In the span of one year, government authorities have revoked licenses from sixty-four pharmaceutical companies. Seventeen drug testing laboratories have been directed to cease operations due to failure to comply with ‘good manufacturing practices’ (GMP) and other procedural standards. As defined by the World Health Organization (WHO), GMP ensures consistent production and control of medicinal products according to quality standards appropriate for their intended use.
In a comprehensive investigation conducted over twelve months, 423 companies, including listed entities and drug testing labs, underwent scrutiny. The investigation, executed in five phases across various manufacturing facilities, resulted in the halting of operations at 101 pharma companies and the suspension of licenses in 52 instances. Additionally, 281 companies received
show-cause notices regarding compliance issues.
Action was taken against 131 drug testing labs, with 52 facing suspension of testing activities due to non-compliance. Corrective measures were initiated in some cases following notices, while suspension and cancellation occurred after repeated violations of GMP.
As reported by businessline, and according to a Union Health Ministry official, India houses approximately 10,500 manufacturing units, with 8,500 falling under the MSME category. Among them, about 2,000 MSMEs, primarily exporters, possess WHO GMP certification. Adherence to GMP is now obligatory for all pharmaceutical companies operating in India.
