India, US seek to better drug-making processes

India, US seek to better drug-making processes

No surprise checks on drug firms as US FAA and its Indian counterpart agree to coordinate in drug making.

Margaret Hamburg
Margaret Hamburg, US FDA commissioner

The US Food and Drug Administration and its Indian counterpart on Monday decided to collaborate on inspection of drug units for good manufacturing practices (GMP) compliance and seamless sharing of regulatory information between them. The move, both sides reckon, will ease tensions between Indian drug companies and the US regulator which have escalated recently.

All alerts/letters due to the company not complying with good manufacturing practices as defined by FDA

This comes even as the US trade representative was slated to announce later in the day a trade enforcement action against India for its disgruntlement over India planning to issue a clutch of “compulsory licences” to local firms sidestepping some patents the US values.

Margaret Hamburg, commissioner of the US FDA, as part of her first, week-long visit to India, inked an agreement with Union health minister Ghulam Nabi Azad under which the two countries will exchange “information relevant to lack of compliance with accepted good manufacturing practices, good clinical practices, or good laboratory practices, as appropriate, by manufacturers and sponsors of medical products”.

Drug companies that have faced adverse regulatory action by the FDA in recent months include Ranbaxy Laboratories, Wockhardt and Strides Acrolab. On January 23, the FDA banned the import of products manufactured by Ranbaxy at its plant at Toansa, the company’s fourth plant to face regulatory action from the FDA, after its Mohali, Paonta Sahib and Dewas plants.


Analysts see the agreement as a sign of the two countries appreciating the mutual benefits of pharmaceutical trade between them — India with its 530 FDA-approved plants is keen to sustain and enhance its exports to the US while the Obama administration’s healthcare plan relies significantly on cheaper generic drugs from countries like India.

India’s pharma exports increased 10% to $14.6 billion during 2012-13, with shipments to the US accounting for about 26% of that. The country’s pharma exports are soon to surpass domestic drug sales in value.

Curiously, USTR Michael Froman was expected to discuss the trade action against India at a news conference in Washington at 2 pm local time (1900 GMT), in what is seen as yet another sign of the mounting US pressure on India to make its patenting regime “more liberal.” India’s patent law has provisions that make it difficult to patent incremental pharmaceutical drugs that don’t satisfactorily improve upon the existing therapies in terms of efficacy. The US is also sore over India not adopting a “data exclusivity” law that could prevent “unfair commercial use” of the information furnished by innovator drug companies with regulators by third parties. Speaking to reporters on Monday, commerce minister Anand Sharma, however, denied any official intimation by the USTR of the reported imminent trade enforcement action.

The FDA commissioner’s India visit comes at a time when several pharma companies in India have come under FDA fire because of alleged serious shortcomings in their production and quality standards.

Hamburg, during her interaction with the health minister, said that “there is huge expectation and dependence of public on the regulator to ensure the quality of what the people consume through drugs and food” without specifying any quality problems. She added that “there should be a common set of standards so that people have quality, safe and efficacious drugs,” emphasising the need for compliance with US GMP standards, which are the considered very strict globally.

Azad, however, defended the quality of drugs exported from India stating that “being affordable should not mean that they are cheap and spurious”. He added that developing countries such as India who have a growing pharma industry should be allowed to grow.

Apart from Ranbaxy, Wockhardt and Strides Acrolab, other Indian firms have also received warning letters regarding manufacturing practices at their units, leading to concerns in some circles that Indian companies are being singled out by the regulator as it supplies low-cost drugs to the developed markets.

As part of the agreement signed on Monday, regulators from both the countries will “inform the respective regulatory authorities before undertaking inspections, so that host-country inspectors may join inspections as observers”.

The 21st commissioner of the FDA, Hamburg also met commerce minister Anand Sharma, later in the day, to discuss collaborative strategies to enhance export of pharmaceutical products, agricultural products, spices and marine products. India is the second largest provider of generic drug products and the eighth largest exporter of food products to the US.

Commerce ministry officials said that Sharma, during his meeting with Hamburg, said that the authority was not giving enough opportunity to Indian pharmaceutical companies to explain themselves before taking action against them for flouting quality norms.


The commerce ministry proposed that it would come up with a paper voicing its concerns with a view to seeking a resolution to the problem at an early date, officials added.

The Financial Express