Ingredients News - CDSCO trains 100 drug inspectors, to train 85 assistant drug inspectors to implement GMP


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CDSCO trains 100 drug inspectors, to train 85 assistant drug inspectors to implement GMP

Shardul Nautiyal, Mumbai August 08 , 2017

The Central Drug Standards Control Organization (CDSCO) has trained 100 drug inspectors in the last one year and is in the process of training 85 assistant drug inspectors on auditing manufacturing units for good manufacturing practices (GMP) across the country.

To ensure quality of drugs supplied to over 200 countries from India, CDSCO also aims to train drug inspectors to increase inspections of manufacturing units in line with current Good Manufacturing Practices (cGMP) practiced globally.

A workshop on best global regulatory practices for CDSCO officials and regulators will also be held at Bhopal in the fourth week of August, 2017 which is meant to train drug regulators on par with global regulators as part of global regulatory harmonisation process.

Going by its mandate to double the manpower by the end of 2017, CDSCO is also planning to increase the count of drug regulators at CDSCO to more than 500. A total of additional 1,195 posts were sanctioned for the upgradation of manpower and labs under the 12th Five Year Plan. Central government had also allocated Rs. 900 crore for enhancing manpower and capacities of mini-labs at port offices and mobile labs at CDSCO level.

CDSCO is also in the process of training its drug inspectors on risk based assessment. Around 17 training programmes on GMP have already been concluded in the past couple of years.

With increasing global requirement for evolving regulatory compliance in regulated and unregulated markets, CDSCO has been conducting training programmes to render uniformity in GMP inspections for supplying quality drugs globally.

In an event of inspection from an international regulator, CDSCO has also started deputing drug inspectors as observers to carry out joint inspections. The exercise done in coordination with state drug regulators is meant to monitor manufacturing plants for quality and compliance.

The practice of deputing drug inspectors as observers through joint inspections has been able to help draw suggestions from global regulatory counterparts on continuing good manufacturing practices.

It will help Indian manufacturers in adopting global practices followed in other countries where medicines manufactured in India are consumed. Similar kinds of inspections have also been carried from India to other importing countries for the sake of ensuring quality and consistency.

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