'World's pharmacy' reaches a crossroads as Indian generic drugs face rising competition, tougher regulation

By Bai Yunyi Source:Global Times Published: 2018/7/17 17:43:40

Despite history of success, India’s controversial generic drugs face unpredictable future amid rising competition, tightened policy

Guests visit a pharmaceutical exhibition held in Mumbai, India in December 2017. Photo: Courtesy of Zou Lan

India has long been known for its leading pharmaceutical industry, despite the country's relatively low overall development level. However, the industry has been promoted under a controversial policy that violates international drug patent rights, leaving it with an uncertain future, especially amid wider global criticism. Meanwhile, competition from neighboring countries and tightened regulation are also posing threats to the country's leading position in the generic drugs sector.

Roy, a Chinese national who is currently conducting foreign trade in Chennai, India, was asked by one of his friends to buy drugs for his father who had just been diagnosed with cancer.

"People who live or work in India commonly have the experience of buying drugs for friends and family back home, there's no exception," Roy told the Global Times over the weekend.

India has long been known for its cheap generic drugs, with almost the same quality and effects as the originals. Thus for people selling Indian drugs in China, it has now developed into a profitable business, driven by the desire to make money and the innate need to care for relatives and friends.

Recently, China's black comedy-drama film Dying to Survive brought the country's generic drugs into the public's spotlight, setting off a nationwide debate in China about imports of cheap Indian generic drugs and the big generic drugs industry.

The film follows a drug purchaser named Cheng Yong, who has been regarded as a hero in part for importing less expensive generic anticancer drugs from India to the Chinese mainland, particularly for patients suffering from chronic myeloid leukemia who can't afford the exorbitant licensed drug produced by Swiss pharmaceutical giant Novartis.

India's pharmaceutical industry has no doubt grabbed the leading place worldwide; it is currently the largest provider of generic drugs globally, accounting for 20 percent of global generic drug exports in terms of volume, according to a report published on the website of the India Brand Equity Foundation, a trust established by the Indian government.

"The country has proven to be the 'world's pharmacy,'" Yang Chen, founder of overseas medical service company Medembassy, who has been living and working in India for many years, told the Global Times.

According to Yang, apart from a comprehensive range of medicine - from everyday drugs used for colds and fevers to specific ones for serious diseases such as anticancer drugs - Indian drugs are generally of good quality. This is especially evident when considering India is the country that has had the most drugs approved by the US Food and Drug Administration (FDA) outside of the US, with more than 100 types getting FDA approval already.

"It is not easy to achieve that, especially for a developing country like India," Yang said.

As such, many Chinese doctors have been recommending to their patients, those who are faced with tremendous health and economic pressures, to buy cheap generic drugs from the country, Roy said.

"And if the volume of drugs they bring back to the country is 'not that much,' customs of the two countries just turn a blind eye," he said.

Successful but controversial

Zou Lan, an industry insider who has been working at India's Hyderabad Pharmaceutical Center  for many years, told the Global Times that the most significant reason behind the successful development of India's generic drugs is the government's policies on the industry as well as on pharmaceutical enterprises.

"Generic drugs in India are not subject to a patent protection period, thus enjoying an advantage in the earlier development stage and making the industry stronger," Zou said.

"You may find a cheaper generic substitute in India just several months after the launch of expensive, original drugs produced by pharmaceutical companies based in Western countries," Yang said, stressing, however, that the move is surely a violation of intellectual property rights of the latter.

In April 2014, India was listed as the country with the worst compliance record when it comes to intellectual property protection, as noted in an annual review report issued by the Office of the US Trade Representative.

"For those Western pharmaceutical companies that own the drug's patent rights, developing a new drug could cost billions of US dollars and take hundreds of thousands of experiments. But cheaper generic drugs, for which the production cost is much lower, of course grab the original drug's market shares," Yang told the Global Times.

"But what if all drug producers began refusing to develop new drugs due to losing benefits? What would those desperate patients do then?" Yang asked.

Industry insiders noted that the "legend" of India's success could also be attributed to its language advantage - English is one of India's official languages - and rates of high-level university education, helping the country's international sales channels.

In fact, the South Asian country is the largest exporter of generic drugs to developed economies such as the US and European countries.

"India has quite a distinguished university education quality compared with other developing countries, nurturing a large number of competitive medical talent that Chinese drug companies have long been hunting for," Zou said.

"Many purchasing managers of Indian pharmaceutical companies are not only good at procurement, but also familiar with related professional medical knowledge in both technology and production areas. We can always learn a lot from them when they come to China for exchanges," she remarked.

Obscure future, regulation changes

Despite its great success, industry analysts have noted that many problems still lie in India's big pharmaceutical industry.

Yang noted that although most generic drugs produced by large-scale pharma companies are reliable in India, there are in fact many small workshops that produce fake drugs as a result of the government's loose regulation.

"You can't even begin to imagine how loose the country's drug supervision is. There are almost no inspections, or random inspections only in [big] pharmaceutical companies. Even if some Indian medicine companies are exposed for quality problems in the US, you barely see them being punished back in India," Yang said.

However, under immense pressure from global criticism for its poor record on drug patent rights protection, India has subsequently revised its patent laws several times over the past 20 years while tightening its domestic generic drugs policy. 

In early 2015, as requested by the  European Commission, the sales of 700 types of generic drugs in India were suspended.

Apart from the pressure from the international community, some Asian counterparts such as Laos, Thailand and Bangladesh have been posing harsh competition in recent years, threatening India's leading position worldwide.

"Actually, there are already signs indicating that Bangladesh might overtake the generic drugs industry of India in the future," Yang said.

Now, the 'world's pharmacy' has reached a crossroads.

Newspaper headline: ‘World’s pharmacy’ in trouble?


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