Sachin Choudhary: Several Big Indian pharma companies under US FDA scrutiny
As compared to previous year, production of substandard medicine increased in country
Quality issues are an ongoing challenge for the Indian pharmaceutical industries.
Apart from actual quality issues, the US FDA has also pointed out that data integrity is a big issue for Indian drug manufacturer.
Warning letters might increasing as 190 facilities are expected to be inspected in the next 3 years
“Quality is a challenge for the Indian pharmaceutical sector”
The largest supplier of drugs to the United States, according to a recent blog by the US Food and Drug Administration (US FDA)
Out of the 42 warning letters sent out by its office of manufacturing quality last year, nine — about one-fifth — were addressed to Indian facilities. The number could rise over the next three years as the US FDA would inspect 190 facilities that it could not in the past five years, wrote Edelweiss Securities.
According to the Edelweiss report, warning letters are not easy to resolve.
FDA announced plans to double the number of its inspectors in India – from about nine to 19
In addition to FDA, India’s regulator, known as the Central Drugs Standard Control Organization (CDSCO), Now a days are very active, aware and doing well as result frequently audits of Indian pharmaceutical manufacturing facilities to meet Schedule M requirement. Mostly plant audited by CDSCO from November 2016 to till date.
Recently, CDSCO announced it would set up a training program to address gaps in inspections. And CDSCO also has been uploading to its website a monthly list of drugs, devices and cosmetics that are either not of standard quality, spurious, adulterated or misbranded.
According to CDSCO official website NSQs (“Not of Standard Quality”) drugs data production of substandard medicine increased in India as compared to previous year.
In 2015 – Total 161 (Medicines Sample Failed)
In 2016 – Total 242 (Medicines Sample Failed)
In 2017 – Total 149 (till end of may) (Medicines Sample Failed)
On XLN government website 510 NSQ Medicines details uploaded 12 December 2016 to till date.
PharmaPathway analyzed total issues of Indian pharmaceutical industries, Problem with India is everyone is so opiniated that they only know every thing and so no amount of any advice or regulation will help. After all everyone in India has a free spirit, “chalta hai” attitude, we know the best, and last but not the least who cares about safety!
It is a sad state of affairs with the pharmaceutical companies when we read everyday that short cuts are been taken to make profits
The India way?
Jugaad
A term-limited to India and applied to a creative idea providing a quick or provisional way of solving or fixing the problem.
Unfortunately, there are two underlying negative aspects
First is that an implicit and unspoken expectation that-as the solution needs to be quick and creative – It is acceptable to make compromises on the quality of product or process.
Second, as focous is on making “it” working quick, there is no intention of making the solution sustainable, thus creating poor quality in the future.
Chalta-hai
Another term common in india describing the attitude to accept that if it is 80% good, works 80% of time, and does 80% of what it is intended to do, it is acceptable.
Unfortunately, again here is an underlying negative aspect
This attitude sharply collides with the fundamental GMP requirement-compliance is based on the attitude of “do it right the first time” and whenever there is a non-conformity, perform in-depth root cause analysis and try to establish a sustainable.
So, Indian pharma companies should shed jugaad (quick-fix solutions) and Chalta hai attitude, that have their own advance research unit/subsidiary will, in my opinion, gain over a period.
