Cipla Ltd has admitted to the serious ADRs in written statements to FDA Goa Director.
- Ignorance of law [Evidence document page 139 para 3]. Cipla Head, Global Pharmacovigilance has submitted in SHOW CAUSE to FDA Goa Director; 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”.
- 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.
- 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.
- 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.
CIPLA LIES EXPOSED
- 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].
CIPLA LIES ON FOLLOWING STATUTORY GUIDELINES
- Cipla’s Lies on admitting to following statutory guidelines; Schedule ‘M’ and reporting to DCG(I), PVPI and FDA Goa [Evidence documents pages 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 document 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 document 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.
CIPLA LIES EXPOSED
- 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].
- 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 drug 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.
- 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].
Cipla has finally reported to FDA, DCG (I) and PVPI. This was conveyed to me by Indian Pharmacopoeia Commission (Pharmacovigilance Program of India) in reply to my RTI query [Evidence documents pages 252-254].
There is nothing left for Navghar Police Station, Mumbai except to arrest the killers and their supporters in regulatory and law enforcement agencies viz CDSCO, FDA and Public Health Departments of Maharashtra.