The Indian government has rejected a request by pharmaceutical companies to extend the upgrade time of production facilities after at least 24 children died after consuming locally made cough syrup, Reuters reported a source as saying on Monday.
Indian-made cough syrup has killed more than 140 children in Africa and Central Asia, leading to 2023 orders for pharmaceutical companies to ensure their factories meet World Health Organization recommendations, the report said, this requires enterprises to invest in the implementation of prevention of cross-contamination, sample batch testing and other norms. India’s government has set a later deadline for small companies to upgrade than big ones, but industry lobbies have been pushing for an extension to give them more time, warning that upgrade costs will force companies into bankruptcy.
Sources close to the situation said the failure to upgrade facilities at the COLDRIF syrup maker Slysan Pharmaceuticals in connection with the latest deaths was a key factor in pushing officials to ignore the requests.
The BBC reported this week that contaminated syrup reappears every time Indian regulators promise reform, reflecting the fragmentation of the country’s pharmaceutical market. Critics say a weak regulatory system makes it difficult to effectively monitor hundreds of low-cost syrups made by small factories and sold without a prescription.
India’s $50 billion pharmaceutical industry consists of about 3,000 companies operating more than 10,000 factories, with about 24 of them producing most of the country’s drugs, Reuters reported, the remaining 40 per cent of medicines are produced mainly by small and medium-sized enterprises, many of which fear that the cost of upgrading their facilities will put significant economic pressure on them. Industry sources said that if the upgrade request can not be extended, there will be drug shortages and unemployment. But regulators no longer seem to accept the argument that“Deadlines can not be extended again and again, people are dying.” The source said the big drug companies that had upgraded their facilities could make up the shortfall. (Yuen Kei Wing)