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DRDO is the Ministry of Defense's R&D department, Govt of India, with a vision to empower India with state-of-the-art weapons systems and a mission to achieve self-reliance on critical defense technology and systems, while equipping our armed forces with state-of-the-art weapons systems and equipment in accordance with the requirements of the three Services.
Today, DRDO is a network of over 50 laboratories dedicated to the development of defense technology covering different disciplines such as aeronautics, armaments, electronics, fighting vehicles, computer systems, instrumentation, missiles, advanced computing and simulation, special materials, naval systems, life sciences, research, information systems, and agriculture.
While the Indian healthcare system is grappling with the increasing demand for personal protective equipment (PPE) in the country, the Union Ministry of Health is facing a major challenge in testing and accrediting a huge quantity of PPE manufactured and imported into the country by only two approved laboratories – South India Textile Research Association (SITRA), Coimbatore & Development Establishment (DRDE), Gwalior.
Personal Protective Equipment (PPEs) are protective devices designed to protect workers' safety by reducing biological agent exposure. Goggles, face-shield, mask, gloves, coverall/gowns (with or without aprons), head cover, and shoe cover are components of PPE.
As per the guideline issued by the ministry of textile, the government of India related to implementing quality control mechanisms the test sample will now be accepted only on submission of a Notarized Affidavit by the authorized signatory of the intending firm as per the prescribed format, attached below.
Institute of Nuclear Medicine and Allied Sciences (INMAS), Delhi has been authorized for laboratory testing of Personal Protective Equipment (PPE) Body Coverall samples for COVID-19, submitted by prospective manufacturers in India. A laboratory test Synthetic Blood Penetration Resistance Test is conducted and a Test Report is issued for the same by INMAS.
Streamline the process of testing and endure that the quality of the PEE coveralls is maintained, it is proposed for testing and certification as per the following process:
➲ The testing Laboratory will accept the sample only on submission of a notarized affidavit by the authorized signatory of organization, intending to get their PEE coverall sample(s) tested in the approved laboratories as per prescribes format. The test sample is to be accepted for testing only after ascertaining that the declaration form is duly filled up and received through the official mail id. the affidavit is to be submitted original along with the test sample and also a scanned copy to be sent on e-mail id. The certificate will be sent on the email from the request was obtained.
➲ The UCC (unique certified code) should now form the basis for placement of orders by M/S HLL Lifecare for PEE coveralls. The test report is to be annexed to UCC only.
➲ The UCC may have a validity of a period of 6 months from the date of the issue.
➲ HLL lifecare is requested to take into cognizance the USSs issued and sent to the official e-mail id of the designated official of HLL, directly from the testing laboratory only.
➲ Until such time the look down is in force, the declaration may be made in a plane paper attested by the notary public. In such cases, the certification may be issued provisionally valid for one month's time. On submission of the notarized affidavit only, the certificate may be made regular.
Approvals for manufacturing of PEE and fabrics used in manufacturing them are given by Coimbatore based SITRA (an autonomous body under textile ministry) and the Gwalior-based DRDE (Defence Research & Development Establishment)
Eight laboratories have now been approved for testing PPE coveralls required for protection from COVID-19:
➲ SITRA (south India textile association), Coimbatore, Tamil Nadu
➲ DRDO-INMAS, New Delhi
➲ Heavy Vehicle Factory, Avadi, Chennai
➲ Small Arms Factory, Kanpur, Uttar Pradesh
➲ Ordnance Factory, Kanpur, Uttar Pradesh
➲ Ordnance Factory, Muradnagar, Uttar Pradesh
➲ Ordnance Factory, Ambernath, Maharastra
➲ Metal and Steel Factory, Inshapor, West Bengal
Process of obtaining UCC certification for PEE Kit:
➲ Pack your sample in seal pack container
➲ Prepare your affidavit as per the prescribed format
➲ Send or submit your sample kit and affidavit to the testing laboratory (physical submission/ courier) (in case of Institute of Nuclear Medicine & Allied Sciences (INMAS) lab send at INMAS, Delhi at reception office from 9 AM to 5:30 PM
➲ A scanned copy of Affidavit and manufacturing company/ product detail shall be sent to testing laboratory official mail id (in case of INMAS send at techcoord@inmas.drdo.in)
➲ Laboratory will test your sample kit and ask for the testing fees which can be submitted in DD form or as per other modes of fee submission asked by the laboratory)
➲ If the sample kit is manufactured as per the parameter and passes all the tests (like waterproof, fireproof, blood penetration etc) then the testing agency will issue a UCC certificate for that manufacturer which will be valid for 6 months.
Documents required for obtaining UCC certificate:
➲ Manufacturing unit detail
➲ Company registration number (certificate of incorporation, COI)
➲ Udyog Aadhar Number (MSME registration certificate)
➲ Declaration (declaring that they are manufacturer and not trader)
➲ Authorized person ID and address proof
➲ Business and Manufacturing unit Address proof
Call or WhatsApp us on +91-99991-39391 for free consultation from our team of experts. You can also email us on reach@corpzo.com.
We share the detailed and reasonable estimated costs, documents and prerequisites for the complete process before starting the process to ensure transparency.
Our team warrants hassle free documentation. We collect the necessary documents and share the relevant drafts to ensure a timely filing and delivery.
Upon collecting the necessary documents and information, we waste no time in preparation and filing of your application. development on your application is brought to your attention.
On successful completion of the case we share all the relevant documents electronically and physically along with an assurance to pay you back if something is wrong.
Regulation of medical devices and their quality systems in India was limited compared with other developed nations that typically have very robust approval systems for medical devices in place.
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