The U.S. Food and Drug Administration (FDA) is set to strengthen its regulatory oversight in India even as many of the local manufacturers continue to grapple with the enforcing quality norms.

The agency recently announced its decision to increase the number of inspectors from nine to 19. Officials from FDA India office said the agency might require even more inspectors to ensure that the ethics committees have the capacity to review the protocols submitted by CROs for accrediting clinical trial sites.

The rise in the number of inspectors is in response to the high rate of filings seeking marketing approvals by Indian firms. Site inspections are part of the review process officials said, while parrying questions that FDA is targeting Indian drug makers.

If there is a perception that the FDA is using a different yardstick while inspecting Indian firms, it is incorrect, stated Howard Sklamberg, U.S. FDA Deputy Commissioner for Global Regulatory Operations and Policy, during his visit to India in March.

India has a larger number of manufacturers looking to market their products in the U.S. than any other region. “The number of entry lines into the U.S. since 2010 has increased by 65%, which is a staggering percentage,” said Mr. Sklamberg.

To ensure compliance with FDA mandated GMP standards, the agency will continue to use enforcement tools when necessary. At the same time, FDA is not planning to waste its resources inspecting firms with good track records of maintaining quality standards, but incentivize them instead.

Carrot & Stick
The U.S. regulators move to incentivize better compliance to quality practices has been well appreciated in the industry as the approach could encourage players committed to quality.

Indian companies, which claim a sizeable share in the U.S. generic market, also have received the highest number of Form 483s—documents listing observations/concerns by the agency during inspections—and other warning letters from the FDA. Leading generic players from India have been repeatedly written up for deviating from the specifications in the agency’s rulebook governing quality standards for pharma products. The listed deviations ranged from elementary to serious violations such as manipulation of data.

Offering its readiness to assist, the FDA began working closely with the Indian drug regulator last year following the visit of the then FDA Commissioner Margaret Hamburg. The agency began the practice of inviting India’s own drug inspectors to join the FDA team while carrying out inspections so that they can understand clearly what the FDA expects of manufacturers.

As part of the training program, the FDA India Office held four workshops in India last year in association with the U.S. Center for Drug Evaluation and Research’s Office of Compliance and the Office of Regulatory Affairs.

In order to make training of personnel more consistent, the regulatory authority in the state of Gujarat is using the services of a third party. Underwriters Laboratories (UL), a U.S.-based independent safety science company, has signed an agreement with the Gujarat Food and Drug Control Authority (FDCA) to train its inspectors.

Lax Attitude?
In an online training platform, UL will use specially designed programs to impart FDCA investigators with the same knowledge that is currently accessible to USFDA investigators, according to UL’s regional officials.

The Indian state of Gujarat, which is spearheading the initiative, is a well-established manufacturing base for APIs and formulations. Several more Indian states with pharmaceutical interests are expected to implement this training model.

With regulators taking a proactive approach, criticism is now mounting against those manufacturers who are slack in utilizing their internal resources to ensure total compliance. These companies neither rely on their capability to resolve data integrity issues nor do they seek expertise from external consultants. One firm is even apprehensive that the FDA is continuously raising the bar and that they are being singled out.

Others do not favor this view. Refuting the witch-hunt theory, they re-emphasize that quality standards can only go up in the future. Issuing of Form 483s are becoming quite rampant, not just in India but across the world, Kiran Mazumdar-Shaw, CMD of Biocon Ltd., pointed out in a recent report.

“This is something that Indian companies have to invest and spend much more in terms of their quality systems than they have in the past,” said the chairperson of India’s largest biopharmaceutical company.