Drug regulator to closely monitor small drug firms

livemint.com:

small and medium enterprises involved in drug manufacturing, said a government official aware of the matter. The primary focus is to ensure strict adherence to the Good Manufacturing Practices (GMP) norms at their production facilities, he added. Separately, Union health secretary Sudhansh Pant on Tuesday chaired a day-long meeting at the Central Drugs Standard Control Organisation (CDSCO) to assess the results of risk-based inspections conducted by drug regulators in various states and Union territories.

The key objective of the meetings was to determine whether these pharmaceutical units were in compliance with the current GMP standards. GMP, as mandated by World Health Organization (WHO), prescribes essential standards to enhance product quality through control measures related to materials, methods, machinery, processes, personnel, facilities, as well as the environment. “The review was done on the basis of all three inspection phases.

Over 200 units were scanned. States were also directed to complete all the pending actions and file compliance reports. It was found that a majority of companies failed to follow the GMP standards and some of their drug samples failed quality check.

Directions were issued to strengthen the testing and other regulatory infrastructure," the government official, who attended the meeting, said seeking anonymity. “Companies failing quality checks of drugs will not be allowed to start manufacturing without completing the compliance. All actions are under strict vigil.