New EU drug export rule likely to hit pharma exports

Exports of $1 billion (around Rs5,400 crore) worth of active pharmaceutical ingredients (APIs) from India to the EU could be impacted by a new rule, even as the EU built additional safeguards to counter what it termed 'counterfeit' imports. The EU is the biggest importer of APIs from India after the US.

Beginning July, all API consignments from India for export to the EU would need to be inspected by a local competent authority and certified that the product being shipped complied with the European cGMP or current good manufacturing practices standards. The EU stated the authority had to be notified by the concerned exporting country.

According to industry sources, quoted by The Indian Express , the Drug Controller General India (DCGI) would likely to be notified by the government to conduct the monitoring, but the agency was already short-staffed, and drug approvals were getting delayed.

According to many of India's nearly 300 API exporters like Dr Reddy's Laboratories and Cipla, some of the restrictions are due to negative publicity. They feel more restrictions would result in delay in drug approvals. Many of India's API makers are also top notch formulations makers.

Meanwhile, in November, the European Fine Chemicals Group (EFCG) had called for global harmonisation of API manufacturing rules and regulations.

The group said in a release, the EFCG is proposing a global harmonisation of the rules and regulations governing the manufacture of active pharmaceutical ingredients (APIs) to level the worldwide playing field to ensure the quality of APIs and medicines containing them meet the high standard recognised by the developed economies (ICH Q7).