regulatory compliance Archives

Anabolic Steroids: Part of QP Pharmachem’s Product Lines

Brian RogersJune 4, 20240182 views

QP Pharmachem Ltd., based in Punjab, India, is a discreet yet significant producer of anabolic steroids, despite its history of producing substandard products and temporary license loss due to quality control issues. The company’s involvement in manufacturing anabolic steroids raises serious safety concerns, especially in light of their recent WHO Medical Product Alert for contaminated cough syrup. This situation underscores the need for stringent regulatory oversight and the importance of sourcing steroids from reliable manufacturers. Consumers should be cautious and informed about the origins and manufacturing standards of anabolic steroids to ensure their safety.

Lifecare Neuro: Quality, Safety, and Family Values in Pharma

Brian RogersJune 4, 20240196 views

Lifecare Neuro Products Limited, a prominent Indian pharmaceutical company, specializes in neuro and psychiatric medications. Known for its adherence to stringent manufacturing standards, Lifecare Neuro operates a WHO-GMP certified facility equipped with advanced machinery. The company prides itself on maintaining high-quality control measures and regulatory compliance, positioning itself as a leader in both domestic and international markets. This review explores Lifecare Neuro’s manufacturing practices, certifications, and the influence of its leadership, highlighting its commitment to safety, quality, and continuous improvement in the pharmaceutical industry.

Resistance to Reform: Punjab Pharmaceutical Manufacturers Push Back Against Modi’s Schedule M Mandate

Brian RogersJune 4, 20240133 views

Prime Minister Narendra Modi’s directive for Indian pharmaceutical plants to achieve WHO GMP certification by the end of 2023 faces significant resistance from some manufacturers. The Pundrug Research Foundation, led by several Punjab-based pharmaceutical companies, argues that the financial and logistical burdens of upgrading to meet these standards are too high, particularly for smaller firms. Despite these challenges, the Indian government emphasizes that such upgrades are essential for ensuring the safety, efficacy, and global competitiveness of Indian pharmaceuticals. The debate underscores the critical need for balancing regulatory compliance with economic realities to maintain India’s position as a leading pharmaceutical producer.

A New Era for Indian Pharma: WHO Certification Mandate by End of 2023

Brian RogersJune 4, 20240408 views

Prime Minister Narendra Modi has set a transformative goal for India’s pharmaceutical industry: by the end of 2023, all pharmaceutical manufacturing plants must adhere to WHO Good Manufacturing Practices (GMP) certification, also known as Schedule M. This directive aims to elevate the quality of India’s pharmaceutical products to meet international standards, ensuring that all medications produced in the country are safe, effective, and of high quality. This ambitious mandate faces significant challenges, including the need for infrastructure upgrades, comprehensive training for personnel, and continuous regulatory compliance. However, the long-term benefits of improved global competitiveness, enhanced industry credibility, and better patient safety make it a crucial move for the Indian pharmaceutical sector.

The Importance of Contract Manufacturing in India’s Pharmaceutical Industry

Brian RogersMay 27, 20240180 views

Contract manufacturing, or third-party manufacturing, involves outsourcing production to external manufacturers and is prevalent in India due to its cost-effective and high-quality production solutions. Key features include cost savings, focus on core competencies, scalability, and regulatory compliance. Pharmaceutical brands must ensure they select licensed manufacturers, conduct regular audits, maintain transparency, and prioritize quality over cost to uphold industry standards. This approach reinforces India’s reputation as a global leader in pharmaceutical manufacturing.

Ensuring Pharmaceutical Integrity: The Case for Independent Third-Party Testing in India

Brian RogersMay 27, 20240120 views

Contract manufacturing in India’s pharmaceutical industry offers cost-effective and high-quality production solutions, crucial for global supply chains. With robust regulatory compliance and significant cost advantages, India has become a hub for pharmaceutical outsourcing. However, pharmaceutical brands must ensure their manufacturing partners meet stringent standards through regular audits and transparency, maintaining the industry’s integrity and reputation as a global leader in quality pharmaceuticals.

Advancements in India’s Pharmaceutical Control and Regulations Over the Last Two Decades

Brian RogersMay 27, 20240138 views

Over the past two decades, India has made remarkable strides in pharmaceutical control and regulation, transforming into a global leader in pharmaceutical manufacturing and quality control. This progress has been driven by robust government initiatives, regulatory reforms, and dedicated agencies ensuring the highest standards of drug safety and efficacy. Significant milestones include the implementation of Good Manufacturing Practices (GMP), the launch of the Pharmacovigilance Programme of India (PvPI), and international collaborations that have bolstered India’s position as the “pharmacy of the world.” Despite challenges like corruption and substandard manufacturing practices, continued efforts towards transparency and independent third-party testing are paving the way for further advancements and global trust in Indian pharmaceuticals.

Responsibilities of Brands Contracting Pharmaceutical Manufacturing in India

Brian RogersMay 27, 20240159 views

When a pharmaceutical brand, such as Healing Pharma, contracts a manufacturing facility like QP Pharmachem, both parties must adhere to stringent regulatory standards to ensure product quality and compliance. This involves obtaining necessary licenses from CDSCO, following Good Manufacturing Practices (GMP), and conducting regular audits. The brand is responsible for providing detailed product specifications, ensuring thorough testing, and maintaining comprehensive documentation and traceability. Additionally, establishing robust pharmacovigilance and clear contractual agreements are crucial for maintaining high standards and protecting intellectual property. For more detailed guidelines, refer to resources from CDSCO, CliniExperts, and Intertek.

Are Indian Pharmacy Manufacturers Required to Post Their Licenses and Accreditation on Their Websites?

Brian RogersMay 27, 20240115 views

Indian pharmacy manufacturers are not explicitly required by law to post their licenses and accreditations on their websites. However, many choose to do so for several regulatory and market-driven reasons. While the Drugs and Cosmetics Act, 1940, and Good Manufacturing Practices (GMP) guidelines mandate adherence to specific standards, they do not specifically require online publication of licenses. Nevertheless, many companies voluntarily publish this information to build trust, demonstrate compliance, and facilitate international trade. Leading firms like Dr. Reddy’s Laboratories and Cipla exemplify this best practice, enhancing credibility and streamlining audits and inspections. For detailed regulatory information, refer to the official CDSCO website and resources from regulatory consulting firms like CliniExperts.