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Social Space - India on the Rails
If life is a journey than, in India at least, it chugs along on two parallel steel lines… the railways. No reference here to the local tra 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 ins of Mumbai, India’s commercial capital, where citizens spend a substantial portion of their waking hours commuting increasing distances ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug. Examples of combination products may in within ever expanding city-limits. This one is grand - a vast rail network criss-crossing the length and breadth of the country, spannin lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together. g over plains and rivers, through forest and deserts, reaching out to the obscurest of villages and connecting them to the rest of this im here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe ense, wonderful conglomeration of people, towns, animals, history and culture, that is India. While air travel saves you time and driving d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations. Combination pro by road lends flexibility to your schedule, there is really no better way to know India than by train. The general compartment especially 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 is a startling microcosm of the multi-caste, multi-lingual eclecticism of the country that immediately disarms you with its robust back-t 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 humping welcome. No formalities here as you are expected to roll up your sleeves and join in the abundant overflow of food, drink, convers nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically tion. Personal details are unabashedly pried into, common ground or acquaintances traced over a maze of memory, addresses exchanged and pr 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 omises to visit, made… A long Indian railway journey is an unparalleled display of the lay of the land. As the train traverses across dif ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi ferent states it unfolds a fascinating tapestry of gradually changing landscapes, people, houses, shops and signboards. From my favourite ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it. Following aspects would a perch, on the steps at the door, I have never failed to harvest intimate glimpses into rural life: a peasant tending his field or enjoying dd to the challenges in developing combination products: Which markets to tap where the combination products can do fairly well? Which combination prod a meal under a shady tree, a young cowherd driving a boisterous herd to pasture, women transporting water over a parched terrain, a herd o cts are meaningful and rational? Which therapeutic categories to select? Which Combinations can address unmet needs of the patients? Do combin f deer peeping nervously through dappled afternoon shadows… And then there are the numerous wayside stations, bustling centers of busy ac tions increase the patient compliance? What would be the developing cost? How to tackle the risks encountered during combination product developmen tivity. Often no more than small shacks, these centers of village activity can be refreshingly beautiful, shaded by trees and with small w 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 ell-tended gardens around them. But even more poignant are the isolated rail cabins or outposts that occur, seemingly in the midst of wind ping new procedures for reviewing their safety, efficacy and quality. Professional from academic institutions, pharmaceutical industries, health care indust swept desolation, as a lone railway official holds out a green flag to give each train an all-clear sign as it hurtles by. It’s then that y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products it strikes you how this gigantic organization, the Indian Railways, the world’s biggest public sector employer, is so critically dependen . 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 t for its smooth everyday functioning on all the various little cogs that keep its wheels turning, right down to the guy who covers an all elopment. They need to be wiser in analyzing the market trends and the regulatory requirements. Companies that provide selfless information through particip ocated distance on foot daily, manually checking the screws in the fish plates to see that everything is right. A humbling thought really 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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