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India’s drug audit office in China yet to come up, awaits approvals from various ministries

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

Dr G N Singh, Drugs Controller General of India (DCGI) says, India-drug-audit-office“There is no plan to drop and we are trying. We will surely establish the drug audit office in China, but it will take time as the project is awaiting for approval from ministry of external affairs and several other ministries involved from both the countries.”

As per the DCGI’s plan, at least four Indian drug inspectors will 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.

An official from Central Drugs Standard Control Organisation (CDSCO) said that there is a provision in the Drugs and Cosmetics Rules, 1945 (D&C Rules) whenever any drug is imported the auditor has to inspect it. But traveling on regular basis is not possible. So, the ministry and CDSCO want the inspection to be carried on the a regular basis. The talks are going on and it is not easy to establish an office in other countries as several approvals from the concerned ministries of both the countries are required. The project has to pass through various levels.

As per the DCGI’s plan, CDSCO was to open its first drug inspection office on March 1, 2013 in Beijing but still its waiting for the approval from various ministry for the implementation.

The DCGI decided to set up a permanent drug manufacturing audit and quality certifying office in China following increasing imports of drug inputs that had the potential to compromise the quality and safety of drug ingredients and intermediates being exported from China to India.

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