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Regulatory Focus™ > News Articles > India Takes Inspiration From FDA, EMA in Bid to Improve CDSCO

India Takes Inspiration From FDA, EMA in Bid to Improve CDSCO

Posted 29 June 2015 | By Michael Mezher 

India Takes Inspiration From FDA, EMA in Bid to Improve CDSCO

India's drug regulator, the Central Drugs Standard Control Organization (CDSCO), might receive a major overhaul and a new name if a proposal by the Ministry of Health is enacted, Bloomberg TV India reports.

Challenges at CDSCO

While India has developed into a pharmaceuticals powerhouse, its regulator has struggled to keep up with the growth of its pharmaceutical industry.

In 2012, a report commissioned by an Indian parliamentary committee found CDSCO struggled with staffing shortages, infrastructure issues and its responsibilities to ensure public safety.

One example cited in the report was the authorization of a clinical trial for a fixed dose combination of aceclofenac and drotaverine, which the report says "is not permitted in North America, Europe or Australia." The trials were allowed to proceed after the manufacturer, Themis Medicare Ltd, was instructed to provide support for the trial from experts selected by the company. The report suspected the expert recommendations had been drafted by Themis based on identical language found in each letter.

Benchmarking FDA, EMA

The report also criticized CDSCO's then mission statement: "[To] meet the aspirations … demands and requirements of the pharmaceutical industry."

CDSCO has since updated its mission statement to read: "To safeguard and enhance the public health by assuring the safety, efficacy and quality of drugs, cosmetics and medical devices," putting its mission in line with regulators like the US Food and Drug Administration (FDA) and European Medicines Agency (EMA).

Now, as Bloomberg TV India reports, India's Ministry of Health is looking to move beyond past issues and benchmark the country's regulator to "world-class" regulators like FDA and EMA.

According to an unnamed official, the Ministry of Health is proposing to change the regulator’s name to the Central Drug Administration (CDA) and triple the agency's staff over the next decade. The proposal would also see the regulator moved from the Directorate General of Health Services to being overseen by the Ministry of Health.

In 2013, the Ministry of Health attempted to create a "Central Drugs Authority" that would oversee drug manufacturing. However, the proposal was rejected in parliament for being overly bureaucratic.


Bloomberg TV India

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