New Delhi: The Drugs Controller General of India (DCGI), Rajeev Raghuvanshi, has given three NABL-accredited private labs the permission to carry out tests on cough syrups intended for export. Previously, only government labs were permitted to conduct these tests.
The authorised private labs include Bee Pharma Labs in Mumbai, Oasis Test House in Ahmedabad, and Shriram Institute for Industrial Research in Delhi. This move aims to expedite the testing process and reduce the workload on government labs. According to experts, testing for Di-Ethylene Glycol and Ethylene Glycol contamination, which is a critical safety measure, typically takes at least 15 days.
Raghuvanshi explained, “It has been decided, with the approval of the Ministry of Health and Family Welfare, to include three NABL-accredited private testing laboratories for testing cough syrups that are intended for export by manufacturers, authorised individuals of manufacturers, and exporters, in addition to the 14 NABL-accredited government labs.”
This decision was prompted by concerns about the quality of Indian-manufactured cough syrups not meeting standards in other countries, leading to the death of children in Uzbekistan and The Gambia.
In June, the Indian government revised its export policy for cough syrups, making testing mandatory before shipping to foreign nations. Pharmaceutical companies must now provide a certificate of analysis before exporting cough syrups.
Of the 10,500 drug manufacturing facilities in India, around 8,500 are Micro, Small, and Medium Enterprises (MSMEs). Only 2,000 of these facilities have obtained the Good Manufacturing Practices certification from the World Health Organisation (WHO).
India, renowned for its global leadership in generic drug production, exported cough syrups worth $17.6 billion in the fiscal year 2022-23, up from $17 billion in 2021-22. The Pharmaceuticals Export Promotion Council of India (Pharmexcil) has over 2,000 manufacturers registered with the company, with a majority manufacturing cough syrups.