India plans ban on branded generics
pharmafile | October 18, 2012 | News story | Manufacturing and Production, Sales and Marketing | India, generics
India is moving ahead with plans to ban the sale of branded generics in the country, adding to marketplace concerns by western pharma firms.
The Economic Times of India reports that a 1 October 2012 order by the Indian health ministry instructs that Indian states should not licence drugs for manufacture and sale on the basis of their brand name.
Instead the health ministry has requested that all state health secretaries only issue licences for generic rather than branded or trade names. The proposals are drawing heavy fire from some of the country’s drugmakers.
The story highlights an upcoming Extraordinary General Meeting (EGM) by the Gujarat chapter of the Indian Drug Manufacturers Association (IDMA), to discuss the fallout of the government’s actions and to examine proposals to obtain a stay order on such actions.
Chirag Doshi, chairman of the IDMA‘s Gujarat chapter, told the Economic Times that the aim of the EGM, held in Ahmedabad, Gujerat, is to discuss the issues drugmakers would face if branded drug sales are stopped.
“The Centre should have spoken to the stakeholders before arriving at such a decision,” Doshi said.
Stakes are high, given that Gujerat boasts 41 of India’s 160 FDA-approved plants. In addition, the state’s pharma industry generates 40% of national turnover and a significant share of pharmaceutical exports.
Corporate representatives and presidents of eight drug associations in Banashkantha, Surendranagar, Navsari, Bhavnagar, and Vadodara have also been invited to attend the EGM.
According to Ketan Patel, chairman and managing director of Troikaa Pharmaceuticals, the proposed move is detrimental to the future of Indian pharma industry. “Brands carry a quality assurance for doctors and patients,” Patel told the publication.
“If the Drug Controller of India goes ahead with its plan to have only generic drugs in India, it will sound the death knell of the industry. The market than will be dominated by middlemen, who already enjoy very high margins of over 35 per cent,” added Vivek Hattangadi, chief executive of The Enablers, a pharma consultancy firm.
The Economic Times also quoted an anonymous drug company executive, who said that the Indian drug regulatory does not have the means to test the impurity issue in drugs.
Susie Lunt
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