The Indian Pharmaceutical Alliance (IPA), which comprises 19 leading Indian pharma companies engaged in R&D, says the United States Food and Drug Administration?s (USFDA) 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% of total Indian drug exports to the US.
?The USFDA 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,” DG Shah, secretary-General of the IPA, told FE.
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.
Incidentally, the USFDA India Office and India’s Central Drugs Standards Control Organization (CDSCO), in association with the IPA, is conducting a series of workshops for the drug industry and regulators from the CDSCO. The first such workshop is being held in Hyderabad on May 5, 2014.
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% of generic drugs and over-the-counter products, accounting for 10% of finished dosages in the US.
According to FDA data till June 30, 2013, in the last four years, warning letters to APIs 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 generics 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% of drug master files (DMFs) and 37% of ANDAs in 2012, got 12% of the warning letters.
Shah explains that an increasing number of companies are attracted to the US and hence the rising number of inspections and defaults. ?Violations of GMP may be related to packaging errors, sterility issues, but more than a third of reported incidents relate to undeclared ingredients and unapproved drugs. However, though these incidents had declined in 2012, they seem to have risen again in 2013,” he added.
The solution is that the industry needs to become more introspective and new companies must not rush to the US market without adequate preparation.