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India’s increased dependence on Chinese APIs causing concern

Maitri Porecha New Delhi | Updated on November 22, 2019 Published on November 22, 2019

Govt initiatives to boost domestic production remain on paper

 

India’s dependence on China importing active pharmaceutical ingredients (API) is the most among all countries, while national strategies to promote indigenous means of production continue to be relegated on paper. API is the most basic building block or component of a medicine. For example, acetaminophen or paracetamol is the chief therapeutic entity in Aspirin or Crocin brand of drug.

Latest statistics from Directorate General of Commercial Intelligence and Statistics tabled in the Parliament reveal that in 2016-17, of the total import totalling $2,738.46 million (₹19,653.25 crore), China constituted 66.69 per cent ($1826.34 million or ₹13,107 crore) of all bulk drugs and drug intermediates. In 2017-18, India imported $2,993.25 million or ₹ 21, 481 crore worth bulk drugs and intermediates, and the share of China in the pie, increased to 68.36 per cent ($2,055.94 million or ₹ 14, 755 crore). Chinese imports levelled at 67.56 per cent ($2,405.42 million or ₹ 17, 263 crore) in 2018-19, still the largest share in total Indian imports worth $3,560.35 million or ₹25, 552 crore. Also, overall India's dependence on imports has gone up by 23 per cent from 2016-17 to 2018-19.

Department of Pharmaceuticals (DoP) in Ministry of Chemicals and Fertilizers said that the imports from China are due to economic considerations, which essentially means that Chinese imports are cheaper and more cost-effective for pharma manufacturers.

In contingencies, such as the most recent one when lakhs of Chinese facilities remained shut for as many as two years to step up their environment compliance, and uncertainty loomed large over whether smaller Chinese units that were unable to comply with stricter norms, would open again, India looks at other sources like United States, Italy, Singapore, Hong Kong for import. However, there is always a fear of a sharp spike in finished drugs when APIs are imported from other countries apart from China.

Policy remains only on paper

And even as India’s dependence on imports is considerable, policies formulated by government to minimize country’s dependence on imports and to give fillip to indigenous manufacturing have remained only on paper.

It has been six years since 2013, when Congress had instituted a high-level committee for fighting the heavy Chinese dependence on bulk drugs. Later, National Security Advisor Ajit Doval had warned that Chinese dependence on API can be a national security threat. An official in Drug Controller General of India (DCGI) confirmed to Businessline, that apart from heavy dependence on legal imports, a large number of illegal imports of APIs from China were a cause of worry for the regulator.

In another reply tabled in the Parliament, DoP informed that an Inter-Ministerial Task Force was also constituted under the Chairmanship of the Minister of State (Chemicals & Fertilizers) on April 18, 2018 to formulate a road map for the enhanced production of Active Pharmaceutical Ingredients (APIs) in the country.

Task force meet

Sources in DoP told Businessline, that the task force has not even met every alternate month since August 2018, when ideally they are supposed to meet every month to take crucial decisions for boosting API productions in proposed bulk drug parks.

DoP has a scheme - ‘Assistance to Bulk Drug Industry for Common Facility Centre,’ for providing assistance to Bulk Drug Industry for Common Facility Centre in any upcoming bulk drug park promoted by state governments or state corporations, the ministry has stated.

Only in-principle approval was given for constructing these parks till now in Himachal Pradesh, Telangana, Andhra Pradesh and Assam. It will still be a couple of years before the projects see the light of the day.

 

Published on November 22, 2019
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