In the first quarter of 2014, there are 3 warning letters for Indian Companies. Add to that the travails of Wockhardt and Ranbaxy over the last couple of years and it looks bleak for Indian Companies in general. I regularly read LinkedIn Groups and I noticed a thread related the question of reliability of Indian Medicines.
Can We trust Indian Drug Companies?
It created a firestorm of responses, many of which were from India. The responses fell into three categories which I will paraphrase
1. The FDA is picking on us – EU and US companies have the same problems
2. I would never take an Indian medicine again
3. Indan regulators find no problem who is the FDA to tell us what our standard should be
1. Of course some US and EU and other country companies have run foul of the law. Actually there are over twice the number of warning letters directed to Pharmacies than Indian companies in Q1. So maybe the FDA is picking on a broader range of companies. Or putting it another way – they are doing their job and hard one it is.
2. Are all Indian companies bad? Of course not. I do not know the statistics but I have heard that 50% (and it could be higher or lower) of the US generics is from India and undoubtedly the major are fine (at least I hope so).
3. I am sorry but if you want to sell drugs on the US market you have to play by the rules here. On paper, the Indian regulations are as tough as the FDAs but the question is detection of issues and enforcement that will separate the theory from the reality.
So what are the issues that are found
UVS issues appear to relate to data integrity. Check my previous posting on the blog . The link to the warning letter is here.
Smruthi Organics Ltd has a Warning Letter with only 3 observations. One centered on data deletion, record destruction and inadequate investigations. The link is here
Canton Laboratories Private LTD has a warning letter with 4 observations. The essence is failure to keep data from testing, failure to actually test, failure to adequately clean equipment and failure to manufacture according to instructions and keep adequate records.. The link to the Warning Letter is here
In reality there is a lot of similarity in all these observations. It does make one wonder about the quality of medicines. Is this the tip of the iceberg? Should I be worried?