Friday, July 25, 2014


Indian pharmaceutical industry has been witnessing significant growth over past few years. But the quality of medicine is still a problem. We have heard that US FDA have banned from exporting the Indian version of drugs from some of the facilities of Wockhardt Ltd ,Sun Pharma Ltd and Ranbaxy Ltd. It means that they cannot sold drugs from that facilities to US, But even with the ban they continues to sell its products in India.  
Central Drugs Standard Control Organisation (CDSCO) is the Indian Organisation which is in charge of quality control of drugs manufactured in India. It has same power and responsibility as USFDA (Food and Drugs Association). The main reason for the flaw on drug safety is that CDSCO is short of staff with only 1500 inspectors for over 10,000 manufacturing plant. It means even if each of these inspectors visited one plant every day of the year, a manufacturing plant wouldn’t receive a visit more than once in over 6 years.

The other key difference between FDA and CDSCO is that quality check under FDA is much more detailed compares to under CDSCO for eg. The clocks on all computers in a facility should show the same time. CDSCO carried out its own tests on Ranbaxy’s medicines but found no quality issues, But during the FDA’s inspection of Ranbaxy’s Toansa plant, inspectors by observing the time stamps, were able to tell that test results for the same batch were being rewritten.

The problem with the Indian investigator is not able put the kind of efforts it required compared to FDA investigator because Indian investigator is probably a good friend of the plant employee or he would get a call from politician to go easy on the inspection.

Despite the ban by USFDA of some these plants, CDSCO has argued that Indian drugs are largely safe. Now it is for us we have to decide that  IS INDIAN MADE MEDICINE IS ADVISABLE?

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