Gujarat’s pharmaceutical industry maintains exemplary compliance with stringent regulations, notably aligning with WHO-GMP standards. This dedication has led to numerous WHO-GMP and USFDA certified manufacturing facilities within the state, establishing Gujarat as a key player in pharmaceutical manufacturing.
Indian pharmaceutical firms, particularly those in Gujarat, have showcased impressive adherence during USFDA inspections, reinforcing India’s standing as a dependable partner in global drug quality and safety protocols.
Gujarat’s strategic advantage in the international pharmaceutical sector is attributed to its strong support system, featuring advanced infrastructure, a skilled workforce, and active collaboration between industry entities and government bodies.
Adoption of Revised Schedule M Guidelines
To enhance regulatory adherence within the pharmaceutical domain, the Gujarat Food and Drug Control Administration (FDCA) is conducting training for 150 officers on the updated Schedule M guidelines.
These sessions, announced on October 10, 2024, coinciding with National cGMP Day, aim for rapid implementation and enforcement of these essential guidelines, ensuring that drug producers in India and Gujarat stay aligned with both national and international mandates.
Gujarat FDCA’s proactive training initiative positions it as a model for others. Concentrating on global standard alignment, the administration reaffirms its intent to maintain India’s leadership in pharmaceuticals. With the sector’s dynamics swiftly evolving, FDCA remains at the cutting edge of regulatory developments and application. Training officers on revised Schedule M guidelines is vital to ensure that the state’s pharmaceutical offerings meet international quality benchmarks.
Dr. H G Koshia, Gujarat FDCA Commissioner, stressed the importance of revised Schedule M guidelines for maintaining manufacturing quality, safety, and efficacy. “Prompt adoption and rigorous enforcement of these guidelines is crucial for ensuring our pharmaceutical sector meets the highest global standards,” he stated.
These revised guidelines enhance standards for manufacturing facilities, equipment, and quality control measures, crucial for refining the quality of Indian-produced drugs as the nation solidifies its place as a dominant global pharmaceutical supplier.
The training will prepare 150 officers on Schedule M facets, including ensuring advanced facilities and equipment to prevent contamination, maintaining high production standards, and employing mechanisms to ensure all products meet required specifications before consumer distribution. Guidelines emphasize manufacturing area cleanliness to prevent cross-contamination and manage air, water, and waste in line with global standards.
Dr. Koshia highlighted Gujarat’s role in ensuring adherence to updated regulations, emphasizing, “Our officers are well-trained to enforce these global standards efficiently, ensuring Gujarat manufacturers uphold product integrity globally.”
The FDCA’s training aligns with rapid guideline adoption across all manufacturing units, responding to increasing global demand for quality assurances.
Dr. Koshia underscored the initiative, “Fast enforcement of Schedule M is essential for public health and competitive positioning globally. Our officers’ mission is to oversee this transition, ensuring seamless compliance.”
The training emphasizes innovation’s role in compliance, promoting new technologies in manufacturing and quality control to boost efficiency and minimize compliance risks.
“Quick industry uptake of these guidelines, alongside rigorous FDCA enforcement, will protect consumers and strengthen Gujarat’s position in the global supply chain,” Dr. Koshia concluded.
Enforcement Actions Taken
The Gujarat FDCA has enacted strict measures against 14 pharmaceutical companies due to significant Good Manufacturing Practice breaches.
Under ongoing risk-based evaluations, actions included Show Cause Notices and cessation orders for companies failing hygiene practices and showing severe quality lapses.
Dr. H G Koshia reported, “From January to March 2024, inspections found 14 companies receiving immediate stop orders, and 9 received SCNs to protect public health.”
Last year, during phase-2 inspections, hygiene non-compliance led to license cancellations and shutdowns. This mainly affected MSMEs in regions like Ahmedabad and Gandhinagar, focusing on hygiene and quality control issues.
Dr. Koshia noted only one facility in Bharuch followed Form 25 and 28 requirements to resume operations.
Further inspections in 2023 led to production halts due to GMP non-compliance, affecting analytical instrument and equipment maintenance. Vadodara saw SCNs issued, and four product licenses canceled.
Phase-3 targeted veterinary drug makers, with orders to stop manufacturing due to quality and safety concerns, particularly in oral solid dosage forms.
WHO-GMP Certification Drive to Boost Exports
WHO-GMP is crucial in pharmaceuticals, ensuring consistent product quality as per WHO standards.
Gujarat FDCA, through its e-governance initiative, introduced online WHO-GMP verification to enhance export prospects, as explained by Dr. Koshia. With QR codes, global regulatory bodies can verify certifications seamlessly.
This follows the new Schedule-M version promoting compliance, export growth, and assuring drug quality trust.
On August 2, 2023, the health ministry set deadlines for certification compliance, urging larger companies to comply within six months and MSMEs within a year.
Gujarat FDCA’s online integration of NCC and PC aligns with Ease of Doing Business goals and complements its m-governance program, streamlining pharmaceutical procurement and regulatory processes.