Indian drug firms need to tighten belts to meet FDA norms

NEW DELHI: Indian generic drug makers could face more actions from the US FDA unless they maintain high quality requirements of the regulator, which has tightened norms for granting permission to sell medicines in America.

The US FDA has the task of regulating and supervising the safety of drugs and cosmetics in the US.

"In recent times, the US FDA ( Food and Drug Administration) has increased its focus on the quality and safety of the drugs...India with large number of generic companies, many of which supply to the US market, will witness continuous monitoring by the US FDA," KPMG India, a consultancy firm, Corporate finance Associate Director Sanjay K Singh said.

The generics drug market in the US is estimated to be over USD 30 billion and it is the biggest market for Indian companies.

In a recent move, the US health regulator has stepped up inspection and compliance activity, after increasing its funding for the purpose during the current and the next year.

Besides this, it has also reduce the responding time to 15 working days from 30 days for companies getting notices for deficiency in compliances.

"India is a recognised and important supplier of generic medicine to the world so it will have a impact if we do not align totally in this direction," Organization of Pharmaceutical Producers in India President Ranjit Shahani said.

They want violative inspection results to be taken seriously in order to protect the consumer, Shahani added.