USP Panel Recommends Quality Upgrade for India's Biopharmaceutical Industry

The expiration of biologics patents has created opportunity for new biopharmaceutical industry to step in with biosimilars. Although this opportunity is recognized in India, the country needs to develop top-down quality to improve standards and procedures, according to a panel of international experts.

“With this changing landscape, industry must evaluate the relevance of quality management systems,” the group wrote about the direction India must go to become a world-class player in biosimilars and biologics in general.

The recently published report was the result of a meeting last year of representatives from United States Pharmacopeia, the Association of Biotechnology Led Enterprises, the FDA, and the World Health Organization. India has standout companies that are competing on the world stage with their medicinal products, including biosimilars, but it is dogged by concerns that there is substantial room for improvement in its pharmaceutical industry overall.

Building a "Culture of Quality"

The group recommended that a “culture of quality” be developed starting in the educational system with training programs on quality processes and a “focus on quality beyond compliance.”

“The curriculum in universities should include knowledge of quality management processes in the biopharmaceutical industry to inculcate [a] quality mindset very early into the students,” the report said.

Further, it recommended that heavier reliance be placed on automation and digitization to ensure accuracy, measurability, and appropriate record keeping.

The recommendations included an emphasis on pharmacovigilance partly because biosimilars undergo fewer clinical trials than originator products and follow-up data are crucial to understand these products.

“Biologics are complex molecules and manufacturing them requires changes at various stages of the manufacturing process,” the report said. “Manufacturers are required to perform rigorous risk assessments through analytical comparability studies for all product quality attributes to demonstrate that there is no impact on quality, safety, and efficacy of the biologics, before or after changes in manufacturing process.”

To accomplish these assessments, it’s necessary to have a comprehensive understanding of the biological product and its development from a “quality by design” perspective, the panel said.

Further, “to develop the necessary culture of quality, manufacturers must first establish robust and rugged control processes,” the report said.

Guidelines for biologic similarity in India were first published in 2012 and then revised in 2016.

The panel said typical red flags during quality inspections worldwide include:

• Absence of written procedures or procedures not followed correctly
• Lack of scientific controls
• Failure to investigate discrepancies and failures
• Lack of cleaning, sanitizing and maintenance
• Absence of control procedures to monitor and validate performance
• Lack of calibration and inspections
• Lack of computer control of master records

Quality, the panel said, starts with ensuring that all involved understand their responsibility for developing and maintaining quality and protecting patient safety, “and this must be instilled from top management.” It said building a culture of quality could be done with:

• Training on quality systems
• Discussing how to enhance scientific knowledge
• Forming partnerships with regulatory agencies and consultants
• Monitoring quality practices

The group specifically recommended that India enhance its focus on automation and digitization, enforcement of regulatory requirements, postmarketing surveillance, and regulator training. Developing a culture of quality could be done by stimulating effective communication and decision making, assigning clear responsibilities, establishing safety protocols, and building trust and respect among staff.

“Defining and ensuring trust and respect among staff is essential to create and maintain a culture of quality. Trusted employees will contribute more, bring more productivity, and will be honest in their actions,” the report said.

India has also been challenged to upgrade its regulatory processes to meet world standards and enable its drugs to be more accepted in world markets.

Reference

Uppal A, Koduri CK, Yadlapalli S, Chirmule N, Chakrabarti R, Atouf F. Recommendations for enhancing quality and capability of Indian biopharmaceutical industry: summary of a workshop. J Pharm Sci. Published online July 21, 2020. doi:10.1016/j.xphs.2020.07.014