The US Food and Drug Administration has tightened rules for selling dietary supplements in the US market, making compliance with current good manufacturing practices mandatory for manufacturers.
The move could impact export of dietary supplements worth roughly Rs 800 crore (Rs 8 billion) and dietary supplement ingredients worth over Rs 2,000 crore (Rs 20 billion) by Indian food processing, pharmaceutical, Ayurveda, Siddha and Unani exporters and suppliers.
However, it could also open up contract manufacturing opportunities for Indian pharmaceutical companies with cGMP facilities, said experts.
Dietary supplements include tablets, capsules, powders, liquids and a wide variety of other products with health-benefiting properties.
The new regulation, effective from August 24, 2007, demands adherence to quality control procedures by manufacturing plants.
Manufacturers will be required to evaluate the identity, purity, strength, and composition of their dietary supplements. If the products fail to meet the specifications, the FDA will brand them as adulterated or misbranded.
The new norms also seek to prevent contamination due to substances such as natural toxins, bacteria, pesticides, glass, lead and other heavy metals, as well as improper packaging and labelling, said the FDA in a statement.
