India-Made Generic Drugs Are Under Fire From The FDA, And America Is Losing Faith In Them Too
The American medical community is growing increasingly concerned about the quality of generic drugs imported from India, sparked by a recent bout of recalls and bans by the Food and Drug Administration. Recently, the FDA has banned the import of drugs manufactured by several India-based companies, citing a range of quality control issues, including data manipulation and inadequate sanitation.
Generic drugs are defined as any drugs marketed under their chemical name, and without advertising. India is America's second biggest supplier of generic drugs after Canada, providing around 40 percent of generic and over-the-counter medicines. Around 85 percent of all medicines prescribed in the U.S. are generic, which are much more affordable than their brand-name counterparts.
In the last few months, the FDA has banned imports from Ranbaxy Laboratories Ltd, Wockhardt Ltd, and Sun Pharmaceutical Industries Ltd. Ranbaxy had recalled over 64,000 bottles of a cholesterol-lowering drug after it was discovered that doses were mixed up in a bottle, and Sun is recalling over 2,500 bottles of a diabetes drug after a bottle was found to contain an epilepsy medication. Back in January, Dr. Reddy's Laboratories Ltd. recalled over 58,000 bottles of lansoprazole, a heartburn drug, because of a microbial contamination.
India's pharmaceutical industry is overseen by the Central Drugs Standard Control Organization. In an opinion piece published by Forbes last month Amir Attarran, a Professor in the Faculties of Law and Medicine at the University of Ottawa, author Roger Bate and Dinesh Thakur, a former Ranbaxy executive turned whistleblower who exposed manufacturing malpractice at the company, explained that CDSCO oversight left a lot to be desired.
CDSCO has been repeatedly cited by the country’s own Parliamentary Committee on Health for corruption and colluding with local companies. Endorsement letters from doctors have been faked to secure marketing authorizations, products approved without conducting proper clinical trials, and bribes paid by companies to speed approval of products. Just last month, India’s Central Bureau of Investigation caught a CDSCO Deputy Controller red-handed accepting bribes to renew the operating license of a blood bank.
Following a visit to India by FDA Commissioner Margaret Hamburg, who pushed for greater collaboration between the U.S. and India with regard to quality control and oversight, India's drug controller general, G. N. Singh, said that the FDA had no authority to regulate practices in India.
"We are losing control over what people are swallowing," Dr. Harry Lever, a cardiologist at the Cleveland Clinic, said in an interview with Reuters. "Now, when a patient comes in who is not doing well, the first thing I do is look at their drugs and find out who makes it."
Lever is trying to raise awareness of the growing quality-control problem among U.S. lawmakers. He recommends to his patients that they seek out drugs that are not manufactured in Indian plants — but this is easier said than done.
Even if doctors specify that they wish their patients to receive the brand-name drug, many insurance companies will refuse to pay for them because of the drastic difference in price.
Doctors are also unable to specify which generic drug they wish their patient to take — this is dependent on which products are stocked by individual pharmacies. This essentially means that the patient would need to trek around several different pharmacies if they wanted to try to find, or avoid, a specific generic drug.
In an attempt to combat the bad publicity that has arisen from the FDA bans and recalls, several Indian drug manufacturers have indicated that they are considering opening plants in the U.S. or Europe.