In a move to enable pharma companies to understand the US drug regulatory norms in a better way, the Indian Pharmaceutical Alliance (IPA) with the support of the CDSCO recently had a joint collaborative meeting with the US FDA on regulatory requirements.  The meeting focussed on sensitising the industry members about the need for adopting effective quality parameters as prescribed by the US FDA for exporting to US, and importance of following the same as required to avoid unhindered exports.

This move comes in the wake of recent spate of warning issued by the US FDA to some Indian generic companies due to issue of non compliance while exporting to US, which is said to be creating unwanted fear and chaos among exporters. IPA informed that the two-day workshop was mainly targeted to apprise the exporters about the real picture and assure them that no harm will fall upon them if they follow the rules as required.

D G Shah, secretary general of IPA stressed that one of the biggest concerns among the industry was lack of understanding on what is required of them from the US FDA. It is with this goal in mind IPA decided to bring in the US FDA officials to directly explain to the industry of what is expected from the Indian companies while exporting to US.

“In the light of the repeated complains from the US FDA questioning the quality parameters adopted by Indians and lack of  data integration initiatives, it became imperative for us to convince them that the Indian companies are in no way lagging behind in following quality parameters or other requirements. The issue was failure in understanding the rules and regulations within the required time and not the lack of interest to follow the same. We got tremendous response from the industry as this exercise helped in easing their doubts and fears relating to US regulatory norms,” Shah said.

Shah pointed out that this was a first of its kind initiative spearheaded by the industry to gauge and effectively comprehend the changing regulatory scenario in the US from the US drug officials directly. This meetings which was held in Hyderabad, Goa, Ahmedabad and Chandigarh was also aimed at giving confidence to the industry members by providing them with a platform to directly interact with the drug regulatory officials from the US FDA.

Among the other initiatives, Shah informed that IPA is also planning to meet the new government representatives by mid-June to impress upon the industries key issues, challenges and demand, while in the sidelines getting acquainted with their approach on the same.