The drug recalls by US arms of Indian drugmakers have turned the spotlight back on the quality issues faced by the domestic pharma companies in the lucrative export market.
Currently, Aurobindo Pharma, Glenmark and Zydus are in the process of recalling their products in the US market due to manufacturing issues. While the concerns around Aurobindo Pharma and Glenmark Pharma pertain to the “deviation from the current good manufacturing practices (cGMP)” norms, in the case of Zydus, wrong labelling is the reason for recall.
Experts said that the recent instances of recall could impact the Indian pharma industry which is already facing the heat globally due to a spate of quality issues over the past two years.
Though the industry experts said that recall is an accepted practice globally, there could be many reasons behind them. “Recalls shouldn’t be taken negatively. It shows that the companies are handling the issues responsibly. It’s not always that there are problems with manufacturing process, there could be issues with the raw material providers or with certain batches of a product,” said Viranchi Shah, national president, Indian Drug Manufacturers’ Association (IDMA).
The latest recalls are classified as Class II which, as per FDA, indicates that a product may cause temporary or reversible health issues, or there is a low chance of serious health consequences. In 2024 alone, there have been 310 cases of drug recalls in the US.
Nevertheless, Indian pharma companies have been at the cross hairs of Indian and foreign drug authorities. In June this year, the USFDA’s division found violations in 11% of the facilities inspected in the country. Last year, the Drugs Controller General of India (DGCI)’s inspection revealed that 18 pharma companies were involved in the manufacturing of spurious medicines. Facing quality concerns, in November, Indian Pharmaceutical Alliance (IPA), has sent a bunch of proposals to DGCI asking it to streamline the drug investigation process.
Meanwhile, the government has given December deadline to domestic companies to adhere to the revised GMP norms which are a set of guidelines to improve manufacturing quality and safety, including comprehensive regulations for product recalls.