At India Pharma 2017, which took place in February last year, the domestic pharma industry told the DoP that it is “unable to compete with China in terms of commercial scale”. (Source: File Photo)
In a bid to curb India’s dependence on China for active pharmaceutical ingredients (APIs), which are used as raw material ingredients to prepare finished medicines, the Department of Pharmaceuticals (DoP) has requested other government departments to chip in with measures to achieve this. The Department of Commerce has been asked to put up a system of ‘canalisation’, which means forcing the import of APIs through a government corporation while the Ministry of Power has been requested to ensure availability of power at cheaper rates for domestic API manufacturing plants. Also, the DoP has petitioned the health ministry to impose higher registration fees on imports and stipulate time-bound requirements for foreign companies, which are exporting active pharmaceutical ingredients to India, to establish their Indian production facilities.
The DoP provided the aforementioned information to Ficci in a written response after the latter raised the issue of “revival of domestic API industry to reduce dependence on imports for critical drugs” last year . India’s API imports from top five countries stood at Rs 18,372 crore in 2016-17 with China accounting for 66 per cent, according to the government data. “India continues to rely on imports of key starting materials, intermediates and APIs on China, with the share of dependence increasing over time. This potentially exposes us to raw material supply disruptions and pricing volatility,” stated a study released by Ficci at ‘India Pharma 2018’ on February 15, 2018.
At India Pharma 2017, which took place in February last year, the domestic pharma industry told the DoP that it is “unable to compete with China in terms of commercial scale”. In response to industry’s concerns, the DoP informed the Ficci that it has prepared an umbrella scheme for development of pharma industry. “One of the component of this scheme is part-financing of government facilities in three bulk drug parks. In-principle approval of Department of Expenditure has been received and EFC (Expenditure Finance Committee) memo has been prepared and circulated for comments,” the DoP stated.
In February 2015, a government committee — headed by former health research secretary V M Katoch — suggested setting up of mega parks for API manufacturing with facilities like assured power supply and effluent treatment plants. The DoP told Ficci that it is proposing to implement a scheme which would provide financial assistance to common facilities at API parks as one of its “sub-schemes”. The DoP has asked the Department of Commerce to check unhindered import of APIs.
The DoP has also asked the health ministry to introduce a mandatory system of consignment-wise testing requirement, which would be on similar lines as practised in China. It has also asked the health ministry to advise government procurement agencies to adopt differential policy for procurement so that it benefits API industry.
Moreover, on the API issue, the Department of Pharmaceuticals has requested the health ministry to undertake the following measures: “Higher registration fees for imports that is comparable with international regulators; increasing the time frame for according registration to overseas companies for marketing the bulk drugs in the country; putting in place stringent documentary and quality-related requirements for site inspections and evaluation by Indian drug regulators; for the foreign companies exporting to India, stipulating time-bound requirements for establishing local production facilities in the country after getting registration for marketing the bulk drugs in India.”
In 2015, Union chemicals and fertilisers minister Ananth Kumar had told Parliament that India was largely dependent on China for API imports of 12 finished medicines that are in the ‘National List of Essential Medicines’. The DoP comes under the Ministry of Chemicals & Fertilisers. Since 2014, the Central government has been talking about this near-absolute reliance of Indian pharma sector on China for bulk drugs. It has tried various measures to boost local API manufacturing.
It even planned to bring out a bulk drug policy. However, in August 2016, Kumar dropped the plans to bring out bulk drug policy.
In a written response on February 6, 2018, Kumar told Parliament: “The policies formulated by government from time to time are made so that the country’s dependence on (API or bulk drug) imports are minimised. In this direction, the government had on January 29, 2016, notified the withdrawal of exemption in customs duties which were earlier given to certain categories of drugs and bulk drugs to provide a boost to the domestic manufacturers. Further, the government has removed bottlenecks in environment clearance etc. which the manufacturers are facing, in order to give a boost to domestic manufacturing of bulk drugs.”
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