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Pharmaceutical Drug Plants in India Under US FDA Ban


The United States Food and Drug Administration (FDA) has imposed a ban on Indian pharmaceutical drug plants. The FDA completely ruled out drugs imported from the Indian Sun Pharmaceutical Industries Ltd’s plant situated in Gujarat, India. This is the latest restrictive sanction that impedes the Indian drug market to export medicines to the United States, and amplifies concerns regarding the international quality standards of the Indian drugs. The FDA has put Indian plants under extreme regulation for imports.

India is the second largest drug supplier of the United States after Canada. The Indian pharmaceutical drug plants that export to the US have failed to meet with FDA standards of quality, thus, the FDA is banning more drug plants day by day. Under the ban, the Indian companies either have to raise their quality or completely withdraw their drugs. According to the analyst of B & K Securities, Rohit Bhatt, the FDA is expanding their quality standards of medicines. The drug market needs to enlarge their quality parameters to reach the FDA eligibility.

On this Wednesday, March 12, the FDA sent out an import warning on the web page against the pharmaceutical company. FDA finds the “inexpensive drugs” with low quality standards fail to comply with generic requirements of the United States. The Sun plant’s spokeswoman said that the company is incorporating numerous initiatives to correct the problems.

The FDA ban’s impact on the company that manufactures the antibiotic cephalosporin is insignificant for many as the export to the US makes only less than one percent of its sales. The Gujarat plant is one of the Sun Pharmaceutical’s twenty-five manufacturing factories. Sun has three plants in Gujarat, and a total of eleven plants throughout India. On Thursday, shares in Sun decreased by 6.4 percent. According to Bhatt, the FDA ban on the Sun drug plant is not apparent because they have not tested the medicines.

The pharmaceutical plant is taking necessary measures to meet the fiscal year sales that terminate in this month. According to the industry officials, domestic regulations in India are not as efficient as the international standards. The reports tell that the emergency of landing on the first spot for the generic drug export is a crucial element that contributes to quality issues, since then the drug company cherishes a six-month exclusivity period, higher commercial status and success.

In February, the FDA notified the Indian manufacturers to work on improving their drug quality standards, and even banned the imports from Ranbaxy Laboratories for low quality. Moreover, in January 2014, the FDA found contamination in lansoprazole (heartburn drug) exported by Dr. Reddy’s Laboratories to the United States. This Wednesday, the notification was posted on the FDA page. The World Health Organization confirms the made-in-India medicines as fake and cheap.

Currently, the United States FDA has banned Ranbaxy, Lupin and Sun Pharmaceutical drug plants for imports. These plants are top suppliers of generic medicines to the United States and other countries, however, now they are under FDA regulations. Wockhardt Ltd is also outlawed for exporting their manufactured medicines to the United Kingdom and the United States. These plants have been found to manufacture duplicate copies of the drugs for export and to use the wrong packaging. The cheap alternative is poor quality with an expired patent. According to a top official of an Indian drug company, with bigger plants comes less supervision; whereas small plants have strong management and supervision. Thus, strengthening the system of the industries’ operations and supervision of pharmaceutical drug plants will produce better quality.

By Iqra Amjad
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