Mumbai: India exports drugs worth more than 15 billion dollars every year, a majority of which are US-bound. Questions are being raised about the standards and quality, after Ranbaxy's whopping 500 million dollar settlement with the US government.
The generic drugs in question were manufactured at Ranbaxy's plants in Paonta Sahib and Dewas in India. They include acne drug Sotret, epilepsy and nerve-pain drug Gabapentin and antibiotic Ciprofloxacin.
Possibly a larger question, when it comes to India's trillion rupee generic drugs industry - where does this leave Indian patients? Drug Expert CM Gulati said, "We need more vigorous and robust quality control system in India. Our problem in India is slightly different from the problem in United States. Here what happens is even if a drug is of high quality when it leaves the premises of the manufacturer by the time it is sold to the patient it becomes sub-standard. And the reason is that the transport of the drugs is not proper, drugs are transported from one place to another in non-refrigerated trucks even when they are temperature sensitive medicines."
Ranbaxy issued a statement to CNN-IBN saying, "Ranbaxy is a different company today. All Ranbaxy products currently in the Indian market and globally are safe and efficacious. Ranbaxy stands by the quality of every medicine that the company makes and distributes in India and every country around the world."
Pharma experts say, it's not just Ranbaxy, and it's not just an Indian problem. Reportedly, 46 import alerts have been issued to pharma companies in India, including, Sterling Biotech, Aurobindo Pharma, Lupin and Claris Lifesciences.
Imports from Wockhardt's Aurangabad plant have been banned in the US, after alerts from the US FDA over the quality of drugs manufactured. This could hit the company sales by a whopping $100 million.
An import alert is issued when the US FDA is concerned about the safety of drugs and it intends to stop further sale of such medicines in the US market. Indian Pharma Alliance Secretary General DG Shah said, "Japan has had 40, UK 43, Canada 63. Developed countries also get issued import alerts. In India, there are 200 US FDA approved facilities which export drugs to America, so we have 46 import alerts. Take that in perspective. US FDA is known for such strict action."
Under the Drugs and Cosmetics Act, drug inspectors have to inspect every manufacturing plant in India at least once a year to ensure compliance with Good Manufacturing practices. Strangely, Indian drug regulators never reported safety issues with Ranbaxy facilities. Many questions still remian unanswered.