The move comes at a time when the Indian pharma industry is embracing global standards through up-gradation of schedule M units into WHO-GMP units. In a major issue with regards to the pharma industry and policymakers, a joint inspection of as many as 17 MSME units in Gujarat is been performed.
In a major issue with regards to the pharma industry and policymakers, a joint inspection of as many as 17 MSME units in Gujarat is been performed. Under the supervision of Gujarat Food and Drug Control Administration (FDCA) in association with Central Drugs Standard Control Organization (CDSCO), the state regulator has served notice to the companies to undertake remedial measures towards the compliance of quality control.
The move comes at a time when Indian pharma industry is embracing global standards through up-gradation of schedule M units into WHO-GMP units.
The objective behind inspections was to develop a quality culture in MSMEs and equip domestic industry towards risk based inspections.
Commenting over these inspections Gujarat FDCA Commissioner Dr HG Koshia said that the inspections were jointly conducted by the central and state regulator to oversee the kind of drug circulated in the government healthcare machinery.
He said that these 17 companies used to supply medicines to government procurement agencies in the country like Gujarat Medical Services Corporation Limited (GMSCL) and Rajasthan Medical Services Corporation Limited (RMSCL).
“Notices for remedial measures have also been positive as the concerned companies are working towards maintaining compliance primarily towards quality management systems,” he added.
Towards audit preparedness for the Indian pharma industry, US based consulting firm World Compliance Seminars (WCS) has also been conducting workshops in Gujarat.
The workshops have already covered subjects for manufacturers like on how to be prepared timely for US Food and Drug Administrator (FDA) inspections and how to develop quality culture from bottom to top management in Indian pharma companies.
It also dealt with topics like data integrity and role of data integrity in various functions, current FDA expectations, current trends of FDA, 483 warning letters among others.
The workshops have covered relevant aspects like what FDA investigators look for in a pharmaceutical product and API facility and how to be equipped to avoid last minute rush.