China has over 960 FDA-approved manufacturing sites, the highest number outside the US, and has around 8% of these sites under an import ban by the FDA, not very different from India in terms of incidence of adverse FDA action. However, if you look at countries like Mexico, the UK and Canada, the number of factories under an import alert as a percentage of total US registered sites is much higher that in India or China.
Remember that India has 526 manufacturing facilities approved by the American regulator, the second-highest number outside of US, and accounts for nearly 40% of the generic drugs sold in the that country.
While 74% of Mexican drug making sites registered with FDA are under a ban, around 30% of Canadian and British manufacturing facilities that are approved by the FDA to supply medicines have been issued an import alert.
FDA’s spokesperson in India, Christopher C Kelly, told FE that while the regulator is “confident that many (Indian) companies understand and have implemented good manufacturing practices (GMP), we (FDA) also remain vigilant to take appropriate action if or when lapses, occur”.
He added: “India’s success in providing a significant share of our generic products used in America and the growing percentage of their exports to the US are ample evidence of the pharmaceutical sector’s ability to meet US standards and regulations.”
India, which is second-largest drug exporter to the US, according to the FDA, exported $4.23 billion or 30% of total exports to the US market in 2012-13. Out of the country’s total pharmaceutical exports of $14.6 billion, India exports 19% to Europe, followed by 17% to Africa, 7% to West Asia and 5% to the CIS countries.
Analysts concede that although the FDA’s meticulousness and stringency of parameters both in terms of the quality of finished products as well as operations, record maintenance and housekeeping, is of a much higher order compared with Indian authorities’, it allows proper hearing to companies found violating its norms.
“Since the FDA is a representative of US consumers, it is vigilant. However, the regulator checks GMP compliance on a company to company basis and recent events are not expected to generate any negative perception of generic drugs made by Indian firms,” said Sarabjit Kour Nangra, vice-president (research) and pharma expert at Angel Broking.
Kelly added that the FDA’s inspection and compliance processes ensure that “companies understand the risks associated with their product’s processes and assure they remain compliant to regulations”.
Prior to imposing the ban on Ranbaxy’s Mohali facility, FDA in its warning documents sent to the company had stated that while an inspection initiated on July 5, 2012, revealed that a tablet was out of its specified weight limit, no investigation was made (by Ranbaxy) to find the root cause, to develop actions to prevent this type of deviation from recurring, and no documented follow-up was conducted.
According to pharma experts, the heart of good manufacturing is documentation and, hence, each step must be recorded and validated to ensure there is no deviation from procedure.
According to Kelly, the number of inspections by the FDA is also on the rise because under the new Food and Drug Administration Safety and Innovation Act the regulator has to achieve the same inspectional schedule for foreign facilities as domestic manufacturers, and to clear the backlog of applications by the end of the first five years. “Having these additional inspectors in-country will assist the agency in meeting our legislative mandates,” he added.
Jayati Ghose & Pallavi Ail