Challenges To The Indian Drug Industry Subtle, Manifold and More Potent Now, Pharma Lobby Tells Government

MUMBAI - A spate of adverse moves by developed countries and international agencies in the past year have been most challenging for the Indian drug industry, says the Indian Pharmaceutical Alliance - the lobby of top Indian generic drug makers.

"The woes of the industry are further compounded by inadequate appreciation of the challenges and apparent lack of determination witnessed in 1995," IPA said.

In 1995, India had delayed its entry into the World Trade Organization Trade-Related Intellectual Properties Agreement by 10 years in a determined effort to protect public health and the Indian pharmaceutical industry. Finally, TRIPS-compliant product patents were accepted in 2005 after suitable amendment were made to the Indian Patent Law.

In a presentation to the department of pharmaceuticals, the Indian Pharmaceutical Alliance notes, "Today, the challenges are more subtle, manifold and far more potent than in 1995."

Global Patenting Dilutes TRIPS Flexibility

The IPA presentation draws from details of the proposed reforms of the Patent Cooperation Treaty that, many feel, could lead to global patenting. The IPA said the new agenda of the World Intellectual Property Organization seeks to move away from capacity-building programs and thereby alienate India and discredit the Indian mission.

The PCT is being specifically designed as a mechanism for reducing overall workload of patent offices worldwide through the use of international reports either as the basis for grants or at least as the basis for an accelerated examination process.

The proposal made by the U.S. Patent and Trademark Office is said to aim at improving the International Patent System so that it would be readily used and accepted by national offices.

However, the IPA argues that the proposals could dilute the flexibilities of the TRIPS Agreement, prevent developing countries from learning the intricacies of intellectual property rights, render patent laws in developing countries irrelevant and make patent challenge almost impossible.

India had sought China's support to oppose the new reforms that were feared to lead to automatic patenting (Also see "India’s Pitch To Oppose “Automatic Patenting” Gets Louder With Moves To Seek China’s Support" - Scrip, 11 May, 2009.).

IPA Critical Of EU Move To Label Generic As Counterfeit

The IPA also criticized moves of European Union countries that allegedly label Indian drugs as counterfeit and block exports of life-saving drugs to Latin American countries.

Consignments in transit from Indian companies to Latin America, mostly Brazil, have been held up at several EU cities on charges of patent violations. According to EU laws, products that are not patented but routed through the EU could be termed as counterfeit drugs (Also see "India Opposes Seizure Of Drugs By EU Even As Dr. Reddy’s Labs Brings Its Goods Back" - Scrip, 29 Jan, 2009.).

The IPA says the moves of EU countries like Germany and Netherlands to block Indian exports is a "crude manifestation of protectionism" and is violative of the TRIPS agreement. "Apart from creating barriers to accessing medicines, the EU has destroyed India's brand equity," the association wrote.

The Indian commerce minister defended Indian companies recently in Washington alleging that this was a move by EU to discredit the generic drug makers (Also see "Indian Commerce Minister Speaks Strongly Against EU Drug Seizures" - Scrip, 23 Jun, 2009.).

Sharply criticizing the International Federation of Pharmaceutical and Manufacturers Association, the Indian pharma lobby said that the association of Big Pharma is leveraging the frustration of African countries to its own advantage and misleading them to frame laws that treat a generic drug as counterfeit.

For the past few months drug authorities in African countries like Nigeria have been scrutinizing medicines supplied by Indian drug companies after a few drug consignments were found to be counterfeit. As part of a larger brand-building exercise, the Indian government has also stepped up efforts to ensure African drug authorities that all safety and quality measures have been put in place in India to ensure that sub-standard drugs do not reach those countries.

Indian industry associations said that MNCs are deliberately raising the issue of counterfeit drugs to prevent Indian companies from tapping the fast emerging African generic drug market.

India's Ranbaxy has a very large presence in African generics market second only to GSK with an average growth of more than 20 percent annually.

Linking India's regulatory and drug approval process to patents is a strategic use of judiciary by multinational companies, says the IPA, adding that it is intended to delay the entry of generics into the market. The IPA implicated the Indian Drug Regulatory Authority in handling intricacies of patents for drugs like Tarceva (erlotinib) and Glivec (imatinib).

The IPA stayed with its objection to data exclusivity on drugs noting that this would be used for defending "weak patents" by multinational companies.

Vikas Dandekar ([email protected])