INDUSTRY PROFILE

The pharmaceutical industry develops, produces, and markets drugs licensed for use as

medications. Pharmaceutical companies are allowed to deal in generic and/or brand medications

and medical devices. They are subject to a variety of laws and regulations regarding the

patenting, testing and ensuring safety and efficacy and marketing of drugs.

The Pharmaceutical industry in India is the world's third-largest in terms of volume

and stands 14th in terms of value. According to Department of Pharmaceuticals, Ministry of

Chemicals and Fertilizers, the total turnover of India's pharmaceuticals industry between 2008

and September 2009 was US$21.04 billion. While the domestic market was worth US$12.26

billion. Sale of all types of medicines in the country is expected to reach around US$19.22

billion by 2012. Exports of pharmaceuticals products from India increased from US$6.23 billion

in 2006-07 to US$8.7 billion in 2008-09 a combined annual growth rate of 21.25%. According to

PricewaterhouseCoopers (PWC) in 2010, India joined among the league of top 10 global

pharmaceuticals markets in terms of sales by 2020 with value reaching US$50 billion.

The government started to encourage the growth of drug manufacturing by Indian

companies in the early 1960s, and with the Patents Act in 1970. However, economic

liberalization in 90s by the former Prime Minister P.V. Narasimha Rao and the then Finance

Minister, Dr. Manmohan Singh enabled the industry to become what it is today. This patent act

removed composition patents from food and drugs, and though it kept process patents, these

were shortened to a period of five to seven years.

The lack of patent protection made the Indian market undesirable to the multinational

companies that had dominated the market, and while they streamed out. Indian companies carved

a niche in both the Indian and world markets with their expertise in reverse-engineering new

processes for manufacturing drugs at low costs. Although some of the larger companies have

taken baby steps towards drug innovation, the industry as a whole has been following this

business model until the present.

India's biopharmaceutical industry clocked a 17 percent growth with revenues of Rs.137 billion

($3 billion) in the 2009-10 financial year over the previous fiscal. Bio-pharma was the biggest

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contributor generating 60 percent of the industry's growth at Rs.8, 829crore, followed by bio-

services at Rs.2, 639crore and bio-agri at Rs.1, 936crore.

Pharmaceutical industry today:

The number of purely Indian pharma companies is fairly low. Indian pharma industry is

mainly operated as well as controlled by dominant foreign companies having subsidiaries in

India due to availability of cheap labor in India at lowest cost. In 2002, over 20,000 registered

drug manufacturers in India sold $9 billion worth of formulations and bulk drugs. 85% of these

formulations were sold in India while over 60% of the bulk drugs were exported, mostly to the

United States and Russia. Most of the players in the market are small-to-medium enterprises; 250

of the largest companies control 70% of the Indian market. Thanks to the 1970 Patent Act,

multinationals represent only 35% of the market, down from 70% thirty years ago.

Most pharma companies operating in India, even the multinationals, employ Indians

almost exclusively from the lowest ranks to high level management. Mirroring the social

structure, firms are very hierarchical. Homegrown pharmaceuticals, like many other businesses

in India, are often a mix of public and private enterprise. Although many of these companies are

publicly owned, leadership passes from father to son and the founding family holds a majority

share.

In terms of the global market, India currently holds a modest 1-2% share, but it has been

growing at approximately 10% per year. India gained its foothold on the global scene with its

innovatively engineered generic drugs and active pharmaceutical ingredients (API), and it is now

seeking to become a major player in outsourced clinical research as well as contract

manufacturing and research. There are 74 U.S. FDA-approved manufacturing facilities in India,

more than in any other country outside the U.S, and in 2005, almost 20% of all Abbreviated New

Drug Applications (ANDA) to the FDA are expected to be filed by Indian companies. Growth in

other fields notwithstanding, generics is still a large part of the picture. London research

company Global Insight estimates that India’s share of the global generics market will have risen

from 4% to 33% by 2007.

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Patents:

As it expands its core business, the industry is being forced to adapt its business model to

recent changes in the operating environment. The first and most significant change was the

January 1, 2005 enactment of an amendment to India’s patent law that reinstated product patents

for the first time since 1972. The legislation took effect on the deadline set by the WTO’s Trade-

Related Aspects of Intellectual Property Rights (TRIPS) agreement, which mandated patent

protection on both products and processes for a period of 20 years. Under this new law, India

will be forced to recognize not only new patents but also any patents filed after January 1, 1995.

Indian companies achieved their status in the domestic market by breaking these product patents,

and it is estimated that within the next few years, they will lose $650 million of the local generics

market to patent-holders.

In the domestic market, this new patent legislation has resulted in fairly clear

segmentation. The multinationals narrowed their focus onto high-end patients who make up only

12% of the market, taking advantage of their newly bestowed patent protection. Meanwhile,

Indian firms have chosen to take their existing product portfolios and target semi-urban and rural

populations.

Product development:

Indian companies are also starting to adapt their product development processes to the

new environment. For years, firms have made their ways into the global market by researching

generic competitors to patented drugs and following up with litigation to challenge the patent.

This approach remains untouched by the new patent regime and looks to increase in the future.

However, those that can afford it have set their sights on an even higher goal: new molecule

discovery. Although the initial investment is huge, companies are lured by the promise of hefty

profit margins and thus a legitimate competitor in the global industry. Local firms have slowly

been investing more money into their R&D programs or have formed alliances to tap into these

opportunities.

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Small and medium enterprises:

As promising as the future is for a whole, the outlook for small and medium enterprises

(SME) is not as bright. The excise structure changed so that companies now have to pay a 16%

tax on the maximum retail price (MRP) of their products, as opposed to on the ex-factory price.

Consequently, larger companies are cutting back on outsourcing and what business is left is

shifting to companies with facilities in the four tax-free states - Himachal Pradesh, Jammu &

Kashmir, Uttaranchal and Jharkhand.[12]Consequently a large number of pharmaceutical

manufacturers shifted their plant to these states, as it became almost impossible to continue

operating in non tax free zones. But in a matter of a couple of years the excise duty was revised

on two occasions, first it was reduced to 8% and then to 4%. As a result the benefits of shifting to

a tax free zone were negated. This resulted in, factories in the tax free zones, to start up third

party manufacturing. Under this these factories produced goods under the brand names of other

parties on job work basis.

As SMEs wrestled with the tax structure, they were also scrambling to meet the July 1

deadline for compliance with the revised Schedule M Good Manufacturing Practices (GMP).

While this should be beneficial to consumers and the industry at large, SMEs have been finding

it difficult to find the funds to upgrade their manufacturing plants, resulting in the closure of

many facilities. Others invested the money to bring their facilities to compliance, but these

operations were located in non-tax-free states, making it difficult to compete in the wake of the

new excise tax.

Challenges:

All of these changes are ultimately good for the Indian pharmaceutical industry, which

suffered in the past from inadequate regulation and large quantities of spurious drugs. They force

the industry to reach a level necessary for global competitiveness. However, they have also

exposed some of the inadequacies in the industry today. Its main weakness is an underdeveloped

new molecule discovery program. Even after the increased investment, market leaders such as

Ranbaxy and Dr. Reddy’s Laboratories spent only 5-10% of their revenues on R&D, lagging

behind Western pharmaceuticals like Pfizer, whose research budget last year was greater than the

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combined revenues of the entire Indian pharmaceutical industry. This disparity is too great to be

explained by cost differentials, and it comes when advances in genomics have made research

equipment more expensive than ever. The drug discovery process is further hindered by a dearth

of qualified molecular biologists. Due to the disconnect between curriculum and industry,

pharmas in India also lack the academic collaboration that is crucial to drug development in the

West

R&D:

Both the Indian central and state governments have recognized R&D as an important

driver in the growth of their pharma businesses and conferred tax deductions for expenses related

to research and development. They have granted other concessions as well, such as reduced

interest rates for export financing and a cut in the number of drugs under price control.

Government support is not the only thing in Indian pharma’s favor, though; companies also have

access to a highly developed IT industry that can partner with them in new molecule discovery in

r&d.

Labor force:

India’s greatest strengths lie in its people. India also boasts of well-educated, English-

speaking labor force that is the base of its competitive advantage. Although molecular biologists

are in short supply, there are a number of talented chemists who are equally as important in the

discovery process. In addition, there has been a reverse brain drain effect in which scientists are

returning from abroad to accept positions at lower salaries at Indian companies. Once there, these

foreign-trained scientists can transfer the benefits of their knowledge and experience to all of

those who work with them. India’s wealth of people extends benefits to another part of the drug

commercialization process as well. With one of the largest and most genetically diverse

populations in any single country, India can recruit for clinical trials more quickly and perform

them more cheaply than countries in the West. Indian firms have just recently started to leverage.

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COMPANY PROFILE

Malladi Drugs and Pharmaceuticals Ltd is one of India’s most traditions conscious and

ethically sound Pharmaceutical Company. Malladi Drugs was founded in 1980 by late Mr. M.L.

N.Sastry, a pioneering microbiologist with expertise in fermentation technology.

Malladi is the leading manufacturer of Active Pharmaceutical Ingredients (API) in the

cough and cold segment along with a dominant presence in other therapeutic segments like Anti-

histamines, Anti-convulsants, Anti-depressants and Anxiolytics (CNS) of the global

pharmaceutical industry.

Malladi is the leading manufacturer of Active Pharmaceutical Ingredients (API) in

the Cough and Cold segment along with a dominant presence in other therapeutic segments like

Anti-histamines, Anti-convulsants, Anti-depressants and Anxiolytics (CNS) of the global

pharmaceutical industry.

MALLADI ACHIEVEMENTS:

The first company in India to manufacture Ephedrine and Pseudoephedrine salts

through a fully indigenous process.

The first Indian company to acquire an API manufacturing facility out of India –

Novus Fine Chemicals in New Jersey, USA.

Malladi markets their products in over 60 Countries and are supported by highly

motivated and talented partners.

Received the prestigious Acharya P C Ray Award for indigenous technology

development for the indigenous process Malladi developed to manufacture

Ephedrine.

6 Successful FDA inspections in 5 years.

C GMP Compliance as per USDFA, TGA guidelines.

Certificates of Suitability (COS) from EDQM 8 DMF are filed with the USDFA.

International Patent for a NCE

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Honored with the Chemexil Award for Exports, for 5 consecutive years.

Safety Award instituted by the Government of Tamil Nadu.

Recognition by the Dept. of Science & Industrial Research Ministry of Science and

Technology Govt. of India in the form of the National Award for R&D efforts in

industry.

Indian Drug Manufacturers Association Quality Excellence Award.

At the heart of this pharmaceutical company there is desire to heal and contribute to the

wellness of mankind. We are constantly innovating; Providing Value added services and always

ensures that we have excellent relationships with everyone which encompasses our businesses

and beyond.

MANUFACTURING FACILITIES:

Malladi has six manufacturing units in India and one is the USA. Malladi is the only

facility in the United States of America for manufacturing Pseudoephedrine HCL.

Malladi manufacturing units, which are ISO 9001:2000, cGMP compliant, audited by the

USFDA, EDQM, TGA and other big Pharma Majors; establish a benchmark for other

manufacturing units in the Industry.

Malladi has validation capabilities across the Product Development Cycle and facilitate

quick and efficient DMF compilation with dedicated QA and QC teams for identified projects.

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Malladi ensures that the manufacturing units are completely safe for the environment as well as

our workers. Our units have Zero effluent discharge and an impeccable safety record.

Malladi undertakes Contract Manufacturing and Custom Synthesis API's, Advanced

Intermediates and Clinical supplies. Malladi reaction conditions range from -70C to +230C.

Malladi also have expertise in Fermentation-based products and can also offer the customers

exclusive project working relationships and utmost confidentiality and protection of IPR.

NOVUS FINE CHEMICALS:

Not content with resting on its laurels, Malladi decided to spread their business further

and better serve the customers in the west. In 2005, Malladi became the first Indian company to

acquire an API manufacturing facility outside India, namely, Novus Fine Chemicals in Carlstadt,

New Jersey, a US FDA manufacturing facility.

Novus was just the right platform that Malladi needed to bridge the gap between the

customer’s requirements and the production capabilities. With Novus, Malladi adopted a unique

near shore/Offshore model with USFDA approved API manufacturing facilities in both the India

and USA. Intermediates produced at manufacturing facilities in India are finished at Novus. Thus

Malladi are able to offer US customers, products manufactured in USA at the cost

competitiveness of an Indian Supplier. This arrangement has also helped Malladi cope with the

growing international demand for the products with improved service and better relationships.

Novus has a total manufacturing area of 70,000 square feet and over 50,000 gallons of

reaction capacity in Stainless Steel, Glass and Hostelry contact surfaces. It also has a pilot plant

to scale up processes from lab-scale to 500 gallon scale reactor trains. Novus offers total

adaptability in production through flexible manufacturing facilities for development, scale-up

and commercial Manufacture of New Chemical Entities (NCEs), mature Active Pharmaceutical

Ingredients (API) and advanced chemical intermediates in a cGMP environment.

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RESEARCH AND DEVELOPMENT:

Research and Development has played a big role in Malladi's success. Our R&D centre

has been recognized by Anna University, a 150-year-old premier institution in Chennai as a

center for doctoral research. The Department of Science and Technology, Government of India

has also Recognized Malladi’s R&D efforts. MALLADI has developed an indigenous process

for the manufacture of Ephedrine HCl. We also have global patents on New Chemical Entities

and have made great strides.

No infringing processes, Synthesis of API's, Complex Advanced Intermediates and

Biosynthesis of APIs, Intermediates and Performance Chemicals. Our research team is staffed

with Scientists and Doctors in Organic Chemistry, Analytical Chemistry, Pharmacology,

Microbiology and Biotechnology. API- any substance or mixture of substance intended to be

used in the manufacture of a drug (medicinal) product and that, when used in the production of a

drug becomes an active ingredient of the drug product. Such substances are intended to furnish

pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment or

prevention of disease or to affect the structure and function of the body.

AREA OF FOCUS:

Synthetic Organic Chemistry Reaction capabilities:

BIOTECHNOLOGY:

Fermentation

Biocatalysts

Enzyme Technology

Have in-house capabilities from strain screening to Pre-clinical studies for bio-

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pharmaceuticals

Competencies include Bio-analytical Service, Media and Yield Optimization, Process

Scale-up and Fermentation Bio-Process Development

ANALYTICAL CHEMISTRY:

Extensive Support to the Synthetic Organic Chemistry and Biotechnology

Department

Evaluates the quality and develops analytical methods for all the products and

intermediates synthesized

Method development and validations

Impurity Profiling, Spectral Studies, Stress Testing and Stability Studies

QUALITY POLICY:

The organization is committed to providing Active Pharmaceutical Ingredient and

intermediaries to meet customer needs and expectations and enhance customer satisfaction.

The organization shall achieve this implementing good manufacturing practice,

objectives and conforming to applicable regulatory requirements and continuously improve the

effectiveness of our Quality Management Systems.

ORGANISATIONAL OBJECTIVES:

Meeting customer needs and expectations through procurement responsiveness of

customer demands.

Complying with regulatory requirements through adoption of stringent control and

monitoring measures in the process.

Attaining maximum yield and reducing waste through dynamic and continual process

improvements.

Achieve organization goals by enhancing relevant knowledge base of the people

through training

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COMPETITORS:

1. MLN Biotech at Mahad, Maharashtra

2. KREBS, Hyderabad.

3. AVON Organics at Sholapur, Maharashtra.

FOREIGN RELATIONS:

The product produced from the organization is an ingredient for bronchial and cough

oriented problems. About 80% of the products are exported to foreign countries like Japan,

Mexico, Pakistan, Srilanka, U.S.A etc. Demand is more during winter and less during summer.

CORPORATE SOCIAL RESPONSIBILITY:

It is a part and parcel of any organization to be socially responsible for the welfare of the

public. MALLADI is one among them to incorporate CSR and they are:

EMERALD Park constructed and maintained by MALLADI at Emerald Nagar in

Ranipet, Vellore.

Donated Rs.3lac to chettithangal village through TWAD for water supply to the

surrounding villages.

Donated centralized washing unit for primary health centre at Lalapet, Manavaram.

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STRUCTURE OF MALLADI:

ORGANISATION STRUCTURE:

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ORGANISATION CHART:

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PLANT LAYOUT:

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Ware House

EffluentTreatmentPlant(ETP)

Dinning Room

Human Resource&General ManagerOffice

Parking

Security Office

Way

WAy

WAy

Entry Gate

Garden

Maintenance Department

MicrobiologyDepartment

Fermentation

Synthesis

Extraction

Sto

res

ProductionQuality ControlQuality Assurance Department

Under Ground Storage for Solvents

VARIOUS DEPARTMENTS IN MALLADI

SYSTEM DEPARTMENT:

In MALLADI, ERP is being used. Here three departments are centralized through ERP.

Main server and recovery centre is placed at UNIT 1, RANIPET. BSNL broad band is used for

connecting MALLADI. The departments centralized through ERP are:

Production

Stores

Finance

STORES DEPARTMENT:

Organization Structure of stores department:

Stores department is responsible for purchase of raw material, spare parts, packaging

materials, labels, office requirements, warehouse, transportation, and planning. Stores

department divided the raw material into two categories for their purchase schedule.

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Major Raw Material:

Molasses, Toluene, methanol, benzaldehyde are the major raw materials

which can be purchased with help of annual schedule. This is annual schedule

based on the forecasting of previous year or month.

Minor Raw Material:

Spare parts, Packaging materials, Labels and office stationeries are the

minor raw materials which can be purchased as per the requirement on weekly

or monthly basis. Purchase request is send from head of respective department

to commercial department.

Raw Materials Used In MALLADI:

1. Molasses

2. Benzaldehyde

3. Toluene

4. Mono methyl Amine

5. Caustic Soda

6. Hydrochloric acid

7. Methanol

8. Acetone

9. Activated Carbon

10. Hydrogen Gas

11. Ethyl Acetate

12. Isopropyl Alcohol

13. Hyflow super cell

14. Raney Nickel Catalyst

15. Mono Ethanol Amine

16. Para toluene sulphonic acid

17. 10% Palladium on Carbon

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PROCESS INVOLVED IN PURCHASING:

The organization requires raw materials from vendors to manufacture the ingredients and

thus it ensures the raw material obtained is of good quality for the supplier to be in the market in

the long run.

For new vendors questionnaire is set based on the turn over and their number of years in

the market and their rapport with other industries is monitored. The new vendors after filling the

questionnaires, sends three set of samples for testing with analytical report and submitted to

quality assurance department. The three sets of samples are tested and if the standards are met

then the organization approves the vendor and now the vendor becomes the approved vendor.

Moreover the approved vendor’s 5 suppliers are monitored. Approved vendor list is sent to

Purchase department and procurement of raw materials is ordered.

ORDERING OF RAW MATERIALS:

Purchase department sends quotation to approved vendors and details of the raw

materials including the quality and quantity is mentioned. Order is placed based on the price,

supply and accessibility.

TRANSPORTATION:

After ordering of raw materials the next basic step is to transport them from the vendor to

the organization. Trucks are used for transportation. Since raw materials like molasses and

methanol are statutory, they are government bonded and thus require permission from the

government to transport since misuse of these two materials can lead to disaster. For instance,

use of methanol if added with contaminants can be used as a cheap alcohol drinks which leads to

blindness, immediate death and loss of lives. This has happened earlier and therefore the

government of Andhra Pradesh has rules and regulations while transporting them. It is

mandatory for the truck drivers to hold ML4 and ML6 license with them, since it is considered as

an acknowledgement from the government. Purchase, transportation, storage of raw materials is

the three stages involved and individual licenses for the three stages are mandatory. When the

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truck enters the Andhra Pradesh check post, the Inspector of Police is provided with an

authentication letter to escort the raw materials to the company for delivery. While unloading the

raw materials from the truck, the District Revenue Officer verifies the bill number, receipt

number, the material content and gives the consent for further processing.

Check list for the truck when it enters the company:

1) Approved vendor

2) Weight is checked

3) Muffler is fitted with spark arrester

4) Combustible items are seized from driver

5) Bill number, Receipt number is verified and checked

WAREHOUSE:

The company has a warehouse to store the raw materials and finished goods. There is

underground warehouse for the storage of solvents which are maintained at a temperature of -23

degree Celsius. For raw materials like molasses it’s a seasonable product and is ordered earlier

and requires ageing. Material ageing is necessary for raw materials like molasses.

PACKING:

Packaging is an important factor for any organization because the finished product

delivered to the end user should be safe and attractive. Packaging is divided into two

Primary:

Primary packing involves polythene bag in which the ingredient is

present and based on the customer’s requirements it is packed in various sizes.

There is 25 kg, 50 kg capacity polythene bags. The polythene bag is tied with

pilfer which does not allow air, and has to be cut open for unpacking.

Aluminum foil in form of bags is used to maintain temperature.

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Secondary:

Secondary packing involves the final packing of the primary packed

content. Usually drums are used and based on customer’s requirements

various sizes of drums are used. Dimensions of 14*19 for 5 bed drum, 16*30

and 28*50 for 50 kg drum. Inner labels and outer labels are pasted for proof

seal, box strapping is done. Tech lock sealing is an anti theft device which is

done at the end. The central government embeds a excise seal on the drum for

shipping to other countries. To accommodate more than one drum, a wooden

pallet or fumigation pallet is used which can hold six drums and a polythene

wrapper is used to envelope around it. This is done to be lifted easily by the

JCP.

PRINTING:

Printing is an essential and significant part of any organization. This function of printing

is almost inevitable in the various departments of the organization. In Malladi it is incorporated

almost in all departments and its utility is of most importance beyond any doubts and questions.

A label distinguishes the different components and makes it easier for the end user to identify the

Component. Labels contain the name, code number, color, date of packing, method of packing

and hazards identification. The printing is outsourced to reputed and approved offset printers.

Intimation for printing is given if labels are out of stock. The labels are verified with master

Labels and if found faulty it is rejected.

PLANNING:

Planning in a stores department is essential since forecasting the demand for raw

materials in a production company makes it to run for longer time and if proper planning is not

implemented then the production is shut down. Inventory control is maintained by proper

planning and forecasting. There are five levels of inventory and they are

a) Maximum stock

b) Re-order level

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c) Minimum stock

d) Critical stock

e) Dead stock

FINANCE DEPARTMENT:

Organization structure of finance department:

The functions performed in the accounts department:

a. Vendor Payment:

Firstly, enter the advance amount in SAP and obtain the Goods Receipt Note (GRN)

from stores and Goods Inspection Note (GIN) from Quality.

The balance payment can be made direct or through Bill of Exchange (B/E). In case

of B/E, it can either be discounted with the bankers, with a commission of 11.5% or

with the company itself (MALLADI Discount) at a rate of

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b. Fixed Asset:

A request is first obtained from the department seeking the asset in the prescribed

format. Next check for the approved budget and get the approval from the CFO and

MD.

The Purchase Order (PO) is raised by the purchase department, and the asset is

capitalized under the respective heads.

The Fixed asset register is updated thereon and the amount of depreciation is

calculated.

c. Daily Bank Balance and Reconciliation:

The daily bank balance is generated through SAP and the same is verified with the

company’s cash register.

This includes all the cash transactions throughout India because all receipts and

payments are directed to the head office.

This report will be sent to the CFO at Chennai through the manager on a daily basis.

d. Action on Delivery Orders:

After receiving the delivery orders from the commercial department, the financiers of

the customers will be contacted and the invoices will be sent to them.

After delivery of products, the follow-up of the payments need to be made as per the

Terms agreed upon.

When the payments are received, entry for the same will be passed and the deal will

be closed.

e. Follow-up of Collections:

The ageing schedule of SAP shows the details of payments overdue, at various stages

and using different signs.

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Accordingly reminders will be prepared and sent to the respective branches and the

customers.

If payment is due more than 90 days, the customer account will be blocked and

further transactions to him will barred.

f. Service Tax:

The service tax due and payable for the different branches are extracted and the

payments for the same are arranged, after the approval of CFO.

The service tax returns are prepared and filed on a half yearly basis.

g. Cash:

The receipts of cash are through cash withdrawal from bank, scrap sales and service

income.

The physical cash is tallied with the SAP on a daily basis and reported to the deputy

manager.

Payment advice and collection of bills are done for the following:

Travel/Tour Advance

Mobile charges Reimbursement

Conveyance

Medical Claim.

h. Travel:

Approval of the travel through the Travel Authorizations Form (TAF)*.

The tickets and the advances are paid against the TAF no.

After the tour is completed, a Travel Expense Statement (TES)* is submitted.

After approval of the TES, the advances are knocked off against the expenses and

The balance amount is recovered or paid, as the case may be.

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i. Sales Tax:

The sales tax accounts are maintained by the respective branches, and a request for

payment of VAT is received from the branches.

After verification, cheques are prepared and sent to the branches and follow up is

made on the payment.

A sales tax return for Andhra Pradesh is prepared and filed.

j. Inventory Reconciliation:

The stocks are physically verified at the plants and the branches and also at the Sub-

contractor’s place.

The physical stock is then verified against the SAP accounts and the difference entries are

made and the books are reconciled.

k. Tax Deducted at Source (TDS):

The TDS accounts are maintained by the respective branches and it gets segregated

into various heads as per the codes maintained.

The returns are filed on a Quarterly basis and the stamped challans from the banks are

filed.

The TDS certificate is issued on an annual basis.

l. Payroll:

Finance department will assist the administration department in preparing the payrolls

for the employees.

It ensures that the adherence to all eligibilities and deductions are done in preparing

the payrolls.

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m. Audit:

Various audits like Internal, External and Tax Audit are co-ordinate and the necessary

data are provided.

The system is being reviewed and made such that the procedures are made easy to

generate information in the future.

The changes in the legal and other regulations are kept track of and complied.

n. Sales tax on various scrap items:

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HUMAN RESOURCE:

The organization Structure of Human Resource Department:

For any organization, Human Resource is an asset. The more efficient the human

resources the more successful the industry would be. Such an efficient human resource is needed

to be governed by a healthy planning. The HR department of MALLADI Drugs and

Pharmaceuticals Ltd has a very rigid structure. This entire management is divided into levels of

organization structure thus making the entire organizations structure a transparent one. The HR

Department is apart from appointing and recruiting also functions in employee appraisal, welfare

activities of employee etc.

WELFARE SCHEMES:

1. The department takes care of the various benefit schemes and welfare activities of

the Employees. They maintain the employees ESI, PF records and contractors’

attendance and Wage records.

2. The benefits given are soap, horlicks, safety shoes, uniform, rain coat and towel.

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3. The facilities provided are medical treatments and rest rooms.

4. Best employee scheme- Every month, from each department a best employee is

chosen on performance based on productivity, housekeeping initiation and attitude

towards work and performance allowance is rewarded to them. A batch process report

is maintained for each employee.

5. An attendance award of Rs.1500/- is awarded to the employees who have a 100%

attendance.

6. Special Events:

a. Festival Advance: It is given in a financial year for one festival. The amount

has to be repaid in equal monthly intervals.

b. Safety Day: Every year March 4 is celebrated as safety day in which various

events are conducted for the employees. The importance of safety is

emphasized in this event.

7. The other benefits and schemes are travel allowance, funeral expenses, group

personnel accident policy (GPA), group insurance (GI), group saving linked insurance

(GSLI), PF, gratuity benevolent fund.

INSURANCE SCHEME:

SHIFT TIMINGS:

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WORKER’S OVERTIME:

HR is in charge of keeping the Time Office functions. They get the OT details from all

the departments, maintain the records and advise the Accounts department for payment.

Wage and Salary Administration:

They prepare the appointment orders of worker-trainees and maintain their monthly

attendance and salary.

Calculation of leave encashment and advice the accounts department.

Preparations of salary, recovery sheets and advice the accounts department for

payment through HDFC cheques.

Generating pay-slips and distributing to all the employees.

TRAINING:

An exclusive training centre has been created to train 50 persons at a time. This training

centre imparts primary and advanced courses on Operation and maintenance, course on safety,

machine owner course on testing for quality products for deriving the best benefits out of

MALLADI DRUGS AND PHARMACEUTICALS PVT LTD. A training calendar is distributed

to employees in the beginning of the year and programs are conducted as per schedule. Special

programs by various eminent trainees are organized.

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PRODUCTION DEPARTMENT:

The organization structure of Production Department

The production department manager is assisted by a team to coordinate, control, co-

operate and maintain quality standards. The company continues to follow current Good

Manufacturing Practice (cGMP) in order to lower cost of production and enhance performance

on quality and delivery parameters.

Further the introduction of batch processing has helped in reducing WIP, throughput time

and increasing on time delivery. Investments are targeted at creating application specific

capabilities, based on customer requirements. Investments are made to upgrade existing

machinery equipments to be an area of focus. The company is planning more such investments in

future with a view to retaining its competitive edge.

Increasing infrastructure activity, booming construction and a flourishing economy in

India brings with it signs of robust demand. Globally, the focus on cost cutting and value for

money sourcing will enable Indian companies to establish a strong foothold. In order to

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capitalize on the Growth opportunities, there are plans to have a presence in China and the

Middle East.

The introduction of VAT is likely to benefit the company as product pricing will be more

standardized across the country. The VAT regime would also help to curb grey market activities

to a large extent. Malladi with its vertically integrated operations, strength in manufacturing

process, stringent quality controls and wide distribution reach will maintain it’s domestic

Leadership and also emerge as a more visible force in the global market.

TOTAL PRODUCTIVE MAINTENANCE:

The TPM department is classified in two departments:

Quality Control

Quality Assurance

The following objectives at MALLADI are:

Avoid wastage in a quickly changing economic environment.

Producing goods without reducing product quality.

Reduce cost.

Produce a low batch quantity at the earliest possible time.

Goods send to the customers must be non defective.

ROLE OF TPM:

Achieve “ZERO EFFECT” by identifying all the upstream factors of equipment causes of

defects and implementing fool-proofing techniques to eliminate man and materials- caused

defects.

Identify all the Q-components.

Implement fool-proofing techniques to prevent man and materials- caused defects.

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Eliminate all chronic effects.

QUALITY CONTROL:

The organization structure of quality control department:

The organization requires raw materials like molasses and methanol which are highly

volatile and need protection to avoid mishap and theft for illegal activities. For this a quality

check is made by the quality control department and assurance is provided to the organization for

further processing of the raw materials. A sample of the raw material is analyzed based on its

qualitative and quantitative. After analysis the sample is tested through twelve analytical tests.

During the process of analysis and testing it is called the quarantine stage where a yellow label is

stuck on the product to differentiate from others and to the employees that it is under quarantine.

If the tested sample shows expected results then it is accepted and a green label is pasted on the

sample to indicate that it could be processed to obtain the value added product and the raw

material is unloaded from the container On the other hand if the results are negative and do not

reach the quality standards then a red label is pasted to indicate that the raw material is rejected

and sent back to the corresponding vendor.

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QUALITY ASSURANCE:

The organization structure of quality assurance department:

Quality Assurance is a wide ranging concept which covers all the matters that the

collectively or individually influence the product quality. The system of Quality Assurance

appropriate to the manufacturing of pharmaceutical products should ensure that the

pharmaceutical products are designed and developed in a way that it takes account of

requirements of GMP, GDP, and GCP

The steps taken at quality assurance department:

1. To train in the cGMP for API’s

2. To introduce general principles of quality management system

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3. Maintenance of quality system.

4. Documentation process.

5. Batch number is noted.

6. System checking is done based on the performance

7. Standard operating procedures complies the specification.

8. Calibration of the instruments is checked.

TOTAL QUALITY MANAGEMENT:

Total Quality Management department is head, approaches a new to improve product

quality and increased customer satisfaction on a Continuous basis by restructuring traditional

management practices.

Features of TQM:

Customer driven quality.

Strong quality leadership.

Continuous improvement.

Actions based on facts, data and analysis.

Improved two way communication systems.

It concentrates more on:

Operating procedures.

Financial performance.

Employee relations.

Customer satisfaction.

TQM is a fundamental shift from what has gone before. The systematic analysis pre

planning and blue printing of operations remains essential but the focus switches from a process

driven by External control through procedure compliance and enhancement to a process of

habitual improvement where control is embedded within and is driven by the culture of the

organization.

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TQM is an approach for continuous improving the quality of goods and services

delivered through the participation of all levels and functions of their organization.

5S Concept in MALLADI:

The organization is concentrated on 5S concept implementations. Every month they

conduct an audit in the entire modules in all the units.

5 S is a methodology to get the whole plant clean, bright and in order. It’s a Japanese

model of housekeeping, which is very popular in the country today. It includes:

SEIRI meaning ‘Sort’.

SEITON meaning ‘Set in Order’.

SEISO meaning ‘Shine’.

SEIKETSU meaning ‘Standardize’

SHITSUKE meaning ‘Sustain’

KAIZEN Technique:

KAIZEN means “change for good”. It’s a Japanese model of change management which

calls for continuous improvements in our working life. Here problems are not shunned out but

welcomed and solved. This is practiced in the plant for Quality Maintenance, in order to

minimize defects. The systematic identification and elimination of waste to produce enhanced

quality product with reduced time and cost to deliver product on time considering the safety and

morale of employees is practiced at MALLADI.

MAINTENANCE DEPARTMENT:

The organization structure of maintenance department

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The maintenance department is head is in charge of engineering services department for

three sections namely fitter, electrician, and boiler operator. There are two boilers namely

thermax and wood boiler which have capacity to produce steam 6 ton/ hr and 3.5 ton/hr

respectively. Steam is sent as energy to the vapor absorption machine (VAM) .There are four

cooling towers for the fermentation section and exhaust fans which are used to transfer heat to

synthetic and extraction section. The boiler runs for 364 days throughout the year and is shut

down only once a year. It takes time for the boiler to start after complete shutdown. The HOD of

the maintenance ensures that motion work is reduced in all the three sections in case of any

failure of the machines. The maintenance department is the most crucial and important

department for the whole organization.

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EFFLUENT TREATMENT PLANT:

The effluent from the bulk drug industries generally consists of high organic content

thereby making the effluent as high COD effluent. For the purpose of treating this effluent,

Evaporation and Drying methods are used. A combination of Industrial Evaporators like Flash

Evaporator, Falling film Evaporator, Forced Circulation Evaporator and the Industrial Dryers

like Agitated Thin Film Dryer, Fluid Bed Dryer etc are used. Other auxiliary techniques such as

centrifuging, filtration, incineration are also employed. But the condensate water generated after

condensation of the vapors formed in evaporation process of this particular effluent tends to

carry the volatile organic compounds thereby increasing the COD of condensate water and

making it unfit for use/disposal. The COD of the condensate water can be brought down by

rectification/ carbon treatment or aeration with a high pressure blower for prolonged periods.

The effluent containing high amount of organics is preheated and then high heated using

steam as heating media and then it enters into flashing chamber where due to flash evaporation,

the maximum quantity of low boiling organics leave the effluent stream and their vapors are

condensed into a condenser. These condensed vapors can be incinerated in an incinerator for

Making the facility a complete zero pollution Plant. The output liquid stream from the flashing

chamber enters the multiple effects falling film evaporator for further concentration. After

concentration in the falling film evaporator, we get a concentrated stream of effluent which can

be then further concentrated or dried in different types of evaporators and dryers depending upon

the actual composition of the individual stream.

Finally, whole of the effluent is converted into solid/sludge form so that it can be

disposed and used as land filling and manure which is mixed with urea for trees and plant in

MALLADI .

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Eliminate wastage:

The organization identifies and eliminates wastage by 3W from:

1. Overproducing

2. Time on hand (waiting)

3. Transporting

4. Processing itself

5. Unnecessary stock on hand

6. Unnecessary motion

7. Producing defective goods

The organization in order to make dramatic improvement, 3D’s is removed at work place

and they are:

1. It is dirty. The possibilities of being dirty it could be dusty, leaky and noisy and the

solution is repetitive work or re-works.

2. It is difficult. The possibilities are heavy to handle, can’t/ access reach, steps hard to

follow, no standard and difficult to read (sense).

3. It is dangerous. The possibilities unsafe to work, for health, loose connections,

deteriorated parts, no ‘fit - to - finish’.

DOCUMENTATION:

Certificate of Inspection:

For a number of products notified under the exports (Quality control and Inspection) Act

1962. It is obligatory for an exporter of specified products to obtain an inspection certificate. The

scheme is administered by the Export Inspection Council of INDIA (EIC).

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Certificate of Quality and Quality control

The importer of any one of the following reason may require these certificates.

1) Assessment of customs duty.

2) 2) Required document in the process of authorizing foreign exchange.

PROCESS LAYOUT:

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Formulations:

This sector includes facilities that process the Active Pharmaceutical Ingredients (APIs)

into pharmaceutical preparations for human and veterinary use. Finished products are sold in

various dosage forms including tablets, capsules, ointments, solutions, suspensions and powders.

Production Operations:

Raw materials for intermediate and API manufacturing should be weighed or measured

under appropriate conditions that do not affect their suitability for use. Weighing and measuring

devices should be of suitable accuracy for the intended use.

If a material is subdivided for later use in production operations, the container receiving

the material should be suitable and should be so identified that the following information is

available:

- Material name and/or item code;

- Receiving or control number;

- Weight or measure of material in the new container; and

- Re-evaluation or retest date if appropriate.

Critical weighing, measuring, or subdividing operations should be witnessed or subjected

to an equivalent control. Prior to use, production personnel should verify that the materials are

those specified in the batch record for the intended intermediate or API. Other critical activities

should be witnessed or subjected to an equivalent control.

Actual yields should be compared with expected yields at designated steps in the

production process. Expected yields with appropriate ranges should be established based on

previous laboratory, pilot scale, or manufacturing data. Deviations in yield associated with

critical process steps should be investigated to determine their impact or potential impact on the

resulting quality of affected batches.

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Any deviation should be documented and explained. Any critical deviation should be

investigated. The processing status of major units of equipment should be indicated either on the

individual units of equipment or by appropriate documentation, computer control systems, or

alternative means. Materials to be reprocessed or reworked should be appropriately controlled to

prevent unauthorized use.

Blending Batches of Intermediates or APIs:

For the purpose of this document, blending is defined as the process of combining

materials within the same specification to produce a homogeneous intermediate or API. In-

process mixing of fractions from single batches (e.g., collecting several centrifuge loads from a

single crystallization batch) or combining fractions from several batches for further processing is

considered to be part of the production process and is not considered to be blending. Out-Of-

Specification batches should not be blended with other batches for the purpose of meeting

specifications. Each batch incorporated into the blend should have been manufactured using an

established process and should have been individually tested and found to meet appropriate

specifications prior to blending. Acceptable blending operations include but are not limited to:

- Blending of small batches to increase batch size

- Blending of tailings (i.e., relatively small quantities of isolated material) from batches of

the same intermediate or API to form a single batch.

Blending processes should be adequately controlled and documented and the blended

batch should be tested for conformance to established specifications where appropriate. The

batch record of the blending process should allow traceability back to the individual batches that

make up the blend. Where physical attributes of the API are critical (e.g., APIs intended for use

in solid oral dosage forms or suspensions), blending operations should be validated to show

homogeneity of the combined batch. Validation should include testing of critical attributes (e.g.,

particle size distribution, bulk density, and tap density) that may be affected by the blending

process. If the blending could adversely affect stability, stability testing of the final blended

batches should be performed. The expiry or retest date of the blended batch should be based on

the manufacturing date of the oldest tailings or batch in the blend.

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Contamination Control:

Residual materials can be carried over into successive batches of the same intermediate

or API if there is adequate control. Examples include residue adhering to the wall of a

micronized, residual layer of damp crystals remaining in a centrifuge bowl after discharge, and

incomplete discharge of fluids or crystals from a processing vessel upon transfer of the material

to the next step in the process. Such carryover should not result in the carryover of degradants or

microbial contamination that may adversely alter the established API impurity profile.

Production operations should be conducted in a manner that will prevent contamination

of intermediates or APIs by other materials. Precautions to avoid contamination should be taken

when APIs are handled after purification.

Packaging and Identification Labeling of APIs and Intermediates:

General:

There should be written procedures describing the receipt, identification, quarantine,

sampling, examination and/or testing and release, and handling of packaging and labeling

materials.

Packaging and labeling materials should conform to established specifications. Those that

do not comply with such specifications should be rejected to prevent their use in operations for

which they are unsuitable. Records should be maintained for each shipment of labels and

packaging materials showing receipt, examination, or testing, and whether accepted or rejected.

Packaging Materials:

Containers should provide adequate protection against deterioration or contamination of

the intermediate or API that may occur during transportation and recommended storage.

Containers should be clean and, where indicated by the nature of the intermediate or API,

sanitized to ensure that they are suitable for their intended use. These containers should not be

reactive, additive, or absorptive so as to alter the quality of the intermediate or API beyond the

specified limits. If containers are re-used, they should be cleaned in accordance with documented

procedures and all previous labels should be removed or defaced.

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Label Issuance and Control:

Access to the label storage areas should be limited to authorized personnel. Procedures

should be used to reconcile the quantities of labels issued, used, and returned and to evaluate

discrepancies found between the number of containers labeled and the number of labels issued.

Such discrepancies should be investigated, and the investigation should be approved by the

quality unit(s).

All excess labels bearing batch numbers or other batch-related printing should be

destroyed. Returned labels should be maintained and stored in a manner that prevents mix-ups

and provides proper identification. Obsolete and out-dated labels should be destroyed. Printing

devices used to print labels for packaging operations should be controlled to ensure that all

imprinting conforms to the print specified in the batch production record. Printed labels issued

for a batch should be carefully examined for proper identity and conformity to specifications in

the master production record. The results of this examination should be documented. A printed

label representative of those used should be included in the batch production record.

Packaging and Labeling Operations:

There should be documented procedures designed to ensure that correct packaging

materials and labels are used. Labeling operations should be designed to prevent mix-ups. There

should be physical or spatial separation from operations involving other intermediates or APIs.

Labels used on containers of intermediates or APIs should indicate the name or identifying code,

the batch number of the product, and storage conditions, when such information is critical to

assure the quality of intermediate or API. If the intermediate or API is intended to be transferred

outside the control of the manufacturer’s material management system, the name and address of

the manufacturer, quantity of contents, and special transport conditions and any special legal

requirements should also be included on the label. For intermediates or APIs with an expiry date,

the expiry date should be indicated on the label and Certificate of Analysis. For Intermediates or

APIs with a retest date, the retest date should be indicated on the label and/or Certificate of

Analysis.

Packaging and labeling facilities should be inspected immediately before use to ensure

that all materials not needed for the next packaging operation have been removed. This

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examination should be documented in the batch production records, the facility log, or other

documentation system. Packaged and labeled intermediates or APIs should be examined to

ensure that containers and packages in the batch have the correct label. This examination should

be part of the packaging operation. Results of these examinations should be recorded in the batch

production or control records. Intermediate or API containers that are transported outside of the

manufacturer's control should be sealed in a manner such that, if the seal is breached or missing,

the recipient will be alerted to the possibility that the contents may have been altered.

The Strategic Approach:

Arising from the above discussion, the broad strategy for evolving a market-based system

which would ensure the availability of drugs at reasonable prices to all sections of the population

rests on the following fundamental principles:

1. Domestic production of bulk drugs should be encouraged to the extent possible.

2. Space for the emergence of new pharmaceutical companies should not be curtailed.

3. Focus should only be on the prices of formulations, i.e. the products actually used by

the consumer.

4. Intra-industry transactions should not be distorted.

5. All regulations should be transparent and non-discriminatory.

6. Choice and exercise of consumer sovereignty should be promoted.

7. Provision should exist for strategic interventions.

8. Interests of the economically weaker sections should be protected.

There are three broad options available to moderate the price of drugs and to sub serve

the above principles without resorting to overt price controls:

(a) Price regulations, involving monitoring and negotiations.

(b) Creating conditions for a competitive market structure in which the existence of

choice and exercise of consumer sovereignty can lead to price competition.

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(c) Encouraging emergence of countervailing forces on the demand side.

In the Indian context, as in many other countries, a combination of all three options will

have to be evolved, given the wide variations in disease conditions in different parts of the

country and the disparate nature of the people in terms of income and awareness.

Bulk procurement procedures:

Since the long-term operation of the proposed price regulatory mechanism is depending

upon the prices prevailing in bulk procurement activities, it is imperative that the bulk purchase

mechanism be streamlined to ensure that the current malpractices are curbed so that the prices

reflect the true value of quality drugs. Since bulk purchases are a valuable method for enabling

smaller companies to diversify and grow, care should be taken to ensure that the bulk purchase

orders are not so large as to exclude smaller manufacturers if they qualify otherwise. It is

suggested that the following conditions should be considered as minimum criteria for evaluating

bulk purchase operations for inclusion in the reference price computations:

(a) Procurement only from pre-qualified manufacturers and not from middle-men or

traders.

(b) GMP compliance of the manufacturer. Although this is now legally required, it needs

to be specified as pre-qualification and enforced.

(c) Minimum three years of track record in sustained production of the concerned drug.

Balance sheets of past three years may be obtained to assess the installed manufacturing

capacity and financial strength of the manufacturer

(d) Post-award inspection of manufacturing facilities

(e) Procurement of preferably generic drugs only.

Bulk procurement systems not conforming to the above requirements should not be taken

into account for working out reference prices. In order to ensure that bulk purchase data is

available from a variety of sources, the government should consider specifying the above

requirements as a condition for any financial support to States and other designated agencies for

procurement of drugs for distribution through the public healthcare system.

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Promotion of Generics:

Public procurement and distribution of drugs through the public health system should

preferably be for generic drugs.

Quality certification may be provided free to generic drug manufacturers through an

appropriate scheme to be formulated by the Department of Chemicals &

Petrochemicals.

No control on price or distribution margins may be specified for generic drugs, but

these may be kept under price monitoring.

SAFETY:

The safety department is well organized and coordinated by Manager of safety

department. In a drugs manufacturing company safety is an important factor to be considered

since raw materials are easily combustible and the employees in particular require safety while

pre and post handling the operations of the machine.

When truck drivers enter at the gate with the raw materials, a flame arrester is provided

on the muffler at the security gate to avoid spark from the engine when the accelerator is raised.

Truck drivers travel from far distances and have their own stove and cooking accessories with

them to cook food, thus these combustible items are removed from them to avoid fire break out.

The truck drivers are frisked for cigarettes, lighters, mobiles, other miscellaneous items if found

are seized in order to maintain safety for any mishaps.

Solvents like toluene, acetone while unloading in the container also require safety. First

of all the ignition of the engine is switched off. The trucks are fitted with gas pipelines to transfer

them into the container and during the flow of solvents static electricity is developed in the

pipelines due to high velocity which causes explosion, to avoid the static electricity the trucks are

body earthed to the earth iron. In front of the tires a wooden block is placed in front of the tires to

avoid the movement of vehicle to pull away from the pipeline which causes wastage of the

solvents. The driver should be near by the truck till the whole transfer process is over since in

any case of emergency, the truck should be driven out.

For the employees personal protective equipments like gloves, helmet, goggles, face

masks, nose masks and safety shoes are provided to ensure safety protection from hazardous

materials and harmful chemicals like acids and bases. It is ensured the personal protective

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equipments are of the ISI quality standards. A register is maintained for each employee to keep a

record of all the equipments issued to the employees and the usage of the equipments is verified

by the supervisors when inspection is done. Color code is provided for pipelines to differentiate

the flow of solvents and combination color code is provided for nut, bolts and other joints.

Similarly numbers for reactors, storage tanks and labels are also present. Temperature and

pressure gauge are fitted to monitor and necessary actions are taken if needed. There is an

underground storage for solvents and they are maintained at a temperature of -23 degree Celsius.

There is a big lightning arrester to allow the flow of charges to the ground when the lightning

strikes and wind sac on roof. In case of any accidents, there is an ambulance which is operating

24*7 and the organization has a tie-up with Ida Scudder Memorial hospital, Vellore. The

employees are ordered to follow the Standard of Procedures (SOP) only before handling the

machine. Every year National Safety Day is celebrated on March 4 and various events like essay

writing, poems; caption writing and prizes are awarded for the winners.

ENVIRONMENTAL POLICY:

We commit ourselves to maintain a clean environment through constant improvements in

methods and trials. We provide a framework for setting and reviewing environmental objectives

and targets. We strive to limit, control and prevent all the spheres of pollution based on scientific

understanding.

SAFETY AND HEALTH POLICY:

We believe that safety and Health of our employees and safe working environment

are fundamental to our operations. We will ensure this by providing and maintaining

safe working conditions, continuous education and training.

We also consider the performance of the employees, with regard to their usage of

PPE, following safety procedure and eliminating unsafe condition in the work place,

during their annual appraisal for increments and career advancement.

All contractors and our customers including transporters are educated and trained to

strictly follow the safety procedure of our organization.

The safety and Health policy report will be part of the annual report of our

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organization.

We shall conduct safety Audit, do hazard and risk analysis, and take preventive

actions to eliminate the accident potential in the work place. We shall record the

accidents then and there, investigate and initiate corrective actions. We shall also

discuss the same in the safety committee meetings.

MATERIAL SAFETY DATA SHEET:

A material safety data sheet (MSDS) is a form containing data regarding the properties of

a particular substance. An important component of product stewardship and stewardship and

workplace safety, it is intended to provide workers and emergency personnel with procedures for

handling or working with that substance in a safe manner, and includes information such as

physical data (melting point, boiling point, flash point, etc), toxicity, health effects, first aid,

reactivity, storage, disposal, protective equipment and spill handling procedures. The exact

format of an MSDS can vary from source to source within a country depending on how specific

is the national requirement. MSDS can be found anywhere chemicals are being used.

There is also a duty to properly label substances on the basis of physio-chemical, health

and/or environmental risk. Labels can include hazard symbols such as European Union standard

black Diagonal cross on an orange back ground, used to denote a harmful substance. An MSDS

for a substance is not primarily intended for use by the general consumer, focusing instead on the

hazards of working with the material in an occupational setting.

Chemicals are widely used in industry. Many of them are toxic, corrosive or flammable.

However, they can be safely handled if information on their physical, chemical and hazardous

properties together with the necessary precautions to take is made available to users.

Chemical or material safety data sheets (MSDS) are used in many countries to provide

the information necessary for the safe handling of hazardous substances. Therefore, MSDS play

an important role in the comprehensive approach to the control of chemical hazards in the work

place.

There is a need to ensure that Material Safety Data Sheets are produced to meet certain

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minimum standards of acceptability.

Role of MSDS:

The material safety data sheet has a number of roles for managing the safe use of

chemicals.

It should first be used to ensure that the product is being used as intended by the

manufacturer or importer. Other use may be possible, but particular care should be taken

when the product is being put to a ‘new’ use – it may give rise to unforeseen hazards.

It is the key tool for risk assessment as it includes detailed hazard information.

The options for appropriate controls included in the MSDS may be 48ehavior for the

design and improvement of control measures and procedures.

Sufficient information should be provided to select the necessary safety equipment and to

develop necessary emergency procedures.

Workplace monitoring and health surveillance strategies may often be based on advice

contained in the MSDS.

The MSDS may be used as the basis of a training program for workers as it covers

hazards, precautions and emergency procedures.

The information content of MSDS is listed as follows:

1. Identification of the substance and of the company

2. Composition/information or ingredients

3. Hazards identification

4. First-aid measures

5. Fire-fighting measures

6. Accidental release measures

7. Handling and storage

8. Exposure controls/personal protection

9. Physical and chemical properties

10. Stability and reactivity

11. Toxicological information

12. Ecological information

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13. Disposal considerations

14. Transport information

15. Other information

COMPARISON OF THEORY AND PRACTICE:

1) 5S Concept:

It’s a Japanese model to keep the whole plant clean, bright and in order and the

observation which I observed in the organization is:

a) SEIRI in office:

Unused or broken pen

Irrelevant or useless papers, notebooks, files.

Old diaries.

Broken furniture.

Unused paper weights.

Expired short hand note book (memo pads) carbon paper and scribbling

pads.

Outdated and obsolete vouchers, slips etc.

b) SEITON in office:

Files not clearly identified.

Tables, drawers are cluttered with papers, keys, pens.

Lack of proper indexing system in cupboards file cabinets.

Papers heaped on the table of keeping urgent trays.

c) SEISO in office:

Dust and grime in type writers, photocopier machines.

Telephones, fax machines.

Computers and printers.

Dirty windows, ventilators.

Dirty fans, tube lights, air conditioners.

Dirty tables, chairs, cupboards, drawers and cards.

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d) SEIKETSU in office:

Toilet and washbasins are disinfected.

e) SHITSUKE in office:

Self discipline.

2) KAIZEN:

Steps for continuous improvement.

Providing leadership from the top.

Establishing Vision and policies.

Establishing and development quality goals.

Establishing measurement.

Rewarding the reward system.

3) ABC Analysis:

Always Better Control (ABC) analysis based on cost criteria helps to exercise

selective control when confronted with large number of items, it rationalizes the number

of orders, number of items and reduces the inventory. This is practiced in the stores

department when order is placed and is an important management tool for materials

management.

4) Storage:

The stores department has a storage area to store materials in a correct way by

arranging them in group wise and alphabetical order which helps the workers for

identification, traceability and retrieval. First in first out principle is followed to avoid

stock out and minimum reorder level is always maintained in order to reduce lead time.

5) Batch Process Report:

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In accordance with the performance appraisal of the employees, the Human

Resources have a Batch Process Report for each employee. In this report the employee’s

good or bad incidents are noted and during the period under consideration for appraisal

have to be acknowledged by the immediate superior or the reporting officer. This ensures

that none of the activities of the employee gets unnoticed before appraisal.

6) Training and Creating awareness:

The Human Resource department plans at the beginning of every year a training

schedule for the employees. The HR takes immense effort to train the employees and

other senior employees also give lectures on current environment issues which creates

awareness among them to protect our surrounding.

7) Approval for vendors:

The quality control and quality assurance department function is to approve the

raw material received from the vendors (supplier). They perform various standards to

verify whether the product meets the quality standards. If it does not meet the standards

then they stick a red label to reject it.

8) Traceability and Identification:

In this method the stores department arranges the materials with unique number for

easy traceability and identification. This method reduces motion time and increases

productivity.

9) Welfare Schemes:

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For the better prosperity and well being of the employees, from each department a

best employee is chosen based on performance in productivity and attitude towards work

and rewards for their work is given. Medical treatments are provided in case of

emergency.

10) Employee Participation:

Employee Participation is important in any organization and can be in the form of

suggestions and quality circle meetings. Effective suggestions are rewarded in the form

of cash rewards, recognition or merit certificate. It is one of the methods for motivating

employees to participate more for the welfare of the company.

LEARNING OBJECTIVES

To observe the practices adopted in each department.

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To understand the management activities performed in each department.

To perceive the insight opportunities of the departmental inter-relations.

It gave me an insight into the production department where I observed the processes

of fermentation, synthesis, and extraction.

There is an opportunity to view the two different types of boilers and their functions

at each stage in the maintenance department.

It will give me a mind experience to study the activities performed in the stores

department like order level, traceability, identification, purchase, transportation, and

warehouse.

It will provide me a platform to interact with various people from different industrial

background and experience.

To learn about the interpersonal communication between the staffs in and between

departments for activities and transaction.

LIMITATIONS

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In undertaking this study, a number of problems were faced. Thus the study has several

limitations. The limitations are:

1. Lack of knowledge:

As a student, in the research field, I have no past practical experience of data collection,

data processing, data analyzing, integrating and presenting. So it is a limiting factor for

obtain accurate information.

2. The HR manager doesn’t provide sufficient data as we required.

3. It is fairly not possible for an internee to cover up the whole thing within a short time.

They run their activities adjacent to all kind of constraints.

4. They didn’t answer my question always. Because they don’t have the permission to talk

about these things. They always treat me like a junior reporter and also an internee.

5. Security is in strict manner that’s why the visiting purpose becomes more difficulty to us.

OBSERVATIONS

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Still they are using MS-EXCEL for pay roll and Microsoft Office for other functions in

Human Resource Department.

In MALLADI, the warehouse is quite small and moreover the stock of goods present in

warehouse is monitored manually by humans which are tedious and time consuming.

The organization is concentrated on 5S concept implementations. 5S as follows:

1. Sort

2. Set in Order

3. Shine

4. Standardize

5. Sustain

Every month they conduct an audit in the entire modules in all the units.

The company didn’t provide any break time in the working hours.

There is no proper visiting hours and no waiting room for Visitors.

The company is not following Any Safety measures towards the Employees health.

The HR manager is interacts with all the subordinators and Superiors in a formal way for

implementing new ideas which is needful to the company.

The company providing Lunch facilities, Insurance facility, Travelling facilities and

uniform & shoes to the Employees.

SUGGESTIONS

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1. The warehouse should be atomized then the lifespan of the finished product will be

increased.

2. The maintenance department should take care of the water facilities provided to the

employees.

3. The company has to provide safety measures to the employees.

4. It is better to build a waiting hall for the visitors.

5. The HR department should be updated by implementing SAP in administration.

6. The company has to Provide Break for 15min in the working hours then the employees

will get refreshed and worked actively.

CONCLUSION

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The organization has more concern towards the environment, employees, union by

following the global principles and put forward its thoughts by promoting environment friendly

business to the world by its new products. It coined profit making and environmental

commitments which are part of their success.

The organization follows international standards to achieve the utmost customer

satisfaction by its timely response and meets the customer requirements by resolving their

problems.

BIBILOGRAPHY

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BOOKS and ARTICLES:

1. SAP HR- PERSONNEL ADMINSTRATION AND RECRUITMENT- P.K.

AGRAWAL Published by ASOKE K.GHOSH, Prentice Hall of India Private Limited,

New Delhi.

2. Barber, C.S. and Tietje, B.C. (2004), “Competency requirements for managerial

development in manufacturing, assembly, and/or material processing functions”, Journal

of Management Development, Vol. 23 No. 6, pp. 596-607.

Websites:

1. www.Malladi.co.in

2. www.wbdg.org/design/warehouse.php

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