India to mandate annual audit of pharma suppliers by drugmakers, ET HealthWorld

by Rahul Devi

India to Tighten Rules for Drugmakers Following Cough Syrup Contamination Scandal

In an effort to ensure the safety and quality of pharmaceutical products, India is set to make it mandatory for drugmakers to conduct annual audits of their raw material suppliers. This decision comes after India-made cough syrups were linked to the deaths of 141 children worldwide. The World Health Organization and other health agencies have found contaminated India-made cough syrups responsible for the deaths of 70 children in Gambia, 65 in Uzbekistan, and at least six in Cameroon.

The new regulations aim to strengthen India’s $42 billion pharmaceuticals industry and reassure international buyers about the safety of its products. Drugmakers will now be required to audit their raw material and packaging suppliers at least once a year, a change from the current practice of occasional audits triggered by events such as product recalls.

The Central Drugs Standard Control Organisation (CDSCO), India’s federal drug regulator, conveyed the decision on mandatory audits during a meeting with industry representatives. The move is part of a broader effort by India to enhance trust and confidence in the quality of its pharmaceutical products and reduce the risk of product failure.

In addition to the audits, drugmakers will also be obligated to inform their licensing authorities of any product recalls. This requirement aims to address the lack of data on product recalls and ensure that companies with previous violations in other states are not granted export licenses.

The deaths of 12 children in India in late 2019 after consuming contaminated cough syrup marked the beginning of a wave of poisoning incidents caused by India-made medicines. The syrups were found to contain high levels of the toxin diethylene glycol (DEG) and/or a related chemical, ethylene glycol.

The trade ministry has been collaborating with drugmakers to review the current regulations in place and prevent further contamination incidents. Maintaining the quality of pharmaceutical products is crucial to guaranteeing patient safety and upholding public confidence in Indian medicines.

The new regulations and increased oversight aim to build trust and confidence in India’s pharmaceutical industry. By taking these steps, India hopes to ensure the safety of its products and maintain its position as one of the world’s leading pharmaceutical manufacturers.

Overall, these regulatory changes are an important step towards strengthening the pharmaceutical industry and maintaining India’s reputation as a trusted supplier of quality medicines. Through these measures, India seeks to safeguard public health and restore confidence in its pharmaceutical exports.

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