Explaining the world's strictest drug regulator to Indian healers

New India head of US FDA to work with domestic pharma to help it upgrade

With leading Indian drug makers such as Ranbaxy and Wockhardt increasingly under the scanner of the US Food & Drug Administration (FDA), its new Director in India, Altaf Ahmed Lal, says his role isn’t easy but one he is “eager” to face. “Accepting the responsibility to assume the helm of FDA’s office in India presents a rather daunting challenge. But as my colleagues, and most certainly my wife and three children will tell you, I am not one to shy away from a challenge — quite the opposite,” Lal recently wrote in a blog on the FDA’s blogging site, FDA Voice.

Lal, a former health attaché at the US embassy here, involved in establishing FDA in India, started his tenure as country director here in June this year. He plans workshops with the industry and regulators in the next few months, to explain the requirements of international standards, according to the blog. “Over the next 12 to 24 months, I look forward to hosting workshops for open, transparent discussions with the industry and regulators on what systems of preventive control need to be in place throughout the lifecycle of any manufacturing process. What controls do we need to guarantee that at the end of the day, products are safe and effective? Which checks & balances should be standard procedure?” he wrote.

India, home to 200 FDA-approved drug making units, is the second largest supplier of pharmaceuticals to the US.

Equating the next challenge with his interest in trekking and climbing, Lal said he was eager to be part of it. “A colleague recently likened my new role at FDA to scaling Mount Everest. But you know, I am fond of trekking and climbing, and view this next challenge much as I do those activities, as both a challenge and an adventure,” he wrote.

The blog, posted on Tuesday, comes amid rising concern in the domestic pharmaceutical industry, in the wake of increasing global enforcements, mainly from the FDA. The regulator, considered the strictest of all global drug regulatory agencies, has planned to increase its activities in India. It has an office each here and in Mumbai, and is exploring whether to open a third in Hyderabad. In March, the FDA was allowed to add seven inspectors, bringing its staff in India to 19, reflecting this country’s growing importance as a supplier to the US.

‘Why are we failing?’
All three key facilities of Ranbaxy Laboratories in India, which were exporting medicines to the US, are now on import alert and undergoing consent decrees — meaning, they effectively cannot. Wockhardt and RPG Life Sciences have also come under the regulator's scanner. Besides import alerts, drug manufacturing facilities in India are also getting warning letters and the FDA Form 483, highlighting deviations from good manufacturing norms.

While Lal has indicated there might be frequent and fast inspections, he wrote that part of the challenge was to “define those milestones” by which success can be measured. He wrote, “I want a manufacturer to ask — and be able to answer – the question, ‘Why are we failing inspections?’”