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Objective: There is a high rate of death due to burns and wound infections in India. Innovators and manufacturers of wound and burn dressings need to keep themselves abreast of the most current rules governing medical devices. The concept of advanced dressings is emerging in India. However, local manufacturing is hindered by an absence of clear regulatory guidelines. The lack of advanced wound and burn dressings on the market critically affects patient survival rates, while imports from other countries make dressings unaffordable and beyond the reach of most patients. This article presents the details of an approval procedure for advanced dressings and provides manufacturers, innovators and investors with a better understanding of the classification rules, import, export and marketing approval processes. We also discus the reasons for high levels of imports and costs, as well as suggestions on how to address this., Method: A critical analysis was conducted of 54 research and review articles, including regulatory guidelines to control the marketing of wound and burn care dressings recommended by international regulatory agencies., Conclusion: India is highly dependent on imports of advanced dressings. Due to lack of clear, quality regulatory guidelines, innovators and manufacturers are facing issues while showcasing their product in the Indian market. Thus development of clear quality regulatory guidelines is crucial. Therefore, this article may guide and encourage manufacturers to develop advanced dressings in India.

Burn injury in pregnant patients is not uncommon in developing countries. The results of the management of six pregnant burns patients, admitted during an 18-month period, were analysed. Successful management of burn injuries ranging from 25 to 65 per cent TBSA occurred in patients during the second and third trimester of pregnancy, using early burn wound excision and skin grafting in four patients and by late skin grafting of a granulating wound in one patient. All five patients delivered live babies with no congenital anomalies. One patient with 60 per cent TBSA burns who was unsuitable for early excision, died of septicaemia. This report suggests the need for early burn wound excision and skin grafting in burns patients with pregnancy, in order to improve maternal and fetal survival. However, in developing countries early surgery is not advisable in patients with extensive burns because of the non-availability of biological skin substitutes.