CDSCO examines export feasibility of hand sanitisers
The Central Drugs Standard Control Organisation (CDSCO) has instructed the Drug Controllers of all the States and Union Territories (UT) to assess the production capacity and sufficiency of availability of hand sanitisers in the domestic market and submit the details by the afternoon of May 15, 2020.
This is a move to examine exports feasibility of hand sanitisers, the government will take a decision in this regard after assessing and analysing excess availability of hand sanitisers in the country.
Details to be furnished by SDCs
The Drug Controllers of each State and UT have been requested to furnish several details such as:
- Name and address of manufacturers
- Average per month production capacity (in litres) of each manufacturer
- Average actual monthly production in April 2020 (in litres)
- Has the firm fulfilled the domestic supply request?
- Does the manufacturer have adequate supply and easy availability of raw materials like ethanol, IPA etc., for manufacturing purpose
- If an excess is available after fulfilment of the domestic request, how much (in litres)?
Moreover, after assessment, it has also asked each Drug Controller to present a summarised, compiled data informing whether there is sufficient availability of hand sanitisers in their respective States and UTs. The data should also inform whether hand sanitisers are being produced by firms in quantities that exceed the demand in domestic markets of India.
Dr TK Rai, Director, Drug Controllers Organisation, Sikkim said, “Before COVID-19, the State did not have a single manufacturer of hand sanitisers, and in the month of March we were completely dependent on other states. However, during the COVID-19 pandemic, many firms obtained the license and started manufacturing, and as a result, the state has hand sanitisers in surplus. Presently, the state has more than 10 firms and three to four distilleries involved in manufacturing of hand sanitisers and its raw material.” He also informed that the State’s drug inspectors have started compiling the data requested by the CDSCO office and will be able to submit the data by tomorrow morning.
Dr Hemant Koshia, Commissioner, Gujarat- FDCA, informed, ‘Every week we monitor the stock levels of hand sanitisers with manufacturers as well as at the distributor level in the state of Gujarat. During COVID-19, we have issued new licenses to 46 companies, a few of them are big players like Rellis India, Asian Paints, Merico, Nivea etc. 346 units have been licensed to manufacture hand sanitisers with a total product license of 1362. Overall, the state has a surplus of hand sanitisers for export.”
Manmohan Taneja, Assistant State Drugs Controller, Haryana commented, “We have issued licences to one and a half dozen distilleries to manufacture hand rubs of WHO-recommended formulas. In addition to this, Haryana has issued dozens of new licenses on Form 32 and Form 25 for manufacturing of hand rubs and sanitisers. We have also granted product approvals to hundreds of already licensed units who had facilities but were not involved in the manufacturing of these products.
Crores of litres of ethanol quota have been recommended by the FDA Haryana, which is the main ingredient for hand rub and sanitisers. Presently, manufacturers of Haryana are not only capable of meeting the demands of their home state, but also supplying these products, pan-India. If the Government of India lifts the ban on the export of alcohol-based hand rubs and sanitisers, Haryana would become the No.1 Indian state in exporting such products.”
Pradeep Mattu, Joint Commissioner – FDA, Punjab said, “There is a huge quantity of hand sanitisers available in the market as well as at the manufacturers’ sites because the government had allowed distilleries to start manufacturing hand sanitisers during the COVID-19 pandemic. As a result, the state has hand sanitisers in surplus. Presently, the state has 92 distilleries, of which six of them have started manufacturing hand sanitisers. A total of 38 dedicated firms are involved in the production of hand sanitisers. Overall, it has a huge capacity and we are also monitoring the quality of the product as recommended by the WHO.”
Jyoti J Sardesai, Commissioner – Food Safety, Director, FDA, Goa, informed, “There is no shortage of hand sanitiers in Goa. We have 22 licensed firms for the manufacture of hand sanitisers and there are 16 distilleries who are involved in its manufacturing. Besides this, six pharma manufacturing companies are also involved in producing hand sanitisers.”
Earlier, the CDSCO has requested details about stock availability of paracetamol APIs/formulations in the domestic market. A few days after this, the National Pharmaceutical Pricing Authority (NPPA), as per the recommendations by the Ministry of Home and Affairs, allowed six major manufacturers of paracetamol APIs to export 2000 metric tonnes.