Key points:
• Seizure of drugs for illegal sale without a valid license.
• False, misleading, evasive replies by FDA Gr Mumbai to my RTI queries.
• Proof of corruption at FDA Gr Mumbai.
• Maharashtra tops in sub-standard drugs.
• Finally, FDA Gr Mumbai Assistant Commissioner told the complainant to go to FDA Goa as the drug was manufactured at Cipla Goa Plant.
a) Complaint dated 28.04.2015 [Evidence documents pages 257-261].
• Complainant had addressed FDA Maharashtra Joint Commissioner in his complaint that his wife, after being admitted to Maruti Nursing Home on 9th June 2014 was shifted after six days in very critical condition and succumbed to her death on 24th June 2014.
• Complainant had attached admission form, purchase bill for Rokfos and bill from Maruti Nursing Home for sale of the said drug.
Complainant had given copy of his complaint to Cipla Ltd dated 16/08/2014 as stated above [Evidence documents pages 96-98].
• Complainant had stated that drugs were sold to him above MRP.
b) Complainant received letter dated 28th January 2016 from Assistant Commissioner (Zone 4) FDA Maharashtra [Evidence document page 262] in respect of seizure of drugs at Maruti Nursing Home for Illegal sale of drugs under Drugs & Cosmetics Act, 1940.
• This letter stated that upon his complaint, FDA had raided Maruti Nursing Home on 22/07/2015 and after a panchnama, had seized drugs worth rupees five lakhs and eight thousand.
• That after investigations, action would be taken very soon.
• This letter was produced by the Complainant in his complaint before the Maharashtra State Consumer Disputes Redressal Commission as well as with the Maharashtra Medical Council.
c) Subsequent complaints, correspondence and deliberate false, evasive and misleading replies to Complainant’s RTI queries by FDA Maharashtra, Mumbai are listed in [Evidence documents pages 263-267].
• The aggrieved Complainant has been taken for a ride for more than six years by officials at the highest levels at FDA Maharashtra; Commissioner, Joint Commissioners, Assistant Commissioners, Drug Inspector.
• False, misleading, evasive replies by FDA Maharashtra, Mumbai to my RTI queries is proof of Foul play and colluding with both Maruti Nursing Home doctors as well as Cipla Ltd, which is now totally exposed :
• That my RTI Queries were in Question & Answer Form.
Note : My RTI queries were specific to death of my wife only, and not for general knowledge on Drugs and Cosmetics Act, 1940 and Rules 1945 thereof.
d) RTI Query & reply dated 16/10/2019.
Rokfos is manufactured by Cipla which comes under the jurisdiction of FDA Goa [Evidence documents pages 268-269].
Note : Whom will residents of Maharashtra address their grievance relating to drug causing death in Mumbai, if not FDA Maharashtra, Mumbai?
e) RTI Query & reply dated 16/10/2019 [Evidence documents pages 268-269].
Drug Inspector of this administration has launched the prosecution against Maruti Nursing Home and other concerned persons in the Court.
Note : They have said that FDA has launched prosecution in Court.
Case filed at 15th Court, Mazgaon was for illegal sale of drugs without a valid licence as required under Drugs and Cosmetics Act, 1940.
My complaint was not for illegal sale of drugs as explained above but regarding death of my wife from ADRs of Rokfos as per my complaint dated 16th August 2014 to Cipla Ltd given to FDA Assistant Commissioner (Zone 4).
f) RTI Query and reply dated 16/10/2019 [Evidence documents pages 268-269].
There is no sub-standard drug report in the record available in this office.
Note : Is the aggrieved supposed to prove sub-standard drugs. What are FDA officials paid for, from tax-payers’ money? Who will implement Drugs and Cosmetics Act, 1940 and Rules thereof?
Note : Schedule ‘M’ of Drugs and Cosmetics Rules should have been followed by both Cipla Ltd as well as FDA Maharashtra.
g) Both drug manufacturer, Cipla Limited as well as FDA officials in collusion violated ‘Statutory Guidelines’ under Drugs and Cosmetics Rules. They did not investigate the said drug as they were aware that the drug would fail the ‘standard quality’ test.
h) Complaint dated 14th May 2018 [Evidence documents pages 270-277] to Joint Commissioner of FDA Maharashtra was for action against Cipla Ltd, Maruti Nursing Home and FDA officials.
• Complainant had enclosed his letter to Cipla Management dated 9th May 2018 [Evidence documents pages 155-157] demanding an unconditional apology for false, baseless and defamatory information given to Director, Food and Drugs Administration, Goa on the health condition of his wife prior to being administered injection IV Rokfos for curing stiff neck in a single day and which caused her death.
• This complaint was also a reminder to the Joint Commissioner for actions taken by FDA Maharashtra, Mumbai against A. Maruti Nursing Home, B. Cipla Ltd. and C. FDA Maharashtra, Mumbai officials.
That actions were requested by A. DCGI, B. PMO complaint forwarded by Drugs Department, Mantralaya, C. Office of Minister for Food, Civil Supplies, Consumer Protection and FDA and D. Office of Chief Minister of Maharashtra.
• After the false explanation by Cipla Head Global Pharmacovigilance were exposed by the Complainant, it was the role of FDA Goa Director and FDA Maharashtra officials to protect pharma company, Cipla Ltd with a conspiracy hatched by the DCG(I) in collusion with CDSCO (WZ), Mumbai.
• Instead of questioning Cipla officials based on my letter of 14th May, 2018, FDA Maharashtra, Mumbai officials did exactly the Opposite.
They sent one sample to government laboratory in Mumbai in the year 2018, i.e. four years after the adverse event and told the complainant that the drug had passed ‘Standard Quality’ test.
• This was to protect Cipla drug Rokfos and consequentially nexus between Maruti Nursing Home and Cipla Limited playing with lives of innocent vulnerable patients.
• This same letter dated 14th May 2018 was quoted by the Joint Investigation Team who were fully aware that Complainant’s wife had died in 2014 and not in 2018. They were fully aware of expiry date (January 2016) of drug Rokfos administered to my wife in the year 2014 and which caused her death.
i) Proof of corruption in FDA Maharashtra – Media report – Arrest of FDA Officer [Evidence document page 278]. This was the same Assistant Commissioner with whom my complaint was registered.
j) Status of case registered at 15th Court, Mazgaon, Mumbai. Even on illegal sale of drugs, there has been no action after case was filed in 2016 i.e. five years subsequently [Evidence documents pages 279-280].
• My complaint was manipulated as a complaint received from a confidential source. My name is not there as the complainant.
• After panchnama by FDA Drug Inspector on 22/07/2015, drugs were not seized. Instead, the Drug Inspector took an undertaking from Dr.Mihirgiri Goswami that drugs will be stored at temperatures below 25*C.
• Only three samples of drugs (other than Rokfos) were sent to the government laboratory for testing.
• There was nothing about drugs sold above MRP. There is nothing regarding ADRs of injection Rokfos.
• Purchase bill for Rokfos should have been produced. I had provided the same in my complaint dated 28/04/2015.
• Status of case shows ‘Evidence before charge’. No evidence has been submitted since five years. Sale invoices should have been produced.
• After raid on 22/07/2015, case was filed only in October 2016, i.e. after one year and three months. This was due to my continued pressure on the Assistant Commissioner.
• License was issued to Maruti Nursing Home eight months later and that too for a different location.
k) Maharashtra tops in sub-standard drugs – MOS, Health’s statement in Parliament on 13th December 2019 [Evidence document page 281].
• About 8% of the drug samples from Maharashtra tested by the FDA had chemicals other than the prescribed dose or were filled with contaminants such as corn starch, potato starch or chalk revealed Union Minister of State for Health and Family Welfare, Shri Ashwini Kumar Choubey on December 13, 2019.
• Between 2014-15 and 2018-19, samples tested in Maharashtra were found to be sub-standard making it the state with the highest rate of drug samples failing FDA test.
• This pathetic state of affairs is due to the pathetic administration at FDA Maharashtra as brought out in this one case caught red-handed.
• There may be thousands of such cases in nexus with unscrupulous pharma companies like Cipla Ltd playing with lives of the citizens of our country.
• Drug Rokfos that killed the Complainant’s wife had chemicals other than 5mg/100ml of Zoledronic acid. Hence, the drug was not tested by Cipla as well as FDA Maharashtra. It was a trial conducted on an innocent, vulnerable patient.