Cipla global quality chief on data integrity violations: ‘Bosses pushing juniors need to be whacked’

Major Indian companies, including Sun Pharma, Lupin and Glenmark, are currently exporting around 40 per cent of their overall sales to US.

Written by Deepak Patel | Bengaluru | Published:February 14, 2017 1:47 am
cipla, cipla integrity violation, indian pharma companies, medicine sector, USFDA, United States Food and Drug Administration, ranjana pathak, indian express news, india news, business news India contributes around 30 per cent of the overall volume of drugs consumed in the US. (Representational image)

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.

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“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.

(The writer was in Bengaluru on the invitation of FICCI and the Ministry of Chemicals and Fertilisers)

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  1. B
    Babu
    Feb 15, 2017 at 5:41 pm
    Very good mirror of the reality
    Reply
    1. S
      Siddharth dwivedi
      Feb 15, 2017 at 5:23 pm
      Very well articulated, Ms Ranjana has highlighted reasltic points which all companies are facing now a days.
      Reply
      1. S
        Sachin jadhav
        Feb 15, 2017 at 2:10 pm
        Very true, She is right and gave exact message to all Indian companies including CEO's. I hope everyone will take positively and work on buliding quality culture within organisation.
        Reply
        1. K
          Krishna Biradar
          Feb 15, 2017 at 4:27 pm
          Its true im Wrking here
          Reply
          1. A
            ABR
            Feb 16, 2017 at 6:44 am
            Very well saidlt;br/gt;Every mnc talked about work culture but do not practice at all.lt;br/gt;Every boss generates undue stress onlt;br/gt; their subodinates for his surviaval or existance. This is the only root cause of all mistakes which do not have CAPA
            Reply
            1. B
              Bodh Raj
              Feb 15, 2017 at 7:58 am
              Only we can make a change the perception and ends with reality to build credibility..
              Reply
              1. G
                Ganesh Rajewar
                Feb 16, 2017 at 2:12 pm
                Mam, Very good explaination of current situation.
                Reply
                1. P
                  pharmacist
                  Feb 16, 2017 at 5:33 am
                  This is real thing you present in front of all. Then think what is happening in Indian pharma market. They want quany not quality. This thing happen in clinical research field as well
                  Reply
                  1. K
                    Ketan Maheshwari
                    Feb 16, 2017 at 1:07 am
                    This is reality of Indian pharmaceutical industries
                    Reply
                    1. S
                      Swatantra
                      Feb 16, 2017 at 2:45 am
                      Just blaw blaw and blaw. We Indian pharma peoples only think about US market. What about Indian people's and medicines supplied in India market. No one bother. We are amongst largest USFDA approve company in country but still not able to deliver the quality drugs for Indian market.
                      Reply
                      1. P
                        Pankaj
                        Feb 16, 2017 at 10:53 am
                        This is the reality not only in India but in many countries, one more reason is non technical bosses, may not understand real issues and difficulties
                        Reply
                        1. R
                          Ramakrishna karanam
                          Feb 16, 2017 at 2:38 am
                          Madam, Explained well and logically about present work culture in pharma industry.
                          Reply
                          1. R
                            Ramakant
                            Feb 15, 2017 at 2:52 pm
                            Very well said....It's about the values which are nurtured in the biggest et of an organization that is employees and how much you believe in their work ethicse on we are working to help society towards a healthy life...We are into business of life...And nothing is of more value than a life.....
                            Reply
                            1. K
                              Karnail Saraon
                              Feb 28, 2017 at 5:50 pm
                              Respected madam,lt;br/gt;lt;br/gt;Very well said..lt;br/gt;Every Indian pharma should concies for data integrity. Proper job disprection n effective cGMP training should be given to the employees. Mostly multi job should be avoid at a time. Pharma company should be quality concise rather then quany. Bosses should also well updated with cGMP norms. People should not allow to enter in the process area until he/she is not very well aware about cGMP norms. People should know a single tablet can save or take the life of leaving creature.
                              Reply
                              1. S
                                Saurav
                                Feb 15, 2017 at 3:23 pm
                                very rightly said.
                                Reply
                                1. S
                                  Shankar karlekar
                                  Feb 15, 2017 at 5:53 pm
                                  Real picture telling in Indian pharma company.
                                  Reply
                                  1. T
                                    T C
                                    Mar 2, 2017 at 2:49 am
                                    I don't agree if any one say it is because of single reason. It is because of multiple reasons. 1. First of all company strategy should be very clear on distributing the quality drugs. 2. Other reasons include improperly designed, evaluated and qualified facilities, equipment, products, processes, 3. Improperly trained and qualified personnel, 4. Atude problems and negligence of the personnel, 5. Improper understanding of equipment function and operation, f etc. Also we should not forget that any boss has to report to his boss. They also should be free of unacceptable pressure. This happens when company identify the precise root cause and keep their strategy very clear on this topic. Apart from this, people should avoid unnecessary tightening of limits and specifications (without any data) to show that they are very good when compared to others. I have seen some companies who mentioned stringent environmental limits (half to the standard limits) for their clean rooms and ultimately started maniting, as they were unable to get it consistently. We can't ignore one more fact also i.e. Unnecessary tightening of the GMP requirement/regulationregulations. Also sometimes the inspection outcomes are observed to be based on atudes and ego's of investigators. My observation is, some times inspection outcomes are varying from 0 to 100 percent based on investigators. Ms. Pathak, every pharmaceutical professional in India knows about what is the level of pressure by boss and job safety in the place where you are working......we are safe in that sense...
                                    Reply
                                    1. u
                                      us_a
                                      Feb 16, 2017 at 8:20 am
                                      This is the situation for products to be sold in highly regulated market like US. Imagine the situation where products are being manufactured for Indian market.
                                      Reply
                                      1. V
                                        Vivek Choudhari
                                        Feb 14, 2017 at 4:37 am
                                        The comments from Ms Ranjana Pathak are well said.... lt;br/gt;lt;br/gt;When the problem is identified, the solutions must also be found out. We need Indian Pharma companies to be Bigger Global Companies too.... We have all the necessary skills and Talent. Why should just the overseas companies be big?
                                        Reply
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