Americans may be concerned by recent reports in the media about the safety of medications made in India (e.g., the New York Times article “Medicines in India Set off Safety Worries”). Problems with Indian drugs should be neither overlooked nor overstated. In this post we try to put this into perspective for American consumers who purchase Indian medication at their local pharmacies, whether they are aware it’s from India or not, or directly from an Indian pharmacy by ordering online.
Over the past decade, prescription medicine made in India has been sold in large quantities in U.S. pharmacies. Today, according to the FDA, Indian medications make up about 33% of all prescriptions filled here. In fact, Walmart’s ability to offer a $4 generic drug program was initially due to importing and selling medicines from the Indian drug companies Ranbaxy and Cipla. However, last year Ranbaxy was found to be making false claims to the U.S. Food and Drug Administration and exporting medications to the United States that did not comply with FDA’s regulations. The FDA fined Ranbaxy $500 million and banned importation of its products made in India.
It’s important to note that well-known brand name pharmaceutical companies, based in the U.S. and other rich countries, also have serious manufacturing problems. GlaxoSmithKline was fined $750 million for knowingly selling adulterated prescription medication that ended up in local U.S. pharmacies. In 2010, Eli Lilly was sent a warning letter from the FDA for violations of good manufacturing practices. Those are two examples of many.
The FDA’s discovery of more problems at Indian manufacturing plants is not necessarily due to new health risks associated with Indian drugs. In the past, the FDA could not afford to conduct regular inspections of many, if not most, foreign drug manufacturing facilities. Greater funding under a new law has enabled more FDA scrutiny of Indian drug companies, which has led to increasing regulatory enforcement by FDA. A major problem is that the Indian counterpart to the FDA, the Central Drug Standard Control Organization, needs to do a better job regulating drug safety. In fact, FDA Commissioner Margaret Hamburg recently travelled to India to engage her counterparts in a plan to improve regulatory oversight of drug manufacturers. We applaud her initiatives with India.
Another issue in India is that some Indian manufacturers make less quality, lower cost medicines for sale to poorer countries and to poorer segments of the population within India. This two-tier system is sad but true.
So where does that leave you as a consumer?
Notwithstanding the greater scrutiny by FDA in India, Indian medications sold to Americans are generally of high quality, whether purchased at a U.S. pharmacy or from a PharmacyChecker-approved online pharmacy dispensing from India. To be approved within the PharmacyChecker.com program, an Indian pharmacy must only dispense medications manufactured in plants which are 1) approved by FDA or by other strong regulatory authorities such as those in Canada and the UK; 2) operated by the largest and best Indian drug manufacturers who are known to most consistently sell high quality medication; or 3) approved by Indian regulators and inspected by qualified American personnel to meet FDA standards of Good Manufacturing Practices. In addition, every Indian pharmacy approved by PharmacyChecker.com has been inspected by an American pharmacist with special expertise in international mail-order pharmacy safety, and its pharmacy license has been verified with regulatory authorities in India.
As we’ve written before, international online pharmacies are not just “Canadian pharmacies.” Most of the reputable ones originated in Canada but are now partnered with pharmacies in several countries, including India. Other verified and safe international pharmacies are located in Australia, New Zealand, and the United Kingdom. There are even pharmacies created specifically for international mail-order pharmacy services on island nations. The ones approved in the PharmacyChecker.com Verification Program meet very high standards.
Where you order from should be based on the best information available and we strive to provide it. India has become the top supplier of generic medications worldwide but not all their medications are created equal.Tagged with: Cipla, Eli Lilly, FDA, GlaxoSmithKline, India, Indian Pharmaceuticals, Ranbaxy