US bans ‘natural’ diabetes drugs, Indian firms on list

WASHINGTON: The US Food and Drug Administration has cracked down on what is widely considered alternative or natural treatment for diabetes, including ayurvedic and homeopathic remedies . Fifteen companies in the US, including some that procure alternative diabetes medication from India, have been served warning letters by the FDA, asking them to stop the sale of products claiming to treat, cure, and prevent diabetes in the US.


Separately, in a case unrelated to this crackdown, Indian pharma major Wockhardt was issued a notice for a range of violations, from manufacturing defects and poor training of personnel to inadequate toilet facilities.

‘‘ Until all corrections have been completed and FDA has confirmed corrections of the violations and your firm’s compliance, FDA may withhold approval of any new applications or supplements listing your firm as a drug product manufacturer ,’’ the July 18 letter warned chairman Habil Khorakiwala , accusing the company of impeding FDA inspections at its Aurangabad plant.

Wockhardt joins Ranbaxy, Sun Pharma and RPG Life Sciences among Indian drug companies that have come under the FDA scrutiny for a range of violations. But, it was the diabetes medication crackdown that sent shock waves through the industry, because the market for alternative diabetes remedies has grown hugely in the past decade. Sales of diabetes medication has increased 60% — from $14 billion to $22 billion — in the past four years, as the world, from developed countries such as US to developing nations like India , got sucked into a sugarstarch overdose.

There are some 30 million diabetes patients in the US and upward of 60 million in India (out of a world total of 300 million), making the two countries a lucrative market for western Big Pharma. Increasingly , diabetes patients are looking for alternative remedies , but the FDA clearly disapproves that route.

‘‘ Diabetes is a serious chronic condition that should be properly managed using safe and effective FDA-approved treatments. Consumers who buy volatile products that claim to be treatments are not only putting themselves at risk but also may not be seeking necessary medical attention, which could affect their diabetes management,” FDA commissioner Margaret A Hamburg said.

Medication cited in the ban order included unapproved versions of metformin and Januvia, procured from India and sold online in the US, and Diexi, manufactured by Amrutam LifeCare of Surat. Amrutam was also cited for dodgy claims with regards to supplements such as Zoom (for erectile dysfunction ), Arexi (for arthritis) Allexi (for allergy), Cholexi (for cholesterol control), and Obexi (for obesity).

The letter said some of these drugs may pose serious health risks because patients with underlying medical issues may take them without knowing about their harm or interaction in dangerous ways with other drugs.