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Global regulators demanding needless drug quality levels, says Indian Gov

Indian Government compares recent success in its cut-price mission to Mars to drug manufacturing

Overzealous and unnecessary quality demands by some regulatory agencies are driving up the cost of medicines, according to the Indian Government.

India has for many years provided low-cost medicines for many countries, supplying 10% of finished drug products for the US alone, the US FDA told this publication. However, a number of high profile lapses in GMP, resulting in warning letters and import alerts, have led to growing concerns about quality.

At last week’s CPhI Paris, a delegation from the Indian Government - including Joint Security Department of Commerce Sudhanshu Pandey and G N Singh, the Drugs Controller General – told in-Pharmatechnologist.com quality concerns were as a result of what it considers are overly strict regulatory requirements, and a global standard pharmacopeia would help erase any negative connotations surrounding Indian manufacturing.

“We have [around 10,000] facilities serving almost 15 markets,” the Drugs Controller General said, with approximately 1,500 WHO approved, 750 US FDA approved, and 200 TGA/EMA approved plants. “Because each market supplies the regulations, [drugmakers] have to make the investment to meet these requirements, so the cost of the medicines will also go up.”

Pandey added “some regulators raise these standards to, at times, ridiculous levels for cost reasons, and it becomes a barrier. This means the same standard of drug can be produced without raising that bar." He declined to name a specific agency but said “this is the trend which is happening in many countries and not driven by a balanced concern for the citizens.”

To cheaply go...

As a “slightly unrelated but relevant observation,” he compared the Indian drug industry to India’s space programme which sent its Mangalyaan satellite to Mars last month at a cost of just 4.5bn rupees ($74m).

“Recently the Indian Mars mission succeeded in first attempt at one tenth of the cost of NASA. Does it mean that the satellite was substandard?”

We asked the delegation whether certain regulatory bodies have therefore pushed their standards too high and if so what affect this has had on the industry. “Say for example, increasing the standard is not giving you any implemental advantage for guaranteeing the quality, what is the point of having that raised standard?

“The company is not going to pay from its pocket if a regulator unreasonably raises the standard, and so either you will pay, or I will pay, or my Government – and therefore the taxpayer - will pay.”

Investing in standard quality

The exact level required would need to be a “subjective decision,” Pandey said, but added the Indian Government was looking to bring this standardisation through a ‘Trust’ programme in collaboration with industry.

“Why don’t we actually bring harmony among various regulatory regimes? Human life is same and equally important in all countries. Why does one particular human life need to be made safer than another.”

Furthermore, according to Singh, India is looking to increase the number of inspectors three-fold from 1,500 to around 5,000 by 2017.

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