- Indian Pharma is growing at the rate of 18-20% & USA accounts for 30% of our exports. Owing to this huge chunk, US Food & Drug Administration (FDA) has increased its scrutiny over quality of these medicines.
- India’s Sun Pharmaceuticals recalled Metformin HCL bottles (used to treat Type 2 Diabetes) after tablets of Gabapentin, an anti-epilepsy drug, was found by a customer.
- The largest Generic Drugs to USA is imported from India, due to which FDA has increased its vigilance, site inspections at short notice through its offices at New Delhi, Mumbai & Hyderabad.
- Though Indian Companies feel targeted, none have contested the claims of US FDA.
Exams Perspective:
- Generic drugs