Pharmabiz
 

CDSCO to recruit 500 drug inspectors to enhance cGMP compliance

Shardul Nautiyal, MumbaiThursday, September 1, 2016, 08:00 Hrs  [IST]

The Central Drug Standards Control Organization (CDSCO) is planning to recruit 500 more drug inspectors in the coming one year going by its mandate to double the manpower by the end of 2017. Meanwhile CDSCO has already concluded the process of recruiting 147 drug inspectors which will enhance inspections of manufacturing units in line with current Good Manufacturing Practices (cGMP).

A total of additional 1,195 posts were sanctioned for the upgradation of manpower and labs under the 12th five year plan. Central government has also allocated Rs. 900 crore for enhancing manpower and capacities of minilabs at port offices and mobile labs at CDSCO level.

To ensure quality of drugs supplied to over 200 countries from India, CDSCO is also in the process of training its drug inspectors on Good Manufacturing Practices (GMP) and risk based assessment. Around 5 such training programmes have already concluded in the past one year.

CDSCO had in the past started deputing drug inspectors as observers to carry out joint inspections on an event of inspection from an international regulator. The exercise done in coordination with state drug regulators was meant to monitor manufacturing plants on GMPs and equip drug inspectors on enforcing its compliance across the country. Following which, around 80 drug inspectors have been recruited at the CDSCO in 2014.

Talking about the increasing global requirement for evolving regulatory compliance in regulated and unregulated markets, an official stressed on the need for uniformity of GMP inspections for supplying quality drugs globally.

Countries globally are concerned about safety and efficacy of medicines to be supplied for the sake of patient safety. 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 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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