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DCGI directs state drug authorities to expedite licensing of manufacturers of hand sanitizers to tackle shortage

Laxmi Yadav, Mumbai
Thursday, March 19, 2020, 08:00 Hrs  [IST]

In a bid to ensure availability of hand sanitizers in adequate quantity and quality in the country in the wake of coronavirus outbreak, the Drugs Controller General of India (DCGI) has directed the state drugs controllers to expedite the licensing of manufacturers of such products and monitor quality standards of the products as per Drugs and Cosmetics Act, 1940.

Hand sanitizers are licensed under Drugs and Cosmetics Rules, 1945. The standards of such products shall be prescribed in the Second Schedule of Drugs and Cosmetics Act and rules made thereunder.

Further, on March 13, 2020, the central government had notified masks (2ply and 3ply surgical masks, N95 masks) and hand sanitizers under Essential Commodities Act, 1955 to regulate their production, quality, distribution and logistics.

In light of existing circumstances arising out of coronavirus outbreak, it is required that the regulatory activities should be intensified to keep strict vigil in the matter so that the people can be protected from malpractices, said DCGI in a letter to state drug authorities on March 17, 2020.

Accordingly, the DCGI has asked state drugs controllers to submit the list of manufacturers who are manufacturing hand sanitizers under their jurisdiction along with product details and further exercise strict vigil and regulatory oversight on manufacturing and distribution of such products.

Similarly, state drugs controllers have also been directed to expedite the licensing process for manufacturers of hand sanitizers by taking proactive measures to meet the present challenges of increased demand of such product in the country.

The DCGI has further asked all zonal and sub zonal offices of CDSCO to coordinate with state and Union territory drugs control authorities in the matter.

Welcoming the DCGI’s initiative to expedite the issuance of manufacturing license for hand sanitizers, Amit Chawla, general secretary of Madhya Pradesh Small Scale Drug Manufacturers Association, said, “To meet domestic supply shortage of hand sanitizer, the government should grant permission to exporters to manufacture the product for export as well as domestic market. It will help meet global as well as domestic demand for the product. There are 152 countries across the globe affected by the new virus.”

Recently Prime Minister Narendra Modi has called on the South Asian Association of Regional Cooperation (SAARC) to fight the coronavirus threat jointly.

Chawla cited the example of Food and Drug Administration of the United States which has called upon licensed pharmacists and physicians to manufacture their own batches of hand sanitizer to meet its growing demand. The agency is concerned that home-made sanitizers are not as safe to use as what pharmacists and doctors could make, using high-quality ingredients and at least 60% alcohol. Most of the stores have reported non-availability of hand sanitizers.

Meanwhile MP licensing authority Rajiv Aggarwal has issued three manufacturing licenses for hand sanitizer in last two weeks to tide over its increasing demand. Gujarat FDCA has also approved product licenses of 189 hand sanitizers.

 

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Sekar S May 10, 2021 7:38 AM
In our laboratory, we have formulate new innovative "Disinfectant Tablet. It is 15 grams each tablet. It can be dilutted with 5 liters . Do we obtain any licence ro produce the same.

G.S.Sekar.
Prashant Apr 16, 2021 4:50 PM
Dear sir we are manufacturer of Cleaning & hygiene products & registered in msme. so I want to make permission to make hand sanitizer pls sir give me permission to make hand sanitizer

thanks regards .

Nature Care Solution
shishir Dec 14, 2020 3:05 PM
Please provide the all necessary documentations permissions and licence requirements for formulation and manufacturing start up unit to start in Bhopal,Madhya Pradesh.
Please also provide the details of regulatory, environmental and fire and safety permissions needed for formulation and manufacturing start up unit to start in .Madhya Pradesh
sanjiv mehrotra Dec 5, 2020 4:20 PM
I want to manufacture disinfection and sanitizer . Please provide me the process to get licenses for manufacturing and who will provide the licenses.
Yashwanth P Oct 6, 2020 7:09 PM
Please provide the all necessary documentations permissions and licence requirements for formulation and manufacturing start up unit to start in Bangalore Karnataka.
Please also provide the details of regulatory, environmental and fire and safety permissions needed for formulation and manufacturing start up unit to start in Karnataka
MANOJ SHARMA Sep 23, 2020 12:14 PM
I want to manufacture phenyl and disinfectant .what will lisence required
Basheer Mohammed Aug 30, 2020 9:42 AM
Sir. I needed information of licence of repacking hydrogen peroxide 6% and sanitizer
C Bhaskara Rao Aug 24, 2020 4:12 PM
Dear Sir
Planning to start manufacturing unit to Antiseptic wipes . Any licenses need to take and Govt.of India permission required?
Mehta Aug 24, 2020 3:48 PM
Sir, I needed information of license for making hand sanitizer, purfume make. Please give me a details of license
Indrajit Maity Jul 29, 2020 2:17 PM
I need lisence to make sanitizer.
Prasad Pandit Jul 28, 2020 7:10 PM
I've GOT Registration...Do I need FDA license to sell Herbal sanitizers & Surface spray....Pl inform asap.
Issac Abraham Jul 23, 2020 7:38 PM
Sir, I'm Issac, I'm planning to start a small scale business, selling of masks by hiring from a production unit. Do I need any license for this?
T NIRMALA Jul 22, 2020 5:45 AM
As a trader I have gstin. Do I need to have drug license or any other license as a trader to buy and sell of imported surface sanitizer which was imported under hs code 34029019
Rajitha Jul 21, 2020 10:22 PM
Dear sir we are manufacturer of Cleaning & hygiene products & registered in msme. so I want to make permission to make hand sanitizer pls sir give me permission to make hand sanitizer thanks regards .
N.Rajitha
Sarthakindustries Jul 21, 2020 7:33 AM
Dear sir we are manufacturer of Cleaning & hygiene products & registered in msme nsic and we belong to SC so I want to make permission to make hand sanitizer pls sir give me permission to make hand sanitizer thanks regards RAKESH BHILWARE
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