Medicines produced by nine Indian pharmaceutical companies do not meet the WHO’s good manufacturing practice (GMP) standards, according to a risk assessment conducted by the Department of Drug Administration.     

The national drug regulatory body has flagged Ozone Pharmaceuticals Ltd, Cipla Ltd Unit II, Concept Pharmaceuticals Pvt Ltd, Intracin Pharmaceuticals Pvt Ltd, Shree Baidynath Ayruvedic Bhawan Pvt Ltd, Lincoln Pharmaceuticals Ltd, Mercury Laboratories Ltd, Sanjivani Parenterals Ltd, and Genetek Lifesciences Pvt Ltd for noncompliance with the WHO-GMP. 

These nine companies are major drug suppliers to the Nepali market. They now stand at risk of their products being prohibited in Nepal.

The department can recall, prohibit the supply and suspend the products of these companies until its inspectors conduct another risk assessment audit and draw a compliance report.

“We are yet to take a decision on these companies and their products which are being currently sold in the Nepali market,” Narayan Prasad Dhakal, the department’s director general, told the Post. “But we will not renew the licences of these companies to supply pharmaceutical products to Nepal in the future.”

He, however, said that the pharmaceutical companies failing to meet the WHO-GMP standard does mean that their products are of substandard quality.

“We will test the quality of the drugs produced by these companies in our own laboratory,” he added.

The department said that declaring non-compliance to products of certain Indian pharmaceutical companies will not make any difference in the drug supply chain, as dozens of national as well as international WHO-GMP certified companies are present in the Nepali market.