- Dr. Reddy's Laboratories is facing a new slate of manufacturing issues, divulging in a letter last week that it received a Form 483 for one of its Indian facilities.
- The letter, dated April 28 and addressed to the Bombay Stock Exchange and the National Stock Exchange of India, said the Food and Drug Administration noted 11 instances where a plant in Bachupally, Telangana, might be in violation of federal standards.
- "These observations are mostly procedural in nature, reflecting the need to improve people capabilities and strengthen documentation and laboratory systems," the drugmaker wrote in the letter. "We will address them comprehensively within the stipulated time."
Dr. Reddy's has tried to improve its manufacturing practices and develop a better relationship with the FDA, but that hasn't worked out so well. The company has acquired a collection of Form 483s — which signal possible violations of the U.S. Food, Drug and Cosmetic Act — since the start of 2017, and hasn't provided much detail on how it intends to become more compliant.
The letter follows an FDA audit of what Dr. Reddy's calls its Formulations Manufacturing Plant–3. The site develops generic, oral, solid drugs, and the company doesn't expect production to halt due to this newest setback, a spokesperson told In-PharmaTechnoLogist.
While the Indian drugmaker doesn't seem too concerned about the issues at the Bachupally manufacturing facility, it's often a slippery slope from a Form 483 to a warning letter, which, if inadequately addressed, can lead to an import ban.
Such restrictions are most common among active pharmaceutical ingredient producers in Asia — especially in China and India — and can wreak havoc on bottom lines. Divi's Laboratories, for instance, saw shares plunge 20% after the FDA banned products coming from its Chippada site.
A tougher stance against current good manufacturing practice from both U.S. and foreign regulators doesn't look as though it will die down anytime soon either. The India government disclosed in mid-2016 plans to inspect 200 domestic and international drugmakers for quality control and compliance.
In a related issue, The Office of the U.S. Trade Representative just released its annual Special 301 Report, which looks at global trends in intellectual property, and flagged counterfeit trademarks as growing issue among ex-U.S. pharmaceutical developers.
"The United States notes its particular concern with the proliferation of counterfeit pharmaceuticals that are manufactured, sold, and/or distributed in numerous trading partners, including China, Guatemala, India, Indonesia, Lebanon, Peru, and Russia," the report said. "While it is impossible to determine an exact figure, studies have suggested that up to 20 percent of drugs sold in the Indian market are counterfeit and could represent a serious threat to patient health and safety."