April 14, 2024 03:30:52 booked.net

Nepal bans the import of medicines from 16 barred companies, know more about curious case of Zydus & Post-Gambia effect?

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, including 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.

Ahmedabad-based Zydus Lifesciences, Divya Pharmacy, the manufacturer of yoga guru Baba Ramdev’s Ayurvedic Patanjali products, and IPCA Laboratories are among the 16 companies in the list published by the Nepalese regulator. Only a few of the Indian companies were registered with the Nepalese regulator.

“Most of the smaller companies whose names have been published don’t supply drugs to Nepal but they had applied to the regulator for supplying drugs, following which we inspected their plants and found WHO GMP violations,” Santosh said.

The curious case of Zydus

According to the Nepalese drug regulator, Zydus Lifesciences, a major drug supplier to Kathmandu, didn’t have regulatory clearance from the Drug Controller General of India (DCGI). The Nepalese regulator said the Ahmedabad-based company was in touch with them to resolve the issue. However, the company said it continues to sell drugs in Nepal.
“We are not in receipt of any such communication. We continue to supply drugs to Nepal,” a Zydus Lifesciences spokesperson told Moneycontrol in an email response.

Zydus Lifesciences recently acquired rights from Denmark-based Pharmacosmos A/S to market MonoFerric (iron isomaltose) injections for treating iron deficiency in adult patients in India and Nepal.

Patanjali’s official spokesperson declined to comment on the matter.

Post-Gambia effect?

Gambia’s President Adama Barrow, who was sworn in at the Gambian embassy in neighbouring Senegal, greets his supporters upon his arrival from Dakar, in Banjul, Gambia January 26, 2017. REUTERS/Afolabi Sotunde

Asked if the ban was an after-effect of the medical alert issued by WHO for alleged adulteration in cough syrups made by Maiden Pharmaceuticals, the DDA official said the ban was a routine affair.

Nepal’s ban on Indian pharma companies comes days after the DCGI, VG Somani, said in a letter to WHO that its statement in October in the matter of Maiden Pharma was amplified by the global media and led to a narrative that targeted the quality of Indian pharmaceutical products.

“This in turn has adversely impacted the image of India’s pharmaceutical products across the globe, and caused irreparable damage to the supply chain of pharmaceutical products, as well as the repute of the national regulatory framework over an assumption that has yet not been substantiated by the WHO or its partners on the ground,” the DCGI said.

Other companies in the list are Radiant Parenterals, Mercury Laboratories, Alliance Biotech, Captab Biotec, Aglowmed, Zee Laboratories, Daffodils Pharmaceuticals, GLS Pharma, Unijules Life Sciences, Concept Pharmaceuticals, Shree Anand Life Sciences, Dial Pharmaceuticals, and Makcur Laboratories.