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  • Useful Advices - Health and Safety at Work

    Not many would be aware of this, but the government has legislation for health and safety of people at work. The Health and Safety at Work etc Act 1974 requires the employers to have proper health and saf
    According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product
    ety management systems at work. The Act makes provision for securing the health of people at work, welfare and safety of the employees including the people who are not directly employed by the company li
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    e contractors and visitors.

    While the law exists and it is mandatory for the employers to follow the guidelines, it is also necessary for the employees to know about their rights and duties regarding the
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    r own health & safety. Employers should conduct a General Risk Assessment to ensure the health and safety of their employees.

    To create awareness about health & safety at work, the employers should have
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    roper employee induction & health and safety training programs whenever new employees join the company. The induction program should educate the employees about the safety standards, procedures and polici
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    es of the company.

    The basics of health and safety at work start with having proper First Aid. Every organization big or small must have proper First Aid Kits and systems. While at work, people can suffe
    ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc
    an injury or fall ill. It is very important for the company / firm to have proper arrangements so that the employees can receive immediate medical attention. A person who has received proper training for
    easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi
    administering First Aid should be appointed for this.

    Fire safety is of prime importance at work. The potential hazards and sources of fuel, oxygen & ignition etc should be identified. Proper Fire detect
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    on and warning systems should be in place to prevent any mishaps. Fire extinguishers should be kept ready in different places throughout the building. There should be exit doors and escape routes in the b
    and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ
    uilding. Electrical equipments and wiring should be proper and checked at regular intervals. The employees should be given training on dealing with fire emergencies. Fire drill and Fire Risk Assessment sh
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    uld be done at regular intervals.

    Stress at work place is common. But if it starts affecting the health of the employee then it is a problem. Employers should identify the factors causing excessive stres
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    to the employees. A stress risk assessment should be done to identify the potential hazards and risks. Proper measures should be adopted to control excessive employee stress. Employees should be given pr
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    per training, support and care to help them prevent & relieve the stress.

    Employers should follow the norms of the Control of Substances Hazardous to Health Regulations. They should assess the health ris
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    ks faced by the employees from the chemicals or substances used at workplace. Proper control measures should be adopted and the same should be followed by the employees. Training and information about the
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    health risks should be provided to the employees.

    The employers are also required to have proper policies for disability health & safety. Employees with cognitive, physical, sensory, ambulant and other d
    t?

    As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel
    sabilities have a right to proper arrangements and facilities at the workplace. There should be proper access, lighting, signage, seating arrangements for the disabled. Other employees of the company sho
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    ld also be sensitized about the same.

    New and expectant mothers have a right to proper care at the workplace. The employers should identify the potential hazards to the mother as well as the baby while a
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    t work. The employers can offer alternative work, different or less work timings or paid leave to ensure the health and safety of the mother and baby. Similarly, arrangements should be made for young pers
    .

    As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de
    ns at work and lone workers. A general risk assessment should be done for the security, health and safety of such employees.

    It is important that the employer as well as the employee is aware of the righ
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    s and duties pertaining to health and safety at workplace. For details you can take the services of a health and safety consultant or just search for “health and safety at work” on any major search engine


    tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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