At a time when major Indian pharma companies are facing fresh heat from United States Food and Drug Administration (USFDA) on the issue of data integrity violations, Ranjana Pathak, global head, quality, Cipla, has said that senior pharma executives — who put undue pressure on junior employees by not giving them time to do their job which leads to such violations — need to be ‘whacked’.
“People (bosses) don’t give other people (juniors) the time to do their damn job. You know jolly well that you can do only five analysis. But guess what, I will tell you do 15. How are you going to do? Indirectly, what am I telling you? Why is the boss putting undue pressure? The boss is the one who has to be whacked and not that little junior person…why will not there be data integrity (issues)?” Pathak told The Indian Express at ‘India Pharma 2017’ exhibition on Sunday.
“At the end of the day, the fish smells on the top. It’s the leadership. It is what you will allow. And people are not stupid. In our industry, we have very smart and intelligent people. It is the unspoken. If the head of the department walks around at 4:30 on a Friday evening, at the close of the quarter, and asks: ‘Is that batch done?’ He may not be saying that give me that batch and I don’t care, but that is the message that he is sending to the person. So, the person touching the batch is worried and nervous thinking that the boss wants it. And this is a true example in India,” she said earlier in the day.
Major Indian companies, including Sun Pharma, Lupin and Glenmark, are currently exporting around 40 per cent of their overall sales to US.
India contributes around 30 per cent of the overall volume of drugs consumed in the US. However, in last few years, the USFDA has found many cases of data integrity violations by Indian pharmaceutical companies.
On December 23, 2016, the USFDA issued a warning letter to Wockhardt for major data integrity violations, wherein it stated “CGMP (Current Good Manufacturing Practice) documentation was discarded without being assessed by your quality unit. Our investigator found torn and shredded equipment maintenance documents, raw material labels, and change control work orders in your scrap yard awaiting incineration.
Your staff lacked knowledge of your corporate procedure for the destruction and incineration of documents.”
The US drug regulator had inspected Unit-II of the Divi Laboratories’ Visakhapatnam plant in Andhra Pradesh between November 29 and December 6 last year, wherein it found data integrity violations. Cipla so far has not received any warning letter from USFDA related to data integrity violations.
On the current situation in the industry, Pathak said: “I just think we all need to take it seriously. We all need to do the right thing. We must have guts to speak up. If the company you are working in does not allow you (to speak), leave the company. I have done that. Leave the company.
No company is worth maligning your reputation or giving you lack of sleep. I tell my folks that no job pays you enough to do the wrong thing. It’s your signature. It is not CEO’s signature. You will go to jail, not him.
Nowadays, that is why they (USFDA) have invoked the park doctrine so that the CEO can’t pretend that I don’t know.”
Talking about the companies and the response of USFDA, Pathak said: “You just don’t need to be clever and beat the system. That is that. You see, when USFDA is pulling up companies, it is not for one incident. It is not. It is because pages and pages of data has been compromised. If you were there (at USFDA’s place), you would have also done the same because you will get angry. Because you are selling medicines. Somebody has got fever. That medicine has to work.”
She added that the Indian pharma industry is not talking much about how to deal with the issues pertaining to data integrity violations. “What if something happens? What if you encounter a data integrity problem? And I think as an industry we are not talking so much about it. We talk about what it is. We talk about we should not do it. But what if it actually happens?…There needs to more training courses on remediation,” she said.