The government has decided to set up a 10-member technical committee to revive India’s lost capacity to make certain crucial drug ingredients, The Indian Express has learnt. The development holds significance as it comes in the backdrop of a steady escalation of Covid-19 cases here as well as a continued shutdown of operations in a major Chinese province that exports these key ingredients to the country.
The development comes over a month after the Department of Pharmaceuticals (DoP) formed an expert committee to monitor the potential impact of the novel coronavirus outbreak in China on its supply of active pharmaceutical ingredients (APIs) to India. The committee, chaired by CDSCO Joint Drug Controller Eswara Reddy, had recommended the formation of this technical committee, which is expected to suggest ways to revive India’s API segment, especially its fermentation-based APIs, said industry sources. APIs are the key ingredients that give a drug its therapeutic effect.
One of the duties of the new technical committee is to look into the cost of setting up fresh API manufacturing capacities — greenfield projects — to wean India off its dependency on imports for these products, according to one of the sources.
The new committee will also examine the latest “viable” technologies to make these products, “including backward integration”, said the source.
It will also examine a proposal to restart manufacturing of some of these APIs by government undertaking Hindustan Antibiotics Limited (HAL), according to another source. Apart from this, it will also look into other existing facilities along with their capacities to make these ingredients.
Around 58 such ingredients had been identified by the committee set up last month, including amoxicillin, vitamin C, neomycin, acyclovir and tetracycline. Exports of some of these ingredients, imported from China’s Hubei province that is currently under lockdown, have been restricted by the Directorate General of Foreign Trade (DGFT).
HAL previously operated a capacity to manufacture a fermentation-based antibiotic called gentamicin in the 1980s, which later closed, according to a vision document by industry body Indian Drug Manufacturers’ Association (IDMA).
The Indian Express first reported on February 21 that the government is planning to revive old drug manufacturing units that produced key ingredients for crucial medicines in the past, but are now being imported from China.
DoP has constituted the new technical committee because it was receiving varied estimates from industry members of how much more expensive it was to make these APIs in India as compared to China.
Between the 1960s to 1980s, India had set up 7-8 manufacturing plants to make as many as 20 crucial fermentation-based ingredients, including penicillin G, erythromycin, citric acid and vitamin B12. However, in the last three decades, these manufacturing plans were shut down due to “cheaper” alternatives from China.
Industry officials had earlier said that this was because Chinese API manufacturers managed to scale up production with government support like cheaper land during that time. Their products became 20-25 per cent cheaper than domestic firms, making Indian API manufacturers less competitive.
“Even with import duties, their products were cheaper, so our formulators began picking them over Indian manufacturers,” one of the officials cited above had said.
India relies on China for nearly 70 per cent of its total API imports, leaving the country in a vulnerable state during the current outbreak of the deadly respiratory coronavirus.
The present stock of APIs “may be sufficient” for 2-3 months to make formulations, said DoP in a release on Tuesday, citing some of the recommendations of the committee that was chaired by CDSCO’s Reddy.
The committee had also recommended that the government establish a “Drug Security Authority” to make India “self-sufficient” and a “global leader” in APIs and other key intermediates domestically as well as an exporter, according to a person aware of its recommendations.
Chinese drug makers outside of Hubei have now resumed operations “partially” and are expected to be fully operational by March-end, DoP stated.
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