GlaxoSmithKline, Novartis respond to report on Indian drug regulator
Last Updated:May 10, 2012 07:48
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GlaxoSmithKline and Novartis responded Thursday to an Indian parliamentary report suggesting that some drugs have been approved in the country without mandatory Phase III trials being conducted as required or seeking expert opinions. The report also alleged that there had been collusion among drugmakers, experts and officials from the Central Drugs Standard Control Organisation (CDSCO)
According to GlaxoSmith Kline, the company was granted a waiver on late-stage studies for its pulmonary arterial hypertension medicine ambrisentan as Indian rules allow concessions for drugs that treat a "rare disease which is life threatening and debilitating." A spokesman for the drugmaker noted that ambrisentan was approved in the US in 2007 and in Europe in 2008. GlaxoSmithKline indicated that it had submitted the complete global clinical data set to regulatory authorities in India in 2009 and that ambrisentan gained marketing approval in the country in 2010.
Meanwhile, Novartis indicated that it "will investigate the allegations presented in the government's report," which claimed that the company's drugs everolimus and aliskiren had been approved without Phase III trials being undertaken. The report added that in the case of everolimus, the CDSCO relied on the judgment of non-medical staff rather than seeking the opinion of independent experts. Novartis said that it followed one global ethical standard for conducting clinical trials worldwide and stood behind the safety and efficacy of its products.
Reference Articles
 Novartis to probe Indian drug approval allegations - (Moneycontrol.com) |
| GlaxoSmithKline: Complied With Indian Rules In Getting Heart, Lung Drug Approved - (NASDAQ) |
Indian Regulator Colludes With Pharma Over Approvals
By Ed Silverman // May 9th, 2012
A scandal is unfolding in India where a report by a parliamentary committee has found that the Drug Controller General has approved, on average, one new drug each month between 2008 and 2010 without conducting mandatory clinical trials or seeking expert medical opinions. As a result, the committee asked the health ministry to withdraw authority given to the Central Drugs Standard Control Organization, which is overseen by the DCGI, to grant approvals to drugmakerss.
Moreover, 13 of the drugs were banned in developing countries and one drug, nimesulide, was banned globally for prescription to children in 2005, LiveMint writes. Those approved without trials included Cubicin, an anti-infective sold by Novartis; the Alimta cancer med sold by Eli Lilly and the Isentress HIV med sold by Merck. In each case, the panel determined there was sufficient time to conduct testing. Manufacturing licenses for some drugs may be revoked..........Continue Reading At Pharmalot
Probe uncovers serious problems with India's drug regulator
NEW DELHI |
NEW DELHI (Reuters) - India's main drug regulator has not been properly scrutinizing some drugs before approving them, and some of its officials are colluding with drug firms and medical experts to circumvent procedure, according to a new parliamentary report.
The report by parliament's health committee, the result of a more than year-long investigation, painted a chaotic picture of the Central Drugs Standard Control Organisation (CDSCO), which oversees the licensing, marketing and trials of drugs in India.
"There is sufficient evidence on record to conclude that there is collusive nexus between drug manufacturers, some functionaries of CDSCO and some medical experts," it said.
It recommended that the government re-examine certain drugs that had been approved, investigate the "gross violation" of Indian laws it had uncovered, and take action against officials alleged to have colluded with the drug companies.
"What we have found is very alarming," Brajesh Pathak, chairman of the Standing Committee on Health and Family Welfare told Reuters. "The health ministry should investigate the matter and take urgent action on the report."
There was no immediate official comment from the CDSCO on the report, which named a number of major international pharmaceutical companies. Health Ministry officials were also not immediately available.
OPINIONS WRITTEN BY "INVISIBLE HANDS"
The report, presented in parliament on Tuesday, found numerous shortcomings in an organization where files of several controversial drugs had mysteriously disappeared and the recommendations of medical experts promoting certain drugs were identically worded, to the point of including the same misspellings.
It said the problems besetting the CDSCO were partly institutional.
The regulatory body suffered chronic staff shortages and was overwhelmed by its responsibilities in a country where more than 10,500 drug manufacturers were operating and the pharmaceutical industry was growing at a rate of about 10 percent a year.
But the report also said the body had for decades neglected the "poor and hapless patient" in favor of the drugs industry.
The parliamentary committee also found a deeply flawed drug-testing system.
It reviewed 39 drugs approved by the CDSCO and found that in the case of 11, Phase III trials - the final stage of testing before a drug is approved - had not been conducted as required.
A review of opinions submitted by experts on various drugs also showed that an "overwhelming majority are recommendations based on personal perception without giving any hard scientific evidence or data".
"Still worse, there is adequate documentary evidence to come to the conclusion that many opinions were actually written by invisible hands of drug manufacturers and experts merely obliged by putting their signatures," the report said.
A senior CDSCO official, who declined to be named because he is not authorized to speak to the media, said the regulator does not require pharmaceutical firms to conduct safety trials again if drugs have already been approved in their home country.
"We ask for clinical trials only if there is any change in the molecule of the original drug, or the drug has not been approved in their own country," he said.
(Writing by Ross Colvin; Editing by John Chalmers and Jeremy Laurence)
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