“Risk Based Inspection” by DCGI made the Pharma Biggies to land up in a soup

Risk Based Inspection” by the Indian drug regulator, DCGI brought the pharma biggies under limelight, but for a wrong reason. Pharma majors like Cipla , Pfizer are being inspected for allegedly selling poor quality medicines and noncompliance to manufacturing norms.

This is a first of such kind of inspection, where 200 companies are being inspected among which 36 from Tamil nadu, Maharashtra, Uttarakhand and Himachal Pradesh have been inspected.

This is not the first time that these biggies are coming under the lens of a drug regulator. Last year Sun Pharma and Dr.Reddy’s were among 7 companies for which US-FDA issued a warning letter on concerns for poor manufacturing practices. Read more about this news here.

Last year Govt. of India had framed few regulatory pathway to assist pharma companies mainly to facilitate speedy approvals, while bringing in transparency, accountability and predictability.

Also read about US-FDA risk based inspections herehere…& here.

Drugs<>Therapeutics<>Big Pharma
impas Natesh Prabhu Administrator & Chief Editor | Clinical Pharmacologist | Diabetic-Sexual Medicine-Regenerative Therapy Consultant | President, Indian Medical Pharmacologists Association