The US FDA, has set its eyes on India to upgrade the skills of the country’s drug control department at the Centre and in the states. The move is an effort to help Indian regulators remain in sync with the rapidly evolving technologies used in manufacturing plants across the country.

India accounts for the largest US FDA audited production plants outside the US with 584 sites registered with the global regulatory authority. The country is gaining prime importance in the global landscape with its approvals of 113 ANDAs (abbreviated new drug applications) and every fourth generic drug prescription in the US being a medicine manufactured from India.

There is a need to remain updated to newer technology and with the onset of several revised guidelines that have come in not just from global regulatory authorities but also India, training from an US FDA team of experts is seen to upgrade the drug inspectors with a broader perspective.

The key objective for US FDA was to ensure Indian regulators upgrade their skills and stay relevant. It was also to enable their exposure and adaptability to novel technologies and systems at the pharma manufacturing locations. “Therefore the focus was on inspection approach to be adopted. It also highlighted the challenges faced by the regulators during GMP audits,” Raghurama Bhandary, Karnataka drugs controller told Pharmabiz.

The two-day good manufacturing practice (GMP) training programme was conducted by US FDA & CDSCO for both central and state regulators here on November 19 and 20 at the drugs control department, Bengaluru. “We perceive that our department was opted to conduct the programme because it is better equipped in terms of infrastructure to accommodate over 200 participants,” he added.

The comprehensive training session had 92 regulatory officers from different states including Andhra Pradesh, Telangana, Goa, Kerala, Tamil Nadu, Pondicherry and Maharashtra. Besides, CDSCO zonal officers and eight regulatory officers of Karnataka participated in the workshop.

US FDA resource team comprised Thomas. J. Cosgrove, director, office of manufacturing and quality (oMPQ), CDER-OC, Thomas Arista- investigator, office of regulatory affairs (ORA), Denise M. DiGuilio, office of pharmaceutical quality (oPQ), CDER, Carmelo Rosa,- Psy D, director, international drug and quality, CDER, and Daniel Roberts, assistant country director, USFDA India Office.

Karnataka drugs control department is now looking forward to host many advanced technical workshops to strengthen the regulatory system in India on par with international regulatory authorities, said Bhandary.