Licences of 18 pharma companies reportedly cancelled over quality issues

India's reputation as the pharmacy of the world is getting a reality check, both in India and overseas. Reports citing Union Health Ministry sources said that licenses of 18 pharmaceutical companies were cancelled recently after a nationwide inspection.

What's the latest

• Apart from the 18 pharmaceutical companies losing their licences to manufacture medicines, 26 other companies were served show cause notices. 
• The licences were suspended over the poor quality of output. However, so far, the names of the companies have not been made public. 

How did it happen? 

• The license repeals come after the Drugs Controller General of India (DCGI) conducted inspections at 76 pharma companies in 20 states over nearly 15 days. 
• Among the states where inspections were carried out were Delhi, Haryana, Himachal Pradesh, Rajasthan, Gujarat, Punjab, Maharashtra, Karnataka, Goa, Puducherry, Tamil Nadu, Uttar Pradesh, West Bengal, etc. 
• Most of the companies inspected were located in Himachal Pradesh, Uttarakhand, and Madhya Pradesh. The inspections are said to continue. 

Government of India cancels licenses of 18 pharma companies for manufacturing of spurious medicines following inspection by Drugs Controller General of India (DCGI) on 76 companies across 20 States: Official sources

— ANI (@ANI) March 28, 2023

Why?

• India's reputation of being the pharmacy of the world was brought into question recently, after a string of incidents involving 'Made in India' medicines overseas. 
• Tamil Nadu-based Global Pharma Healthcare had to recall an entire lot of eye drops in the US after reports of vision loss and even death in certain cases linked to contamination of the eye drops. 
• Before the US incident, Indian-made cough syrups were linked to the deaths of children in Gambia and Uzbekistan. 

WHO: India's Maiden Pharmaceuticals' Cough Syrup Causes Death Among Children In Gambia#WHO #Tedros #Medicines #NewsMo pic.twitter.com/AHD7WaUm08

— IndiaToday (@IndiaToday) October 6, 2022

• After Gambia sounded the alarm, WHO also took notice issuing, alerts about cough syrups made in India. 
• The cough syrups in Gambia's case were linked to Haryana-based Maiden pharmaceuticals. 
• Incidentally, two executives of the pharma company were sentenced to two-and-a-half years in jail for exporting poor-quality drugs to Vietnam nearly a decade ago. 
• In the Uzbekistan cough syrup case, three employees of the manufacturer, Marion Biotech, were arrested for manufacturing and selling adulterated drugs. 
• Not just overseas, Indian-made medicines have caused illness and death in India too in the past. 

The issues with Indian pharma

• Around 5% of Indian-made drugs, many made by major companies, failed quality tests, according to a CDSCO survey in 2014-16. 
• The issue of quality control with Indian pharma has been flagged by authorities all over the world. In 2018, the US FDA decreased the approvals given to Indian pharma companies. 
• What makes the quality issue in Indian pharma more concerning is the rise of counterfeit drugs.