CDSCO comes up with new checklist and evaluation tool for inspection of sites
The Central Drug Standard Control Organisation (CDSCO) has come up with a risk based criteria for inspecting drug manufacturing sites across the country.
May 29, 2016: This has been undertaken to improve the quality and ensure efficacy and safety of medicines produced. The organisation has drafted a checklist and evaluation tool to be followed while conducting inspection of drug manufacturing sites and report its findings to CDSCO and state drug regulators.
For transparent roll out of the new system, the CDSCO has also organised training programmes for drug inspectors so that they do not cause undue harassment to manufacturers and employees of companies. The inspections would be carried out jointly by CDSCO officials and state drug regulators. The inspection will assess the compliance of (Good Manufacturing Practice) GMP and (Good Laboratory Practice) GLP requirements and identify loopholes and endeavour to harmonise procedures of conduct of inspectors throughout the country. The exercise will help identify gaps in the manufacturing practices of producers and motivate them to attain internationally accepted standards.
The current round of inspection would be carried on the basis of the system developed by CDSCO, though suggestions from all related stakeholders would be taken into consideration for second and third round of inspections.
The above exercise is yet another example of undying efforts undertaken by the Indian regulator to help Indian pharma companies improve their compliance standards and thus attain higher standards for the industry as a whole.