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.
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 p.m. 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