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Glaxo Smithkline Consumer Healthcare Ltd.(GSKCH) is an Indian associate of GlaxoSmithkline plc,U.K. GSKCH is one of the largest players in the Health Food Drinks Industry in India. The Company, with its manufacturing plants located in Nabha, Rajahmundry and Sonepat. Has a total workforce of over 2700 people, each driven by a spirit of enterprise.Its flagship product, Horlicks, is a highly respected brand which is over 100 years old in India. The Company also manufactures and markets Boost, Viva, Maltova, Biscuits and in addition promotes and distributes number of products in diverse categories, including prominent brands such as Eno, Crocin, Iodex.GSKCH has a strong marketing and distribution network in India comprising over 1800 wholesalers and direct coverage of over 4,00,000 retail outlets. . The company has dedicated consumer healthcare R&D center takes research as seriously as marketing excellence, offering cutting-edge capability in both.
Photo: Our Mission and Spirit“Our Global Quest is to improve the quality of human life by enabling people to do more, feel better and live longer.”
As a Global Organization, we are united in our approach to how we conduct ourselves. For us to take pride in our contribution and make a difference, we all must be in touch with the elements that make us successful.
“We undertake our quest with the enthusiasm of entrepreneurs, excited by the constant search for innovation. We value performance achieved with integrity. We will attain success as a world class leader with each member of our team contributing with passion and an unmatched sense of urgency”
Our spirit gives us the qualities as individuals and as an organization that will enable us to turn our opportunities into achievements. Our spirit will guide us, keep us focused, and differentiate us from the competition.
OVERVIEW of company
The first plant was set up at Nabha by M/S Horlicks was being imported and marketed India after being packed in the bottles. The reason why the plant to produce Horlicks was set up in Punjab(Nabha) was because the import of Horlicks was stopped by the government of India,following which the company decided to set up a plant in India itself and the raSw material i.e.milk was available in Punjab.The Maharaja of Nabha laid this foundation stone of the factory. Maharaja Pratap Singh In Nabha on 31st May 1959. The Factory went in for production in March 1960. Barley Malt and Wheat Flour were easily available but the procurement of milk was creating a problem. So to solve it,many milk centres were opened in village around Nabha. Field Officers were appointed to go to the villages for guiding and encouraging farmer to sell milk and tame more milk giving animals for the better income. In the very first year the factory earned profits and about 37% bonus was distributed amongst the employees. Within five years the factories production capacity doubled as the demand for the Horlicks increased and in period of nine years there was four-fold increase in the production of Horlicks. As the demand went on increasing, the production of Horlicks also increased in the Nabha unit. However there was still a gap between the demand and supply therefore, 50% workmen were made permanent and the casuals were enrolled as per the requirement. As the main market for sale was in the south and west of India, the need was felt for establishing small packaging stations of Horlicks is dispatched from Nabha in bulk quantity to Different packaging stations namely Calcutta, Madras, Hyderabad, and Ballabgarh. Only the Calcutta packaging stations, is owned by the company the other packaging stations are on contract.
Company Glaxo Smithkline Consumer Healthcare Ltd.
Head Office Gurgaon,Haryana
Registered Office Nabha(Punjab) Status Multinational Co.
Sales Turnover (2006) Rs. 12,143 (millions), 11.5% increase as . compared last year
Profit Before Tax (2006) Rs. 1,905.6 (millions)
Export Operations to places Bangladesh, Myanmar, Sri Lanka, Middle East, Nepal, Hong Kong, Malaysia and Fiji
SECOND LARGEST COMPANY
GlaxoSmithkline Consumer Healthcare(GSKCH)is the world's second largest over-the-counterhealthcare products company and is also ranked second globally in sales of oral-care products. GSK is one of the world's leading research-based pharmaceutical and healthcare companies, with annual sales of nearly $3billion in 2001 an estimated seven percent of the worlds pharmaceutical market. GSK has over 100,00 employees worldwide.
Ø Every second, more than 3 doses of vaccines are distributed by GSK.
Ø Every minute, more than 110 prescriptions are written for GSK products.
Ø Every hour, GSK spends more than $45000to find new medicines
GlaxoSmithKline is a pharmaceutical and healthcare company born out of the merger of two leading international organizations. Smithkline Beecham and Glaxo Welcome. Its global mission is “To Improve the quality of human life by enabling people to do more,feel better and live longer.”
* THE YEAR 1955
Horlicks a milk product manufactured by Horlicks Ltd. Slough, England was being imported, bottled and sold in India. Due to changes in import policy import stopped.
* THE YEAR 1956-57
A team from the organization visited to explore the possibilities of setting up a plant with the support of Maharaja of Nabha, His highness PRATAP SINGH, and a plant was set up at Nabha.
* THE YEAR 1958
On May 31st 1958, Mr. Pratap Singh laid the foundation stone of the Company at Nabha.
· THE YEAR 1960
On 24th March 1960, the factory went into Production.
· THE YEAR 1969
§ Horlicks Group disposed off their holding in India and U.K.
§ To “BEECHAM GROUP OF INDUSTRIES” which is multinational and owns more than 200 countries engaged in manufacturing of Brylcream , Haircream, Eno fruit salt, Toothpaste , Pure Silvikrin etc.
Immediately after taking the management, Beecham Group shifted its head office from Nabha to Delhi.
THE YEAR 1979
Beecham India (Pvt.) Ltd. Mumbai merged with Hindustan Milkfood Manufacturers Ltd. and the name was changed to H.M.M.Ltd.Beecham Group Plc.
THE YEAR 1991
§ Smithkline U.S.A. merged on September 16,1991 to form Smithkline Beecham consumer Brands,Plc. with its registered office in the U.K.
§ H.M.M. became a part of smithkline Beecham Consumer Brands, one of the three sector of Smithkline Consumer Brands Ltd.
* THE YEAR 1994
§ The name was changed to Smithkline Consumer Healthcare Ltd. to reasset the company's promise of providing Healthcare to consumers.
§ The company decided to do away with its toiletry products and sold its brands like Brylcream and Silvikrin to Sara Lee.
· THE YEAR 2000
The Company acquired MALTOVA and VIVA brands of nutritional from Jagjit Industries Ltd. A merger took place between Smithkline Beecham and Glaxo Wellcome and the new company Glaxo Smithkline (GSK) was formed on 27-12-2000
· THE YEAR 2002 :
Change of name took place effective April 23rd, 2002.
· THE YEAR 2004 :
The Bank of Punjab has tied up with the company for facilitating finance on attractive terms to its milk suppliers. The company started packing Horlicks in ½ kg and 1 kg pouches. Packing machines was imported and installed. As the main market for sale of Horlicks was in the South and East India, need was felt for the sale of Horlicks in small units of the country. Therefore packing station was opened at different places. At present Horlicks is dispatched from Nabha in bulk quantity to the following packing stations:
§ Baddi(Himachal Pradesh)
The marketing of the company's products is done through various Regional Sales Offices(RSO) situated at :
§ North Delhi
§ West Mumbai
§ East Kolkata
§ South Chennai
The Company has established a new plant in Sonepat with a capital layout of Rs.246.69 crores.This plant is fully automatic using Spray Dry Technology. This plant has the State of Art Plant and machinery, and is biggest Spray Drying Plant in Asia with European GMP and safety standardsThe Company's manufacturing facilities at Nabha, Sonepat and Rajamundry have received prestigious ISO 14001,ISO 901 certification and its packing facility at Hyderabad and Ballabhgarh continue to maintain the prestigious ISO 9001 certification by SGC, a leading International Certification Company.
Company has also started B2B operations with its leading vendor for the purchase of raw material and service under the area information technology. The company has implemented two ERP packages namely JD Edwards and AS400 and connecting up all its business locations all over the country via satellite link.
The various departments in GSKCH LTD. Located at Nabha are:
ü Human Resource and Administration Department.
ü Manufacturing Department.
ü Procurement Department(Milk Sourcing Procurement and Purchase Department)
ü Quality Assurance Department.
ü Total Quality Management Department.
ü Information Resources(IR)
ü Finance Department
ü Warehouse Supply Chain Management
ü Engineering Department.
ü Environment, Health and Safety Department(EHS).
INTRODUCTION TO TOPIC
The term labor welfare refers to the facilities provided to workers in and outside the factory premises such as canteen, rest room, recreational facility, housing and all other services that contribute to the wellbeing of workers
In the early stages of industrialization. Welfare activities for factory workers did not receive adequate attention. Employers were not inclined to accept the financial burden of welfare programs. Whenever employers provide for such amenities, it was more with a Paternalistic approach to labor rather than a recogonisation of a worker needs.
Hence state has to intervene and compulsory provisions are thus incorporated in factories, other establishments where manufacturing is carried out.
Welfare is anything that is done for the comfort o and improvement of employees and is provided over and above the wages. Welfare helps in keeping the morale and motivation high so as to retain the employees for longer duration.
Welfare measures need not in monetary terms only but it can be any kind or form. Labor welfare entails all those activities which are directed towards providing the employees with certain facilities and services in addition to wages and salaries.
* TO PROVIDE BETTER LIFE AND HEALTH TO WORKERS
* TO MAKE THE WORKERS HAPPY AND SATISFIED.
* TO RELIEVE WORKERS FROM INDUSTRIAL FATIGUE AND TO IMPROVE INTELLECTUAL, CULTURAL AND MATERIAL CONDITIONS OF LIVING OF WORKERS.
The govt. of India has enacted various labor laws, social security and welfare schemes to adequately protect the interest of working class. In case of welfare provisions we have a distribution of statutory and non- statutory measures or voluntary measures-
* WASHING FACILITY
* STORING AND DRYING CLOTHES FACILITY
* FACILITY FOR SITTING
* SHELTERS, REST ROOMS AND LUNCH ROOMS
* WELFARE OFFICERS
NON- STATUTORY MEASURES
* MEDICAL BENEFITS
* EDUCATIONAL BENEFITS
* HOUSING FACILITY
* RECREATIONAL FACILITY
* CONSUMER COPERATIVE SHOPS
* TRANSPORTATION FACILITY
* VOCATIONAL TRAINING
* HOLIDAY HOME ANDLEAVE TRAVEL FACILITY NAD MANY MORE.
Statutory measures in GSK nabha
1. Facilities for sitting sec 44
* For workers who are to work in a standing position, suitable arrangement for sitting shall be provided in the factories. This enables workers to take advantage of any opportunities for rest which may occur in the course of their work.
* In GSK with the workshops there are sitting facilities available like desk and benches at the corner of walls and are there in order to enable worker to take rest because of any opportunity which may occur in course of their work.
2. First Aid Appliances:
* Sec 45 of factories act states that if a factory possesses 150 workers then there should be a first aid box and cupboards equipped with the required contents in every factory. This should be readily accessible to them during all working hours. The number of such first aid boxes shall not be less than one 150 workers in the factory.
* Now in case of GSK there are two ambulances which are available for 24: 7 within the factory premises. There is small dispensary which has trained doctors, two nurses and a compounder during the factory hours. These doctors and medical staff and other medical staff is available during the night hours.
* Even there are 10-15 first Aid boxes available in respective departments of HEEP and CFFP i.e. in material department, production department, Administrative buildings, workshops, even in canteen.
3. Canteens :
* we have in total of 3 canteens in GSK , Hardwar unit. 2 canteens are in HEEP unit and 1 canteen in CFFP unit.
* In HEEP we have one staff canteen where executives can have lunch and other two canteens were from shop level to supervisor have lunch. GSK offers subsidized canteen facility to its employees.
* One plate of food cost 50 paisa and one tea two snacks costs 25 paisa. Also there is a officer appointed to check on food quality the canteen is run by organization itself.
4)Shelters rest room and lunch rooms:
* As per section47 of factories act 1948, GSK have rest rooms, small lunch rooms, gardens where employees/workers can rest during lunch hour or free time.
* The rooms are cleaned everyday having separate area for drinking water. There is separate water room for water cooler, comfortable table and chairs for rest purpose.
5) Crèches facilities:
* Under section 48in GSK NABHA, we have the facility of crèche available for women workers employed in the factory.
* The crèches is located within the factory premises near the entrance gate rooms are well adequately lighted ventilated, clean and with a trained woman who looks after the children and infants.
* The children are given healthy food with milk thrice in a day in morning during noon and once in evening time
4. Welfare officers:
* AS per sec.49 GSK is having a separate department which looks after the facilities (welfare) provided to workers.
* They keep check on quality of food in canteen, in crèche, also on condition of rooms.
* Mr.C.S. SHARMA is head of welfare department in GSK NABHA..
These above statutory measures are followed at very large level in all GSK units admit has lead to building up of a positive, motivated(1130) which can b retained for a longer period.
Non statutory/voluntary measures-
1.Medical benefit at GSK
Medicare is a federally administered health insurance program for people 65 years of age or older, certain disabled individuals that have been receiving Social Security Disability Insurance for 24 months, and for people with End-Stage Renal Disease (permanent kidney failure treated with dialysis or a transplant). Medicare was created as part of the Social Security Act of 1965, and currently provides benefits to over 40 million people.Effective January 1, 2006, Medicare will begin providing outpatient prescription drug benefits to beneficiaries for the first time in the history of the program. Drug coverage and benefit design varies according to the Part D plan selected. Each year, Medicare beneficiaries may elect to sign up for a Medicare plan that includes Part D coverage. During this inaugural year, the open enrollment period runs through May 15, 2006. Additional information is available at www.medicare.gov and through Centers for Medicare and Medicaid Services.
2) Educational facility-
GSKprovides VOCATIONAL TRAINING to different students of different field such as MBA-HR and FINANCE, b-tech all.
3) Housing facility-
* GSK provides housing facility to its employees and has its own township which is called “BIR NIWAS” in nabha.
* Each apartment has set of rooms from 2-5 and employees are charged very minimal amount as rent of house.
* With the housing, GSK also provide free electricity (certain units), free water facility and free housing maintence etc.
* Also for the retired employed, GSK also provide them free housing facility for first 2 months of retirement, but other are charged Rs.4000/month as per separate accommodation.
4) Recreational facilities-
* Not only focusing on productivity, GSK keep their employees engaged in various sports and cultural activities.
* We have “GSK CLUB “and STADIUM where different activities like sports and swimming are played.
* In CONVENTIONAL HALL for picture and plays, cultural activities are conducted.
* On the eve of Independence Day, republic day there are various cultural programs, parade are organized.
* Not only these, within factory premises, there are inter- unit competitions are conducted like different sports activities running are conducted on national holidays.
* For the welfare of women there is ladies club managed by wives of employees.
* They have their own work related by weaving, stiching, photocopy, making masalas etc.
* Every year, GSK contributes some part of their earning into WOMEN/LADIES CLUB.
Other Voluntary measures/ Benefits and pay (TotalReward)
Ø TotalReward is how GSK rewards its employees for their contribution to its success. But it's more than just a salary - it rewards high performance, invests in development, partners with employees to save for the future, and supports employees' health and wellbeing:
* Pay - salary, bonus/sales incentives and recognition awards
* Shares & Savings - share plans, savings plans, pension plan
* Health & Life- Healthcare Plan, Health MOT, Holidays, Employee Assistance Programme, Tax-free: Plans, Discounts
* Development - Performance and Development Plan
* The composition of the pay and benefits package and details of individual benefits schemes are subject to change at the discretion of GSK.
* Offering competitive pay that rewards performance is critical to their long-term success. GSK pay programmes are designed to give the opportunity to earn good rewards for good performance and superior rewards for superior performance.
Ø A competitive base salary
* An annual bonus which is the main reward for performance, both Company performance and individual performance
* A Recognition Program to recognize and reward special achievements and contributions by employees and teams
* The composition of the pay and benefits package and details of individual benefits schemes are subject to change at the discretion of GSK.
Ø Shares & Savings
* The GSK share plans give employees a stake in GSK's success and the ability to gain in line with the shareholder value them help create. GSK also helps their employees save for the future by contributing to their pension, and offering a range of tax-efficient savings plans and financial education programmes to help them make the most of their TotalReward.
* A money purchase Pension Plan in which GSK contributes a minimum of 5% of your pensionable pay and matches employee contributions up to another 5%
* A ShareReward plan in which employee receive a free GSK share for every share they buy
* Financial Education Programme, providing employee with a wide range of financial planning options
* Long-term incentives, if eligible, to give employee a personal stake in GSK's future
* The composition of the pay and benefits package and details of individual benefits schemes are subject to change at the discretion of GSK
Ø Health & Life
* GSK's mission is to help people 'do more, feel better and live longer', and this approach is extended to GSK employees. Health & Life plans are designed to make it easier for you to balance your work and personal life and to care for yourself and your family - whatever your circumstances.
* Healthcare: designed to give employee and their family access to prompt medical treatment when and where they need it
* Employee Assistance Programme: designed to offer a helping hand when it comes to organising and dealing with the pressures of work and family life
* Tax-free: bikes, childcare, health assessment and holiday: a range of salary sacrifice plans designed to save money in exchange for benefits
* Car Allowance: if eligible, a monthly car allowance which employee can use to purchase a car through the scheme or take as cash - the choice is their.
* Discounts: a range of discounted products and services designed to support employee health, wealth and well-being
* Holidays: employees are entitled to 26 paid personal holiday days each year (increasing to 27 days after five years service and 28 days after 10 years service) plus eight paid public holidays and the opportunity to sacrifice salary to buy five more additional days. If they join during the year (January to December) their entitlement will be prorated .The composition of the pay and benefits package and details of individual benefits schemes are subject to change at the discretion of GSK.
* Be the best that you can be. At GSK, your Performance and Development Plan helps you understand what you need to do to contribute to GSK's success, how you need to perform and how to develop your career at GSK.
* PDP: helps you identify what you need to do and the behaviours you need to demonstrate to achieve success as well as the areas you need to develop to attain greater reward
* The composition of the pay and benefits package and details of individual benefits schemes are subject to change at the discretion of GSK.
1) GSK REIMBURSEMENT RESOURCE CENTER
The BEXXAR® THERAPEUTIC REGIMEN (Tositumomab and Iodine I Tositumomab)
PATIENT INFORMATION FORM
Please fax completed Form to: (866) 216-5292 Phone: (800) 745-2967
Patient's Last Name First Middle Initial Social Security Number Date of Birth
Street Address City State ZIP Code Home Telephone
Primary Insurance Secondary Insurance
Company Name ______________________________________________ __________________________________________
Telephone _______________________________________________________ __________________________________________
Subscriber's Name __________________________________________ __________________________________________
Relationship to Patient _________________________________________ __________________________________________
Social Security #______________________ Date of Birth _____________ _____________________ Date of Bir___________
Policy ID # ______________________ Group # ____________________ ________________________Group #____________
Employer ___________________________________________________ __________________________________________
Please attach GSK Reimbursement Resource Center - Patient Authorization to Release and Disclose Medical Information Form
(If you do not have the patient authorization form, please call (800) 745-2967 to request it. We will not be able to provide
patient-specific reimbursement services without the signed authorization.)
Patient Medical Information
Name of Treatment Site where BEXXAR will be administered:_____________________________________________________
Administering treatment site contact name Contact Telephone #
BEXXAR Therapeutic Regimen will be provided [ ] Outpatient Hospital [ ] Inpatient Hospital [ ] Free Standing Facility
Primary Diagnosis (Please provide actual code or codes): _________________________________________________________________________________
Previous Treatment(s): ______________________________________________________________________________________
Justification for BEXXAR Therapeutic Regimen (check all that apply)
[ ] Statement of Medical Necessity attached [ ] Other (please specify) __________________________________________________________________
Authorized Prescribing Physician's Signature Date
Authorized Prescribing Physician's Name (Please print)
Issues regarding GLAXO SMITHKLINE
1) ARTICLE(issue addressed on child healthcare by gsk)
The Children's Health Fund's Referral Management Initiative
Logo of The Children's Health FundHomeless and disadvantaged children are especially vulnerable to illness. They're more likely to suffer from acute and chronic illnesses such as asthma. Many do not receive vaccinations.
Yet millions of these children cannot get healthcare because there is no transportation, or because there aren't enough doctors, in disadvantaged communities. Sometimes there are language barriers. These problems all make it difficult for their families to keep hospital appointments.
The Children's Health Fund provides a Referral Management Initiative (RMI) to help children get the care they need whenever they are referred to a specialist.
The RMI reminds families about doctor appointments by phone and mail. It also provides door-to-door transport to clinics and can even provide translation services if necessary.
When the program began, one in twenty children who were referred to a specialist actually made it to the appointment; now—through the RMI—three out of four do.
GSK is the sole funder of the RMI and has awarded $8 million to date. The program is expanded from New York to Washington, DC, Dallas, Los Angeles, Philadelphia, and South Florida,india. CHF hopes to introduce similar initiatives nationwide.
Irwin Redlener, President of the Children's Health Fund, comments "The Children's Health Fund partnership with GSK has been responsible for positively transforming the lives of tens of thousands of medically underserved children in need of specialist care."
THE article discuss about the issue of healthcare in different countries like Washington, DC, Dallas, Los Angeles, Philadelphia, and South Florida,india which has been addressed by gsk at large scale by initiating a system of referral management initiative which aims at providing funds and healthcare facility to children in above mentioned countries and this initiative has been applied to the labour working in the same company through same RMI system though an expeniditure of dollar 8 million till date that means GSK is not only concerned about their employees only but they are concerned about the society from which they are coming and hence creating better human resource.
2) CASE STUDY(issue regarding allotment of medical benefit to workers aswell as society)
GLOBAL P U B L I C P O L I C Y I S S U E S GlaxoSmithKline's Position GSK is a leader in:
• Applying computerised statistical tools to facilitate the evaluation of safety information through, for example, the identification of unexpected adverse events that are being reported on a disproportionate basis (safety signals).
• Evaluating and applying pharmacogenetics2 to enhance the risks and benefits of our medicines for patients. As part of our efforts, we collect blood samples for potential DNA analysis in the majority of our Phase I, II and III drug development trials (with ethics committee review .. GSK is in regular dialogue with Regulators (e.g. US FDA, EMEA and Japan's Ministry of Health, Labour and Welfare) regarding how PGx data should be interpreted and applied on a case by case basis during the development, licensing and post marketing phase of a medicine.
• Supporting the public disclosure of the results (including safety information) from GSK sponsored clinical trials. In 2004 we launched the GSK Clinical Study Register which provides summary results from all GSK sponsored trials (phase I-IV) of marketed medicines completed since the formation of GSK. These summaries include all the serious adverse events and common adverse events reported in the trials.
Proposal for Enhancing Pharmacovigilance
Data Collection and Evaluation
The tools and processes used in pharmacovigilance are continually evolving. Effective use of these tools, along with improved reporting and communication tools, helps to ensure that potential and actual side effects can be better identified in investigational and marketed medicines. GSK recommends that initiatives to improve the pharmacovigilance framework should include:
• Improved reporting:
Collection of data on rare side effects through company or regulatory agency databases serves as an important starting point for possible further action. However, one of the shortcomings of this system is the variable nature of reporting and the quality of reports received. One of the chief difficulties with side effect reporting is ensuring the quality of the databases, and obtaining any necessary follow-up information. Resources are often expended in contacting health care professionals regarding aspects of a report they have filed. In some instances, the reporter is unable or unwilling to provide sufficient detail to allow for a rigorous evaluation of the reported event. GSK would therefore support initiatives aimed at improving pharmacovigilance through improved education of medical students and physicians regarding the quality of ADR reporting. Training modules could explain the role and responsibilities of healthcare professionals in reporting ADRs; how to identify and evaluate an ADR; and how to prepare and submit reports of high quality
* Real-life / real-time databases:
Pharmacovigilance could be enhanced by using novel technologies to allow companies and regulators to access anonymised data obtained from the use of medicines in clinical practice. For example, information captured systematically in electronic patient records could help identify a potential association between a side effect and a particular medicine or combination of medicines, by facilitating a comparison of side effects between patients who have and have not taken the medicine(s). The incidence of side effects associated with the natural history of diseases would also be of value in helping evaluate more effectively whether a side effect is more likely to have been caused by the medicine or whether it is more likely to have been caused by another treatment or the disease.
• Research into Risk Management Methodologies:
Risk Management is defined as a set of pharmacovigilance activities and interventions designed to identify, characterise and prevent or minimise risks relating to medicinal products, including risk communication and the assessment of the effectiveness of risk minimisation interventions. It is important that research is undertaken to establish the most effective ways to minimise the risks of medicines including effective ways of communicating the risks and benefits of medicines to healthcare professionals and patients. This research could be conducted through collaborative approaches (industry, regulators, patients and academia). An ideal framework to conduct this research is the proposed European Technology Platform on Innovative medicines
• Pregnancy registries:
Rare side effects that occur in a particular sub-group of the patient population are particularly challenging to detect because of the low number of patients and the low incidence of the side effect. In this regard, pregnancy registries could be established by public health systems that require information on medicines given during pregnancy to be recorded together with the health outcome for the mother and baby.
The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) was established in 1990. It brings together the regulatory authorities of Europe, Japan and the United States, and experts from the pharmaceutical industry via its three regional trade associations, plus key observers (including the WHO).
The ICH's main purpose is to recommend ways of achieving greater harmonisation in the interpretation and application of technical guidelines and requirements for product registration. Over 45 guidelines on a range of activities have been adopted since the ICH's creation.
Increased international harmonisation of pharmacovigilance rules is very important. It is critical that the rules are consistently implemented into national or regional frameworks. Inconsistencies can result in resources being used to meet complex regulations rather than being used to enhance the risks and benefits of medicines for patients. More importantly regulations and their harmonisation should be based on the scientific evidence available and where necessary further research should be conducted. GLOBAL P U B L I C P O L I C Y I S S U E S GlaxoSmithKline's Position research into the effectiveness of risk minimization methodologies should be undertaken to inform the effective incorporation of the recently published guidance ICH E2E on pharmacovigilance planning into national legislation within the EU, US, and Japan.
Pharmacovigilance in Europe
The divergence of rules in different EU Member States makes it impossible for a pharmaceutical company to have a single pharmacovigilance system throughout Europe. This ties up resources that could be better focused on the evaluation of drug safety and risk management to the benefit of public health.
Under current rules, medicines are authorized under different approval procedures (e.g. national, mutual recognition and centralized authorization). This leads to a number of different processes running parallel within the EU framework. For example:
• There are different labelling requirements. As a result, medicines authorized under a national system might well be labelled in a way that could make it difficult for a physician to understand and compare the risk/benefit profile of that product with a product that is centrally authorized. This cannot be in the best interests of public health.
• There are different expedited reporting requirements depending on approval procedure and country of origin of the reports. For example all serious ADRs from within the EU but only serious unexpected reactions from outside the EU need be reported. Pharmacovigilance should not be affected by national borders.
• Pharmaceutical companies are required to submit all serious unexpected drug reactions to each individual Member State. This amounts to an unnecessary duplication of work. It would be far more efficient and logical to report all serious cases to a single point in the EU (or better still, to report all cases to a single point)
GSK's main recommendation for addressing this inconsistent and inefficient system of reporting within Europe would be the adoption of a Council Regulation on Pharmacovigilance (‘PV Regulation').
• A PV Regulation should contain clear and concise provisions that would simplify, strengthen and provide legal certainty to the EU legislative framework for pharmacovigilance. A Regulation is directly applicable and legally binding on all interested parties in all EU Member States, and would therefore eliminate burdensome national discrepancies throughout an enlarged European Union. The PV Regulation should:
Contain a single set of simplified rules for expedited and periodic reporting of ADRs in the EU and provide for a single reporting point for ADRs within the broader European Economic Area (ie. the 25 EU Member States plus Norway, Iceland and Liechtenstein).
Remove the “unexpected/expected” concept, and require the reporting of all serious cases when electronic reporting is implemented (or potentially all cases, following a feasibility study/pilot).
GLOBAL P U B L I C P O L I C Y I S S U E S GlaxoSmithKline's Contain clear and flexible provisions regarding EU Qualified Persons (‘QPs') responsible for pharmacovigilance that allow individual companies to appoint the number of QPs best suited to their respective organizations.
Eliminate personal liability for QPs in order to ensure the availability of highly qualified professionals willing to perform the function of QP
Provide for consistent standards for inspections of company pharmacovigilance departments by the EMEA and EU Member State authorities
Pharmacovigilance in the United States
In recent years, Federal lawmakers have responded to public concerns regarding product safety with several oversight hearings and legislative proposals. The most prominent proposals have been to require greater clinical data transparency and to expand the FDA's post-market surveillance powers.
In September 2007, in conjunction with the reauthorization of the Prescription Drug User Fee Act (PDUFA), the US Government enacted significant new laws relating to drug safety. This legislation, entitled the FDA Amendments Act (FDAAA) includes provisions in the areas of:
• Expanded post-marketing authorities for FDA, particularly in the area of requiring post-marketing studies and clinical trials.
• Establishment of a Risk Evaluation and Mitigation Strategy (REMS) infrastructure that will allow FDA to require additional communication and reporting around drug safety, as well as possible restrictions on distribution and use.
• Clinical Trial Registration and Results Database.
• Active Safety Surveillance, using anonymized data from large health care databases.
FDAAA also authorizes significant new user fee funding to be directed toward drug safety efforts.
GSK recognises and shares the FDA's goal of creating a more effective pharmacovigilance framework through its ongoing efforts, as well as through the implementation of the provisions within FDAAA, and we will continue to work with the Agency toward that goal.
Problem The case study discuss the issue of application of programme named pharmacovigilance which was aimed at allotment of medical aid to workers and their dependent family and also to under priviledged society people in the countries like EU, USA and INDIA but the problem comes when data collected through different sources in different countries comes out to be more than estimated one which cause the problem of demand -supply mismatch. Most of the labour class report the problem of inadequacy of medicine being allotted to them
Solution Then solution was given in one of the meeting where it was proposed that proper stastical tools will be applied during collection, analyzing of data and thenmedicines will be stocked as per need of masses including realtime data. This programme was run with the help of WHO funds distribution data so as to ensure statutory bodies and their workers also that medicine which is being provided to them is of standardized quality.
1) The first point to emphasize is that gender equality in social protection is more than a question of securing equal treatment of men and women in the formal sense. It is also a matter of taking account, in an appropriate way, of gender roles in society, roles which differ between societies and have in recent years undergone immense change in very many countries. Thus social protection schemes should be designed, on the one hand, to guarantee equality of treatment between men and women and, on the other hand, to take into account different gender roles and serve as a tool for the promotion of gender equality.After briefly reviewing what ILO social security Conventions and Recommendations have to say on discrimination on the basis of sex
2) GSK is adhering with the convention c-135 of child labour , under which they are not recruiting any child below 15 in their company to work or them in hazardous working pharmaceutical conditions
3) They are providing vocational and non vocational training to 150 students every year in different department like HR ,FINANCE,MARKETING AND PRODUCTION with supreme supervision of high authority in every department and ensuring the safety and security of each student.
1) As there is always a scope of better administrative system in every organization particularly in production oriented company like GSK ,therefore the management should focus on key area that is workers in the company by addressing their grievance issues from time to time regarding their wage, medical provision, health and safety etc.
2) It should also be considered that while revising wage structure, gratuity acts, pension plans and other non statutory benefits company should make revised plans as going rate concern in labour market so as to satisfy their employees economically as monetary rewards speaks louder than other non monetary rewards.
3) In order to allocate any benefit like medical benefit or bonus to workers GSK should first match supply of allocation with demand by conducting proper survey and feedback system.
4) GSK , in order to create good corporate and social image in any country, should more indulge itself in labour welfare and security practices so that employee attrition cannot hamper its growth.