Indo-China Talks put on Fast Track to Bring Down Drug Approval Timeline and Import Tariff on Priority Therapeutics

In an attempt to boost pharma exports to China, the Union commerce ministry has initiated talks with China Food and Drug Administration (CFDA) to fast track drug approval process and waive off import tariff on a slew of therapeutic areas including cardiovascular, gastrointestinal, diabetes, neurology and respiratory diseases in line with oncology segment.

China had earlier exempted 28 drugs including cancer medicines from import tariff. Earlier the import duty on these drugs was 5-6 per cent.

It is learnt that a higher level delegation of the Commerce Ministry and Pharmaceuticals Export Promotion Council of India (Pharmexcil) has recently called on CDFA and China Chamber of Commerce for Import & Export of Medicines & Health Products seeking reduction in drug approval timeline from 5-7 years to 1-3 years and exemption on import duty on several therapeutic areas which remain priority for Chinese population.

The delegation sought one year timeframe for CFDA approval of Indian units approved by US FDA and EU authority and three years for the rest of manufacturing companies. India is a global leader in specialty generics. Speedy approval will provide opening to Indian drug makers to market their economically priced drugs in China.

“We are optimistic in terms of breaking through the Chinese market. The Chinese authority assured us that they would consider our demands positively,” sources from commerce ministry said.

Meanwhile, exporters have welcomed the government initiative to boost India’s drug export to China. Swift regulatory permissions in China would enable Indian companies to increase revenue at a time when pricing pressure and regulatory hurdles have taken toll on US sales. Over the next 5 years, there is a tremendous opportunity for Indian players to tap highest market share in China, said a member of committee of administration (CoA), Pharmexcil.

We have appealed to the government to take steps with Chinese counterpart to reduce custom duty on certain therapeutic areas providing Indian companies room to grow, he said.

A Pharmexcil delegation led by its assistant director Murli Krishna is expected to visit China on August 22 to interact with stakeholders and take the discussion further.

The Indian pharmaceutical industry is trying to find ground in China which is the world’s second-largest pharmaceutical market. In 2017 the market stood at US$ 122.6 billion with growth tipped to reach US$ 145 billion to US$ 175 billion by 2022, according to health-care information company IQVIA.

The talks are going on to iron out opaque regulatory issues thereby helping Indian companies make inroads in the Chinese market which constitutes one per cent of India’s export worth US$ 17.3 billion in 2017-18. There is realisation on both sides Chinese regulatory authority and general public that Indian generics are of high quality and cheaper. This augurs well for Indian plants approved by US FDA, Japan, EU, South Korea etc, said the CoA member.

In 2016-17 India’s total export to China valued at US$ 146 million including bulk drugs and drug intermediates (US$ 104.30 million), drug formulations and biologics (US$ 23.23 million), Ayush (US$ 0.59 million), herbal products (US$ 5.31 million), surgical (US$ 2.57 million).

During April-January 2017-18 India’s export to China stood at US$ 170 million as compared to US$ 114 million export during the same period last year.

In 2016-17 India’s import of pharmaceuticals from China touched US$ 1948.367 million including Ayush and herbal products (US$ 0.083 million), bulk drugs and drug intermediates (US$ 1818.988), drug formulations and biologicals (US$ 128.630 million), surgicals (US$ 0.216 million).

In 2017-18 (upto October), the country’s import of pharmaceuticals from China valued at US$ 1220.679 million including Ayush and herbal products (US$ 0.034 million), bulk drugs and drug intermediates (US$ 1146.600 million), drug formulations and biologicals (US$ 73.291 million), surgicals (US$ 0.754 million).-Pharmabiz