The Drugs (Amendment) Rules, 2022.
As per the amendment under rule 96(5) every active pharmaceutical ingredient (bulk drug) manufactured or imported in India shall bear Quick Response code on its label at each level packaging that store data or information readable with software application to facilitate tracking and tracing.
DoT notifies guidelines for grant of unified license.
The Unified License shall be issued on non-exclusive basis, for a period of 10 years. However depending on technological development and experience gathered, this duration of license may be reviewed after 3-4 years.
DGFT issues clarification regarding Steel Import Monitoring System (SIMS).
Based on the request, DGFT has clarified that the re-import of steel for packaging purposes will not be covered under SIMS as it is not primarily meant for value addition, rather being re-imported for packaging only.
The Medical Devices (Draft Amendment) Rules, 2021.
If the manufacturer or licensee fails to comply with any of the conditions of an import license, or any provisions of the Act and these rules, the Central Licensing Authority may after giving the manufacturer or licensee an opportunity to show cause why such an order should not be passed, by an order in writing stating the reasons therefor, cancel a license issued under rules, or suspend it for such period as it thinks fit either wholly or in respect of any of the part of medical device to which it relates.
Ministry of Finance notifies e-advance rulings Scheme, 2022.
The advance ruling mechanism is provided in the Income Tax Act to provide upfront clarity to non-residents and certain other specified taxpayers, regarding the taxability of their transactions in India under Indian I-T laws.
Delhi Goods and Services Tax (Eighth Amendment) Rules, 2021
The registered person who has been issued a certificate of registration shall, undergo authentication of the Aadhaar number of the proprietor, in the case of proprietorship firm, or of any partner, in the case of a partnership firm, or of the karta, in the case of a Hindu undivided family, or of the Managing Director or any whole time Director, in the case of a company, or of any of the Members of the Managing Committee of an Association of persons or body of individuals or a Society, or of the Trustee in the Board of Trustees, in the case of a Trust and in case of a proprietorship concern, the Permanent Account Number of the proprietor shall also be linked with the Aadhaar number of the proprietor.
Medical Devices (Amendment) Rules, 2022
The amendment provides that a provisional registration number shall be generated which will remain valid up to the 31st May, 2022 if the applicant submits, on or before the 28th February, 2022, an undertaking that applicant shall obtain the ISO 13485 certificate on or before the 31st May, 2022 in lieu of certificate of compliance
Revised criteria to receive sums from MSME fund
Beneficiary of this fund cannot claim benefits from any other Scheme or programme of Central Government
or any State Government or Union territory Administration for that project or scheme or activity.
Ministry of MSME extends relaxation period for Udyam Registration
All existing enterprises registered under EM–Part-II or UAM shall register again on the Udyam Registration portal on or after the 1st day of July, 2020. The existing enterprises registered prior to 30th June, 2020, shall continue to be valid only for a period up to the 31st day of March, 2022.
FSSAI operationalizes draft Food Safety and Standards(Packaging) amendment Regulations, 2022
Carry bags maybe used for packaging food products as and when standards and guidelines are framed from food authority. They shall also comply with national standards for plastic.
