The Indian Pharmaceutical Alliance (IPA)-United States Food and Drugs Administration (US FDA) workshop held in Hyderabad stressed on the need for the Industry to continuously upgrade and strengthen manufacturing facilities to face zero tolerance from regulators. According to Dr. Albinus, Deputy Country Director (India), US FDA, the regulators are not biased to any country or company. He stressed US FDA adopts zero-tolerance policy and accordingly the Indian firms needs to continuously upgrade their facilities to uphold quality and safety of pharmaceutical products.

IPA, which represents 19 leading Indian pharma companies engaged in R&D, stressed that US FDA's zero-tolerance policy requires Indian drug firms to reorient not just processes, but also organisational culture, to serve regulated markets credibly. These 19 companies constitute about 75 per cent of total Indian drug exports to the US.

When asked why is the US FDA targeting the Indian pharma companies and increasing inspections, Satish Reddy, managing director of Dr. Reddy’s opined that though the recent incidents of Ranbaxy may have instigated the US FDA to enhance inspections on India companies. But, he stressed that, as more and more Indian companies are exporting their products to USA every year, it’s a common practice that US FDA increases its frequency of inspections and thus more faults are visible.

DG Shah, secretary-general of IPA expressed that Indian companies need to change their mindset and get prepared for zero tolerance by US FDA. “The US FDA has zero tolerance for manufacturing deficiencies. There is a need for attitudinal change that requires time, patience and commitment from the management. This change demands compliance with not only technical standards but also ethical standards. It cannot be limited to one section of the organisation, but should be implemented across the organisation,” he said.

Further shah said, “We will be conducting a series of workshops and our aim is to create more awareness among the Indian firms about the emerging regulatory aspects and very soon we want to see zero import alerts by US FDA.” Explaining the increased scrutiny by regulatory authorities, with the FDA setting higher standards of safety and quality, Shah cited the numbers of import alerts by country: China 75, Canada 63, Mexico 63, Hong Kong 48, Thailand 47, India 46, UK 42, Japan 40, Germany 35 and South Korea 35. So, it is incorrect to think that India is being targeted, he added.

The IPA-FDA workshop held in Hyderabad is first among the series of workshops to be conducted in collaboration with US FDA India Office and India's Central Drugs Standards Control Organisation (CDSCO). These workshops which are conducted in association with IPA will not only train and create awareness among the manufacturers of drug industry but also help the regulators from the CDSCO to learn more about emerging trends in drug regulations across the world.

The domestic pharmaceutical industry is attracting the attention of foreign regulators, such as the FDA. It's easy to see why India is the biggest supplier of medicines to the US, with about 200 FDA-approved drug manufacturing units. Indeed, India produces nearly 40 per cent of generic drugs and over-the-counter products, accounting for 10 per cent of finished dosages in the US.

According to FDA data till June 30, 2013, in the last four years, warning letters to API units have decreased from seven in 2010 to one in 2013. However, good manufacturing practices (GMP) violations at formulation units are growing alarmingly, from 7 in 2010 to 13 in 2013. About 66 companies, including innovators and generic companies such as Novartis, Novo Nordisk, Sanofi Aventis, Teva and Wyeth Lederle, have received warning letters. The data show that Indian companies, which accounted for 40 per cent of drug master files (DMFs) and 37 per cent of ANDAs in 2012, got 12 per cent of the warning letters.