Where Are The Opportunities For Chinese Generic Drugs In India Pharmaceutical Companies?

It's not wolf. There's a tiger behind the wolf.

China is a large country of generic drugs. More than 95% of the drugs are generic drugs, with varying quality and few exports to overseas countries.

In February 2012, the State Council issued the "12th Five-Year plan" for national drug safety. It clearly mentioned that there is a big gap between the quality of some generic drugs and the international advanced level. According to the plan, the generic drugs approved before the implementation of the drug registration and management regulations revised in 2007 (according to CDE data, 95% of China's existing 18.9 million licenses for drug marketing is distributed before 2007, and the products of Zheng Xiaoyu era).

The consistency evaluation of generic drugs refers to the quality consistency evaluation of generic drugs approved and listed in batches according to the principle of quality and curative effect of the original research products. The consistency of the approved generic drugs is a history lesson.

At the end of November 2012, the former Office of national food and Drug Administration established the office of quality consistency evaluation of generic drugs and launched the evaluation work. Since then, the former State Food and drug administration has started to promote the quality consistency evaluation of generic drugs, and has chosen 75 pilot varieties in two batches for consistency evaluation.

But there was a cry of wolves.

Generic companies are still making money, and many companies are losing their safe generic drugs into medicine and then converting them into profits in the gold sales mode, and some companies are also enjoying the approval of scalping. Some local governments even shouted slogans "want to build rich pharmaceutical factories".

By 2015, the new administration of the State Food and drug administration took office and the Chinese Drug Administration entered a new era. The former State Food and drug administration has introduced a series of reform policies, one of which focuses on the overall implementation of the generic drug consistency evaluation. In November 2015, it also issued the "opinions on the evaluation of the quality and efficacy of generic drugs (Draft)", and most of the generic drug companies continued to wait and see.

In March 5, 2016, the general office of the State Council issued the "opinions on the evaluation of the consistency of quality and efficacy of generic drugs". All the generic drugs approved before October 1, 2007 and listed in the list of national essential medicines must be completed before the end of 2018. In March 18, 2016, the former State Food and Drug Administration announced three technical guidelines for selection of reference preparations, dissolution curve determination and bioequivalence study.

This time, the generic drug companies really discovered that the wolf was still there. Some people were gambling. The conformance evaluation will not die. But they bet on the wrong. Even after the new management change of the State Food and drug administration, the policy is continuing. Moreover, the follow-up countries have launched a series of group boxing, putting forward rational drug use and eliminating the "magic medicine". The subsequent 4+7 purchasing has directly strengthened the country's determination to need high quality generic drugs.

On the basis of consistency evaluation, Zhengda Tian Qing, Cologne pharmaceutical and Qilu pharmaceutical enterprises have gained a lot in 4+7 purchasing.

For example, as the first Concord pharmaceutical company in the same field and the first conformance evaluation product in the same field, the company has rapidly covered more than 200 tier three hospitals in 11 key cities after the successful bid of 4+7, which has promoted the overall sales growth significantly. The sales volume in the first half of this year has increased by 97.14% over the same period last year. Meanwhile, with the further promotion of the successful results of the linkage 4+7 in Fujian and Hebei provinces, the market share of the company will be further improved.

On the hand, there are also a large number of shares of Harbin medicine, and they began to put in the consistency evaluation very early, but they were not serious.

At the moment, the price of a generic generic consistency evaluation is around 8 million -1000. Under the background of the pharmaceutical policy, the generic pharmaceutical companies either insist on consistent evaluation or give up or transform.

The Chinese market is also a global market, and India, a generic power company, is eyeing. In June 21st last year, the Sino Indian drug regulatory exchange held discussions on the export of India's drugs to China by drug regulatory agencies of China and India. India pharmaceutical companies, which had smelled business opportunities, had begun to be ready to stir up trouble.

In 2019, the alliance of generics and pharmaceuticals purchased with quantity, and India's Dr. Reddy was selected by Olanzapine Tablets, which was approved by the generic drug consistency evaluation. The supply rights of 8 provinces (Hainan, Qinghai, Zhejiang, Hunan, Guangxi, Inner Mongolia, Xinjiang and Shanxi) were regarded as a breakthrough in the field of India generic drugs entering the Chinese market.

In November 6th, at the second China International Import fair, AstraZeneca signed a cooperation agreement with India sun Pharmaceutical Co., which will be responsible for the introduction and promotion of a variety of cancer products in Taiyang pharmaceutical industry. It will bring more high-quality and superior quality medicines to Chinese patients, and more India drugs will enter China.

Data show that India exports drugs to more than 200 countries around the world, accounting for about 20% of the global market share. From April 2017 to March 2018, the scale of drug exports in India reached US $17 billion 300 million, including exports to the United States and the European Union. Among them, the United States accounts for 40% of India's total drug exports, while the European Union accounts for about 15%, while China accounts for only 1%.

More and more India products will be listed in China in 2020. Insiders speculate that, according to the provisions of the current "4+7" expansion alliance procurement, India generic drugs are likely to be evenly distributed with domestic enterprises, and the India enterprises entering the country are the top local enterprises with high internationalization and ranking in India. The products provided are products of generic quality approved by FDA and cheap.

China's generic drugs are not only for survival, but also for improving the quality and at the same time going out. For generic drugs, taking the Sino US double newspaper route can save R & D resources and enhance R & D return rate, which will help pharmaceutical enterprises gain rapid competitiveness. More importantly, we can improve the quality of medicines and have the two largest markets in China and the United States.

In fact, the ongoing generic drug consistency evaluation is one of the ways to integrate with the international market, forcing Chinese pharmaceutical companies to attach importance to enhancing R & D capability, technological capability and quality management capability. To enhance the quality of domestic generic drugs, we can have more international market. Such as Huahai pharmaceutical and other enterprises are taking such a route, the sales of generic drugs in the United States are increasing year by year.