09 May 2012
By Kounteya Sinha
New Delhi India
Is the pill you are popping safe? No one can say for sure.
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 parliamentary standing committee for health and family welfare, which looked at the functioning of the country’s highest office on drugs–the Central Drugs Standard Control Organization (CDSCO)–
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 (Sanofi’s Dronedarone and Novartis’ Aliskiran), trials were held only on 21 and 46 patients against the stipulated 100.
In one case (Irsogladine of Macleods), trials were conducted at just two hospitals against the required 3–4.Anti–cancer drug being used to treat infertility
Accusing officials of the Central Drugs Standard Control Organization of “colluding with private interests” to get controversial drug Letrozole approved in India to treat infertility problems in young women, the parliamentary panel has asked the Union health ministry to take action against those involved in the “violation of laws”. Letrozole is an anti–cancer drug used globally only in post–menopausal women. Its side–effects are believed to have led to severe genetic abnormalities in babies born to women who had been given the drug.P 11 Irrelevant drugs risking Indians’ health: Panel
New Delhi: The parliamentary standing committee for health and family welfare has indicted CDSCO for okaying new drugs without mandatory clinical trails. In the case of four drugs (Everolimus of Novartis, Buclizine of UCB, Pemetexid of Eli Lilly and FDC of Pregabalin), not only were the mandatory phase III clinical trials not conducted, but expert opinion was also not sought. Non–medical staff of CDSCO unilaterally approved these drugs.
Jyoti Mirdha, a member of the standing committee, said, “By not putting these new drugs 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. This was being overlooked till now because drug trials are 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).
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 or four.
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 committeesaid, “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.”