India will relaunch the inspections of API facilities in China

In order to ensure only quality active pharmaceutical ingredients (API) are imported from countries like China, Indian Government will be restarting inspections of drug manufacturing facilities in China soon.

“In the light of the fact that India has faced repeated scrutiny of its manufacturing facilities in the name of quality medicines, the commerce ministry along with other concerned ministries are serious to set up a permanent audit office in China to conduct inspections on a regular basis in China,” says Drug Controller General of India Dr G N Singh

“Audits and Inspections are meant to ensure that medicines, APIs and products manufactured from the importing country adhere to global GMP standards so that safe medicines are made available to the common man,” he added.

The Union health ministry is also in the final stages to release a draft guideline towards enhancement of GMP to align India-specific standards with global regulations for better product quality of pharmaceutical products.

The plan to establish a drug audit office in China for inspection of drug manufacturing units in that country on a regular basis is in the pipeline for the past 3 years as the project is waiting for the approval from the several ministries of both the countries.

As per plan the Drug Controller General of India (DCGI), at least four Indian drug inspectors were supposed to be posted in China to examine manufacturing sites and check that these units are complying with good manufacturing practices. The proposed drug audit office in China will be equivalent to the audit office of US FDA and other representative offices of any foreign drug regulatory agency which operates in India and elsewhere.

To ensure that only quality products are sourced by Indian companies from abroad, the health ministry in 2011 started the process of auditing and inspection of manufacturing plants outside India.

The ministry and Central Drugs Standard Control Organisation (CDSCO) want the inspection to be carried on a regular basis. As per the DCGI’s plan, CDSCO was to open its first drug inspection office on March 1, 2013 in Beijing but still it is waiting for the approval from various ministries.


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