There is news today that the US FDA made observations about Sun Pharma’s facility at Mohali that are very similar to what led to the import alert for products manufactured at this facility back in 2013. The Economic Times and Live Mint both report of what inspectors from the US FDA found about data integrity violations at this facility. Upon closer inspection, these observations are no different from what foreign regulators have been finding and documenting in various actions on the veracity of the data that Indian pharmaceutical companies use to secure market authorization in their respective countries. A cursory search will list many such examples from both manufacturing and clinical facilities in India.
In parallel, it was reported in the Economic Times that the national drug regulator, CDSCO has inspected approximately 200 manufacturing facilities that supply medicines to the Indian market and found that none of them to be compliant with the Indian version of cGMP (Schedule M). It is a different discussion altogether whether Schedule M is consistent with cGMP, but for the sake of today’s discussion, let us assume that it is. By their own admission, 100% of manufacturing facilities that supply life saving medicine to the India patients do not comply with the standard that the country’s regulator expects them to.
In the past, the standard response from the industry association representing pharmaceutical companies was that somehow western interests were out to defame and destroy the Indian pharmaceutical industry. Clearly, the country’s drug regulator finds substance independent of what foreign drug regulators have consistently found when it comes to compliance with standards for manufacturing medicines. I wonder what the next argument from the industry association will now be?
The larger question to ask is why is it that after three years of not being able to export product to the largest and most lucrative market in the world, the country’s largest pharmaceutical company once again finds itself in the same place it did earlier? Were the army of consultants who professed to “train” its employees not effective? Was the hundreds of millions of dollars of investment which was touted to upgrade its facilities to make it compliant with US standards not enough? Why is it that time again, we come back to the same question?
The answer is not hiring external consultants who charge exorbitant fees or building shiny new manufacturing facilities to impress the regulators. I spoke about this very topic recently at the Rx360 Annual Conference in Washington DC and here is my take on it.
As to the question of what the DCGI will ever do with its own findings about the 200 odd manufacturing facilities it found not to be compliant with its own standards, I am not holding my breath. Unless the regulation changes, and people are held accountable for making and selling substandard medicines, nothing will change. I had documented cases where despite proving guilt, the legal justice system in the country lets such people go with nothing more than a slap on the wrist. If the highest court in the land thought that was an academic issue, what more is there to say?