Indian drug regulator to begin surprise inspections at manufacturing sites
- India's drug regulator will reportedly begin conducting surprise inspections at pharmaceutical manufacturing sites across the country, the Economic Times reports.
- Teams from the Central Drugs Standard Control Organization plan to audit between 20 and 30 sites in the first phase of inspections, according to the report.
- Over the past year, the FDA has sent over a dozen manufacturing-related warning letters to facilities in India as it steps up its enforcement of drug quality standards.
The FDA has previously flagged violations at facilities operated by some of India's largest drug firms, such as Sun Pharmaceuticals, Dr. Reddy's, and Cadila. Compliance issues were also found at the Indian facilities of other global drug manufacturers like Novarti’s Sandoz unit or Canada-based Apotex.
As India is a huge exporter of generics drugs and active pharmaceutical ingredients in other branded products, drug quality is a major concern. Many of the warning letters from the FDA cite issues with maintaining sanitary conditions and preventing contamination. Weak controls over sample and production data, especially electronic data, are also a problem at many facilities.
The India Health Ministry recently banned nearly 350 fixed dose combination drugs due to concerns over risk to humans. Courts in India have issued a stay on the ban for many products made by international drug companies but the high-profile move only serves to further highlight the ongoing compliance battle.
With this planned aggressive ramp up of inspections, the Indian government appears to be taking concerns over its drug industry more seriously.
- Economic Times CDSCO plans surprise checks at drug manufacturing sites
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