INTRODUCTION
At the beginning of the COVID-19 pandemic,
when India was juggling with the lockdown rules, there was a class of
entrepreneurs ready to take the risk of starting with the new product line and
turning the trouble into an opportunity. A class of importers started importing
IR thermometers, Oximeters, Medicines, Masks, PPE Kits, etc. While on an initial
basis, some of the items required prior approval from statutory authorities,
the Government of India relaxed the law, allowed importing such items, and
introduced the post import approval process within a reasonable period of time.
However, there is an important aspect that needs to understand concerning
approvals and registrations under the stipulated laws governing such
devices/instruments. All such business houses who are/were planning to
manufacture, import, and/or sell or manufactured imported Infrared Thermometer
in the Indian marketplace should also check the mandatory compliances that need
to be followed regarding such products.
This article will provide you insight into
various applicable legal provisions and appraise you with the repercussions of
non-compliance.
COMPLIANCES FOR IMPORT/ MANUFACTURE OF INFRARED THERMOMETER UNDER LEGAL
METROLOGY
1.
Model Approval:
Section 22 of the Legal Metrology Act, 2009 stipulates that every person,
before manufacturing or importing any weight or measure shall seek the approval
of model of such weight or measure in such manner, on payment of such fee and
from such authority as may be prescribed.
Here, we discuss the
import or manufacturing of measuring instruments such as Infrared thermometer;
the application must be filled before the Legal Metrology department along with
prescribed fees for testing and submit the required samples to the Government
Accredited Laboratory.
Due to the COVID
emergency, Legal Metrology Department and the Customs Authority had allowed importing
Infrared Thermometer without prior model approval subject to an undertaking in
which the importer undertook to get the model approved within three months from
the date of clearance of the consignment.
Now, it is an importer's
obligation to first apply for the model approval online and submit the samples
to the Government Authorised laboratory for calibration along with the required
confidential information of the model.
Consequences for failure to get model
approved:
- Whoever
fails or omits to submit a model of any weight or measure for approval
shall be punished with a fine which may extend to twenty thousand rupees
and for the second or subsequent offense, with imprisonment for a term
which may extend to one year and also with fine.
- In
addition to the above, if the importer fails to comply with the
requirements/ specifications laid down under the prescribed rules, he
shall withdraw all the infrared thermometers from the market at its own
cost.
We,
Compliance Chambers having expertise in Legal Metrology, offer Importer/Manufacturer
our best services on PAN India basis at a very reasonable cost with clear
separation of Government fees/ Laboratory charges and our Professional Fees. We
believe in giving timely solutions to our clients and assist them in every
possible manner.
2.
Registration of importer
or license as a manufacturer: Section 19 of the Legal
Metrology Act, 2009 stipulates that No person shall import any weight or
measure unless he is registered with the Director in such manner and on payment
of such fees, as may be prescribed.
On the other side,
Section 23(1) stipulates that No person shall manufacture, repair, or sell, or
offer, expose, or possess for repair or sale, any weight or measure unless he
holds a license issued by the Controller under sub-section (2).
The Importer or the
Manufacturer of the Infrared Thermometer also mandatorily require Registration
or License for import or manufacturer of weight or measure under the Legal
Metrology Act, 2009. Suppose the said registrations are not obtained by the
manufacturer, importer, and packer. In that case, the same can amount to
non-compliance, and the said non-compliance can attract monetary under Rule 32
of the Legal Metrology (Packaged Commodities) Rules, 2011. The Repercussions of
the same are stated below:
Penalty for such Contraventions
For Importer:
Whoever imports any weight or measure without being registered under this Act
shall be punished with fine which may extend to twenty-five thousand rupees and
for the second or subsequent offense, with imprisonment for a term which may
extend to six months, or with fine, or with both.
For Manufacturer: Whoever, being required to obtain a license
under this Act or the rules made thereunder, manufactures, without being in
possession of a valid permit, any weight or measure, shall be punished with
fine which may extend to twenty thousand rupees and for the second or
subsequent offense, with imprisonment for a term which may extend to one year,
or with fine, or with both.
3.
Registration of manufacturer
& Packer: The manufacturer of the Infrared
Thermometer is a packer. The Package Commodities Rules are also applicable, and
he needs to apply separately as Registration of manufacturer & Packer.
Every such person must obtain the packer registration for Infrared Thermometers
by making the application to the Director or Controller along-with the
prescribed documents within a period of ninety days from the date on which he
or it commences pre-packaging.
4.
Registration of Importer:
Every importer who imports any Infrared Thermometer for sale, distribution, or
delivery shall also make an application under the Packaged Commodities
Rules. Every such person must obtain the
registration for Infrared Thermometers by applying to the Director or
Controller along with the prescribed documents.
We at Compliance Chambers
offer the following services in respect of infrared thermometer:
a.
Application
for Model approval.
b.
Submitting
samples to Lab.
c.
Communicating
scientific & Technical information of the product to the Lab.
d.
Coordinating
with lab officials and handling their queries.
e.
Follow up
with the Metrology Department.
f.
Assistance
in preparing and filing the application for registration under the Legal
Metrology Act and Packaged Commodities Rules.
g.
Packaging
Compliances and declarations.
COMPLIANCES FOR
IMPORT/ MANUFACTURE OF INFRARED THERMOMETER UNDER DRUGS AND COSMETIC LAWS:
From January 1, 2021, the digital
thermometers shall be classified as a medical device, and the manufacturer/
importer of such devices shall be required to register the device with the
Central Drugs Standard Control Organization (CDSCO) as well. The applicant
would require submitting the device with CDSCO along with the prescribed fees
and documents. Once the registration has been done, a registration number shall
be allotted to the device, which has to be mentioned on the device's label.
It is advisable for those importers who
have applied online for the model approval but still has not submitted the
samples to the Authorised Laboratory to submit the samples ASAP. Such Act of
non-submission will lead to rejection of the application under Legal Metrology,
and unknowingly the importers are handing over the smoking gun to the
Department to initiate legal action against themselves.
For further information or assistance, you
contact our Senior Associate Mr. Gaurav Gupta at +91 88518 81966 or mail him at
gauravg@compliancechambers.com
or you can reach us at:
Compliance Chambers
Advisory & Consulting
Address F-2 / 151, Sector - 11
Rohini, New Delhi | Pin Code 110085
Email Us at: info@compliancechambers.com,
Website: https://www.compliancechambers.com/
Manish Nama: +91 88007 22330
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