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Drugs getting approval without clinical trials

August 25, 2012

Drugs continue to be approved in India without having undergone proper clinical trials on the local population.

Just months after the parliamentary standing committee on health exposed how the country’s highest office on drugs – the Central Drugs Standard Control Organization (CDSCO) — approved 33 new drugs between January, 2008 and October, 2010 without testing them through trials on Indian patients, Union health minister Ghulam Nabi Azad said on Friday that between January and July 2012, the CDSCOhas approved 14 new drug molecules of which only nine have undergone clinical trials.

Azad said, last year 41 new drugs were approved by the CDSCO of which only 38 had undergone clinical trials.

In 2010, 65 such molecules were approved of which 52 had undergone trials. In 2009, 72 new molecules were approved of which as many as 12 had not undergone clinical trials.

The standing committee report recently said several popular medicines in India are being sold in the country without having undergone clinical trials to check for their safety.

On an average, the committee said that the drug controller general of India (DCGI) was approving one drug every month without trials.

Azad said on Friday, “As per schedule Y of the drugs and cosmetics rules 1945, for new drug approved outside India, phase III clinical trials need to be carried out primarily to generate evidence of efficacy and safety of the drugs in Indian patients.”

He added, “However the requirement of such clinical trial may not be necessary of the drug is of such a nature that the licensing authority may, in public interest, decide to grant permission to import/manufacture the new drug on the basis of data available from other countries.”

Further, said Azad, as per clause 1(3) of Schedule Y, for drugs indicated in life threatening/serious diseases or diseases of special relevance to the Indian health scenario, clinical data requirements may be abbreviated, deferred or omitted, as deemed appropriate by the licensing authority.

This was exactly the argument that the standing committee took strong exception to.

The committee 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 rare disease in India?).”

The panel 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.”

Azad said new drug applications are being examined in consultation with 12 new drug advisory committees (NDACs) consisting of experts/specialists from carious reputed institutions and medical colleges from across India.

The standing committee 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 United States, 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 usually three to 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 added.

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.”

The committee 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.”

According to the report, “It would appear that the intention of those who framed the Act and Rules was to leave a small door ajar for entry of new drugs without undergoing trials in serious emergency situations such as epidemic of a new hitherto unknown disease like SARS, Bird Flu orSwine flu where there may not be time enough to test new drugs and there is no alternative but to take calculated risk. None of the 33 drugs fall in this category of emergency treatments. Besides, many drugs were launched in overseas markets years ago with ample time to conduct trials in India.”

The committee said it seems that expert opinion was sought in only 5 of 33 such out-of- the-way approvals.

The number of clinical trials taking place in India has increased substantially since 2005. As many as 2,282 trials have been approved by the DCGI between 2005 and 2010. As per the Union health ministry’s status note, a total of 1,514 subjects have died in the years 2008 to August, 2010 during clinical trials.

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