A step towards global harmonisation of GMP inspection protocols

In a letter dated March 21, the US FDA India office country director Sarah McMullen said that four states (Gujarat, Telangana, Goa and Karnataka) had been ‘sensitised to FDA’s inspection process and, as such, are eligible for inclusion as observers for relevant inspection in their respective states.’ The letter goes on to mention, ‘We would appreciate relevant opportunities being made available to state inspectors to attend as observers as practical.’

US FDA’s ‘Observed Inspection Program‘ involves interaction between the USFDA India office and State Drug Control Authorities, with the former inviting the latter as observers during inspections. As the letter indicates, ‘FDA has shared best practices and inspectional protocols in regulatory forums with several states.’

It is logical that the US FDA would now turn to replicate these efforts in other states, especially those with many FDA-registered facilities, like Maharashtra, for instance, and explore the possibility of adding to this list.

While increased cooperation between regulatory authorities will promote standardisation and global harmonisation of regulatory protocols, there is a steep learning curve. For both state regulators as well as regulatory affairs personnel in pharma companies.

The concerns are many. Firstly, pharma companies have manufacturing facilities in multiple states, some might be on the observed inspection programme and others might not be on this list. Will this impact the results of US FDA inspections and state drug controllers? Pharma companies are ideally supposed to ensure that all manufacturing facilities follow the same procedures, but this is not always the case. Such observed inspection programmes could take them one step closer to this reality. State regulators should share learnings from such observed inspections with each other more systematically for the programme to reap multiple benefits.

Looking ahead, are we looking at having such an observed inspection programme with other global inspection agencies like UK MHRA, EU EMA, etc? As head of Gujarat’s state drug regulatory body, Dr HG Koshia, Commissioner, Food and Drug Control Administration (FDCA) Gujarat recounts that for a short time, a couple of years back, his team did have a similar informal arrangement with the UK MHRA and were invited as observers on a few MHRA inspections in Gujarat. He says such a programme opens a world of different experiences to state inspectors and results in an improved quality consciousness.

The vexing issue of varying levels of manufacturing quality among India’s pharma facilities has surfaced during the analysis of electoral bonds. Media groups investigating the source and recipients of these bonds are joining the dots. In some cases, the purchase of these bonds by pharma companies is linked to IT raids and GST evasion. As per an Indian Express report, (Facing GST heat | A telling pattern: In pharma, different firms buy electoral bonds on same days) just on November 10, 2022, major pharma companies including Cipla, Dr Reddy’s, and Ipca Laboratories purchased bonds totalling close to Rs 50 crore. Glenmark Pharma and Mankind also purchased bonds a day in several tranches worth over Rs 30 crore. And, three days later, on November 14, Alembic Pharmaceuticals, Alkem Laboratories and Piramal bought bonds worth over Rs 20 crore.

In other cases, the pharma companies’ manufacturing units were pulled up by overseas regulators for poor GMP practices. Reports allege that they resorted to buying electoral bonds to prevent follow-up inspections from state regulators. As an open letter to pharma CEOs points out, (An open letter: Concerns on electoral bonds and pharma industry) as consumers of medicines, we are all at risk if these alleged substandard medicines are still on chemists’ shelves, not just in India but across the world.

Linking the purchase of electoral bonds to inaction on questionable quality standards is yet another warning to all pharma companies to get their act together. The US FDA’s observed inspection programme is yet another sign that slowly but surely, local inspection procedures and processes will need to work up to global best practices. It follows that pharma companies will also have to up their quality game.