New Delhi, May 8: The Union health ministry’s drug regulators have broken laws of the land, approving drugs without trials, at times relying on dubious stamps of approval from private and government doctors, according to a report tabled in Parliament today.
The report from the standing committee on health says that drug regulators have in recent years approved medicines to treat a range of conditions — from infections to liver and lung diseases to sexual dysfunction — either without clinical trials or through irregular procedures.
The committee, which obtained and scrutinised files on drug approvals, has cited examples of irregularities, including approvals to paediatric nimesulide, a medicine used to treat fever, and to buclazine, marketed in India as an appetite stimulant for children but banned in many countries. The irregular approvals to several medicines appear to have spared drug producers cost and effort (of conducting clinical trials) but has put Indian patients at risk, it said.
“It is difficult to believe that these irregularities... were merely due to oversight or unintentional,” the committee observed in its report, calling on the ministry to investigate all the cases listed and act against erring officials “whether currently in service or retired”.
The committee scrutinised some random cases in which drug officials had sought the opinion of independent experts on new drugs.
“There is adequate documentary evidence to come to the conclusion that many (expert) opinions were actually written by the invisible hands of drug manufacturers and the experts merely obliged by putting their signatures,” the committee has observed.
In one example the committee cited, a doctor each from AIIMS, New Delhi, Lilavati Hospital, Mumbai, the Postgraduate Medical Institute, Chandigarh, and Yashoda Hospital, Secunderabad, had recommended approval to pirfenidone, used to treat a lung disease.
Their letters were written on four days in May and June 2010, but they were all received by the office of the drugs controller-general of India (DCGI) on July 2, 2010, with consecutive diarised numbers: 4877, 4878, 4879 and 4880.
This suggests the letters were picked up by the interested party (the manufacturer) from the four cities and handed over to the DCGI office on the same day, indicating the manufacturer was in the loop about the process of consultation with experts.
But the doctors, whose letters are part of annexures to the report, have said they wereexpressing their scientific opinions. “I am shocked at the innuendos being made — just because language is similar or identical, you cannot presume hanky-panky,” said a doctor in Delhi who had sent a recommendation for an anti-asthmatic drug.
A senior doctor at AIIMS who had written a letter recommending approval to pirfenidone without a clinical trial today said there was a “scientific and ethical rationale” for the decision.