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Pharmexcil to hold capacity building programmes on quality, regulatory expectations, etc with focus on MSMEs

Shardul Nautiyal, Mumbai
Monday, September 18, 2023, 08:00 Hrs  [IST]

The Pharmaceuticals Export Promotion Council of India (Pharmexcil) will soon roll out capacity building programmes on quality, compliance, patient safety, best industry practices and regulatory expectations in different states having strong manufacturing base with focus on the Micro, Small and Medium Enterprises (MSMEs). The first one in the series of capacity building programmes was held recently in Ahmedabad.

These programmes will be targeted towards professionals involved in the manufacturing and regulation of pharmaceutical products and their excipients in the form of in-person conferences or workshops in various regions across different states.

Proposed locations are Ahmedabad, Hyderabad, Chandigarh, Indore, Chennai, Bengaluru, Mumbai, Sikkim, Visakhapatnam and Goa.

According to Uday Bhaskar, director general (DG), Pharmexcil, “Indian pharma units, especially, the MSMEs are facing new challenges under resource-poor settings to meet global as well as domestic health care regulatory expectations. With the recent World Health Organisation (WHO) medical alerts and reporting of cases involving fatalities due to supply of contaminated medications by some Indian companies have tarnished the image of the Indian pharmaceutical industry. This has happened due to non-compliance with the good manufacturing practices (GMP) and product quality norms by these units.”

Bhaskar further informed that these capacity building programmes, which will be rolled out pan-India will benefit pharmaceutical manufacturing companies and their staff, including production managers, quality assurance managers, regulatory affairs managers, raw material suppliers, API and excipients manufacturers, contract manufacturers, testing labs, Central Drugs Standard Control Organisation (CDSCO) and State Food and Drug Administration (FDA) officers, scientists from Drug Testing laboratories of CDSCO, Regional Drugs Testing Labs (RDTL), and state FDA laboratories.

Key speakers in these programs would include resource persons from the CDSCO, industry experts and consultants who have vast experience in dealing with highly regulated and semi regulated markets.

“The conference will consist of a series of presentations covering the following topics like Significance of Quality by Design Concept, Importance of Excipient Testing in Pharma Manufacturing, Key Global Excipient Regulations for Generic Drug Development, Good Analytical Practices for detecting Di-Ethylene Glycol (DEG) limits in finished drug products, Market Control and Surveillance of Excipients and Regulatory Challenges and Expectations: Risk Assessment, Confirmatory Testing and Control Strategy for all products, GMP and Good Lab Practices (GLP) Compliance,” Bhaskar informed.

Maintaining the quality of pharmaceutical products is crucial to guaranteeing the patient's safety, which could have long-term ramifications for the global public's confidence on Made in India medicines.

Therefore, these programmes are aimed to create awareness on the importance of manufacture and supply of quality and efficacious medicines to the world. The objectives also include fostering public health awareness among pharmaceutical manufacturers and contract manufacturers regarding the potential public health burden posed by Di-ethylene Glycol (DEG) contamination in glycerine. This will also help to identify and discuss the manufacturing challenges that lead to DEG contamination in pharmaceutical products and their excipients.

Other objectives include reviewing the regulatory perspectives on DEG contamination and discussing the current regulations in place to prevent it and to facilitate knowledge sharing and networking among the stakeholders.


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