail prices in case of some of the generic
medicines, were very high, which shows a very high margin of profit-
taking in view of limited price control mechanisms, it is in this light,
 8

that the government need to intervene in generic medicine business by

conducting an audit for some costly frequently used medicines.
There is no doubt that The intention of our government in
making rule for these generic drugs mandatory is extremely good and
that is purely in the interest of consumers/patients. However, while
doing this it is also the duty of government to ensure it that the patient
gets correct drug with quality that is at par with presently available
some of the branded ones. Therefore if we have only one manufacturer
company for generic drug under government, that would be the best
way to achieve the real goal of government to provide medicines to
public at a cheaper rate without compromising the quality or trust of
doctor/patient and at the same time it will boost the economy of
country by creating more jobs in government sector.
Petitioner humbly prays this hon’ble court, after considering
above facts, kindly intervene in this matter and take an appropriate
action in prayer made in this petition.
 9

LIST OF DATES
. . . . . Jul-Sep; 2015 : Publication in Journal of Family Med Prim Care
reporting the difference between procurement prices and retail prices
in case of some of the generic medicines, were as high as 28 times,
which shows a very high margin of profit-taking in view of limited
price control mechanisms [ Annexure 4, page ]

. . . . . 18th April, 2017: Report to bring law to ensure docs prescribe

generic drugs by Prime Minister to break doctors-pharma Companies
nexus [Annexure 2, page ]

………….. Apr 20, 2017:another report on quality control say that

some experts believe no more than 1% of generic drugs sold in India
undergo quality tests [annexure 6, page ].

. . . . 24th April, 2017: Circular from Medical Council of India to

principals and directors of all medical colleges and hospitals showing
legislation that will make it mandatory for the registered medical
practitioners to prescribe generic only drugs to all patients [annexure
1, ].

. . . . . 3rd May, 2017: report of Indian Medical Association showing

a study has shown that 10.9% of the products tested were of poor-
quality with presence of none or less than the required dosage of
active pharmaceutical ingredients [2014]. Of this 10.9 percent, 7
percent contained less than the required dosage of active ingredients,
while 3.9 percent were drugs without any of the necessary active
ingredients [annexure 5, page ].

. . . . . 3rd May, 2017: report also show that the quality assurance
mechanism in our country is very weak. India has more than 67,000
drug formulations, the quality assurance mechanism in our country
can ascertain the quality control of only 15753 [25%] drugs annually
 10

i.e. Combined testing capacity of all the Central Drugs Testing

Laboratories [annexure5, page ].

. . . . . on 8th sept, 2017 to petitioner communicated to Shri Ananth

Kumar, Hon’ble Minister of Chemicals & Fertilizers and Sh.
Sudhansh Pant, Jt Secretary (Pharma Policy, Pricing, Norms, IC
including PMBJP) through letter sharing all such concerns and
requested to take necessary actions in this regards, however, he did not
get any response from these authorities.

. . . . . Oct. 08, 2017 : The Times of India reports that Currently , India
gets 70-80% of its medicines and medical devices supplies, including
raw material for pharmaceuticals (Active Pharmaceutical Ingredient)
from China. This poses a major risk of severe drug shortage if India's
diplomatic relations with China worsens.

06.07.18 . . . . . .hence this writ petition

 11

IN THE HON’BLE HIGH COURT OF DELHI AT NEW DELHI

Writ Petition (CIVIL) No. of 2017

In the matter of:

DR SANJAY KULSHRESTHA,
1/171, DELHI GATE, GULAB RAI MARG, AGRA 2 (UP),
drsankul2008@gmail.com, 9897078456
………….. Petitioners
Versus
Union of India & others ………………… Respondents

1. UNION OF INDIA
THROUGH SECRETARY
MINISTRY OF HEALTH AND FAMILY WELFARE
NIRMAN BHAWAN, MAULANA AZAD ROAD
NEW DELHI- 110001

2. THROUGH SECRETARY
MINISTRY OF CHEMICALS & FERTILIZERS,
344, A-WING, 3RD FLOOR,
SHASTRI BHAWAN,
NEW DELHI-110001
………………… RESPONDENTS
 12

TO,
THE HON'BLE CHIEF JUSTICEAND HIS COMPANION
JUSTICESHON'BLE HIGH COURT OF DELHI

THE HUMBLE PETITION OF THE PETITIONER ABOVE-NAMED

MOST RESPECTFULLY SHOWETH:

1. That this is a Public Interest Litigation under Article 21 and 32of

the constitution of India. The petitioner is a Senior Consultant
Pediatric Surgeon. As a medical professional and as a conscious
citizen of India, he would like to attract your kind attention
towards some alarming facts on serious health risks arising as a
result of legislation that will make it mandatory for the registered
medical practitioners to prescribe generic only drugs to all
patients. This clause will be a legal provision as a rule under the
existing Drugs and Cosmetics Act and any violation will be
punishable under the provisions of the law [annexure 1 & 2,
page ]. There are some apprehensions or shortcomings in the
present form of generic drugs business that petitioner is sharing
with this honourable court.

2. No doubt, the concept of generic medicine is very good and it

would certainly make the treatment more economical or cheaper.
Since medicines account for 70-75% of a household's out of
pocket expenditure on health[ Annexure 2 , page ], and
multiple studies have proven that saving through substitution of
originator brands by cheaper generic medicines, savings in the
range of 10-90% can be achieved. Most national governments
have been encouraging the use of generic medicines worldwide
and many healthcare systems have policies of substituting
expensive branded original medications with generic medicines.
 13

3. However, this would be possible only if government take

precautions and make necessary arrangements against loop holes
in the generic system of medicines. In other words unless
government ensures that standard of drugs are maintained at par
not only quantitatively [i.e. contains the exact amount of
compound] but also qualitatively [i.e. purity of compound with
no mixture of other]. If we fail to do so, we would not achieve
the very basic goal of this concept i.e. to provide a cost effective
drug of equally good quality. In fact this may be further risky as
now this patient can’t buy other branded medicine and patient is
totally on the mercy of chemist or pharmacists with fair
possibility of substandard drug by chemist having more margin.

4. on 8th sept, 2017 to petitioner communicated to Shri Ananth

Kumar, Hon’ble Minister of Chemicals & Fertilizers and Sh.
Sudhansh Pant, Joint Secretary (Pharma Policy, Pricing, Norms,
IC including PMBJP) through letter sharing all such concerns and
requested to take necessary actions in this regards, hwever, he did
not get any response from these authorities

5. To understand the whole issue, we first need to understand

various terms used for medicines:
a) In branded medicines, companies are free to decide the name and
price of drug and are usually marketed and promoted through the
doctors, using organized set up of well-trained medical sales
representatives. Out of branded medicines some are patented
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
 14

drug either as separate branded or as generic name. 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% [annexure 2, page ].
b) Generic one is mostly made and marketed by local companies in
the unorganized sector and usually promoted through the trade
chemists in the unorganized sector without any Medical Sales
Representative and other Marketing Staff, no R&D set up. 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.
Though the compound in both branded and generic drug is the
same therefore the quality in both must be the same, however, the
quality is questionable because there is lack of current Good
Manufacturing Practices (cGMP) assurance in manufacturing
plants in generic ones.

6. We humbly submit following important points in favour of our

prayer why there is a need for public sector pharmaceutical
company to manufacture some selected commonly used drugs.
Or in other words what are the risks if generic medicines are
made by private companies. Just shifting the onus on to the
doctors alone will not help the purpose. The root cause of the
problem has to be analyzed and solved by a multi-pronged
approach.

7. TRUST AND RESPONSIBILITY: when patient is buying

some branded drug it is the trust of doctor and patient in that
particular brand. However, if some doctor write some generic
medicine then it is totally discretion of chemist to choose the
particular company or what he gives to patient. Here we are
straightway transferring legal authority of a doctor to a chemist
or pharmacist who has not even seen the patient, who may not be
 15

held responsible if some complication arises due to substandard

drugs that he provides. Therefore, if generic comes from
government, this trust of doctor in government company would
remain intact and doctor will more confidently write to patients.
Many studies have revealed apprehensions among physicians in
prescribing UB medicines to their patients. Most of these
apprehensions are related to quality of the product and the fear of
losing patients. Therefore if government is making generic then
this fear would go away.

8. Generic companies can exploit consumers if not properly

controlled. Since the basic compound is same in generic drug,
there is no logic why the price of one generic medicine should
vary from other generic products with same compound produced
by other generic drug makers. But practically this is not so as
there are great variation in pricing even in generic drugs [like
branded ones].
Procurement price of essential medicines is generally
lower but the difference between procurement prices and retail
prices in case of some of the generic medicines, are as high as 28
times, which shows a very high margin of profit-taking in view
of limited price control mechanisms [annexure 3, page ]. Due
to complexity of the market and the intensity of the competition
between companies to lure retailers they try to increase more and
more margins of profit and this is possible only by increasing the
maximum selling price. We are not against profit as some profit
margin is essential to maintain cost effectiveness of drugs and
manpower to manufacture and distribute drug but a
disproportionate very high price with the same compound is not
acceptable at least in generic drug. Since large number of
companies is in generic business, it would not be possible to
examine or check co. and that is possible when government itself
 16

enters in this business. It is in this light, that the government

needs to intervene in generic medicine business.

9. 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,
depending on what the retailer keeps in each case and retail
margins sometimes more than 1,000% of the manufacturer's price
i.e. ten times. Distributors and Retailers have a strong financial
incentive to push specific generic drug. Thus like branded drugs,
if we allow many companies to make generic drugs, there would
be an unethical competition among generic makers to keep
maximum selling price more and more to retailer and this will
defeat the purpose of government’s basic aim to provide cheaper
rate of drugs through generic medicine.
Eventually what is appearing to be economical or
affordable potentially may not a quality product and its cost will
be far higher. Such high discounts and price variations in generic
drugs can be stopped if Government insists with policy to ensure
manufacturing drugs under one drug- one price- one company
policy and that is only possible with government owned
company.

10.To ensure a good quality of generic drug in India is also a big

issue. A 2014 study has shown that 10.9% of the products tested
were of poor-quality with presence of none or less than the
required dosage of active pharmaceutical ingredients. Of this
10.9 percent, 7 percent contained less than the required dosage of
active ingredients, while 3.9 percent were drugs without any of
the necessary active ingredients [annexure 4, page ]. This
poses a huge risk of major adverse events including death and
sufferings to patients/consumers. For example due to poor quality
of drugs or contaminated drugs in one of the major reasons for
number of deaths that had occurred in the sterilization camp in
 17

Chhattisgarh was due to generic drugs used. The verdict of the

Chhattisgarh High Court in this issue has gone in favor of the
doctor and the deaths had been found due to sub-standard generic
drugs used during the operative course.

11.The quality assurance mechanism in our country is very weak.

India has more than 67,000 drug formulations, the quality
assurance mechanism in our country can ascertain the quality
control of only 15753 drugs annually (Combined testing capacity
of all the Central Drugs Testing Laboratories) [annexure 4, page
]. That means to the maximum only 25% drug formula can be
checked in a year in India by government machinery. While some
experts believe no more than 1% of generic drugs sold in India
undergo quality tests [annexure 5, page ]. Generic drugs
should work “therapeutically” and the government should ensure
“uniform quality”, experts say ; only then can doctors prescribe
them with confidence.
So if there is one generic brand that too by government
itself, this would not only make is easy for government to keep a
quality check but also discourage or reduce the mushrooming of
new substandard generic drug companies. In India, where
substantial population of generic manufacturer operate in the
unorganized sector, quality of the final product may not be
assured and the law enforcement on quality of drugs needs
substantial improvement, mere ordering the doctors to write
generic drugs without a brand name is not in the interest of the
society.

12.This concept of one generic drug by one company by public

sector will not affect the business model of branded pharma
companies in India. Doctors and patient will still have choice if
they need branded drugs. On the other hand if we allow many
companies to make a particular generic drug then there are fair
 18

chances that retailer can cheat patients. The reason being the
name on pack would be the same in all 100 generic companies
while in branded the name of every company is different for the
same compound, therefore retailer is bound to give that particular
product while in generic medicine, retailer will supply only that
generic one having maximum margin.
If large number of companies are allowed for generic drugs
then what would be the difference between generic company and
a branded company that procure same drug. Why not to have
only one company if chemical compound is same and that is
govt. Why to allow 100 co to produce same thing with same
name on the pack with so many variation in pricing just by
imparting some new color, packaging. If quantity and quality of
compound is same then on what ground these companies can
raise the price? If pricing is variable in generic also, then what is
the difference between branded and generic medicines. In that
case to select drug from branded category is easier but difficult to
select amongst 100 generic as all would have the same name!

13. Many Central Public Sector pharma companies are

already doing an excellent job in drug manufacturing like: [a]
Karnataka Antibiotics & Pharmaceuticals Limited (KAPL) is a
profit making Central Company. It has been continuously
generating profits for the last 13 years and the performance of the
company has improved over the years [annexure 6, page ].
[b]. Rajasthan Drugs and Pharmaceuticals Limited (RDPL) is a
consistently profit making Central Public Sector Unit where
Government of India (GoI) and Rajasthan State Industrial
Development & Investment Corporation Limited (RIICO) hold
51% and 49% respectively. [c]. Hindustan Antibiotics Ltd.
(HAL), Pune produces a wide range of Pharmaceutical
formulations. [d]. INDIAN DRUGS & PHARMACEUTICALS
LIMITED (IDPL), IDPL played a major role in the strategic
 19

National Health Programmes like Family Welfare Programme&

Populations Control (Mala-D & Mala –N) anti-malarials
(Chloroquine) and prevention of dehydration (ORS) by providing
quality medicines. During sudden outbreak of Plague in 1994,
IDPL was the only company which played a pivotal role in
supplying Tetracycline to the affected areas. Similarly, company
had made uninterrupted supply of Chloroquine to combat Malaria
epidemic in different parts of the country. Therefore our
government owned or public sector pharma companies are quite
dependable and capable to produce cost effective good quality
drugs in sufficient quantity in India.
Another important reason to promote production by our
public sector pharma companies is that currently, India gets 70-
80% of its medicines including raw material for pharmaceuticals
(Active Pharmaceutical Ingredient) from China. This is not only
affecting the growth of pharma sector [having more than 1 lakh
crore in India] but more importantly, India’s relations with china
are strained, therefore, it poses a major risk of severe drug
shortage if India's diplomatic relations with China worsen or
china suddenly stops life saving items! [Annexure 7, page ]

14.Common people do not know much about business module of

pharma industry. They may know well about their daily needs
items of grocery or eatables and can decide easily about quality
and pricing of daily needs items but can’t decide about the drugs
and for that they are totally dependent on faith of doctor they
consult and purity of drugs they consumes for their treatment!

15.Even majority of our day to day commodities or gadgets carry ISI

mark before they come into the market. ISI mark is nothing but a
certification mark for industrial products in Indiaas developed by
the Bureau of Indian Standards (BIS). Similarly there is a
statutory body in medical profession like MCI is to regulate and
 20

prescribe minimum standards in medical education and the

yardstick of ethics so that we can maintain some minimum
standards in teaching and treatment in medical colleges and
hospitals in India. Thus why not to maintain standards of generic
medicines, especially if we are going to make it compulsory for
every doctor. Drugs make a integral part of treatment besides a
quality consultation but no batch of drugs available in the market
carries the seal of quality. Because of problems in Government’s
control system in licensing, inspection, cGMP compliance,
quality assurance mechanism in drug manufacturing is not very
good [as discussed in para 10], the most appropriate way to
ensure quality is to allow only one chemical drug, one company,
one price i.e. by public sector company.

16.A regular audit of most commonly used drugs is necessary for

fixing up the rate. Like fixing the rate of crop every year, govt
should fix up the rate of generic medicines. The policy makers in
the country needs to get a realization that the share of drugs in
out-of-pocket expenditure (OPP) is around 80% in India and a
tighter regulatory framework is needed to protect the consumers
against exploitation. Except the company that has invented drug
by r&d, no other company should be allowed to add a
disproportionate price to a medicine. Since, the difference
between procurement prices and retail prices in case of some of
the generic medicines are very high, which shows a very high
margin of profit-taking in view of limited price control
mechanisms. It is in this light, that the government needs to
intervene in generic medicine business by conducting a n audit
for some costly frequently used medicines.

17.Production by public sector Co. will also boost up the economy

of our country by creating employment in organized sector and
increasing the direct revenue of government. For example 20-30
 21

years ago most of the vaccines were used to be prepared in public

sector companies but due to poor control and wrong policies of
government, most of the vaccines business has been captured by
private companies.

18.There is no doubt that The intention of government for making

rule for writing these generic drugs mandatory is extremely good
and that is purely in the interest of consumers/patients. However,
while doing this it is also the duty of government to ensure it that
the patient gets correct drug with quality that is at par with
presently available some of the branded ones.
Therefore, if we have only one manufacturer company for
generic drug under government, that would be the best way to
achieve the real goal of government to provide medicines to
public at a cheaper rate without compromising the quality,
without affecting trust of doctor or public and without the need to
huge manpower to promote drug to doctors through medical
representatives, etc.

PRAYER
Therefore, this is most respectfully prayed that in order to
maintain the quality of generic drugs and to make them more cost
effective, this Hon’ble Court may kindly be pleased to pass:
[a] A writ of Mandamus under Article 32 of the Constitution of India
directing the government to implement ‘one generic drug with one
company ’ regulations.
[b] to pass an order not to allow same pharma company to manufacture
both generic as well as branded drugs. In other words one pharma
company should be allowed to manufacture only one kind of drug i.e.
either branded or generic.
[c] Pass directions to government to take over production of some
selected or commonly used generic medicines in India through existing
public sector drug manufacturing companies.
 22

[d] Pass an order to authority to conduct a regular audit for selected

commonly used drugs to check the genuineness of highly inflated prices
of branded medicines in the name of manufacturing, marketing,
research and development etc.
[e] PASS such other order or orders as this Hon'ble Court may deem fit
and proper in the facts and circumstances of the present case;

DR SANJAY KULSHRESTHA,
NEW DELHI PETITIONER
Dated 20.07.2018

COUNSEL FOR THE PETITIONER

 23

IN THE HON’BLE HIGH COURT OF DELHI AT NEW DELHI

Writ Petition (CIVIL) No. of 2017
In the matter of:

DrSanjay Kulshrestha& another ………….. Petitioners

Versus
Union of India & others ………………… Respondents
I, Dr Sanjay Kulshrestha, Son of Late Shri S S Kulshrestha, aged 57
years, R/o 1/171, Delhi Gate, Gulab Rai Marg, Agra-2., today present
in Delhi do hereby solemnly affirm and declare as under:
1. That I am the petitioner in the above case and as such I am fully
conversant with the facts and circumstances of the instant case.
2. That the contents of para 1 to 18 accompanying Petition have been
read over and explained to me which have been drafted under my
instructions and upon legal advice received and I say that the contents
of the same are true and correct based upon my knowledge and upon
information derived from the available records.
3. That the annexure filed with the writ are true and correct copies of
their respective originals.

Deponent

Verification:
Verified at New Delhi on this 20 day of July, 2018 that the contents of
paras (1) to (18) of the above Affidavit are true and correct. Nothing
material has been concealed there from, nor any part of it is false.

Deponent