New Delhi: A parliamentary committee has assailed the health ministry for failing to take substantive action based on the panel’s findings of irregularities in the way the country’s drug regulator functions.
Terming the ministry’s so-called Action Taken Report “vague, inconclusive, evasive, and dilatory”, the parliamentary standing committee on health, headed by Bahujan Samaj Party lawmaker Brajesh Pathak, said in a report released on Friday that it was “hugely disappointed” by the ministry’s “paralytic inertia” in acting against guilty officials in the Central Drug Standard Control Organization (CDSCO).
In its report, submitted in May 2012, the panel had said that the office of the Drug Controller General of India (DGCI), which oversees CDSCO and is responsible for the regulation of drugs and medical devices, had been approving, on average, one new drug a month without the requisite clinical trials and without seeking expert medical opinion.
The conflict between the panel and the ministry, and the panel’s report, highlight the poor state of drug regulation in India. The drug regulator is also the body in charge of overseeing clinical trials in the country and Mint has reported several damning gaps in this process and the consequences, including the death of some of the subjects who participated in such trials. To be sure, the parliamentary panel didn’t specifically look at clinical trials.
Last year’s report by the panel said the drug regulator had approved 33 new drugs between January 2008 and October 2010 without conducting clinical trials and 25 drugs without seeking the opinion of medically qualified experts.
The drugs approved without clinical trials included Cipla Ltd’s antibiotic drug colistimethate and pirfenidone, used to treat idiopathic pulmonary fibrosis, a lung disease; Novartis AG’s aliskiren, used to treat hypertension; and GlaxoSmithKline Plc’s ambrisentan, a treatment for pulmonary hypertension, .
Cipla clarified that it was not mandatory to conduct clinical trials in India before launching a new drug while Novartis maintained that it followed standard international procedures. GlaxoSmithKline said it was granted a local clinical trial waiver because ambrisetan treated a rare disease “which is life threatening and debilitating”.
Two days after the panel submitted the report, health minister Ghulam Nabi Azad appointed a three-member committee comprising V.M. Katoch, secretary, department of health research; P.N. Tandon, president, National Brain Research Centre; and S.S. Aggarwal, a former director of the Sanjay Gandhi Post-Graduate Institute of Medical Sciences, Lucknow, to suggest steps for institutional improvement of the drug controller’s office within three months.
Out of the 69 recommendations submitted by the parliamentary panel, only 19 have been implemented to varying degrees. The parliamentary panel said the inaction on the remaining recommendations was motivated by the “intent to delay, obfuscate, stagger implementation or not implement at all with a view to delay/negate action in proven cases of wrong doing.”
The parliamentary panel said the ministry is “almost directionless on several vital aspects of drug regulation in the country” and gave it 15 days to adopt “simple and effective global best practices.”
Reacting to the criticism, DCGI G.N. Singh said the authorities were doing the best that was “humanly possible” at this time. “Within our constraints, we are doing our best. We have an honest approach and things will reach a logical conclusion in due course of time,” he said.
The parliementary panel was critical of the three-member committee, saying it had “by design or default” overlooked the unlawful approval of Deanxit, an anti-depressasnt made by Denmark’s H. Lundbeck A/S, which was approved without any paperwork and is banned in most developed countries.
The panel found the ministry guilty of furnishing information that was “diversionary and misleading” in Deanxit’s case. It said the ministry and the committee had gone out of their way to defend marketing approval for the medicine. Lundbeck has not reacted to the controversy after being named in last year’s report by the parliamentary committee.
The panel said the responses of the health ministry were a case of “clear stonewalling to protect the guilty”. It said the three-member committee, instead of suggesting concrete measures, has recommended setting up more enquiry panels.
“This is a case where no extraordinary investigative skills or legal acumen is required to fix responsibility and punish the guilty official(s). A rule has been violated, all evidence is on board and the extraordinary interest of the perpetrator(s) is clearly visible. What purposes, other than delaying the judgment day, would a series of inquiries serve?”
The panel has again recommended action against those officials at the drug regulator who may have colluded with private companies to approve unsafe drugs.
Ranjit Shahani, president of the Organization of Pharmaceutical Producers of India (OPPI), the lobby group for foreign drug producers in India, said, “Anyone who does not make drugs of the right standard needs to be severely dealt with. There are strong laws about it and we hope they can be implemented strongly.”