New Delhi: A report by the parliamentary standing committee for health and family welfare, which looked at the functioning of the Central Drugs Standard Control Organization (CDSCO), reveals that some drug companies have been writing scientific recommendations of their own products and submitting them to the Drug Controller General of India (DCGI) after getting them endorsed by top doctors for a quicker marketing approval.
The committee has found that in case of several drugs, expert advice and letters of recommendation from these experts read the same – word by word – and were submitted on the same day.
Usually, scientific recommendations are submitted by experts after they have studied a drug’s content. The endorsement is considered a crucial testimony that convinces the CDSCO to trust the drug’s effectiveness, in turn, allowing it to be launched in the market.
The report says there is “ample evidence to show that several scientific recommendations submitted to the CDSCO to push a drug were actually written by invisible hands of drug companies themselves and experts merely obliged by putting their signatures.” It adds, “There is sufficient evidence on record to conclude that there is collusive nexus between drug manufacturers, some functionaries of CDSCO and some medical experts.” [Source: ToI]
Read the full report
An excerpt of the report:
7.31 A review of the opinions submitted by the experts on various drugs shows that an overwhelming majority are recommendations based on personal perception without giving any hard scientific evidence or data. Such opinions are of extremely limited value and merely a formality. Still worse, there is adequate documentary evidence to come to the conclusion that many opinions were actually written by the invisible hands of drug manufacturers and experts merely obliged by putting their signatures. The Committee observed the following facts on scrutiny of opinions:
• In the case of clevudine (of Phamasset Inc.), three experts (a Professor of Medicine of All India Institute of Medical Sciences, New Delhi; a Professor of Medicine of K. B. N. Medical College, Gulbarga; a Professor of Medicine of R. G. Kar Medical College, Kolkata) located at different places thousands of miles apart from each other sent word to word identical letters of recommendation. In addition all of them went out of the way and gave unsolicited advice, in identical language, to the DCGI to give permission to the company to market the drug without conducting mandatory clinical trials in India (Annexure 1).
• In case of sertindole (Serdolect of Lundbeck), an anti-psychotic drug, three experts located at three different places (a Professor and Head of the Department of Psychiatry of Stanley Medical College, Chennai; Professor of SKP Psychiatric Nursing Home, Ahmedabad and a Professor and Head of the Department of Psychiatry of LTM Medical College, Mumbai) wrote letters of recommendation in nearly word-to-word, identical language and not surprisingly all of them used the incorrect full form of DCGI in the address! Is such a coincidence possible unless the person behind the scene who actually drafted the letters is one and the same person? (Annexure 2).
• In the case of doxofylline, an anti-asthmatic, two opinions (from Professor of Medicine of M. G. M. Medical College, Indore and Consultant, Indraprastha Apollo Hospital, New Delhi) are exactly, word-to-word identical. (Annexure 3).
• The three opinions (from Professor of Orthopaedics, All India Institute of Medical Sciences, New Delhi; Consultant at Dayanand Medical College, Ludhiana and Professor of Orthopaedics, St. Johns Medical College, Bangalore) on rivaroxaban (Bayer) a drug for prevention of clotting are merely ditto copies of each other. (Annexure 4).
• In case of ademetionine, all four letters of recommendation (from Professor of the Department of Gastroenterology, Lokmanya Tilak Medical College, Mumbai and Professor of Gastroenterology, Medical College, Thiruvananthapuram; Professor and Head of the Digestive and Liver Diseases, IPGMER, Kolkata; Chairman and Chief of Hepatology Services, Sir Ganga Ram Hospital, New Delhi) made similar comments; three out of four letters are undated (is it merely a coincidence?) while one is dated 11-8-2010. The letter from Asst. Drugs Controller (India) seeking expert opinion is dated 9-8-2010. It is amazing that letter dated 9th August 2010 from New Delhi not only reached Mumbai on 11th August 2010 but was replied the very same day, that too, after reviewing 131 pages of scientific papers. All the four letters are addressed incorrectly though identically to “Directorate General of Health Services” without any address and without even a PIN code. None of the letters were diarized by the office of the Drugs Controller General (India) when received. The drug was approved on 1-9-2010 without Phase III clinical trials. (Annexure 5).
• Letters of opinion recommending approval for pirfenidone of Cipla from Professor of Pulmonary Medicine, AIIMS, New Delhi dated 19th June, 2010, Consultant Chest Physician, Lilavati Hospital, Mumbai dated May 25, 2010; Additional Professor of Pulmonary Medicine, PGI, Chandigarh dated 14th June, 2010; Pulmonologist of Yashoda Hospital, Secunderabad dated 12th June 2010 were all received exactly on the same day 2-7-2010 and diarized by DCGI office under consecutive references 4877, 4878, 4879 and 4880. Is the Committee mistaken in coming to the conclusion that all these letters were collected by interested party from New Delhi, Mumbai, Chandigarh and Secunderabad and handed over to office of the DCGI on the same day? If so, it is obvious that the interested party was in the loop in the entire process of consultation with experts. (Annexure 6).
• Letters of opinion recommending approval of dapoxetine from Professor and Head, Department of Urology, T. N. Medical College, Mumbai dated 25-3-2010; Professor and Head, Department of Psychiatry, L. T. M. Medical College, Mumbai dated 19-3-2010; Professor and Head, Department of Urology, Calcutta National Medical College, Kolkata dated 24-2-2010 all reached the office of DCGI exactly on the same date 6th April 2010 and were diarized under consecutive references 3667, 3668 and 3669. It is surprising that letter dated 24-2-2010 from Kolkata took more than six weeks to reach Delhi. Is it unreasonable on the part of the Committee to come to the conclusion that all these letters were collected by interested party from New Delhi, Mumbai and Kolkata and delivered to the office of DCGI on the same day? (Annexure 7).
• Letters of opinion recommending approval of nimesulide injection from Professor and Head, Department of Medicine, Government Medical College, Aurangabad dated 17-8-2005 and Sr. Consultant Orthopaedic Surgeon, Indraprastha Apollo Hospital, New Delhi dated 17-6-2005 reached exactly on the same day i.e. 23-8-2005 and were diarized under consecutive reference 3537 and 3538. It is inconceivable that a letter dated 17-6-2005 from New Delhi will be delivered to the office of DCGI also in New Delhi after more than two months. The conclusion, as in aforementioned cases, is obvious. (Annexure 8).
7.32 If the above cases are not enough to prove the apparent nexus that exists between drug manufacturers and many experts whose opinion matters so much in the decision making process at the CDSCO, nothing can be more outrageous than clinical trial approval given to the Fixed Dose Combination of aceclofenac with drotaverine which is not permitted in any developed country of North America, Europe or Australasia. In this case, vide his letter number 12-298/06-DC dated 12-2-2007, an official of CDSCO advised the manufacturer, Themis Medicare Ltd. not only to select experts but get their opinions and deliver them to the office of DCGI! No wonder that many experts gave letters of recommendation in identical language apparently drafted by the interested drug manufacturer. These experts include:
i. Professor & Head, Department of Pharmacology, PGI, Chandigarh.
ii. Professor & Head, Department of Pharmacology & Clinical Pharmacology, Christian Medical College, Vellore.
iii. Professor of Surgery, L. T. M. Medical College, Mumbai.
iv. Professor of Medicine, Gandhi Medical College, Secunderabad.
v. Professor and Head of Postgraduate Department of Surgery, S. C. B. Medical College, Cuttack.
vi. Professor of Medicine and Civil Surgeon, Gandhi Medical College, Secunderabad. (Annexure 9).
7.33 In the above case, the Ministry should direct DCGI to conduct an enquiry and take appropriate action against the official(s) who gave authority to the interested party to select and obtain expert opinion and finally approved the drug.
7.34 Such expert opinions in identical language and/or submitted on the same day raise one question: Are the experts really selected by the staff of CDSCO as mentioned in written submission by the Ministry? If so how can they, situated thousands of miles away from each other, draft identically worded letters of recommendation? Is it not reasonable to conclude the names of experts to be consulted are actually suggested by the relevant drug manufacturers? It has been admitted that CDSCO does not have a data bank on experts, that there are no guidelines on how experts should be identified and approached for opinion.
7.35 The Committee is of the view that many actions by experts listed above are clearly unethical and may be in violation of the Code of Ethics of the Medical Council of India applicable to doctors. Hence the matter should be referred to MCI for necessary follow up and action. In addition, in the case of government employed doctors, the matter must also be taken up with medical colleges/hospital authorities for suitable action.