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THE ACHILLES' HEEL OF API

Ramesh Shankar
Wednesday, May 16, 2018, 08:00 Hrs  [IST]

The Central government has constituted yet another high-level task force, this time headed by Union Minister of State for Chemicals and Fertilisers, to formulate a roadmap for the enhanced production of active pharmaceutical ingredients in the country. The panel will formulate a roadmap for the APIs with implementable recommendations. It will also look into required interventions concerning Central and State governments and various regulatory bodies. Given the ever deteriorating Sino-Indian border relations, the government's intention is quite understandable as it wanted to end over-dependence of Indian pharma companies on China for APIs. As per official data, currently India is importing about $3 billion worth of APIs, intermediates and other chemicals from China. This is more than 80 per cent of the country’s annual requirements of APIs. If the ongoing border skirmishes reach a flashpoint and as a retaliatory measure China decides to stop export of APIs and other raw materials to India, the result would be disastrous for the country as the industry does not have any alternate sources to procure these basic raw materials. This would mean that production of several essential and life saving drugs required within the country will be in trouble. Earlier in 2014, government had constituted another committee on API under the then DG, ICMR Dr V M Katoch to formulate a long term policy and strategy for promoting domestic manufacture of APIs. In its report to the government, the Katoch panel made some sweeping recommendations for revival of API manufacturing in India including tax free status to cluster developers and cluster participants for 15 years. It also recommended establishment of six mega parks for APIs with common facilities.

That the government was seized of the issue was clear from the fact that it declared the year-2015 as 'Year of Active Pharmaceutical Ingredients' under its 'Make in India' programme. But somewhere down the line, the government lost its direction as after more than three years of Katoch panel recommendations, no mega cluster has come up anywhere in the country. The much-publicised mega park project, which was expected to transform the nation in the availability of APIs, has hit the wall in the absence a conducive regulatory environment. It will be worthwhile to mention here that till two decades ago, the country has been producing most of the APIs required in the country and even exporting a major part of the same to Europe and the US. But, the high cost of production because of comparatively low scale of operations and higher input costs rendered the domestic API production economically unviable. And stringent environmental regulations added fuel to the fire, forcing the pharma companies to turn to China which emerged as a producer of cheap APIs with huge capacities and lower cost of production. Now, it is time the government should take some leafs out of the Chinese success stories and act immediately. Instead of forming committee after committee, the government should reform the archaic rules as there are some serious anomalies in the current regulatory framework in the country which are destroying the indigenous manufacturing of APIs.

 

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K C S May 23, 2018 10:03 AM
We plan.. deploy special task forces, give them mobiles, laptops, and nothing below Apple and Galaxy.

How many Special Taskforces were created till now ?? countless. Its just a picnic trip and an extra income for Govt. Officials.

These Govt officials are not aware of the real issues faced by Industry.

We'll not see any development until the Govt guys' increments are evaluated based on performances. These guys get salaries and increments on time and have no responsiblity
pradeep awasthi May 21, 2018 7:50 AM
The cross border conflict between India and China on LOC is certainly not favouring bilateral long-term relationships of both the nations.China who is the mighty asian country claims to be more powerful in terms of technology and economy compared to its another big neighbouring rivalry nation India. Its fact about Indian pharmaceutical companies which are largely depending and monopolised by china for production of API,which is imported to the tune of 3 billion annually.The most predicted danger for India due to cross border conflicts will be withdrawal of china to export API which will make India handicap of producing several life saving drugs.

Though Central government has made special task force,in synergy with state government and regulatory authorities to formulate strategies for manufacturing production of API in India.But again before two decades our API production was withdrawn due to high cost,lower operation and exorbitant input cost.Therefore to again challen
 
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