- Schedule ‘M’ of Drugs & Cosmetics Rules :
a) Protocol to be followed by manufacturing companies in case of serious adverse drug reactions [Evidence documents pages 94-95].
b) As per Schedule ‘M’ of Drugs and Cosmetics Rules, all complaints concerning product quality, shall be carefully reviewed and recorded according to written procedures by the manufacturing companies. Each complaint shall be investigated/evaluated by the designated personnel of the company and records of investigation and remedial action taken thereof shall be maintained. There shall be written procedures describing the action to be taken, recall to be made of the defective product. Reports of serious adverse drug reactions resulting from the use of a drug along with comments and documents shall be forthwith reported to the concerned licensing authority.
- My Complaint dated 16.08.2014 to Cipla Limited [Evidence documents pages 96-98]
a) I had said that my wife was administered injection Rokfos when her condition did not require this drug to be given to her. That she was diagnosed for Cervical Spondylitis with pain in the neck when this drug was given straightaway on admission to Maruti Nursing Home.
b) I had said that my wife is no more but I need to know the causes that led to her death due to Aplastic Anaemia, reason being drug-induced. I had given batch number, manufacturing date, expiry date, etc.
c) Subsequent correspondence, complaints to Cipla Drugs Safety, Product Queries and Global CEO & M.D., Shri Umang Vohra :
- Email dated 26/08/2014 to Dr.Akhtar of Cipla Drugs Safety [Evidence documents pages 99-100]. I had reminded him that I have not received his official reply as promised earlier.
- Reply from Cipla Drug Safety – Email dated 27/08/2014 [Evidence documents pages 101-104]. Cipla Drug Safety offered condolences on death of my wife. Cipla did not contest the ADRs and sent FAQs on Zoledronic Acid.
Product information of injection Rokfos was sent with the above reply. [Evidence documents pages 105-119]. - Email to Cipla Drugs Safety dated 07/07/2016 for follow up on my complaint and reply received from Cipla Drug Safety [Evidence documents pages 120-125]. I had requested to meet Cipla officials along with audio of the meeting at Maruti Nursing Home wherein the doctors had admitted categorically that Rokfos caused the ADRs.
- The only reply received to this email was “Thank you information”.
d) Email to Mr. Umang Vohra, Managing Director & Global CEO, Cipla Ltd. dated 18/04/2017 and Reply received from Drug Safety Division. [Evidence documents pages 126-130].
I had said :
• The following letter is sent to the Managing Director of Cipla today by courier.
• Request anyone concerned to answer my queries on ADRs and the protocol to be followed in order to pursue my case against the guilty doctors.
• The only reply received to this email was “Thank you for notification”. “We acknowledge the receipt of this email” “We will take appropriate action”.
Thanks & Regards, Pramod Dighe, Drug Safety Division I Cipla Ltd.
• This email was followed with letter dated 18/04/2017 sent to Mr. Umang Vohra, Managing Director & Global CEO, Cipla Ltd. [Evidence documents pages 131-136]. I had given references to my earlier emails as follows :
• My email dated 26/08/2014 addressed to prc@cipla.com, productqueries@cipla.com.
• Dr. Akhtar’s reply dated 27/08/2014 from drugsafety@Cipla.com,
• My email dated 07/07/2016 addressed to drugsafety@Cipla.com,
• Reply dated 07/07/2016 from drugsafety@Cipla.com.
• I had said that this mail is only to get information from Cipla on specific points towards the end of my letter in order to follow up on my cases filed at Maharashtra State Consumer Disputes Redressal Commission and with Food and Drugs Administration.
• That I am only interested in knowing what action Cipla has taken after ADRs were informed to Cipla, CDSCO, National Pharmacovigilance Centre, and BYL Nair Hospital, Mumbai and also to Food and Drugs Administration (FDA) by me.
• That Dr. Goswami has admitted that he has informed Cipla Medical Advisor regarding the death due to IV Rokfos.
I had also said :
• I am not accusing Cipla in any manner.
• Although Cipla has replied to my mail and has expressed regret for the death of my wife, there is no report by them to FDA about their drug causing ADRs. They have sent indications of use to Dr. Goswami as well as the Complainant.
• What is the reason that Cipla did not investigate into their drug Rokfos causing severe Adverse Reactions ultimately leading to the patient’s death?
• Why did Cipla not inform FDA or CDSCO about these rare disorders ultimately leading to death ?
• Was it because of bad publicity or to protect Dr. Goswami who failed to take action as the drugs were sold illegally?
• Or was the drug really sub-standard?
• There is no information forthcoming from Cipla, FDA, Maruti Nursing Home as also other hospitals involved in the treatment.
• That I need to put my complaint before the Prime Minister’s Office and Central and State Health Ministers.
• I will seek the PMO’s help in asking FDA to intervene in my complaints to them so that justice is meted out to me as per law.
• If you can give your valuable input to help me seek justice, I can include the same in my complaint to the PMO.
• There was no reply from Global CEO and M.D., Umang Vohra.
e) Letter from Director, Food & Drugs Administration, Goa dated 16/04/2018 to the Complainant enclosing reply by Cipla Ltd in hearing before FDA Goa Directorate [Evidence document page 137].
f) Cipla Head Global Pharmacovigilance, Dr.Avinash Kakade’s explanation in Show Cause to FDA Goa Director dated 26.03.2018 [Evidence documents pages 138-150].
g) Letter from Complainant to FDA Goa Director dated 21.04.2018 on false explanation by Cipla Ltd [Evidence documents pages 151-152].
h) Letter from Complainant to Cipla Head Global Pharmacovigilance, Dr. Avinash Kakade dated 01.05.2018 on his false explanation [Evidence documents pages 153-154].
i) Demand for unconditional apology by complainant from Cipla Management and Board of Directors for portraying the deceased as ‘paralytic’ and critically ill patient prior to drug Rokfos being administered to her and which caused her death.
j) Letter from Complainant to Cipla Board of Directors dated 09.05.2018. [Evidence documents pages 155-157].
k) Reply by Cipla Authorised Representative to my demand for apology dated 18.05.2018 and threatening legal proceedings [Evidence documents pages 158-159].
l) Complainant’s reply dated 28.05.2018 to the above letter for threatening legal proceedings [Evidence documents pages 160-170].
m) Cipla Authorised Representative’s letter dated 31.05.2018 [Evidence documents pages 171-176].
n) Based on Cipla’s explanation to FDA Goa Director dated 26.03.2018, Cipla’s letter to the Complainant dated 18.05.2018 and Cipla’s letter to the Complainant dated 31.05.2018, the following false statements have been exposed :
o) Ignorance of law pertaining to reporting of serious ADRs; Schedule ‘M’ of Drugs & Cosmetics Rules [Evidence document page 139, para 3]. Cipla Head Global Pharmacovigilance said “We were unaware of the fact that Schedule M mandates that “Reports of serious adverse drug reactions resulting from the use of a drug along with comments and documents shall be forthwith reported to the concerned licensing authority”. Ignorance of the law cannot be an excuse in a homicide case.
p) Linking imaginary diseases to the deceased prior to drug Rokfos being administered to her [Evidence documents pages 141-142].
• Unknown to Ongoing – Concurrent condition – Tuberculosis of spine (Bone tuberculosis).
• Unknown to Ongoing – Concurrent condition – Arm paralysis (Monoplegia).
• The patient’s medical history and concomitant medications were not reported. The patient’s concurrent conditions included spinal tuberculosis, cervical spondylitis, arthralgia and one paralytic arm.
Note : Arthralgia occurred after injection Rokfos and is a known side effect of the drug.
q) When a senior editor of a leading newspaper had asked the PR of Cipla with a questionnaire on the above statements by Cipla, he had told him that he will fix an appointment with the doctors at Maruti Nursing Home. Subsequently, succeeded in silencing the journalist.
r) Linking Imaginary treatment for the imaginary diseases [Evidence documents pages 142-144].
• On an unknown date, the patient received one shot of steroids for tuberculosis treatment.
• The unknown steroid which was administered on unknown date could also be the cause of aplastic anaemia.
s) The above false, imaginary diseases and statements to deceive FDA Goa Director was exposed by in-patient record noting of physician, Dr.Aafaque Dolare who had certified Complainant’s wife as ‘Fit for Surgery’.
He had noted that she was “Pre-morbidly healthy” “No known allergies” “No addictions” “No major illness in the past” [Evidence document page 177].
t) Cipla’s Lies on admitting to following statutory guidelines; Schedule ‘M’ and reporting to DCG(I), PVPI and FDA Goa [Evidence documents page 173-175].
• “The Company denies that it did not carry out any investigation. In fact, immediately after receiving information from Dr. Mihirgiri Goswami, Company representatives followed a procedure in speaking on telephone with the treating doctor, Dr. Mihirgiri Goswami who informed that the late Smt. Kamini Barkur was suffering from spinal tuberculosis and that her one arm was paralytic; annotated in the telephone record form (“TRF”) on August 7, 2014. Later following pharmacovigilance guidelines six CIOMS forms were submitted on August 20, 2014, Sept. 08, 2014, July 21, 2016, May 2, 2017, March 7, 2018 and May 22, 2018 to the DCGI. Therefore, your allegations on attempts to suppress material whether of the alleged adverse drug reactions or otherwise is clearly devoid of any merit and denied [Evidence documents page 173].
• “As stated earlier, the Company had immediately informed the appropriate licensing authority of the adverse event. Similarly, the explanations given to the FDA Goa on non-compliance of Schedule ‘M’ has no relevance to the issue at hand. In any event, our explanation has been accepted by the FDA, Goa and has been adequately dealt with” [Evidence documents page 174].
• “Applicable provision of Schedule M of Drugs and Cosmetics Rules (referred by you) relates to reporting to the licensing authority, which the Company has complied with in having informed the DCGI (the appropriate licensing authority), the Pharmacovigilance Program of India and later FDA, Goa”. [ Evidence document page 175].
• Copies of this explanation were sent to FDA Maharashtra, FDA Goa, Directorate of Public Grievances, Government of Goa, Directorate of Health Services, Mantralaya, Government of Maharashtra.
u) Cipla’s lies on reporting of the ADRs were exposed as follows :
• Reply to RTI Query of the Complainant from FDA Goa dated 17/01/2018 stating that they had not received any report of serious adverse drug reactions of IV Rokfos from Cipla. As per records available at Cipla Goa no any drugs recalled is conducted [Evidence document page 178].
• Reply to RTI Query of the Complainant from Indian Pharmacopoeia Commission; The National Coordination Centre for Pharmacovigilance Programme of India does not have record of the adverse event of Rokfos – IV Infusion manufactured by Cipla. Indian Pharmacopoeia Commission does not possess any other information in this regard. [Evidence document page 179].
v) Letter from ADC(I), CDSCO dated 15/02/2018; Public Grievance; in relation to conduct investigation for alleged nexus between M/s Cipla Ltd. and M/s Maruti Nursing Home’s, Mulund, Mumbai in sale of sub-standard drugs Rokfos i.v.; reg. [Evidence documents pages 180-181].
Note : If Cipla had followed statutory guidelines, investigated their drug Rokfos and reported the serious ADRs, there was no reason to conduct an investigation.
w) Complainant’s reply dated 06.06.2018 to letter dated 31.05.2018 from Cipla’s Authorised Representative [Evidence documents pages 182-211].
x) Letter dated 26.06.2018 from Cipla Authorised Representative stating that they will comply with the directions of the authorities as and when received. [Evidence documents pages 212-213].
y) Complainant’s letter dated 04.03.2019 to Mr.Yusuf Hamied, Cipla Chairman for malpractices and criminal offences at Cipla claiming lives of innocents [Evidence documents pages 214-215].
z) Complainant’s letter dated 04.03.2019 to Mr.Yusuf Hamied for an Inspirational Science Program and ‘Yusuf Hamied Quotes’ vs ‘Reality at Cipla’ [Evidence documents pages 216-241].
aa) US FDA Warning to Cipla Limited – Media report [Evidence document page 242]. Newspaper report – Hindustan Times, Mumbai Edition dated February 27, 2020.
bb) US FDA Detailed warning to Cipla – Violation of Good Manufacturing Practices at Goa plant [Evidence documents pages 243-251].
This warning letter to Cipla for Goa manufacturing facility summarizes significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. Because their methods, facilities or controls for manufacturing, processing, packing or holding do not conform to CGMP, their drug products are adulterated.
Note: Drug Rokfos which caused my wife’s death was manufactured at this facility.
cc) Cipla’s official reporting to FDA, DCGI and IPC (PVPI) five years after the adverse event – Information was given by Indian Pharmacopoeia Commission (PVPI) dated 17/10/2019 in response to Complainant’s RTI query whether Cipla has finally reported the serious adverse drug reactions of injection Rokfos to FDA authorities, IPC (PVPI) and DCGI [Evidence documents pages 252-254]. Reply stated a categoric ‘Yes’.
dd) Media report on Cipla overcharging of drugs [Evidence documents pages 255-256].
Unethical selling practices is now exposed in media report by Himani Chandna of ‘ThePrint’ dated 13th January 2021. Among several pharma companies, Cipla Ltd has to pay the maximum penalty of over Rs.3,000 crores. This is as per watchdog NPPA (National Pharmaceutical Pricing Authority).