Less than three weeks ago,a report of the parliamentary standing committee on health and family welfare shook the country revealing the existence of an alleged nexus between some doctors from prestigious medical colleges and pharmaceutical companies to approve drugs without clinical trials. The report also mentioned the names of two doctors from Post Graduate Institute of Medical Education & Research (PGIMER),Chandigarh,along with several others from institutes such as AIIMS,New Delhi,Christian Medical College,Vellore,Calcutta National Medical College,Kolkata,and Sanjay Gandhi Postgraduate Institute of Medical Sciences (SGPGI),Lucknow.
However,PGI director Dr Y K Chawla came out in defence of its two doctors,who were named in the report. The doctors were only approving the drugs for the good of patients, Chawla said.
It was on May 8,when a report of the parliamentary standing committee was tabled in the Rajya Sabha,in which names of the doctors,whose letters recommending drugs,were mentioned. The letters had identical content and were received by the office of the Drug Controller General Of India (DCGI) on the same day,raising serious doubts.
Interestingly,the letters of all the experts were in the same font and same size. As per the report which was tabled in the Rajya Sabha,letters of opinion recommending approval for Pirfenidone of Cipla from Dr Dheeraj Gupta,additional professor of Pulmonary Medicine,PGIMER,and Dr Pralhad P Prabhudesai from Lilavati Hospital,Mumbai,mentioned how the drug was successfully clinically tried in Japan.
Coming to the rescue of the doctors,Chawla,said,At times it happens that doctors are too busy in OPDs,so company representatives could be asked to draft the letters and doctors would recommend the medicine. When a specific medicine has been established as a cure in few other countries and when we are aware that in our country there is a huge disease burden,then there should be no delay in approving the medicines for the sake of patients.
When questioned on the allegations in the report that pharmaceutical giants and doctors have a nexus for vested interests,Chawla while refuting the charges said,It is not true. I have full faith in all my doctors,who are absolutely clean and all these allegations are false.
Gupta said,I have quoted the example of Japan as at that time in 2010,when the letter was sent,as it was the only country where clinical trials on a huge scale,on over 2,000 patients,were conducted. Moreover,Japan was the pioneer country where the drug was first initiated as a cure to Idiopathic Pulmonary Fiberosis,which is a life threatening condition and has no drug available for treatment. I am not aware if other experts have also quoted the same example.
On being questioned on same date of receipt of recommendation letters and consecutive diary numbers at the DCGI office,Gupta said,I do not follow each and every letter that I send to government offices. I am duty bound as a government employee to follow the orders of DCGI. I was asked to send my opinion on the drug and I did it.