Between 2010 and 2015, the US Food and Drug Administration (FDA) rejected as many as 13,334 products made in India. FDA is responsible for protecting the public health by assuring the safety, effectiveness and quality of drugs and other biological products. Some of the rejected products
comprise of patent medicines, generic medicines, snacks, bakery products, spices (ground, mixed) and seasonings, bath soaps, with reasons such as misbranding, contamination, products manufactured in unhygienic condition, pesticides being above permissible limits, and problems in packaging. At the same time, the regulator also rejected 15,087 Chinese products in the same period, of which 314 products were in January 2016.
The data showed that in January 2016 alone, the US agency rejected 228 products which is huge given that over the past one year there has been a steady push by the Narendra Modi-led NDA government for ‘Make in India’ campaign. The campaign looks at transforming India into a global manufacturing powerhouse fit to compete with its neighbor China. Recently, IPCA Laboratories received warning letter from the US health regulator for three facilities on which the
regulator had earlier imposed a import ban for not adhering to the good manufacturing norms. In regulatory filings to the bourses, IPCA had said that USFDA after inspections at its manufacturing units situated at Ratlam, SEZ Indore and Piparia had issued Form 483 observations “which subsequently resulted in issuance of import alert on these manufacturing units.”
On January 5, 2016, three drugs from Intas Pharmaceutical Limited and Sanofi India Limited, were rejected as they were unapproved drugs under sections “505(a), 801(a)(3)” of the US regulator’s guidelines.
According to Biocon CMD Kiran Mazumdar-Shaw, there is a problem, which range from clean environments, data
integrity, and so on.
Data on the US FDA website shows that it has rejected more snack imports from India than any other country in the first five months of 2015.
A report mentions that more than half of all snacks that were tested and then restricted from being sold in the US this year were from India
, which also leads the number of snack rejects across the world. Likewise, baked Indian snacks also find it difficult to enter the States. More than half of the 217 imported baked products rejected by the US FDA so far this year were from India.
According to experts, such high rejection rates from the US are not new. Ajay Sahai, director general & CEO of the Federation of Indian Export Organisation (Fieo), said: “Until a year ago, the Indian industry’s focus was not on standard and quality. There may be a lot of reasons for this, but if one has to compete in the global market, this has to be adhered to.” Food-safety is an important and sensitive thing in developed countries, which is why countries like the US adopt very stringent measures including infrastructure and quality standards, and a lot of this is still to come in developing countries.
In India, food regulator, the Food Safety and Standards Authority of India (FSSAI) came into existence in September 2008, while regulations became operational from August 5, 2011. It is right time that Indian companies look into adopting strict food safety system that focuses on development of science-based food safety standards and rigorous enforcement, so that rejection by US food regulator becomes less.