May 11, 2017
The interesting finding from USFDA’s recent audits is that ‘Indianism’ is hitting Indian Pharma industry so badly. US business is critical for this Industry in India, as it accounts for $14 billions benefiting 330 companies directly and 24000 companies indirectly.
Most interestingly two points are quite common in the observations during recent USFDA audits. They are ‘data integrity’ and ‘unhygienic toilets/behaviour’. Aren’t we ashamed of that? Are Indians dirty and dishonest? It is quite understandable from the way we manage our garbage, roads and public places that we are not hygienic? But traditionally Indians are honest, right?
Honesty in our belief system is related to money. That means if a person is not stealing money, not bribing and not looting, then he is honest. Honesty is not measured in actions. Do we follow traffic regulations? Do we pay our tax without hiding income? Do we respect intellectual rights? Do we walk our talk?
Problem lies there. We don’t walk the talk .We create SOPs, but deviate from it. We don’t record the deviations. We don’t document, if the analytical results are not passing. Systems are put on paper not in spirit. We are dishonest in our actions. Honesty is first required in admitting that we were dishonest.
We were stage-managing the audits so far. However that was expected from our indigenous compliance authorities be it food, drug, safety, pollution or taxes? We address all these issues at knowledge level, not at culture. Leadership and values of the organizations are to be critically looked at to surf this audit tsunami. Compliance should be one of the values for the organizations and leadership should be committed for it.
Hygiene is regarded as a cheap thing, which is taken care by housekeeping team. Does any Plant manager, COO or CEO visit worker’s rest room at least once in a month? If any one does it, then probably you are one among few companies surviving USFDA tide.
Training workmen in hygienic practices, demonstration and follow up are required to show up the level of commitment by management. Bulldozing for manufacturing targets are required for business. But compromising in quality and safety can make any business extinct. Encouraging transparency in the organization, support to the team for correcting mistakes, balanced and sustainable business targets are the need to regain global confidence for Indian medicine.
Interesting fact is Indian drugs are not rejected for their chemical purity, but for GMP violations. It shows we are brainy but silly in practices? We need not to think USFDA for our drugs. We need to think above and beyond FDA, actually for the consumer who believes we are lifesavers. Do we become hygienic and honest?
The author is founder at Greenmile consultancy Services Pvt Ltd. At Greenmile, We are committed to provide solutions for organizations in achieving excellence in every business process. We are passionate in networking with diverse industry professionals and utilizing their expertise in bringing excellence. Our highly energetic strategic team has professionals having decades of experience in Chemical, Pharma, FMCG, Automotive, Oil & Gas, IT and ITES. Also our network has access to numerous functional experts. This model works very effectively for us to provide cost effective solutions for any kind of challenges faced in business.