India, China in focus: US lawmakers write to GAO over fake drug concern

By: |
December 28, 2015 7:03 AM

Questions USFDA's progress in meeting demands

Sun PharmaThe letter comes amid India’s largest drug maker Sun Pharma receiving a warning letter from the US FDA for its manufacturing facility based in Halol, Gujarat.

Raising concern over the “still inadequate oversight with regard to foreign drug plants”, lawmakers in the US have written to the Government Accountability Office (GAO) to assess the US Food and Drug Administration’s (FDA) activities and accomplishments in the areas of foreign drug inspections in wake of counterfeiting and sub-standard manufacturing in India and China.

In a letter to Gene L Dodaro, comptroller general, GAO, Fred Upton, chairman of committee on energy and commerce, raised questions on the FDA’s “actual progress in meeting with the demands of a global pharma supply chain” as “import lines from emerging markets including China and India have grown more rapidly in recent years than lines from developed markets. China is now the world’s largest supplier of active pharmaceutical ingredient (API) and has largest number of foreign, FDA-registered, drug manufacturing establishments, followed by India. In addition to APIs, China and India are now making finished drug products, including sterile injectables. The volume of imported drugs, the growing number of foreign entities producing these drugs and the increasing complexity of the pharma supply chain have all significantly complicated FDA’s ability to provide sufficient oversight.”

The letter comes amid India’s largest drug maker Sun Pharma receiving a warning letter from the US FDA for its manufacturing facility based in Halol, Gujarat. This is amongst the largest site for Sun Pharma from where multiple formulations are sent to the US. The FDA has notified over 20 issues of violations of standard manufacturing norms.


It is expected to mount pressure on India’s pharma industry, already under fire due to alleged lack of good manufacturing practices brought to fore by several FDA inspections in the recent past.

Pointing out that the US import human drugs over $52 billion every year, the chairman said that globalisation had had an impact on the ability of the FDA to ensure the safety and efficacy of drugs entering the US from overseas.

An industry player, on the condition of anonymity said that the letter is an attempt to put a pressure on the Indian industry, which is giving tough competition to the US domestic companies in the area of generic drugs and APIs.

Questioning the achievements of the FDA, the committee has sought to know the implementation of risk-based inspection and the frequency in selecting foreign drug manufacturing facilities for inspection along with the number of surveillance inspections conducted by it on foreign establishments has in the last 5 years. It has also asked for rate of inspections of foreign drug manufacturing establishments compared to domestic drug manufacturing establishments along with the specific accomplishments of FDA’s foreign offices.

“… We remain concerned about the agency’s actual progress in meeting with the demands of a global pharma supply chain. In particular, there is a history over two decades in both India and China of counterfeiting, adulteration, substandard manufacturing and data falsification in drug manufacturing,” the letter said.

It though acknowledged that FDA has already adopted a multi-pronged approach to strengthen its regulatory capacity and has formed a new office — the office of global regulatory operations and policy. It has also enacted the FDA Safety and Innovation Act in 2012 to expand its mandate to improve the security and integrity of the supply chain and take ‘risk-based’ approach in conducting both foreign and domestic inspection.

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