2/13/2018
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`Failings exposed at India’s drug regulator : Nature News & Comment
`
`NATURE | NEWS
`Failings exposed at India’s drug regulator
`Inadequate testing and insufficient staffing plague the granting of pharmaceutical licences.
`
`Gayathri Vaidyanathan
`
`18 May 2012
`
`India's drug-regulatory system is failing in its job, according to a
`report from an Indian parliamentary committee. The report found
`evidence that pharmaceutical companies exploit loopholes in
`Indian law and sometimes collude with the drug-regulatory
`authority to get licences for their products without adequate tests
`being done.
`
`The performance of the Central Drugs Standard Control
`Organization (CDSCO), based in New Delhi, was scrutinized by
`the Committee on Health and Family Welfare for a report
`presented in parliament earlier this month. Despite the CDSCO
`being India’s equivalent of the US Food and Drug
`Administration, the committee’s report revealed that it is understaffed and has insufficient resources to carry out
`its duties.
`
`India's drug regulator has been accused of
`colluding with pharmaceutical companies to
`approve drugs without adequate testing.
`
`The report also highlights an apparent conflict of interest, which it suggests is at the heart of many of the
`CDSCO’s problems: the agency’s mandate is to “meet the aspirations … demands and requirements of the
`pharmaceutical industry”. The report suggests that this has led to “skewed priorities and perceptions” at the
`agency.
`
`As part of its analysis, the parliamentary committee reviewed the approval process for 42 randomly selected
`drugs, most of which were awarded licences between 2004 and 2010. Documentation for three of the drugs —
`which the report describes as “controversial” because they are not licensed for use in most Western nations —
`was missing, and 11 of the remaining 39 had been licensed apparently without undergoing phase III clinical trials.
`
`Drugs approved for use in other countries still have to undergo a phase III trial in India before they are approved
`because a patient’s response to the treatment can be affected by their ethnic background. For example, the
`cholesterol-lowering drug rosuvastatin is effective in Asian patients at half the dose needed in Western patients1.
`The only time this requirement can be waived is in an emergency — such as the public health threat posed by
`H5N1 avian influenza. But the report found that such emergency exceptions have been granted by the CDSCO
`for an average of one drug every month between 2008 and 2010.
`
`Expert opinion
`
`https://www.nature.com/news/failings-exposed-at-india-s-drug-regulator-1.10668
`
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`Failings exposed at India’s drug regulator : Nature News & Comment
`2/13/2018
`The committee’s report also raises concerns about the way in which licences were approved for the drugs it
`reviewed that bypassed clinical trials. The CDSCO sometimes granted exemptions without consulting experts,
`and at other times, the agency asked pharmaceutical companies to submit letters from doctors who vouched for
`the drugs. In some cases, the companies were allowed to choose these experts, who then provided letters that
`appeared to be word-for-word copies of each other.
`
`“There is a nexus between the drug companies and the so-called experts, and the Drug Controller General of
`India,” says Chandra Gulhati, editor of drug-reference guide the Monthly Index of Medical Specialities India. “If
`the opinion of three experts is sought, then you’d expect at least the language of the three letters to be different
`from each other.”
`
`Gyanendra Nath Singh, the Drug Controller General of India, who heads the CDSCO, did not respond to Nature’s
`request for comment.
`
`Blood-pressure drug ambrisentan, made by GlaxoSmithKline, was one of those approved by the CDSCO without
`clinical trials. The report does not mention whether the agency sought expert opinion on the drug before granting
`an exemption. The company notes that the drug has been approved in 44 countries and that those approvals
`were based on phase III trials in 400 patients of multiple ethnicities.
`
`Two of the drugs approved without trials were made by Novartis, though the company was not one of those that
`submitted suspicious expert opinion letters. It says that its regulatory approvals are transparent, and were
`granted under rules that “allow concessions for drugs that treat a rare disease which is life threatening and
`debilitating”.
`
`Indian drug company Cipla also had two drugs that were approved without trials or expert opinion. The company
`denies any collusion with the CDSCO, saying that phase III trials are not mandatory for some drugs.
`
`The committee was also scathing about the CDSCO’s approval of 13 of the 42 drugs reviewed that are not
`licensed for use in most developed countries. The majority of these treatments were domestically manufactured
`tablets containing a mixture of two or more compounds, called fixed dose combinations (FDCs). These are
`supposed to make patients more likely to take their medication by reducing the complexity of their treatment.
`
`But FDCs can cause problems: some that mix antibiotics can lead to the evolution of bacterial resistance, notes
`Gulhati. “If these combinations are valid and wonderful, why would Western countries not adopt them?” he asks.
`
`Nature doi:10.1038/nature.2012.10668
`
`References
`
`1. Yang, J. et al. Acta Pharmacol. Sinica. 32, 116–125 (2011).
`
`Article ISI ChemPort
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`Related stories and links
`
`Failings exposed at India’s drug regulator : Nature News & Comment
`
`From nature.com
`Pakistani drug regulator 'destined to be a failure'
`04 April 2012
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`02 March 2012
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`19 January 2012
`
`From elsewhere
`Parliamentary report on CDSCO
`Central Drugs Standard Control Organisation
`
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