Central and state governments in India have been fast-tracking licences for the production of alcohol and hand sanitisers to meet rising demand during the national lockdown over coronavirus Covid-19.
On 13 March, a central government Order deemed hand sanitisers "essential commodities" for Covid-19 management. The Order will remain in place until 30 June.
In a communication to state drug controllers, the overarching Drugs Controller General of India (DGCI) directed them to expedite licensing for manufacturing hand sanitiser – and monitor its quality – under the Drugs and Cosmetics Act 1940.
"Controllers in states need to submit the list of manufacturers that are manufacturing sanitisers within their jurisdiction, along with product details, and exercise regulatory oversight on the manufacturing process and distribution of such products," it said.
Producers must submit information on the production process to the state-level drug controllers' office, including on volumes and additives.
But there is no rule that mandates that every batch should be tested. Instead the Central Drugs Standard Control Organization (CDSCO) or state drug controllers will arrange for their testing on a random basis. The CDSCO is the national regulatory body for Indian pharmaceuticals and medical devices, equivalent to the European Medicines Agency in the EU.
Switching production
According to an official with the All India Distillers’ Association (AIDA), over 150 distilleries in the country have so far repurposed their plants to produce hand sanitisers.
Leading Indian alcoholic beverage makers are also diverting their raw materials to produce the products.
For example, whisky producer Jagajit Industries has expanded its use of extra neutral alcohol (ENA), a raw material used to produce both alcohol and hand sanitiser.
The company has "started production but is facing major challenges in backward integration of the supply chain and movement across state borders during the lock-down period," said Roshni Jaiswal, its chief restructuring officer.
On 24 March, the Director General of Foreign Trade (DGFT) issued a statement banning all exports of hand sanitisers with immediate effect. There is no official data available on the total export figures or the impact this could have on other countries.
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