Indian pharmaceutical companies are among the leading suppliers of generic medicine to the United States. After setting up the most USFDA-approved plants, they have had some quality-related issues in recent years. Ever since USFDA opened its India office, Indian companies are no longer forewarned of the arrival of the inspection team, just like in the US.

The Indian Pharmaceutical Alliance through its quality cell has prepared a comprehensive folder on the most common issue related to Form 483—that indicate a potential violation of the FDA’s good manufacturing practices (GMP) requirements. Recently, Lupin was given seven observations after a six-day visit.

At one time Indian pharmaceutical companies had the most USFDA approved plants. Since they are among the largest suppliers of API, they also seem to get the largest number of 483. What has changed?

The problems encountered by FDA’s investigators in India are similar to those around the world. This includes inadequate or poor quality systems implementation, data integrity issues, inadequate validation of various processes used in manufacturing or testing, and product contamination. While some Indian companies meet U.S. product quality standards, others do encounter problems and operational challenges.

Are the regulations not familiar or are they changing and compliance officers are unable to keep pace with change in regulations?

The FDA finished dosage form GMP regulations remain very similar to that published in 1978, with occasional modifications over the years. The regulations have changed slowly, and this is not a factor influencing non-compliance. Indian regulators have become important strategic partners for the FDA. Our staff in India regularly engage with government counterparts and industry to share information about new guidelines, best practices or changes in regulations, so that industry representatives can take steps to bring their facilities or companies into compliance. By participating in product association meetings and conferences in India, our staff are able to disseminate information to many industry representatives simultaneously.

Aren't companies aware of regulations as they are being updated?

The FDA publishes all proposed and final regulations and major guidance documents for industry in the Federal Register. When proposed rules are issued, there is an opportunity for public comment prior to the rule being finalised. The FDA website contains links to the good manufacturing regulations, all guidance documents, and various resources to help drug companies comply with the law.

The FDA also conducts outreach in India through presentations in meetings and conferences, to discuss and explain the GMP requirements, the latest policies, and the agency’s expectations.

Given the sentiments of various policy makers, how much do regulations have to be in keeping with lobbying regarding patient health?

In a globalised world, with so many products originating outside the United States, and with increasingly complex supply chains, industry has the responsibility to ensure quality of their product and integrity of their supply chains. We believe information sharing, knowledge of best practices and changing regulations is a significant enabler to meeting our roles.

How does FDA assist companies upgrade manufacturing systems to meet its standards?

The FDA India Office has allowed us to collaborate more effectively with Indian regulatory counterparts and enables us to leverage our combined resources, ensure standards consistency and increase regulatory capacity, which includes information sharing, exchange programmes and specialty training. Through our India Office, the FDA also works to ensure Indian manufacturers shipping to the United States understand the risks associated with their product's processes and they remain compliant with FDA regulations.

Why do manufacturing units get observations and then warning letters?

We conduct inspections and assessments of regulated facilities to determine a firm's compliance with applicable laws and regulations, such as the Food, Drug, and Cosmetic Act and related Acts.

When FDA finds a manufacturer has significantly violated the regulations, we notify the manufacturer. This is often in the form of a warning letter. It identifies the violation—such as poor manufacturing practices, problems with claims for what a product can do, or incorrect directions for use. The letter also makes clear that the company must correct the problem and provides directions and a timeframe to inform FDA of its plans for correction. FDA then checks to ensure that the company’s corrections are adequate.

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