This article mainly focuses on the approval process of drug import and export from India. Now a day’s foreign pharmaceutical companies have a better legal foundation for releasing new drugs in India. The Indian medical regulatory system has become more complicated, and new drugs can take a year or more to be approved for marketing. Ever-changing laws and regulations are driving demand for regulatory affairs professionals to provide the current needs of industries for the global competition and who can help pharmaceutical companies to effectively bring their medical products to the Indian market. In today’s competitive scenario, the reduction of the time taken to launch the product is imperative and hence vital for company’s success. This article will be helpful to all pharma manufacturer/importer, regulatory, preclinical, formulation scientists, and clinical trial professional who are involved directly or indirectly in new drug registration process. Need integrated knowledge and broad perspectives which you need to effectively manage the regulatory process for approval of new drugs in India.

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