All the excitement prompted by a new import law that has European drugmakers and their API suppliers worried about a regulatory train wreck come July appears to have moved the needle in one crucial API producing country: India. An official there says India now has a plan in place to get the required inspections done, or so it seems.
Citing an unnamed source with the Drug Controller General of India, the Economic Times reports that the agency is setting up separate audit teams to inspect EU-bound APIs and make sure they meet World Health Organization (WHO) standards. The plan is for two inspectors from zone offices to check out manufacturing plants, the official said. A "qualified inspector" will lead each team, and there might be a quality-control expert from the central drug-testing lab or a regional drug-testing lab. There was no indication whether India can get the inspections completed to meet the rapidly arriving deadline. According to the Economic Times, India exports about $1 billion worth of APIs to Europe each year.
The new legislation is designed to prevent inferior APIs from getting into Europe. It requires that all shipments carry a guarantee that the maker has been inspected by its home country and that its products meet EU standards. But drugmakers were afraid that two of the largest producers of APIs in the world, China and India, would be unable to get a process in place and inspections done in time to meet the July deadline.
The director-general of India's drug regulator, the Pharmaceutical Export Promotion Council of India (Pharmexcil), said 6 months ago that India was working to solve the problem. But India has given little public sign it was getting its act together. The European Federation of Pharmaceutical Industries and Associations (EFPIA) this month pleaded with European regulators to raise their level of urgency in negotiations with China and India so there are no shortages. China has given no public indication that it is on top of the new rules.
While drugmakers in Europe have been fretting over API shortages, API makers in the U.S. have been concerned about losing their customers. The EC is granting exemptions from the rules to countries that it certifies as meeting EC standards. The U.S. asked for that exemption in January, but it took Europe 7 months to grant just one, which Switzerland received.
- read the Economic Times story
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