India's biotech industry has made a strong pitch to the government to recognise anti-cancer drugs as life-saving drugs, bring pre-clinical studies under the ambit of service tax exemption and called for a robust regulatory mechanism and world-class accreditation agency.
Association of Biotechnology Led Enterprises said customs duty at 12.5 per cent, excise/countervailing duty at 16.32 per cent, education cess at two per cent and additional duty on customs at four per cent result in 36.74 per cent increase in the price of cancer drugs, leading to cost to the patient going up.
President of the ABLE, Vijay Chandru, also said that to provide a fillip to the services sector, ABLE would like the coming Union Budget to extend service tax exemption to pre-clinical studies 'currently, only clinical trials are exempt from service tax and there is no rationale to exclude pre-clinical studies from this exemption', Prof Chandru, also chairman and CEO of Strand Life Sciences, told PTI.
To accelerate the growth of the Indian biotech sector and make it a globally-strong industry, the government needs to ensure a robust, unambiguous, time-bound and transparent regulatory mechanism.
Chadru also said, 'the government should set up a world-class internationally recognised accreditation agency which can set standards and protocols that are in harmony with global regulations and standards'.
The biotech industry has also sought tax concessions such as a weighted average tax deduction fo 150 per cent on all market development expenditure pertaining to innovator products, 10-year excise duty exemption on all innovator products manufactured in India and customs duty exemption for all innovator products manufactured in special economic zones in India for a ten-year period from the date of marketing approval.
The industry pushed for tax holidays for hosting biotech inventions -- income-tax holiday in respect of royalty income derived from licensing of biotech innovations hosted by the companies in India for a five-year period and exemption in respect of capital gains derived by companies from sale of biotech inventions hosted in India.
"The industry needs weighted average tax deduction on R&D expenditure and inclusion of international patent filing costs and market development costs u/s 35 (2AB)", Chandru said.
To spur manufacturing, ABLE would like the Budget to rectify the anomaly with respect to imported and indigenous life saving drugs and diagnostics, wherein raw materials and components used by indigenous manufacturers for such products are levied customs duty and excise duty whereas the finished products are allowed to be imported duty-free.
Kiran Mazumdar-Shaw, head of Biocon Ltd, said a 10-year tax holiday is needed on all indigenously developed biotech drugs and products to act as an investment incentive for R&D.
"We also wish for all indigenously developed biotech drugs to be exempt of price control for 10 years which currently provides for five years", the biotech veteran told PTI.
"Five years is simply not enough to compete with MNCs who enjoy much higher drugs prices, thanks to a skewed way of deriving price levels which is based on unverified transfer pricing in the case of MNCs and audited cost prices for Indian companies", she said.
The biotech industry also sought SEZ-like incentives for biotech export oriented units.
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