GoI should restructure India's quality control (rules, implementation and inspection) system in drugs manufacturing

"Drugs manufactured at the Indian plant of Canadian generics giant Apotex came under fire from regulatory experts this week after health concerns were sparked by the revelation that the company sold prescription drugs that it knew were defective."

FDA records shows that, "in June this year Apotex employees at a facility in Bangalore that makes drugs exported to North America “did not report undesirable test results and doctored bacterial growth test records.”

This is not the first time a drug manufacturing facility located in India is coming under USFDA scanner.

I am very much concerned about two things,

1. How come only US-FDA is finding all these problems? What Indian regulatory bodies are doing? Aren't they responsible for inspections?

2. If this is the quality of drugs for export to US (which have one of the toughest inspection system), Canada and EU, then can anyone imagine the quality of drugs we are consuming?

Healthcare is one of the areas where India has strong growth potential. Many of our companies championed generics and mastered global delivery systems. But, continuous failure in quality check will force them out of biggest markets like US, Canada and EU. Not only that, other countries will also view Indian drugs with suspicion only.

The faster the government acts the better.

Sajeev

Photo Courtesy - USFDA