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Strict regulations on India’s Food And Drug Firms: FDA

The Food and Drug Administration (FDA) is insisting the regulations in this regard are strictly followed. This ensures the products that come into the US are of the highest quality, have safety built into them and are effective. The US Food and Drug Administration (FDA) is increasing the frequency of inspections in India.

The centre and state level regulatory authorities of country's will ensure collaboration. Indian companies should welcome increased inspection. The aim of inspection  is not to harm. Inspections are designed to help. If there is a deficiency in a firm and the firm knows or does not know and we point deficiency in the firm that is in the interest of the public health. The Food and Drug Administration (FDA) is responsible for protecting and promoting health of people worldwide.

Howard Sklamberg, the US FDA Deputy Commissioner for Global Regulatory Operations and Policy announced "In the coming years with the help of Indian industry and regulators in various areas through joint inspections, inspector training, data sharing etc, we will build relationships”. As from many years exports of food and drugs from India to the US is increasing that’s increasing the attraction toward more inspections. This will strictly show impact on the companies not meeting their standards in recent years.

Poor Data management is an important issue for many drug companies. Poor understanding of the study protocol is also a problem. Indian drug companies are increasingly found guilty of poor data maintenance and in many cases falsified data.  

Sklamberg  said, The US FDA is developing many matrix and policies for future, It will involve  developing a system on which we can rely, which we can use to identify firms that really are committed to quality and are committed to implementing that. Also, for us that's going to affect how do we evaluate applications and how often do we inspectand trying to establish and maintain higher level of quality standards. The FDA will soon fill up its 19 sanctioned posts in India, he added.


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