Will India achieve pharma vision 2020?

The government is committed to making India one of the world's leading destinations for end-to-end drug discovery and innovation by 2020. Although India has achieved the distinction of being the world's No. 1 supplier of low-cost generic medicines, in recent years, a toxic brew of misguided government policy and shortsighted business practices has crippled our efforts to become a drug discovery and innovation powerhouse, even while jeopardising our access to foreign markets due to quality issues ..

2013 has been a year with mixed blessings and some policy decisions taken this year are likely to have farreaching impact on the future of the pharmaceutical industry in India. In March this year, the Intellectual Property Appellate Board upheld the compulsory licence (CL) issued for the manufacture and sale of a generic version of Bayer's Nexavar in India citing affordability and product access as the reasons for the decision. While the grant of a CL is justified in a national emergency, broadening the scope to affordability can result in abuse of this provision and be counterproductive to pharmaceutical innovation in India. CL must remain the exception rather than the rule.

On the upside, after much deliberation, the government ruled in favour of 100% foreign direct investment in the pharmaceutical industry. This is a positive move and will allow India to invest in R&D, enhance local capabilities and find solutions to endemic health problems.

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China halts imports of Pfizer drug on paperwork glitch

China suspended imports of U.S. drugmaker Pfizer Inc's AIDS-related drug Diflucan on Tuesday, citing a problem with late paperwork, the country's food and drug watchdog said in a statement on its website.

Pfizer, the largest drugmaker in the United States, contravened Chinese law when one of its France-based factories failed to submit a supplementary application on time, the China Food and Drug Administration (FDA) said in the statement.

With the country's healthcare spending forecast to nearly triple to $1 trillion by 2020 from $357 billion in 2011, according to consulting firm McKinsey, China is a magnet for makers of medicines and medical equipment.

Pfizer has taken steps to resolve the issue and is working with China's FDA to ensure its products comply with Chinese law, it said in a statement on its Chinese-language website. The issue is not linked to quality or safety, it added.

Some analysts said the incident looked like a paperwork "glitch" and should be short-lived.

"It should not impact too much Pfizer's business in China and I am sure the imports will be resumed once the procedure is complete," said Simon Li, Shanghai-based general manager at Kantar Health China.

China has been cracking down this year on the healthcare sector, with investigations ranging from allegations of corporate bribery to how drugs are priced, as well as drives to increase quality and safety levels across the sector.

Diflucan, which treats fungal infections linked to AIDS, had worldwide sales of $259 million in 2012, according to Pfizer's latest annual financial statement, a small fraction of the firm's $59 billion revenue that year. Pfizer has more than 9,000 employees in China and operates in more than 250 Chinese cities

~Reuters