FDA Comes to the Defense of India-Based Manufacturers
[Thursday, March 7, 2019]
In an unprecedented press release, FDA’s top officials refuted claims that quality of drugs manufactured in India and China are suspect. Rather they presented the strongest case ever, made openly by FDA officials, in support of the reliability of products manufactured in India and China, naming products and citing enforcement activities to emphasize why US consumers should not worry due to the faulty narrative spread by news media. In the last decade, manufacturing sites located in India have been targeted negatively by US news organizations for non-compliance with every Warning Letter or audit finding ending up on headlines. All such episodes were used to create a perception of wide-spread non-compliance in India and claims that lives of US consumers were at risk. FDA has earlier denied that was the case. India continues to supply more generic drugs to the US market than any other country. India is home to the World’s largest generic drug industry supplying more products to not just the US but practically every part of the globe. Taking advantage of cheaper labor and resources, India-based manufacturing sites can compete on price and meet aggressive demands for supply of large quantities of drug products. While FDA inspectors have found some of the most egregious cases of non-compliance at some manufacturing sites in India, it cannot be denied that overall quality of drugs imported from India have been satisfactory. Reports of safety events related to drugs sourced from India are rare. Compliance is a balanced concept where risk and benefits are equally evaluated to identify “Good” practices. Regulations require manufacturers to follow “Good” practices, and not the higher grades of “Best” or “Excellent”. Processes can always be improved but so long as they meet the regulatory requirements, they are accepted. FDA has the ultimate authority to determine if the practices followed at a given site are acceptable (or “Good”), a process that involves review of all the relevant documents by experts, on-site inspections, and experience from other similar manufacturers. FDA’s determinations are comprehensive since it has access to non-public proprietary information and the ability to compare to that to the vast amount of information it possesses; an investigation by a news organization cannot be expected to equal that of the FDA. But a few major news outlets have anyway used a few bad reports to profile an entire country, unfairly, which could potentially affect the US supply chain if patients start discriminating against drugs sourced from India based on reports in the press. Hence FDA took this extraordinary step of defending manufacturers in India. FDA presented a point by point rebuttal to complaints of non-compliance making the case that drugs coming to the US from India were as safe and effective as those produced anywhere else, and that the FDA’s enforcement activities in India are robust and assure good quality drugs reach the US. FDA even used the increased number of Warning Letter issued to manufacturers in India as evidence that it is enforcing its rules diligently. The numbers don’t lie. FDA did its job to assure US consumers, now it is for the rest of us to do ours and dispel one-sided opinions presented as “news”. Profiling is bad, period.