Regulator begins major enforcement drive on poor drug-making practices

The CDSCO enforcement a joint operation between centre & states.

Indian drug regulator Central Drugs Standard Control Organisation (CDSCO) has begun operations for a major enforcement drive to keep check on poor manufacturing practices, sources told CNBC TV18.

This drive also includes action against public testing labs and clinical research organisations, according to the report.

The last round of risk-based inspection was carried out by the regulator in 2016-17. These enforcement actions are a part of risk-based inspection to ensure Good Manufacturing Practices (GMP) norms are met.

The actions will be across India with inspection on various categories of medicines. The CDSCO enforcement a joint operation between the Centre and states.

The CDSCO has asked enforcement teams asked to pick up random samples from manufacturing premises. Investigations will be conducted for Fixed Dose Combinations (FDC), vaccines, syrups, complex formulations and bulk drugs. The enforcement drive to ensure production, verification and validation of manufacturing standards.

This CDSCO enforcement drive to build confidence after instances of contamination. Earlier in the week, Mumbai-based eyedrops maker Kilitch Healthcare India had recalled 27 types of eyedrops sold in the US for potential safety reasons, the US Food and Drug Administration (USFDA) said. The US regulator had warned consumers in October not to purchase or use store-brand eyedrops from Walmart Inc, CVS Health Corp, Target Corp and other companies "due to risk of eye infection", without naming Kilitch as the manufacturer.

Bloomberg had earlier reported that Kilitch made the eyedrops in an unsanitary factory in India where some workers went barefoot and submitted fabricated test results.

In February, Chennai’s Global Pharma Healthcare voluntarily recalled its Artificial Tears Lubricant Eyedrops after reports of death and blindness were reported in the US.

Samples which are found to be 'not of standard quality' will be sent for further testing at CDL Kolkata. CDSCO will then direct enforcement teams to take legal actions for non-compliance like Not of Standard Quality (NSQs).

India is known as the pharmacy of the world with around 10,500 pharma manufacturing units, of which around 8,500 falls under the MSME category (with an annual turnover of less than Rs 250 crore).