So what if we endorsed drugs,our views don’t count,say doctors

So what if we endorsed drugs,our views don’t count,say doctors

Their letters cited in MPs’ report,they say clearance is regulator’s prerogative

While indicating a possible nexus involved in the clearance of various drugs,a parliamentary panel had annexed letters of recommendation by several senior doctors. Now,many of these doctors say their recommendations were never meant to be the final word. They are being targeted,they allege,when the larger problem lies within the drug regulation mechanism itself.

A recent report of the Parliamentary Standing Committee on Health on the functioning of the Central Drugs Standard Control Organisation had cited the fact that different doctors wrote identical letters recommending the same drugs,and that each arrived at the Drugs Controller General India (DGCI) office the same day. It suggested that doctors mandatorily declare their pecuniary relationships with the drugs company,if any,and that they back up their recommendations with medical evidence.

“There is a proforma given to us by companies and if we agree,we sign it. What is wrong with that?” says Dr R K Mani,director of pulmonology at Artemis Hospital,whose letter recommending the anti-asthmatic doxofylline is cited in the appendix with report. “Why are expert opinions needed at all?” Dr Mani says. “ It is up to the DCGI to do drug regulation; clinical trials are under their jurisdiction. Doctors have nothing to do with it.”

Accusing the report of “innuendos based purely on what can at best be called dark suspicions”,Dr Mani says,“There are so many problems in this country — drugs that are selling at several times their market price in government hospitals. Ignoring that elephant,MPs chose to focus on a non-issue like this.”


Dr Dheeraj Gupta,additional professor of pulmonary medicine at PGIMER Chandigarh,who recommended pirfenidone,refused to discuss the inclusion of his letter. Dr Prahlad Prabhudesai,consultant chest physician at Lilavati Hospital,recommended the same drug. He says he did so because it is the only available drug for idiopathic pulmonary fibrosis and it is approved in the European Union and Japan.

“I lost my mother to the disease and I know what difference this drug can make to the quality of life,” he says. “Earlier we were procuring the same drug from Japan at Rs 45,000 to Rs 50,000 per month. against Rs 5,000 to

Rs 6,000. What was DCGI doing when the drug was being used without approval? And the letter to give a recommendation came from DCGI. We recommend so many things; are all those accepted?”

Dr Randeep Guleria,AIIMS professor of medicine who endorsed clevudine and pirfenidone; AIIMS professor of orthopaedics Dr Rajesh Malhotra who recommended rivaroxaban,a drug to prevent clotting; and Dr Anil Arora of Sir Ganga Ram Hospital,who recommended introduction of ademetionine without additional clinical trials,could not be contacted for comment.

Dr Raju Vaishya,senior consultant of orthopaedics at Indraprastha Apollo Hospitals,says he does not remember writing a recommendation for a nimesulide injection,as cited in the appendix. “I do not remember anything about this letter and I do not know anything about the contents of the report either. I cannot comment on the observations made on my letter as I am busy with patients.”

Dr Hemant R Pathak,head of urology at TN Medical College and B Y L Nair Hospital,wrote a recommendation for dapoxetine that,the panel found,reached the DCGI office the same day as did two other recommendations for the same drug. When told about the three diary items being numbered consecutively (3667,3668 and 3669),he says,“I do not remember clearly but what difference does our recommendation make in any case? It is the DCGI’s call.”