EFFORTS BY:

BHAVNA AILSINGHANI DEBOPRIYA BASU SUGHANDHI GUPTA NISHA KHANWANI VARSHA MAKHIJA

(05) (16) (44) (52) (69)

SUBMITTED TO: SMRITI MAM

MISSION STATEMENT

INTRODUCTION
SSI sector occupies a very dominant place in the Indian Economy. To overcome the two major problems of unemployment and poverty, development of SSI sector has been considered to be essential as it could fulfill the twin objectives of providing large-scale employment in a capital scarce economy. The SSI sector has emerged as a dynamic and vibrant sector. The sector accounts for 40% of the industrial production, 35% of the total exports and employs about 170 lakh people. The sector manufactures a wide range of more than 7,500 products. As per the quick Estimates of Third All India Census of Small Scale Industries, there are over 23 lakhs registered ssi units employing about 34.5 lakh persons. Total investment in the SSI sector is to the tune of Rs. 53,35,580.77 lakhs, with the total gross output of 1,14,20,438 lakhs. The Cluster Development Approach has been quite successful in the national and international arena for the development of small-scale industries. The focussed development of clusters has been strongly recommended by the Abid Hussain Committee as well as by the Dr. SP Gupta Committee for SSIs. The pharmaceutical industry is the part of mother Health Care Industry. The pharma sector is a remarkable success story. While medicines may be retailed at around 25-50 paise per tablet in India, in the US and Europe, no tablet is sold for less than half a dollar. Pharma analysts are upbeat about the sector's export prospects. Says Prashant Nair of Pranav Securities, "The export scenario in the pharma sector looks good. The outsourcing angle is applicable here, too. Big companies can make it on their own while smaller ones may supply basic raw material and bulk drugs to global majors." Analysts say that exports would remain the main growth driver for the industry.

COMPANY PROFILE
Wincoat Colours and Coatings Pvt. Ltd. is engaged functional coatings. The company began in 1993 by the name Tamhane Coatings and subsequently merged with Wincoat Colours and Coatings Pvt. Ltd. In 1997 operations were initiated from its ultra modern production facility at Ambernath, Maharashtra - about 60 kms. From Mumbai city. The company's premises and operations were approved and was the first in its category to be granted a manufacturing license from Food and Drug Administration, Maharashtra, India. Our production facility is well equipped with the latest Technology and Instrumentation for Research and Development. Jet Mills, air handling units and modern manufacturing equipments. The company was awarded "UdyogShree" in the year 2001 by the state Government for excellence and outstanding contribution in Business Development. WHO GMP (good manufacturing practices) certified company. FDA approved facility and product range. Strong presence in the domestic and overseas market. Professionally trained technical staff. Strong R&D application base. in manufacturing with Readymix special for Tablet on Coating. The range comprises of functional and noncoatings, emphasis environmental friendly and cost effective aqueous

PROFILE OF THE PERSON INTERVIWED:

NAME: MR. AJAY. RAJE DESIGNATION: Works manager & production Incharge. CONTACT ADDRESS: WINCOAT COLOURS & COATINGS PVT. LTD FACTORY: D-24, M.I.D.C., Additional Ambernath, industrial Area, Ambernath (east), 421506, Maharashtra, India. OFFICE: S-152, Vedant Commercial Complex, Pokhran Road no.1, Vartak Nagar, Thane (West) 400606, India. TELEFAX: ++91-251-2621778. E-MAIL: wincoat@vsnl.com. WEBSITE: www.wincoat.com.

PRODUCTS:
They prepare ready mix for the pharmaceutical tablet coating i.e. powder for coating the tablets. In simple words giving colour to already produced tablets. WINCOAT* is a ready to use film coating system with film forming polymers like Hydroxy Propyl Methyl Cellulose, Cellulose Acetate Phthalate, Hydroxy Propyl Methyl Cellulose Phthalate, Plasticizers, Opacifiers and colours. WINCOAT* forms a very uniform, smooth, sprayable suspension either in organic solvent or water using simple propeller stirrer. Suspension will be ready to use within 45 minutes. No additional homogenizing or grinding is required. Normal coating time is 90 to 120 minutes. WINCOAT* Aqueous eliminates the use of hazardous, expensive and explosive solvents thereby helps in further reduction of costs and making it safer to use. WINCOAT* provides your tablets with edible shrink-wrap forming uniform thin film on tablet. All embossing on the tablet are visible even after coating. WINCOAT* gives and maintains the identity of your product.

TABLE GRADE
GRADE
WINCOAT WT WINCOAT(AQ) WINCOAT WT-SWINCOAT WT-N

MODE OF COATING
REGULAR FILM COATING REGULAR FILM COATING (AQUEOUS COATING) REGULAR FILM COATING ENTERIC FILM COATING

POLYMER
Hydroxy propyl methyl cellulose Hydroxy propyl methyl cellulose Hydroxy propyl methyl cellulose Hydroxy propyl methyl cellulose phthalate or cellulose acetate phthalate Hydroxy propyl methyl cellulose & cellulose acetate phthalate Hydroxy propyl methyl cellulose & cellulose acetate phthalate

WINCOAT WT-MP WINCOAT WT-TR

MOISTURE PROTECTIVE TRANSPARENT FILM COATING

ORGANIZATION STRUCTURE:
There are various departments in this company, such as: Production, stores, security, accounts, R&D, logistics, QCQA (Quality control & Quality assurance), marketing. The organization structure is as follows:

REGISTRATION:
They are registered under the SSI Act. Along with it they are also registered with different institutions as follows: They are registered with

FDA (Food and Drugs Administration),

WHO-GMP:

Wincoat Colours and Coatings Pvt. Ltd. have been awarded the prestigious GMP certification by WHO certificate No. :WHO-GMP-CERT/KD/36. GMP adheres to international pre-requisites as shown below:

All manufacturing processes are clearly defined and systematically reviewed from time to time Change control procedures and process validation are being regularly reviewed and documented. The following necessary facilities for GMP have been provided Appropriate qualified and trained personnel, adequate premises and space, suitable equipment and services, appropriate materials containers and labels, approved standard operating procedures, suitable storage and transport. All personnel including technical operators and workmen are trained and their knowledge is regularly updated by way of audio-video systems and other methods.

Proper systems are recorded and maintained for manufacturing, filling, packing, storing, distribution and recalling.

HALAL(JAMIAT ULAMA E MAHARASHTRA)

This certifies that no part of any animal or any animal skin is being used in coating the tablets.

NUMBER OF EMPLOYEES:
There are round about 22-30 employees in this company.

INCENTIVES/BENEFITS TO THE EMPLOYEES:

Bonus, provident fund and production incentives are given as per the individual performances based on skilled, semiskilled or unskilled.

CUSTOMERS:
WINCOAT* formulations are custom made and hence flexible and can be adopted as per customers need. Innumerable shades are available in a range of synthetic as well as natural colours. Necessary care is taken while using the colorants with respect to international legislative requirements. The customers are domestic as well as international customers. The business of this company is distributed as: Domestic 75%, International 25%. Which are about 150 customers overall. Some of the customers are as follows: CADILA
CARE, PHARMACEUTICALS, CADILA ZYDUS, CADILA HEALTH

NICHOLAS

PIRAMAL.

DISTRIBUTION CHANNEL:
As the order comes, they supply directly to the company through various modes of channels such as the road transport, air freight, & courier or hand delivery for companies in vicinity.

TURNOVER:
The turnover of this company is round about 1.5 to 2 crores.

COMPETITORS:

The competitors of this company are COLORCON, IDEAL CURE, and PHARMACEUTICAL COATING.

RAW MATERIALS:
POLYMERS: Those are generally imported from the countries like CHINA and USA. Although these are available in INDIA too but not up the grade required and so they are imported with specific government permission.

INVENTORY:
The inventory is maintained through LOT system and BATCH system.

MARKETING:
The products are marketed through different exhibitions & trade fairs. During these exhibitions they display different brochures and highlight information about the company and if the persons are interested or convinced with them, they provide different samples to the prospective buyers and accordingly orders are placed. The another way used for getting the orders is through e-mails, i.e sending mails to the different pharmaceutical companies and providing information regarding the products,speed posts, courier and sometimes they personally visit and convince the customers. For exports they look or surf different sites and see what their needs are and accordingly provide information and get orders through mails. EXAMPLE: The company participated in the TRADE FAIR organized by IPC (Indian Pharmaceutical Congress) held in Varanasi.

PRODUCTION FACILITY:
Production is well equipped with sophisticated machineries

Air handling system is provided to control microbial contamination and dust particles 5 filtered UV treated water is used for cleaning the equipments GMP is strictly followed Dedicated areas are provided for each colour to avoid cross contamination Jet mill is used to reduce the particle size, to ensure smooth appearance of coated tablets using WINCOAT Documentation is maintained for efficient control of all the operations.

QUALITY CONTROL:
Quality is well equipped with sophisticated instruments like UV Spectrophotometer, Brookfield Viscometer & Reflectance Spectrometer with Computerized Colour Matching Programme. Each and every consignment is completely analyzed for all quality parameters and due documentation in the form of the following reports is provided.

QUALITATIVE ANALYSIS:
It gives the list of ingredients of particular WINCOAT* along with the name of the pharmacopoeia to which they are complying. For colours C.I.No. Is specified. This helps the customer while registering their products

CERTIFICATE OF ANALYSIS:
It gives the tests carried out of that particular WINCOAT*, limits and results obtained.

COLOUR MATCHING REPORT:

It shows graphs of both standard and batch. From the graph we can make out how the colour is matched. It also helps in identification of colourants.

INSPECTION CERTIFICATE

PACKAGING:
WINCOAT is packed in double line polythene bags which inturn is packed in polymer coated fiber drums having a metal rim with a tamper proof plastic seal. Smaller quantities of WINCOAT are available in HDPE jars.

GOVERNMENT ASSISTANCE:
Being an SSI they get the following benefits/assistance from the government: Duty drawback Sales tax is partly exempted under form no. 31 Benefit in VAT The government also assists them by giving them orders. Some of the government bodies are: Hindustan Antibiotics (pune), Haffkine (parel).

SOURCE OF CAPITAL:
Basically the main source of capital is loan from the government at the concessional interest rates.

TOKEN OF APPRECIATION:

TOKEN OF APPRECIATION BY ASSOCIATION OF PHARMACEUTICAL PRODUCERS OF NEPAL (APPON) This is the first Nepal Pharma & Healthcare Expo 2005 Organized by APPON

EXPRESS

PHARMA PULSE AWARDS

(30TH MARCH 2000)

UDHYOG SHREE AWARD

GROWTH PROSPECTS OF THE COMPANY:

Pilot scale studies have been completed in edible ink, to be launched soon in the market "Development activity for natural color applications in WINCOAT"

 Customer test trials completed in fast sugar coating ready-mix -"

WINGLO". The time consuming aspect of coloring the sub-coat is minimized with WINGLO. Various economical alternatives are being evaluated to substitute the conventional polymers.

BENEFITS OF BEING AN SSI:

Reduction of excise duty from the current 16 per cent to 8 per cent and increase in the turnover criteria for SSIs to Rs 5 crore from Rs 3 crore will offer a breather and a level playing field for the SSI units, served as an advantage to this company. Being an SSI,the company gets taxation benefits from the government

PROBLEMS OF BEING AN SSI:

Problems faced by this company are: The most critical problem faced by the company is the power failure. Though the one day is fixed for complete power failure but many a times the company faces the problem of irregular loadsheding because of which there are many interruptions in the production process. Huge investments for establishing in-house R&D and testing facilities Adding more woes, a recent decision of the Drug Controller General of

India (DCGI) not to license fixed drug combinations and register new drugs with the office caused the SSI units to stop new product introductions. Adherence to international standards of quality. Lack of waste disposal facilities. Spurious drugs flooding the market: Nationally, reported to be worth Rs. 4000 Cr. and offenders are punished measly. Brand maintaining techniques are expensive. One of the major problems faced by this company is during its establishment. It has to seek permissions from various authorities at every stage. Firstly it has to seek permission from the government for approval of the plant in the MIDC. Then various inspections are to be held from various authorities. Also permission has to be taken from FDA (Food and Drug Authority). All such authorities give their own opinions and views regarding the set up and the company has to adjust as per their requirements. complicated. Thus the process of setting up of business gets

MAJOR CONCERNS/ PROBLEMS (SSI IN GENERAL):

More than half of the small-scale pharmaceutical units operational in India have either closed down or indefinitely suspended business activities in the last two years, having being struck by un-favorable government policies and the inability to compete with big companies in the changing business environment. TS Jaishankar, chairman of the Confederation of Indian Pharmaceutical Industries (CIPI), a national grouping of small-scale pharmaceutical associations in various states. Said that they estimated that functional SSI pharmaceutical

units, currently, are less than 2,000 and most are fighting for survival. If the SSI units were introducing about 1,000 brands every year with licences from the state drug controllers, this number has shrunk to less than 100. New drug registrations are expensive for the SSIs since they have to give safety and efficacy data to the authority for approval. Issues like debt burden and loans from banks force most sick units to sell the companies or surrender their manufacturing licences. Since the units are not well modernized, big pharmaceutical units are not interested in taking over the manufacturing assets, said Jaishankar. "At least 1,000 units are up for sale, but there are no takers," he added. Two major policy initiatives in 2005 -- to mandate good manufacturing practices (GMP) for all pharmaceutical units The GMP norms forced them to invest heavily in modernization to comply with the rules. As a result, many manufacturers surviving on thin profit margins exited the business, instead of risking investments on borrowed capital, said sources. According to a Union Health Ministry data published in 2007, as many as 788 units have either cancelled or suspended operations after the Government implemented the GMP norms.

VIEWS &SUGGESTIONS
SSI sector has always remained backbone of pharmaceutical industry, especially in terms of export growth; this sector still requires assistance and flexibilities from the Government so that the growth memento is not disturbed. With the product patent in place on 1.1.2005 taking place of reverse engineering, there will be more dependants on generics, in which tough competition from the global market is ahead. Anticipating contract business from the global manufacturers for production in India, keeping the low cost advantage, SSI sector has to gear up to produce quality products which is acceptable internationally. For maintaining the top class

quality as per the International standards, adequate infrastructure is to be provided to this sector, which needs funds from the Government. According to us the basic problem of the power failure should be solved. Apart from the days fixed for the power cutoff in M.I.D.C. area, there should be no power failure on the rest of the days, and if at all it is necessary to cutoff the power on the other days then it should be done prior to the working hours or after the working hours in order to avoid interruptions during the production. Since the company has to seek permissions from the various authorities during its establishment due to which much of the time & money is wasted & this poses as a great difficulty for the company to go according to all these different norms & procedures. So it is suggested that there should be One Window System i.e. there should be only one specific authority from whom the company should seek permissions regarding the conduct & setup of the business. Considering the point of exports, the pharmaceutical company has to maintain the quality standards & lab layout as per the rules & norms of the foreign countries & usually the big companies are over & above the small companies in maintaining those standards. So it is suggested that the small companies should get some assistance from the government for adhering to the international quality standards.