Saturday, December 6, 2014

India drugs regulation capability fact of the day

The spate of punitive actions by the US FDA on drugs manufacturing facilities in India in recent months on grounds of impurities in samples and falsification of test results draws attention to the role of the Indian regulator, the Drugs Controller General of India (DCGI). In particular, this from a Business Standard report stands out,
While the Indian regulator has a total staff of 650, the USFDA has 20 times more at 13,000. 
For a sector with exports worth $14.6 bn in 2012-13, of which 26% went to the US, and with over 370 US FDA approved pharmaceuticals manufacturing facilities, the largest number outside the US, the level of regulatory over-sight leaves much to be desired. Apart from being a reflection of the doubtful corporate governance standards, the punitive actions are a reminder of the glaring deficiencies in India's state capability. If the "Make in India" campaign, and sustainable economic growth itself, is to stand any chance of success, the country needs to fix its sorely deficient state capability.

The grossly inadequate regulatory personnel is a first order deficiency and is representative of governance and regulatory failures across sectors. Early this year, the US FAA had downgraded the country's aviation safety ranking to Category II citing 31 inadequacies, including deficient technical expertise, lack of trained personnel (more than 500 vacancies), record-keeping, and inspection procedures being followed by the Director General of Civil Aviation (DGCA). 

Postscript : The Times carries an article on the government's efforts to ease environmental regulatory burdens by scrapping a layer of pollution inspections with voluntary disclosure and compliance by business owners. While streamlining the processes is welcome, it is unlikely to yield much benefits in the absence of its effective implementation.

It is here that India's state capability problems surface. Across states, the Pollution Control Boards (PCBs) are perceived as extremely corrupt and sorely lacking the professional competence and bandwidth to effectively discharge their implementation responsibilities. This is instructive of the capability deficit,
The newly appointed National Board for Wildlife, which must approve projects in and around protected areas, plowed through 140 pending projects during a two-day gathering in mid-August. One member said they worked at a rate of 15 to 30 minutes per file.
The point being made is that the weak state capability is as much a bandwidth problem as a professional competency problem. 

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