Pain is an abominable sensory and emotional experience associated with actual or potential tissue damage or described in terms of such damage.Most pain resolves once the noxious stimulus is removed and the body has healed, but it may persevere despite the removal of the stimulus and apparent healing of the body. Sometimes pain arises in the absence of any detectable stimulus, damage or disease.
Pain is usually transitory, lasting only until the noxious stimulus is removed or the underlying damage or pathology has healed, but some painful conditions, such as rheumatoid arthritis, peripheral neuropathy, cancer and idiopathic pain, may persist for years. Pain that lasts a long time is called chronic or persistent, and pain that resolves quickly is called acute. The pain that is dull and persisting cause discomfort and affects the life. Non-steroidal anti-inflammatory drugs are adopted to treat pain. There are several formulations containing these have been permitted by various regulatory bodies throughout the globe. Aceclofenac and paracetamol combination is one such formulation adopted in the therapy of pain due to arthralgia, pyrexia, lumbago, osteoarthritis, rheumatoid arthritis and other chronic and acute diseases.Aceclofenac and paracetamol tablets are used for the management of chronic pain in diseases. There are several formulations available in the market: the cost of them ranges from Rs.
5.7 (generic formulations) to 64 (branded formulations). Hence the cost of the medication plays a major factor in selecting the formulation. The government of India thinking of such vast difference in the cost of these drugs; took an initiative to make such life-saving drugs available to common people at affordable cost by starting Janaushadhi Kendras throughout the country. The drugs sold here are generic formulations.
As a result of this, many generic formulations available in them are highly cost-effective. e.g. the cost for 10 tablets of aceclofenac and paracetamol in Jan aushadhi in Kendra is 5.
7 rupees whereas the cost of branded Intas pharmaceuticals – Hifenac P aceclofenac and paracetamol tablets is 64 rupees. The wide range of difference in the cost created confusions in the common man regarding the quality of the formulations available at Janaushadhi Kendras. Further, there are certain lobbies with a vested interest which are propagating that the quality of formulations available in the Janaushadhi Kendras are poor in quality and will not serve the purpose.
But these formulations are also approved and quality of them is assured by competent authorities. Therefore it was thought to rule out the confusions created in the minds of the people regarding the quality of the drugs available in Janaushadhi Kendras. Hence it was hypothesized that the quality of formulations available at Janaushadhi Kendras is also equipotent and will help the poor and deserved to relieve of their ailment. However, there are no reports regarding the comparative assessment of branded and formulations and generic drugs. Hence the present study is designed to comparatively assess the bioavailability, bioequivalence and the pharmacodynamic property of branded formulation and generic formulations containing aceclofenac and paracetamol. The outcome of the study will help the common man in choosing the equipotent formulation containing aceclofenac and paracetamol at an affordable cost. Therefore the present study is needed and justifiable.