PHARMA COMPANY IN NEXUS WITH DOCTORS CAUSING DEATH OF MY WIFE. THIS WAS SUPPORTED BY FDA.
2. Cancer drug Rokfos was administered as a trial to cure stiff neck in a single day at Maruti Nursing Home, Mumbai.
3. The drug caused serious adverse drug reactions (ADRs) never seen before with zoledronic acid, the ingredient of the injection.
4. This injection has to be administered only once in a year even for bone cancer patients. It was administered without the patient's or relatives' consent. Maruti Nursing Home doctors watched the patient sinking to her death for five days and sent her to Platinum Hospitals with no details in Discharge Card.
5. Platinum Hospitals also colluded with Maruti Nursing Home and hushed up the serious ADRs. Nothing of ADRs in in-patient records or Discharge Card.
6. Jupiter Hospital where my wife finally succumbed to her death gave a false Death Certificate and hushed up the serious ADRs in in-patient records.
7. Drug manufacturer Cipla Limited hushed up the ADRs in spite of repeated appeals by me to investigate the said drug in the interest of medical science to save lives in the future.
8. FDA Maharashtra Mumbai fully colluded with Cipla Limited as well as the doctors and hospitals.
9. FDA Maharashtra Commissioner, Dr.Pallavi Darade suppressed Order for immediate action by PMOPG cell dated 06/12/2018.
10. CDSCO is making the aggrieved party run from Pillar to Post since 1 1/2 years in spite of full evidence of FOUL PLAY and in spite of Order from Consumer Court holding the doctors and hospitals "Guilty" of causing death of my wife from drug Rokfos.
11. Cipla was informed of the ADRs by the treating doctor and myself in August 2014.
12. Cipla did not follow statutory guidelines. Did not investigate, did not recall the drugs (mandatorily required as per Schedule 'M' of Drugs and Cosmetics Rules) and did not report to FDA, DCGI and PVPI.
13. Cipla took the aggrieved consumer for a ride for four long years.
14. Finally law caught up with Cipla and a show cause was sent to Cipla Goa by FDA Goa (the drug was manufactured at Goa). Cipla Goa informed that all product complaints were handled at Cipla Drugs Safety, Mumbai and not at Goa.
15. However, Cipla Global Head Pharmacovigilance gave his explanation to FDA Goa Director who sent a copy of the same to me.
16. On finding the totally false and fictitious explanation from Cipla which included false, defamatory, derogatory and disgusting remarks on my wife's health condition, i have asked for an unconditional apology from Cipla Board and Management.
17. The physician who had certified my wife as "fit for surgery" for cord compression (cause of stiff neck) had noted in in-patient record that my wife was "pre-morbidly healthy" "No major illness in the past" "No addictions" "No known allergies"
18. Cipla pharmacovigilance portrayed my wife as "PARALYTIC" having spinal tuberculosis, bone tuberculosis and arthralgia.
19. Further stated that "On an unknown date she was administered an unknown steroid for bone tuberculosis. That this unknown steroid could be the cause of Aplastic Anaemia or bone marrow failure.
20. Cipla created an imaginary THESIS - Aplastic Anaemia vs Anti-tubercular therapy and deceived FDA Goa Director that their drug Rokfos was not the cause of death.
21. After four long years Cipla told me that they had investigated their drug and reported to FDA Goa, DCGI and PVPI. Cipla was not aware that i had already asked the three concerned authorities who had confirmed to me that Cipla had not reported the ADRs to them.
22. Finally, Cipla after getting cornered had told me that they will comply with the directions of the concerned authorities.
23. CDSCO/FDA Mumbai/FDA Goa/Mumbai Police are not acting since five years.
24. This made me address the issue jointly with the President, PM and CJI on 17th December 2019.
25. Supreme Court has registered my grievance.
26.PM has warned pharma companies.
27. PM is aware of the full story. Why don't CDSCO/FDA/Mumbai Police take action against Cipla, doctors and hospitals in my criminal complaints ?
26. This shows the Power and might of the Pharma Industry over the Government.
27. Can Local Circles take this matter further to the PM ?
Thanking you for your co-operation,
Sincerely Yours,
Umeshchandra Barkur more