Joint Investigation Report – umeshchandrabarkur.com

Key Points & Lies in Joint Investigation Report [Evidence documents pages 282-292]:

Background of the report:

Complaint dated 23^rd July 2018 made by Shri Umeshchandra Barkur to CDSCO, WZ, Mumbai regarding death of his wife (Late Smt. Kamini Barkur) from serious adverse drug reactions of sub-standard drug IV Rokfos, manufactured by M/s Cipla Limited and administered at Maruti Nursing Home, Mulund to Smt.Kamini Barkur.

This report was prepared based on Complaint to CDSCO, WZ, Mumbai dated 23.07.2018 and also emails from CDSCO (HQ) to CDSCO, WZ, Mumbai. That my written complaint was dated 23.07.2018 to DDC(I), WZ, Mumbai and I had submitted photograph of carton of drug Rokfos produced by treating doctor in in-patient record of my wife [Evidence document page 286].

Note: Complainant’s wife died in June 2014. Complaint was made to Cipla Ltd on 16.08.2014 and to FDA Gr Mumbai on 28.04.2015.

Note: There was no investigation conducted by either Cipla Ltd or FDA Gr Mumbai in August 2014 as per statutory guidelines; Schedule ‘M’ of Drugs and Cosmetics Rules.

Pages 1-4 of the report [Evidence documents pages 284-287].

That only single dose of drug Zoledronic acid was administered on 09/06/2014 and the said drug was not administered to her again.

Note: There were no allegations of injection Rokfos being administered again during her hospitalisation at Maruti Nursing Home.

Note: The report is silent on treating doctor’s in-patient record noting of ADRs of injection Zoledronic acid “Post Zobone Arthralgia” meaning joint pains after injection Zoledronic acid [Evidence document page 298].

Drug Inspector, FDA Maharashtra has filed a case against Dr.Mihirgiri Goswami and Smt. Ashwini Kallapa Kamble, receptionist cum salesman at M/s Maruti Nursing Home in the Court of Hon’ble Metropolitan Magistrate’s 15^th Mazgaon Court, at Sewree, Mumbai for contravention of section 18 (c), Section 18-A and section 22 (1) (cca) of Drugs and Cosmetics Act, 1940.

Note: Case is not filed for serious ADRs of injection Rokfos till date which was not questioned by the Joint Investigation Team.

Note: Joint Investigation Team did not deem it fit to question manufacturer of injection Rokfos, Cipla Ltd and what action was taken on my complaint dated 16/08/2014.

Cipla had acknowledged my complaint, offered condolences on death of my wife, sent me indications of use but had not followed statutory guidelines of Schedule ‘M’ of Drugs and Cosmetics Rules.

Photograph of carton of drug Rokfos was sent [Evidence document page 293].

Purchase invoice No.00788 dated 25/04/2014 for drug Rokfos received from AMI Agency [Evidence document page 294]..

Maruti Nursing Home bill for Rokfos sold to Complainant @Rs.3,500/- [Evidence document page 295].

They had deliberately not investigated their drug Rokfos.

The drug batch was manufactured in February 2014 and there would have been plenty of stock available when my complaint was made.

Drug Inspector Mr.P.D.Thorat, Drugs Inspector at CDSCO (WZ), Mumbai should be aware of Schedule ‘M’ guidelines of Drugs and Cosmetics Rules 1945. He did not question FDA Maharashtra, Mumbai Drug Inspector also.

Note: The matter is sub-judice since eight years even for illegal sale of drugs due to deliberate non-submission of evidence by the Drug Inspector of FDA Maharashtra.

Note: Open collusion by FDA Gr Mumbai officials and CDSCO officials with both Cipla Ltd as well as Maruti Nursing Home.

Pages 5-9 of the report

Complainant made complaint dated 14^th May 2018 to Joint Commissioner FDA, Greater Mumbai Division, Maharashtra w.r.t death of his wife from serious adverse drug reactions of injection IV Rokfos manufactured by Cipla Limited.

Note: Complainant did not make complaint dated 14^th May 2018 to Joint Commissioner FDA, Greater Mumbai Division, Maharashtra w.r.t death of his wife.

Note: Complainant’s wife died in 2014 and complaint was registered on 16.08.2014 with Cipla and with FDA Maharashtra on 28.04.2015 along with copy of complaint to Cipla Limited.

Note: Drugs Inspector of CDSCO (West Zone) should have questioned the Drug Inspector of FDA Maharashtra regarding objective for sending a sample four years after the adverse event and more than two years after the shelf life of the drug batch of February 2014 in question was over.

Note: What forbade Cipla Limited from sending one sample for testing from the batch in 2014 after my reporting to them on 16.08.2014.

Note: Why did FDA Maharashtra, Mumbai not send one sample of the batch for testing when the complaint was made in April 2015? or from the remaining four injections purchased by Maruti Nursing Home?

Sale invoices were not produced during the raid by FDA and neither was drug Rokfos in stock as per list of drugs seized during the panchnama.

It was observed that Smt.Kamini Barkur w/o Sh. Umeshchandra Barkur was hospitalised in M/s Maruti Nursing Home, Mulund, Mumbai for treatment of Cervical-Spondylitis & Stiff Neck and it is not a case of clinical trial as defined under Rule 122-DAA of Drugs and Cosmetics.

Note: That is exactly the point. Why was Zoledronic acid administered on the day of admission for curing stiff neck? Stiff neck is not in the indications of use of Rokfos.

In view of inadequate information available with respect to patient history, other drugs administered & the sequence of events occurred after discharge of patient from Maruti Nursing Home, Mulund, clinical investigation reports as well as the exact cause of death (Post Mortem findings, if done); it is difficult to comment on whether there was lapse in the standard of care administered. Opinion of the concerned speciality expert’s i.e. Rheumatologist, Intensivists, TB – Chest specialist etc. may be sought to ascertain this.

Note: There was voluminous, abundant and adequate information available with respect to patient history at Maruti Nursing Home.

There were two complaints; 1) with Maharashtra Medical Council and 2) with Maharashtra State Commission.

Note: In-patient record noting of physician, Dr.Aafaque Dolare who certified complainant’s wife as ‘Fit for Surgery’ was available. He had noted that she was “Pre-morbidly healthy” “No known allergies” “No addictions” “No major illness in the past” [Evidence document page 177].

Note: The patient was certified as ‘Fit for surgery’ subject to CRP (quantitative) test being normal. Professor in Joint Investigation Team did not bother to check with treating doctor whether he had conducted this test [Evidence document page 297].

Note: Other drugs administered were available in Maruti Nursing Home in-patient records. Drug Rokfos was administered within seven hours of admission of my wife to Maruti Nursing Home.

Note: ADRs occurred within twenty hours and were noted by treating doctor as “Post Zobone Arthralgia” meaning “Joint pains after injection Zoledronic acid”. She was bed-ridden till her death two weeks later.

Note: Drug Inspectors of both FDA Maharashtra as well as CDSCO (WZ) should be aware of section 27 (a) and drug causing “Grievous Hurt” within the meaning of section 320 of the Indian Penal Code.

Note: Blood investigations were available from 9^th June 2014 till 14^th June 2014 at Maruti Nursing Home. Pancytopenia is a typical side effect of drug Zoledronic acid.

Chart of complete blood counts (CBC) is reproduced below to prove that bone marrow had failed at Maruti Nursing Home itself.

Chart of CBC is given by the treating doctors themselves in their submissions before the Maharashtra Medical Council :

Sr.No	Date	HB	WBC Count	Platelets
1	09/06/2014	10.1	13,900	74,000
2	11/06/2014	10.5	20,080	142,000
3 SRL	12/06/2014	9.5	2,300	95,000
	PATIENT WAS	IN	PANCYTOPENIA
4	13/06/2014	9.2	2,800	59,000

After shifting the patient in a critical condition, bed-ridden, unable to swallow even saliva, petechial rashes on her arms and legs and pancytopenia since 12^th June 2014, results of first CBC taken at Platinum Hospitals were :

	Date	HB	WBC Count	Platelets
	14/06/2014	7.6	200	20,000

After blood and blood products administered after 11.30 p.m. on the night of 14^th June 2014 and during the day on 15^th June 2014 blood counts were as follows :

	Date	HB	WBC Count	Platelets
	15/06/2014	8.1	150	12,000

It is very clear that there was no effect of blood transfusions and blood products administered. Bone marrow had failed at Maruti Nursing Home itself. Pancytopenia was not treated for three days from 12^th June 2014 till 14^th June 2014. Pancytopenia was not informed to Platinum Hospital.

Note: Blood disorders is listed first in the list of side effects of Rokfos as per indications of use.

Note: Google search will give side effects of Rokfos (Zoledronic acid) [Evidence document page 299]. Petechial Rash and Pancytopenia are typical side effects.

Note: Rash was noted in in-patient records.

Note: Pancytopenia was revealed in blood test reports as proved above.

Note: Side effects of Rokfos in Cipla booklet were available at Maruti Nursing Home. It lists blood disorders, arthralgia, myalgia, bone pain, back pain, rash, blood creatinine increase and blood calcium decrease. All these side effects had occurred in death of the patient.

Note: The expert doctor and Professor from L.T. Hospital did not deem fit to investigate Rokfos indications of use.

Note: Creatinine clearance test is a Contra-indication. The Professor in Joint Investigation Team did not look into this.

Note: Sequence of events that occurred after discharge of patient from Maruti Nursing Home, Mulund, were available at Maruti Nursing Home in Complaint file with Maharashtra State Consumer Disputes Redressal Commission as well as Maharashtra Medical Council.

Note: Exact cause of death was Aplastic Anaemia as per bone marrow biopsy report [Evidence document page 88].

There was no need of Post Mortem findings. These reports were all there at Maruti Nursing Home.

Note: Consumer Court had held the treating doctors and Maruti Nursing Home ‘Guilty’ vide Order dated 21/02/2019. These facts must have been informed by DCG(I) under CDSCO (HQ) to CDSCO (WZ) DDC(I).

The Joint Investigation Team says that It was difficult to comment on whether there was lapse in the standard of care administered. Opinion of the concerned speciality expert’s i.e. Rheumatologist, Intensivists, TB – Chest specialist etc. may be sought to ascertain this.

Note: There were lapses not only by the treating doctors but also by the Joint Investigation Team whose only objective was to absolve both Maruti Nursing Home as well as injection Rokfos manufactured by multi-national company Cipla Lted.

Note: Lapses in standard of care is proved in Order of the Executive Committee of Maharashtra Medical Council by removing the name of treating delinquent doctor, Dr. Mihirgiri Goswami from their Register.

Note: There was no need for TB Chest specialist as MRI report was available at Maruti Nursing Home which suggested clinical diagnosis and follow up for Koch’s. The Joint Investigation Team did not deem it proper to question treating doctor why this was not followed.

Note: TB was never proved as surgery was never performed.

Note: Subject Expert Committee (SEC) at CDSCO (HQ) had deliberated on Rheumatism and had opined that the reported adverse reactions like arthralgia, myalgia, bone pain, etc. were known side effects of Zoledronic acid.

Note: SEC did not deem it fit or proper to deliberate on other known side effects of Zoledronic acid which occurred in this case; pancytopenia, petechial rashes, dysphagia, serum calcium decrease, serum creatinine increase that occurred in quick succession in three days.

Note: Petechial rash and pancytopenia are typical symptoms and characteristic features of Aplastic Anaemia as per standard medical textbooks on Aplastic Anaemia produced by the complainant in his criminal complaints. The Complainant’s wife died of Aplastic Anaemia.

Remarks of the Joint Investigation Team :

As per in-patient records available with M/s Maruti Nursing Home, Mulund, Mumbai it was observed that only single dose of drug Zoledronic Acid IV was administered to Smt.Kamini Barkur on 09/06/2014 and said drug was not administered to her again during her hospitalisation at M/s Maruti Nursing Home till 14/06/2014.

Note: As stated earlier, Zoledronic acid 5mg/100ml has to be administered only once in a year. There is no need to protect the treating doctor by the Investigation Team by this remark of ‘Single dose’ repeatedly.

There were no allegations that another dose was administered.
It is observed that Smt.Kamini Barkur w/o Sh.Umeshchandra Barkur was hospitalised in M/s Maruti Nursing Home, Mulund, Mumbai for treatment of Cervical Spondylitis & Stiff Neck and it is not a case of clinical trial as defined under Rule 122-DAA of Drugs and Cosmetics Rules 1945.

Note: There was no need to repeat this again and again. As explained in details of meeting on 22^nd August 2014, explained above, this was an unauthorised ‘Clinical Trial’ to cure ‘Stiff Neck’ in a single day. Not in indications of use and hence not investigated by manufacturer Cipla Ltd.

As complaint is related to adverse drug reaction, opinion of National Coordination Centre, Pharmacovigilance Programme of India, IPC, Ghaziabad may be obtained to take necessary action in the matter.

Note: Secretary-cum-Scientific Director of IPC, Ghaziabad has given his opinion to the complainant on 10^th January 2019 [Evidence document page 304]. That Indian Pharmacopoeia Commission is not the Regulatory Authority to oversee and regulate matters related to manufacturing, sales and Clinical Trials induced adverse drug reactions/death. As such the grievance is not pertaining to IPC. Matters relating to clinical trials and adverse drug reactions/death in this country are regulated by CDSCO under DGHS, MOHFW, Govt. of India headed by DCG(I). That the matter stands clarified from their end.

Also opinion of the concerned speciality expert’s i.e. Rheumatologist, Intensivists, TB – Chest specialist etc. may be sought to ascertain lapses in the standard of care administered, if any?

Note: This has been clarified above under Subject Expert Committee by CDSCO. SEC did not deem fit to investigate petechial rashes and pancytopenia, dysphagia, serum calcium decrease and serum creatinine increase. All these side effects occurred, one by one in three days’ time.

Note: As per indications of use of Zoledronic acid [Evidence document 296], my wife was not admitted for any of the indications. As per Orders by both Maharashtra Medical Council and Maharashtra State Commission, ADRs of injection Rokfos was responsible for pancytopenia and subsequently bone marrow failure.

Note: Statements made by the doctors at the meeting held on August 22^nd 2014 and inferences drawn from the statements explained above proves nexus between Maruti Nursing Home and Cipla Limited for trials conducted to treat minor bone problems like joint pains, bone pain, etc which are not there in indications of use of Zoledronic acid.

That only single dose was administered.
Who had alleged that double dose was administered? What about indications of use ignored by the Professor? What about Zoledronic acid for stiff neck?
What about precautions?

Note: The same pattern instructed by the DCG(I) was followed. Place the matter in Orbit so that the aggrieved will be forced to abort seeking justice. Inhuman Professors and Regulatory authorities.

Note: From the facts explained in detail above by the Complainant, it is evident that the Joint Investigation Report was a farce conducted by CDSCO (WZ) in collusion with CDSCO (HQ) and FDA Maharashtra as well as FDA Goa Director to absolve both doctors at Maruti Nursing Home as well as Cipla Limited for hushing up side effects of drug Rokfos causing death of the Complainant’s wife.

Note: To which authorities was this Joint Investigation Report submitted. The Complainant was sending reminders and RTI queries to all concerned authorities viz CDSCO and FDA Maharashtra.

Note: The DCG(I) under CDSCO (HQ) and DDC(I) under CDSCO (WZ), Mumbai had a limited agenda to the Joint Investigation team :

To declare that it was not a ‘Clinical Trial’.
Keep the matter in Orbit on the ADRs.
Pass the buck to PVPI. (PVPI had already given their opinion).
Finally say that the matter is sub-judice.
But in this case, the conspirators will be answerable to the Nation.
FDA Maharashtra is exposed after Status of case at Mazgaon Court was produced by the Complainant.
The Joint Investigation Team as well as FDA Maharashtra, FDA Goa, CDSCO (WZ) and CDSCO (HQ) are answerable for colluding with criminal offenders, gross dereliction of duty, abetment to crimes against humanity and taking a senior citizen for a ride for more than six and half years seeking justice in the untimely, unnatural and merciless death of his wife.
Officials in CDSCO (HQ), DCG(I), FDA Maharashtra and FDA Goa Director have to be booked for playing with lives of citizens and colluding in pharma-doctor nexus. These are very serious anti-national acts along with foreign promoters,

Indications of use of Zoledronic acid sent by DGHS to the Complainant is for the following [Evidence document page 296].:
Paget’s disease of bone.
Prevention and treatment of postmenopausal osteoporosis.
For the treatment of osteoporosis in postmenopausal women and in men who are at risk of fracture, including those with a trauma of hip fracture.
Bone metastasis and multiple myeloma.
Treatment of hypercalcaemia of malignancy.
Rokfos booklet on indications of use runs into 15 pages [Evidence documents pages 105-119]. Cervical spondylitis and stiff neck are not there in indications of use. There are multiple precautions to be followed. None were followed. Creatinine clearance test which is a contra-indication was also not performed.
My wife was not admitted for any of the above-mentioned diseases nor is there any mention of the above-mentioned diseases in in-patient records of Maruti Nursing Home or in the in-patient records of Platinum Hospitals or Jupiter Hospital.
Joint Investigation Team and especially Drugs Inspector of CDSCO (WZ) and Expert on Pharmacology did not deem it necessary to question the treating doctor at Maruti Nursing Home on his faulty treatment.
There were no conclusive actions after this investigation and in Remarks of the Investigating team (20^th March 2019) except the following which is junked and proved as protecting the killers of my wife.
Very next day (i.e. 21^st March 2019) after “Fake Investigation Report” report, letter was issued by FDA Goa Director to Cipla Limited that no action is taken against the company [Evidence document page 306].
Investigation was regarding homicide of my wife but Report was not sent to the aggrieved complainant.
Report was leaked to the complainant after two years by Public Health Departments of Maharashtra after they themselves were trapped destroying “Expert Committee Report” in Lokayukta hearings.
Investigation was regarding drug Rokfos manufactured by Cipla Ltd but Cipla Ltd was not involved.
Date of Investigation : 29-01-2019 & 01-02-2019
Date of Report : 20 March 2019
Cipla Head Global Pharmacovigilance, Dr. Avinash Kakade’s explanation in Show Cause to FDA Goa Director was dated 26.03.2018.
Dr.Eswara Reddy did not consider Cipla’s written submissions a year ago on 26.03.2018. This proves Dr.S.Eswara Reddy as a fraudster.
Corrections to dates in both the letters is obvious [Evidence documents pages 283 and 306]. This proves that it was a coordinated conspiracy between CDSCO and FDA authorities of Gr Mumbai and Directorate of Food & Drugs Administration, Govt. of Goa.
This was one year after FDA Goa Director had warned Cipla Limited of Legal Action [Evidence documents pages 766-767]. Obviously, bribing was the reason for the sudden U-Turn by Director of Food and Drugs Administration, Government of Goa.
After false explanations by Cipla Ltd, FDA Goa Director had passed the matter to DCG(I) for action from his side [Evidence document page 305].
Instead of legal action against Cipla Ltd, DCG(I) Dr. S. Eswara Reddy passed the matter to Secretary-cum-Scientific Director of Indian Pharmacopoeia Commission, Dr. G.N. Singh four times in five months [Evidence documents pages 768-769 / 770-771 / 772-773 / 774].
10th January 2019 – Letter to the complainant from Dr. G.N.Singh (Secretary-cum-Scientific Director, IPC) [Evidence document page 304] stating the following :

Indian Pharmacopoeia (IPC) is not the Regulatory Authority to oversee and regulate matters related to manufacturing, sales and Clinical Trials induced adverse drug reactions/death. As such, the grievance is not pertaining to IPC. Matters related to clinical trials and adverse drug reactions/death in this country are regulated by the Central Drugs Standards Control Organisation (CDSCO) under DGHS, Ministry of Health and Family Welfare, Government of India headed by Drugs Controller General (India). I hope that with the above information, the matter stands clarified from our end.

Dr. S.Eswara Reddy was forced to take legal action against Cipla Ltd.
However, Dr. S.Eswara Reddy abandoned his duty, moral and legal responsibility and conspired to protect an unscrupulous international pharmaceutical company playing with lives of 141 crore citizens.
Cipla Ltd should have been prosecuted in 2018 itself but for this criminal conspiracy engineered by Dr.S.Eswara Reddy.
I received an Email from cpgrams-darpg@nic dated 25^th March 2019 regarding my grievance with registration No. PMOPG/E/2018/0214210 for providing my feedback on resolution on my grievance. This was immediately after FDA Goa Director issued letter dated 21/03/2019 to Cipla Ltd that no action is taken against them.
I wrote to Dr.S.Eswara Reddy [Evidence documents pages 777-778] that it was he who has to order immediate cancellation of Cipla licence for playing with lives of citizens of India. Nexus with doctors/private hospitals in conducting clinical trials on unsuspecting patients, deceiving FDA authorities, taking consumers for a ride and fooling the world with fake public claims.
There was no response by DCG(I) Dr.Eswara Reddy who abandoned his duty towards the citizens for whom he was appointed.
Around 800 pages of evidence documents have been submitted to Navghar Police, Mulund, Mumbai.
Human Rights Violation in its worst form in the largest democracy in the world by bribing & corrupting every authority in India by Cipla Limited. “INHUMAN”.