NEW DELHI: The government is apprehensive that the Indian drug companies' strategy of launching generic version of patented drugs could trigger retaliation from overseas countries that may hit the country's ambitious drug export plans.
"If MNCs patents are not protected, then their governments can also put up non-tariff barriers to restrict entry of Indian drugs," a government official, familiar with the development said.
India exported medicines worth $13.2 billion last fiscal and the government plans to double it to $25 billion by March 2014. "We are concerned that our exports will be targeted," he said, adding that hurdles could be inmany forms such as increasing cost or registration or delaying registration.
Local companies led by Cipla and Natco Pharma are aggressively challenging patents of MNCs and have launched generic version of patented drugs such as Swiss company Roche's Tarceva, Germany's Bayer AG Nexavar and US-based BMS's Sprycel.
Though the patent holders have sued them for alleged infringement of patents, Indian courts have allowed the local companies to sell their drug during pendency of the final verdict, in public interest. However, if the Indian companies are found guilty of violating the patents, then they will have to pay penalties to the original drug maker.
In May, Hyderabad-based Natco Pharma also bagged the country's first compulsory license to legally make and sell its low-cost version of Bayer AG's patented cancer drug Nexavar, raising concerns among MNCs. US-based Merck, Pfizer Inc and GSK have also received demands from local firms to waive off patent rights of its drugs, failing which the Indian companies can seek a compulsory license.
One such move seen as a non-tariff barrier is the European Commission directive to make it mandatory from July next year for all active pharmaceutical ingredients exported from India to be certified by the country's s drug controller for EU equivalence certificate. There are concerns that India does not have the manpower or resources to comply with this norm which may affect exports to the region worth about $2 billion.
But the government body responsible for promoting exports hopes that such hurdles are not put up. "We should not have problem because we are exporting off-patented quality generic drugs," Pharmaceutical Export Council of India (Pharmexcil), Director General P V Appaji said.
India adopted a new patent regime which provides 20 years marketing exclusivity of the patent holder. But, there has been a fierce debate about its implementation in the country with several MNCs and government alleging lapses in protection of intellectual property rights.
Indian Pharmaceutical Alliance (IPA) the lobby body of big Indian companies said foreign countries been raising hurdles for the last five years and it was wrong to relate any retaliatory action to the recent developments. Several countries in Europe had seized drugs on Indian companies in transit since the drugs are saying that the drugs violated patents companies.
"How can one conclude that Natco's challenge (of BMS's sprucel last week) is wrong when the matter is subjudice? Enforcement and protection of patents is the court's duty and not that of the government," IPA's secretary general of D G Shah.
On the other hand, the lobby body of MNCs in India Organisation of Pharmaceutical Producers of India (OPPI) said that each country will protect the business interest of its domestic industries. Indian government also raised similar concerns on many subjects related or otherwise, with the respective foreign governments (seizure of drugs in European ports) to protect business interest of Indian industries recently..
"That said, it appears rather impractical to envisage that routine grant of CL by the Indian Patent Office or allowing violations of patents will be able to resolve the critical issue of access to patented medicines on a long term basis," OPPI Director General Tapan Ray said, adding that CL should be used after exhausting all other access improvement measures.
India is also expected to announce a patented drug pricing which has made global companies more jittery.
Source : economictimes.indiatimes.com