Killer pharma company, Cipla Ltd was fully supported by the Health Ministry (Drug Controllers), Health Secretary, Health Ministers Dr.Harsh Vardhan, Mr.J.P.Nadda, Mr. Mansukh Mandaviya and Indian Pharmacopoeia Commission. All are answerable before the Law.
Drugs Controller General of India DCG(I) under CDSCO (HQ), New Delhi under DGHS under MOHFW.
- Reply to RTI query application no. DTGHS/R/2017/90070 dated 20.11.2017; Protocol to be followed by drug manufacturing companies in case of serious adverse drug reactions; Statutory guidelines explained under [Evidence documents pages 94-95]. Statutory guidelines were not followed by Cipla nor by FDA authorities of Maharashtra and Goa and neither did the DCG(I) question Cipla or the State Licensing Authorities.
- CDSCO is the National Regulatory body for drugs and drug Rokfos (Zoledronic acid) had caused serious ADRs never seen before.
Zoledronic acid is manufactured by several companies in the world and used by millions across the world.
- It was absolutely required to be investigated in the interest of ‘Medical Science’.
- Reply to RTI query dated 14/09/2019 by CDSCO. Subject Expert Committee (SEC) meeting on 11.04.2019 pertaining to Analgesic and Rheumatology [Evidence documents pages 302-303] deliberated on serious ADRs of injection Rokfos and said that the reported adverse reactions like arthralgia, myalgia, bone pain are known side effects of drug Rokfos.
- Apart from these side effects, more serious ADRs were petechial rashes and pancytopenia which were not deliberated upon at the said SEC meeting. Both are typical symptoms and characteristic features of Aplastic Anaemia and my wife died of Aplastic Anaemia.
- CDSCO reply proves protection given to Cipla for their drug causing death of my wife and to divert the matter to State Licensing Authority which was FDA Goa.
- Both the authorities (CDSCO and FDA Goa) were compromised. DCGI not even questioning Cipla Limited tells the story. We were hearing of DCGI’s involvement in giving approvals to vaccines and other regulatory issues daily on the news channels. In spite of my repeated messages and emails, Dr.V.G.Somani preferred to remain silent.
- My complaint against FDA Goa Director was with the Chief Minister of Goa and I have not got, even an acknowledgement.
- My complaint with CPGRAMS PMOPG/E/2018/0214210 was disposed of on 25/03/2019 with a request to view details and provide my feedback on resolution of my grievance. This confirms that my grievance was genuine. Grievance was death caused by Cipla drug ADRs which were hushed up.
- I had sent my feedback to the DCGI on 26/03/2019 as this matter was under examination of Ministry of Health and Family Welfare and under the active consideration of CDSCO – Officer concerns – DCGI.
- Periodically the DCG(I) was hinting at compensation whereas I was claiming penalty and punishment as per section 27 of Drugs and Cosmetics Act, 1940. There has been no action by the DCG(I) since six years.
- Replies by CDSCO/DCGI is clear evidence that the authorities have been taking a senior citizen for a ride seeking justice in death of his wife. Attempt to silence the aggrieved, so that he aborts seeking justice.
- Joint Investigation Report proves that CDSCO (HQ) and CDSCO (WZ) are involved in malpractices with FDA Maharashtra and FDA Goa.
- DCG(I) was the person co-ordinating the suppression of the serious ADRs with FDA Maharashtra and later with FDA Goa.
- It was an unbelievable scam with billionaire foreign promoters, amounting to anti-national and seditious activities.
- Total Foul Play by the DCG(I) who was the kingpin of the conspiracies to protect criminal offenders deserving stringent action.
- Dr.S.Eswara Reddy was arrested by the CBI in Biocon Biologics bribery case. CBI had tapped phones of Drug Controllers and hence he was caught.
- I complained to CBI Director that Dr.S.Eswara Reddy was also involved in Cipla Drug Trial case who organized “Fake Joint Investigation” to protect Cipla Ltd.