Saturday, April 26, 2014

A damning indictment of drug regulation in India - The CDSCO and expert opinions

(This post is the third part of a series examining the functioning of India's drug regulatory authority, the CDSCO).

One of the requirements to be completed for a new drug approval is to obtain opinions from several qualified experts as to whether the drug should receive approval or not. These experts, at least in India, are usually professors affiliated with medical colleges.

The Committee investigated the process by which these expert opinions are sought and submitted. And here I tip my hat to those Sherlockian committee members who painstakingly sifted through the records and gathered substantial evidence to suggest that many of the letters submitted were "...actually written by the invisible hands of drug manufacturers and experts merely obliged by putting their signatures." Copies of the letters in question have been attached to the report as annexures.

  • In one case, letters from three medical professors affiliated to colleges thousands of kilometres apart were identical, word for word.
  • A second case again had three such identical letters, with the added twist that all three had the same error in the DGCI's address.
  • Letters related to multiple other drugs were also found to be exact (or nearly exact) copies of each other.
  • In one case, a letter seeking an expert opinion was dispatched by an official from New Delhi on 9th August, 2010. By 11th August, not only had the letter reached Mumbai, but had been replied to as well, by an individual apparently capable of examining 131 pages of scientific documents and formulating an expert opinion within a few hours. In the case of this drug, all four expert letters had been dispatched with an incorrect version of the organization's name, no postal address, and no pin code. I salute the Indian postal service if they were apparently able to deduce from this fragmentary information that all four letters were meant for the Delhi office of the CDSCO.
  • Letters dispatched from four different cities (New Delhi, Chandigarh, Mumbai and Secunderabad, all of which are quite far from each other), somehow landed up at the DGCI's office on the same day. The Committee deduces, probably correctly, that someone personally collected these letters and delivered them to the DGCI's office, which means that " is obvious that the interested party was in the loop in the entire process of consultation with experts." 
  • In another case, a letter took two months to travel from New Delhi to...New Delhi. Both the hospital from which it was sent and the DGCI's office are in the same city, but it apparently took two months for the letter to be delivered.
  • In the case of one particular drug (a fixed dose combination which is not approved in any developed country), an official of the CDSCO was found to have written a letter to the manufacturer suggesting that they select experts themselves and have the letters delivered to the DGCI's office. Not surprisingly, many of the experts turned in identical letters which had probably been drafted by the manufacturer.

Based on this mountain of evidence, the Committee concluded that

"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?"
"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."
"There is sufficient evidence on record to conclude that there is collusive nexus between drug manufacturers, some functionaries of CDSCO and some medical experts."
"On a more fundamental issue the Committee has come to the conclusion that when it comes to approving new drugs, too much is left to the absolute discretion of the CDSCO officials...the decision to seek or not to seek expert opinion on new drugs lies exclusively with the non-medical functionaries of CDSCO leaving the doors wide open to the risk of irrational and incorrect decisions with potential to harm public health apart from the possibility of abuse of arbitrary discretionary powers."
The Committee recommended that there should to be a set of comprehensive guidelines to be obeyed while selecting medical experts. Conflicts of interest (if any) should be filed by all experts, and they must be asked to provide hard evidence to back up their recommendations.

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