New EU rule could hurt drug ingredient exports

Drug

Exports of $1 billion (around R5,400 crore) worth of active pharmaceutical ingredients (APIs) from India to the European Union is likely to be impacted by a new rule, even as the EU builds more safeguards to prevent what it calls 'counterfeit' imports. After the US, the EU is the biggest importer of Indian APIs or ingredients that go into the manufacturing of drugs.

Starting July, every consignment of APIs made in India and exported to the EU should be inspected by a local competent authority and certified that the product being shipped complies with the European cGMP or current good manufacturing practices standards. This authority has to be notified by the concerned exporting country, the EU states.

Industry sources said the Drug Controller General India (DCGI) is likely to be notified by the government to conduct the monitoring, but the major concern is that the agency is already short-staffed, delaying drug approvals.

India's nearly 300 API exporters like Dr Reddy's Laboratories and Cipla, who are also top-rung formulations makers, and others like Granules India, Shasun Chemicals, Ipca Labs, Aarti Drugs and Arch Pharmalabs, feel that some of the restrictions arise from 'negative publicity', and more regulations will lead to delay in approvals.

"Europe has come out with the Falsified Medicines Act to overhaul the entire health and pharma supply chain mechanism. However, there should not be another delay in the name of clearances," said PV Appaji, director general at the Pharmaceutical Export Promotion Council of India (Pharmexcil), an apex body of exports from the country. "We are working with both the EU and the Indian government to put systems in place fast to avoid delays."

One of the suggestions put forward by Pharmexcil is that the government should accord the power to issue such certificates to the deputy drug controllers in zonal offices rather than follow a centralised process. "Appropriate timelines should also be put in place," said Appaji. Pharmexcil is organising an international expo in Mumbai next year called iPhex 2013 to showcase the quality of Indian products to the international community.

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