India's drugs regulator has colluded with pharmaceutical companies in approving drugs without conducting the required local clinical trials and has brought to market drugs which are banned in other countries, a group of legislators has said.
Following an 18-month investigation, India’s Parliamentary Standing Committee on Health says it has found "gross violation" of Indian laws by drugmakers and officials of India's Central Drugs Standard Control Organisation (CDSCO) and has called for the drugs whose approval has raised concerns to be re-examined.
"There is sufficient evidence on record to conclude that there is collusive nexus between drug manufacturers, some functionaries of CDSCO and some medical experts. Such irregular approvals spare drug producers the cost and efforts but put Indian patients at risk," says the Committee's report.
The legislators looked at a random sample of 42 medicines from the list of new drugs uploaded by CDSCO on its website, accounting for just 2% of the 2,167 new drugs approved by the Drug Controller General of India (DCGI) during January 2001-November 2010. They found that, of these 42 products, 33 had been approved without clinical trials being conducted on Indian patients from January 2008 to October 2010.
Of the 42 drugs picked up randomly for scrutiny, the Health Ministry was unable to provide the Committee with any documents on three - the fluoroquinolone antibacterials pefloxacin, lomefloxacin and sparfloxacin - on the grounds that their files were non-traceable.
"All these drugs had been approved on different dates and different years, creating doubt if disappearance was accidental," says the report.
It adds: "strangely, all these cases also happened to be controversial drugs - one was never marketed in the US, Canada, Britain, Australia and other countries with well-developed regulatory systems, while the other two were discontinued later on. In India, all the three drugs are currently being sold."
Of the 39 drugs on which information was available: - for 11, the mandatory Phase III clinical trials had not been conducted; - for two, clinical trials were conducted on 21 and 46 patients respectively, against the statutory requirement of at least 100 patients; - in one case, trials were conducted at two hospitals, against the legal requirement of three to four sites; and - in the case of four drugs, not only were the mandatory Phase II trials not conducted, but the opinion of experts was not sought - the decision to approve the drugs was taken solely by the non-medical staff of the CDSCO.
And a review of opinions provided by medical experts found that an "overwhelming majority are recommendations based on personal perception without giving any hard scientific evidence or data," say the legislators.
They add: "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."
Moreover, 13 of the 39 drugs examined are not approved for sale in any of the major developed nations - the US, Canada, UK, European Union (EU) nations and Australia - and none of them has any special or specific relevance to the medical needs of India, says the report.
There is no scientific evidence to show that the 33 drugs approved without clinical trials are safe and effective in Indian patients, say the legislators, who had questioned the Health Ministry on the matter. Ministry officials had replied that the DCGI has the power to approve drugs without such trials if it is in the public interest. But, said the panel, no explanation was available as to what constitutes public interest, although some reasons given for irregular approvals were:
- serious disease: "all the more reason to conduct clinical trials to ensure that patients in India really benefit from such imported, exorbitantly expensive drugs," says the Committee;
- rare disease status according to the US Food and Drug Administration (FDA): the Committee asks: "how can US FDA decide what is a rare disease in India?" and
- orphan drug status in Europe and India: but, say the legislators, there is no provision in Indian law to give special treatment to such foreign drugs.