Drugs sold without undergoing clinical trials in India: Panel report

By Jitender Singh May 9th, 2012 ( 2 Comments )

New Delhi: Indian Parliamentary standing committee for health and family welfare on Tuesday revealed that several highly popular medicines in India are being sold without having undergone clinical trials to check for their safety.

In a damning report by the committee, 33 new medicines were found to have been approved between January, 2008, and October, 2010, without undergoing human trials.

According to the Committee, on an average, the Drug Controller General of India (DCGI) is approving one drug every month without trials.

In a separate scrutiny of 39 randomly picked drugs in India by the panel, it found that in case of 11 drugs (28%), mandatory phase-III clinical trials were not conducted.

Some of these drugs belong to reputed firms like Novartis, Cipla and Eli Lily. In the case of two drugs (Dronedarone of Sanofi and Aliskiran of Novartis), trials were conducted only on 21 and 46 patients, respectively, as against the stipulated 100.

Jyoti Mirdha, a member of the standing committee, said that by not putting these new drugs go through clinical trials, they are compromising the safety of Indians.

“The purpose of the phase-III trial is to test it on ethnic groups, and there are a large number of such groups in the country,” she said adding that it was being overlooked till now because drug trials were a technical subject and nobody noticed.

The report said that of the cases scrutinized, there were 13 drugs (33%), which did not have permission for sale in any of the major developed countries (the US, Canada, Britain, European Union nations and Australia).

“None of these drugs have any special or specific relevance to the medical needs of India,” the committee said.

In the case of 25 drugs (64%), opinion of medically qualified experts was not obtained before approval. In these cases (14 out of 39 drugs), where expert opinion was sought, the number of experts consulted was only three-four.

“In a country where seven lakh doctors of modern medicine are in practice, such a miniscule number of opinions are hardly adequate to get diverse views and come to a well considered rational decision apart from the possibility of manipulation by interested parties. As against this, to review just the dose of popular pain-killer paracetamol, the United States Food and Drug Administration (USFDA) constituted a panel of 37,” it said.

The Union health ministry, however, explained that as per the rules, the DCGI has the power to approve drugs without clinical trials in “public interest”.

The committee, however, said, “No explanation is available as to what constitutes public interest. How can approvals given to foreign drugs without testing on Indians be in public interest? Some of the reasons given for irregular approvals are: “Serious disease” (all the more reason to conduct clinical trials to ensure that patients in India really benefit from such imported, exorbitantly expensive drugs) and “rare disease status according to US FDA (how can USFDA decide which is a rare disease in India?).”

It added, “Such irregular approvals spare drug producers the cost and efforts but put Indian patients at risk. This cannot be in public interest by any stretch of imagination.”

In cases where foreign drugs were approved without clinical trials in the country, the ministry said, “Most of the drugs are approved in other countries based on multinational clinical trials on various ethnic/racial populations.”

It said, “This is implying that Indians would be included and hence conducting trials in India was not necessary. However, this presumptive remark is not accompanied by any evidence.”