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Gujarat’s pharmaceutical sector has consistently adhered to rigorous compliance standards, particularly emphasizing compliance with WHO-GMP regulations. This commitment has resulted in a substantial number of WHO-GMP and USFDA compliant manufacturing plants in the state, contributing to its reputation as a trusted hub for pharmaceutical production.
Indian pharmaceutical companies, especially those in Gujarat, have demonstrated commendable compliance levels during USFDA audits. This recognition reaffirms India’s position as a reliable partner in upholding drug quality and safety standards globally.
Gujarat’s competitive edge in the global pharmaceutical market stems from its robust ecosystem comprising cutting-edge infrastructure, skilled workforce, and proactive industry-government collaboration.
Training on Revised Schedule M Guidelines
In an initiative to boost regulatory compliance in the pharmaceutical sector, the Gujarat Food and Drug Control Administration (FDCA) has rolled out training sessions for 150 regulatory and enforcement officers on the revised Schedule M guidelines.
The training sessions which were announced on October 10, 2024, to mark the National cGMP Day celebrations, aims at the speedy adoption and enforcement of these critical guidelines to ensure that drug manufacturers in India and Gujarat align with both national and international standards.
Gujarat FDCA’s proactive approach to training and enforcement sets a benchmark for other states to follow. The administration’s focus on aligning with global standards reaffirms its commitment to maintaining India’s leadership in the pharmaceutical sector. As the pharmaceutical landscape evolves, Gujarat FDCA remains at the forefront of regulatory innovation and enforcement. The training of 150 officers on the revised Schedule M guidelines is a crucial step toward ensuring that the state’s pharmaceutical products meet global quality standards.
Gujarat FDCA Commissioner Dr. H G Koshia, emphasized the importance of the revised Schedule M guidelines in maintaining quality, safety, and efficacy in pharmaceutical manufacturing. “The rapid adoption and stringent enforcement of the revised Schedule M guidelines is pivotal to ensuring that our pharmaceutical industry complies with the highest global standards,” he said.
The revised Schedule M guidelines provide updated standards for manufacturing facilities, equipment, and quality control measures. These guidelines are crucial for improving the quality of drugs produced in India, particularly as the country solidifies its position as a leading global pharmaceutical supplier.
As part of the training, 150 officers will be equipped on several key aspects of Schedule M, including the need for state-of-the-art facilities and equipment to prevent contamination and maintain high production standards, strengthening mechanisms to ensure all products meet the required specifications before reaching consumers. The revised guidelines place a greater emphasis on cleanliness in manufacturing areas to avoid cross-contamination and ensuring adequate measures to control air, water, and waste management within facilities, aligning with global environmental standards.
Dr Koshia highlighted that Gujarat, as a pharmaceutical hub producing over 30 per cent of India’s drugs, is leading the way in ensuring compliance with these updated regulations. “Our officers are today very much oriented and equipped to enforce these global standards swiftly and effectively, ensuring manufacturers in Gujarat uphold the integrity and quality of their products in the world,” he noted.
The Gujarat FDCA’s training program aligns with the state’s goal to rapidly adopt the revised Schedule M guidelines and enforce them across all pharmaceutical manufacturing units. With the rising demand for quality assurance in global markets, compliance with these revised guidelines is essential for maintaining international trade partnerships and market access.
Dr Koshia further emphasized the urgency of this initiative, stating, “The swift enforcement of Schedule M will not only safeguard public health but also ensure Gujarat’s pharmaceutical industry remains competitive on the global stage. Our officers’ mission and preparedness is to oversee the industry’s transition to the revised guidelines, ensuring seamless compliance.”
The training also stresses the role of innovation in maintaining compliance with Schedule M and on adopting new technologies in manufacturing and quality control processes, which are expected to enhance overall efficiency and reduce the risk of non-compliance.
“The swift adoption of these guidelines by the industry, coupled with rigorous enforcement by the FDCA, will not only protect consumers but also bolster Gujarat’s position as a key player in the global pharmaceutical supply chain,” Dr Koshia added.
Stop manufacturing orders issued
The Gujarat FDCA has taken stern regulatory actions against 14 pharmaceutical manufacturing companies for serious violation of Good Manufacturing Practices (GMPs).
As part of the ongoing risk-based inspections, these regulatory actions include issuance of Show Cause Notices (SCNs) and stop manufacturing orders to companies which were not following hygiene practices and were targeted for very serious quality concerns.
Dr. H G Koshia informed, “Based on the inspections conducted between January and March 2024 of a total 23 companies, around 14 companies were issued stop manufacturing orders with immediate effect and 9 companies were issued SCNs in the interest of public health and safety.”
The state regulator had taken similar regulatory actions against eleven pharmaceutical companies located in Bharuch, Baroda, Ahmedabad, and Gandhinagar last year in November.
During phase-2 of the risk-based inspections last year, 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 GMPs, particularly affecting MSMEs. This phase also saw the initiation of plant shutdowns in companies located in Ahmedabad and Gandhinagar.
Gujarat FDCA commissioner highlighted that only one pharmaceutical manufacturing unit at Ankleshwar in Bharuch district, which adhered to Form 25 and 28 licensing requirements, was approved for restarting operations.
Regulatory actions were also taken in June 2023, during which manufacturing and production of several manufacturing plants 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 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 stop manufacturing following a SCN. The reasons cited included quality lapses deemed detrimental to patient safety, particularly in the production of oral solid dosage forms.
WHO-GMP certificate verification to boost exports
Good Manufacturing Practice (GMP) is a critical concept in the pharmaceutical industry. According to the World Health Organization (WHO), WHO-GMP certification ensures that products are consistently produced and controlled, according to quality standards by the manufacturers.
With the effective implementation of its flagship e-governance programme, Gujarat FDCA’s online WHO-GMP certificate verification is all poised to boost pharma exports, informed Dr Koshia.
He further added that now with a QR Code, regulatory agencies of any country to which India exports can now verify the WHO- GMP certificate in a timely, instant, seamless and transparent manner.
This comes close on the heels of the notification for implementation of the new version of Schedule-M aimed to ensure compliance to standards of drugs, promotion of exports, and also to build trust on the quality of drugs manufactured and sold.
Under the revised norms, the words ‘Good Manufacturing Practices’ (GMP) have been replaced with ‘Good Manufacturing Practices and Requirements of Premises, Plant and Equipment for Pharmaceutical Products’.
On August 2, 2023, the Union health ministry had given 12 months’ time for small manufacturers and 6 months’ time to large units to get their WHO-GMP certification. Larger companies with a turnover of over Rs. 250 crore have been asked to implement the changes within 6-months, while medium and small-scale enterprises with turnover of less than Rs. 250 crore have been asked to do so within one year.
Gujarat FDCA has also made Non-Conviction Certificates (NCC) and Performance Certificates (PC) for pharma companies online to make the procurement process of medicines seamless and less time consuming.
Gujarat FDCA has rolled out the online mechanism for granting NCC and PC to pharma companies towards Ease of Doing Business (EoDB). The rolling out of NCC and PC online will also complement the Gujarat FDCA’s flagship m-governance programme.
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