Here is some rather troubling news for pharmaceutical and life sciences supply chains.
FDA News and other India news outlets report that 200 drug manufacturers have been now cited by India’s national drug regulator for noncompliance and “high risk” for quality control lapses as part of an initial effort to crackdown on the country’s pharmaceutical sector. At face value, that represents a troubling portion of domestic capacity.
According to the report, The Central Drugs Standard Control Organization joined forces with state regulators to inspect upwards of 135 drug production facilities across India. Regulators initiated these steps to follow U.S. Federal Drug Administration (FDA) enforcement model guidelines and to address what was described as rampart quality control problems in the country’s drug market.
Apparently, none of the cited drug makers have been publicly named.
A Times of India report published in June indicated that the 200 drug manufacturers were scheduled for risk-based inspections based on an analysis of regulatory data recorded over the prior 5 years.
Global based pharmaceutical and life sciences companies that are currently outsourcing API or drug manufacturing within India should obviously take notice of this development.