The much-awaited inspection of overseas sites by the team from the Central Drugs Standard Organisation (CDSCO) is expected to finally begin in March with the office of the Drugs Controller General of India identifying 10 sites in China in the first phase.
The DCGI office has finalised the list of manufacturing sites and the drug inspectors to be sent for auditing and inspection and the process will begin sometime in March itself, sources said. China has been selected as the first stop for the inspection in the wake of increasing complaints against the quality of drugs and APIs being imported from there.
In the second phase, the inspections will most likely to cover Italy as first country in Europe, with the view to ensure quality of products coming to India, sources added, without revealing the identified sites in China. The necessary training for the short-listed drug inspectors has already been given in accordance with the international standards. Further course of action will be taken by the authorities based on the report of the visiting drug inspectors, sources added.
The DCGI had some time back banned the import of raw materials from 10 Chinese drug companies as they did not comply with the mandatory regulatory standards here. It is not known whether the manufacturing sites of these companies were also included in the list prepared now for inspections.
The proposal for overseas inspections has been gathering momentum for quite a long time as there was strong call by the domestic industry to the authorities and make it part of the import registration policy, as followed by many other developed nations. Countries like United States have their own representative offices in India and other places to conduct these kinds of audits regularly.
