The US FDA India has accepted the Karnataka DC department's request for a 'observer' role during plant audits

The US FDA India office has in principle agreed to the Karnataka drugs control department’s request for ‘observer’ role during the plant audits by the US FDA inspectors. The role as an observer would benefit making the audits more effective. Going forward, State regulatory authority can in turn guide the pharma industry in Karnataka on the compliances to be put in place prior to audits to ensure the inspections have a successful outcome.

After the recently concluded first annual Regulatory Forum meeting between the US FDA and Karnataka drugs control department held to identify the best practices for future strategic collaborations and initiatives, Bhagoji T Khanapure, drugs controller, government of Karnataka noted that the objective of this Forum was to bring out the best out of the situation for the regulators representing the two countries. The coordinated effort enables both the US FDA and Karnataka drugs control department understand and learn about one another’s current practices for further engagement.

This paves the way for a conducive global regulatory audit with our inspectors being part of it. In fact, it reiterates Karnataka drugs control department’s high quality inspections. Of the Karnataka’s 402 production plants, 24 are US FDA certified. Moreover, Karnataka is the second state after Gujarat to have this Regulatory Forum, Khanapure added. Further, Karnataka drugs control department was given a certificate of appreciation that was received by Khanapure. The two-day event had the presence of 120 representatives from the state drugs control department and the CDSCO. It helped the participants address operational and policy matters.

The team from US FDA India office had Dr Sarah McMullen, country director, Yvins Dezan, consumer safety officer, Dhruv Shah, medical products safety coordinator and Kellia Hicks, consumer safety officer. In sync with the latest developments in the pharma industry globally and in India, there was a four pronged strategy devised to focus on topics of relevance. The first was on approaches to pharmaceutical quality system (PQS). The second was on risk-based approaches to GMP inspections. The third was on Observed Inspection standard operating procedures (SOPs). The fourth was on GMP case study.

All these are critical components for a pharma industry to ensure high standards of manufacturing. PQS assures drug quality. Various aspects of PQS helps the regulatory authority to evaluate and assure product quality during inspections. An overview of the US FDA’s GMP inspection lifecycle, presentation of the risk-based approach for GMP inspections with the recent trends was also provided.

The segment on Observed Inspection SOP is an important component as an observer in the USFDA led inspection and a case study of GMP facility was also equal significance for companies to understand the indispensability of good practices, he said. According to Amaresh Tumbagi, additional drugs controller, Karnataka drugs control department, the meeting was a fruitful one and we intend to work closely with the US FDA India office going forward. It is required to implement laws firmly and stringently.

The big benefit for the Karnataka drugs control department is that our enforcement team will be a part of the US FDA inspections which indicates a transformation on the state’s regulatory landscape. The outcome of the Regulatory Forum between the US FDA and Karnataka drugs control department was that it focused across quality systems for facility, manufacturing equipment, material system, production process, packaging, labelling and laboratory controls. It creates an ecosystem to reduce and prevent recalls of products. We are confident that it will facilitate continual improvement to make available safe, effective and standard quality drugs, stated Khanapure and Tumbagi.