The Food and Drug Administration (FDA) has been cracking down on drug manufacturers selling generic medications in the United States, which are made at certain plants in India.
In 2014, the FDA banned U.S. imports of some generic drugs associated with the Canadian pharmaceutical company Apotex, which like so many drug makers, has a manufacturing presence in India, presumably to keep costs low, according to Consumer Reports.
Apart from Apotex, there are many other companies situated in India, which have been subjected to sanctions, including Sun Pharmaceutical, Wockhardt, Ranbaxy, among others.
These sanctions raise concerns about the quality of the drugs that come from India and other parts of the world.
Consumer Reports talked to the FDA and industry experts to understand whether or not generic drugs developed in India are safe.
The number of FDA sanctions against Indian companies has increased and one of the main reasons is that drug inspectors are leaving no stone unturned in ramping up efforts to ensure that Indian companies follow strict manufacturing standards and regulations laid by the FDA.
In 2014, a spokesman of the FDA told Consumer Reports, “What we’ve found is that most Indian firms understand good manufacturing practices and use them, but we’ve seen problems with a few companies. That’s why we‘ve chosen to make quality one of our highest priorities this year.”
The representative said the problems are not only confined to India but other parts of the world. “The problems FDA investigators encounter in India are similar to those seen around the world in manufacturing,” the FDA representative said.
So, is Generic Cialis from India safe?
It is unclear whether generic Cialis manufactured in India is safe for use in the United States, although manufacturing standards are the same for brand-name and generic drugs. In fact, most brand-name drugs are developed overseas, including India, often in the same plants as the generic equivalents.
Most generic Cialis medications sold online come from India and drug inspectors are not sure about the percentage of the active and inactive ingredients in those medications.
However, a survey has found that more than 40% of the medications Americans use are made in other nations, including India. In fact, India and China are the world’s leading drug exporters, with nearly 1,000 plants registered with the FDA.
A medicine needs at least 80% of the active ingredient, but it is very difficult to know about the percentage of the ingredients of a medication coming from India,
Barbara Young of the American Society of Health-System Pharmacists told Consumer Reports, “These days it can be very hard to track where your drugs come from. There’s not even always a straight line from the manufacturer. Sometimes drugs are repackaged and rebranded along the way.”
Meanwhile, the FDA is working closely with drug regulatory bodies of other countries. Also, the agency has started a major research initiative to improve the safety and availability of generic drugs in the U.S.
Generic Cialis is a medicine that contains tadalafil as an active ingredient. Tadalafil is an FDA-approved erectile dysfunction (ED) drug, though it is also used for treating benign prostate hyperplasia and pulmonary hypertension. Visit Consumer Reports for information on whether generic drugs made in India safe.
