Separately, in a case unrelated to diabetes crackdown, the Indian pharma major Wockhardt was also 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 Wockhardt chairman Habil Khorakiwala, accusing the company of impeding FDA inspectors at its Aurangabad plant.
Wockhardt joins Ranbaxy, Sun Pharma, RPG Life Sciences among Indian drug companies that have come under FDA scrutiny for violations that range from poorly trained personnel, to dodgy record keeping, to stinky toilets.
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 per cent â€” from $14 billion to $22 billion â€” in the last four years alone, as the world, from developed countries such as U.S to developing nations like India, have gotten sucked into a sugar-starch overdose.
There are some 30 million diabetes patients in the U.S and upward of 60 million in India (out of a world total of 300 million diabetes victims), 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 in a statement.
Medications cited in the ban order included unapproved versions of metformin and Januvia, which is procured from India and sold online in the U.S., 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 FDA letter said some of these drugs may pose serious health risks because patients with underlying medical issues may take it without knowing that it can cause serious harm or interact in dangerous ways with other drugs.
For example, the letter to Amrutam said, “By marketing your products ‘Diexi’ and ‘Zoom’ as ‘all-natural,’ ‘safe and effective’ treatments with ‘no chemically generated compounds,’ consumers are misled to believe your products do not bear unknown risks nor contain APIs found in approved prescription drugs. Accordingly, the failure to disclose the presence of metformin and sildenafil renders these products’ labeling false and misleading.”