Nepal’s Department of Drug Administration has published a list of 16 Indian pharmaceutical companies that failed to comply with World Health Organization (WHO) good manufacturing practices, including Divya Pharmacy, which manufactures Yoga guru Ramdev’s Patanjali products.
According to the Kathmandu Post daily, the department’s publication of the list, the national regulatory body of the drug markets, both allopathic and ayurvedic, means that medicines manufactured by those companies cannot be imported into Nepal.
“After inspection of the manufacturing facilities of the pharmaceutical companies, which had applied to export their products to our country, we have published the list of the companies that do not comply with the WHO’s good manufacturing practices,” said Santosh KC, a Department spokesperson.
According to the news report, good manufacturing practice is a system for ensuring that products are consistently produced and controlled according to the set quality standards. It is designed to reduce the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product.
The Department sent a team of drug inspectors to India in April and July to inspect the manufacturing facilities of pharmaceutical companies that had applied to supply their products to Nepal.
Aside from Divya Pharmacy, the list includes 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, Shree Anand Life Sciences Ltd, IPCA laboratories Ltd, Cadila Healthcare Ltd, Dial Pharmaceuticals Ltd, Dial Pharmaceuticals Ltd, Dial Pharmaceutical, Aglowmed Limited and Mackur laboratories Ltd.
According to the Department, some of the Indian companies it has barred are already registered, while others are new.
Some companies’ products do not meet regulatory requirements, and others do not follow good manufacturing practices. Some of their products are used in critical care, dental cartridges, and vaccines.
The department has also published a list of 46 drug manufacturing companies that have been found to follow WHO good manufacturing practices.
The Department’s regular duty is to inspect the good manufacturing practices of pharmaceutical companies, both domestic and foreign.
A few months ago, the Department directed drug inspectors to increase surveillance in order to prevent the import and sale of cough syrups manufactured by an Indian pharmaceutical company after scores of children in Gambia allegedly died of kidney failure after consuming the syrups.
The move came after the World Health Organization issued a global alert about four cough syrups that may have been linked to the deaths of children in the West African country in July, August, and September.
A few months ago, the Department directed drug inspectors to increase surveillance in order to prevent the import and sale of cough syrups manufactured by an Indian pharmaceutical company after scores of children in Gambia allegedly died of kidney failure after consuming the syrups.
The move came after the World Health Organization issued a global alert about four cough syrups that may have been linked to the deaths of children in the West African country in July, August, and September.
Source:OCN