In a significant development, the Indian government has revised its export policy for cough syrups, mandating that export consignments will only be cleared upon obtaining certification from government-approved laboratories. The Directorate General of Foreign Trade, operating under the Ministry of Commerce, issued a notification announcing the amendment.
According to the new policy, cough syrups intended for export must undergo testing of export samples and provide a certificate of analysis from one of the designated laboratories. The approved laboratories include the Central Drug Laboratory in Kolkata, Central Drug Testing Labs in Chennai, Mumbai, and Hyderabad, as well as the Regional Drug Testing Labs in Chandigarh and Guwahati. Additionally, any state drug testing labs accredited by the National Accreditation Board for Testing and Calibration Laboratories (NABL) are eligible for providing the required certification.
This revision in policy comes in the wake of numerous global alerts concerning Indian-manufactured cough syrups. The World Health Organization (WHO) previously issued a medical alert in October, raising concerns about cough syrups from Maidan Pharma, based in Sonepat, and their alleged connection to over 70 child deaths in Gambia. Subsequently, 18 Uzbek children were reported to have died due to links with cough syrups produced by Marion Biotech, a Noida-based company. In April, WHO issued another alert involving cough syrups manufactured in Punjab and Haryana.
The stricter export regulations aim to ensure the safety and quality of Indian cough syrup products in the international market. By mandating government lab certification, the government seeks to address concerns and prevent any potential harm associated with the export of these medicines. It is a proactive step towards enhancing the credibility and reliability of Indian pharmaceutical exports, safeguarding public health globally.
This amendment highlights the government’s commitment to upholding stringent quality standards in the pharmaceutical sector and reflects its dedication to maintaining the integrity of Indian exports. The implementation of these measures is expected to contribute to building trust and reinforcing India’s reputation as a responsible exporter of pharmaceutical products.