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Trial And Horror

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India's drug administration is in poor health. On 9 May, the findings of a parliamentary panel that studied the functioning of the Central Drugs Standard Control Organisation (CDSCO) were made public. A  random scrutiny by the Parliamentary Standing Committee on Health found that as many as 33 drugs had been  approved without proper clinical trials on Indian patients between January 2008 and October 2010.  But the 118-page report says much more.

Here's an example: "For decades together, it (CDSCO) has been according primacy to the propagation and facilitation of the drugs industry, due to which unfortunately the interest of the biggest stakeholder, the consumer, has never been ensured." The report goes on to criticise the mission statement of the CDSCO while comparing it with those of drug regulatory agencies in the developed world.

The committee randomly reviewed the approval process for 42 of the 2,167 drugs approved by the Drug Controller General of India between January 2001 and November 2010. It found that data was missing for three drugs; mandatory Phase III trials were not conducted for 11 drugs; in three cases, trials were conducted on less than the prescribed number of patients; 13 drugs banned in the developed world were approved in India.
Then, expert medical opinion was either not sought or limited to just 3-4 opinions in a number of instances; also medical opinion was not backed by adequate scientific data but based on personal perception. The report cites cases of identical medical opinions from different ‘experts' on the same drug.

India's Rs 1,20,000-crore pharma industry is managed by a handful of people. The CDSCO, headquartered in New Delhi, has six zonal offices, three sub-zonal offices, and 11 offices at ports and airports. Four deputy drug controllers and five assistant drug controllers at Delhi handle roughly 20,000 applications, meet 11,000 public / industry representatives, respond to 700 parliamentary questions, attend sub-committee hearings and 150 court cases.

The number of drugs approved without proper clinical trials

As for staff strength, out of 327 sanctioned positions, only 124 have been filled. Compare this with the US Food and Drug Administration (FDA), which employed over 11,500 people across various divisions as of October 2009, the latest date for which data is available.

Could this be a contributing factor to the rot in the system? When drug makers collect medical opinions for the drugs they manufacture and deliver it to CDSCO — the parliamentary committee's report cites one such instance — the scope for collusion expands enormously. 

The report also calls for urgent manpower augmentation, improving infrastructure at the regulator's various state and central offices and drug testing laboratories. It also suggests that the educational and professional qualifications required at the highest levels of CDSCO be raised to a standard comparable to that of the chief of USFDA and the UK's Medicine and Healthcare Regulatory Authority.

The enforcement machinery in various states is another concern. There are about 600,000 retail outlets and 10,500 manufacturing units in India, which require 3,200 drug inspectors. But there are only 846 of them. Centre-state coordination on implementation of the Drugs and Cosmetics Act and Rules, and collecting and sharing data are the other areas that need serious attention. The committee's report is a wake-up call. But treating just the symptoms may not be enough.


(This story was published in the magazine dated 21 may 2012.)