Aarti Drugs fourth Indian drug firm to get a reprimand from US FDA in 2014

Mumbai-based Aarti Drugs has become the fourth Indian drug company this year to be on the radar of the US Food and Drugs Administration (US FDA) for violating the Good Manufacturing Practices (CGMP) standards for exporting drugs to the US.

Aarti Drugs said on Tuesday that two of its facilities in Tarapur received an import alert on March 23 as per the FDA website.

However, only one of the two facilities is a US FDA facility-the other one was already delisted from the US FDA website a couple of years back. Aarti says the facility had been reinspected by the US FDA in August 2014 and the company had submitted four responses. The company is yet to receive an official communication from the US FDA on the import.

The FDA had issued a warning letter to Apotex Research Private Ltd on January 30 for violating manufacturing norms at its Bangalore unit. The observed violations included failure to ensure laboratory records included complete data derived from all tests, failure to exercise appropriate controls over computer or related systems,  failure to establish and follow appropriate written procedures applicable to quality control unit, etc.

On January 9, the FDA had issued a warning letter to Bangalore based pharmaceutical company Micro Labs for violating CGMP norms at its Verna facility. The FDA said that the plant had serious CGMP deficiencies and violations related to accuracy and integrity of the data. A few weeks ago, Ahmedabad based Cadila Pharmaceuticals was issued a warning letter for violating manufacturing norms at its active pharmaceutical ingredients (APIs) unit at Ankleswar in Gujarat.

In 2014, the Office of Manufacturing and Product Quality wing of the FDA had issued 19 warning letters and notice of violation, of which eight letters were issued to Indian companies. It included Cadila Pharmaceuticals, Sharp Global, Marc Biosciences, Apotex Pharmachem India, Sun Pharmaceutical Industries, Smruti Organics, Canton Laboratories and USV Limited.  

India has the maximum number of FDA approved plants outside of the US. The regulator is constantly upgrading its standards for import of drugs to the US, the world's largest drug market. Normally warning letters give time for rectifying the defects subject to further audits. If action is not taken, the FDA may issue an import alert barring the company from exporting drugs to the US.

Aarti Drugs claims the import alert is not going to affect the company since the facility contributes only one percent to its revenues. The Aarti Group of Industries had a consolidated turnover of Rs 2632.49 crore in 2013/14, which included export revenues of Rs 1281.30 crore.

Aarti, which mainly makes specialty chemicals and APIs, has 15 plants located across India. The group is also setting up plants for ethylene based technologies with an investment of around Rs 500-Rs 600 crore. Globally, Aarti's benzene based products and technologies like chlorination and  nitration are ranked among the world's top four.

Its benzene based ammonolysis and hydrogenation are ranked in the top two. Over 1000 chemical and pharmaceutical companies in different parts of the world are its clients. "About 84 percent of revenues are from specialty chemicals, 10 percent from pharmaceuticals and the rest from home and personal care chemicals", Rajendra V Gogri, CMD of Aarti had said recently.