The Central Drugs Standard Control Organization of India (CDSCO) issued a health alert after detecting irregularities in 167 specific batches of drugs sold in the country, which did not meet the required quality standards in random tests. The monthly surveillance report, published this January, shows, on the one hand, technical failures in large pharmaceutical companies such as IPCA Laboratories, and on the other hand, the detection of seven “spurious” (fake) drugs, four of which come from the same source in Ghaziabad, a satellite town of the Indian capital. Among the affected drugs are batches of common use, such as the analgesic paracetamol, antacids, antihypertensives and antibiotics.
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Although most of the non-compliance comes from small regional laboratories, the list also points to major players such as IPCA Laboratories, one of the largest listed pharmaceutical companies in the country with a global presence, which the regulator detected quality failures in batches of painkillers.
The identified problems include failures in dissolution tests, implying that the pill does not dissolve correctly in the body to take effect, as well as errors in chemical assays and water content. India has been the subject of intense international scrutiny after recording episodes that have called into question the quality control of its pharmaceutical industry, one of the world’s largest producers of generics. In recent years, syrups made in India have been investigated for contamination with diethylene glycol, a toxic industrial solvent, and have been linked to the deaths of children in countries such as Uzbekistan, Cambodia, and Gambia. Known as ‘the pharmacy of the world’ for its large-scale, low-cost production, India has the second-largest number of production plants approved by the US FDA.
