Drugmakers in Europe have been worried that the bulk drug industry in India they lean on as a cheap source of active pharmaceutical ingredients would not get its act together to meet the July 2 deadline for certifying APIs. With just weeks to go, one India government agency has just laid out the guidelines for API makers to follow in order to meet the new EU standards.
The new legislation is designed to prevent inferior APIs from getting into Europe by requiring that all shipments carry a guarantee that the maker has been inspected by its home country and that its products meet EU standards. India's Central Drugs Standard Control Organization last week detailed the manufacturing standards that API makers should follow so their drugs aren't banned from any of the 27 countries in the EU, The Economic Times reports. But that is only part of the process. All the APIs must also receive a certification by another Indian agency that the plants where they are made have been inspected and meet the standards the EU imposes on its own API manufacturers. According to in-PharmaTechnologist.com, only Teva Pharmaceutical Industries ($TEVA) so far has wrangled a certification for its Indian plants.
Associations representing drugmakers in the EU have been pushing authorities there to do whatever they could to make sure that both India and China can meet the rules since they produce the biggest part of the APIs European drugmakers need. China and India combined have more than 930 API makers that need a signoff, more than 60% of all the manufacturers tracked by the European Commission. China has told the EU it will not inspect any API makers that do not also produce for its own drugmakers, leaving the EU to figure that one out, in-PharmaTechnologist.com reported.
API makers in Europe will be allowed to use third-party audits to prove they are meeting the new rules, the publication points out. It said that the European Medicines Agency (EMA) has itself just published details of what it wants to see in the way of documentation from European API makers. That includes being able to quickly produce documents on cleaning, risks of cross contamination, potential for impurities and a host of other standard cGMP requirements.