Production Planning for

Pharmaceutical Company

Group 3, LBSIM

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Submitted by Group 3
Abhilash Endigeri (127)
Madhurkant Gaur (128)
Rachit Taneja (130)
Pragun Kanungo (150)
Aatish Mathur (152)
Akshay Kumar (157)
Mohit Gupta (183/2013)

Contents

Introduction

Production Planning
4

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GlaxoSmithKline plc (GSK) An Overview

About Crocin
9

Production Planning (Crocin Advance 500mg Tablets)

10

Manufacturing Process (Batch size: 1 Million Tablets)

12

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1. Introduction

The Indian pharmaceuticals market is third largest in terms of volume and thirteen largest in terms of
value, as per a pharmaceuticals sector analysis report by equity master. The market is dominated majorly
by branded generics which constitute nearly 70 to 80 per cent of the market. Considered to be a highly
fragmented industry,consolidation has increasingly become an important feature of the Indian
pharmaceutical market.

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India has achieved an eminent global position in pharma sector. The country also has a huge pool of
scientists and engineers who have the potential to take the industry to a very high level.
The UN-backed Medicines Patents Pool has signed six sub-licenses with Aurobindo, Cipla, Desano,
Emcure, Hetero Labs and Laurus Labs, allowing them to make generic anti-AIDS medicine
TenofovirAlafenamide (TAF) for 112 developing countries.

The Indian Pharmaceutical market (IPM) is highly fragmented with about 24,000 players (330 in the
organized sector). The top ten companies make up for more than a third of the market. The market is
dominated majorly by branded generics which constitutes of nearly 70% to 80% of market.
The IPM is valued at Rs 750 bn for the year ending March 2014.The growth in 2014 was subdued at 6%
YoYvs 12% in 2013. The growth was impacted as the drug price control order (DPCO) issued notice to
bring 348 drugs under price control. Despite this, the Indian pharma market remains one of the fastest
growing pharma markets in the world. Currently the IPM is third largest in terms of volume and thirteen
largest in terms of value.
Besides the domestic market, Indian pharma companies also have a large chunk of their revenues coming
from exports. While some are focusing on the generics market in the US, Europe and semi-regulated
markets, others are focusing on custom manufacturing for innovator companies. Biopharmaceuticals is
also increasingly becoming an area of interest given the complexity in manufacture and limited
competition.
Introduction of GDUFA (Generic drug User Fee Act) in the US during July 2012 too had a negative
impact on pharma companies. As per this Act, the generic companies are required to pay user fees to
USFDA, for application of drugs and manufacturing facilities. This fee will be utilized by USFDA to
engage additional resources in order to speed up the approval process. While the drug filling fees was
applicable since some time, from Oct 2014 even plant inspection fees have come into effect.
As the patent cliff is approaching, Indian pharma companies have increased their R&D expenses. The
companies are spending more to establish niche product portfolios for the future.

Consolidation has increasingly become an important feature of IPM. The recent deals viz; Sun pharma
acquiring Ranbaxy, Wyeth and Pfizer merger, Strides selling its injectable arm and so on are the classic
cases

The Indian Patents Act 1970

This legislation implemented in 1972 made pharmaceutical product innovations, as well as those for food
and agrochemicals, unpatentable in India thus greatly weakening IPR protection. It allowed innovations
patented elsewhere to be freely copied and marketed in India. Therefore foreign firms did not find
patenting in India worthwhile. This act further restricted import of finished formulations, imposed high
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tariff rates and introduced strict price control regulation with the 1970 Drugs Price Control Order. This
gave a boost to the Indian pharmaceutical industry.
TRIPs, the intellectual property component of the Uruguay round of the GATT Treaty, have given rise to
an acrimonious debate between the developed countries and less developed countries (LDCs). Business
interests in the developed world claimed large losses from the imitation and use of their innovations in
LDCs. They also asserted that IPRs would benefit the developing countries by encouraging foreign
investment, by enabling transfer of technology and greater domestic research and development (R&D).
On the other side, LDC governments were worried about the higher prices that stronger IPRs would entail
and about the harm that their introduction might cause to infant high tech industries. India was very
actively involved in opposing the TRIPs component of the GATT agreement, especially the proposal for
product patents on pharmaceutical innovations. Indira Gandhi succinctly summed up the national
sentiment at the World Health Assembly in 1982: "The idea of a better-ordered world is one in which
medical discoveries will be free of patents and there will be no profiteering from life and death." Now that
India has signed the treaty, though most unwillingly, it is committed to introducing pharmaceutical
product patents 2004, a value analysis i.e. cost-benefit analysis of this move is essential for India.

2. Production Planning
There are four stages, steps, techniques or essentials in the process of production
planning and control
The four stages or steps in production planning and control are:
1.

Routing,

2.

Scheduling,

3.

Dispatching, and

4.

Follow-up.

Initial two steps i.e. Routing and Scheduling, relate to production planning. Last two
steps i.e. Dispatching and Follow-up, relate to production control. Now let's continue
our discussion further to understand each step in detail.

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1.

Routing

Routing is the first step in production planning and control.

Routing can be defined as the process of deciding the path (route) of work and the
sequence of operations.
Routing fixes in advance:

The
The
The
The

quantity and quality of the product.

men, machines, materials, etc. to be used.
type, number and sequence of manufacturing operations, and
place of production

In short, routing determines What, How much, with which, How and Where to
produce.
Routing may be either very simple or complex. This depends upon the nature of
production. In a continuous production, it is automatic, i.e. it is very simple.
However, in a job order, it is very complex.
Routing is affected by the human factor. Therefore, it should recognize human
needs, desires and expectations. It is also affected by plant-layout, characteristics of
the equipment, etc.

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The main objective of routing is to determine (fix) the best and cheapest sequence
of operations and to ensure that this sequence is followed in the factory.
Routing gives a very systematic method of converting raw-materials into finished
goods. It leads to smooth and efficient work. It leads to optimum utilization of
resources; namely, men, machines, materials, etc. It leads to division of labour. It
ensures a continuous flow of materials without any backtracking. It saves time and
space. It makes the work easy for the production engineers and foremen. It has a
great influence on design of factory's building and installed machines.
So, routing is an important step in production planning and control. Production
planning starts with it

2.

Scheduling

Scheduling is the second step in production planning and control. It comes after
routing.
Scheduling means to:

Fix the amount of work to do.

Arrange the different manufacturing operations in order of priority.
Fix the starting and completing, date and time, for each operation.

Scheduling is also done for materials, parts, machines, etc. So, it is like a time-table
of production. It is similar to the time-table, prepared by the railways.
Time element is given special importance in scheduling. There are different types of
schedules; namely, Master schedule, Operation schedule and Daily schedule.
Scheduling helps manufacturers to make optimum use of time. It sees that each
piece of work is started and completed at a certain predetermined time. It helps to
complete the job systematically and in time. It brings time coordination in
production planning. All this helps to deliver the goods to the customers in time. It
also eliminates the idle capacity. It keeps labour continuously employed.
So, scheduling is an important step in production planning and control. It is essential
in a factory, where many products are produced at the same time
3.

Dispatching

Dispatching is the third step in production planning and control. It is the action,
doing or implementation stage. It comes after routing and scheduling.

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Dispatching, generally means starting the process of production. It provides the

necessary authority to start the work. It is based on route-sheets and schedule
sheets.
Dispatching includes the following:

Issue of materials, tools, fixtures, etc., which are necessary for actual
production.
Issue of orders, instructions, drawings, etc. for starting the work.
Maintaining proper records of the starting and completing each job on time.
Moving the work from one process to another as per the schedule.
Starting the control procedure.
Recording the idle time of machines.

Dispatching may be either centralized or decentralized:

1.
Under centralized dispatching, orders are issued directly by a centralized
authority.
2.
Under decentralized dispatching, orders are issued by the concerned
department.

4.

Follow-up

Follow-up or expediting is the last step in production planning and control. It is a

controlling device. It is concerned with evaluation of the results.
Follow-up finds out and removes the defects, delays, limitations, bottlenecks,
loopholes, etc. in the production process. It measures the actual performance and
compares it to the expected performance. It maintains proper records of work,
delays and bottlenecks. Such records are used in future to control production.
Follow-up is performed by Expediters or Stock Chasers.
Follow-up is necessary when production decreases even when there is proper
routing and scheduling. Production may be disturbed due to break-downs of
machinery, failure of power, shortage of materials, strikes, absenteeism, etc. Followup removes these difficulties and allows a smooth production.

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3. GlaxoSmithKline plc (GSK) An Overview
GlaxoSmithKline plc. (GSK), incorporated on December 6, 1999, is a healthcare company that researches
and develops pharmaceuticals, vaccines and consumer healthcare products. The Company operates in two
segments: Pharmaceuticals and Vaccines, and Consumer Healthcare. Its brands include Sensodyne,
Panadol, Horlicks, Polident, Paradontax, Tums, ENO, NiQuitin/Nicorette, Abreva, Zovirax and
Aquafresh. The Company has its presence in over 150 markets, a network of 84 manufacturing sites in 36
countries and research and development (R&D) centers in the United Kingdom, the United States,
Belgium and China. The Company owns the biological conjugation platform.

Pharmaceuticals and Vaccines

The Company's Pharmaceuticals segment develops and makes medicines to treat a range of acute and
chronic diseases. The Company engages in delivering products for respiratory disease and portfolio of
mature products, such as Seretide/Advair, Ventolin and Flovent. It also includes Relvar/Breo Ellipta,
which is an inhaled corticosteroid (ICS) and long-acting beta2 agonist (LABA) combination; Anoro
Ellipta, which is a long-acting muscarinic antagonist (LAMA) and LABA dual bronchodilator; Incruse
Ellipta (LAMA), and Arnuity Ellipta (ICS). It has respiratory products in its pipeline, including
mepolizumab, which is an investigational anti-IL5 monoclonal antibody, to treat severe eosinophilic
asthma, and its closed triple combination treatment to treat chronic obstructive pulmonary disease
(COPD). GSK's vaccines have a portfolio of over 30 paediatric, adolescent, adult travel vaccines. Its four

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Vaccines include Infanrix (diphtheria and tetanus), Hepatitis, Rotarix (rotavirus) and Synflorix
(pneumonia).
The Company's human immunodeficiency virus (HIV) business is managed through ViiV Healthcare,
which is a specialist company in HIV that it owns, with Pfizer and Shionogi. ViiV Healthcare has various
other antiretroviral medicines in clinical development, including cabotegravir. It also has a portfolio of
other Pharmaceutical products for the treatment of conditions, such as lupus (Benlysta), benign prostatic
hyperplasia (Avodart/Jalyn), type 2 diabetes and bacterial infections (Augmentin). Its other products
include Tykerb/Tyverb, Votrient, Promacta/Revolade, Arzerra, Tafinlar and Mekinist. The GSK's
Established Products Portfolio (EPP) includes over 50 off-patent products, as well as its branded generics
business and other local products.
Within respiratory, Anoro Ellipta, its once-daily medicine combining two bronchodilators, which is a
long-acting muscarinic antagonist (LAMA), and a long-acting beta2 agonist (LABA), which is a single
inhaler, was approved in Europe for COPD. Incruse Ellipta, its monotherapy LAMA, was approved as a
once-daily treatment for COPD, including chronic bronchitis or emphysema. Arnuity Ellipta, which is a
once-daily inhaled corticosteroid medicine to treat asthma, was approved for asthma treatment. All these
respiratory medicines are administered using its dry powder inhaler, Ellipta.
Mekinist, which is its MEK inhibitor, is approved for the treatment of BRAF mutant metastatic
melanoma. This oral targeted therapy also received approval under the Food and Drug Administration's
(FDA) accelerated approval process, for use in combination with Tafinlar, a previously approved oral
targeted therapy. This accelerated approval is contingent on the results of a Phase III trial, which is
designed to evaluate the clinical benefits of the combination.
ViiV Healthcare gained EU approval for Tivicay (dolutegravir), which is an integrase inhibitor. Approval
was also given for Triumeq, which is a single-pill regimen for the treatment of HIV, combining
dolutegravir with the nucleoside reverse transcriptase inhibitors (NRTIs) abacavir and lamivudine.
Tanzeum, which is a new GLP-1 treatment for type 2 diabetes, received approval offering a once-weekly
injectable option for patients. The same product, under the name Eperzan, was also approved. The
Company has submitted a regulatory file to the European Medicines Agency's (EMA), for a variation to
the marketing authorisation for Volibris, which is its medicine for pulmonary arterial hypertension (PAH)
to include its use in initial combination therapy in PAH patients.

Consumer Healthcare
The Company's Consumer Healthcare business develops and markets products in four categories, such as
wellness, oral health, nutrition and skin health. The segment's Wellness category focuses on pain
management, respiratory health, gastrointestinal health and smokers' health. Panadol is the paracetamol
brand and Tums is the antacid brand. It is a specialist in oral health, with brands, including Sensitivity
(Sensodyne), Acid Erosion (Pronamel), Denture Care and Gum Health. In Nutrition, its Horlicks brand is
the nutritional supplement in the Indian subcontinent. Its Skin health brands include Abreva and Zovirax.
Its brands are available in over 100 countries.
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The Company competes with AbbVie, Amgen, Astra Zeneca, Bayer, Bristol-Myers Squibb, Eli Lilly,
Johnson & Johnson, Merck & Co, Novartis, Novo Nordisk, Pfizer, Roche Holdings, Sanofi, Takeda,
Colgate-Palmolive, Johnson & Johnson, Procter & Gamble and Reckitt Benckiser.

4. About Crocin
Crocin has been a trusted household healthcare name for over three decades and
enjoys a strong medical heritage. Widely used as an effective remedy for mild-tomoderate pain, Crocin is an over-the-counter medicine which is easily accessible to
patients. It commands a strong medical equity and enjoys the confidence and trust
of medical practitioners across the country.
Sometimes ordinary paracetamol tablets may take a longer time to release its
medicine as it doesn?t easily disintegrates within the human system. Crocin
Advance with Optizorb technology releases its medicine up to five times faster than
ordinary paracetamol tablets, providing you fast and effective relief.
Over the years, Crocin has evolved from a pain, body ache relieving drug to a
household medicine and a brand of choice and trust. With a continuous series of
innovations, it has evolved significantly from its simple 500 Mg paracetamol variant
to a range of product extensions like Crocin Pain Relief, Crocin Cold & Flu, Crocin
650 Mg tablets alongside a pipeline of liquid formats for Children and Kids.
Qualitative & Quantitative CompositionEach uncoated tablet contains Crocin 500 mg
1. Maize Starch IP
2. Pregelatinised Maize Starch BP (Lycatab PGS)
3. Potassium Sorbate BP/PhEur
4. Povidone IP (Plasone K-25)
5. Talc IP
6. Stearic Acid IP
7. Purified water I.P
Shelf life -24 months from the date of manufacturing
Nature and specification of the container
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Crocin 500mg: PVC-aluminium blister packs of 15 Tablets

Therapeutic indications
Analgesic and Antipyretic

5. Production Planning (Crocin Advance 500mg Tablets)

As discussed earlier this process involves 4 steps ie Routing, Scheduling,
Dispatching and Feedback.
We will start the procedure with routing.
ROUTING
a) The quantity and Quality of Product
To determine the quantity of product required, we have to first estimate the demand
of the product. We have sales data from IMS of previous months which could be
used to estimate the demand of this month
PRODUC
T

Crocin
500mg
15
Tablets
Total
Tablets
.

MTH ~
07/2015
UNT.UNITS

MTH ~
06/2015
UNT.UNITS

MTH ~
05/2015
UNT.UNITS

MTH ~
04/2015
UNT.UNITS

MTH ~
03/2015
UNT.UNITS

MTH ~
02/2015
UNT.UNITS

6,00,423

5,24,246

5,81,663

5,94,316

6,33,872

6,61,616

90,06,345

78,63,690

87,24,945

89,14,740

95,08,080

99,24,240

Estimated demand for August would be average of the previous six months sales.
Estimated sales= 8990340 + 3(54928)=9155126
b) Men, machine and materials to be used
Generally in the PNCB (Paranitrochloro benzene) route for paracetamol
production manpower of 50 is required.
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Raw materials
Raw material requirements for Paracetamol production:
Basis : One tonne of Paracetamol
Para nitrochloro benzene (PNCB)
Acetic anhydride
Acetic acid
Caustic soda
Iron powder
Hydrose
Activated carbon
Sulphuric acid

1.25
0.76
0.34
0.75
0.30
0.01
0.01
0.25

Machines Installed And Plant Location

GSK manufacturing plant is located in Nasik.

Dispenser Machine
Granulator Machine
Tableting Machine
Packaging Machine

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tonne
tonne
tonne
tonne
tonne
tonne
tonne
tonne

6. Manufacturing Process (Batch size: 1 Million

Tablets)
Dispensing Process
In this process all the raw materials are mixed in the machine with rotating blades
and prepare a uniform mix. This process usually takes 2 hrs.
Granulation and Drying
The steps involved in wet granulation were, Weighing, Mixing, Granulation,
Screening the damp mass, Drying, Dry screening, Lubrication and Compression. This
process takes approximately 10 hrs.
Tableting
In this process the dried mix is converted into tablets using the tableting machine,
500 mg in our case. This process takes nearly 2 shifts i.e 16hrs.
Packaging
The tablets are then packaged into strips of 15 tablets each. This process requires 8
hrs.

Scheduling Process
a) Fixing the amount of work
The monthly demand is 91, 55,126 tablets of crocin 500mg and process for
the production of 10 lacs tables is nearly 36hrs. This process has to be
repeated 5 times every month to meet the demand.

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Ideal time calculation

Here tasks means

Machine 158hrs

Task 1- dispensing process

Machine 2- 25hrs

Task 2- granulation and drying

Machine 3- 0hrs

Task 3-tableting

Machine 4- 34hrs

Task 4- packaging

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