New NOC From CDSCO Zonal Offices Required for Export of Unapproved Or Banned Drugs

The Central Drugs Standard Control Organization (CDSCO) has announced a simplified process for obtaining No Objection Certificates (NOCs) for exporting unapproved, banned, or new drugs. Manufacturers shall obtain NOCs from CDSCO zonal offices through the online SUGAM portal (effective May 15th, 2024) before applying for a manufacturing license from state authorities.

Revamped Pharmaceuticals Technology Upgradation Assistance Scheme (RPTUAS)

This initiative seeks to upgrade the technological capabilities of the Indian pharmaceutical industry, aligning it with global standards. The revised guidelines aim to support the pharmaceutical industry’s upgradation to the Revised Schedule-M & WHO-GMP standards, thereby enhancing the quality and safety of pharmaceutical products manufactured in the country.

India Strengthens International Cooperation in Medical Product Regulation

The Union Cabinet has been apprised of Memorandums of Intent (MoIs) and Understanding (MoUs) signed between the Central Drugs Standard Control Organization (CDSCO) and regulatory bodies from the Netherlands, the Dominican Republic and the Republic of Ecuador. These agreements focus on cooperation in the field of Medical Products Regulation.

Free Registration of Pharmacists on Pradhan Mantri Jan Aushadhi Pariyojana Website

Pradhan Mantri Bhartiya Jan Aushadhi Pariyojana (PMBJP) is an initiative by the Department of Pharmaceuticals, Government of India. PMBI has started an initiative of registering pharmacists on its website. The aim of this exercise is to connect pharmacists with PACS employers and other applicants and to enable them to also become owners of PMBJK.

NPPA sets Retail Prices for 19 Formulations

Manufacturers of specific formulations categorized as “new drugs” under the Drug Price Control Order (DPCO), 2013 (DPCO, 2013) are required to set the retail price as indicated in this notification. Manufacturers can add Goods and Services Tax to the retail price only if they have already paid or are liable to pay the government on the mentioned retail price. Manufacturers must issue a price list in Form–V via IPDMS to the National Pharmaceutical Pricing Authority (NPPA) and submit copies to State Drug Controllers and dealers.

Scheme for Promotion of Research and Innovation in Pharma MedTech Sector

The primary objective of this initiative is to transition the Indian Pharma MedTech sector from a cost-based to an innovation-based growth model. This transformation aims to strengthen research infrastructure, foster industry-academia collaborations in priority areas, cultivate a culture of quality research, and nurture a pool of talented scientists.