47 Drug Mfg Licenses, 636 Sale Licenses Cancelled for Non-Compliance to Norms

MUMBAI:
Having served 155 notices to drug manufacturers in the state for non-compliance in the past six months, the Maharashtra Food and Drug Administration (FDA) has recently canceled 47 manufacturing licenses, 636 sale licenses and lodged four FIRs in certain cases for non-compliance to norms. The state regulator also suspended 2,490 sale licenses and 79 manufacturing licenses.
This comes close on the heels of Central Drugs Standard Control Organisation (CDSCO)’s proactive approach to conduct risk based inspections of Schedule M units in collaboration with the state drug regulator for effective oversight on compliance to good manufacturing practices (GMP), according to a senior FDA official.
CDSCO has been conducting risk-based inspections across the country to verify GMP compliance as per the provisions stated under Schedule M of Drugs and Cosmetics Rules, 1945.
Based on the current GMP and Good Laboratory Practices (GLP) under the Drugs & Cosmetics, Rules, 1945, the World Health Organisation (WHO), GMPs and requirements in terms of Pharmaceutical Inspection Cooperation Scheme (PICS), the CDSCO developed a comprehensive checklist for risk based inspection of pharmaceutical manufacturing units in the country in 2016.
Further, on the basis of a careful analysis of the risks involved, the CDSCO identified a number of companies manufacturing drugs in the country for being inspected in terms of the aforesaid criteria.
In the wake of rampant cases of spurious drugs detected recently in Aurangabad recently, government has also mandated that manufacturers are required to ensure stability of all drugs manufactured by them throughout their shelf life so that patients get quality, effective and safe medicine.
Maharashtra FDA had earlier verified compliance reports of self -audits by around 800 manufacturers in the state. The exercise was meant to assess adherence to the licensing conditions by the concerned manufacturer as envisaged in the Drugs and Cosmetics Act.
The state drug regulator had earlier canceled 36 manufacturing licenses and suspended another 90 after serving 136 show cause notices (SCN) for non-compliance as part of 837 inspections for the period from April 2017 to October 2017.