New Delhi, May 10: In a shocking disclosure, some drug companies have been caught red-handed 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.
Usually, scientific recommendations are submitted by experts after they have studied a drug's content.
The endorsement is considered a crucial testimony that convinces India's Central Drugs Standard Control Organization (CDSCO) to trust the drug's effectiveness, in turn, allowing it to be launched in the market.
Clear evidence has been unearthed, whereby the scientific recommendations submitted to the CDSCO were being written by drug companies themselves with "experts merely putting their signatures".
What's worse, some of India's top medicine experts - some are even head of departments - from the country's most iconic medical institutes like PGI Chandigarh; CMC Vellore; AIIMS Delhi and St John's Medical College, Bangalore had signed these recommendations.
The parliamentary standing committee on health and family welfare has found that in case of several drugs, "expert advise and letters of recommendation" from these experts read the same - word by word - and were submitted on the same day.
The committee, which placed its scathing report on the functioning of the CDSCO in Rajya Sabha on Tuesday, 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 says, "There is sufficient evidence on record to conclude that there is collusive nexus between drug manufacturers, some functionaries of CDSCO and some medical experts."
Drug expert Dr CM Gulati says, "This is a big scam. It has unveiled how the crucial testimonies, some as long as 500 pages were written by drug companies themselves and signed by top doctors. The DCGI does not have doctors in his staff, and so tends to believe these testimonies before allowing a drug to hit the market."
He adds, "In one case, letters written in March, April and May by three separate experts land up in the DCGI's officer together on the same day. Some letters read the same, word by word. These experts are supposed to give sound scientific evidence. Instead, they are working for these drug companies."
The panel says, "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 action. In the case of government employed doctors, the matter must also be taken up with medical colleges/hospital authorities for suitable action. In the case involving a drug named Clevudine (Phamasset Inc), three professors of medicine - from AIIMS, KBN Medical College, Gulbarga and RG Kar Medical College, Kolkata - located at different places and thousands of miles apart from each other sent a word for word identical letters of recommendation. Besides, 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."
Letters read same
In another case, involving Sertindole (Lundbeck), an anti-psychotic drug, three experts located at three different places (head of the department of psychiatry of Stanley Medical College, Chennai, doctor from Psychiatric Nursing Home, Ahmedabad and HoD psychiatry of LTM Medical College, Mumbai) wrote letters of recommendation in nearly word-by-word, identical language.
Ironically, all of them used the incorrect form of DGCI.
The Committee says, "Is such a coincidence possible unless the person behind the scene who actually drafted the letters is one and the same person?"
Letters of opinion recommending approval for Pirfenidone of Cipla from professor of pulmonary medicine, AIIMS; a chest physician from Lilavati Hospital, Mumbai; an additional professor of pulmonary medicine from PGI, Chandigarh and a pulmonologist of Yashoda Hospital, Secunderabad, "were all received exactly on the same day 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," the report adds.
The committee says that if these 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, through his letter, 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 HoD of department of pharmacology, PGI (Chandigarh); HOD department of pharmacology at Christian Medical College (Vellore); professor of surgery LTM Medical College (Mumbai) professor of medicine, Gandhi Medical College (Secunderabad), head of postgraduate department of surgery, S C B Medical College (Cuttack) and professor of medicine, Gandhi Medical College (Secunderabad)," the report says.
Now, the Committee has asked the Union health ministry to direct the DCGI to conduct an enquiry and take appropriate action against the officials, who gave authority to the interested party to select and obtain expert opinion and finally approved the drug.
Remarkable coincidence?
* Three opinions from Prof of orthopedics, AIIMS; consultant at Dayanand Medical College, Ludhiana and professor of orthopedics from St Johns Medical College, Bangalore, on rivaroxaban ( Bayer), a drug for prevention of clotting, "are ditto copies of each other".
* In the case of doxofylline, an anti-asthmatic, two opinions (from Prof of medicine of MGM Medical College, Indore and a consultant from Indraprastha Apollo Hospital, New Delhi) are also "word-by-word identical".
* In case of Ademetionine, all four letters of recommendation (from doctors belonging to Lokmanya Tilak Medical College, Mumbai; Medical College, Thiruvananthapuram; IPGMER Kolkata and chairman and chief of hepatology of Sir Ganga Ram Hospital, Delhi) made similar comments.
* Letters of opinion recommending approval of nimesulide injection from HoD of medicine, Government Medical College, Aurangabad and senior consultant orthopedic surgeon of Indraprastha Apollo Hospital, Delhi, reached on the same day and were mentioned in the records under consecutive reference 3537 and 3538.
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