Mumbai: The Gujarat Food and Drug Control Administration (FDCA) has taken regulatory measures against eleven pharmaceutical companies located in Bharuch, Baroda, Ahmedabad, and Gandhinagar.
Collaborating with the Drugs Controller General of India (DCGI) as part of the joint risk-based inspections, these measures include the cancellation of licenses of four companies and halting of production of one company, specifically targeting non-compliance and quality concerns.
During phase-2 of the risk-based inspections, seven companies in Ahmedabad and Gandhinagar faced regulatory scrutiny, resulting in the cancellation of licenses for four because of poor compliance in hygiene standards. The issues were also related to quality control and Good Manufacturing Practices (GMP), particularly affecting MSMEs. This phase also saw the initiation of plant shutdowns in companies located in Ahmedabad and Gandhinagar.
Gujarat FDCA Commissioner Dr. H G Koshia provided insights into the situation, highlighting that only one pharmaceutical manufacturing unit at Ankleshwar in Bharuch district, which adhered to Form 25 and 28 licensing requirements, has been approved for restarting operations. This decision follows inspections in June 2023, during which manufacturing and production were halted due to non-compliance with GMPs. This also included inadequate maintenance of analytical instruments and production equipment. In Vadodara alone, two companies received show cause notices (SCNs), and four product licenses were cancelled due to quality issues.
The third phase of the risk-based inspections targeted four companies involved in the production of veterinary drugs, with three ordered to cease manufacturing following a SCN. The reasons cited included quality lapses deemed detrimental to patient safety, particularly in the production of oral solid dosage forms.
As the third phase of risk-based inspections concludes, Gujarat FDCA and DCGI are set to extend their scrutiny to 52 private and public drug testing labs in Gujarat, as confirmed by Dr. Koshia.
Industry experts have also been urging the Union health ministry to grant authorization to National Accreditation Board for Testing and Calibration Laboratories (NABL) accredited private testing labs.
This plea comes in response to the public notice from the Directorate General of Foreign Trade (DGFT), mandating the testing of cough syrup samples before exports due to contamination concerns. The DGFT’s order, issued on May 22, 2023, restricts the export of cough syrups until samples are tested in government laboratories. This move follows incidents where India-made cough syrups were found to be contaminated, leading to multiple child deaths in Gambia and Uzbekistan.
At the end of December 2022, Uzbekistan’s Ministry of Health reported that 18 out of 21 children with acute respiratory diseases died after consuming India-made cough syrups from a pharma company based in Noida, Uttar Pradesh.
