Indian drug advisory board backs proposed API import license fee hike

By Gareth Macdonald contact

- Last updated on GMT

iStock/Singh_Lens
iStock/Singh_Lens

Related tags: Pharmaceutical drug, Pharmacology

A plan to charge drug firms more to import APIs into India has won the support of the Government’s Drugs Technical Advisory Board (DTAB).

The fee increase – which was proposed by the Indian Ministry of Health and Family Welfare in December​ – was discussed at a DTAB meeting on May 13​ where members agreed more funds are needed to support the Central Drugs Standard Control Organization (​CDSCO).

The DTAB highlighted the cost of an Indian active pharmaceutical ingredient (API) import license as an example, suggesting the current low fee is encouraging drug manufacturers to source actives from outside the country to the detriment of local producers.

In India, registration per product costs about $1000 while similar registration costs about $35,500 per product in China” it said, adding that “This is having an impact on the Indian bulk drug industry.”

This view is in keeping with concerns voiced by Indian Minister of Chemicals and Fertilizers, Ananth Kumar, who promised reforms to encourage local production and reduce the country’s dependence on APIs from China in 2015​.

Fee hike

The Ministry of Health and Family welfare proposed revising the Drugs and Cosmetics Act, 1940 to increase the importation fee from “one thousand US dollars​” to “five thousand US dollars​” per API imported.

The DTAB said the actual fee increase should the Government should decide on the level of fee increase in discussion with industry stakeholders.

The organisation is open to the idea of charge drug firms more to make and sell finished drug products in India. It pointed out that amount charged for manufacturing and sales licenses has not increased in a decade depite the country's economic growth.

CDSCO funding

In addition to higher license fees for API importation, drug manufacturing and sales, the DTAB also supported the idea of higher fees for medical device importation licenses, approvals to conduct clinical trials and overseas facility inspections.

The Board cited ongoing efforts to strengthen the CDSCO – outlined in the Indian Government’s latest five year plan​ – as the basis for its position.

CDSCO is being strengthened by setting up of new office, enhancing the drugs testing capacity human resources development, introduction of E-governance etc.

These activities however, necessitate exploration of more avenues for revenue generation and review of the existing fee structure​.”

Earlier this month CDSCO announced​ it is working on a new version of the Drugs and Cosmetics Act.

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