India to thwart attempt by MNCs to get generics tagged spurious by WHO

NEW DELHI: With multinational pharmaceutical companies approaching the World Health Organisation (WHO) once again to formulate guidelines which would put generic versions of patented drugs in the same bracket as unsafe and ineffective drugs, India has geared up to protect its generic (off-patent drugs) industry. In a WHO meeting scheduled later in the week, the country is prepared to thwart the MNCs’ attempts to get the organisation make definitions of counterfeits and spurious drugs interchangeable, a commerce department official has said.

India believes that the difference is crucial as counterfeits are actually high quality drugs manufactured by producers other than the patent holder while a spurious drug is a low quality drug which may be harmful for health.

Moreover, while a drug considered as counterfeit in one country where the patent for it is held by an individual or a company, may not be a counterfeit in another country where it is off-patent, a spurious drug is harmful under any circumstances.

The departments of commerce, chemical & petrochemicals and the ministry of health have joined hands to protect the reputation of India’s generic producers at the international forum. “We are all together in our mission to protect our generic industry which supplies low-cost life saving medicines to poor countries,” commerce additional secretary D K Mittal told ET.  

The MNCs had approached WHO last year too to make changes in its definition for counterfeit medicines but had failed in its attempts. With $80-billion of pharmaceuticals produced by a number of MNCs like Pfizer and Aventis to go off patent next year, they have become restless and want to disrupt the generics industry, another government official, who did not want to be named, said.

“The MNCs have become desperate. Not only are they trying to influence African countries against buying generics produced by India by feeding them false information, they are also trying to influence international law making,” the official said.
 
India exports about Rs 30,000 crore of generics every year of which about 15% goes to African countries. Kenya and Tanzania have recently passed anti-counterfeit legislations which could hamper exports of Indian generics if not implemented carefully. India has started holding diplomatic consultations with most of its African buyers stressing on the need for them to distinguish between counterfeits and spurious drugs.

The country is also keeping a watch on the operations of MNC drug companies functioning in India. “As a country, we will closely scrutinise the operations of the Indian arms of the MNCs which are lobbying to get the law passed at the WHO. We will examine their financing, their equity structure, technical operations and also their exports,” Mr Mittal said.

The WHO meeting, scheduled on May 16, will be attended by all countries and India is expecting support from countries like Brazil which had, on other occasions, joined forces with it to fight MNC pharmaceutical companies.