India lists 38 drug raw materials for which it wants to end dependence on China

15 Nov.,2022


4-Acetamidophenol CAS 103-90-2 Paracetamol

New Delhi: The Modi government has drawn up a list of 38 drug raw materials that it wants locally produced in a bid to end the country’s dependence on Chinese imports for them, ThePrint learnt. 

In an hour-long meeting chaired by Amitabh Kant, CEO of think-tank NITI Aayog Wednesday, the government has asked leaders of the Indian pharmaceutical industry to boost the manufacturing of these raw materials, which are scientifically called active pharmaceutical ingredients (APIs).

The APIs, also known as bulk drugs, are the key raw material used for manufacturing medicines. For instance, paracetamol is the API for Crocin.

“The government’s apex body, the Central Drug Standards Control Organisation (CDSCO) has prepared a list of 38 essential APIs where India needs to be self-dependent. The government has informed us about the list but has not circulated it yet,” said V.V. Krishna Reddy, national president, Bulk Drug Manufacturers Association (BDMA) who was part of the meeting. “However, it is still a suggestion and not an imposition to start the production of these selected APIs.” 

The list is likely to contain the fermentation process-based drugs such as crucial antibiotics penicillin, amoxicillin, ampicillin, tetracycline and essential vitamin and hormonal pills. It’s a market that China dominates across the globe.   

Indian drugmakers import around 70 per cent of their total bulk drugs from China. In 2018-19 fiscal, the government had informed the Lok Sabha that the country’s firms imported bulk drugs and intermediates worth $2.4 billion from China. 

Also read: Modi govt halts plan to stop medicine export as firms in coronavirus-hit China resume work

In meeting, industry lists its difficulties

Wednesday’s meeting was attended by Sudhir Mehta of Torrent Pharmaceuticals, Pankaj Patel of Cadila Healthcare, Dilip Shanghvi of Sun Pharma and Satish Reddy of Dr. Reddy’s Laboratories among several other heads of Indian pharmaceutical companies. 

In the hour-long meeting, the industry highlighted its difficulty in procuring environmental clearances and the need for tax concessions for re-starting the production of APIs.

“The objective of the meeting was to understand from the industry how the government can help to revive the production of APIs in India. The idea is to come up with a comprehensive policy on API production in India,” said a government official who was part of the meeting. 

“We are already in talks with multiple ministries to facilitate the easy manufacturing of these products in India,” the official added.

The government has involved several ministries including the Ministry of Environment, Forest and Climate Change, Ministry of Commerce and Trade, Ministry of Health, Department of Pharmaceuticals and the Ministry of Finance to draw up the final policy to revive the production.  

Lockdown in China 

India is, however, likely to struggle with a shortage of APIs due to the shutdown of the Chinese market. 

While several Indian drugmakers were well-stocked when the deadly coronavirus hit China,  the industry might run out of the key ingredients by mid-March. 

“Indian industry is so intertwined that it is impossible in our view to find a single player that would not be impacted by Chinese API shortages, should these materialise from post-mid-March,” said a paper titled India Pharmaceuticals: Coronavirus Impact and published by the Hong Kong-based equity research firm, Haitong International Securities Group.

In 2014, national security adviser (NSA) Ajit Doval had warned that “India runs the risk of a severe shortage of medicines because of its over-dependence on China for sourcing raw material for drugs”.  

Also read: Don’t arrange hotels, sightseeing for doctors — Modi govt’s fresh warning to pharma firms