How to get plastic EPR certificate?

Plastic is lightweight, flexible, impervious to moisture, and reasonably affordable. It is extensively used in industries and for a variety of household uses because of its special qualities. The use of plastic has increased recently, having a negative effect on both the environment and human health.

According to a recent report by the Indian government, 3.47 tonnes of plastic waste were created in India between 2019 and 2020. In response to the growing environmental problems, a number of strategies have been developed to handle the management of plastic waste. One effort by the Indian government to safeguard the environment from plastic waste is called EPR. To cut down on plastic waste, many regions of the globe have adopted Extended Producers Responsibility, or EPR.

Producers, importers, and brand owners are required by Extended Producers Responsibility (EPR) to recycle and dispose of plastic waste in a way that doesn't damage the environment. The Schedule II of the Fourth Amendment to the Plastic Waste Management Rules contains the specific EPR rules. The EPR standards must be followed by producers, importers, and brand owners. The Central Pollution Control Board (CPCB) has created an internet registration and strict compliance portal. The registration procedure has established specific requirements, which are listed below:

Plastic packaging materials covered by extended producer responsibility (EPR)

There are four distinct categories for plastic packaging. The Plastic Waste Processor must be used to process the plastic packaging on the inventory. (PWP). A PWP certificate will be given to PIBOs in order to help them reach the goal set by EPR if they follow the EPR recommendations.

rigid plastic container is one example.

2. Plastic packaging with a single layer of plastic or multiple layers of plastic are included in the second group.

3. Multilayer plastic packaging is included in the third group. In this scenario, one layer must be made of plastic while the remaining levels may be made of other substances but not plastic.

4. The fourth group includes all compostable plastic used in carry bags and for packaging purposes.

How to get CDSCO NOC for Medical Devices?

Notified medical instruments are classified as drugs under the 1940 Drugs and Cosmetic Act and Rules established in 1945. The surgical bandages, surgical staples, ligatures, surgical sutures, blood collection bags, blood component collection bags, and compounds used in-vitro and in surgical dressings are included in the sub-clause (i) of the Drugs and Cosmetic Act, 1940 and 1945.

The department of medical devices discharges the following roles:

This division of the CDSCO issues licenses to medical device manufacturers for use in conducting clinical investigations, tests, evaluations, and other reasons.

This medical devices division issues licenses to import medical devices for use in conducting clinical investigations, tests, evaluations, and other reasons.

. A clinical assessment of a brand-new in-vitro diagnostic medical instrument is also permitted.

It allows for the manufacture or importation of medical devices of a comparable type. This section grants approval to manufacturers or importers for the new in-vitro diagnostic medical device's sale or distribution.

The medical device section verifies the registration of candidates who have applied to the laboratory for testing medical devices.

It creates FAQs and directions on significant topics.

How to get CDSCO NOC for new drug manufacturing?

ule 122-E of the Drugs and Cosmetics Rules consider new drugs as drug. Rule 122-E also includes bulk drug substances or phytopharmaceutical drugs which means any drug that has not been used significantly and the same drug has been considered ineffective by the licensing authority (under Rule 21). Apart from these, derived drugs like vaccines and Recombinant DNA (r-DNA) and drugs with certain modifications such as dosage, indication and route of administration approved by licensing authority to be marketed are taken as drugs as per rule 21. A drug will be considered a new drug for 4 years from the date it is approved.

The effectiveness of a drug is necessary to check before it is marketed to ensure that the drug is safe for human use. The following rules govern the clinical trial of new drugs:

Rules Description 122-A Application to permit the import of new drug 122-B Application to approve manufacture of new drugs 122-DA Contains condition to get permission from DCG (I) to conduct a clinical trial of a new drug 122 DAB Guidelines to examine serious adverse event (SAE) and compensation in case of injury and death and other related trial cases. Rule 122 DAC Guidelines to follow Good Clinical Practices (GCP) and debarment of an applicant for not following the rules. Rule 122 E Contains the definition of new drugs Schedule Y Instructions to follow and requirements needed to conduct clinical trials and approval of new drugs

Role of New Drug Approval Division

- The department processes the application for New drugs. The application is reviewed in accordance with Schedule Y, Rule 122 A, 122 B, 122 DA, 122 DAB, 122 DAC and 122 E under Drugs & Cosmetics Rules 1945. - The department is given the duty to check the application thoroughly for clinical trials and Academic Clinical Trials (as per GSR 313 E dated 16th March 2016). - It reviews and deal with RTI and parliament questions. - Evaluation of (ICD), Investigational Medicinal Product Dossier (IMPD), Development Safety Update Reports (DSUR), Change in Principal Investigator, Information Brochure (IB),Clinical Trial Agreements, Ethics committee approval of PI sites, etc. - It monitors the safety of medical products that have been approved for marketing purposes on the basis of documents like PSURs, SAE reports, complaints received etc. - The department also deals with the application to update the prescribing data. - It is also responsible to process Signal Review Panel (PvPI-NCC, IPC) recommendations for vital Regulatory Action.

New Drugs Approval Procedure

The DCG(I) approves the application for a drug product or drug substance. The following processes are followed to approve drugs: - The applicant submits the application with the required fees. - The application then goes to preliminary evaluation. If any discrepancy is found the applicant is informed to resolve the issue. In case, no discrepancy is found the application is forwarded for Regulatory evaluation. - If the application is for CT (Clinical Trial) or BE (Bioequivalence) permission is granted and then the application is reviewed by the Subject Expert Committee (SEC). The application goes for NOC (No Objection Certificate), the report is reviewed and if the data is satisfactory, the site facility is inspected (if required) before the final approval. - But if the application is not for BE and CT, the application goes for review of CMC (Chemistry & Manufacturing Control) data and then forwarded for IPC testing and NOC (No Objection Certificate) is provided. IPC Test Report must comply before it goes for final approval. Before the application goes for final approval, if required, the site facility is inspected.