By admin From augmenting manpower to combating counterfeit drugs and enhancing regulatory compliance, Gujarat Food and Drug Control Administration (FDCA) Commissioner Dr. H. G. Koshia offers a detailed account of FDCA’s relentless pursuit of excellence in ensuring the safety and efficacy of pharmaceuticals.
Gujarat FDCA recently got state government approval for a state-of-the-art lab in Surat, alongside plans for another facility in Rajkot. These strategic expansions, coupled with an existing lab in Vadodara, constitute a robust network aimed at enhancing testing capabilities and ensuring the quality of pharmaceutical products throughout Gujarat.
This comprehensive dialogue with Shardul Nautiyal illuminates the multi-faceted strategies employed by the Gujarat FDCA to fortify public health defenses and uphold the integrity of the pharmaceutical sector in India and Gujarat. Excerpts:
Please give a brief on the recent strides made in strengthening manpower within Gujarat FDCA?
The recent sanctioning of an additional 35 posts, encompassing joint commissioners, deputy commissioners, drug inspectors, and allied staff, reflects our commitment to bolstering the workforce. With this augmentation, we aim to reinforce the capabilities of our existing 1529 personnel, empowering them to uphold stringent regulatory standards.
Please elaborate your plans for strengthening and expansion of labs?
A new lab in South Gujarat in Surat has been approved with an estimated budget of Rs 26 crores for which 2500 square meters of land has also been earmarked. Another lab at Rajkot is also being planned. This will strengthen the lab network with the existing lab at Vadodara. In total, there will be three labs in Gujarat.
The recent crackdown on spurious drugs has garnered considerable attention. Could you shed more light on Gujarat FDCA’s proactive measures in addressing this critical issue?
The Gujarat FDCA authorities in Gujarat have seized fake drugs worth over Rs. 1.75 crores in a series of coordinated raids across multiple cities. The operation has uncovered a sophisticated network involved in the illegal production and distribution of substandard antibiotics.
These actions underscore our unwavering commitment to combating illegal production and distribution of substandard pharmaceuticals. Through rigorous enforcement efforts, we aim to safeguard public health and reaffirm the integrity of our regulatory framework.
The crackdown on counterfeit drugs serves as a stern warning to those engaged in illicit activities, affirming the Gujarat FDCA’s determination to safeguard public health and safety against such grave threats. A similar fake drug racket worth Rs. 55 lakhs were uncovered in October 2023 in Ahmedabad and Himmatnagar. Legal action is being taken within the state against those who manipulate drug samples, and the Gujarat FDCA is resolute in taking strict measures against those involved in the sale of illegal and counterfeit drugs.
As part of the current investigation, nine samples of various drugs, including azithromycin tablets, cefixime dispersible tablets, amoxicillin and potassium clavulanate tablets, aceclofenac, paracetamol, and serratiopeptidase tablets, were seized and sent to the Food and Drug Laboratory (FDL) in Vadodara for analysis.
A team led by R M Patel, deputy commissioner (IB), Y G Darji, deputy commissioner (Headquarters), V D Dobariya, assistant commissioner, Ahmedabad Rural, senior drugs inspector M R Mangalpara, and other officers from the Gujarat FDCA conducted a raid on potentially fraudulent factories engaged in the illegal production of unlicensed and fake medicines.
The crackdown led to the seizure of a fake manufacturing factory equipped with a range of machinery including a mass mixer, compression machine, coating machine, and packing machines. Valued at about Rs. 1.25 crore, including coating material and prepared tablets, the factory was illegally operating under the name and license of a firm licensed in another state. This illicit operation posed a serious threat to public health, as raw materials and substandard medicines were sold to sick individuals without proper testing or technical oversight.
The illegal drugs, produced in the seized factory, were distributed to various cities within Gujarat, including Bhuj, Ahmedabad, Surat, Vadodara, and Idar. Among the distributors implicated in the operation were Tara Medical Agency, R.H.T. Drug House, Naysar Pharma, Medicasa Healthcare, Maa Chandra Pharma, Neelcare Life Sciences, Deegen Remedies, Natron Pharma, CSP Distributors, J.D. Pharma, and Keshav Drug Agency.
The seizure of drugs worth around Rs. 51 lakhs in these cities underscores the widespread reach of the counterfeit medicine trade in Gujarat. Investigations are underway in other regions of the state to dismantle similar operations and bring those responsible to justice.
What has been the action on manufacturing units for non -compliance to norms?
Gujarat FDCA has acted against 11 Gujarat-based companies for non-compliance to norms 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.
These actions follow 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.
What has been Gujarat FDCA’s other initiatives in terms of capacity building?
The Gujarat FDCA has comprehensively discussed with the US FDA Commissioner Robert M Califf about the plans to equip Indian drug regulators with enforcement and regulatory compliances related to good manufacturing practices (GMP) among others in a recent meet.
The meeting also discussed the benefits of the US FDA-Gujarat FDCA Bilateral Regulatory Forum which has been addressing issues related to quality audit for compliance to GMPs among other relevant subjects since 2008.
Ambassador of the United States of America (USA) Eric M Garcetti facilitated the meeting with Dr Robert Califf, Commissioner, US FDA on the occasion of his visit to India. This meeting was a very historic and significant one because it was a rare opportunity of the US FDA Commissioner visiting India and meeting Gujarat FDCA regulatory officials.
Training on audit readiness was the key highlight of the US FDA-Gujarat FDCA Regulatory Forum meet in February 2023 towards achieving compliance and quality. The US FDA delegation which was led by Sarah McMullen, director of the Office of Global Policy and Strategy, US FDA, India Office (INO), New Delhi also had made a factory visit of a cardiac stent manufacturing unit of Sahajanand Laser Technology Ltd (SLTL) at Gandhinagar.
They had appreciated the high level of quality protocols being followed in manufacturing the cardiac stents. The US FDA officials had also visited the Gujarat FDCA office in the month of August 2021 to attend regulatory forum meetings for information sharing and capacity building to tackle Covid-19 pandemic.
During the last FDA-Gujarat FDCA Regulatory Forum meet held virtually in 2022, Gujarat FDCA discussed plans to scale up presence of more US FDA and WHO-GMP compliant units in Gujarat towards enhancing production of quality medicines for the benefit of patient safety and compliance.
Started in the year 2008, US FDA-Gujarat FDCA Regulatory Forum is based on the premise of training, networking, knowledge sharing and compliance. This helps Indian regulators in understanding regulatory requirements of the US FDA.
Gujarat has more than 1081 WHO-GMP compliance units and more than 140 US FDA approved drug manufacturing units in the country.
A team of US FDA officials had also visited Gujarat FDCA in 2019 in which Letitia Robinson, country director, OIP, India Office, US FDA had comprehensively discussed building regulatory compliance in both the US and India. As the top official of the FDA, Dr. Califf is committed to strengthening programs and policies that enable the agency to carry out its mission to protect and promote public health.