An independent safety science company Underwriters Laboratories (UL) is set to train Food and Drug Control Authority (FDCA) inspectors on audit norms across the country.
"The strategic partnership with the Gujarat government to train FDCA inspectors is the first in a series programmes with other state government bodies to provide consultation, training and support in the areas of quality and control management," UL South Asia (India, Bangladesh and Sri Lanka) Vice President and Managing Director Suresh Sugavanam told PTI here.
The company has signed a Memorandum of Understanding (MoU) with the Gujarat government to train 60 Gujarat Food and Drug Control Authority (FDCA) inspectors and plan to add more in the near future, he said.
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UL will be using specially designed online programmes in keeping with international regulatory guidelines, to help ensure the quality and safety of pharmaceuticals manufactured in the countrty, Sugavanam said.
It plans to empower the Gujarat FDCA (Food and Drug Control Authority) investigators with the same source of knowledge that is currently accessible to U S Federal Drug Administration (USFDA) investigators.
Last year, India's pharmaceutical exports to the United States rose by 32 per cent to USD 4.2 billion. India accounts for about 40 per cent of generic and over-the-counter products and 10 per cent of finished dosages used in the US.
Given these numbers, it is not surprising that the Government of India and foreign regulatory agencies emphasise the need to ensure consistent quality of drug products.
Audit regulation is a step in the direction to bring Indian pharmaceutical standards on par with the United States Food and Drug Administration's (FDA) and enables India to maintain a competitive advantage.
