In the pharmaceutical industry, we need to ensure safety, efficacy and quality of drugs manufactured and sold by us. It is important to conduct stability studies in order to ensure that our products are complying with our label claims and are also in full potency under various storage conditions prevailing in the country. Every manufacturer, before embarking on manufacturing of a formulation need to conduct the stability studies on their products in order to satisfy themselves that the product will pass all the specifications and remain so throughout the shelf life. It will be prudent to market the product only after the same.
With respect to products already manufactured by them, they need to conduct periodical stability studies in order to ascertain the efficacy and quality of their products. More than the regulation, we should consider this as our responsibility.
u.sharma@expressindia.com