Fewer Indian pharma plants get US FDA action notice in 2023, so far

6 per cent of inspections in first 6 months of CY23 resulted in OAI status

Indian pharmaceutical manufacturing units have received only three official action indicated (OAI) status from the US Food and Drug Administration (US FDA) in the first six months of 2023, against 16 in the previous two years, even as they face increased scrutiny from the American drug regulator. 

An OAI status means that objectionable conditions had been found during the inspection by the FDA and regulatory action is recommended.

An analysis of data by the Indian Pharmaceutical Alliance (IPA), which represents the top 24 drug firms in India, shows that of 52 inspections during 2023, so far, 49 resulted in either VAI (voluntary action indicated) or NAI (no action indicated) status. VAI implies objectionable conditions were found and documented but the agency is not prepared to take or recommend regulatory action, while NAI implies no objectionable condition or practice was found during the inspection (or the significance of the documented objectionable conditions found does not justify further action).

Therefore, in the first six months of 2023, only 6 per cent of total inspections resulted in an OAI status. This is comparable with global inspections –of 217 inspections in 2023 thus far, around 8 per cent resulted in an OAI status.

India accounted for 48 per cent of total abbreviated new drug applications (ANDAs) approved by the FDA in 2022. The country ranks first when it comes to the number of US FDA-approved plants outside the US at over 530. The US imports $7.3 billion worth pharmaceutical products from India.

Sudarshan Jain, secretary general of the IPA, said the alliance has been making efforts to improve quality assurance across the Indian pharma industry for several years and “IPA Quality Forum was formed in 2015 with a vision to help the Indian pharma industry achieve quality excellence”. “What started in 2015 as activation and mobilisation, focused on developing best practices of key elements between 2017 and 2019,” Jain said. From 2021 onwards, IPA Quality Forum has been focusing on capability building.

“We have on-boarded members from the Indian Drug Manufacturers Association. We are working closely with the Pharmacy Council of India for training teachers and students, so pass-outs are industry-ready,” Jain said. The alliance also collaborated with the WHO in developing current-good manufacturing practices (cGMP) training modules for MSMEs.

Vikas Bhadoria, senior partner, McKinsey & Company, said if one does a root-cause analysis of the OAIs that Indian sites received in 2018 and now, there is a significant shift in reasons for a site receiving an OAI status. “Core operations are now stable and under control, and therefore, the FDA is now focusing on ancillary operations -- for example, starting and stopping of equipment in the event of power failures,” Bhadoria explained. There needs to be an SoP for even the simplest of things like starting and stopping equipment and cleaning ducts.

Focus on quality assurance assumes greater significance now as several small and medium Indian drug exporters have come under the scanner in semi-regulated countries for making substandard or contaminated drugs. The Indian regulator thus has cracked down on several sites across the country, and has also now proposed that cough syrups meant for exports need to be cleared by the Central Drugs Laboratories.

Jain said that the alliance is in discussions with the government regarding the stringent implementation of revised Schedule M, which specifies requirements for a quality management system that shall be used by the manufacturer for the design and manufacturing of drug substances.