Nepal bans import of medicines from 16 Indian companies, including Patanjali’s Divya Pharmacy, Zydus

The Nepal government has said that it would not import medicines manufactured by 16 Indian companies, including Patanjali’s Divya Pharmacy, Zydus Lifesciences, for failing to keep up with the World Health Organization's (WHO) good manufacturing practices. The move comes after the WHO issued an alert on Indian-made cough syrups, which were allegedly responsible for the deaths of children in Gambia. 

The Department of Drug Administration of Nepal has released a list of 16 Indian pharmaceutical companies, includes the names of Shree Anand Life Sciences Ltd, IPCA laboratories Ltd, Cadila Healthcare Ltd, Dial Pharmaceuticals, Aglowmed Limited and Mackur laboratories Ltd, Radiant Parenterals Ltd., Mercury Laboratories Ltd., Alliance Biotech, Captab Biotec, Aglowmed Limited, Zee Laboratories Ltd, Daffodils Pharmaceuticals Ltd,GLS Pharma Limited, Unijules Life Science Ltd, Concept Pharmaceuticals Pvt etc. 

After issuing the order, the Nepalese drug regulator said the step was a “routine” one and the affected companies could seek reconsideration of their applications, a report in Moneycontrol said.  

As per the report, the Department of Drug Administration of Nepal sent a team to look into the manufacturing facilities of these pharma companies, which had applied for permission to supply pharmaceutical products to Nepal. The inspections were conducted between March 31 and July 22. “After an audit conducted by the Nepalese drug authorities this year, we have found 16 companies not complying with the good manufacturing practices set by WHO,” said Santosh KC, senior drug administrator in Nepal’s Department of Drug Administration (DDA).  

WHO has issued certain guidelines around a good manufacturing practice system, which is aimed at ensuring that products are “consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorisation”. 

In October, WHO issued an alert against four cough and cold syrups made by Haryana-based pharmaceutical company Maiden Pharmaceuticals, saying that it might be linked to the deaths of 66 minor children in the Gambia. The international health body reportedly said that cough and cold syrups have ingredients, such as diethylene glycol and ethylene glycol, which can be toxic to human beings.  The WHO in its alert issued on October 5 listed the name of the syrups - Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup, and Magrip N Cold Syrup. 

After conducting tests, the Indian government told WHO that the samples taken from Maiden Pharma have been found to be within specifications. The samples had not been contaminated with ethylene glycol and diethylene glycol, DCGI chief VG Somani said in a letter to the WHO earlier this month.