- Reply to RTI query dated 24th November 2017; 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]
- 26th July 2018 – Letter from DCGI to IPC asking to examine the whole issue under PvPI and to give their considered opinion so as to take further necessary action in the matter. That the complainant is repeatedly writing letters to their office and other parties asking for re-examination in the matter for judgement and due compensation [Evidence documents pages 768-769].
- 10th September 2018 – Letter from Assistant Drugs Controller (India) to Dr.G.N.Singh, the Secretary-cum-Scientific Director, Indian Pharmacopoeia Commission asking to examine the whole issue under PvPI and to give their considered opinion so as to take further necessary action in the matter. That the complainant is repeatedly writing letters to their office and other parties asking for re-examination in the matter for judgement and due compensation [Evidence documents pages 770-771].
- 30th November 2018 – Letter from Deputy Drugs Controller (India) Shri A.K.Pradhan to Secretary-cum-Scientific Director, Indian Pharmacopoeia Commission stating that since the matter is related to alleged ADR reported with drug Rokfos (Zoledronic acid) for infusion and not related to any clinical trial, you are requested to examine the whole issue under PvPI and give your considered opinion so as to take further necessary action in the matter [Evidence documents pages 772-773].
- 05th December 2018 – Letter from Assistant Drugs Controller (India), Shri Somnath Basu to the complainant that since the alleged ADR related to Zoledronic acid for Infusion (manufactured by M/S Cipla Limited) is not related to clinical trial this office has once again requested Secretary-cum-Scientific Director, IPC Ghaziabad to examine the whole matter under PvPI and to give his considered opinion in the matter [Evidence documents pages 774].
- 10th January 2019 – Letter to the complainant by Dr.G.N.Singh (Secretary-cum-Scientific Director) [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.
- 2nd October 2019 – RTI Query to IPC – 1) Whether the serious adverse drug reactions of injection Rokfos has been finally reported by Cipla Limited to FDA authorities, IPC (PVPI) and DCGI.
Has the ADRs reported to all authorities involved in pharmacovigilance across the world and especially to WHO. 3) Can I get the report from authorities as I am the aggrieved party in this homicide case [Evidence documents pages 252-254].
- 17th October 2019 – Reply to the above RTI query – Reply Point No.1 “YES”. Reply Point No.2 “Does not pertain to IPC” Reply Point No.3 “Exempted from disclosure under Section-8(1)(d) of the RTI Act”. CPIO – V.Kalaiselvan.
- 23rd August 2020 – RTI Query to IPC – Were the seriousADRs of injection Rokfos manufactured by Cipla Ltd informed to W.H.O. worldwide.
- 14th September 2020 – Reply to the above by the same CPIO V.Kalaiselvan – Reply :- “Yes”. The Indian Pharmacopoeia Commission – National Coordination Centre for Pharmacovigilance Programme of India has transmitted the suspected Adverse Drug Reaction associated with Rokfos injection to Uppsala Monitoring Centre (UMC) – World Health Organisation Collaborating Centre for International Drug Monitoring Programme. CPIO – V.Kalaiselvan. The CPIO lied to W.H.O.
- 18th September 2020 – My email to the Secretary-cum-Scientific Director and CPIO Shri Kalaiselvan regarding false information given to Uppsala Monitoring Centre (UMC) World Health Organisation Collaborating Centre for International Drug Monitoring Programme has not been answered. Copies of this letter were sent to the Health Minister, DCG(I) along with Order/Advise by Cabinet Secretariat, Shri Rajiv Gauba for action in CIPLA DRUG TRIAL case.
I stated that the ADRs were “NOT SUSPECTED” but “REAL and HUSHED UP”. I asked all concerned including Uppsala Monitoring Centre (UMC) World Health Organisation Collaborating Centre for International Drug Monitoring Programme for investigating and reporting.
There has been no reply from any of the authorities concerned. Such a massive cover up. What is the role of PvPI and IPC if ADRs are hushed up at W.H.O. level also? Such a hue and cry on Pharmacovigilance and an unscrupulous international pharma company, Cipla Limited having around 55 subsidiaries across the world is playing with lives of innocents.