Drug regulator to closely monitor small drug firms

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. There will be no compromise on the quality of drugs and patient safety.”

Queries to the health ministry did not elicit a response till press time.

The meeting was held because some drugs produced by these companies failed to meet the WHO requirements even as they met Indian standards. “Consequently, there is a need for more rigorous parameters to be implemented in India’s pharma sector. This progress is essential to enable India to effectively compete in the international market, the official said.

Updated: 01 Sep 2023, 11:28 PM IST