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USP’s public standard-setting process is very rigorous

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USP, through its various programmes and public quality standards, helps the pharma industry ensure confidence in the quality of their ingredients and products throughout development and production. Dr Koduru V Surendra Nath, Senior Vice President, Global Sites, USP reveals more about USP’s role in the pharma sector and the issues challenging the industry in an interaction with Express Pharma

What is the recent trend in new pharma facilities registering with the FDA in India in the past two years? Have the numbers increased or decreased?

It should be noted that USP, as an independent non-profit standards-setting organisation, is not part of US-FDA or the US government and cannot speak on behalf of the US FDA.

With regard to the facilities registered with US-FDA, the information is available online via the FDA’s Drug Establishments Current Registration Site: https://www.fda.gov/drugs/drug-approvals-and-databases/drug-establishments-current-registration-site.

However, we note data from Pharmaceutical Exports Council of India (Pharmexcil) and Indian Brand Equity Forum (IBEF), indicating the domestic sales of pharmaceutical products increased in FY18 and FY19 by approximately 10 per cent both years (2) and exports of pharma products globally also increased by 10 per cent in FY19 (2). This is indicative of the growth of the Indian pharma industry. USP, through its various programmes and public quality standards, supports this growth by helping the industry ensure confidence in the quality of their ingredients and products throughout development and production.

Some of these programmes and offerings include:

  • Pharmacopeial standards (physical and documentary) to help ensure that drug substances and products produced are of high quality
  • Training courses for capability building
  • Capacity building through GMP audits and ingredient verification programmes
  • Value-added services such its recently launched Impurities program to support the regulatory requirement of impurities outside of USP’s catalogue of physical standards
  • Collaborative efforts with state authorities to strengthen public procurement of drugs in India
  • Thought leadership and efforts to bring together stakeholders to combat anti-microbial resistance

USP collaborates with the central and state regulatory agencies in India, industry associations such as Indian Pharmaceutical Alliance (IPA), Indian Drug Manufacturers Association (IDMA), and policy think tanks like Access Health to help ensure the quality, safety and benefit of medicines.

USP brings 200 years of experience building trust in the world’s medicines, dietary supplements and foods to the effort. Through our commitment to rigorous science, USP creates quality standards that build trust in the world’s medicine. Trust is an essential ingredient that gives patients, physicians, pharmacists and regulators confidence in the medicines that improve and save lives.

What are your views on the increasing number of warning letters issued to Indian pharmaceutical companies in recent years?

USP has a history of supporting medicine quality around the world, partnering with the United States Agency for International Development (USAID) and other global health donors and governments in low- and middle-income countries to build capacity and strengthen regulatory systems.

As mentioned above, the Indian pharma industry is growing. However, at the same time, there have been cases of non-compliance with regulatory requirements, some of which have led to warning letters. Warning letters are available on US-FDA’s website at https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/compliance-actions-and-activities/warning-letters.

While the overall number of FDA warning letters to global pharma manufacturers has not significantly increased in recent years, the number of cited violations related to basic cGMP quality issues has sharply increased. For example, a recent USP analysis revealed that from 2017 to 2019, FDA’s Center for Drug Evaluation and Research (CDER) issued 58 warning letters citing lack of adequate excipient testing to pharma firms in the US and 15 other countries, including two letters issued in India. This compares to three warning letters citing these issues globally in the four years from 2013 to 2016.

So, while during this time period, facilities in India did not receive as many warning letters as other countries, we live in a time of rapid supply chain globalisation, where one country’s introduction of substandard or falsified ingredients can have an impact across borders and cost undue harm or lives lost. It is notable that 483s, warning letters, quality issues, import alerts, and related events cannot be confined to just one country.

The increased regulatory focus on basic quality issues should serve as a call to action for Indian pharma manufacturers that regular quality testing should not be ignored. With increasingly globalised supply chains, quality issues evidenced by warning letters and import alerts are seen in all regions of the world. While required from a regulatory enforcement focus, ensuring the identity and quality of every ingredient released for manufacture is critical as an industry best practice to safeguard the health of patients both in and out of India.

Documentary and physical standards for active pharmaceutical ingredients (APIs), excipients and impurities can be used in the development and manufacturing quality systems to confidently characterise ingredients and products. Over 800 global science and health professionals volunteer their time and expertise to develop standards. USP’s public standard-setting process is very rigorous and is based on strong collaboration with stakeholders – both in India and globally.

Detailed information on USP’s standard-setting process is available at https://www.usp.org/chemical-medicines/how-reference-standards-and-monographs-developed

Additionally, USP’s ingredient verification programmes for excipients and APIs can serve as a means of supplier qualification, reducing the need for supplier audits and the risk of inconsistent and substandard ingredient quality. The ingredient-level evaluations included in these programmes include a GMP audit, ingredient testing, manufacturing documentation review, ongoing monitoring, and surveillance.

USP has also developed tools in consultation with stakeholders to help achieve regulatory compliance and improve global public health. These tools will help the industry develop capabilities to have world-class quality systems that ultimately drive the quality of medicines globally. For example, last year, USP launched a capability-building initiative to help strengthen the industry’s effort to create a multilevel culture of quality. The initiative has training courses that are specifically developed to train across levels of experience starting from new professionals up to CXO, and divisions including R&D QC, QA and RA. Topics include change control management, audits, handling product investigations, cleaning validations, setting of specifications and data integrity. These training also complement USP’s ever-expanding global catalogue of courses related to its documentary standards. Over time, USP will expand the breadth of its training to cover the entire pharma supply chain.

How are Indian companies impacted by FDA warning letters?

Failure to comply with remedial actions in US FDA warning letters can result in a variety of outcomes, including seizure or injunction, without further notice.

While all USP initiatives are geared to strengthen capability, capacity and achieve higher standards in their own ways, USP’s ingredient verification programmes can help manufacturers of pharma components proactively address regulatory compliance through quality assurance for manufacturers of pharma components. The ingredient-level evaluations included in these programmes include a GMP audit, ingredient testing, manufacturing documentation review, ongoing monitoring, and surveillance. Use of USP verified components by drug manufactures may help reduce the risk of reliance on supplier information and may help satisfy US regulations regarding periodic validation of supplier data.

What is the number of drug inspections carried out in Indian pharma manufacturing facilities in the present year and have you observed any trends?

The US FDA maintains public information on a number of investigations done in different regions. This information can be accessed at https://www.fda.gov/inspection-classification-database and https://datadashboard.fda.gov/ora/cd/inspections.htm. Please note that the US-FDA alerts that some inspection data may be not be posted until final enforcement action is taken. This database does not represent a comprehensive listing of all conducted inspections and should not be used as a source to compile official data. 

However, trends in US-FDA enforcement actions outside of the US can often be as dependent on FDA resource availability as on issues with manufacturers in that country, so it is difficult to draw conclusions based on the volume of regional actions alone. (3)

Can you shed some light on the recent cases of drug recall in India and the number of cases involved with it?

Information on drug recalls is publicly available on the US FDA website. The link below lists and describes drug recalls by date and company name: https://www.fda.gov/drugs/drug-safety-and-availability/drug-recalls.

For USP, safeguarding the pharma supply chain is a global issue, in which India plays a key role. Drug recalls not only create a dent in the growth of the industry in India but also impact the availability of medicines globally.

Many of the programmes we’ve described previously, may help prevent drug recalls when such recalls are due to failures of the quality management system, compliance with good manufacturing practices, and use of pharmacopeial standards.

References

1. https://www.expresspharma.in/latest-updates/indian-pharma-exports-may-touch-22-billion-in-fy20-pharmexcil/

2. https://www.ibef.org/download/Pharmaceuticals-July-2019.pdf

  1. https://www.raps.org/news-and-articles/news-articles/2019/12/foreign-drug-inspections-decline-as-fda-hiring-str

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